CONTACT US 2,423 1,727 2.2% 319 14,517 Margin (% of net sales)² EBITDA pre² -696 Margin (% of net sales)² Margin (% of net sales)² Operating result (EBIT)² Net sales in % Change € million 2017 EBITDA² -28.7% 11.6% 16.7% 2,615 3,396 Earnings per share pre (€)² Earnings per share (€) Profit after tax 29.3% 25.6% -10.5% -446 4,246 3,800 28.7% 23.8% -15.3% -636 4,164 3,528 2018 781 € million MERCK GROUP 1668 Since pushing boundaries and making new discoveries. countries share a passion for 66 Employees in hearts at Merck beat for science. the name Merck has stood for Around 52,000 € 2.2 BILLION Merck do. ... is at the heart of every- thing we Merck ANNUAL REPORT 2018 science invested in research and development in 2018. the positive power of science. MERCK ANNUAL REPORT 2018 FINANCES Key Figures for 2018 Chairman of the Executive Board and CEO STEFAN OSCHMANN benefit us all." logical advantages possible that make techno- entrepreneurship and responsible exploration scientific "We believe that annualreport/2018 www.merckgroup.com/en/ You can find out what else makes our research hearts beat faster at Online MAGAZINE SCIENCE Key figures¹ 7.76 14,836 1.77 June 20 years of Merck 350 + 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 May 3 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. Merck sells Consumer Health April 19 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. February 21 Highlights of 2018 HIGHLIGHTS OF 2018 4 Performance Materials Science Healthcare 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. Life June 20 June 20 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 6 5.99 U- 5 HIGHLIGHTS OF 2018 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. 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. Merck 中国 ² Not defined by International Financial Reporting Standards (IFRSS). 14,517 2017¹ • 14,836 2018¹- € million Net sales MERCK GROUP 2 Not defined by International Financial Reporting Standard (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. -685 -21.4% 2,508 Business free cash flow² 29.9% 29.5% -13.9% -0.82 5.92 5.10 Business Sectors 2016 15,024 3,193 12,845 1 Excluding the Consumer Health business divested in fiscal 2018. Key figure for fiscal 2017 adjusted. 2015 3,388 2014 — 3,630 2015 4,490 2016 4,246 - 3,800 2018¹- 2014 € million MERCK GROUP EBITDA pre² 11,363 2017¹- 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. VALUING CULTURAL DIVERSITY People at Merck Fundamental Information about the Group Combined Management 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. 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. 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. 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. 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. 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. 92 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. A HOLISTIC RECRUITMENT APPROACH 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. 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. 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. 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. Furthering and asking more of talent 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. 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 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. Combined Management Report. Driving innovation through curious people — People at Merck Fundamental Information about the Group 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. 1,153 — People at Merck Asia-Pacific (APAC) 10,486 93 Semiconductor Solutions The technology area of gas-phase deposition materials (such as atomic layer deposition, ALD) is an area with high growth rates for our Semiconductor Solutions business unit. Thanks to increased research activities in collaboration with original equipment manufac- turers and chip producers, we are steadily improving our positioning. Our research projects seek to identify new materials for metallization processes with low resistance and various dielectric characteristics for faster and better processors, servers and data storage density. 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. 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. 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. Surface Solutions 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. Combined Management Report. Fundamental Information about the Group 91 People at Merck "Bring Your Curiosity to Life" - our promise as an employer describes how we at Merck collaborate, how we advance our business, how our employees can develop within the company and who we are. Our development into a global science and technology company over the past 350 years would not have been possible without the passion, creativity and curiosity of our employees. And we are certain that our current and future employees safeguard our economic success. They create innovations for patients and customers, and secure our ability to compete. For this reason, the development of all our employ- ees is such an important concern to us. In short, we are working to create an environment where people are able to develop and to reach their full potential. - 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. OVERVIEW OF OUR HEADCOUNT FIGURES 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 DISTRIBUTION OF EMPLOYEES by region 21% North America 10,978 50% Europe 25,792 0 6% Latin America 3,340 20% 2% Middle East and Africa (MEA) 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. 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. TARGETED ADVANCED TRAINING AND MAXIMIZING PERFORMANCE CAPABILITY 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 REWARD SYSTEM At Merck, we reward the performance of every individual through appropriate and competitive total compensation. For years, we have been achieving this through global processes and programs that are supported by digital platforms. We also offer our managers flexible, market- and needs-oriented compensation tools. These support well-informed decisions and thus provide comprehensible, 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 ⚫ Health and well-being and Latin America, for example. Moreover, in 2018 we ran the "Managerial Foundation Program" (MFP) for new people managers in 20 countries with 795 participants. The "Advanced Management Program" (AMP) for experienced leaders ("managers of managers") builds on the MFP and was attended by 242 people managers in five countries. For the top management we also offer a "Global Leader- ship Program" (GLP). This program addresses issues such as lead- ership culture and prepares participants for the leadership challenges of tomorrow. Since 2016, 678 leaders have participated in the GLP. In 2018, we once again expanded our workforce pool to internally fill management positions when they become vacant. In 2018 once again, most management position vacancies were filled by internal candidates. In addition, we recruited highly qualified external exec- utives in order to add new perspectives to our long-standing in-house expertise. • Service offers 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. The results are used to identify strategic focus areas and they feed into the company-wide work on an ongoing basis. 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. 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. 95 — People at Merck Fundamental Information about the Group 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. 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 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. 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. 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. 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. Building empowered leaders 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. 94 Combined Management Report Fundamental Information about the Group People at Merck STRATEGIC COMPETENCY DEVELOPMENT A transparent competency model is a further pillar of our personnel development efforts. Managers and employees should show strategic competence by being purposeful, future-oriented, innovative, results- driven, collaborative and empowering. By demonstrating these qual- ities, our 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 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. 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. 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. MANAGEMENT PROGRAMS FOR EXECUTIVES 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 Combined Management Report. Since 2016, we have also been working on a specially developed program to help refugees enter the job market. As part of the "Inte- grating refugees through training" program, a further group of twelve young people who were forced to flee their home countries started language, technical, cultural, and career-related training to prepare them for vocational training and thus for the labor market. Our 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 Fundamental Information about the Group _ Research and Development 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. Psoriasis Phase II5 Osteoarthritis Phase I Immunology Phase I Malaria Phase I 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. 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. 2 Avelumab in combination with talazoparib. 3 Avelumab combination studies with talazoparib, axitinib, ALK inhibitors, chemotherapy or novel immunotherapies. Phase II 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. Akt APRIL ATM ATR BLYS BTK IgA IL mAb MetAP2 PD-L1 PeEF2 ADAMTS-5 PK Systemic lupus erythematosus Rheumatoid arthritis Combined Management Report Fundamental Information about the Group _ Research and Development 87 BIOPHARMA PIPELINE as of December 31, 2018 Therapeutic area Compound Immunology Sprifermin (fibroblast growth factor 18). Atacicept (anti-BLYS/anti-APRIL fusion protein) Atacicept (anti-BLYS/anti-APRIL fusion protein) Evobrutinib (BTK inhibitor) Phase II Evobrutinib (BTK inhibitor) M6495 (anti-ADAMTS-5 nanobody) M5049 (immune receptor inhibitor) General Medicine M5717 (PeEF2 inhibitor) Indication Status Osteoarthritis 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. Systemic lupus erythematosus Phase II IgA nephropathy Phase II M1095 (ALX-0761, anti-IL-17 A/F nanobody) TGFB Phase II A proliferation-inducing ligand 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. 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 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. 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. An expanded portfolio to benefit our customers 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. 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. Combined Management Report Fundamental Information about the Group _ Research and Development 89 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. 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. Partnerships and agreements to broaden our reach 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. 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%. Recognized for award-winning innovation 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. 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. 90 Combined Management Report Fundamental Information about the Group _ Research and Development Performance Materials 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. 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. Display Solutions A disintegrin and metalloproteinase with thrombospondin motifs Protein kinase B 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. 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. 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 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. Ataxia Telangiectasia Mutated kinase 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. Ataxia Telangiectasia and Rad3-related kinase B-lymphocyte stimulator Bruton's tyrosine kinase Immunoglobulin A Interleukin Methionine aminopeptidase 2 Programmed cell death ligand 1 Plasmodium eukaryotic elongation factor 2 Protein kinase Transforming growth factor ẞ 88 Monoclonal antibody • • Meet customer needs Combined Management Report • Partner with the global scientific community Invest in new and disruptive technologies for the long term Improve and expand our portfolio • 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. In 2018, we continued to focus on delivering the promise of accelerating access to health for people everywhere. We launched nearly 13,000 products, including nearly 6,000 chemicals, while aim- ing to: Across our three Life Science business units of Research Solutions, Process Solutions and Applied Solutions, our R&D teams are dedi- cated to finding innovative solutions to our customers' toughest chal- lenges. In our Life Science business sector, we invest significantly in R&D, with more than 1,750 employees working in various R&D func- tions around the world. Life Science Allergopharma, our allergy business, is one of the leading manufac- turers of diagnostics and prescription drugs for allergen immuno- therapy. As experts, we are determined to fully understand allergies as well as be able to discover new solutions and therapeutic concepts. In close cooperation with research institutions and other partners throughout the world, we gain valuable insights regarding the com- plex immunological mechanisms responsible for allergy development. And we pursue new paths in developing innovative treatments. Thus, we want to create the best conditions today for the next generation of products for optimally taking care of patients suffering from allergies. Allergopharma 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 Business free cash flow 3,193 EPS pre 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 € 5.92 EBITDA pre 4,246 Q1/2018 plant and equipment, as well as digitalization initiatives, higher inven- Ongoing adjustment processes in the Liquid Crystals business that will not be offset despite the enhanced diversification of Performance Materials and active cost management Moderately negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets Low double-digit percentage decline Lower EBITDA pre and investments in property, tories due to changes in the product mix and volume growth 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 Forecasts for 2018 in the interim report: business sector Net sales 14,517 Corporate and Other Forecast for 2018 in the 2017 Annual Report¹ For Life Science we had expected organic EBITDA pre growth to be similarly dynamic as in 2017 at around +8% due to the expected Q2/2018 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. Performance Materials 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. 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. BUSINESS FREE CASH FLOW 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. 106 Combined Management Report Report on Economic Position Review of Forecast against Actual Business Developments MERCK GROUP Actual results 2017 in € million Main comments Q3/2018 (-10.5%: in € million ~2,340 to 2,630 € 5.00 to € 5.30 Exchange rate effect - 8% to -10% 3,800 2,508 -21.4% 5.10 -13.9% -1.6% Organic, 0.0% Portfolio, 0.0% Portfolio, -3.9% Currency) 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. -8.9% Currency) 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%. ~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% Organic growth + 3% to +5% Exchange rate effect -4% to -6% ~15,000 to 15,500 (excluding Consumer Health ~14,000 to 14,500) Organic decline -1% to -3% vs. 2017 Exchange rate effect -5% to -7% ~3,950 to 4,150 (excluding Consumer Health ~ 2,460 to 2,770 EPS pre € 5.30 to € 5.65 (excluding Consumer (excluding Consumer Health Results 2018 ~ 2,310 to 2,620) € 5.00 to € 5.40) ~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 ~2,380 to 2,670 € 5.00 to € 5.40 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 Health business Healthcare Life Science EBITDA PRE 4.7% 4.6% 4.8% Men 10.6% 10.7% 12.5% global, total 14.7% 14.5% 14.5% global, total 62.5% 62.1% 61.1% global, total 22.8% 23.4% 24.4% 41.3 41.4 41.7 Asia-Pacific (APAC) global, total 5,698 5,267 4,507 32.3%5 in Germany 28.7%³ 29.7%³ 30.9%5 global, total 5.7%³ 6.0% 3,4 6.5%5 Percentage of executives who are not German citizens 36.7 64.7%³ 63.6%5 Number of nationalities 703 653 705 576 588 604 5.1% 4.4% 4.1% 64.4%³ 36.9 36.9 Europe 4 Ratio adjusted retrospectively. 5 Not including the Sigma-Aldrich legal entity in Steinheim (Germany) or Allergopharma. 98 Combined Management Report Fundamental Information about the Group People at Merck REPORT ON ECONOMIC POSITION 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. REPORT ON ECONOMIC POSITION 101 Macroeconomic and Sector-Specific Environment 3 Not including Sigma-Aldrich legal entities in Germany or Allergopharma. 104 111 Course of Business and Economic Position Merck Group Healthcare Life Science Performance Materials Corporate and Other Combined Management Report Report on Economic Position Macroeconomic and Sector-Specific Environment 101 Review of Forecast against Actual Business Developments 30.3%³ 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. 14.5 42.4 42.5 42.8 Latin America 39.9 40.3 40.4 Middle East and Africa (MEA) 39.3 39.4 39.2 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. North America 44.1 44.1 Germany global, total 42.9 43.0 43.3 9.9 9.8 10.0 14.2 14.0 44.3 28.8%³ 38.9% 39.1% Merck (overall) Dec. 31, 2018² global, total 50,414 52,941 51,749 Asia-Pacific (APAC) 10,754 11,294 10,486 Europe 24,438 Merck (overall) Dec. 31, 2017 25,980 by region Latin America 4,140 4,050 3,340 Middle East and Africa (MEA) 1,045 1,097 1,153 North America 25,792 10,037 Merck (overall) Dec. 31, 2016 Average length of service Combined Management Report. Fundamental Information about the Group — People at Merck 97 OVERVIEW OF EMPLOYEE FIGURES¹ Number of employees Number of employees (FTE - full-time equivalents) Number of countries Number of legal entities Number of nationalities Number of nationalities working in Germany Average length of service in Germany Percentage of employees with German citizenship Percentage of employees working outside Germany Percentage of employees with global managers Percentage of women in leadership positions (= role 4 or higher) global, total in Germany global, total Percentage of executives (= role 4 or higher) Number of employees in vocational training in Germany Vocational training rate Number of employees in the "mywork@merck" model (Germany) Percentage of employees working part-time Percentage of employees aged 17-29 years Percentage of employees aged 30-49 years Percentage of employees aged 50+ Average age globally Average age by region Percentage of women in the workforce Report on Economic Position Macroeconomic and Sector-Specific Environment 10,520 global, total global, total global, total 215 217 207 129 131 136 91 97 95 66 23.1% 24.1% 75.3% 74.9% 73.9% 9.7% 10.2% 10.6% 42.8% 43.1% 44.0% 38.6% 23.2% 10,978 66 10,959.6 49,652.7 52,223.5 51,039.8 Asia-Pacific (APAC) 10,725.3 11,272.1 10,462.9 Europe 23,727.1 25,302.5 25,126.8 66 by region 4,136.5 4,046.2 3,339.5 Middle East and Africa (MEA) 1,041.8 1,096.1 1,151.1 North America 10,022.0 10,506.7 Latin America 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. 99-136 (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%). HEALTHCARE 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%). 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 € 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. 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%). Combined Management Report Report on Economic Position Macroeconomic and Sector-Specific Environment 103 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, 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. 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. 4 Growth of display area is a pure volume indicator, which is counteracted by a negative price momentum. 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 PERFORMANCE MATERIALS 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. 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 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%. 104 Combined Management Report 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. 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. Due to this portfolio change, the following analysis reflects the new structure of the Merck Group: it takes the Consumer Health business into account as "discontinued operation". For 2018, we had forecast moderate organic net sales growth for the Merck Group. In the second half of 2018, Merck recorded more dynamic sales growth in all business sectors than expected at the start of the year; this means that for 2018 as a whole we realized a strong organic rise in net sales of +6.1%, thereby slightly exceeding our forecast. 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. 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. 2.2% 0.0% 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% Growth of wafer area for semiconductor chips Growth of LC display surface area Global sales of cosmetics and care products Development Development 2018¹ 2017 4.8% 2.7% 2.6% 7.4% 9.7% 9.2% 9.2% 7.4% 5.1% -0.7% 3.6% 3.4% 27.9% 25.9% 7.6% 10.0% 8.6% 6.0% 3.3% 3.5% Global automobile sales volumes Due to the emerging unfavorable development of the exchange rate between the euro and the U.S. dollar and various currencies in 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. NET SALES 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 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 Combined Management Report. 102 Report on Economic Position 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 Life Science 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 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. Performance Materials For our Life Science business sector, at the beginning of the year we had forecast solid organic sales growth, slightly above expected medium-term market growth of around +4% per year. The business sector achieved very strong organic growth of +8.8% in 2018. This means that it exceeded the top end of our forecast of between + 7% and +8% that we had raised in our report on the third quarter of 2018, thanks to the very positive organic sales development in the fourth quarter of 2018. As expected, Process Solutions was the most dynamic business unit, delivering the largest contribution to organic sales growth within Life Science. As expected, Applied Solutions and Research Solutions also contributed positively to the organic sales performance, albeit to a significantly lesser extent than Process Solutions. 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 -1.7% 2,406 14,836 16% 100% 1.7% In contrast, expected currency hedging gains should have a compensating effect in 2018 6.1% -3.4% -3.9% Q2/2018 ~ 360 to 320 ~ 500 to 450 ~ 400 to -360 40% Q1/2018 EBITDA² Margin (% of net sales)² Operating result (EBIT)² Net sales € million Change Key figures¹ MERCK GROUP • Net financial liabilities reduced by -33.9% to € 6.7 billion (Decem- ber 31, 2017: € 10.1 billion) • Decrease in business free cash flow to € 2.5 billion (2017: € 3.2 bil- lion) Earnings per share pre declined to € 5.10 (2017: € 5.92) ~ 400 to 360 • 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% ~ 490 to -440 ~-500 to -550 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. -381 30.6% • 5,882 -4.3% -3.6% 2,615 781 29.9% Earnings per share (€) 7.76 5.99 1.77 29.5% Earnings per share pre (€)² Business free cash flow² 5.10 2,508 5.92 3,396 -0.82 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). DEVELOPMENT OF NET SALES AND RESULTS OF OPERATIONS 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. 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. 112 Combined Management Report Report on Economic Position -13.9% 29.3% 25.6% -10.5% Margin (% of net sales)² EBITDA pre² Margin (% of net sales)² Profit after tax 2018 2017 € million in % 14,836 14,517 319 2.2% 1,727 2,423 -696 -28.7% 11.6% 16.7% 3,528 4,164 -636 -15.3% 23.8% 28.7% 3,800 4,246 -446 Merck Group The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: MERCK GROUP Net sales and organic growth¹ by quarter²,3 MERCK GROUP Net sales by business sector¹ € million Healthcare Life Science Performance Materials Merck Group 42% Healthcare 6,246 2018 Share Organic growth² Exchange rate effects Acquisitions/ divestments Total change 2017 Share 6,246 42% 5.2% 0.9% 6,190 43% 6,185 42% 8.8% Life Science 6,185 5.2% 42% Performance Materials € million/organic growth in % Q1 2018 3,486 2017 3,657 % - -3.2% Q2 Q3 Q4 3,714 3,749 3,888 3,695 3,517 3,648 5.2% 8.8% 7.2% 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. 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. MERCK GROUP Net sales by business sector - 2018 € million/% of net sales 16% 2,406 Forecasts for 2018 in the interim report: Business free cash flow 2017 Annual Report¹ Combined Management Report 108 -22.0% 1,025 ~1,030 to 1,110 ~1,060 to 1,140 (excluding Consumer Health ~1,000 to 1,080) ~1,140 to 1,240 Increase in working capital due to product mix effects Decline in EBITDA pre Single-digit percentage decline -10.7% Currency) 0.0% Portfolio, -1.6% Organic, (-12.2%: 1,556 -9% to -11% Report on Economic Position exchange effect Review of Forecast against Actual Business Developments Actual results 2017 Business free cash flow 1,402 Negative foreign exchange effect, particularly owing to the development of the U.S. dollar 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 No significant portfolio effect from the acquisition of Natrix Separations Negative foreign exchange effect, particularly owing to the development of the U.S. dollar albeit to a smaller extent Research Solutions will also contribute positively to organic sales development, Process Solutions is likely to remain the strongest growth driver, followed by Applied Solutions Solid organic growth, slightly above expected market growth Moderately negative foreign exchange effect Organic earnings growth with a similar EBITDA pre 1,786 5,882 Net sales Main comments Forecast for 2018 in the 2017 Annual Report¹ in € million LIFE SCIENCE Significantly negative foreign ~1,540 to 1,600 Organic decline of -1% to -2% Organic decline of -1% to -2% Exchange rate effect -5% to -7% Negative foreign exchange effect, driven primarily by the exchange rate of the U.S. dollar and currencies of various growth markets Continued price pressure in Europe and also in the Asia-Pacific as well as Middle East and Africa regions BavencioⓇ and MavencladⓇ will contribute visibly to sales growth Solid organic growth of our Consumer Health business Moderately negative exchange rate effect Organic sales growth in growth markets will compensate for the organic decline in RebifⓇ sales, which is expected to be in the high single-digit percentage range Moderate organic growth 1,314 2,446 EBITDA pre 1,773 Net sales 6,190 Main comments Forecast for 2018 in the 2017 Annual Report¹ in € million Actual results 2017 HEALTHCARE 107 Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report Continued high investments in research and development as well as in market- ing and sales; absence of positive one- time effects from the previous year Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies of various growth markets Forecasts for 2018 in the interim report: ~1,580 to 1,650 (excluding Consumer Health ~1,580 to 1,650) ~1,770 to 1,830 Organic decline of -1% to -2% Exchange rate effect -5% to -7% 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. 0.0% Portfolio, -4.3% Currency) +5.2% Organic, 6,246 (+0.9%: Slightly below the prior-year level Moderately negative foreign exchange effect -4% to -6% Moderately negative foreign exchange effect -4% to -6% Moderate organic growth +3% to +5% Moderate organic growth Moderately negative foreign exchange effect in € million Results 2018 Q3/2018 Q2/2018 Q1/2018 Solid organic growth +4% to +5% Improved EBITDA pre Higher inventories reflect the expected sales growth and changed product mix Forecasts for 2018 in the interim report: +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 Double-digit percentage decline Negative foreign exchange effect, particularly owing to the development of the U.S. dollar and currencies in key Asian markets 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 Volume increase in all businesses; strong dynamics particularly in Advanced Technologies and IC Materials Market share adjustment and price decline in the Liquid Crystals business Negative exchange rate effect, especially due to the forecast development of the U.S. dollar and currencies in key Asian markets Main comments 0.0% Portfolio, -3.4% Currency) ¹The 2018 forecast in the 2017 Annual Report included the Consumer Health business. Organic decline -14% to -16% vs. 2017 Exchange rate effect - 8% to -10% ~ 480 to 550 Forecast for 2018 in the Actual results 2017 in € million Business free cash flow -429 EBITDA pre -292 CORPORATE AND OTHER Review of Forecast against Actual Business Developments Report on Economic Position Combined Management Report Organically slightly to moderately below the year-earlier level Moderately negative foreign exchange effect 110 -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% 588 -35.1% Main comments 2017 Annual Report¹ 906 ~1,820 to 1,870 Organic growth at around the previous year's level of +8% Exchange rate effect -4% to -6% 1The 2018 forecast in the 2017 Annual Report included the Consumer Health business. 0.0% Portfolio, -3.6% Currency) +8.8% Organic, 6,185 (+5.2%: Moderately negative foreign exchange effect -3% to -5% Organic growth +7% to +8%, considerably above medium-term average market growth of 4% p.a. Moderately negative foreign exchange effect -3% to -5% Organic growth of +5% to +6%, slightly above medium-term average market growth of 4% p.a. Moderately negative foreign exchange effect 4% p.a. Organic growth slightly above the medium-term market average of Results 2018 in € million Q3/2018 Q2/2018 Q1/2018 ~1,830 to 1,880 Organic growth of around +8% Exchange rate effect -3% to -5% ~1,830 to 1,880 Organic growth of around +8% Exchange rate effect -3% to -5% ~1,310 to 1,400 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 Forecast for 2018 in the Report on Economic Position -3.9% Currency) 0.0% Portfolio, +7.0% Organic, -0.7% 1,393 1,840 (+3.0%: ~1,300 to 1,390 ~1,310 to 1,400 Combined Management Report 17% -1.5% 14,517 13,764 -1.8% -513 in % € million in % 79.1% 28,166 € million Other intangible assets in % 75.0% € million Change Dec. 31,2017 Dec. 31, 2018 Goodwill of which: Non-current assets Balance sheet structure 27,652 7,237 Property, plant and equipment 4,811 of which: Current liabilities Other non-current liabilities Non-current financial liabilities Other non-current provisions Provisions for pensions and other post-employment benefits of which: Non-current liabilities Equity Total assets Cash and cash equivalents Other current assets Current financial assets Trade accounts receivable Inventories of which: Current assets 1,840 Other non-current assets MERCK GROUP Current provisions¹ Merck Group Combined Management Report 1,066 950 Q4 Q3 963 920 Q2 -19.1% % 1,023 1,195 967 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 2017 962 -13.7% -5.9% 116 2 Not presented: Decline in Group EBITDA pre by € - 381 million due to Corporate and Other. Healthcare 1,556 37% 1 Not defined by International Financial Reporting Standards (IFRSS). Life Science 1,840 44% 786 Performance Materials 19% € million/in % business sector² - 2018 EBITDA pre¹ by 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% Report on Economic Position Merck Group Trade accounts payable/Refund liabilities Total equity and liabilities -117 24.2% 8,635 23.1% 8,517 -502 -1,352 -7 -1.4% 80 8,033 788 2,257 1,340 6,681 780 2,336 -13.8% 1,842 600 2,215 2,238 2.2% 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 43 143 -576 100.0% 35,621 3,191 2,195 2,790 457 100.0% 36,888 3,464 -1,782 Other current liabilities¹ 36.3% 30.2% 2,170 1,345 24 2,931 2,764 23.9% 1,781 20.9% 2,632 7,455 9,236 299 85 -1,080 183 1,755 4,512 8,317 13,582 25.0% 133 2,923 8 11,138 22.5% 3,167 39.5% 14,066 46.7% 17,233 3.6% 1,267 100.0% 35,621 100.0% 36,888 1,582 589 124 1,221 -66 90 12,919 Report on Economic Position Current financial liabilities 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". 4% 14,517 544 2.2% -2.9% -3.9% 2.9% 6.1% 4% 100% 544 14,836 100% Merck Group Middle East and 7% 996 -4.6% -14.8% 10.2% 6% 950 Africa (MEA) 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). The consolidated income statement of the Merck Group is as follows: 6.1% -311 2.2% in % € million 319 100.0% -34.9% 65.1% 14,517 -5,071 9,446 in % 2017 in % 100.0% -36.3% 63.7% 14,836 -5,382 9,454 2018 Change Gross profit Cost of sales Net sales € million Consolidated Income Statement¹ MERCK GROUP 33% 8 4,761 -3.5% effects Exchange rate Organic growth² Share 2018 € million Net sales by region¹ MERCK GROUP Acquisitions/ divestments performance: 113 Merck Group 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. Combined Management Report 100% In 2018, the Merck Group recorded the following regional sales Total change 2017 Share 7.8% 33% 4,965 Asia-Pacific (APAC) 26% 3,810 0.2% -4.5% 4.7% 26% 3,818 North America 30% 4,406 3.5% 4.9% 31% 4,559 Europe 4.3% 0.1% Latin America Marketing and selling expenses 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. > 100.0% -12 769 -0.1% 17.9% -10 2,605 -0.2% 22.7% -22 3,374 Net income 2 Not defined by International Financial Reporting Standards (IFRSS). Non-controlling interests > 100.0% -57.3% > 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 29.9% 114 Combined Management Report Report on Economic Position 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). 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. 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 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. 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%). Merck Group 2,303 7.4% 29.5% -29.5% -6.7% -117 -14.5% 2.3% 10.5% -95 -6.2% 0.8% -35 -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 1,093 -4,384 -993 5.6% -458 -30.0% Administration expenses -2.5% > 100.0% Profit after tax from discontinued operation Profit after tax Profit after tax from continuing operations Income tax -9.6% -31.4% 28 -668 -2.0% 14.7% -294 2,129 9.8% -368 -1.8% -266 Profit before income tax Financial result -28.7% -696 1,461 16.7% 62 48 Africa (MEA) Middle East and -10.2% Asia-Pacific (APAC) 12 North America 920 -5.0% 64% Latin America -3.5% 4% 1% 3% € million 816 437 255 71 28% 4.3% 100% 6,190 -11.7% 100% 54 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). Combined Management Report Report on Economic Position Healthcare 123 HEALTHCARE Sales and organic growth¹ of Rebif® and ErbituxⓇ by region - 2018 Total € million 1,438 Europe 395 Rebif® Organic growth¹ in % -6.5% % of sales ErbituxⓇ 1,494 0.4% 2017 Share Europe 2,203 35% 4.6% -2.2% 2.4% 2,152 35% North America 1,432 23% 0.1% -4.2% -4.1% Asia-Pacific (APAC) 24% 0.9% Total change Organic growth¹ in % Exchange rate Acquisitions/ divestments Organic growth² -0.8% % of sales 100% 53% -0.3% 31% 8.7% 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 effects -4.3% Neurology & Immunology 4% > 100.0% 5 0% Fertility 1,162 19% 11.1% -5.0% 6.2% 1,094 18% of which: Gonal-f® 708 11% 5.3% -4.8% 0.5% 704 11% -33.3% General Medicine & > 100.0% 90 1,501 21 0% 1,529 24% -1.1% -4.2% -5.4% 1,616 26% of which: RebifⓇ 1,438 23% -6.5% -4.1% -10.7% 1,611 26% of which: MavencladⓇ 1% 5.2% Endocrinology 38% Other Healthcare 363 6% 1.9% - 3.8% -1.9% 370 6% 234 4% -3.1% -6.3% -9.4% 259 4% 270 6,246 4% 100% 226 of which: SaizenⓇ 2,341 of which: Euthyrox® 444 5.8% -4.4% 1.5% 2,308 37% of which: GlucophageⓇ 733 12% 15.1% -4.4% 10.7% 662 11% of which: ConcorⓇ 475 8% 11.2% -4.5% 6.7% 7% 24% € million -217 -3.1% -316 16 1,773 28.6% -5 -31.9% -9 -34.5% 342 > 100% -8 -51.0% -217 -12.2% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). Gross profit of the Healthcare business sector was weighed down by foreign exchange rate effects in 2018. At € 4,820 million (2017: € 4,850 million) it remained flat, resulting in a gross margin of 77.2% (2017: 78.4%). The decrease in marketing and selling expenses was due mainly to foreign exchange effects. Research and development costs reflected continued investments in the Biopharma development pipe- line and amounted to € 1,686 million (2017: € 1,600 million). The decline in other operating expenses and income was due to multiple factors in both 2018 and 2017. Thus the 2017 figure included the gain on the divestment of the Biosimilars business amounting to € 319 million, which was adjusted when calculating EBITDA pre. The previous year's figures also included milestone payments for the approval of Bavencio® (€ 124 million) as well as income from an agreement on a one-time payment for future license payments (€ 116 million). The year 2018 included receipt of a milestone pay- ment of € 50 million from BioMarin Pharmaceutical Inc., United 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. 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%). 27 Combined Management Report 17 1,556 -605 -67.6% -45.3% 761 12.2% 691 11.2% (11) (-51) 69 (63) 1,492 23.9% 2,028 32.8% -536 10.0% (>100%) -26.4% 12 18 26 8 24.9% 21.6% Report on Economic Position 125 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. DEVELOPMENT OF BUSINESS FREE CASH FLOW In 2018, business free cash flow amounted to € 1,025 million (2017: € 1,314 million). The decline was primarily attributable to lower EBITDA pre and a rise in receivables. HEALTHCARE Business free cash flow¹,2 € million EBITDA pre² Change 2018 2017 1,556 1,773 > 100.0% in % -12.2% Investments in property, plant and equipment, software as well as advance payments for intangible assets 1 Not defined by International Financial Reporting Standards (IFRSS). Healthcare 22.1% 339 The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: HEALTHCARE EBITDA pre¹ and change by quarter²,3 € million/change in % Q1 2018 381 2017 586 % -34.9% Q2 379 450 -16.0% Q3 Q4 381 414 397 -3.9% 8.7% 1,337 731 100% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 124 Combined Management Report Report on Economic Position Healthcare The results of operations developed as follows: HEALTHCARE Results of operations¹ € million Net sales Cost of sales Gross profit Marketing and selling expenses Administration expenses Research and development costs Remaining operating expenses and income Operating result (EBIT)² 7% Depreciation/amortization/impairment losses/reversals 6,190 0.9% 5.6% 1,421 23% Latin America 661 11% 10.9% -14.5% -3.7% 687 11% Middle East and Africa (MEA) Healthcare 448 6,246 7% 100% 5.9% 5.2% -3.2% -4.3% 2.8% 436 11.7% of impairment losses EBITDA² -37.4% -4.8% -2,373 -271 -38.3% 34 -1.4% -4.4% - 30 11.0% -1,686 -27.0% -1,600 - 25.8% -86 5.4% 237 3.8% 731 11.8% -494 -2,339 - 301 (of which: adjustments) -0.6% 78.4% 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 in % 56 0.9% - 21.6% -85 6.4% 4,850 -30 -10.8% 20% 1% 19 10,144 118 Combined Management Report Report on Economic Position Merck Group 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 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: MERCK GROUP Free cash flow¹ Change € million 2018 2017 Cash flow from operating activities according to the cash flow statement 2,219 2,696 € million -477 in % -17.7% 6,701 Payments for investments in intangible assets -167 -1,433 - 3,129 -17.8% 2,170 24 589 90 1,582 > 100.0% 6,701 10,144 -66 -3,443 -72.9% -33.9% 2018 2017 10,144 11,513 126 -429 768 624 17 -1,301 93 -1,928 -106 286 Q1 2018 718 2017. 747 % -3.8% Q2 514 Q3 711 1,006 890 -48.9% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. -20.1% Q4 565 2.7% Business free cash flow¹ and change by quarter² € million/change in % -392 MERCK GROUP 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". -72.9% Payments from the disposal of intangible assets 67 4 62 > 100.0% 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% The distribution of business free cash flow across the individual quar- ters and the percentage changes in comparison with 2017 were as follows: 550 10,823 11.4% 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. Change Dec. 31, 2018 2,931 Dec. 31, 2017 2,923 less: € million Financial liabilities Liabilities from derivatives (financial transactions) Combined Management Report Report on Economic Position Merck Group 117 € million Trade accounts receivable Receivables from royalties and licenses Inventories Trade accounts payable/Refund liabilities Working capital¹ 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 Liabilities to related parties Loans from third parties and other financial liabilities Finance lease liabilities 8,896 in % 0.3% in % -11.3% 620 1,653 -1,034 -62.5% 824 767 57 7.4% 72 73 -1 -1.4% 90 113 -23 -20.6% 4 4 -927 8 8,213 € million 29 28 1 1.8% 2,764 2,632 133 5.0% -2,238 -2,195 -43 1.9% 3,486 3,387 99 2.9% Change Dec. 31, 2018 Dec. 31, 2017 7,286 > 100.0% Combined Management Report Merck Group 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 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. The net sales in the individual quarters as well as the respective organic growth rates in 2018 are presented in the following graph: HEALTHCARE Net sales and organic growth¹ by quarter²,3 € million/organic growth in % Q1 2018 1,435 2017 1,531 % - 0.9% Q2 1,584 1,587 -22.0% Q3 -289 1,025 0.9% 731 1,337 -605 -45.3% 11.7% 21.6% 1,492 2,028 -536 -26.4% 23.9% 32.8% 1,556 1,773 -217 -12.2% 24.9% 28.6% 1,314 56 1,596 Q4 Share Oncology 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 2017 1,498 Total change Organic growth² 1,630 1,573 4.7% 9.9% 5.5% 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 Net sales of the key product lines and products developed as follows in 2018: HEALTHCARE Net sales by major product lines/products¹ € million 2018 Share Exchange rate effects Report on Economic Position 6,190 € million The development of key balance sheet figures was as follows: MERCK GROUP Key balance sheet figures in % Equity ratio¹ Equity Dec. 31, 2018 Dec. 31, 2017 Dec. 31, 2016 Dec. 31, 2015 Dec. 31, 2014 46.7% 39.5% 36.7% 33.8% 45.4% Total assets Non-current assets Asset ratio¹ Merck Group 75.0% Report on Economic Position 120 119 MERCK GROUP Business free cash flow¹ by business sector² - 2018 € million/in % - 395 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. 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. Combined Management Report in % 79.1% 80.7% 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). 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. Healthcare HEALTHCARE Key figures¹ Combined Management Report Report on Economic Position Healthcare 121 Change € million Net sales Operating result (EBIT)² 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 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. 80.0% 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). OVERALL ASSESSMENT OF BUSINESS PERFORMANCE AND ECONOMIC SITUATION 59.7% Total assets Equity Asset coverage¹ 62.3% 49.9% 45.9% 41.8% 76.0% Non-current assets Current liabilities Finance structure¹ 43.3% 40.1% 37.5% 37.2% 46.5% Liabilities (total) 1 Not defined by International Financial Reporting Standards (IFRSS). 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. -375 MERCK GROUP 126 Healthcare The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: HEALTHCARE Business free cash flow¹ and change by quarter²,3 € million/change in % Q1 2018 299 2017 342 % -12.8% Q2 232 433 -46.5% 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. -19 5.2% Changes in inventories -55 -34 -21 63.1% Q4 Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow² -49 -32 64.6% 1,025 1,314 -289 -22.0% -81 254 Q3 343 -25.9% 23.2% 195 Working capital¹ 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. 240 Africa (MEA) Middle East and 2% 37 -12.1% -8.3% Latin America 2% 32 Performance Materials 80% € million Net sales Cost of sales -3.8% 8 - 20.0% 0% Gross profit PERFORMANCE MATERIALS The development of results of operations is set out below: 1 Not defined by International Financial Reporting Standards (IFRSS). 100% 2,446 -1.7% -3.4% 1.7% 100% 0% 10 Results of operations -1.6% -18.4% 2,406 Change Organic growth² in % 100.0% -51.2% 48.8% Administration expenses -90 -3.7% -72 -2.9% -18 5.2% 25.1% -242 -10.1% -225 -9.2% -17 7.5% Research and development costs -13 -9.9% -242 2017 2,446 -1,145 1,301 in % 100.0% -46.8% 53.2% 1,945 € million in % -40 -1.7% -86 7.5% -127 -9.7% Marketing and selling expenses -255 -10.6% 2018 2,406 -1,231 1,175 -0.7% -3.5% 2.9% -40 508 689 -181 -1.7% -26.3% 21.1% 28.2% 769 32.0% 947 -178 -18.8% 38.7% 2,446 786 32.7% 588 -194 -19.8% 906 -318 -35.1% DEVELOPMENT OF NET SALES AND RESULTS 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: 980 40.1% PERFORMANCE MATERIALS in % 2017 Q4 338 282 -36.6% -1.3% 20.1% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. 132 Combined Management Report Report on Economic Position Performance Materials € million 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 PERFORMANCE MATERIALS Remaining operating expenses and income Net sales and organic growth¹ by quarters² Q1 Share growth¹ Exchange rate effects Acquisitions/ divestments Total change 2017 Share Europe 220 9% -4.8% -0.3% 2018 -5.0% 9% North America 214 9% 0.3% -4.6% -4.3% 223 9% Asia-Pacific (APAC) 1,932 80% 231 € million/organic growth in % € million Net sales by region 2018 564 2017 - 645 % -4.0% Q2 587 612 Q3 626 611 Organic Q4 579 0.4% 3.4% 7.8% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Combined Management Report Report on Economic Position Performance Materials 133 Net sales of the Performance Materials business sector by region developed as follows: PERFORMANCE MATERIALS 629 -81 769 -73 Report on Economic Position 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 Combined Management Report Q3 2018 137 143 152 155 2017 233 239 % Q4 -41.0% ¹ Not defined by International Financial Reporting Standards (IFRSS). -318 € 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 -35.1% -44 -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 -14 980 222 -40.5% -437 -111 25.5% -488 -391 -97 24.8% -381 -292 -548 -89 -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. 1,481 30.6% 212 in % 2017 -31.3% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. -26.7% 136 Combined Management Report Report on Economic Position Corporate and Other Corporate and Other € million 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 CORPORATE AND OTHER Key figures¹ € million Operating result (EBIT)² EBITDA² EBITDA pre² Business free cash flow² Change 2018 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. 786 2017 2018 38.7% (-5) -178 1.3% (-19.1%) -18.8% Restructuring expenses Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments 947 EBITDA pre¹ 1 15 5 20 1 -4 -78.5% -6 -27.1% ¹ Not defined by International Financial Reporting Standards (IFRSS). -1 32.0% EBITDA¹ -3.0% -7 9.8% Operating result (EBIT)¹ 508 21.1% 689 28.2% -181 416 -26.3% reversals of impairment losses 261 10.9% 258 10.5% 3 (of which: adjustments) (21) (26) Depreciation/amortization/impairment losses/ 1 7 786 196 239 -18.2% 1 Not defined by International Financial Reporting Standards (IFRSS). 2 Quarterly breakdown unaudited. Q3 203 Q4 191 249 Q2 228 -16.4% DEVELOPMENT OF BUSINESS FREE CASH FLOW At € 588 million, the business free cash flow of the Performance Materials business sector in 2018 fell short of the prior-year figure (2017: € 906 million). This resulted from the reduction in EBITDA pre, a rise in receivables as of the 2018 balance sheet date that was primarily due to one-time project-related sales of liquid crystals in the fourth quarter of 2018, and higher inventories in the Surface Solutions business unit. PERFORMANCE MATERIALS Business free cash flow¹ € million EBITDA pre¹ Change -18.3% -25.7% % 263 32.7% 980 40.1% -6 -194 -89.5% -19.8% In 2018, gross profit was € 127 million below the previous year's level and amounted to € 1,175 million (2017: € 1,301 million), resulting in an expected reduction in the gross margin to 48.8% (2017: 53.2%). The development of the gross margin is essentially explained by the price declines observed in the display industry and by falling sales in the Surface Solutions business unit. 134 Combined Management Report Report on Economic Position Performance Materials The operating result (EBIT) decreased to € 508 million in 2018 (2017: € 689 million). In addition to the sales and margin-related decline in gross profit, this was due to higher marketing and selling expenses as well as additional research and development costs. While the rise in marketing and selling expenses was primarily attributable to logis- tics costs, the increase in research costs was chiefly due to the tapping of new growth areas in materials for the production of integrated circuits. EBITDA pre of the business sector declined by -19.8% to € 786 mil- lion (2017: € 980 million). The negative foreign exchange impact of -6.9% lowered this key performance indicator. Consequently, at 32.7%, the EBITDA pre margin was below the prior-year figure (2017: 40.1%). The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: PERFORMANCE MATERIALS EBITDA pre¹ and change by quarter² € million/change in % Q1 2018 196 2017 -3.3% 33.5% 24 423 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. The Research Solutions business unit, which provides products and services to support life science work in pharmaceutical, biotech- nology and academic research laboratories, recorded a moderate organic sales increase of 4.1% in 2018. Strong performance by both Lab & Specialty Chemicals and Reagents & Kits in particular led to the growth in net sales of Research Solutions, which increased to € 2,048 million (2017: € 2,038 million), representing 33% (2017: 35%) of the business sector's net sales. In regional terms, Asia- Pacific was the strongest growth driver for Research Solutions in 2018. The Applied Solutions business unit generated strong organic sales growth of 6.3% with its broad range of products for researchers as well as scientific and industrial laboratories. Net sales increased to € 1,650 million (2017: € 1,609 million). Accordingly, the business unit contributed 27% (2017: 27%) to net sales of the Life Science business sector. The sales performance of Applied Solutions was driven by all business fields, and primarily by the North America and Asia-Pacific regions. Net sales of the business sector by region developed as follows: LIFE SCIENCE Net sales by region € million 2018 1 Previous year's figures have been adjusted due to an internal realignment. 2 Not defined by International Financial Reporting Standards (IFRSS). Share Exchange rate effects Acquisitions/ divestments Total change 2017 Share Europe 2,136 35% Organic growth¹ 6.4% 100% 5.2% Research Solutions 2,048 33% 4.1% -3.6% 0.5% 2,038 35% Applied Solutions 5,882 1,650 6.3% Life Science 6,185 100% 8.8% - 3.8% -3.6% 2.5% 1,609 27% 27% -0.8% 5.6% 2,022 Middle East and Africa (MEA) 1% -8.7% -1.7% -10.4% Life Science 6,185 100% 5% 8.8% 5.2% 98 5,882 2% 100% ¹ Not defined by International Financial Reporting Standards (IFRSS). Combined Management Report Report on Economic Position Life Science 129 -3.6% 273 -6.0% -16.5% 34% North America 2,173 35% 8.4% -4.6% 3.8% 2,093 35% Asia-Pacific (APAC) 1,532 25% 13.6% -3.8% 9.8% 1,395 24% Latin America 256 4% 10.5% 38% The results of operations of the Life Science business sector devel- oped as follows: 2,234 -3.5% Life Science LIFE SCIENCE Key figures Combined Management Report Report on Economic Position Life Science 127 € million Net sales 8.8% 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 (IFRSS). Change 2018 2017 Margin (% of net sales)¹ € million Q2 Q4 Share 2018 € million Net sales by business unit¹ LIFE SCIENCE Life Science Report on Economic Position Combined Management Report 128 Q3 8.8% ¹ Not defined by International Financial Reporting Standards (IFRSS). 9.8% 7.7% 1,496 1,408 1,495 1,628 1,527 1,543 2 Quarterly breakdown unaudited. in % 6,185 5,882 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 DEVELOPMENT OF NET SALES AND RESULTS 2018 2017 Acquisitions/ divestments Total change 2017 Share Process Solutions 2,487 40% 14.8% 1,487 -0.7% 9 1,402 304 5.2% 1,036 834 202 24.2% 16.7% 14.2% 1,755 1,580 175 11.1% 28.4% 26.9% 1,840 1,786 54 3.0% 29.8% 30.4% 1,393 11.3% % LIFE SCIENCE € million 2018 455 452 460 474 2017 445 454 426 Q4 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 In 2018, the business free cash flow of the Life Science business sector remained stable at the previous year's level at € 1,393 million (2017: € 1,402 million). Essentially, the inventory build-up to support sales growth was offset by higher EBITDA pre and lower investments. LIFE SCIENCE Business free cash flow¹ % 2.8% Q3 Q1 22 1,786 28 -61 -97.2% -19 30.4% 54 -86.5% 3.0% Gross profit increased by 5.1% to € 3,463 million (2017: € 3,294 mil- lion). Despite currency headwinds, the strong increase was driven by organic growth in sales across all business units. Marketing and selling expenses increased by 2.4% to € 1,775 million (2017: € 1,734 million), while R&D expenses increased by 3.4% to € 249 mil- lion (2017: € 241 million). The decline in other operating expenses and income of - 46.2% to € -121 million (2017: € -224 million) was the result of lower acquisition-related adjustments and a fall in adjust- ments for integration expenses/IT expenses that were included in Q2 this item. In comparison with 2017, the operating result (EBIT) of Life Science rose by € 202 million to € 1,036 million (2017: € 834 mil- lion). After eliminating depreciation and amortization as well as adjustments, EBITDA pre -the key indicator to assess the earning power increased by 3.0% to € 1,840 million (2017: € 1,786 mil- lion). EBITDA pre improved by 7.0% over the prior year in organic terms, whereas negative foreign exchange rate effects depressed this key indicator by -3.9%. 130 Combined Management Report Report on Economic Position Life Science The development of EBITDA pre in the individual quarters in com- parison with 2017 is presented in the following overview: LIFE SCIENCE EBITDA pre¹ and change by quarter² € million/change in % - Change € million 2018 1,402 -9 -59.3% -0.7% Combined Management Report Report on Economic Position Life Science 131 The development of business free cash flow items in the individual quarters in comparison with 2017 is presented in the following over- view: LIFE SCIENCE 1,393 Business free cash flow¹ and change by quarter² Q1 Q2 Q3 2018 375 269 411 2017 281 € million/change in % Exchange rate effects -41 -17 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% Changes in trade accounts receivable as well as receivables from royalties and licenses Business free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). 29.8% Results of operations 1,840 > 100% 2.4% Administration expenses -282 -4.6% -261 -4.4% -22 8.3% Research and development costs -41 -249 -241 -4.1% -8 3.4% Remaining operating expenses and income -121 -2.0% -224 -3.8% -4.0% 104 -29.5% -28.7% 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 -1,734 in % 5.2% -135 5.2% 56.0% 169 5.1% Gross profit Marketing and selling expenses -1,775 304 -46.2% Operating result (EBIT)¹ 1,036 (>100%) 1,755 28.4% 1,580 26.9% 175 11.1% 3 86 (20) -8 5 114 1 63 -2 -45.0% -29 -25.0% -9 2 (3) (23) -3.6% 16.7% 834 14.2% 202 24.2% Depreciation/amortization/impairment losses/ reversals of impairment losses (of which: adjustments) EBITDA¹ Restructuring expenses Integration expenses/IT expenses Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments Other adjustments EBITDA pre¹ 1 Not defined by International Financial Reporting Standards (IFRSS). 719 11.6% 746 12.7% -27 3 88 % S&P/Moody's / Scope 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 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. Opportunities from new active ingredients for cosmetics 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. 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. 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. 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. Opportunities provided by the CRISPR technology 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. The new center is one of three worldwide supporting Merck's biotech partners in developing their processes from early clinical stages to commercialization by providing end-to-end solutions. tion and high quality. However, the drug development process is long and complex, and requires biotech companies to make significant financial investments. The manufacture of biopharmaceuticals, or biomanufacturing, is a growing industry that is increasingly focused on optimized produc- In June 2018, Merck opened North America's first BioRelianceⓇ End- to-End Biodevelopment Center for drug manufacturers in Burlington, Massachusetts. The center provides practical experience and offers expert advice for each stage of biotechnological development and manufacture. Opportunities offered by customer proximity The CRISPR technologies open up promising new avenues for med- ical research and the treatment of some of the most difficult diseases to treat, such as cancer as well as hereditary and rare diseases. The CRISPR technology is used in genome editing. In 2018, Merck was awarded several patents for this. Fundamental CRISPR patents exist in Australia, China, Europe, Israel, Canada, Singapore and South Korea. In 2018, we expanded our competencies with a PMatX incubator for electronics of the next generation in Israel in the Performance Materials area. Opportunities in the semiconductor industry We are pursuing a strategy of leveraging our expertise as the global market leader in liquid crystals in order to develop new fields of application for innovative liquid crystal technologies. For instance, we are pressing ahead to capture the future markets for liquid crystal windows (LCWs) and mobile antennas. Thanks to licrivision™ tech- nology, LCWs create new architectural possibilities. Through contin- uously variable brightness control, they can for example increase a building's energy efficiency. Moreover, the dynamic solar shading product eyrise TM s350 launched in the EU and North America allows solar shading to be managed while the windows remain transparent and color-neutral. Due to growing demand for dynamic glass, we see great potential for the new eyriseTM product brand. Antennas that can receive signals transmitted in the high frequency range can also be realized with the aid of corresponding liquid crystal mixtures. As a result, mobile data exchange could improve significantly in a wide variety of fields of application. Since novel liquid crystal materials for antennas are currently being developed, the market launch of liquid crystal antennas could take a few years. Opportunities due to new application possibilities for liquid crystals 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. 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. 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. 140 Combined Management Report Report on Risks and Opportunities 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. 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. MARKET RISKS AND OPPORTUNITIES registered via the United Kingdom; changes to supply routes and the planned build-up of inventories of critical products, which are also designed to cushion the risk of delays in cross-border traffic, which is difficult to predict. The United Kingdom's intended exit from the European Union ("Brexit") gives rise to risks for our existing business in that country (2018: sales of € 636 million, 1,442 employees and 5 production sites), including the devaluation of the pound sterling, a weakening of the United Kingdom's economy, regulatory changes, the creation of trade barriers such as tariffs as well as, particularly in the event of a Brexit without a transition phase ("hard Brexit"), operational risks due to, for example, delays in the supply chain that could have an impact on our profitability. To analyze these risks and in order to counteract them early in a targeted manner, we established Group- internal working groups that considered various scenarios, including the possibility of a "hard Brexit". Mitigation measures exist for these scenarios, which shall ensure market access and the stability of the supply chain in the best possible way. They also include, for example, a relocation of the marketing authorization holder for drugs currently Potential negative macroeconomic developments, for example in Argentina, can also impact our business. To minimize these impacts, corresponding measures pertaining to the sales strategy have been initiated in these countries. Risk of negative political and macroeconomic developments The destabilization of political systems (as for example in Turkey or the Middle East), the possible establishment of trade barriers, sanc- tions and foreign exchange policy changes can lead to declines in sales in certain countries and regions. These risks are taken into account as far as possible in the business plans of the affected countries and regions and mitigated through product, industry and regional diversification. Likewise, in our Life Science and Performance Materials business sectors, we must adhere to a multitude of regulatory specifications regarding the manufacturing, testing and marketing of many of our products. Specifically in the European Union, we are subject to the European chemicals regulation REACH. It demands comprehensive tests for chemical products. Moreover, the use of chemicals in pro- duction could be restricted, which would make it impossible to con- tinue manufacturing certain products. We are constantly pursuing research and development in substance characterization and the possible substitution of critical substances so as to reduce the occur- rence of this risk, and therefore view it as unlikely. Nevertheless, it is classified as a medium risk given its critical negative impact on the net assets, financial position and results of operations. Risk of stricter regulations for the manufacturing, testing and marketing of products Remaining risks beyond the current plans resulting from restrictive regulatory requirements are classified as a medium risk owing to the possible critical or partly probable and moderate negative impact. 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. 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. 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. 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. A/A2 A-/A3 Rete/Reel BBB/Baa2 • S&P • Moody's Scope 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 LIQUIDITY RISKS Overview of rating development REPORT ON RISKS AND OPPORTUNITIES 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. COUNTERPARTY RISKS 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. 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. - 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). 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 aforementioned risks and opportunities (further infor- 2018 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. 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. 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 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. 146 Combined Management Report Report on Risks and Opportunities 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 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. OPPORTUNITIES Legal risks Nevertheless, we are still exposed to litigation risks or legal pro- ceedings. In particular, these include risks in the areas of product liability, competition and antitrust law, pharmaceutical law, patent law, trademark law, 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. in high-growth markets Opportunities due to an expanding local presence Quality controls along the entire value chain reduce the risks related to product quality and availability. This starts with the qualification of our suppliers. Quality controls also include comprehensive quality requirements for raw materials, purchased semi-finished products and plants. We are dependent on individual suppliers for a number of precursor products, packaging materials and finished goods. In the event that one of these suppliers curtails or discontinues production, or supply is disrupted, this could potentially have a critical impact on the business concerned. With long-term strategic alliances for pre- cursor products critical to supply and price as well as alternative sourcing strategies, we reduce the probability of occurrence of these risks and rate them as unlikely. Overall, these are classified as medium risks. Risks of dependency on suppliers Report on Risks and Opportunities Combined Management Report 144 Although the occurrence of these risks is considered unlikely, an individual event could have a critical negative effect on the net assets, financial position and results of operations, and they are therefore classified as a medium risk. Further risks include operational failures due to fire or force majeure, for example natural disasters such as floods or earthquakes, which could lead to a substantial interruption or restriction of business activities. Insofar as it is possible and economically viable, the Group limits its damage risks with insurance coverage, the nature and extent of which is constantly adapted to current requirements. Like- wise, we are exposed to risks of production outages and the related supply bottlenecks that can be triggered by technical problems in production facilities with very high capacity utilization. Furthermore, there are risks of supply bottlenecks due to a lack or disappearance of capacity. We are working to continuously mitigate the risks by making regular investments, setting up alternative sourcing options and maintaining inventory levels. Risks of production availability We are required to comply with the highest standards of quality in the manufacturing of pharmaceutical products (Good Manufacturing Practice or official pharmacopoeia). In this regard we are subject to the supervision of the regulatory authorities. Conditions imposed by national regulatory authorities could result in a temporary ban on prod- ucts/production facilities, and possibly affect new registrations with the respective authority. We make the utmost effort to ensure compliance with regulations, regularly perform our own internal inspections and also carry out external audits. Thanks to these quality assurance pro- cesses, the occurrence of a risk with a critical negative impact is unlikely, however cannot be entirely ruled out. Depending on the product concerned and the severity of the objection, such a risk can have a moderate negative impact on the net assets, financial position and results of operations. Therefore, we rate this as a medium risk. Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards RISKS AND OPPORTUNITIES RELATED TO THE QUALITY AND AVAILABILITY OF PRODUCTS Furthermore, there is the risk that regulatory authorities either do not grant or delay approval or grant only restricted approval. Additionally, there is the risk that undesirable side effects of a phar- maceutical product could remain undetected until after approval or registration, which could result in a restriction of approval or with- drawal from the market. Well-advanced programs in our pipeline and those of our partners result in potential new approvals; on the other hand, missing targets in this area may have critical negative effects on the financial position and operating result, for example due to lower net sales or the non-occurrence of milestone payments from collaboration agreements. Overall, these risks are considered to be medium risks, with probabilities ranging from unlikely to possible. Risks of discontinuing development projects and regulatory approval of developed medicines Sometimes development projects are discontinued after high levels of investment at a late phase of clinical development. Decisions - such as those relating to the transition to the next clinical phase - are taken with a view to minimizing risk. We are currently not aware of any risks beyond general development risks that could significantly affect the net assets, financial position and results of operations. 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. Product liability risks Companies in the chemical and pharmaceutical industries are exposed to product liability risks in particular. Product liability risks can lead to considerable claims for damages, loss of reputation and costs to avert damages. We have taken out the liability insurance that is standard in the industry for such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered unlikely, individual cases could still have a critical negative effect on the net assets, financial position and results of operations. We therefore rate a potential product liability risk as a medium risk. 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. 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. 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. 145 Report on Risks and Opportunities 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. Combined Management Report 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. 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. Overall, the liquidity risk is unlikely and rated as low. 139 Combined Management Report 51-80% > 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 Report on Risks and Opportunities Combined Management Report 138 If the occurrence of the identified opportunities is rated as likely, they are incorporated into the business plans and the short-term forecasts. Trends going beyond this or events that could lead to a positive development in the net assets, financial position and results of operations are presented in the following report as opportunities. These could have a positive effect on our medium-term prospects. The risk management system described concentrates on business risks, and not on opportunities at the same time. The opportunity management process is integrated into our internal controlling pro- cesses and carried out in the operating units on the basis of the Group strategy. The businesses analyze and assess potential market opportunities as part of strategy and planning processes. In this context, investment opportunities are examined and prioritized pri- marily in terms of their potential value proposition in order to ensure an effective allocation of resources. We selectively invest in growth markets to leverage the opportunities of dynamic development and customer proximity at a local level. OPPORTUNITY MANAGEMENT PROCESS Within the scope of audits, Group Internal Auditing regularly reviews the performance of risk management processes within the units and, at the same time, the communication of relevant risks from the operating businesses to Group Risk Management. For reporting risks with a potential negative impact on our EBIT, a minimum threshold is set at a value of € 5 million in the standard process and at a value of € 25 million in the ad hoc process. Risks below these thresholds are steered independently within the business sectors. The relevant timeframe for internal risk reporting is five years. The effects of risks described in this report on risks and oppor- tunities are presented as annual values. The assessment of the risks presented relates to December 31, 2018. There were no relevant changes after the balance sheet date that would have necessitated an amended presentation of the risk situation of the Group. Report on Risks and Opportunities Combined Management Report Report on Risks and Opportunities 137 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 planning and intra-year business plans. DEGREE OF IMPACT Risk and opportunity management 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. 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. Degree of impact 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. € 20-50 million Medium Medium Medium High High Medium High Low Low Low Low Probability of occurrence <20% 20-50% 51-80% > 80% > € 50 million Medium Medium Medium Medium Low Explanation €5 <20 million Critical negative impact on the net assets, financial position and results of operations Substantial negative impact on the net assets, financial position and results of operations Moderate negative impact on the net assets, financial position and results of operations Immaterial negative impact on the net assets, financial position and results of operations The combination of the two factors results in the risk matrix below, which shows the individual risks and their significance to the Group. RISK MATRIX € 20-50 million € 5-20 million > € 50 million Impact Explanation Unlikely Possible Likely Very likely < € 5 million < € 5 million Environmental and safety 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. 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. Combined Management Report Report on Risks and Opportunities 149 Risks of the divestment, acquisition and integration of companies and businesses 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 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. 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 precautions - we 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. 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. 150 Combined Management Report 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. Overall view of the risk and opportunity situation and management assessment 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. 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. 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. 147 Report on Risks and Opportunities Combined Management Report Nevertheless, potentially critical negative impacts of the litigation on the financial position cannot be ruled out. In the Performance Materials business sector, Merck is involved in a legal dispute with JNC Corporation, Japan, (JNC). JNC claims that by manufacturing and marketing certain liquid crystals mixtures, Merck has infringed JNC patents. Merck maintains that JNC's patent infringement assertion is invalid owing to relevant prior art and has filed the corresponding nullity actions, which in three cases were already successful in first-instance proceedings. JNC has filed com- plaints in each case. In a correction trial, a decision in favor of JNC was issued in the second instance. Both Merck and the Korean Patent Office have filed complaints with the Korean Supreme Court. In par- allel, JNC filed two patent infringement suits. In 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. Report on Expected Developments RISKS DUE TO ANTITRUST AND OTHER GOVERNMENT PROCEEDINGS RaptivaⓇ: In December 2011, the federal state of São Paulo, Brazil, sued Merck for damages because of alleged collusion between various pharmaceutical companies and an association of patients suffering from psoriasis and vitiligo. This collusion is alleged to have been intended to increase sales of the medicines from the companies involved to the detriment of patients and state coffers. Moreover, patients are also suing for damages in connection with the product RaptivaⓇ. Merck has taken appropriate accounting measures for these issues, which relate to various legal cases. Risks in excess of this with a substantial negative effect on the net assets, financial position and results of operations cannot be ruled out, but are considered unlikely. This is rated as a medium risk. 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. 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. Combined Management Report 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. Human resources risks 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. 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. Information technology risks 148 Report on Expected Developments - Moderate increase 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 Higher EBITDA pre and positive effects in working capital offset higher investments in property, plant and equipment as well as digitalization initiatives 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. EBITDA PRE 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 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. 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. Combined Management Report - Report on Expected Developments 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 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. FORECAST FOR THE HEALTHCARE BUSINESS SECTOR € million Actual results 2018 Forecast for 2019 Key assumptions Net sales BUSINESS FREE CASH FLOW 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. -First-time application of IFRS 16 with a positive contribution of around € 130 million - Growth driven by Healthcare and Life Science, which more than offsets the decline of Performance Materials 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. FORECAST FOR THE MERCK GROUP Actual results € million 2018 Forecast for 2019 Net sales 14,836 - - Moderate organic growth - Slightly negative foreign ex- change effect of -1% to -2% - Negative foreign exchange effect of between -3% and -4% EBITDA pre Business free cash flow 3,800 2,508 Key assumptions - Growth driven by Life Science and Healthcare, which more than offsets the decline of Performance Materials - Foreign exchange effect primarily resulting from several emerging market currencies Pronounced organic percent- age growth in the low teens range 151 NET SALES 6,246 NET SALES 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. 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. BUSINESS FREE CASH FLOW - Decline in EBITDA pre 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. 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). Corporate and Other 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. - Neutral foreign exchange effect due to the development of the exchange rate of the euro against the U.S. dollar - 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 - Drop in liquid crystal prices cannot be offset by growth in other businesses and active cost management low double-digit percentage decline 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 - Foreign exchange effect roughly neutral Actual results 2018 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 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 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) The management report of Merck KGaA has been combined with the Group management report. The annual financial statements and the combined management report of the Merck Group and Merck KGaA for 2018 are being filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and are available on the website of the German company register. Merck KGaA, 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. 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 Combined Management Report Statement on Corporate Governance Effects of material company agree- ments on the net assets, financial position and results of operations SPIN-OFF OF OPERATING BUSINESS ACTIVITIES OF THE BUSINESS SECTORS AND TEMPORARY LEASEBACK OF THE SPUN-OFF BUSINESS ACTIVITIES 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 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. 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. 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 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. 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. 156 The company is not authorized to acquire its own shares. of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG once or repeatedly up to and including April 27, 2022 by up to a total of € 56,521,124.19 by issuing new no-par value bearer shares against cash and/or non-cash contributions ("Authorized Capital 2017"). Limited liability shareholders shall be generally granted the statutory right to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude the limited liability shareholders' subscription right in full or in part in case of a capital increase against cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares which are issued under exclusion of the subscription right do not exceed a proportional amount of 10% of the share capital either at the time of the Authorized Capital 2017 taking effect or at the time of the Authorized Capital 2017 being utilized. This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares 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. 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. 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. 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 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. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 divided into 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with Article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. Moreover, the share capital is contingently increased by up to € 16,801,491.20 composed of up to 12,924,224 no par value bearer shares (Contingent Capital II). This increase in contingent capital is only to be implemented insofar as the bearers or creditors of option or conversion rights or with an obligation to convert or exercise options on warrant bonds, option participation certificates, option participation bonds, convertible bonds, convertible participation 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. 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. € million 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. 153 - 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 - Positive net working capital effects (including positive effects from the sale of the Consumer Health business) NET SALES 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. - 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 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. In 2019, we expect business free cash flow of the Healthcare business sector to show an increase in the low twenties percentage range. - - Expected substantial earnings contributions from our new products, especially MavencladⓇ, more than offset negative mix effects associated with the projected decline of RebifⓇ sales FORECAST FOR THE PERFORMANCE MATERIALS BUSINESS SECTOR EBITDA pre 1,556 Moderate organic growth - Moderately negative foreign exchange effect - Moderate increase in research and development expenses due to the develop- ment of our pipeline, but down in relation to sales - Pronounced organic growth rate in the low-to-mid-twen- ties percentage range -Strongly negative foreign exchange effect 1,025 -Increase in the low teens percentage range - 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 Business free cash flow 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). measures. Actual results - Negative foreign exchange effect, particularly on account of the development of emerging market currencies Improved EBITDA pre - Increase in investments in property, plant and equipment in strategic projects NET SALES 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. - In addition, positive contribution to organic income growth from the switch to IFRS 16 EBITDA PRE 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 Combined Management Report FORECAST FOR THE LIFE SCIENCE BUSINESS SECTOR Report on Expected Developments In 2019, the Life Science business sector is expected to show a sharp increase in organic EBITDA pre totaling nearly double-digit growth Organic income growth on account of the expected sales growth and slight margin expansion 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. - 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 € million 6,185 EBITDA pre Business free cash flow 1,840 1,393 Forecast for 2019 Net sales - Organic growth slightly above medium-term market growth of 4% p.a. - Process Solutions is expected to remain the main driver of growth, followed by Applied Solutions Key assumptions Moderately below 2018 levels 2018 - Organic growth ranging from strong to a double-digit per- centage rate - Slightly negative foreign exchange effect - Moderately negative foreign exchange effect 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. 195 Report of the Supervisory Board 193 166 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. Statement on Corporate Governance Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 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) RESULTS OF OPERATIONS Combined Management Report 157 in accordance with the sector-specific ERP introduction at an individual time to the OpCo in question in a targeted manner. On the basis of the operating lease contract, Merck KGaA will temporarily continue to operate the spun-off business as a leaseholder in its own name and for its own account. Once the relevant ERP systems have been introduced for the respective OpCo, the business lease with this OpCo will be terminated and the business previously leased out will pass to the OpCo. The aforementioned spin-off and business leasing contracts form part of an overall entrepreneurial concept. They were submitted to the General Meeting of Merck KGaA for approval on April 27, 2018 (2018 Annual General Meeting) as a coherent restructuring measure and approved by it. The gradual implementation of the measures is due to be completed in 2020. In 2018, the Healthcare OpCo changed its legal form to that of a German corporation with general partners ("Kommanditgesellschaft auf Aktien") and has since been trading under the name of Merck Healthcare KGaA, Darmstadt. The table below shows the balance sheet of Merck KGaA after the operating spin-off, holding company spin-off and temporary lease- back as of 0:00 hours on January 1, 2018. The impact in fiscal 2018 of the spin-offs was mainly lower depreciation, amortization and write-downs of fixed assets and lower pension expenses. On the other hand, business lease expenses and the passing-on of costs for personnel-related provisions led to an increase in other operating expenses. € million Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise 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. Corporate Governance Board of Partners of E. Merck KG 165 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. Capital Structure and Corporate Bodies of Merck KGaA MONITORING 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 General partners with no equity interest Executive Board of Merck KGaA 565,211,241.95 € Total capital of Merck KGaA Corporate Bodies of Merck KGaA Capital Structure and ASSETS A. Fixed assets Intangible assets Tangible assets Net retained profit: shareholders B. Current assets 28.5 20,015.3 168.0 397.2 3,813.7 701.6 168.0 397.2 3,813.7 701.6 60.3 60.3 187.1 187.1 5,327.9 5,327.9 B. Provisions Provisions for pensions and other post-employment benefits 200.4 110.7 Other provisions 1,112.1 946.1 1,312.5 1,056.8 C. Liabilities Financial liabilities Trade accounts payable Other liabilities 1,500.0 1,500.0 1,462.6 Financial assets 1,762.6 1.4 Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents C. Prepaid expenses Total ASSETS 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. EQUITY AND LIABILITIES A. Net equity Subscribed capital General partner's equity Capital reserves Retained earnings Profit carried forward E. Merck KG Merck KGaA Dec. 31, 2017 Merck KGaA Jan. 1, 2018¹ 489.7 1,173.0 16,485.7 191.8 821.6 17,510.7 18,148.4 18,524.2 688.3 688.3 181.3 181.3 891.6 591.6 1.4 28.5 19,939.5 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. 292.1 11,820.7 5.3% 315 181 134 73.7% 1,293 892 401 45.0% 3 1 2 142.9% 34 28 6 21.1% 37 688 725 32.5% 18,670 239 18,148 490 522 in % 2.9% -251 -51.2% 899 21,040 1,173 -23.4% 17,532 16,486 1,046 6.3% 2,336 1,763 573 -274 19,940 1,100 5.5% 1,312 -193 288 200 87 832 1,112 -280 1,119 in % 43.2% -25.2% 14,575 13,281 1,295 9.8% 1,500 446 1,500 292 0.0% -14.7% € million 1 5,329 160 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 5,328 Other provisions Financial liabilities Trade accounts payable Other liabilities Deferred income Change Dec. 31, 2018 Dec. 31, 2017 € million Liabilities 12,629 Dec. 31, 2017 Change -1,258 -47 3.7% Depreciation, amortization and write-downs -112 -183 71 -38.8% Other operating expenses -2,152 -1,801 -351 19.5% Investment income/Write-downs of financial assets 1,234 847 387 −1,305 Personnel expenses 18.0% -271 Change € million Sales Other income 2018 2017 € million 4,785 45.7% 4,807 in % -0.5% 172 212 -40 - 18.9% Cost of materials -1,776 -1,505 -22 Financial result -262 -201 The decline in other income was mainly the result of lower gains from the release of provisions. 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 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. Depreciation, amortization and write-downs fell by 38.8% as a result of the decline in fixed assets following the spin-off. 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". Investment income rose essentially on account of higher profit transfers by OpCo companies; see section "Effects of material com- pany agreements on the net assets, financial position and results of operations". However, the reduced dividend payment by the Merck Holding GmbH had an offsetting effect. The Financial result deteriorated due to lower fair values of plan assets. ASSETS -116.3% -5.3% € million Intangible assets Tangible assets Financial assets Current assets Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents Prepaid expenses Fixed assets Dec. 31, 2018 -9 162 -61 30.3% Profit before profit transfers and taxes 584 917 -334 292.1 11,489.1 13,281.3 -36.4% 171 Profit transfers -553 99 -17.9% Taxes 32 -193 225 Profit after profit transfers and taxes -454 11,489 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. 52.7% 9.9% 307 4,807 4,785 308 in % -0.5% -23 4,500 4,477 € million 2017 2018 Change 13,612.8 D. Deferred income Total LIABILITIES 1 After operating spin-off, holding company spin-off and temporary leaseback. 17.9 19,939.5 1 0.3% -22 -0.5% 162 Combined Management Report 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 159 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Combined Management Report 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. 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. 17.9 -0.5% in % -4.4% -193 170 -22 467 4,807 637 4,785 € million 2017 4,341 2018 4,148 Change 36.5% 20,015.3 158 Combined Management Report 1,399 -13 -0.9% 309 4,785 228 82 35.8% 4,807 1,386 -22 The share of sales with other Group companies (Group sales) amounted to 93.6% in 2018 (2017: 93.6%). € million Group sales Sales to third parties Total At 86.7% (2017: 90.3%), the share of exports in 2018 was below the previous year's level. Outside Germany Germany Total 154 1,141 € million -0.5% 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. 0.4% 777 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Business development Merck KGaA's net sales decreased slightly in 2018. The decline of € 22 million resulted primarily from the Healthcare and Performance Materials business sectors, offset mainly by an increase in other sales. € million Healthcare Life Science Performance Materials Other sales 3 Total 2018 2017 € million 2,310 2,404 -94 in % -3.9% 780 Change 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%). Other sales mainly included intragroup cross-charging for IT services, rent and other administrative services. 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). 196 48.0% Life Science 46 35 11 31.4% Performance Materials 260 220 40 18.2% Other R&D spending that cannot be allocated to individual business sectors Total 13 22 -9 -40.9% 408 604 Healthcare in % 18 17 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%). 21,040 19,940 -1 1,100 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". The increase in current assets (€ + 573 million) was mainly attri- butable to higher receivables from affiliates for profit transfers and other group cross-charging. 923 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". Research and development 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 COSTS Change € million 2018 2017 € million The rise in other liabilities resulted primarily from the clearing account with the Merck Financial Services GmbH, Darmstadt. 685 -6.1% 5.5% 34.7% 3,536 3,213 3,072 2,674 2,515 671 648 590 574 79 128 10,983 10,473 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. 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 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. 238 3,756 2017 Risks and opportunities Total Combined Management Report Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) 161 2018 Personnel As of December 31, 2018, Merck KGaA had 11,133 employees, representing an increase over the previous year (2017: 10,677). Average number of employees by functional area: Dividend For 2018, we are proposing to the General Meeting the payment of 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. PERSONNEL Other a dividend of € 1.25 per share. Logistics Research Sales and marketing Forecast for Merck KGaA Average number of employees during the year Production Administration • 171 Statement on Corporate Governance Corporate Governance Extraordinary performance leading to a clear overachievement of targets for relevant key performance indicators in the area of responsibility; 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. 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: Adjustment criteria for lowering profit sharing could include the following: • Violations of internal rules and guidelines (for example, the Merck Code of Conduct), legislation or other binding external requirements in the area of responsibility; 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. 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). Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; • 3 Three-year average of the profit after tax X X individual of the E. Merck Group Payout 2018 (€) Profit after tax Profit after tax Profit after tax factor for + + FY 2016 FY 2017 FY 2018 Adjustment performance 0.7-1.3 a) the performance of the Merck share price compared with the performance of the DAX® with a weighting of 50%, • Statement on Corporate Governance FY 2017 FY 2018 FY 2019 FY 2020 Grant in € Reference Merck share price at the Corporate Governance beginning number of MSUS for the grant Performance cycle Performance Individual rate in % of the Merck share price vs. the DAX® Potential 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; 172 b) EBITDA pre margin, as a proportion of a defined target value with a weighting of 25%, and 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. Merck Long-Term Incentive Plan MERCK LONG-TERM INCENTIVE PLAN (LTIP) Key performance indicators • Share price performance relative to the DAX® (50% weighting) Cycle Limit c) the organic sales growth of the Merck Group as a proportion of a defined target value with a weighting of 25%. Reference price (share price for conversion into numbers or for payment) • Organic sales growth (25% weighting) Three years Absolute capped amount totaling 250% of the individual grant Average closing price of Merck shares in XetraⓇ trading during the last 60 trading days prior to the beginning or the end of the performance cycle 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: 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 perfor- mance cycle: • EBITDA pre margin (25% weighting) 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. • Distribution of responsibilities among Executive Board members Granting of loans and salary advances Individual absolute capped amount (The compensation report is part of the notes to the audited consol- idated financial statements). COMPENSATION PHILOSOPHY 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 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. 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 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: REGULATORY REQUIREMENTS AND PRINCIPLES OF Compensation report GOOD CORPORATE GOVERNANCE 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 towards the key performance indicators of the Group. LONG-TERM INTERESTS OF OUR SHAREHOLDERS The long-term interests of our shareholders are taken into account through a significantly high amount of variable, performance-related compensation as a proportion of total compensation as well as the compensation system's strong focus on the share price. The 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: • Structure and examination of the performance-independent and performance-related compensation elements • • Contract terms of members of the Executive Board 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. Assumption of honorary offices, board positions or other sideline activities Statement on Corporate Governance 168 EBITDA pre margin Corporate Governance Statement on Corporate Governance 167 THE GENERAL MEETING OF MERCK KGAA 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%. 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. Corporate Governance "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. Darmstadt, February 26, 2019 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: For the Executive Board For the Supervisory Board s. Stefan Oschmann s. Wolfgang Büchele 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." 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 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. 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: ADDITIONAL BENEFITS Fixed compensation The fixed compensation received by the members of the Executive Board comprises fixed and non-performance related amounts that are paid in the form of 12 equivalent monthly installments. Additional benefits In addition, the members of the Executive Board receive non- performance related additional benefits. These consist mainly of contributions to insurance policies, personal security expenses and a company car, which they may use privately. PERFORMANCE-RELATED COMPENSATION Performance-related compensation comprises profit sharing as well as the Merck Long-Term Incentive Plan. Both performance-related compensation components are based on multi-year steering 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. 170 PERFORMANCE-INDEPENDENT COMPENSATION AND Corporate Governance Profit sharing PROFIT SHARING Key perfor- mance indicator Period Limit Three-year average of the profit after tax of the E. Merck Group Three years Statement on Corporate Governance OVERVIEW OF THE STRUCTURE AND THE COMPONENTS OF THE COMPENSATION SYSTEM ¹Excluding additional benefits and company pension. Performance- independent Corporate Governance Statement on Corporate Governance 169 COMPENSATION ELEMENTS AND COMPENSATION STRUCTURE1 Performance- related compensation Merck Long-Term Incentive Plan Fixed compensation • 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%) • Absolute capped amount totaling 250% of the individual grant Profit sharing • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group • Consideration of individual performance via the performance factor in a range from 0.7 to 1.3 • Individual absolute capped amount • Organic sales growth 2,860 x 1,240 1,401 168 1,569 1,369 166 9,802 10,955 6,958 1,535 16,760 7,025 17,980 1The percentage entitlement increases until retirement by two percentage points per year of service up to 70%. Corporate Governance Statement on Corporate Governance 175 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 (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. PAYMENTS TO FORMER EXECUTIVE BOARD MEMBERS AND THEIR SURVIVING DEPENDENTS 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). 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 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. 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. LOANS AND ADVANCES Total 65 490 Walter Galinat (left on: September 30, 2018) 421 2,512 2,958 1,600 1,599 1,610 11,284 12,987 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). Defined-benefit obligations The members of the Executive Board did not receive any advances or loans in fiscal 2018. € thousand IFRS Pensionable Percentage compensation entitlement Service cost of pension obligations earned in the current year 2017 Present value of the defined-benefit pension obligation as of Dec. 31 2018 2017 2018 Stefan Oschmann¹ 750 64 Member of the Executive Board 426 176 Statement on Corporate Governance factor for individual perfor- mance 2018 1.49 1 1.13 1 0.97 1 0.89 1 1.57 1.3 0.89 1 The amount of profit-sharing for Belén Garijo was increased by a factor of 1.3. The following positive criterion was used to justify the increase in profit participation: Extraordinary performance in the execution of especially important projects or the achievement of other exceptionally important objectives in the area of responsibility; Belén Garijo fulfilled this positive criterion in 2018 due to the following achievements. • Success with the multi-year repositioning of the R&D area and significant productivity increases in pharmaceutical research. . • Many important gains in the pharmaceutical pipeline (BavencioⓇ, Evobrutinib, TGF-ẞ trap). Approval and market introduction of Cladribin/MavencladⓇ in the European Union. Today the Merck pipeline is seen by external experts as having very high value, and this also significantly eases the task of winning top-level talent for Merck. Performance Average profit- sharing rate in per mille in 2018 Marcus Kuhnert Belén Garijo 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 2015 1,066 2016 1,559 2017 2018 2,549 Corporate Governance 3,324 1,724 Three-year average profit after tax of the E. Merck Group (2016-2018) 2,477 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 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: Member of the Executive Board Stefan Oschmann Udit Batra Kai Beckmann Walter Galinat (left on: September 30, 2018) Three-year average profit after tax of the E. Merck Group (2015-2017) 400 4,637 4,162 Kai Beckmann Walter Galinat (left on: September 30, 2018) Belén Garijo Marcus Kuhnert Maximum limit Fixed compensation Maximum profit sharing limit Merck Long-Term Incentive Plan Maximum limit overall compensation 1,300 4,810 5,638 9,800 1,000 3,640 4,263 8,000 1,000 Udit Batra Stefan Oschmann Member of the Executive Board € thousand Weighting: 50% Weighting: 25% Weighting: 25% Reference Merck share price at the end 0%-200% Amount paid out in € (0%- 250% of the grant in €) 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. 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%). Clawback provision 3,120 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. To further increase the transparency of the Executive Board com- pensation system, the performance corridor for the key performance indicators used in the Merck Long-Term Incentive Plan will be subse- quently disclosed. However, the company will continue to refrain from publishing this performance corridor in advance as this could permit market-related and competitively relevant conclusions to be drawn about strategic objectives. Corporate Governance Statement on Corporate Governance 173 Share Ownership Guideline A Share Ownership Guideline was introduced in 2017. This obligates the Executive Board members, for the duration of their employment relationship, to permanently hold Merck shares in an amount equal to 100% of their annual gross fixed compensation. Owing to his position as Chairman of the Executive Board, Stefan Oschmann is obligated to hold a higher amount, or at least 200% of his annual gross fixed compensation, in Merck shares. The duty to provide evidence of the complete number of shares must be met no later than on expiration of four years after having joined the Executive Board or after the introduction of the rule. The Share Ownership Guideline promotes even stronger alignment between the interests of the Executive Board members and those of our shareholders and it additionally raises the entrepreneurial responsibility of the Executive Board members. Moreover, the introduction of the Share Ownership Guideline takes into account the widespread practice of share own- ership among management and executive board members in inter- national peer comparisons. OVERALL COMPENSATION LIMIT 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. 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. 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. 3,575 8,000 800 IFRS Service cost of pension Contribution level obligations earned in the current year Present value of the defined-contribution pension obligation as of Dec. 31 2017 2018 2017 2018 400 Total 379 633 990 400 396 395 3,977 4,402 400 398 394 400 Number of MSUS actually achieved 0%-150% Marcus Kuhnert³ Kai Beckmann¹ 2,860 3,300 8,000 1,100 3,900 4,675 8,000 3,300 8,000 PENSION ENTITLEMENTS Belén Garijo² 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. 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. 1 For accounting purposes, this corresponds to a defined-benefit obligation within the meaning of IAS 19.8. 174 Corporate Governance Statement on Corporate Governance 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: Defined-contribution obligation € thousand Member of the Executive Board Udit Batra 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. 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. 900 Total Additional benefits 2018 (min.) 2018 (max.) 2018 2017 2018 (min.) 2018 (max.) 2018 1,000 1,000 Fixed compensation 2017 Benefits granted (€ thousand) Member of the Executive Board (left on: September 30, 2018) Walter Galinat Member of the Executive Board Kai Beckmann 9,341 1,438 5,316 5,814 13,303 2,855 7,981 36 8,711 81 1,000 2,400 2,400 Profit sharing 626 626 626 832 1,081 1,081 1,081 1,036 Total 26 26 26 32 81 600 600 600 800 1,000 81 3,120 400 400 3,640 2,800 2,800 4,810 3,700 3,700 Profit sharing 1,038 1,038 1,038 1,012 1,486 1,486 1,486 1,464 Total 38 38 38 12 186 Multi-year variable compensation 400 LTI 2017 (2017 to 2019) 1,623 379 1,369 1,369 1,369 1,401 Total compensation Service cost 8,941 1,038 4,916 5,435 11,934 1,486 6,612 7,310 Total 4,263 1,078 5,638 1,426 LTI 2018 (2018 to 2020) 2,146 2,200 2,200 2,860 Multi-year variable compensation 2,860 2,200 2,200 3,900 3,900 3,000 Profit sharing 926 926 926 821 1,166 1,166 1,166 1,149 Total 26 26 26 21 LTI 2017 (2017 to 2019) 66 1,779 LTI 2018 (2018 to 2020) 1,604 394 10,135 394 1,560 394 6,643 8,510 Total compensation²,3 2,582 Service cost 7,086 926 3,961 4,277 9,741 1,166 6,249 5,928 Total 3,300 835 4,675 1,183 1,256 900 900 900 6,786 626 3,661 4,288 7,776 1,081 4,385 395 4,780 2,769 Total compensation¹ -2,028 Service cost 4,797 3,300 835 3,575 904 LTI 2018 (2018 to 2020) 1,256 1,361 LTI 2017 (2017 to 2019) Multi-year variable compensation 395 1,476 395 8,171 168 166 800 1,100 2018 (min.) 2018 (max.) 2018 2017 2018 2018 (min.) 2018 (max.) 1,100 1,100 66 66 49 Additional benefits 1,100 186 Fixed compensation Benefits granted (€ thousand) Member of the Executive Board Marcus Kuhnert Member of the Executive Board 6,952 792 3,827 4,456 166 166 2017 186 164 Additional benefits 14,391 1,320 2,200 26 600 2018 Walter Galinat -388 4,797 1,361 14,954 1,430 2,400 36 1,000 2017 Kai Beckmann 2,387 4,385 904 15,590 835 1,430 3,661 (left on: September 30, 2018) 1,100 2017 Belén Garijo 2,969 6,249 1,183 20,386 1,870 3,900 66 1,100 2018 91 4,288 1,256 13,804 1,320 2,200 32 800 2017 2,051 2,400 81 1,000 164 1,300 2017 Stefan Oschmann 3,536 6,612 1,426 24,584 2,255 3,700 186 1,300 2018 Member of the Executive Board (€ thousand) (€ thousand) Time value² (€ thousand) MSUS Number of Grant value (€ thousand) (€ thousand) (€ thousand) (€ thousand) 3,700 2,255 23,581 2,146 2018 -335 5,435 1,623 17,830 1,705 2,800 12 1,000 2017 49 Udit Batra 4,916 1,078 18,588 1,705 2,800 38 1,000 2018 -375 7,310 2,791 421 3,000 19,555 based com- 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 178 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. 116.7% 29% 31% 28% 25% (internal key performance indicator) EBITDA pre margin 19.5% -16.1% 50% Performance-related components 0% Total Profit sharing 2018 (min.) 2018 (max.) 1,000 1,000 2018 1,000 1,000 2017 2018 (min.) 2018 (max.) 1,300 1,300 1,300 1,300 Fixed compensation 2018 2017 Benefits granted (€ thousand) Member of the Executive Board Udit Batra Chairman of the Executive Board Merck Long-Term Incentive Plan (with a long-term incentive effect) incentive effect) benefits Fixed com- Additional pensation long-term (without a pensation³ -20% (external key performance indicator) Share price performance relative to the DAX® 4,277 1,256 13,804 1,320 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 -385 Total 2018 2017 5,900 6,000 Key performance indicator¹ ment Merck LTIP tranche 2015 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. INFORMATION IN ACCORDANCE WITH THE REQUIRE- MENTS OF THE GERMAN CORPORATE GOVERNANCE CODE In accordance with the requirements of the German Corporate Governance Code, the following tables present the compensation 179 Statement on Corporate Governance Corporate Governance 3 In accordance with IFRS, the expense recorded for 2018 includes the values for the 2016, 2017 and 2018 LTIP tranches. In accordance with IFRS, the expense recorded for 2017 includes the values for the 2015, 2016 and 2017 LTIP tranches. 1,870 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. -1,768 32,035 15,937 29,784 6,261 9,421 107,930 103,528 9,900 9,900 17,200 16,300 314 423 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. 421 Belén Garijo 5,881 183 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. 421 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 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. 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. 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. REPORTING 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 As a member of corporate bodies of E. Merck KG, Supervisory Board member Gregor Schulz received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Theo Siegert received an additional payment of € 150,000 for performing this function in 2018 (2017: € 150,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Tobias Thelen received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Siegfried Karjetta received an additional payment of € 140,000 for performing this function in 2018 (2017: € 140,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Albrecht Merck received an additional payment of € 120,000 for performing this function in 2018 (2017: € 120,000). As a member of corporate bodies of E. Merck KG, Supervisory Board member Helga Rübsamen-Schaeff received an additional payment of € 150,000 for performing this function in 2018 (2017: € 150,000). FURTHER REPORTS 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). 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. - 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. 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. 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 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 50,000.00 50,000.00 50,000.00 49,250.00 50,000.00 50,000.00 Edeltraud Glänzer Gabriele Eismann Mechthild Auge Crocifissa Attardo (Vice Chairman) Michael Fletterich Wolfgang Büchele (Chairman) in € year. The Chairman receives double and the Vice Chairman receives one and a half times this amount. Moreover, the members receive additional compensation of € 750 per meeting. The individual values are presented in the following table: The compensation of the Supervisory Board members is defined by Article 20 of the Articles of Association of Merck KGaA. The members of the Supervisory Board receive fixed compensation of € 47,000 per COMPENSATION FOR THE SUPERVISORY BOARD MEMBERS OF MERCK KGAA 181 Statement on Corporate Governance Corporate Governance ¹Kai Beckmann's total compensation in 2017 comprised current service costs of € 396 thousand and past service revenues of € 2,424 thousand (total: € 2,028 thousand). 2 Belén Garijo's total compensation in 2017 comprised current service costs of € 398 thousand and past service costs of € 2,184 thousand (total: € 2,582 thousand). 3 Marcus Kuhnert's total compensation in 2017 comprised current service costs of € 426 thousand and past service costs of € 1,178 thousand (total: € 1,604 thousand). 265 2,077 499 2,769 265 499 Michaela Freifrau von Glenck Siegfried Karjetta Albrecht Merck Dietmar Oeter 3,000.00 2,250.00 3,000.00 70,500.00 70,500.00 2,250.00 72,750.00 73,500.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 47,000.00 47,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 2,250.00 50,000.00 49,250.00 47,000.00 47,000.00 3,000.00 2,250.00 50,000.00 49,250.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 2,250.00 3,000.00 49,250.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 47,000.00 47,000.00 3,000.00 3,000.00 50,000.00 50,000.00 822,500.00 822,500.00 46,500.00 45,750.00 869,000.00 868,250.00 97,000.00 97,000.00 3,000.00 3,000.00 94,000.00 94,000.00 2017 2018 2017 2018 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. 2017 Compensation for meeting attendance 2018 Fixed compensation Total Veit Ulshöfer Tobias Thelen Theo Siegert Gregor Schulz Helga Rübsamen-Schaeff Alexander Putz Total compensation 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. 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. 1 Internal board position. Sachsenheim, Merck Global Head of Research and Bioinformatics Veit Ulshöfer 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 Cures GmbH, Wuppertal Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Michelstadt, Full-time member of the Merck Joint Works Council Helga Rübsamen-Schaeff Alexander Putz 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 2 Members appointed according to Article 6 (5) of the Articles of Association. Memberships of (a) statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations 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 (a) 4SC AG, Martinsried no board positions no board positions Michaela Freifrau von Glenck (b) - E. Merck KG, Darmstadt¹ no board positions - Evonik Industries AG, Essen (Vice Chairperson) (a) B. Braun Melsungen AG, Melsungen no board positions no board positions b) - Merck BKK (rotating chairperson) no board positions - Kemira Oyj, Helsinki, Finland (b) E. Merck KG, Darmstadt¹ (a) - Gelita AG, Eberbach (Vice Chairman) (b) - E. Merck KG, Darmstadt¹ 2,077 (IG BCE), Hanover Edeltraud Glänzer Marcus Kuhnert Frankfurt am Main, CEO Healthcare Belén Garijo Eppertshausen, Member of the Executive Board until September 30, 2018 Walter Galinat Darmstadt, CEO Performance Materials Kai Beckmann Wellesley (Massachusetts, United States), CEO Life Science Udit Batra Munich, Chairman Stefan Oschmann Member (b) comparable German and foreign supervisory bodies of corporations (a) statutory supervisory boards and Memberships of 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 Corporate Governance 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. Königstein, Chief Financial Officer no board positions (b) EMD Millipore Corporation, Billerica, Massachusetts, United States (President) (a) - Bundesdruckerei GmbH, Berlin Seeheim-Jugenheim, Senior Product Manager Gabriele Eismann Wehrheim, Full-time member of the Merck Joint Works Council Mechthild Auge Darmstadt, Full-time member of the Merck Joint Works Council Crocifissa Attardo Gernsheim, Chairman of the Merck Joint Works Council Michael Fletterich Munich, Chairman of Exyte AG, Stuttgart Wolfgang Büchele Hanover, Vice Chairperson of IG Bergbau, Chemie, Energie Member Corporate Governance SUPERVISORY BOARD 186 The Executive Board passes its resolutions in meetings that are normally held once a month. 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 provides the Supervisory Board with regular, up-to-date and comprehensive reports about all company-relevant issues concerning strategy, planning, business developments, the risk situation, risk management and compliance. The rules of procedure of the Executive Board and of the Supervisory Board as well as a Supervisory Board resolution regulate further details on the informa- tion and reporting duties of the Executive Board vis-à-vis the Super- visory Board. The 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 Statement on Corporate Governance 2,769 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. Service cost 7,154 8,642 379 1,369 1,401 4,080 5,513 4,164 4,214 5,785 7,241 599 326 599 Total compensation¹ Service cost Total LTI 2015 (2015 to 2017) 2,077 402 2,077 4,593 LTI 2014 (2014 to 2016) 400 4,564 395 800 1,100 1,100 600 800 2018 2017 2018 2017 2018 2017 (left on: September 30, 2018) Fixed compensation Allocation (€ thousand) Member of the Executive Board Marcus Kuhnert Member of the Executive Board Member of the Executive Board Belén Garijo Walter Galinat 4,475 -2,028 3,485 900 Multi-year variable compensation 2,400 2018 2017 2018 2017 2018 Member of the Executive Board Kai Beckmann Member of the Executive Board Chairman of the Executive Board 2017 Fixed compensation Allocation (€ thousand) Udit Batra Stefan Oschmann ALLOCATION FOR THE FISCAL YEAR 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 1,300 2,400 1,300 1,000 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 Total compensation 12 186 164 Additional benefits 1,000 1,000 1,000 Additional benefits 38 26 3,340 168 3,725 3,887 5,665 5,343 2,931 3,172 599 599 105 866 1,194 140 Total compensation², 3 Service cost Total LTI 2015 (2015 to 2017) LTI 2014 (2014 to 2016) Multi-year variable compensation 2,200 166 3,097 2,582 394 1,604 32 Total LTI 2015 (2015 to 2017) 2017 Member of the Executive Board (left on: August 31, 2016). LTI 2014 (2014 to 2016) Multi-year variable compensation Profit sharing Total Additional benefits 2,200 Allocation (€ thousand) Fixed compensation 2017 2018 (left on: April 29, 2016) Member of the Executive Board Bernd Reckmann 4,146 5,491 6,059 7,925 421 2018 3,900 Karl-Ludwig Kley 2,200 Actually achieved value Merck LTIP tranche 2014 50% 0% -20% Upper target corridor limit Target Lower target corridor limit (external key performance indicator) Share price development relative to the DAX® Key performance indicator¹ 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. 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 177 Statement on Corporate Governance Corporate Governance Total 26 21 66 3,000 49 Target achieve- ment Merck LTIP tranche 2014 36.3% Merck Long-Term Incentive Plan EBITDA pre margin 2,200 Profit sharing 136.3% 926 821 1,166 1,149 626 value Merck LTIP tranche 2015 Upper target corridor limit Target 832 Target achieve- 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 2014. (internal key performance indicator) 126.7% 25% 29.6% 31% Lower target corridor limit 28% 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 Sales Expert, Life Science, CADORE São Paulo, Brazil Get to know our Merck team from Healthcare, Billerica, United States Hearts beats SHINJI OKITSU Group Leader Immunology, ANA LUISA 11 HEARTBEATS Semiconductors as a new driver of growth 26-27 HEARTBEATS Research drives us all 12-17 2. Vibrant China around the world at China is on the way to becoming a leading high-tech nation. We intend to take an active role in shaping this transformation with our China strategy. Big plans for China 20-22 The health platform for everyone 22-23 1 New partner 24-25 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. The needle-free sensor 30-31 A platform for the fight against cancer 32-33 Real meat without the side effects 34-35 New heroes wanted 36-37 10 3. Beyond tomorrow https://www.merckgroup.com/en/ Research drives us all MARC FEIGLIN 16 the passion. HEARTBEATS Yavne, Israel Head of Alliance Management & Partnership, MARC FEIGLIN 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." dreamed of helping "Even as a child, I 15 HEARTBEATS UVEX Billerica, United States Group Leader Immunology, Healthcare, SHINJI OKITSU "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." Research drives us all Head of Alliance Management & Partnership, Yavne, Israel FRANZISKA HÖLY Deputy Foreman, Performance Materials, Darmstadt, Germany SUNNY CHOI Talent and Development Manager, Seoul, Korea Research drives us all HEARTBEATS annualreport/2018/magazine/heartbeats 13 it makes my heart beat faster." SUNNY CHOI Talent and Development Manager, Seoul, Korea 14 HEARTBEATS "It's my job to give people the courage to explore new things that did not exist before. If they succeed at that, Why science? What fascinates us about it? We wanted to find out - so we followed "I am passionate about science, because sometimes it only takes a small finding for the big breakthrough that improves the lives of many people." Magazine 1. Heartbeats Research drives us all São Paulo, Brazil Sales Expert, Life Science, ANA LUISA CADORE 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 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. September 11 راق Table of Contents HIGHLIGHTS OF 2018 9 TABLE OF CONTENTS MAGAZINE November 28 Fourth place in the Access to Medicine Index This result means that we have maintained our ranking since the index was last published in 2016. We are proud of our efforts to improve access to medicine and thus the health of underserved populations. 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. 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 19 HIGHLIGHTS OF 2018 80 7 November 20 Darmstadt, Chairman of the Executive Board and Cures GmbH, Wuppertal General Partner of E. Merck KG, Vice Chairman Wolfgang Büchele Munich, Chairman of Exyte AG, Stuttgart Helga Rübsamen-Schaeff Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Michael Kleinemeier Köln, Head of Infrastructure Development at DB Netz AG, Frankfurt am Main Katharina Kraft Mannheim, Senior Management Consultant at BASF SE, Ludwigshafen Helene von Roeder Frankfurt am Main, Member of the Executive Board of Vonovia SE, Bochum Daniel Thelen Simon Thelen Köln, Senior Physician at the Clinic for Trauma and Hand Surgery, University Hospital Düsseldorf Memberships of Frank Stangenberg-Haverkamp Heidelberg, Member of the Executive Board of SAP SE, Walldorf Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman (a) - Merck KGaA, Darmstadt On January 27, 2019, a new election of the Board of Partners was held. The Board of Partners now consists of the following members: (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 Member - 4SC AG, Martinsried (a) - Merck KGaA, Darmstadt (a) - Merck KGaA, Darmstadt - Henkel AG & Co. KGaA, Düsseldorf (b) DKSH Holding Ltd., Zurich, Switzerland (a) Merck KGaA, Darmstadt Corporate Governance Statement on Corporate Governance 189 · Supervisory Board of Bonn University Hospital Johannes Baillou • (b) comparable German and foreign supervisory bodies of corporations Johannes Baillou Member The Board of Partners has nine members. During fiscal 2018 and up until January 27, 2019, the Board of Partners was composed as follows: Statement on Corporate Governance Corporate Governance 188 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. BOARD OF PARTNERS OF E. MERCK KG The German Stock Corporation Act prescribes that the Supervisory Board of a publicly listed company must have at least one member who has professional expertise in accounting or auditing. Theo Siegert satisfies these requirements and is furthermore the Chairman of the Finance Committee of the Board of Partners of E. Merck KG. The rules of procedure prescribe that the Supervisory Board may form committees. 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. The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairmen of the two boards. of the Group. The adoption of the annual financial statements is not the responsibility of the Supervisory Board, but of the General Meeting. The Supervisory Board normally meets four times a year. Further meetings may be convened if requested by a member of either the Supervisory Board or the Executive Board. As a rule, resolutions of the Supervisory Board are passed at meetings. At the instruction of the chairman, in exceptional cases a resolution may be passed by other means, details of which are given in the rules of procedure. The Supervisory Board examines the annual financial statements as well as the consolidated financial statements and the combined management report, taking into account in each case the reports of the auditor. Moreover, the Supervisory Board discusses the quarterly releases and the half-year financial report, taking into account in the latter case the report of the auditor on the audit review of the abridged financial statements and the interim management report However, the fact that the Supervisory Board has no possibilities to directly influence the Executive Board restricts neither its infor- mation rights nor audit duties. The Supervisory Board must monitor the Executive Board in terms of legality, regularity, usefulness and economic efficiency. In particular, the Supervisory Board has the duty to examine the reports provided by the Executive Board. This includes regular reports on the intended business policy, as well as other fundamental issues pertaining to corporate planning, especially financial, investment and HR planning; the profitability of the Merck Group; the progress of business; the risk situation; risk management (including compliance); and the internal auditing system. In addition, by means of consultation with the Executive Board, it creates the basis for supervision of the management of the company by the Supervisory Board according to section 111 (1) AktG. The Supervisory Board performs a monitoring function. It supervises the management of the company by the Executive Board. In com- parison with the supervisory board of a German stock corporation, the role of the supervisory board of a corporation with general partners (KGaA) is limited. This is due to the fact that the members of the Executive Board are personally liable partners and therefore are themselves responsible for the management of the company. In particular, the Supervisory Board is not responsible for appointing and dismissing general partners or for regulating the terms and conditions of their contracts. This is the responsibility of E. Merck KG. Nor does the Supervisory Board have the authority to issue rules of procedure for the Executive Board or a catalog of business trans- actions requiring approval. This authority likewise belongs to E. Merck KG (Article 13 (3) sentence 1 and (4) sentence 1 of the Articles of Association). 187 Statement on Corporate Governance Corporate Governance (a) statutory supervisory boards and Vienna, Austria, Vice Chairman of the Executive Board and General Partner of E. Merck KG, Chairman no board positions Frank Stangenberg-Haverkamp General Partner of E. Merck KG, Vice Chairman (a) statutory supervisory boards and Memberships of Munich, Managing Partner of Altmann Analytik GmbH & Co. KG, Munich Tobias Thelen Carstanjen & Söhne KG, Düsseldorf Düsseldorf, Managing Partner of de Haen Theo Siegert Umkirch, Pediatrician Gregor Schulz Cures GmbH, Wuppertal Langenburg, Chairperson of the Advisory Board of AiCuris Antiinfective Helga Rübsamen-Schaeff Bad Dürkheim Schriesheim, Commercial Director of the Castel Peter Winery, Albrecht Merck Darmstadt, Physician Siegfried Karjetta Munich, Chairman of Exyte AG, Stuttgart Wolfgang Büchele Darmstadt, Chairman of the Executive Board and (b) comparable German and foreign supervisory bodies of corporations Statement on Corporate Governance (b) - Fortas GmbH, Rösrath (Chairman) • Recognition and measurement of provisions for tax liabilities 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 194 Corporate Governance Report of the Supervisory Board • Goodwill impairment tests • Impairment testing of interests in associates • • Measurement of provisions for patent disputes • Measurement of disposal gains/losses from the divestment of the Consumer Health business 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. 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. CORPORATE GOVERNANCE AND DECLARATION OF CONFORMITY Corporate governance is a topic of high priority for the Supervisory Board. Recognisition and measurement of income tax liabilities and deferred tax liabilities 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 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. More than one-half of our Supervisory Board members are uni- versity graduates and hold doctorates. 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. 2Each country with at least one active employee is considered one country. Corporate Governance Report of the Supervisory Board Report of the Supervisory Board 193 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. COOPERATION 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. 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. 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. 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. 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. 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 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. 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). COMMITTEES Women on the Supervisory Board Six women are currently members of the Supervisory Board of Merck KGaA. Accordingly, women make up 37.5% of the Supervisory Board. When nominating candidates for election to the Supervisory Board or making proposals for delegations, the Supervisory Board shall examine whether the percentage of women can be increased by suitable candidates. The Supervisory Board considers the 37.5% share of women members to be satisfactory at the present time. This applies both owing to the percentage of women in leadership positions at Merck as well as the fact that the supervisory boards of other companies have a comparable percentage of women. Number of independent members, no material conflicts of interest The Supervisory Board shall have an appropriate number of 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. Age limit As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. Regular limit on the length of Supervisory Board membership The objective of the Supervisory Board regarding its composition is that, as a rule, all members belong to the board for an uninterrupted period of no more than 15 years (corresponds to three regular terms of office). With one exception, this objective is also met at the present time. Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise PROFILE OF SKILLS AND EXPERTISE 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. 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. Knowledge of business administration 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 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. no board positions 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. Corporate Governance 196 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. Apart from the Nomination Committee, the Supervisory Board of Merck KGaA currently has no further committees on account of the special features that apply to the Supervisory Board of a corporation with general partners (KGaA) under German company law and because a corresponding need for this has not emerged to date. The members of the Nomination Committee convened on November 9, 2018, in order to recommend suitable candidates to the Supervisory Board for the Supervisory Board elections in 2019. At its meeting, the committee discussed potential candidates. The discussion took into account the statutory requirements as well as the candidate's fit into the full Supervisory Board, the objectives of the Supervisory Board regarding its composition, its profile of skills and expertise and the diversity policy. No report is given on the work of further committees. PERSONNEL MATTERS 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. Darmstadt, February 26, 2019 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 195 Objectives of the Supervisory Board with respect to Its Composition and Profile of Skills and Expertise INITIAL SITUATION 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. GENERAL NOTES ON THE COMPOSITION OF THE SUPERVISORY BOARD 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. 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. OBJECTIVES OF THE SUPERVISORY BOARD WITH RESPECT TO ITS COMPOSITION In accordance with section 5.4.1 (2) of the German Corporate Governance Code, the Supervisory Board has specified the following objectives regarding its composition and reports on the status of implementation below: Internationality 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. 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. 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: The key prerequisites for high-performance leadership teams are both the diversity of the individual competency profiles and a balance Corporate Governance Statement on Corporate Governance 191 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 (see also pages 186 et seq. for the description of Supervisory Board procedures). that are listed or subject to co-determination stipulates binding targets Diversity policy pursuant to section for the percentage of positions on the Supervisory Board and on the Management Board held by women. However, for Merck KGaA, stip- ulations pursuant to section 111 (5) AktG need not be set for the following reasons: The statutory target of 30% pursuant to section 96 (2) AktG is already applied 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). 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 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 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: Management experience Gender Internationality, Gender diversity also plays a crucial role since it enables us to benefit from a larger talent pool, and allows us as a company to develop a better understanding of important customer groups. We have set ourselves the (global) strategic objective of maintaining the proportion of women in leadership positions (managers, experts and project managers in role 4 and higher¹) at a stable level of 30% by 2021 (please also refer to the description on page 94 under "Diversity and Management"). GENDER 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. 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. AGE Statement on Corporate Governance 1The relevant group represents approximately 6% of the entire workforce; see the section entitled "Diversity and Management" (on page 94). Corporate Governance In addition to the aspects presented in the following, reference is made to the objectives of the Supervisory Board with respect to its composition and the profile of skills and expertise of the Supervisory Board (see the information on the "Objectives of the Supervisory Board with respect to its composition and profile of skills and expertise" on pages 195 et seq.). The statements made there are part of the diversity policy for the Supervisory Board presented here. Our Group-wide diversity policy encompasses both voluntary as well as legally defined objectives that we continuously and sustainably work on to achieve. In this context, it should be noted that with respect to the Executive Board of Merck KGaA, many rules can only be applied correspondingly. This is because the Executive Board com- prises personally liable general partners of Merck KGaA and is not a management board with employed members of a corporate body (for details, please also see the "Joint Report of the Executive Board and the Supervisory Board" on pages 166 et seq.). Educational background Industry knowledge Age global mindset 192 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 (b) AVW Versicherungsmakler GmbH, Hamburg - Vonovia Finance B.V., Amsterdam, Netherlands No board positions - EDUCATIONAL BACKGROUND Supervisory Board of Bonn University Hospital - 4SC AG, Martinsried No board positions Merck KGaA, Darmstadt (b) - Kemira Oyj, Helsinki, Finland - Gelita AG, Eberbach (Vice Chairman) (a) Merck KGaA, Darmstadt - Travel Asset Group Ltd., London, United Kingdom (Chairman) Oras Invest Ltd, Helsinki, Finland - (a) 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. 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. 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 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. RESEARCH AND DEVELOPMENT COMMITTEE FINANCE COMMITTEE The Personnel Committee is responsible for, among other things, the following decisions concerning members and former members of the Executive Board: contents of and entry into employment con- tracts and pension contracts; granting of loans and advance pay- ments; changes to the compensation structure and adaptation of compensation; approval for taking on honorary offices, board posi- tions and other sideline activities; and division of responsibilities within the Executive Board of Merck KGaA. The Personnel Committee passes its resolutions by a simple majority; in matters concerning the Chairman of the Executive Board, unanimity is required. The Chairman of the Committee regularly informs the Board of Partners of its activities. Corporate Governance 190 The Personnel Committee has four members. During fiscal 2018 and up until January 27, 2019, these were: Johannes Baillou (Chairman), Wolfgang Büchele, Theo Siegert and Frank Stangenberg-Haverkamp. As of January 27, 2019, the Personnel Committee comprises Johannes Baillou, Wolfgang Büchele, Michael Kleinemeier and Frank Stangenberg- Haverkamp. The Personnel Committee meets at least twice a year. Further meetings are convened as and when necessary. Meetings of the Personnel Committee are attended by the Chairman of the Exec- utive Board of Merck KGaA unless the Committee decides otherwise. PERSONNEL COMMITTEE The 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. 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. (a) innogy SE, Essen 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 Mate- rials, respectively. Currently, the Executive Board has the full breadth of the sector- specific experience required. 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. 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. INTERNATIONALITY AND GLOBAL MINDSET MANAGEMENT EXPERIENCE Depreciation/amortization/impairment losses/reversals of impairments Profit after tax¹ € million Consolidated Cash Flow Statement 203 Consolidated Cash Flow Statement Consolidated Financial Statements 35,621 Changes in inventories 36,888 Total equity and liabilities 8,635 8,517 → 5 2,175 2,288 → 28 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". Changes in trade accounts receivable Changes in other assets and liabilities Changes in provisions Repayment of bonds Repayment of financial liabilities to E. Merck KG Payments from new borrowings of financial liabilities from E. Merck KG Dividend payments to E. Merck KG Dividend payments to non-controlling interests Dividend payments to Merck KGaA shareholders thereof: from discontinued operation Payments from the disposal of assets held for sale less transferred cash and cash equivalents Net cash flows from investing activities Payments from other divestments less transferred cash and cash equivalents Changes in trade accounts payable/refund liabilities Payments from the disposal of other financial assets 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 Net cash flows from operating activities thereof: from discontinued operation Other non-cash income and expenses¹ Neutralization of gains/losses on disposal of assets Liabilities directly related to assets held for sale Payments for acquisitions less acquired cash and cash equivalents Other current liabilities 1,016 1,176 → 28 Other non-current liabilities 8,033 6,681 → 35 Non-current financial liabilities 2,257 788 2,336 780 → 26 52 Other non-current provisions Provisions for pensions and other post-employment benefits Non-current liabilities 14,066 63 14,003 1,081 12,358 565 565 15,006 1,629 17,200 33 17,233 → 25 354 Deferred tax liabilities → 14 → 14 472 → 30 2,195 1,766 29 2,790 2,215 → 35 457 600 → 26 Income tax liabilities¹ Refund liabilities² Trade accounts payable² Current financial liabilities Current provisions¹ Current liabilities 12,919 1,489 1,288 11,138 Payments from new borrowings of other current and non-current financial liabilities Repayment of other current and non-current financial liabilities Note thereof: from discontinued operation 4 -593 -466 375 349 -319 -314 -323 -932 32 Comprehensive income 147 → 41 -1,821 -2,825 -496 5 -1,870 182 1,586 - 320 -13 -155 -162 -42 -106 -392 67 4 -910 -919 31 -75 44 -219 Changes in cash and cash equivalents due to currency translation -17 185 11 3,129 156 → 31 2,191 Non-controlling interests -1,147 3,042 55 -5 -30 Dividend payments 11 -346 -2,733 -1,256 -288 103 199 234 104 -7 -221 -184 -172 1,758 1,812 2,615 3,396 2017 2018 Changes in cash and cash equivalents -109 Net cash flows from financing activities → 18 2,696 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 2,219 24 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity For details see Note (36) "Equity". € million January 1, 2017 (as reported) Adjustment due to mandatory retrospective adoption of IFRS 9¹ January 1, 2017 (restated) Profit after tax² Other comprehensive income² 103 Consolidated Statement of Changes in Net Equity Equity attributable to Merck KGaA shareholders thereof: from continuing operations Reserves¹ → 37 7 -1 8 1 142 -13 29 -1 29 142 -41 2 141 -34 -7 → 25 2,615 3,396 2017 -71 88 52 12 619 -51 -7 -2,011 626 Other comprehensive income¹ Changes recognized in equity Reclassification to profit or loss Changes taken directly to equity 2018 4 10 5 -5 -47 → 37 69 -7 -31 12 -32 5.87 5.25 0.12 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 Debt instruments² Cash flow hedge reserve Reclassification to profit or loss Reclassification to assets Tax effect Changes recognized in equity Cost of cash flow hedge reserve¹ Fair value adjustments Reclassification to profit or loss Tax effect Changes recognized in equity Fair value adjustments -2,062 to profit or loss in subsequent periods Changes recognized in equity 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". 3 Not defined by International Financial Reporting Standard (IFRSS). Consolidated Financial Statements Statement of Comprehensive Income 201 Consolidated Statement of Comprehensive Income Items of other comprehensive income that may be reclassified € million 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 Profit after tax¹ 581 -1,989 568 2,764 23 -> 28,166 27,652 1,106 1,091 → 14 205 2,632 138 444 610 → 34 4,512 4,811 → 21 8,317 7,237 - 20 → 22 13,582 → 24 2,923 Equity capital → 36 Total equity 35,621 7,455 9,236 36,888 → 5 589 2,170 2,931 → 33 460 → 14 731 886 22 - 90 24 34 490 Gains/losses recognized in equity¹ 13,764 Dec. 31, 2017 67 2,330 thereof: from discontinued operation 700 1,634 Profit transfer to/from E. Merck KG 767 3,964 Comprehensive income 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". 6 → 36 thereof: attributable to non-controlling interests 761 3,943 767 3,964 thereof: attributable to Merck KGaA shareholders Comprehensive income -1,847 22 → 19 202 Consolidated Balance Sheet Dec. 31, 2018 Note Total assets Assets held for sale Cash and cash equivalents Income tax receivables Other current assets Current financial assets Trade accounts receivable Consolidated Financial Statements Inventories Deferred tax assets Other non-current assets Non-current financial assets Property, plant and equipment Other intangible assets Goodwill Non-current assets € million Consolidated Balance Sheet Current assets including changes in reserves Consolidated Statement of Changes in Net Equity Changes in scope of consolidation/Other 13,989 3,229 Total equity interests to Merck KGaA Non-controlling translation Equity attributable difference Cost of hedging reserve¹ Cash flow hedge reserve -191 24 instruments¹ financial assets¹ Currency Fair value reserve for debt Available-for-sale Gains/losses recognized in equity 205 CONSOLIDATED FINANCIAL STATEMENTS 61 14,050 3 24 761 -2,057 -4 69 7 -1,847 -4 -1,843 -2,057 197-321 69 2,615 10 2,605 14,050 61 13,989 3,229 3 -191 7 CONSOLIDATED FINANCIAL STATEMENTS Consolidated Income Statement 200 (20) Other intangible assets 234 (21) Property, plant and equipment 237 (22) Other assets 239 (23) Inventories 240 (24) Trade accounts receivable 240 (25) Provisions for pensions and other post-employment benefits 241 (26) Other provisions 247 (27) Contingent liabilities 252 (28) Other liabilities 253 (29) Trade accounts payable 254 (30) Refund liabilities 254 (19) Goodwill 231 (31) Net cash flows from investing activities 254 (32) Financial result/net gains or losses from financial instruments 255 (33) Cash and cash equivalents 257 (34) Financial assets 257 (35) Financial liabilities/capital management 258 (36) Equity 260 (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 Capital Structure, Investments and Financing Activities 255-285 6 (6) Collaborations of material significance 213 Group structure 210-215 Result from Operating Activities and Income Taxes 216-230 Consolidated Statement of Comprehensive Income 201 Consolidated Balance Sheet 202 Consolidated Cash Flow Statement 203 (7) Segment reporting 216 (8) Net sales 221 (9) Cost of sales 223 (10) Marketing and selling expenses 223 (11) Research and development costs 223 (12) Other operating income 224 (13) Other operating expenses 225 (14) Income tax 226 (4) Changes in the scope of consolidation 210 (5) Acquisitions and divestments 210 (15) Cost of materials 229 (17) Earnings per share 230 (18) Net cash flows from operating activities 230 Consolidated Statement of Changes in Net Equity 204 Operating Assets, Liabilities and Contingent Liabilities 231-254 General disclosures 206-209 (1) Company information 206 (2) Reporting principles 206 (3) Management judgments and sources of estimation uncertainty 208 (16) Personnel expenses/headcount 229 (45) Corporate governance 287 767 4 -175 -515 -515 -55 55 -3 -93 -96 -1 -128 -33 1,790 17,200 33 17,233 206 Consolidated Financial Statements Notes to the Consolidated Financial Statements -13 -162 3,964 22 -121 Note -1 1,171 13,992 63 14,055 3,374 22 General Disclosures 3,396 -32 619 569 -1 568 -7 -32 619 3,943 -7 (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 14,066 63 14,003 1,171 -1 -121 -31 31 14,066 -15 63 1,171 -1 -121 31 1 1 -593 -593 -159 14,003 -155 -15 4 These consolidated financial statements have been prepared in accordance with the International Financial Reporting Standards in force on the reporting date as issued by the International Accounting Standards Board (IFRS and IAS) and the IFRS Interpretations Com- mittee (IFRIC and SIC) and as adopted by the European Union as well as the additionally applicable provisions of section 315e of the German Commercial Code (HGB). The fiscal year corresponds to the calendar year. These financial statements have been prepared in euros, the reporting currency. The figures reported in the consoli- dated financial statements have been rounded, which may lead to individual values not adding up to the totals presented. The accounting and measurement policies used in the consolidated financial statements are presented in Notes (50) "Measurement pol- icies" to (69) "Share-based compensation programs". Regulations applicable as of fiscal 2018 and other presentation and measurement changes The following regulations take effect as of fiscal 2018: • IFRS 9 "Financial Instruments" • IFRS 15 "Revenue from Contracts with Customers" • IFRIC 22 "Foreign Currency Transactions and Advance Consideration" Amendment to IAS 40 "Investment Property" • • Amendment to IFRS 2 "Share-based payment" 1 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. -1 4 • 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" (46) Companies opting for exemption under section 264 (3) HGB or section 264b HGB 287 (47) Information on preparation and approval 287 (48) Subsequent events 288 59 -46 Changes in scope of consolidation/Other -55 Transactions with no change of control -515 including changes in reserves -162 29 -41 3,374 29 -41 Profit transfer to/from E. Merck KG Dividend payments Comprehensive income Other comprehensive income Profit after tax 3,374 -16 December 31, 2018 397 168 Earnings per share (in €) basic thereof: from continuing operations thereof: from discontinued operation diluted → 17 7.76 5.99 2.51 5.87 .6 5.25 7.76 5.99 2.51 Consolidated Financial Statements 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". 7 -1,340 12,525 3,814 0.12 -1,358 9,930 3,814 2,605 -1,501 8,046 3,814 168 397 -3 -1,501 for equity instruments 142 of defined benefit plans 3,814 Remeasurement Fair value reserve Capital reserves (share premium) Merck KGaA partner's equity Subscribed capital Merck KGaA Merck KGaA 168 397 General Retained earnings Equity capital December 31, 2017² Retained earnings/ net retained profit 8,049 10 2,605 -155 168 397 4 January 1, 2018 (restated) Adjustment on application of IAS 29¹ - -1,358 9,903 23 Adjustment on initial application of IFRS 91 Adjustment on initial application of IFRS 15¹ 142 3,814 397 January 1, 2018 -1,358 9,903 3,814 168 397 1 -593 168 22 → 36 thereof: attributable to non-controlling interests Net sales Cost of sales Gross profit Note 2018 2017 →8 14,836 14,517 € million → 9 -5,071 9,454 9,446 Marketing and selling expenses → 10 -4,384 -4,349 Administration expenses -993 -5,382 -899 Consolidated Income Statement¹ Consolidated Financial Statements Accounting and Measurement Policies 288-311 (49) Effects from new accounting standards and other presentation and measurement changes 288 (50) Measurement policies 301 (51) Consolidation methods 302 (52) Currency translation 302 (53) Recognition of net sales and other income 303 (54) Collaboration agreements, in-licensing and out-licensing in the Healthcare business sector 304 (55) Research and development costs 305 (56) Goodwill 305 (57) Other intangible assets 305 (58) Property, plant and equipment 306 (59) Leasing 306 (60) Financial assets 306 Consolidated Income Statement (61) Financial liabilities 308 (63) Contingent consideration 309 (64) Other non-financial assets and liabilities 309 (65) Deferred taxes 309 (66) Inventories 310 (67) Provisions for pensions and other post-employment benefits 310 (68) Other provisions and contingent liabilities 310 (69) Share-based compensation programs 311 List of Shareholdings 312-321 (70) List of shareholdings 312 200 (62) Derivatives and hedge accounting 308 Transactions with no change of control Research and development costs -2,225 -345 1,461 2,129 Income tax → 14 -368 428 Profit after tax from continuing operations 1,093 -343 2,557 → 5 2,303 57 Profit after tax 3,396 2,615 thereof: attributable to Merck KGaA shareholders (net income) 3,374 2,605 Profit after tax from discontinued operation → 11 → 32 77 -2,108 Impairment losses and reversals of impairment losses on financial assets (net)2 → 38 27 Other operating income → 12 627 1,212 Other operating expenses 51 → 13 -880 Operating result (EBIT)³ 1,727 2,423 Finance income Finance costs Profit before income tax - 32 -780 Exchange differences on translating foreign operations Notes to the 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 medium IAS 2 Trade accounts receivable 2,931 → 24, 38 yes Determination of impairment amount medium IFRS 9 Other financial assets Identification of impairments (or reversal of impairments) →34, 39 Determination of fair values of contingent considerations high 259 IFRS 13 IFRS 9, Determination of fair values of equity instruments medium 274 IFRS 13 Provisions for pensions and other post-employment benefits yes → 25 no 2,764 -20 yes In-licensing of intangible assets medium IAS 38 Identification of impairments (or reversal of impairments) medium IAS 36 Determination of amortization medium → 23 IAS 38 4,811 → 21 no Identification of impairments (or reversal of impairments) medium IAS 36 Determination of depreciation medium IAS 16 Inventories Property, plant and equipment yes Determination of present value of defined-benefit obligations medium high -1,176 IAS 12 Recognition and measurement of deferred taxes from temporary differences Recognition of deferred tax assets from loss carryforwards medium medium IAS 12 33 IAS 12 Assets held for sale → 5 Recognition and measurement of income tax liabilities no high IFRS 5 210 Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure (4) Changes in the scope of consolidation The scope of consolidation changed as follows in the reporting period: Consolidated subsidiaries as of December 31, 2017 Additions Date on which assets and liabilities are classified as "held for sale" no → 14 Income tax -4,719 IAS 19 Other provisions and contingent liabilities -1,381 → 26,27 no Recognition and measurement of contingent liabilities high IAS 37 Recognition and measurement of other provisions high IAS 37 Determination of fair values of share-based compensation programs medium IFRS 2 Revenue recognition → 6,8,30 yes Determination of type and timing of revenue recognition (including upfront and milestone payments received) Measurement of sales deductions, and refund liabilities medium medium IFRS 15 IFRS 15 7,237 Retirements Other intangible assets high 30.4% 29.8% 28.6% 24.9% 1,786 1,840 1,773 1,556 1,580 206 85 7,568 -256 1,755 2,028 Consolidated Financial Statements Notes to the Consolidated Financial Statements 207 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. Furthermore, Merck's consolidated financial statements will not be affected by the new sale-and-lease-back regulations introduced per IFRS 16. 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 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. 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. 63 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: 8,184 20,422 3 Not defined by International Financial Reporting Standard (IFRSS). 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 2 Excluding intersegment sales. 1,025 Business free cash flow³ 1,402 1,393 1,314 1,516 1,621 1,629 20,860 1,159 19 310 327 313 359 379 59 -1,254 -1,333 -2,985 -2,893 55 Consolidated Balance Sheet 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. 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: • IFRS 17 "Insurance Contracts" • Amendment to IAS 1 "Presentation of Financial Statements" • Amendment to IAS 8 "Accounting Policies, Changes in Accounting Estimates and Errors" • Amendment to IAS 19 "Employee Benefits" (3) Management judgments and sources of estimation uncertainty 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 209 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: Discretion- Goodwill ary scope/ estimation uncertainty Carrying amount Dec. 31, 2018 (€ million) See Note for details Sensitivity analysis IFRSS 13,764 → 19 yes Determination of recoverable amount Items 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. Consolidated Income Statement Consolidated Cash Flow Statement € million Non-current assets Land, land rights and buildings, including buildings on third-party land Plant and machinery Other facilities, operating and office equipment January 1, 2019 € ~ 385 million € ~15 million € ~ 70 million 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). 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. 208 Consolidated Financial Statements Notes to the Consolidated Financial Statements Merck will make use of the following practical expedients of IFRS 16: • as before, right-of-use assets, including the corresponding liabilities, from leases of low-value assets will not be recognized in the con- solidated balance sheet; • leases of intangible assets within the scope of IAS 38 will not be recognized in accordance with IFRS 16; 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 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. Merck will not apply the practical expedient regarding leases with a term of less than 12 months. • Amendment to IFRS 3 "Business Combinations" • Annual Improvements to IFRSS 2015-2017 Cycle • Amendments to References to the Conceptual Framework in IFRS Standards IAS 36 Establishment Acquisitions Materiality STRATEGIC ALLIANCE WITH PFIZER INC., UNITED STATES, TO CO-DEVELOP AND CO-COMMERCIALIZE ACTIVE INGREDIENTS IN IMMUNO-ONCOLOGY On November 17, 2014, Merck formed a global strategic alliance with Pfizer Inc., United States, (Pfizer) to co-develop and co-commercialize the anti-PD-L1 antibody avelumab and an anti-PD-1 antibody con- tributed by Pfizer. In 2017, avelumab was approved for the first time under the trade name BavencioⓇ for the treatment of patients with metastatic Merkel cell carcinoma as well as patients with locally advanced or metastatic urothelial cancer. This antibody is also being studied in multiple broad-based clinical trials as a potential treatment for further tumor types. The active ingredient is to be developed as a single agent as well as in various combinations with a broad portfolio of approved and investigational active ingredients. The overriding objective of the strategic alliance is sharing the development risks and to accelerate the two companies' presence in immuno-oncology. According to the collaboration agreement, during the development period each company bears one-half of the development expenses. In the commercialization phase, Merck realizes the vast majority of sales from the commercialization of BavencioⓇ while Merck and Pfizer evenly split the net amount of sales less defined expense compo- nents. The execution of the collaboration agreement is not being structured through a separate vehicle. Upon entry into the agreement in 2014, Pfizer made an upfront cash payment of US$ 850 million (€ 678 million) to Merck. Pfizer also committed to make further payments of up to US$ 2 billion to Merck subject to the achievement of defined regulatory and commercial mile- stones. Based on the collaboration agreement, Merck additionally received the right to co-promote for multiple years Xalkori® (crizotinib), 214 Consolidated Financial Statements Notes to the Consolidated Financial Statements a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive or whose tumors are metastatic ROS1-positive. During co-promotion of XalkoriⓇ, Merck receives from Pfizer a profit share, which is reported in net sales. In 2018, this profit share income amounted to € 58 million (2017: € 72 million). At initial recognition, the right was measured at fair value by an inde- pendent external expert using the multi-period excess earnings method. The right was capitalized when it was granted and is being amortized over the term of the agreement. The residual book value of this intangible asset as of December 31, 2018, was € 68 million (December 31, 2017: € 93 million). An impairment loss of € 33 million was recognized for rights to XalkoriⓇ in 2017. 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). SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - COLLABORATION AGREEMENTS In the past, Merck occasionally recognized income for upfront and milestone payments as well as license fees received under collabora- tion agreements. 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). In this context, Merck had to assess the extent to which the requirements of IFRS 15 had to be applied directly or indirectly. 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. 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. 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). AGREEMENT WITH BRISTOL-MYERS SQUIBB COMPANY, UNITED STATES, FOR THE CO-COMMERCIALIZATION OF GLUCOPHAGE® IN CHINA 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 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). Consolidated Financial Statements Notes to the Consolidated Financial Statements 215 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. If so, Merck had to determine whether Merck's contractually promised goods or services contained in the collaboration agreement could be separated or not. 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. ACQUISITIONS IN THE PREVIOUS YEAR On August 31, 2017, Merck completed the divestment of the Biosim- ilars business to subsidiaries of Fresenius SE & Co. KGaA. In addition to the divestment of the business activities, the contract parties entered into supply and services agreements, which include drug development support and manufacturing services. As compensation for the sale of the business activities, Merck received an upfront payment of € 156 million. According to the agreed terms of the trans- action, Merck was entitled to future milestone payments of up to € 497 million, which were partly covered by services to be performed, as well as tiered royalties on product sales. The disposal gain amounted to € 319 million and was recorded under other operating income. Further information regarding the fair values determined in 2017 by an external expert for the contingent consideration compo- nents and the sensitivity analysis can be found in Note (39) "Infor- mation on fair value measurement". 60 14 75 128 699 93 606 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - ASSETS HELD FOR SALE, DISPOSAL GROUPS AND DISCONTINUED OPERATIONS The assessment as to when a non-current asset, disposal group or discontinued operation meets the prerequisites of IFRS 5 for classi- fication as "held for sale" is subject to significant discretionary judg- ment. Even in the case of an existing management decision to review a disposal, an assessment subject to uncertainties has to be made as to the probability that a corresponding disposal will occur during the year or not. Regarding the divestment of the Consumer Health business, material information was made available to potential buyers first in fiscal 2018, using electronic data rooms. It was only on the basis of this information that potential buyers were able to submit binding offers that were analyzed by Merck based on its price expectations. During Consolidated Financial Statements 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. Notes to the Consolidated Financial Statements the subsequent negotiations with potential buyers, the negotiating parties were able to define the transaction in more specific terms, i.e. material changes to the disposal plan were not unlikely at the balance sheet date (December 31, 2017). Against this background at December 31, 2017, the Executive Board did not consider the divestment of the Consumer Health business within the next twelve months as highly probable. DIVESTMENT OF FLOW CYTOMETRY BUSINESS On October 18, 2018, Merck signed an agreement with Luminex Corporation, United States, concerning the divestment of the flow cytometry business. These business activities comprised the flow cytrometry platforms Amnis® and GuavaⓇ as well as the associated reagents under these brands. The disposal proceeds amounted to € 66 million (US$ 75 million), of which € 61 million (US$ 70 million) was paid in fiscal 2018. The remaining € 5 million will be paid in fiscal 2019. The transaction was completed on December 31, 2018. The business activities assigned to the Life Science business sector primarily consisted of the allocated goodwill as well as intangible assets and inventories. This divestment generated a disposal gain of € 9 million which was recognized in other operating income. On September 15, 2017, Merck acquired a 100% interest in Natrix Separations, Inc. (Natrix). The company, which is headquartered in Burlington, Canada, supplies hydrogel membrane products for single- use chromatography. Natrix was integrated into the Life Science business sector. The purchase price comprised fixed compensation of around US$ 14 million (€ 12 million) as well as milestone payments of up to US$ 8 million (€ 7 million). The purchase price allocations for GSI and Natrix remained unchanged compared to December 31, 2017. The most significant impact from the purchase price allocations resulted, in both cases, from the remeasurement of technology-related intangible assets. (6) Collaborations of material significance DIVESTMENT OF BIOSIMILARS BUSINESS IN PREVIOUS YEAR 213 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, 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 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. Life Science 2018 2017 2018 2017 6,246 6,190 6,185 5,882 51 Healthcare 57 1,337 1,036 834 747 726 696 743 13 53 23 731 Net cash flows from operating activities Investments in intangible assets 4 Investments in property, plant and equipment4 IMMUNO-ONCOLOGY COLLABORATION WITH F-STAR DELTA LTD., UNITED KINGDOM 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. DEVELOPMENT AGREEMENT WITH THE SFJ PHARMACEUTICALS GROUP, UNITED STATES, TO DEVELOP ABITUZUMAB 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. 216 Consolidated Financial Statements Notes to the Consolidated Financial Statements Result from Operating Activities and Income Taxes (7) Segment reporting INFORMATION BY BUSINESS SECTOR¹ € million Net sales² Intersegment sales Operating result (EBIT)³ Depreciation and amortization Impairment losses Reversals of impairment losses EBITDA³ Adjustments³ EBITDA pre (Segment result)³ EBITDA pre margin (in % of net sales)³ Assets by business sector Liabilities by business sector 54 7 46 827 Expenses Gain on the disposal of discontinued operation Profit/loss of discontinued operation before income tax Income tax on ordinary activities Income tax on the gain on the disposal of discontinued operation Proift/loss of discontinued operation after income tax thereof: attributable to Merck KGaA shareholders thereof: attributable to non-controlling interests 2018 2017 748 809 Net sales -680 2,614 2,682 101 -8 -43 -370 2,303 57 2,281 53 -709 € 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 Liquidations/mergers Divestments Immateriality Loss of control Consolidated subsidiaries as of December 31, 2018 Non-consolidated subsidiaries as of December 31, 2017 Non-consolidated subsidiaries as of December 31, 2018 314 5 1 10 -16 -13 301 59 44 Overall, the impact of subsidiaries not consolidated due to immate- riality on net sales, profit after tax, assets and equity was less than 1% relative to the entire Merck Group. Investments held in non-con- solidated subsidiaries were disclosed under non-current financial assets (see Note (34) "Financial assets"). The list of non-consolidated subsidiaries mainly comprises non-operating shelf companies as well as entities subject to liquidation procedures, which are measured at fair value through other comprehensive income. 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"). (5) Acquisitions and divestments 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 commercial operations in 44 countries, the Consumer Health business also comprised two production facilities in Austria and India. Moreover, with respect to the transfer of the shareholdings in Merck Ltd., India, the commercial operations of other business sectors were transferred as well, and immediately repurchased. About 3,300 employees trans- ferred to P&G as part of the Consumer Health business divestment. In addition to the divestment agreement, Merck and P&G signed a number of manufacturing, supply and service agreements. With the signing of the agreement to divest the Consumer Health business, in the opinion of the Executive Board the preconditions for classification as a discontinued operation pursuant to IFRS 5 were given. Until transaction closing, the parts of the Consumer Health business being transferred to P&G were disclosed in the consolidated balance sheet as assets held for sale and as liabilities directly related to assets held for sale. 1,492 Consolidated Financial Statements Notes to the Consolidated Financial Statements 22 4 According to the consolidated cash flow statement. 4 The following table provides the reconciliation from the disposal proceeds to the preliminary net gain from the disposal of discon- tinued operation before tax: Other current assets Total assets Non-current liabilities Provisions for pensions and other post-employment benefits Other non-current liabilities and provisions Current liabilities Trade accounts payable Other current liabilities and provisions Total liabilities Net assets divested (including non-controlling interests) thereof: non-controlling interests Net assets divested Receivables Carrying 251 84 48 8 391 241 43 115 38 436 amounts on the disposal date Inventories Cash and cash equivalents Current assets € million Disposal proceeds less: net assets divested Subtotal Transaction costs related to the disposal Realized currency translation effects on equity Disposal gain before tax 2018 3,364 -606 2,758 -103 -41 2,614 212 Consolidated Financial Statements Notes to the Consolidated Financial Statements Net assets divested comprised the following items: € million Non-current assets Goodwill Property, plant and equipment Deferred tax assets Other non-current assets Neither net gains nor losses on fair value measurement less costs to sell were recognized for fiscal 2018 or the previous year. 3 INFORMATION BY COUNTRY AND REGION¹ € million 14,868 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 -902 623 2,839 -1,050 927 -166 Number of employees 25,791 25,979 13,513 13,302 2,234 2,151 10,978 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. Europe 1,024 -186 2,124 -87 575 1,002 4,406 4,559 Net sales by customer location² 2017 2018 945 2018 North America thereof: Switzerland thereof: Germany 2018 2017 2018 614 2017 211 2017 3,818 6,537 223 Goodwill and other intangible assets 3,835 3,871 390 360 1,416 1,407 4,828 5,012 Net sales by company location² 3,810 5,562 996 3,704 544 544 14,836 14,517 950 959 4,718 4,532 1,659 1,416 879 357 364 14,836 1,583 3,672 1,869 2017 4,965 thereof: China Latin America Middle East and Africa Merck Group 2018 14,517 2018 2017 4,761 2018 2018 2017 2018 2017 2018 2017 3,627 3,623 2017 14,857 127 570 -30 -26 -17 -17 -14 -12 -2,225 -2,108 -73 10,486 3,550 3,324 3,337 4,027 1,121 1,060 51,713 52,880 11,294 14,675 -69 4,512 665 32 39 2 2 21,001 21,899 1,020 -185 10,800 -165 10,339 923 531 266 214 Asia-Pacific 114 43 45 4,811 585 thereof: United States 910 2,508 232 60 41 1,743 1,742 21 26 4 240 58 -87 769 947 -488 -391 3,528 4,164 17 86 2,423 1,727 -437 217 Performance Materials Corporate and Other Merck Group 2018 2017 2018 2017 2018 2017 2,406 2,446 14,836 14,517 -51 -57 508 689 -548 33 2,696 3,193 107 272 13 14 100 15 116 218 919 13 106 116 392 969 -1,303 -1,418 2,219 588 906 -497 -429 742 119 -21,554 -19,655 82 786 980 -381 -292 3,800 4,246 32.7% 40.1% 25.6% 29.3% 4,046 3,942 -489 -484 4,414 -14,940 3,073 -16,832 36,888 35,621 99 Consolidated Financial Statements -292 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. -2 -23 -272 Impairment losses - 18 -14 -19 -3 -190 -55 Adjustments (total)¹ -63 -27 -209 -2 -26 -327 ¹Not defined by International Financial Reporting Standards (IFRSS). Reversals of impairment losses 220 -13 reversals of impairment losses¹ -3 -99 -1 -142 Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Other adjustments -45 -2 -3 -50 -25 -25 -2 2 -58 Adjustments before impairment losses/ -6 Consolidated Financial Statements Notes to the Consolidated Financial Statements € million -188 Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses 310 310 Acquisition-related adjustments -1 -3 -5 -63 Other adjustments -13 -10 -42 -5 -11 -81 -56 -131 -21 -31 2017 Restructuring expenses thereof: marketing thereof: cost of sales¹ and selling thereof: administration thereof: research and development thereof: other operating income expenses¹ expenses¹ costs¹ and expenses¹ Total¹ -5 -12 -41 -3 -61 -46 Notes to the Consolidated Financial Statements -39 Total Operating result (EBIT)² 1,727 2,423 Financial result -266 -294 Profit before income tax 1,461 -82 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). Notes to the Consolidated Financial Statements 219 The adjustments comprised the following: € million Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Consolidated Financial Statements Other adjustments -272 -1,741 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. 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. 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. The following table presents the reconciliation of EBITDA pre of all operating businesses to the profit before income tax of the Merck Group: € million EBITDA pre of the operating businesses² Adjustments² 2018 4,181 4,538 Corporate and Other EBITDA pre of the Merck Group² - 381 3,800 4,246 Depreciation/amortization/impairment losses/reversals of impairment losses -1,801 20171 Adjustments before impairment losses/reversals of impairment losses² Impairment losses Reversals of impairment losses the Biosimilars business in the previous year, and were included in other operating expenses. 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 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: € million 2018 Restructuring expenses Integration expenses/IT expenses thereof: 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 cost of sales -39 thereof: marketing and selling thereof: administration thereof: research and development expenses expenses costs thereof: other operating income and expenses -1 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 -327 Adjustments (total)² 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). 2018 20171 -46 -61 -142 -188 -25 310 -2 -63 -58 -81 -272 -82 -55 -68 87 -6 2,129 reversals of impairment losses² 428 6,246 100% 6,185 100% 2,406 100% 14,836 100% The following tables present a breakdown of net sales by key product lines/products: HEALTHCARE € million/in % Oncology thereof: ErbituxⓇ thereof: BavencioⓇ Neurology & Immunology thereof: Rebif® thereof: MavencladⓇ Fertility thereof: Gonal-f® 2018 944 15% 816 13% 4% 69 544 1% 2,173 35% 214 9% 3,818 26% 1,501 24% 1,532 25% 1,932 80% 4,965 33% 661 11% 256 4% 32 2% 950 6% 448 7% 88 8 23% 1% 24% 222 Consolidated Financial Statements Notes to the Consolidated Financial Statements LIFE SCIENCE € million/in % Process Solutions Research Solutions Applied Solutions Total PERFORMANCE MATERIALS € million/in % Display Solutions Surface Solutions Semiconductor Solutions Other Total 2018 2,487 40% 2,048 33% 1,650 27% 6,185 100% 100% 1,529 6,246 270 1,438 23% 90 1% 1,162 19% 708 11% General Medicine & Endocrinology 2,341 38% thereof: GlucophageⓇ 733 12% thereof: ConcorⓇ® 475 8% thereof: Euthyrox® 363 6% thereof: SaizenⓇ 234 4% Other Total 4% 2018 1,432 4,559 20171 4,246 -932 -1,012 Changes in inventories -214 -18 Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems -145 -22 -2 Business free cash flow² 2,508 3,193 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). Consolidated Financial Statements Notes to the Consolidated Financial Statements 221 (8) Net sales The following tables present a more detailed breakdown of net sales from contracts with customers by business sector. € million/in % Net sales by nature of the products Goods Equipment/hardware 2018 Healthcare 2018 3,800 6,085 software as well as advance payments for intangible assets EBITDA pre² -50 -43 -219 -5 235 -82 Impairment losses -6 -33 -16 -14 -68 Reversals of impairment losses 87 87 Adjustments (total)² 31 -76 -219 -21 222 -64 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). Business free cash flow was determined as follows: € million Investments in property, plant and equipment, 31% 98% 87% Net sales by region (customer location) Europe North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) Total 58 1% 58 6,246 100% 6,185 100% 2,406 100% 14,836 100% 2,203 35% 2,136 35% 220 9% Total Life Science 5,413 agreements 14 Performance Materials 2,404 Group 100% 13,902 94% 4 343 6% 347 2% 84 1% 424 7% 2 510 4% 4 4 1 15 Services License income Notes to the Consolidated Financial Statements Commission income Income from co-commercialisation Adjustments before impairment losses/ 1,332 476 -25 -7 -23 -13 -6 -23 -2 -6 -36 -185 -218 -780 -880 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. 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. Litigation expenses amounting to € 74 million (2017: € 108 million) arose primarily from additions to provisions for legal disputes (see Note (26) "Other provisions"). Impairments of non-financial assets amounted to € 58 million (2017: € 86 million), € 20 million of which were attributable to a technology in the Performance Materials business sector and € 19 million of which were attributable to software modules in the Life Science business sector which are not further developed and no longer used (see Note (20) "Other intangible assets"). Restructuring expenses in the amount of € 45 million (2017: € 64 million) resulted, among other things, from the adjustment of corporate structures in Darmstadt and Gernsheim. In addition, Merck incurred further expenses from the relocation of the shared service organization. In the previous year, restructuring expenses also arose in connection with the planned closure of German sites of the Life Science business sector. 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. 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. 226 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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: -40 Impairment losses -31 -31 Project expenses Expenses for miscellaneous services Losses on disposal of businesses and non-current assets Acquisition expenses Impairment losses on financial assets² Remaining other operating expenses Other operating expenses 2018 2017¹ -104 -156 -74 -108 -62 -3 -58 -86 -53 -54 -46 -27 -45 -64 -36 -38 -2 Expenses for the company's 350-year anniversary (including employee bonus) Expenses for company's 350-year anniversary Cost of sales -1 Total -45 -64 -58 -86 -31 -40 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". (14) Income tax € million Current income taxes in the period Income taxes for previous periods Deferred taxes in the period Income taxes 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". TAX RECONCILIATION 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. 2018 -579 20171 -694 -79 -14 290 1,137 -368 -14 € million -3 - 5 Marketing and selling expenses Administration expenses Restructuring expenses 2018 on non-financial assets (including employee bonus) 20171 2018 20171 2018 20171 -23 -6 -6 -17 -15 -33 -1 -12 - 39 -45 -19 -30 -21 Research and development costs -33 Other operating expenses 55% Expenses for the revaluation of contingent considerations Restructuring 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). (10) Marketing and selling expenses Marketing and selling expenses comprised the following items: € million Sales force Internal sales services Sales promotion Logistics Amortization of intangible assets² Royalty and license expenses Other marketing and selling expenses Marketing and selling expenses 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. 2018 2017¹ -913 -918 -808 -795 -509 -504 -702 -649 -975 -1,014 (9) Cost of sales -213 223 Consolidated Financial Statements 20% 596 25% 1 2,406 100% 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. 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 from customer-specific equipment/hardware in the Life Science busi- ness sector. 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. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - REVENUE RECOGNITION • historical experience, • pricing information as well as expected product growth rates Sales deductions 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. The measurement of sales deductions and refund liabilities resulting from expected rebates and discounts took into consideration. The measurement of sales deductions and refund liabilities resulting from rights of return took • historical return rates of individual product groups, 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. 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". Notes to the Consolidated Financial Statements Premiums, fees and contributions -224 -245 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. 15 10 1 91 87 138 627 100 1,212 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). 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 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). 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 225 (13) Other operating expenses The breakdown of other operating expenses was as follows: € million Integration expenses/IT expenses Litigation Exchange rate differences from operating activities (net) Impairment losses on non-financial assets Non-income related taxes Profit share expenses Other operating income -263 Remaining other operating income Reversal of impairment losses on financial assets² -4,384 -4,349 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. € 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. (11) Research and development costs 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. 224 Consolidated Financial Statements Notes to the Consolidated Financial Statements (12) Other operating income Other operating income was as follows: € million 2018 2017¹ Income from upfront payments, milestone payments, rights and royalties 368 564 Gains on disposal of businesses and non-current assets 83 350 Gains from the release of provisions for litigation 21 10 Income from miscellaneous services Income from the revaluation of contingent considerations Reversal of impairment losses on non-financial asset Consolidated Financial Statements Marketing authorizations 3,953 3,726 191 4,012 143 6,786 146 7,243 197 9,272 160 9,856 680 15,570 623 16,239 thereof: Consumer Health Total Total Consumer Health¹ thereof: 2017 2018 172 Other 15,445 15,073 Operating Assets, Liabilities and Contingent Liabilities 231 Notes to the Consolidated Financial Statements Consolidated Financial Statements In the period under review, the neutralization of the profits/losses from the disposal of assets and other disposals mainly comprised the gain from the divestment of the Consumer Health business; in the previous year, this item mainly comprised the gain from the divest- ment of the Biosimilars business. In the previous year, the changes of other assets and liabilities included the adjustment of deferred taxes as a result of the U.S. tax reform. In 2018, tax payments totaled € 900 million (2017: € 702 million). Tax refunds totaled € 65 million (2017: € 73 million). Interest paid totaled € 286 million (2017: € 297 million). Interest received amounted to € 34 million (2017: € 28 million). (18) Net cash flows from operating activities The calculation of diluted earnings per share had to take into account a potential dilution effect that arose from the free grant of Merck shares to eligible employees on the occasion of the 350th anniversary of the company. The shares required for this were pur- chased on the market. Pursuant to IAS 33, this led to an increase of 17,924 in the weighted average (diluted) number of shares to 434,795,802 shares. However, this did not lead to an arithmetical dilution effect on the indicator so that diluted earnings per share corresponded to basic earnings per share. Basic earnings per share are calculated by dividing the profit after tax (net income of the Group) attributable to the shareholders of Merck KGaA by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's capital is not represented by shares. The share capital of € 168 million was divided into 129,242,252 shares. Accordingly, the general partner's capital of € 397 million was divided into 305,535,626 theoretical shares. Over- all, equity capital thus amounted to € 565 million or 434,777,878 theoretical shares outstanding. The weighted average (basic) number of shares in 2018 was likewise 434,777,878. (17) Earnings per share 1The average number of employees of the Consumer-Health-business during the time of affiliation to the group from January to November 2018 was 3,358. 965 53,760 Average number of employees 3,456 51,990 3,100 11 1,563 7 2,253 1,973 (19) Goodwill Marketing and Sales Research and Development 2017 2018 € million Personnel expenses comprised the following: (16) Personnel expenses/headcount Material costs in 2018 amounted to € 2,598 million (2017: € 2,322 mil- lion) and were largely reported under cost of sales. (15) Cost of materials ⚫the existing tax planning of the respective Group company. ⚫ results planning and ⚫ results history, The recognition of deferred tax assets from loss carryforwards required an estimate of the probability of the future realizability of loss carryforwards. The following influencing factors were taken into account as part of this assessment: ticularly related to deferred taxes recognized in the context of the acquisitions of the Sigma-Aldrich Corporation, the Millipore Corpo- ration, Serono SA, and AZ Electronic Materials S.A. With regard to deferred tax items, there were degrees of uncer- tainty concerning the date on which an asset is realized or a liability settled and concerning the tax rate applicable on this date. This par- The recognized income tax liabilities and provisions were partially based on estimates and interpretations of tax laws and ordinances in different jurisdictions. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - INCOME TAXES The calculation of the reported assets and liabilities from current and deferred income taxes required extensive discretionary judgments, assumptions and estimates. The disclosure of interest and penalties related to income taxes was adjusted with retrospective effect as of January 1, 2017, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". As of December 31, 2018, income tax liabilities, including provisions for uncertain tax obligations, amounted to € 1,176 million (Decem- ber 31, 2017: € 1,016 million). INCOME TAX RECEIVABLES AND INCOME TAX LIABILITIES Income tax receivables amounted to € 460 million (December 31, 2017: € 490 million). Tax receivables resulted primarily from tax prepayments that exceeded the actual amount of tax payable for 2018 and prior fiscal years, and from refund claims for prior years. 229 Notes to the Consolidated Financial Statements Consolidated Financial Statements Wages and salaries Supply Chain 4,111 619 Administration Production The following table provides the number of employees by function (annual average): Effective December 31, 2018, the number of employees at Merck Group stood at 51,713 (December 31, 2017: 52,880 employees). The previous year's figure included all employees at the Consumer Health business. Personnel expenses comprised expenses of € 91 million (2017: € 86 million) for defined contribution plans which are funded exclu- sively using external funds and therefore do not represent any obli- gation for Merck other than making contribution payments. In 2017, this included an amount of € 1 million attributable to the Consumer Health business. In addition, employer contributions amounting to € 81 million (2017: € 76 million) were transferred to the German stat- utory pension insurance system and € 44 million (2017: € 46 million) to statutory pension insurance systems abroad. Each of these total transfer amounts included an amount of € 1 million attributable to the Consumer Health business (2017: € 2 million). Notes to the Consolidated Financial Statements Consolidated Financial Statements 230 4,632 4,820 Personnel expenses (as reported in the functional costs) 211 204 Consumer Health 4,843 5,024 Personnel expenses (including Consumer Health) 304 295 Pension expenses 586 Compulsory social security contributions and special financial assistance to the retained earnings of subsidiaries, for which no deferred taxes are recognized, amounted to € 9,934 million (December 31, 2017: € 2,856 million). € million Changes in scope of consolidation 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 13,764 1,334 10,896 1,534 Net carrying amount as of December 31, 2018 13,764 1,334 10,896 1,534 464 57 408 -282 -31 -251 -1 13,582 1,278 10,519 1,785 13,582 232 1,278 Consolidated Financial Statements Goodwill was incurred mainly in connection with the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A., the Millipore Corporation and Serono SA. The changes in goodwill caused by for- eign exchange rates resulted almost exclusively from translating the goodwill from the acquisitions of the Sigma-Aldrich Corporation, AZ Electronic Materials S.A. and the Millipore Corporation, which were partially denominated in U.S. dollars, into the reporting currency. Discount rate after tax (weighted average cost of capital - WACC) Long-term growth rate after the detailed planning period Net cash flows Most recent financial medium-term planning approved by the Executive Board and used for internal purposes 4 years Performance Materials Life Science Consumer Health¹ (previous year) Healthcare (excluding Consumer Health) Value in use Determination of the value of the key assumptions Detailed planning period Key assumptions Planning basis Measurement basis Impairment test level When conducting the impairment tests the following parameters were used: The determination of the recoverable amount is subject to manage- ment judgements and estimation uncertainties. GOODWILL - OF ESTIMATION UNCERTAINTY SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES As in 2017, goodwill was not subject to impairment in fiscal 2018. In the Healthcare business sector, the reclassifications to assets held for sale were attributable to the divestment of the Consumer Health business to The Procter & Gamble Company, United States, and in the Life Science business sector to the divestment of the flow cytom- etry business AmnisⓇ and GuavaⓇ to the Luminex Corporation, United States (see Note (5) "Acquisitions and divestments"). Notes to the Consolidated Financial Statements Cost as at January 1, 2017 10,519 -25 -1,425 13,582 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost as at January 1, 2018¹ Net carrying amount as of December 31, 2017 December 31, 2017 Currency translation Reversals of impairment losses Transfers Disposals Impairment losses Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions December 31, 2018 1,785 Accumulated amortization and impairment losses, January 1, 2018 Impairment losses 1,278 -174 -1,250 10,519 1,785 -1 -25 17 Total 15,015 1,452 11,752 17 1,811 Performance Materials Life Science Healthcare Goodwill December 31, 2018 Currency translation Classification as held for sale or transfer to a disposal group Reversals of impairment losses Transfers Disposals Changes in scope of consolidation Net cash flows 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 1,106 Notes to the Consolidated Financial Statements Consolidated Financial Statements 228 As in the previous year, changes in scope of consolidation/currency translation/other mainly resulted from exchange rate fluctuations between the euro and the U.S. dollar. 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 1,137 290 Deferred taxes (consolidated income statement) -164 135 Changes in scope of consolidation/currency translation/other 15 -2 Deferred taxes credited/debited to equity -41 -30 Changes from reclassification into assets held for sale 1,235 201 93 -15 CHANGES IN TAX LOSS CARRYFORWARDS 2017¹ Tax loss carryforwards were structured as follows: Tax loss carryforwards 160 56 211 152 59 deferred tax asset is recognized Tax loss carry forwards for which a 1,171 1,054 117 1,187 1,069 118 Total Abroad Germany Total Abroad Germany Dec. 31, 2017 Dec. 31, 2018 € million 216 2018 € million -37 Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods 263 150 Tax rate differences -675 -463 Theoretical income tax expense 31.7% 31.7% Tax rate 2,129 1,461 20171 2018 Profit before income tax € million 227 Notes to the Consolidated Financial Statements Consolidated Financial Statements Finite useful life -71 Change in deferred tax assets (consolidated balance sheet) Change in deferred tax liabilities (consolidated balance sheet) -79 Tax effect on tax loss carryforwards DEFERRED TAXES (CONSOLIDATED INCOME STATEMENT) The reconciliation between deferred taxes in the consolidated balance sheet and deferred taxes in the consolidated income statement is presented in the following table: and led to an increase in the current tax expense of the previous year by € 114 million. Please refer to the tax reconciliation of the previous year for further information on material effects from the US tax reform. IMPACT OF TAX REFORM IN THE UNITED STATES IN 2017 The Tax Cuts and Jobs Act became effective in the US on Decem- ber 22, 2017, and introduced new rules on the taxation of profits of foreign subsidiaries. This resulted in additional taxation of past profits Income taxes consisted of corporation and trade taxes for the com- panies domiciled in Germany as well as comparable income taxes for foreign companies. Income taxes for previous periods recognized in fiscal 2018 resulted mainly from completed tax audits and mutual agreement procedures, and from additions to provisions for tax audits. -20.1% 25.2% 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Tax ratio according to consolidated income statement 428 -368 -114 401 619 732 34 193 52 -14 2232 -25 Tax effect 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 1,489 Tax loss carry forwards for which no 59 35 190 66 236 92 485 37 454 Provisions for pensions and other post-employment benefits Other provisions 2 21 5 25 Current and non-current receivables/other assets 14 554 18 564 Inventories 41 5 Liabilities 3 67 69 1,288 -442 -442 -515 -515 1,091 Deferred taxes (consolidated balance sheet) Offset deferred tax assets and liabilities 1,931 1,548 1,803 1,606 Deferred taxes (before offsetting) 86 58 98 60 Tax refund claims/other 32 33 Tax loss carryforwards 9 12 deferred tax asset is recognized 12 98 32 25 7 33 24 9 tax loss carryforwards Recognized deferred tax assets on 288 269 19 281 254 27 tax loss carry forwards Potential deferred tax assets for 955 894 61 976 917 Not recognized deferred tax assets Current and non-current financial assets on tax loss carryforwards 230 23 84 34 1,555 111 1,479 119 Liabilities Dec. 31, 2017 Assets Liabilities Assets Property, plant and equipment Intangible assets € million Dec. 31, 2018 DEFERRED TAXES (CONSOLIDATED BALANCE SHEET) Deferred tax assets and liabilities correspond to the following balance sheet items: The vast majority of the tax loss carryforwards either has no expiry date or can be utilized for up to 20 years. In 2018, the income tax expense was reduced by € 34 million (2017: €0 million) due to the utilization of tax loss carryforwards from prior years for which no deferred tax asset had been recognized in prior periods. 256 244 12 248 18 ⚫ Sales growth Classification as held for sale or transfer to a disposal group • Profit margins 24 Classification as held for sale or transfer to a disposal group Reversals of impairment losses -40 26 7 -19 -1,231 -57 -1 14 5 -21 -747 -427 Transfers Disposals Impairment losses Amortization -11,260 -357 -596 38 -8,438 2 Currency translation Performance Remaining useful life in The carrying amounts of customer relationships, brands and trade- marks as well as marketing authorizations, patents, licenses, similar rights and other were attributable to the business sectors as follows: 235 Notes to the Consolidated Financial Statements Consolidated Financial Statements 7,237 329 289 1,543 5,076 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 -104 -12,544 -426 -596 -9,195 -2,326 December 31, 2018 -3 -40 -61 65 Total -1,868 19,780 Disposals 106 55 35 14 1 Additions Changes in scope of consolidation Cost at January 1, 2018 19,577 705 1,017 10,685 7,171 8,317 348 421 2,246 5,303 Net carrying amounts as of December 31, 2017 258 -11,260 -6 Accumulated amortization and impairment losses, January 1, 2018 Changes in scope of consolidation -37 -8 755 885 10,739 7,402 December 31, 2018 342 6 71 265 Currency translation -87 -7 -51 -29 Classification as held for sale or transfer to a disposal group 4 4 -56 57 Transfers -162 -111 Total € million Customer relationships, brands and trademarks Customer relationships 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 61 6 10 77 54 Not yet available for use 285 4 289 421 32 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. 32 62 Rebif® 561 329 653 1,543 2,246 Xalkori® SaizenⓇ Gonal-fⓇ Other marketing authorizations 1.0 369 3.0 68 1.0 31 369 737 68 93 31 95 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. 569 0.5-8.5 3,693 3,496 1 3,495 17.9-18.9 thereof: acquisition of Sigma-Aldrich Corporation thereof: acquisition of Millipore Corporation Brands and trademarks 4,422 4,263 155 4,108 0.5-18.9 5,303 5,076 162 4,914 Materials Dec. 31, 2018 Dec. 31, 2017 Life Science Healthcare years 569 681 4.5-8.9 806 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 15 -357 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. 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). Marketing authorizations, patents, licenses, similar rights and other 695 655 655 8.9 thereof: acquisition of Sigma-Aldrich Corporation 881 813 7 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). -596 Net carrying amounts as of December 31, 2018 100 -8,438 2018 2017 2018 Decrease in net cash flows Increase in cost of capital after tax growth rate Decrease in long-term externally available forecasts and the recoverable amounts deter- mined were validated using valuation multiples based on peer group information. In addition, sensitivity analyses of the key assumptions were performed as part of the impairment tests. As a result, no change of a significant assumption deemed possible by management would have resulted in an impairment. The following table presents the amount by which key assumptions would have to change before an impairment would need to be recognized as a result of the impair- ment tests: In all the impairment tests performed, the recoverable amount was more than 10% higher than the carrying amount of the respective cash-generating unit or group of cash-generating units. Irrespective of this, the planning data used were checked for plausibility against Net cash flows were discounted using cost of capital after tax. The aforementioned cost of capital before tax was subsequently derived iteratively. All of the aforementioned assumptions are considered a source of estimation uncertainty due to their inherent uncertainty. ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. 7.5% 7.4% 5.9% 5.8% 0.50% 0.50% 1,278 8.4% 8.8% 6.8% 2017 7.2% 2018 in percentage points Performance Materials > 5 > 5 1.8 0.9 > 2 1.2 > 5 > 2 > 2 Life Science Consumer Health¹ > 5 > 5 > 2 > 2 > 2 > 2 Healthcare (excluding Consumer Health) in % in percentage points 2017 > 2 1.75% 10,519 € million/in% Cost of capital before tax Cost of capital after tax Long-term growth rate Goodwill The long-term growth rates and weighted average costs of capital (WACC) used to conduct the goodwill impairment tests were as fol- lows: 233 Notes to the Consolidated Financial Statements 1 ¹At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. Derived from market data and the respective peer group • Cost of debt and capital structure Range as recommended by the Technical Committee for Business Valuation and Commerce of the Institute of Public Auditors in Germany (Institut der Wirtschaftsprüfer e. V. - IDW) Derived from the respective peer group Market risk premium: Risk-free interest rate: Derived from the returns of long-term government bonds Beta factor: ⚫ Cost of equity Discount rate after taxes (weighted average cost of capital - WACC) Based on long-term inflation expectations and expected long-term sector growth Long-term growth rate after the detailed planning period Based on past experiences, adjusted for expected changes 2018 1.75% 2017 2017 10,896 1,334 Performance Materials Life Science 8.2% 6.6% 2.00% 251 Consumer Health¹ 8.9% 8.5% 6.7% 6.4% 0.00% 0.00% 1,534 1,534 Healthcare (excluding Consumer Health) 2017 2018 2017 2018 2018 > 2 Consolidated Financial Statements > 2 Amortization -10,259 -356 -585 -7,759 -1,560 Accumulated amortization and impairment losses, January 1, 2017 Changes in scope of consolidation 19,577 705 1,017 10,685 7,171 -1,053 -25 -1 -190 -838 2 2 4 8 Impairment losses -8 Disposals Reversals of impairment losses >2 -1,868 142 December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group 17 1 -2 2 33 27 5 1 -67 -17 -50 -1,243 -41 -751 -451 Transfers 6 17 -32 Marketing authorizations, and software Software Customer relation- ships, brands and trademarks December 31, 2017 Currency translation Classification as held for sale or transfer to a disposal group Transfers Disposals Additions Changes in scope of consolidation Cost at January 1, 2017 € million (20) Other intangible assets Notes to the Consolidated Financial Statements Consolidated Financial Statements the higher beta factor of individual entities in the peer group. The resulting effects more than offset the increase in net cash flows during the detailed planning period compared to the previous period. The lower sensitivity of the impairment test for the cash-generating unit Life Science regarding changes in the long-term growth rate and the capital costs declined compared to 2017. This was due to an increase in weighted average costs of capital (WACC) on account of 1 At the date of the impairment test in the previous year, Consumer Health was not classified as a discontinued operation pursuant to IFRS 5. > 5 -2 > 5 patents, licenses, similar in develop- 234 ment rights and other -1 398 110 24 20 21 -1 20,239 -27 263 766 639 Advance payments Total Not yet Finite useful life -5 available for use 8,011 10,824 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. Derivatives with a hedging relationship (operational) Derivatives without a hedging relationship through profit or loss Subsequent measurement at fair value 295 Other receivables 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. Current Determination of impairment amount € million 239 Notes to the Consolidated Financial Statements Other assets comprised: (22) Other assets (operational) Subsequent measurement at amortized cost Consolidated Financial Statements 45 Dec. 31, 2018 30 4 1 EQUIPMENT 4 46 46 276 29 Total Non-current Dec. 31, 2017 45 247 312 17 Current Total Non-current Financial items SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - PROPERTY, PLANT AND 4,811 9 2,228 Net carrying amounts as of December 31, 2018 -5,740 -977 -3,150 -1,609 66 -44 -5 1,163 -23 13 Dec. 31, 2017 13 December 31, 2018 Currency translation 15 Reversals of impairment losses Classification as held for sale or transfer to a disposal group -16 328 1,092 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". 1 1 5 8 Dec. 31, 2017 Dec. 31, 2018 Net carrying amount of assets classified as finance lease Other property, plant and equipment Land and buildings € million The carrying amounts of assets classified as finance leases were as follows: 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"). 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. 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 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. 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 238 5 45 205 63 Changes in scope of consolidation/other Currency effects Classification as held for sale or transfer to disposal group Reclassification from non-current to current Reclassification to receivables Additions January 1, 2018 € million December 31, 2018 The following table provides details on contract assets representing completed performances not yet invoiced: Consolidated Financial Statements 240 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. Other receivables also comprised license receivables in the amount of € 29 million (December 31, 2017: € 28 million). 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. 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". 936 731 Notes to the Consolidated Financial Statements 1,024 (23) Inventories € million -24 1 -1 -1 52 1 1 -78 -78 This item comprises the following items: 95 35 35 Total Contract assets Non-current Current Finished goods/goods for resale Inventories Work in progress Raw materials and supplies 94 138 886 Other assets 107 8 99 121 5 117 Prepaid expenses 277 Contract assets¹ 38 326 8 318 Receivables from non-income related taxes 367 91 277 361 239 52 1 52 568 114 454 663 76 587 Non-financial items 184 69 115 156 62 94 Remaining other assets¹ 1 1 7 7 Assets from defined benefit plans 299 24 481 2 January 1, 2017 Accumulated depreciation and impairment losses 9,852 1,026 1,176 4,136 3,514 December 31, 2017 -1,361 -306 -33 -103 -131 Currency translation 39 -2 41 Classification as held for sale or transfer to a disposal group -40 -5 -2,949 -5,171 209 32 138 39 Disposals -5 -2 -2 -858 Impairment losses -9 21 -103 -266 -147 Depreciation 2 - 31 Changes in the scope of consolidation -516 -543 96 258 3,391 Total to vendors and contractors progress and advance payments Construction in operating and office equipment Plant and machinery land 4,068 Cost at January 1, 2017 on third-party Other facilities, Land, land rights and buildings, including buildings (21) Property, plant and equipment 237 Notes to the Consolidated Financial Statements Consolidated Financial Statements 52 € million 1,136 807 9,402 184 Transfers -241 -16 -34 -142 -50 Disposals 936 818 35 54 30 Additions 28 -24 2 49 Changes in the scope of consolidation Transfers Reversals of impairment losses 35 35 10,551 1,096 1,305 4,313 3,837 December 31, 2018 90 10 Accumulated depreciation and impairment losses 6 43 Currency translation -134 -2 -20 -69 -43 Classification as held for sale or transfer to a disposal group 31 January 1, 2018¹ -1,474 -2,978 42 59 11 -18 -2 -1 -3 -12 -517 -115 -246 -156 Transfers Disposals Impairment losses Depreciation Changes in the scope of consolidation -5,343 -887 -696 116 140 319 1,022 291 1,158 2,042 -5,340 122 -40 69 4,512 Net carrying amounts as of December 31, 2017 -1,472 December 31, 2017 63 37 Currency translation 1 -41 Classification as held for sale or transfer to a disposal group -2,978 21 -886 Cost at January 1, 2018¹ Transfers -152 -28 -46 -64 -14 Disposals 890 786 47 41 16 Additions Changes in the scope of consolidation 9,857 1,026 1,178 4,136 3,517 237 Dec. 31, 2018 510 40 656 The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant ctuarial assumptions. 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. 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 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - PROVISIONS FOR PENSIONS AND OTHER POST-EMPLOYMENT BENEFITS 0 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. 2,452 176 2,276 2,391 182 4,719 2,209 8 8 19 19 81 81 77 77 Other Insurance contracts 421 Fair value of the plan assets 313 456 778 SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - INVENTORIES As of the balance sheet date, no inventories were pledged as security for liabilities. 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. Impairments of inventories in 2018 amounted to € 183 million (2017: € 144 million); reversals amounted to € 77 million (2017: € 110 million). The increase in inventories in 2018 was due to the overall acceler- ating business volume in all three business sectors. 2,632 2,764 1,355 1,420 795 834 563 777 67 1,407 6 33 39 6 6 10 10 26 26 3,172 1,137 1 420 458 458 No quoted market price in price in an active market € million Quoted market Dec. 31, 2017 Dec. 31, 2018 The fair value of the plan assets can be allocated to the following categories: Notes to the Consolidated Financial Statements Consolidated Financial Statements 246 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. 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). 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 The plan assets serve exclusively to meet the defined benefit obligations. Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which occur in some countries (e.g. Switzerland and the United Kingdom) on the basis of legal requirements and in other countries (e.g. Germany) on a voluntary basis. Plan assets for funded defined benefit obligations primarily comprised fixed-income securities, stocks, and investment funds. They did not directly include financial instruments issued by Merck Group compa- nies or real estate used by Group companies. -1,668 65 -1,637 121 -115 7 -18 8 139 5 -40 Quoted market 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 price in an an active market Investment funds 94 94 105 105 Direct investments in real estate 957 957 993 993 Debt instruments 814 814 592 592 Equity instruments 77 77 147 147 Cash and cash equivalents Total an active market active market Total No quoted market price in 2017 -1,820 11 inventories. There were estimation uncertainties with respect to the calculation of the net realizable value. It was determined, in particular, on the basis of information on changes in selling and procurement prices and on the expected cost of completion. Notes to the Consolidated Financial Statements 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: € million Benefit based on final salary 2,257 Annuity 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 Switzerland Lump sum 2,336 1 7 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 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 Future pension increases Dec. 31, 2018 Dec. 31, 2017 4,719 4,707 -2,391 2,328 -2,452 2,255 1 2,329 1 2,256 Dec 31, 2018 United Kingdom Other countries 2,602 1 Additions January 1, 2018 Adjustment on initial application of IFRS 15 Adjustment on initial application of IFRS 9 December 31, 2017 € million The following table provides details on the development of trade accounts receivable before loss allowances during the period under review: 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. 2,923 2,931 -367 -73 3,290 3,004 21 Dec. 31, 2017 3,290 Dec. 31, 2018 2,983 Allowances on receivables subsequently measured at fair value through other comprehensive income Net trade accounts receivable Allowances on receivables subsequently measured at amortized cost Gross trade accounts receivable Subsequently measured at fair value through other comprehensive income Subsequently measured at amortized cost € million (24) Trade accounts receivable 241 thereof: attributable to performance obligations satisfied in prior periods Consolidated Financial Statements Customer payments/defaults Classification as held for sale or transfer to disposal group 450 Total 84 93 3,137 93 1 Notes to the Consolidated Financial Statements Consolidated Financial Statements 242 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 com- prise both obligations from current pensions and accrued benefits for pensions payable in the future. (25) Provisions for pensions and other post-employment benefits 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. 3 3,004 -86 6 -16,590 1 16,395 3,277 -4 -9 counts receivable 3,290 Gross trade ac- Change in scope of consolidation/other December 31, 2018 Currency effects -1,668 450 Cumulative actuarial gains (+)/losses (-) recognized in equity, December 31 Pension payments Employer contributions Employee contributions Payment transactions -40 139 -18 -40 139 -18 -115 Actuarial gains (+)/losses (-) -115 -115 -34 124 -49 75 48 -14 14 110 13 123 81 Actuarial gains (+)/losses (-) Changes in the effects of the asset ceilings arising from experience adjustments 4 Currency translation differences recognized in income -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 2 -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 Actuarial gains (+)/losses (-) Changes in the scope of consolidation Reclassification to liabilities directly related to assets held for sale 48 Present value of the defined benefit obligations -4,698 Fair value of the plan assets 2,386 Effects of the asset ceilings Net defined benefit liability -2,313 -160 -160 -86 -86 43 43 -2 -2 -8 -8 Currency translation differences recognized in income 40 -33 Other effects recognized in income -3 -2 Items recognized in income -217 2018 Gains (+) or losses (-) on settlement 4 Past service cost Interest income -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 -2,329 244 Consolidated Financial Statements Notes to the Consolidated Financial Statements € million January 1, 2017 Current service cost Interest expense Plan administration costs recognized in income -2 48 42 20 112 -2 114 13 -13 36 36 76 -51 127 141 121 121 121 7 8 5 -5 -211 -5 7 20 20 7 -14 8 6 -46 Reclassification within retained earnings Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) arising from experience adjustments Effects of the asset ceilings Remeasurements of plan assets Actuarial gains (+)/losses (−) arising from experience adjustments Actuarial gains (+)/losses (-) arising from changes in demographic assumptions Actuarial gains (+)/losses (-) arising from changes in financial assumptions Remeasurements of defined benefit obligations Cumulative actuarial gains (+)/losses (−) recognized in equity, January 1 Currency translation differences € million The development of cumulative actuarial gains (+) and losses (-) I was as follows: 245 Notes to the Consolidated Financial Statements -2 The actual loss on plan assets amounted to € 73 million in 2018 (2017: return of € 164 million). 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. -2,256 2,452 -4,707 15 -59 74 -12 1 -13 21 67 5 Consolidated Financial Statements Other Consolidated Financial Statements Notes to the Consolidated Financial Statements 243 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. 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. 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: € 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 Fair value of the plan assets 2,452 Effects of the asset ceilings Net defined benefit liability -2,256 -161 -161 -85 -85 December 31, 2017 42 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. 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 -4,707 148 Other changes 2,391 Changes in the scope of consolidation Payment transactions Employee contributions Employer contributions Pension payments Actuarial gains (+)/losses (-) Changes in the effects of the asset ceilings arising from experience adjustments Actuarial gains (+)/losses (-) Remeasurements of plan assets arising from experience adjustments Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) 6 thereof: attributable to the divested Consumer Health business arising from changes in financial assumptions -8 3 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) Reclassification to liabilities directly related to assets held for sale Currency translation differences recognized in equity arising from changes in demographic assumptions -294 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 -294 7 5 8 -1 7 -14 -13 -1 -343 -15 -345 Financial result -51 -266 -56 Capital loss from disposal of debt instruments with subsequent measurement at amortized cost Expenses from fair value changes -2 Currency differences from financing activities in other intangible assets (32) Financial result/net gains or losses from financial instruments € million Interest income and similar income Income from fair value changes 2018 20171 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Capital Structure, Investments and Financing Activities 55 23 Interest expenses from interest rate derivatives 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 1 - Finance income 77 167 27 51 Interest expenses and similar expenses Capitalized borrowing costs of qualifying assets in property, plant and equipment 5 The currency differences from financing activities mainly comprised gains or losses from hedging intragroup transactions in foreign currency. through profit or loss Consolidated Financial Statements Subsequent measurement at fair value through profit or loss 2017 € million Held for trading Held to maturity Loans and receivables 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 -259 -77 105 Net gains and losses Reversals of Interest Impairment losses impairment losses 21 255 -54 Subsequent measurement at amortized cost Financial liabilities Subsequent measurement at fair value 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 Interest result Net gains and losses Currency translation Dividends Interest income Interest expenses 256 Impairment losses Fair value adjustments Disposal gains/losses Financial assets Subsequent measurement at amortized cost -47 Subsequent measurement at fair value through other comprehensive income Equity instruments Debt instruments Reversals of impairment losses Notes to the Consolidated Financial Statements Reclassification from non-current to current 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. 412 -582 -2 -583 193 -193 2 2 -2 2 332 4 2 336 As of January 1, 2018, contract liabilities amounted to € 506 million, of which € 299 million was recognized in fiscal 2018. 254 Consolidated Financial Statements Notes to the Consolidated Financial Statements (29) Trade accounts payable 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. Given the first-time application of IFRS 15 as of January 1, 2018, some items previously recognized in trade accounts payable were 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"). (30) Refund liabilities The following table shows the development of refund liabilities in the period under review: € million 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. January 1, 2018 410 194 315 1,427 Other liabilities 2,288 52 2,341 2,175 354 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". 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 506 Additions Cumulative catch-up adjustments to revenue -39 Reclassification to liabilities directly related to assets held for sale Currency translation Change in scope of consolidation/other December 31, 2018 2,529 The following table provides details on the development of contract liabilities related to payments received before performance completion: Contract liabilities Current Non-current Total 311 Recognition of income/reversal Additions Utilizations/reversals Cumulative catch-up adjustments to revenue -34 -25 -24 -3 3 -28 12 12 1 1 13 -16 -3 -3 -1 -1 423 274 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. (31) Net cash flows from investing 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. 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. -19 -3 -30 -31 thereof: attributable to performance obligations satisfied in prior periods 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: Total 379 United States Total United States Total 244 52 32 431 1,273 951 44 23 1,317 -1,193 -902 -43 -22 -1,235 Consolidated Financial Statements 97 Contract liabilities¹ -14 600 370 58 203 111 11 27 780 248 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. Product-related and patent disputes 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. 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. 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. 184 46 19 26 -1 -4 -3 -15 December 31, 2018 551 90 316 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. 137 46 211 1,381 thereof: current thereof: non-current 182 32 112 30 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. 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 Term Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) 250 DAX® value (60-day average of the DAX® prior to the start of the performance cycle) Jan. 1, 2016 - Dec. 31, 2018 3 years 87.92 10,669.76 2017 tranche Jan. 1, 2017 - Dec. 31, 2019 3 years 2018 tranche Jan. 1, 2018 - Dec. 31, 2020 2016 tranche -6 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. 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. 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. Consolidated Financial Statements Notes to the 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 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. ⚫ the legal situation and current legislation in comparable proceedings in the jurisdiction in question. were ⚫ the duration of proceedings in pending litigation, ⚫ the likelihood of possible outcomes of the proceedings, ⚫ the license rate to be applied (in patent disputes) and the discount rate to be used. • 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. RESTRUCTURING Restructuring provisions mainly included commitments to employees in connection with restructuring projects and provisions for related onerous contracts. The main parameters when determining the amount of provisions 3 years to assets held for sale Changes in scope of consolidation/other (26) Other provisions Other provisions developed as follows: € million January 1, 2018 Additions Utilizations Release Interest and Litigation Restructuring Personnel Environmental protection Acceptance and follow-on penalties related to obligations income taxes Other -196 Dec. 31, 2018 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. 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements 247 Dec. 31, 2017 -435 -438 503 508 Total 151 -130 -133 251 256 -198 € million Increase (+)/decrease (-) in present value of all defined benefit obligations if the discount rate is 50 basis points higher the discount rate is 50 basis points lower 155 526 92 254 -66 -2 -7 -10 -90 -206 11 2 -9 2 1 5 2 6 -1 -2 Interest portion Currency translation 14 Reclassification to liabilities directly related -21 -40 137 26 43 166 1,245 65 30 203 -174 9 13 176 511 -22 -22 -78 -8 -3 15 95.63 10,822.06 91.73 13 1,032 1,038 21 Total 1,059 172 172 174 174 94 94 95 95 78 25 18 43 Dec. 31, 2017 Non-current Current Total Non-current 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 253 (28) Other liabilities 33 Other liabilities comprised the following: Other financial liabilities thereof: payroll liabilies thereof: interest accruals Liabilities from derivatives with a hedging relationship (operative) Financial items Dec. 31, 2018 Current 1,019 € million 1,110 1,063 39 21 303 211 514 Other non-financial liabilities 99 99 Non-financial items 21 1,211 1,230 1,112 -203 Disposal gains/ losses Fair value adjustments 735 -669 -294 19 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. Deferred income¹ 5 1,102 58 1,077 23 20 Accruals for personnel expenses 687 687 150 665 332 4 336 Liabilities from non-income related taxes 171 15 186 144 665 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. 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 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. Transferred as part of the disposal of Consumer Health Dec. 31, 2018 16,336 39,889 23,760 774,850 829,632 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. € million Variation of Merck share price Variation of DAX® value Consolidated Financial Statements Notes to the Consolidated Financial Statements 37,953 13,988 47,676 Forfeited 13,089.39 Potential number of MSUS Potential number offered for the first time in 2016 763,463 Forfeited 24,392 Dec. 31, 2016 739,071 251 Potential number offered for the first time in 2017 Forfeited 31,105 24,897 Dec. 31, 2017 707,966 828,727 Potential number offered for the first time in 2018 891,345 853,624 5 +10% +10% -10% ⚫ the discount rate. The measurement was carried out regularly in consultation with inde- pendent experts. 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. 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 payables. In previous periods, such items were disclosed in income tax liabilities in full. For further information on these disclosure changes, please refer to Note (49) "Effects from new accounting standards and other pres- entation and measurement changes". MISCELLANEOUS OTHER PROVISIONS Miscellaneous other provisions mainly comprised provisions for war- ranty obligations and for uncertain commitments from contributions, fees and other duties. ⚫ the associated future costs, and 252 Notes to the Consolidated Financial Statements (27) Contingent liabilities € million Contingent liabilities from legal disputes and tax matters Other contingent liabilities Dec. 31, 2018 47 Dec. 31, 2017 66 1 1 Consolidated Financial Statements ⚫ the applicable remediation methods, the actual severity of the identified contamination, . Increase (+)/decrease (-) of the provision Dec. 31, 2018 14 -15 -10 8 Dec. 31, 2017 15 -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. With respect to provisions for pensions and other post-employment benefits, see Note (25) "Provisions for pensions and other post-em- ployment benefits". 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. SIGNIFICANT MANAGEMENT JUDGMENTS AND SOURCES OF ESTIMATION UNCERTAINTY - OTHER PROVISIONS FOR ENVIRONMENTAL PROTECTION The calculation of the present value of the future settlement amount of provisions for environmental protection required estimates to be made of ⚫ the future settlement date, -10% 643,954 Loans from third parties and other financial liabilities 20 -60 16 14 30 24 610 635 90 Derivatives without a hedging relationship (financial transactions) Financial assets 444 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 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. 258 Consolidated Financial Statements Notes to the Consolidated Financial Statements (35) Financial liabilities/ capital management 535 50 50 Other debt instruments 278 285 Equity instruments 274 274 Debt instruments 8 4 12 Subsequent measurement at fair value through profit and loss 16 324 340 Equity instruments Contingent considerations 259 259 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 Bonds (current) 869 335 Commercial paper 113 838 Bank loans 370 803 Liabilities to related parties 824 767 1 Effect of the first-time application of IFRS 9, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -47 -81 1 -33 € 8 70 € Dec. 31, 2017 Interest rate € million € million Maturity % USD bond 2015/2018 Eurobond 2015/2019 Eurobond 2009/2019 799 70 335 March 2018 Sept. 2019 Dec. 2019 1.700% 0.750% million 400 Currency USD 800 4.250% other comprehensive income Subsequent measurement at fair value through 9 265 Fair value/carrying amount Positive market values Financial transactions Operative transactions Current Non-current Current Non-current 4 1 Consolidated Financial Statements Notes to the Consolidated Financial Statements 257 (33) Cash and cash equivalents Cash and cash equivalents comprised the following items: € million Notes to the Consolidated Financial Statements Cash, bank balances and checks Consolidated Financial Statements 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. 1,100 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 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. December 31, 2018 Short-term cash investments (up to 3 months) Dec. 31, 2018 780 Total 35 420 454 47 29 12 59 13 22 Subsequent measurement at amortized cost Loans against third parties 1 9 10 1 9 Dec. 31, 2017 Non-current Cash and cash equivalents Current Non-current Dec. 31, 2017 481 1,391 108 2,170 589 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 € 295 million (December 31, 2017: € 238 million). This relates mainly to cash and cash equivalents with subsidiaries which the Group only had restricted access to owing to foreign exchange controls. The maximum default risk is equivalent to the carrying value of the cash and cash equivalents. (34) Financial assets € million Available-for-sale financial assets Loans and receivables Derivative assets (financial transactions) Dec. 31, 2018 Current Total -1 13 10 27 9 86 13 86 27 46 13 9 18 25 15 30 18 25 Non-current Current 46 Non-current 9 30 Derivative financial liabilities Derivative financial assets Dec. 31, 2017 € million Derivative financial liabilities Derivative financial assets Dec. 31, 2018 € million 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 18 25 86 27 62 13 Gross Current Financial transactions 73 73 16 45 14 14 16 20 58 1 4 - 20 58 Non-current Current Non-current Current 16 Operative transactions 16 16 Negative market values 15 30 Non-current Current Non-current Operative transactions Financial transactions Current Positive market values Fair value/carrying amount 20 58 73 16 46 4 14 45 5,286 presentation Net presentation -2 13 -1 -2 85 5 -68 -123 1 -1 December 31, 2017 Tax effect -5 3 3 of options currency forwards Reclassification to assets Reclassification to profit or loss -25 Fair value adjustment (directly recognized in equity) -4 -64 Tax effect Reclassification to assets 14 38 5 Reclassification to profit or loss -68 -3 -48 1 Fair value adjustment (directly recognized in equity) -60 -64 3 -1 January 1, 2018 Negative market values 3 Netting January 1, 2017 (after adjustment) January 1, 2017 agreements due to master netting Potential netting volume of the Group applied to the following hedging instruments: The reserves for cash flow hedges and the cost of cash flow hedging -155 -155 113 113 Net presentation Netting presentation Gross -168 -168 80 80 due to financial collateral Adjustment due to mandatory retrospective adoption of IFRS 9¹ Potential net amount 51 -139 € million swaps -68 -123 Interest rate Intrinsic value Spot component of of options currency forwards Forward component of Time value Cash flow hedge Cost of hedging -96 -60 54 60 Potential net amount due to financial collateral due to master netting agreements Potential netting volume 29 -29 366 1,573 366 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. Merck repaid a USD bond with a volume of € 323 million in March 2018. 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 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 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. 874 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). 550 1,000 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). € million Consolidated Financial Statements Notes to the Consolidated Financial Statements 259 • Eurobond • USD bond¹ • Hybrid bond² 500 2019 2020 2021 2022 2023 2024 2025 1.350 800 70 0.75%/ 4.25% 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. 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: Syndicated loan 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 € million 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 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 10,144 589 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 USD Non-current financial liabilities 1,350 Liabilities from derivatives (financial transactions) Finance lease liabilities Liabilities to related parties 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) Bank loans Loans from third parties and other financial liabilities 90 € 1,000 500 € 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% 2.950% € 2.625% USD 548 548 Sept. 2022 1.375% 550 € 1,389 1,328 994 992 498 497 March 2025 Dec. 2074¹ Dec. 2074² 3.250% 1,600 USD 1,000 Operative transactions E. MERCK KG'S SHARE OF NET PROFIT Consolidated Financial Statements -5 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 -5 Profit transfer to E. Merck KG/ withdrawal by E. Merck KG -7 -611 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 Merck & Cie -62 Merck KGaA -447 Total -509 Merck & Cie Merck KGaA Total -63 -548 -7 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 -62 - 63 Interest Currency No hedge accounting Interest Currency Equity DEC. 31, 2017 € million Cash flow hedge Interest Currency No hedge accounting Interest Currency Equity Nominal volume Current 1,573 Non-current Cash flow hedge -430 € million The following derivatives were held by Merck as of the balance sheet date: -515 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 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). Merck & Cie is a partnership under Swiss law that is controlled by Merck KGaA, but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. The proposed withdrawal of E. Merck KG in the amount of € 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 263 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 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. 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 DEC. 31, 2018 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). 25 26 -16 616 723 20 56 (100%) -24 637 -16 780 (70.274%) 447 -447 548 -548 (29.726%) 7 -24 -7 Merck KGaA Merck KGaA 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 Basis for appropriation of profits 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 E. Merck KG 60 5 -20 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 -5 Dividend proposal Retained earnings Merck KGaA -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 Net income Profit carried forward previous year Withdrawal from revenue reserves Transfer to revenue reserves Withdrawal by E. Merck KG Financial transactions € million 4 Cash flows Cash flows 1-5 years Cash flows <1 year Notes to the Consolidated Financial Statements Consolidated Financial Statements 270 1,899 85 4,769 508 5.528 241 12,244 2 2 4 472 472 20 > 5 years 58 € million Bonds and commercial paper 850 4 803 18 1,653 Repayment 1,839 143 Interest Repayment 5,234 590 1,171 210 8,213 Interest Repayment Interest amount Carrying Bank loans Dec. 31, 2017 Trade accounts payable 78 16 984 208 7,286 Repayment Interest Repayment Interest Interest Repayment 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 Contingent considerations Subsequent measurement at fair value through profit or loss 458 45 620 369 15 90 4 1 5 50 17 67 13 508 522 1,335 1,335 1,766 1,766 1,899 85 4,430 250 2 17 2,195 2,195 Liabilities to related parties Group Performance Materials Life Science Healthcare € million Dec. 31, 2018 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 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 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. 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 External credit rating at least AA- (rating agency Standard & Poor's) or Aa3 (rating agency Moody's) -75 856 437 Dec. 31, 2018 Impairments based on expected credit losses for trade accounts receivable as of December 31, 2018, were as follows: 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. 3,004 Trade accounts receivable before 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 21 146 252 External credit rating at least BBB- (rating agency Standard & Poor's) or Baa3 (rating agency Moody's) 2,120 827 -77 2018 of debt instruments subsequently measured at fair value through other comprehensive income Net impairment losses on financial assets Finance lease liabilities 18 59 52 15 155 Liabilities from derivatives 54 4 19 1 73 Loans from third parties and other financial liabilities 21 453 474 Other financial liabilities 1,352 1,352 4 1 2 14,120 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. Loans from third parties and other financial liabilities 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. According to IFRS 9, there is a rebuttable presumption that the credit risk has increased significantly when contractual payments are more than 90 days past due. Merck therefore analyzes all financial assets that are more than 90 days past due and examines whether there is objective evidence of impairment requiring additional risk provisions. Credit risk for Merck means the risk of a financial loss if a customer or other contract partner is not able to meet its contractual payment obligations. Merck is generally exposed to credit risks from existing trade accounts receivable other debt instruments, derivatives and contract assets. CREDIT RISKS 1,839 143 6,179 657 6,046 243 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 Other financial liabilities Liabilities to related parties Trade accounts payable Maturity date thereof: positive market value (asset) thereof: negative market value (liability) Fair value of the hedging instrument thereof: non-current thereof: credit impaired Loss allowances thereof: credit impaired Overdue by Not yet due 90 days Overdue by 180 days 0.5% 0.8% 3.3% Overdue by 360 days 34.8% More than 360 days past due 53.1% Total 2,415 399 USD 60 CHF TWD 24 47 53 125 85 101 122 129 125 169 88 85 125 1,055 85 178 1,180 KRW JPY CNY 66 64 3,004 loss allowances thereof: credit impaired Loss allowances thereof: credit impaired Overdue by Not yet due 90 days Overdue by 180 days Overdue by 360 days 0.9% 1.3% 6.0% 14.1% More than 360 days past due 93.3% Total 2,408 402 61 45 Trade accounts receivable before Expected loss rate € million Jan. 1, 2018 2 1 2 16 30 51 -12 -3 -2 44 -23 -73 -1 -14 -29 -44 272 Consolidated Financial Statements Notes to the Consolidated Financial Statements As of January 1, 2018, the date of first-time application of the impair- ment rules amended through IFRS 9, impairments based on expected credit losses for trade accounts receivable were as follows: -34 Expected loss rate -49 -5 Effects on consolidated income statement Change in market interest rate € million 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 The Merck Group's net exposure to interest rate changes comprised the following: INTEREST RATE RISKS 1The 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 Effects on equity 36.68 2018 +100 basis points 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”. The risk that Merck cannot meet its payment obligations resulting from financial liabilities, is limited by establishing the required financial LIQUIDITY RISKS The shares in publicly listed companies amounting to € 134 million (December 31, 2017: € 16 million) are generally exposed to a risk of fluctuations in fair value. A 10% change in the value of the stock market would impact equity by € 13 million (December 31, 2017: € 2 million). This change in value would be recognized in equity. SHARE PRICE RISKS 16 -26 -9 6 -100 basis points +100 basis points -100 basis points 2017 8.48 1.12 1.22 1:1 1:1 1:1 January 2019- January 2019- December 2019 January 2019- December 2020 December 2020 January 2019- loss allowances -10 -3 -8 -5 -3 -49 3 2 -10 -8 December 2020 1:1 January 2019- December 2020 1:1 January 2019- January 2021 1:1 (including forward points) Weighted average hedged rate for the year 7 6 3 3 -5 58 January 1, 2018 -2 determine hedge effectiveness since -7 -6 3 -3 5 -58 instruments since January 1, 2018 Change in value of outstanding hedging Hedge ratio¹ Change in value of hedged item used to 460 -9 12 Current financial assets Cash and cash equivalents Dec. 31, 20171 Fair value, items Non-financial Carrying amount according to IAS 172 Fair value At cost cost Amortized Carrying amount Subsequent measurement according to IAS 39 589 Assets € million 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: 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 Dec. 31, 2017 2 589 47 46 Derivatives without a hedging relationship 568 92 276 936 Other current and non-current assets 2,923 2,923 Loans and receivables 2,923 2,923 Trade accounts receivable 90 Derivatives with a hedging relationship 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 35 2 5,530 Total (measured in accordance with IAS 17)² 696 492 174 30 6,098 673 5,425 Total 1 1 (measured in accordance with IAS 17)² Finance lease receivables 4 Financial liabilities 4 45 30 50 27 22 259 259 4 1 76 59 50 50 76 Subsequent measurement at amortized cost Trade accounts payable Other financial liabilities Finance lease liabilities 472 472 Refund liabilities 78 90 90 78 5 5 78 20 58 Derivatives with a hedging relationship 90 73 16 Derivatives without a hedging relationship 5 4 1 Contingent considerations through profit or loss Subsequent measurement at fair value 9,935 2,677 7,258 1,766 9,830 6,615 1,766 3,215 46 259 46 276 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 30 in listed companies) Shares (equity investments Description of the measurement technique Financial liabilities assets Financial Financial instruments concerned Fair Value € million DEC. 31, 2018 is presented in the following table: The determination of the fair values of financial assets and liabilities Notes to the Consolidated Financial Statements Consolidated Financial Statements 17 276 7,258 factors observable in the market (Level 2) Equity instruments 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 Quoted prices in an active market and volatilities observable on the market Volatilities observable on the market Quoted prices in an active market Main input factors used to determine fair values Derivation from active market Liabilities to banks and other loan liabilities 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 Derivatives (with or without a hedging relationship) Debt instruments (subsequent measurement through profit or loss) Derivation from active market considering liquidity discount 118 Shares (equity investments in listed companies) Interest rate swaps 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 Liabilities Derivatives with a hedging relationship 416 416 4 420 Available for sale 12 12 Loans and receivables Held to maturity 13 13 Current and non-current financial liabilities Derivatives without a hedging relationship Other financial liabilities 13 429 4 12 444 Non-current financial assets 568 568 Non-financial items 45 45 45 Derivatives with a hedging relationship 276 Derivatives without a hedging relationship 10,823 10,707 113 1,427 Non-financial items 43 43 43 Derivatives with a hedging relationship 1,059 1,059 Other financial liabilities Derivatives without a hedging relationship 113 11,074 1,427 43 1,059 2,529 2,195 2,195 2,195 2,195 4 Current and non-current other liabilities Other financial liabilities Trade accounts payable Liabilities from finance leases Derivatives with a hedging relationship 10,707 10,707 4 113 113 Loans and receivables 259 64 Derivatives with a hedging relationship -184 449 135 75 115 Exchange rate -10% Consolidated income statement -122 18 -45 -14 -8 -12 1,215 (€ depreciation) -172 39 -44 -38 -19 -18 Exchange rate +10% (€ appreciation) Consolidated income statement 122 -18 45 14 8 Equity 12 KRW TWD -15 -13 -16 -135 20 -19 -11 -14 Consolidated income statement 62 -27 74 15 JPY 13 Equity 110 -16 8 15 10 12 € million Dec. 31, 2017 Net exposure USD CHF CNY 16 Equity 147 -31 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 -367 -325 -2 -1 -373 -336 359 336 3,277 360 3264 -6 -4 -5 -22 -6 -6 -373 -75 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 Notes to the Consolidated Financial Statements Accordingly, they do not affect the net exposure presented above. The impact of cash flow hedge accounting for forecasted transactions in foreign currency on the Group's net assets and results of opera- tions was as follows for the major currencies: € million Dec. 31, 2018 Notional amount thereof: current up to 12 months up to 6 months up to 3 months Past due, but not impaired Neither past due nor impaired € million The maturity structure of the carrying amounts of trade accounts receivable as of December 31, 2017, was as follows: 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 -74 27 -62 Consolidated income statement Equity 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 Carrying amount Subsequent measurement at fair value through Total Other debt instruments 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 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. 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. (excluding leasing receivables) 2,170 2,170 2,909 Derivatives without a hedging relationship Other debt instruments Contingent considerations Equity instruments through profit or loss Subsequent measurement at fair value 12 12 12 4 8 Other debt instruments 21 21 21 21 Trade accounts receivable 274 140 118 17 274 274 Equity instruments other comprehensive income 322 26 296 2,909 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. 7 assessment was undertaken as of the balance sheet date and the initially assumed risk profile was maintained. Credit risks from other financial assets 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. Forward exchange contracts are used to hedge foreign exchange risks arising from transactions already recognized in the balance sheet. Forecast transactions and firm purchase commitments in non-functional currency are hedged using forward exchange con- tracts and currency options which are due within the next 36 months. The following table shows the net exposure and the effects of transactional exchange rate movements of the key currencies against the euro in relation to the net income and equity of the Group on the balance sheet date. € million Consolidated Financial Statements Dec. 31, 2018 CHF CNY TWD JPY KRW Net exposure Exchange rate -10% 618 -274 741 153 132 163 (€ depreciation) Exchange rate +10% (€ appreciation) USD up to 24 months over 2 years Impaired 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 -464 2017 In fiscal 2017, previously recognized impairments were reversed as a result of the improved solvency of customers, particularly in the Middle East. December 31 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 1 7 32 50 392 Dec. 31, 2017 2,391 Trade accounts receivable 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 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. DEC. 31, 2018 281 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). 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. 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). From January to December 2018, Merck KGaA performed services for E. Merck KG with a value of € 1.0 million (2017: € 0.9 million) and for E. Merck Beteiligungen KG with a value of € 0.3 million (2017: € 0.1 million); in the previous year, Merck KGaA performed services for Emanuel-Merck-Vermögens-KG with a value of € 0.2 million. During the same period, E. Merck KG performed services for Merck KGaA with a value of € 0.5 million (2017: € 0.5 million). As of December 31, 2018, there were 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. 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. (42) Related-party disclosures Other Disclosures Notes to the Consolidated Financial Statements Consolidated Financial Statements 286 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". the consolidated cash flow statement includes cash changes in assets from derivatives that are not contained in the changes noted above. 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 "Other changes" relate to the reclassification of bonds owing to a change from long-term to short-term. 2,683 10,823 -16 729 349 -314 765 Other current and non-current financial liabilities Financial liabilities 3,136 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". 147 12,597 497 -1,792 -38 -16 -463 -546 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. rial impact on profit before income tax. of the other contingent compensations would not have had a mate- A change in the main input parameters used for the measurement unchanged (6.3%) 6.8% 5.8% Change of discount rate Change in probability of regulatory approval € million internal sales plans and sales plans of external industry services were used. The discount rate (after tax) of between 6.3% and 7.3% (December 31, 2017: 6.5% to 7.6%) was calculated using the weighted average cost of capital. 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, the sales planning assumed to derive royalties and ⚫ the discount rate used. the estimated probability of occurrence of the individual milestone events, • • 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: Liabilities to related parties -10% 10% For the period from January to December 2018, fixed salaries of € 5.9 million (2017: € 6.0 million), variable compensation of € 17.2 million (2017: € 16.3 million), and additional benefits of € 0.4 million (2017: € 0.3 million) were recorded for members of the Executive Board of Merck KGaA by E. Merck KG and by companies included in these consolidated financial statements. Furthermore, additions to provisions for the Long-Term Incentive Plan for members of the Executive Board of Merck KGaA resulted in expense of € 15.9 million from (2017: gains of € 1.8 million from the release of provisions), and additions to the pension provisions for members of the Executive Board of Merck KGaA included current service costs of € 3.1 million (2017: € 3.2 million) and, in 2017, past service costs of € 0.9 million. The compensation of the Supervisory Board amounting to € 869.0 thousand (2017: € 868.3 thousand) consisted of a fixed portion of € 822.5 thousand (2017: € 822.5 thousand) and meeting attendance compensation of € 46.5 thousand (2017: € 45.8 thousand). Notes to the Consolidated Financial Statements € million Consolidated Financial Statements 32 unchanged -5 38 0 -38 45 5 -34 -42 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 7,040 -400 869 869 -12 -323 335 7,173 121 -323 2018 Other Dec. 31, Fair value changes Currency translation 2018 Cash inflows Repayments consolidation 7,375 Changes in scope of Jan. 1, Financial liabilities¹ 106 530 Consolidated Financial Statements Notes to the Consolidated Financial Statements 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. 7,040 (41) Net cash flows from financing activities € million Bonds thereof: current thereof: non-current Liabilities to related parties Other current and non-current financial liabilities¹ The change in financial debt was as follows: 133 -869 6,304 Changes in scope of Cash inflows Repayments consolidation -932 Currency translation -425 Fair value changes Dec. 31, Other Jan. 1, 2017 8,731 937 2017 -932 -25 354 335 thereof: non-current 7,794 7,375 -354 thereof: current € million 765 375 - 319 821 2,687 10,827 32 407 Bonds -1,821 -2,463 5 119 5 902 8,896 1 Values effective January 1, 2018, have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes". -2 AND SOURCES OF ESTIMATION UNCERTAINTY - CONTINGENT CONSIDERATIONS SIGNIFICANT MANAGEMENT JUDGMENTS 0 259 from the sale and purchase of businesses or shares in corporations Interests in 19 unlisted funds Bond with embedded 7 settlement option for equity Used of standard market valuation models in a unlisted company 492 5 Market observable interest rates 278 Consolidated Financial Statements Shares (equity investments in listed companies) Main input factors used to determine fair values measurement technique Description of the Financial liabilities assets Contingent considerations Financial Classified as available for sale Fair value determined by official prices and quoted market values (Level 1) Fair Value € million DEC. 31, 2017 Notes to the Consolidated Financial Statements Financial instruments concerned Total Other debt instruments Contingent considerations 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 Description of the measurement technique Discounting of expected future cash flows 129 10 Equity interests in unlisted companies Financial liabilities 45 assets Financial instruments concerned Fair Value Fair value determined using input factors unobservable in the market (Level 3) Equity instruments 277 Notes to the Consolidated Financial Statements Consolidated Financial Statements Financial 16 Option pricing models Taking into account the fair value of the companies in which the funds are invested 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 5 Discounting of probability- weighted future milestone payments and license fees Trade accounts receivable 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 1 Bonds, investment funds Derived from Publicly-traded funds company 46 Option on equity instru- ments in an unlisted Derivatives without a hedging relationship 18 Interests in unlisted funds Total from the sale and purchase of businesses or shares in corporations Contingent considerations 96 6 Financial liabilities Financial assets Fair Value 277 Equity investements in unlisted companies Description of the measurement technique Discounting of expected future cash flows Main input factors used to determine fair values 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%) 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 280 3 Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date 443 Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Net asset values of the fund interests Option pricing models Taking into account the fair value of the companies in which the funds are invested 3 Discounting of probability- weighted future milestone payments and license fees Observable prices derived from equity refinancing Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates 287 Financial instruments concerned 279 54 Forward exchange contracts Total Classified as other Liabilities Fair value determined using input factors observable in the market (Level 2) Derivatives with and without a hedging relationship Quoted prices in an active market 70 7,719 7,719 2 active market 35 Bonds Classified as other liabilities Total 53 Fair Value determined using input factors unobservable on the market (Level 3) Classified as available for sale/ classified as other liabilities and currency options actuarial methods Notes to the Consolidated Financial Statements Consolidated Financial Statements € million DEC. 31, 2017 Market observable interest rates Interest rate curves available on the market Use of recognized Spot and forward rates ob- servable on the market and exchange rate volatilities 67 3,355 Discounting of future cash flows Liabilities to banks and other loan liabilities 86 13 Interest rate swaps 3,511 137 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: 3 3 22 -1 Gains (+)/losses (-) recognized in other comprehensive income 30 30 Currency translation 1 I 1 Disposals due to divestments/ payments received -80 Transfers out of Level 3 into Level 1/Level 2 Other -9 -8 259 27 487 -1 -3 3 24 December 31, 2018 (IFRS 9) 8 -9 -28 -29 -20 -4 Net carrying amounts, held as of the balance sheet date thereof: attributable to assets/liabilities 22 49 Fair value changes of Level 1/Level 2 Transfers into Level 3 out 33 I Gains (+)/losses (-) 8 I 105 conclusion of factoring agreements Additions due to acquisitions/divestments/ 106 46 15 45 recognized in profit or loss 2 24 thereof: financial result -36 -1 -37 held as of the balance sheet date -7 thereof: attributable to assets/liabilities -1 -31 operating result thereof: other -1 -7 -29 140 21 -5 3 held as of the balance sheet date thereof: attributable to assets/liabilities 3 4 03 3 3 -9 -9 held as of the balance sheet date thereof: attributable to assets/liabilities -4 -9 thereof: financial result -9 3 recognized in other comprehensive income 4 397 440 Net carrying amounts, December 31, 2017 (IAS 39) Transfers out of Level 3 into Level 1/Level 2 -1 Gains (+)/losses (-) -1 -2 -2 Currency translation -1 5 5 Disposals due to divestments 277 thereof: other operating result -6 Other liabilities thereof: Derivatives contingent without a hedging considerations relationship financial assets Total Available-for-sale Financial liabilities thereof: contingent considerations Financial assets € 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". 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- Notes to the Consolidated Financial Statements Consolidated Financial Statements 282 Net carrying amounts, January 1, 2017 (IAS 39) -6 74 50 recognized in profit or loss. Gains (+)/losses (-) Fair value changes 68 68 measurement at cost/Level 1/Level 2 75 Transfers to Level 3 from previous -2 46 228 258 302 -1 Additions as result of acquisitions/divestments 21 3 January 1, 2018 (IFRS 9) € million Obligations to acquire intangible assets and from collaboration agreements within one year in 1-5 years more than 5 years 266 Dec. 31, 2017 247 1,572 1,242 1,509 2,763 3,328 Other financial obligations were recognized at nominal value. 1,255 447 Dec. 31, 2018 Notes to the Consolidated Financial Statements 151 577 530 150 236 52 The expected maturities of these obligations were as follows: 63 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. 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) 284 Consolidated Financial Statements 3,686 144 € million Present value of future payments from finance leases 4 131 308 138 577 More than 2 Within 1 year 5 years Total 4 1 2 1 1-5 years Dec. 31, 2018 2 2 Interest component of finance leases Future finance lease payments Future operating lease payments € million Dec. 31, 2017 Present value of future payments from finance leases Total 4 Interest component of finance leases Future operating lease payments More than Within 1 year 1-5 years 5 years 2 Future finance lease payments Dec. 31, 2017 3,328 The maturities of liabilities from lease agreements were as follows: Dec. 31, 2018 46 € million Financial assets Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income Financial liabilities Subsequent measure- ment at fair value through profit or loss Equity instruments Other debt Contingent Derivatives without a hedging relationship Equity instruments 277 Trade accounts 2,763 Net carrying amounts, 102 4 21 -18 7 -1 Adjustment on initial application of IFRS 9 277 18 440 December 31, 2017 (IAS 39) Net carrying amounts, Contingent receivable considerations 46 Consolidated Financial Statements instruments considerations 283 Operating lease Long-term purchase commitments Remaining other financial obligations Other financial obligations Fair value at the date of disposal The cumulative gain (+) or loss (-) on disposal included in other Transfers of the cumulative gain (+) or loss (-) within group comprehensive equity in retained income earnings 40 32 32 Notes to the Consolidated Financial Statements -17 Acquisition of property, plant and equipment Acquisition of intangible assets and due to collaboration agreements -17 M Ventures portfolio companies The following equity instruments measured at fair value through other comprehensive income were disposed of in fiscal year 2018: 2018 € million Equity instrument¹ € million Cascadian Therapeutics, Inc., United States Nature's Best Health Products Ltd., United Kingdom 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. (40) Other financial obligations Other financial obligations comprised the following: 1 Disposals due to liquidations are not included. China's plan for the future Focus on biotechnology in China's Five-Year Plan employees on site What role does the collaboration with Tongji University play in all of this? 25 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. VIBRANT CHINA 3,500 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. 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 Does Merck also provide expertise? 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. New partner How did the partnership with Tongji University come about? 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. 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. 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. trends such as AI are driving an increase Technology mega- 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. Semiconductors as a new driver of growth 26 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 How does Merck benefit from this partnership? VIBRANT CHINA 85 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. Investments in the Nantong production site since 2017: Owing to China's large population, the need for digital treatment solutions there is enormous. TWO SECTORS, TWO SITES IN NANTONG 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. NO.1PRA ZARA Lil 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. 24 New partner New partner A chat with Steve Vermant, Managing Director of Merck's Life Science business sector and Head of Research Solutions in China, about the partnership with Tongji University under the CRISPR Core Partnership Program and the potential for CRISPR/ Cas9 in China. Steve Vermant, Managing Director of the Life Science business sector and Head of Research Solutions in China What role do technologies such as CRISPR/Cas9 play in academic research in China? "The demand from chip manufacturers VIBRANT CHINA years of presence in China "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. MIDO € 250 million SWIFTER DECISION-MAKING, A MORE PRAGMATIC APPROACH 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. At the end of this transformation, Merck will pro- duce and offer its services in China for China and thus grow along with the country as part of the local ecosystem, boosted by a national focus on innovation. The health platform for everyone 瑞士美度 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 23 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- ness. Radis 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. in China for inno- 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." - 19 vibrant china.. China is on the way to becoming a leading high-tech. nation. We intend to take an active role in shaping this transformation with our China strategy. T31142 20 VIBRANT CHINA VIBRANT CHINA Big plans for China Beijing 在中国展宏图 Big plans for china China intends to become a leading high- tech nation. Merck is benefiting from this transformation and will soon implement an important aspect of its China strategy: increasing production and research in China for China. After a long history as one of the world's largest sales markets, the country will now take on a key role in the realization of Merck's global strategy. 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. 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." 25005 PAPAR RECERCE 路 Research drives us all vative materials HEARTBEATS 17 "I am simply fascinated by everything we 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." FRANZISKA HÖLY Deputy Foreman, Performance Materials, Darmstadt, Germany MERCK 10 18 VIBRANT CHINA 上海银行 15709 DYNAMIC EVOLUTION, MOTIVATED TEAM 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 2 A GROWTH MARKET WITH IMMENSE POTENTIAL VIBRANT CHINA Big plans for China signed with the local authorities to build an Inno- vation Hub. Located at the heart of Guangzhou International Biotech Island, this hub will serve as a place of knowledge exchange for experts, partners and customers in all three business sec- tors, enabling them to develop and enhance inno- vative technologies for strategic markets in the Pearl River Delta and beyond. Stefan Oschmann announced the launch of inno- vation hubs in China during his visit to the coun- try in February 2018. To achieve this goal, a team of representatives from science and industry is being set up in Shanghai to form the Merck China Innovation team. The team members have ex- tensive knowledge in the areas of healthcare, chemistry and digital technologies and are led by Sophie Sun, Head of Merck China Innovation Hub. Together, they will explore the opportuni- ties in the Chinese innovation ecosystem. "A very lively innovation ecosystem is developing in China, allowing the country to become an indus- try leader for technological innovation," says Sun. "The Chinese government promotes innova- tion and industry developments through a number of programs and initiatives that are also highly relevant to Merck's areas of business and expertise. We therefore want to collaborate closely with startups, academic institutions, industry players and local governments so that we can jointly develop new technologies and solutions for China and for the world." 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. At least 22 40 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." The semiconductor industry is another focal point of China's development strategy. In the medium to long term, China aims to operate on an equal footing with leading countries such as the United States or South Korea. According to the "Economist", China's goal is to nearly quintuple the sales vol- ume from local chip manufacturers in the coming years from USD 65 billion in 2016 to more than USD 305 billion in 2030. By the same year, it also wants most of the domestic demand to be met with products made in China. So far, this is only true for a third of the country's total demand. China intends to invest about USD 150 billion in its domestic industry - a plan that also offers Merck the opportunity to further enhance its position as the leading solution provider for the electronics industry. The Performance Materials business sector sees enormous growth potential for semiconductor mate- rials in China. "The Semiconductor Solutions sec- tor is active in specialized markets. Our innovative per year should be treated with medications from Merck by the year 2025. 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 million patients 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." Big plans for China VIBRANT CHINA NEW INNOVATION CENTERS 21 The optimism with which our employees work on the diverse projects in China is also a product of our current success: In 2018, Merck generated sales of €1.9 billion in the country, an increase of more than 18% over the previous year. China is thus the largest growth driver for Merck, with the highest sales after the United States. And in the business units Display Solutions (Performance Materials) as well as General Medicine & Endocrinology (Healthcare), China is already the number one global market for Merck. 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." Similar ideas were voiced by Allan Gabor: "When 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." will probably con- materials contribute to the development of new "By 2025 we want every single person in China 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. DEMAND FOR TECHNOLOGIES AND EXPERTISE 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. ALLAN GABOR to come into contact with our products or services in a positive way." President of Merck China and Head of Performance Materials in China Notes to the Consolidated Financial Statements Subsequent measurement at amortized cost Derivatives without a hedging relationship Subsequent measurement at fair value through profit or loss +c+d Other non-current financial assets Loans and receivables Derivatives without a hedging relationship Derivatives with a hedging relationship Subsequent measurement at fair value through other comprehensive Available-for-sale financial assets income (debt instruments) Subsequent measurement at amortized cost Derivatives without a hedging relationship Derivatives with a hedging relationship Adjustments from the first-time application of IFRS 9 ƏT Consolidated Financial Statements (debt instruments) Financial assets Subsequent measurement at amortized cost Loans and receivables 291 Consolidated balance sheet item Cash and cash equivalents IAS 39 IFRS 9 Explanation Cash and cash equivalents Subsequent measurement at amortized cost Trade accounts receivable Loans and receivables Measurement category →a Current financial assets Loans and receivables Subsequent measurement at amortized cost Available-for-sale financial assets Subsequent measurement at fair value through other comprehensive income (debt instruments) Derivatives without a hedging relationship Other current financial assets Derivatives without a hedging relationship Loans and receivables Non-current financial assets → b Subsequent measurement at amortized cost →a Derivatives with a hedging relationship Derivatives with a hedging relationship Carrying amount 13 Remeasure- -1 30 30 12 12 € million 13 297 8 420 29 46 15 -8 123 29 -6 -23 29 29 46 46 15 246 in accordance with IAS 39 Dec. 31, 2017 247 9 ment due to the application of the impairment model 589 Carrying amount in accordance with IFRS 9 Jan. 1, 2018 Retained earnings Retained earnings/ Fair value reserve Gains/losses recognized in equity Fair value reserve net retained profit effect Jan. 1, 2018 for equity instrustuments Jan. 1, 2018 Available-for-sale financial assets Jan 1, 2018 for debt instruments Jan. 1, 2018 589 2,923 -15 2,908 47 35 47 35 9 -13 - ▬▬ RECONCILIATION OF FINANCIAL ASSETS FROM IAS 39 TO IFRS 9 AS OF JANUARY 1, 2018 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. Notes to the Consolidated Financial Statements 0.3 0.2 0.9 0.4 0.6 0.4 1.0 0.9 11.3 4.1 0.2 10.4 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. (45) Corporate governance The Statement of Compliance in accordance with section 161 of the German Stock Corporation Act (Aktiengesetz) was published in the corporate governance section of the website www.merckgroup.com/ investors → Corporate governance in March 2018 and thus made permanently available. • Litec-LLL GmbH, Greifswald • Merck 12. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 16. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck 20. Allgemeine Beteiligungs-GmbH, Darmstadt • Merck Accounting Solutions & Services Europe GmbH, Darmstadt • Merck Chemicals GmbH, Darmstadt • Merck Export GmbH, Darmstadt • Merck Healthcare KGaA, Darmstadt 3.9 0.4 2.4 8.5 4,415 Consolidated Financial Statements Notes to the Consolidated Financial Statements 287 Further individualized information and details can be found in the Compensation Report on pages 168 et seq. (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 2018 2017 thereof: KPMG AG Wirtschaftsprü- fungsgesellschaft, thereof: KPMG AG Wirtschaftsprü- fungsgesellschaft, Merck Group Germany Merck Group Germany 10.0 3.5 • Merck Life Science Germany GmbH, Darmstadt 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: • Merck Life Science GmbH, Eppelheim Merck Performance Materials Germany GmbH, Darmstadt Notes to the Consolidated Financial Statements 289 CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES RESULTING FROM IFRS 9 "FINANCIAL INSTRUMENTS" IFRS 9 sets forth new rules for classification and measurement of financial instruments and the impairment of financial assets as well as for hedge accounting. The modified retrospective method was used for the adoption of IFRS 9 at Merck, with the exception of the provisions for hedge accounting. In the case of hedging relationships where Merck used options as hedging instruments, the first-time application of IFRS 9 was made retrospectively, as required, by dis- closing comparative information for prior periods (see "Adjustments of prior periods" in this Note). In the case of hedging relationships where Merck used forward contracts as hedging instruments, the new IFRS 9 rules were applied for the first time using the prospective method. Classification and measurement According to IFRS 9, the classification and measurement of financial assets are determined by the business model of the company and the characteristics of the cash flows of the respective financial asset. Upon initial recognition, a financial asset is designated either as "at amortized cost", "at fair value through other comprehensive income" or "at fair value through profit or loss". For equity instruments held as of January 1, 2018, that are not held for trading, Merck has uniformly exercised the option of recog- nizing future changes in fair value in other comprehensive income in the consolidated statement of comprehensive income, and thus retaining them in consolidated equity upon disposal of the financial instrument. The first-time application of IFRS 9 did not lead to any material changes in the disclosure of financial liabilities. Impairments The first-time application of IFRS 9 resulted in the application of a new impairment model which takes into account expected credit losses already at initial recognition of a financial asset. This account- ing change leads to an earlier recognition of impairment losses for financial assets. The following financial assets are affected by the new impairment model: Consolidated Financial Statements • Trade accounts receivable • Other debt instruments measured at amortized cost • Debt instruments measured at fair value through other compre- hensive income 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". Hedge accounting 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. The adjustments relevant to Merck arising from the first-time appli- cation of the IFRS 9 provisions regarding hedge accounting are pre- sented below: • In the case of hedging relationships where Merck uses options as hedging instruments, only the intrinsic value of options has been designated as the hedging instrument since the first-time applica- tion of IFRS 9. Changes in the fair value of the time value compo- nent of options that are used for hedge accounting have to be recognized in other comprehensive income and in a new reserve for hedging costs within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. The table presented under "Adjustments of prior periods" shows the effects on the affected financial statement components arising from the retrospective application of the hedging approach in accor- dance with IFRS 9. • In the case of hedging relationships where Merck uses forward contracts as hedging instruments, only the spot element is desig- nated as a hedging instrument. Changes in the fair value of the forward element in forward contracts are initially recognized in a new reserve for hedging costs within equity. The subsequent accounting of these amounts depends on the type of the hedged transaction. These amendments did not have any impact on the consolidated balance sheet as of January 1, 2018. 290 Consolidated Financial Statements • Contract assets 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". • Merck Real Estate GmbH, Darmstadt • Merck Serono GmbH, Darmstadt (46) Companies opting for exemption under section 264 (3) HGB or section 264b HGB The following companies, which have been consolidated in these financial statements, opted for exemption: Allergopharma GmbH & Co. KG, Reinbek • Allergopharma Verwaltungs GmbH, Darmstadt • Biochrom GmbH, Berlin • Chemitra GmbH, Darmstadt (47) Information on preparation and approval The Executive Board of Merck KGaA prepared the consolidated financial statements on February 14, 2019, and approved them for forwarding to the Supervisory Board. The Supervisory Board has the responsi- bility to examine the consolidated financial statements and to declare whether it approves them. 288 Consolidated Financial Statements Notes to the Consolidated Financial Statements (48) Subsequent events 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). 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 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. Subsequent to the balance sheet date, no further events of special importance occurred that could have a material impact on the net assets, financial position and results of operations. Accounting and Measurement Policies (49) Effects from new accounting standards and other presentation and measurement changes FIRST-TIME APPLICATION OF IAS 29 "FINANCIAL REPORTING IN HYPERINFLATIONARY ECONOMIES" IN ARGENTINA • Merck Patent GmbH, Darmstadt -16 Derivatives without a hedging relationship 23 1,106 28,166 Current assets Inventories 2,632 2,632 Trade accounts receivable 2,923 2,923 Current financial assets 90 90 Other current assets 731 731 Income tax receivables Cash and cash equivalents Assets held for sale 490 490 589 589 Total assets Total equity 7,455 35,621 7,455 205 35,621 444 8,317 EFFECTS OF CHANGED ACCOUNTING AND MEASUREMENT POLICIES ON THE CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2017, AND JANUARY 1, 2018 The following table shows the effects of the aforementioned changes to the accounting and measurement principles on the consolidated balance sheet. € million Dec. 31, 2017 (as reported) IFRS 9 IAS 12/IAS 37 Reclassification (mandatory retro- spective adoption) Reclassification of interest and penalties related to income taxes Dec. 31, 2017 (restated)/ January 1, 2018 (before adjustments) Non-current assets Goodwill Other intangible assets Property, plant and equipment Non-current financial assets Other non-current assets Deferred tax assets 13,582 8,317 4,512 444 205 1,106 28,166 13,582 4,512 Notes to the Consolidated Financial Statements 565 12,358 2,257 788 8,033 354 1,489 12,919 414 43 457 2,790 2,790 2,195 2,195 Income tax liabilities 1,059 -43 1,016 Other current liabilities 2,175 2,175 Liabilities directly related to assets held for sale Total equity and liabilities 8,635 35,621 8,635 35,621 4,399 14,066 565 63 12,919 1,081 Equity capital Reserves 12,357 Gains/losses recognized in equity 1,082 Equity attributable to Merck KGaA shareholders 14,003 Non-controlling interests 63 14,066 Non-current liabilities Provisions for pensions and other post-employment benefits 2,257 Other non-current provisions 788 Non-current financial liabilities Other non-current liabilities 8,033 354 Deferred tax liabilities 1,489 Current liabilities Current provisions Current financial liabilities Trade accounts payable Refund liabilities 14,003 Consolidated Financial Statements 1 12,379 • collaboration agreements ⚫ costs of obtaining or fulfilling a contract principal-agent relationships bill-and-hold arrangements financing components • barter transactions • repurchase agreements •⚫ separate performance obligations from transportation or other logistic services 294 Consolidated Financial Statements Notes to the Consolidated Financial Statements The following table shows the consolidated income statement in the reporting period had IAS 18 been applied on an ongoing basis: € million Net sales Cost of sales Gross profit Other operating income Other income and expenses/financial result Profit before income tax 2018 IFRS 15 (as reported) 14,836 -5,382 Reconciliation to IAS 18 IAS 18 -6 14,830 3 consignment arrangements -5,379 • revenue recognition over time for long-term service contracts and customer-specific construction contracts 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. 296 -6 -31 -1 292 Consolidated Financial Statements Notes to the Consolidated Financial Statements The first-time application of IFRS 9 led to the following transition effects: 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. 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. 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. 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. CHANGES TO ACCOUNTING AND MEASUREMENT PRINCIPLES RESULTING FROM IFRS 15 "REVENUE FROM CONTRACTS WITH CUSTOMERS" 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. 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: 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. 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements 293 . • 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. 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. 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: • 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. • 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. Moreover, the new rules of IFRS 15 in the following areas were of no relevance - or only very minor relevance - for Merck: 9,454 • variable consideration 9,451 December 31, 2017 (restated)/January 1, 2018 (before adjustments) 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 IFRS 15 (before income tax) Timing of transfer of control from the sale of goods Out-licensing of intellectual property Take-or-pay contracts Multiple-element arrangements Income tax effect IFRS 15 IAS 29 (after income tax) Hyperinflation in Argentina January 1, 2018 (restated) 1 1 12,358 16 32 -16 2 2 -20 17 4 1 -2 -3 4 4 Hedge accounting (mandatory retrospective adoption) IFRS 9 (after income tax) 12,357 -368 -8,621 December 31, 2017 (as reported) 627 -8,621 1,461 -2 1,459 Income tax -1 -369 Profit after tax from continuing operations 1,093 628 1,090 -3 Consolidated Financial Statements 2,303 2 2,305 Profit after tax 3,396 -1 3,395 Profit after tax from discontinued operation Notes to the Consolidated Financial Statements 295 EFFECTS OF CHANGED ACCOUNTING AND MEASUREMENT POLICIES ON RESERVES AS OF DECEMBER 31, 2017, AND JANUARY 1, 2018 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. € million Other operating expenses Operating result (EBIT)¹ Income tax Profit before income tax Financial result Other operating income -4,702 Administration expenses Marketing and selling expenses Consolidated Income Statement as reported Profit after tax from continuing operations Gross profit Research and development costs Profit after tax from discontinued operation -5,071 15,327 -5,320 10,007 2017 IFRS 9 adjustment IFRS 5 adjustment adjusted -809 14,517 249 -560 9,446 Cost of sales Profit after tax Net sales 788 ADJUSTMENTS OF PREVIOUS PERIODS 353 4 14,055 2,257 8,036 -17 334 1,489 -17 1 12,903 457 2,790 -434 431 € million 1,761 1,016 25 2,200 -3 25 8,657 -15 -3 7 5 35,614 298 Consolidated Financial Statements Notes to the Consolidated Financial Statements 431 -4,349 has significant influence were recognized in accordance with IAS 28 using the equity method of accounting. 31 10 thereof: attributable to Merck KGaA shareholders (net income) thereof: attributable to non-controlling interests 2,600 4 10 Earnings per share in € (basic/diluted) - attributable to continuing operations - attributable to discontinued operation Consolidated Statement of Comprehensive Income Profit after tax Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods: Cost of cash flow hedge reserve Fair value adjustments Tax effect 2,605 Other comprehensive income 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 Consolidated Financial Statements The functional currency concept applies to the translation of financial statements of consolidated companies prepared in foreign currencies. The subsidiaries of the Merck Group generally conduct their operations independently. The functional currency of these companies is nor- mally the respective local currency. Assets and liabilities are mea- sured at the closing rate, and income and expenses are measured at weighted average annual rates in euros, the reporting currency. Any currency translation differences arising during consolidation of Group companies are recognized in equity. If Group companies are deconsolidated, existing currency differences are reversed and reclassified to profit or loss. (52) Currency translation Intragroup sales, expenses and income, as well as all receivables and payables between the consolidated companies, are eliminated. The effects of intragroup deliveries reported under non-current assets and inventories are adjusted by eliminating any intragroup profits. In accordance with IAS 12, deferred taxes are applied to these consolidation measures. 63 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". Comprehensive income -930 57 2,615 2,610 -899 -2,140 32 -2,108 1,227 -14 1,212 -937 56 -880 2,525 -102 2,423 -300 4 5 -294 2,224 5 -101 2,129 386 -1 43 428 2,610 4 -57 2,557 57 1 13,992 1.195 1,049 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 Consolidated Financial Statements 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-licensing and out-licensing in the Healthcare business sector (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 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 Consolidated Financial Statements The marketing authorizations, patents, licenses and similar rights, (58) Property, plant and equipment Consolidated Financial Statements Notes to the Consolidated Financial Statements 297 IFRS 9 IFRS 15 IAS 29 Reclassification Remeasurement Reclassification Remeasurement Remeasurement 1 Jan. 1, 2018 (after adjustments) 1 13,582 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. Notes to the Consolidated Financial Statements Since January 1, 2018, the classification and measurement of finan- cial assets are determined by the business model of the company and the characteristics of the cash flows of the respective financial asset in accordance with IFRS 9. Upon initial recognition, a financial asset is designated either as "at amortized cost", as "at fair value through other comprehensive income" or as "at fair value through profit or loss". Where non-current assets are leased and economic ownership lies with Merck (finance lease), the asset is recognized at the present value of the minimum lease payments or the lower fair value in accordance with IAS 17 and depreciated over its useful life. The corresponding payment obligations from future lease payments are recognized as liabilities. If an operating lease is concerned, the associated expenses are recognized in the period in which they are incurred. (59) Leasing The useful lives of the assets are reviewed regularly and adjusted if (60) Financial assets necessary. If indications of a decline in value exist, an impairment test is performed. If the reasons for an impairment loss no longer exist, a reversal of the impairment loss recognized in prior periods is recognized. 3 to 10 years maximum of 33 years maximum of 40 years 6 to 25 years Useful life Operating and office equipment; other facilities 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. CLASSIFICATION 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. 28,167 5 2 2,639 -15 4 2,904 90 735 490 589 -16 -3 9 2 2 -15 -3 7 5 35,614 32 -15 -32 3 -3 -15 -15 565 4 12,379 7,447 -2 1,105 205 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). Expected tax payments based on tax rates that have been enacted or substantively enacted by the end of the reporting period Fair value 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 Dec. 31, 2018 7.869 126.131 2017 7.621 126.921 2018 7.815 130.372 1.153 1,294.331 35.544 1.181 Closing rate 444 2 8,317 companies prepared in the functional currency are translated at the respective closing rates. Exchange differences from the translation of monetary items are recognized in the income statement with the exception of net investments in a foreign operation. Currency translation was based on the following key exchange rates: 4 € 1 = Japanese yen (JPY) Swiss franc (CHF) South Korean won (KRW) Taiwan dollar (TWD) U.S. dollar (USD) Average annual rate Chinese renminbi (CNY) Expected reimbursement amount Other receivables (financial instruments)¹ Settlement amount 3,318 -2 -2 -22 2 -24 -18 5 -23 -1,012 35 -1,047 4,246 -168 -125 4,414 -168 4,414 81 -26 106 63 63 -310 -310 188 -1 189 61 -23 4,246 84 3,193 Consolidated Financial Statements 32 -1,632 Research and development costs -271 28 -299 Administration expenses -2,373 349 -2,722 Marketing and selling expenses 4,850 -562 5,412 300 -1,340 6,190 -809 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 248 -1,600 4,164 4,282 299 2017 as reported IFRS 5 adjustment adjusted Reconciliation of EBIT¹ to EBITDA pre¹ Operating result (EBIT)¹ Depreciation/amortization/impairment losses/reversals of impairments EBITDA¹ Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Other adjustments Notes to the Consolidated Financial Statements EBITDA pre¹ EBITDA pre¹ Investments in property, plant and equipment, software as well as advance payments for intangible assets Changes in inventories Changes in trade accounts receivable as well as receivables from royalties and licenses Elimination first-time consolidation of BioControl Systems Business free cash flow¹ ¹ Not defined by International Financial Reporting Standards (IFRSS). 2,525 -102 2,423 1,758 -17 1,741 Business free cash flow¹ -118 Consolidated Financial Statements Group 5.98 0.01 -0.12 0.12 5.87 0.12 2,610 4 2,615 -5 -5 1 1 -1,843 -4 € million -1,847 767 Consolidated Cash Flow Statement Profit after tax 2,610 4 2,615 Other non-cash income and expenses -3 -4 -7 Net cash flows from operating activities 2,696 2,696 1 Not defined by International Financial Reporting Standards (IFRSS). 767 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 Other operating income and expenses 43 1 As from January 1, 2018, in accordance with IFRS 9; see Note (49) "Effects from new accounting standards and other presentation and measurement changes". Lower of carrying amount and fair value less costs to sell Amortized cost Expected tax refunds based on tax rates that have been enacted or substantively enacted by the end of the reporting period According to IAS 17 (see Note (59) "Leasing") Amortized cost Lower of cost and net realizable value to the period when the asset is realized or the liability is settled Undiscounted measurement based on tax rates that are expected to apply Amortized cost Fair value Amortized cost Fair value Amortized cost or fair value, depending on the business model (see Note (60) "Financial assets"). 302 Fair value Cash and cash equivalents¹ Income tax receivables Lease receivables Trade accounts receivable (without lease receivables)¹ Inventories Deferred tax assets Non-financial items Derivative assets (operative)¹ Other 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) Assets held for sale Measurement principle Consolidated Financial Statements Balance sheet item Settlement amount Fair value Liabilities directy related to assets held for sale Income tax liabilities Refund liabilities Trade accounts payable Deferred tax liabilities Amortized cost Fair value Amortized cost Amortized cost Amortized cost Amortized cost Present value of the expenditures expected to be required to settle the obligation Notes to the Consolidated Financial Statements Projected unit credit method Other liabilities Liabilities from non-income related taxes Liabilities from derivatives (operative)¹ Other liabilities (current/non-current) Finance lease liabilities Liabilities from derivatives (financial transactions)¹ Loans from third parties and other financial liabilities Liabilities to related parties Bank loans Bonds and commercial paper Financial liabilities (current/non-current) Other provisions (current/non-current) Provisions for pensions and other post-employment benefits Equity and liabilities Measurement principle 688 Equity instruments Property, plant and equipment -177 1,949 16 -26 42 -316 -316 27 28 17 -23 40 Business free cash flow¹ EBITDA pre¹ 1,773 Other adjustments Gains (+)/losses (-) on the divestment of businesses Restructuring 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 Acquisition-related adjustments Financial assets (current/non-current)¹ EBITDA pre¹ -177 With indefinite useful life or not yet available for use With finite useful life Other intangible assets Goodwill Assets Balance sheet item sheet are measured as follows: The main assets and liabilities disclosed in the consolidated balance (50) Measurement policies 301 Notes to the Consolidated Financial Statements Consolidated Financial Statements ¹ Not defined by International Financial Reporting Standards (IFRSS). 1,314 1,949 -134 -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 1,448 Integration expenses/IT expenses 4,514 100.00 Merck d.o.o. Croatia 100.00 Sofia Merck Bulgaria EAD Bulgaria 100.00 Overijse 100.00 Overijse 100.00 Overijse Sigma-Aldrich BVBA/SPRL Merck N. V.-S. A. Zagreb Merck Chemicals N. V./S. A. Belgium Belgium 100.00 Vienna Sigma-Aldrich Handels GmbH Austria 100.00 Vienna 100.00 Vienna Merck Chemicals and Life Science GesmbH Merck Gesellschaft mbH Austria Austria 100.00 Belgium 100.00 Czech Republic Merck spol. s r. o. 100.00 Espoo Merck Life Science OY Finland 100.00 Tallinn Merck Serono OÜ Estonia 100.00 100.00 Frederiksberg Survac ApS Denmark 100.00 Soborg Sigma-Aldrich Denmark ApS Denmark Prague 100.00 Czech Republic Sigma-Aldrich spol. s r. o. Prague 100.00 Vienna Denmark Soborg 100.00 Denmark Merck Life Science A/S Soborg 100.00 Merck A/S Finland Allergopharma Vertriebsgesellschaft m.b.H. countries 100.00 Darmstadt Merck Wohnungs- und Grundstücksverwaltungsgesellschaft mbH Germany 100.00 Gernsheim Merck Vierte Allgemeine Beteiligungsgesellschaft mbH Germany 100.00 100.00 Thereof: Merck KGaA (%) Equity interest (%) Registered office Darmstadt Merck Serono GmbH 100.00 Germany Country 313 Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 100.00 Hohenbrunn Merck Schuchardt OHG Germany 100.00 100.00 Darmstadt Merck Real Estate GmbH Germany Company Germany Millipart GmbH Gernsheim Other European 100.00 100.00 Steinheim Sigma-Aldrich Verwaltungs GmbH Germany 100.00 Steinheim Sigma-Aldrich Produktions GmbH Germany 100.00 Steinheim Sigma-Aldrich Logistik GmbH Germany 100.00 Steinheim Sigma-Aldrich Grundstücks GmbH & Co. KG 100.00 Germany Sigma-Aldrich Biochemie GmbH Steinheim 100.00 Germany Austria Sigma-Aldrich Chemie GmbH 100.00 Germany Sigma-Aldrich Chemie Holding GmbH Taufkirchen 100.00 Germany Steinheim Merck OY Espoo 100.00 100.00 Rome Istituto di Ricerche Biomediche Antoine Marxer RBM S. p. A. Allergopharma S. p. A. Italy Italy 100.00 Arklow 100.00 Arklow Thereof: Merck KGaA (%) Equity interest (%) Registered office Silverberry Limited Colleretto Giacosa Sigma-Aldrich Ireland Ltd. Country Ireland Ireland Notes to the Consolidated Financial Statements Consolidated Financial Statements 314 100.00 Arklow 100.00 Carrigtwohill Millipore Cork Unlimited Company Shrawdine Limited Ireland Ireland 100.00 Dublin Company Riga 100.00 Italy China China Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. Hong Kong 100.00 Hong Kong 100.00 China China China Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Nantong 100.00 Nantong 100.00 Beijing 100.00 Merck S. p.A. Milan 100.00 Italy Merck Serono S. p. A. Rome Merck Serono (Ireland) Ltd. 99.74 Sigma-Aldrich S. r. I. Milan 100.00 Latvia Merck KGaA (%) Thereof: Italy Ireland 100.00 Carrigtwohill 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 Fontenay s/Bois Finland Sigma-Aldrich Finland OY Espoo 100.00 France Gonnon S. A. S. 100.00 Lyon France Merck Biodevelopment S.A. S. Lyon 100.00 France Merck Chimie S.A. S. 100.00 100.00 France Molsheim Merck Millipore Ltd. Ireland 100.00 Carrigtwohill Merck Finance Limited Ireland 100.00 Budapest Sigma-Aldrich Kft. Hungary 100.00 Budapest Merck Kft. Hungary 100.00 Maroussi, Athens Merck A. E. 100.00 France Sigma-Aldrich Chimie S. a. r. l. Saint Quentin Fallavier 100.00 France Millipore S.A.S. Sigma-Aldrich Chimie SNC 100.00 France Sigma-Aldrich Holding S. a. r.l. Saint Quentin Fallavier 100.00 Greece Saint Quentin Fallavier 100.00 100.00 Merck Performance Materials Holding GmbH and other post-employment benefits (67) Provisions for pensions assets. Inventory prepayments are recognized under other current 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. 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 310 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. 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. 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 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. 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. 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. (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. - (65) Deferred taxes (68) Other provisions and contingent liabilities Provisions are recognized if it is more likely than not that an outflow of resources will be required to settle the obligation and the amount of the obligation can be measured reliably. The car- rying amount of other provisions takes into account the amounts required to cover future payment obligations, recognizable risks and uncertain obligations of the Merck Group to third parties. Measurement of other provisions is based on the settlement amount with the highest probability or, if a large number of similar cases exist with respect to the provision being measured, it is based on the expected value of the settlement amounts. Long-term provisions are discounted and carried at their present value as of the balance sheet date if the discount rate effect is material. To the extent that reimbursement claims exist as defined in IAS 37, they are recognized as an asset - separately from provisions - if their realization is virtually certain and the asset recognition criteria have been met. Restructuring provi- sions are recognized after detailed restructuring plans have been established and disclosed. Merck KGaA Germany Germany 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. (70) List of Shareholdings List of Shareholdings Notes to the Consolidated Financial Statements Consolidated Financial Statements 312 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. Contingent liabilities comprise not only possible obligations arising from past events and whose existence is subject to the occurrence of uncertain future events, but also present obligations arising from past events where an outflow of resources embody- ing economic benefits is not probable or where the amount of the obligation cannot be measured reliably. Contingent liabilities that were not assumed within the context of a business combi- nation are not recognized in the consolidated balance sheet. Unless the possibility of an outflow of resources embodying eco- nomic benefits is remote, information on the relevant contingent liabilities is disclosed in the notes. In this context, the present value of the future settlement amount is used as the basis for measurement. The settlement amount is determined in accor- dance with the rules set out in IAS 37 and is based on the best estimate. Consolidated Financial Statements Notes to the Consolidated Financial Statements 311 (69) Share-based compensation programs 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. - 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. 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). Darmstadt 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. Contingent consideration, as well as derivatives with negative market values, are subsequently measured at fair value. Value changes are recognized through profit or loss. ⚫ 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 through other com- Subsequent mea- amortized cost 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 surement at fair value Foreign currency gains or losses Other operating income or other operating expenses Financial result Other operating income or other operating expenses LIABILITIES SUBSEQUENTLY MEASURED AT FAIR VALUE THROUGH PROFIT OR LOSS 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. OTHER FINANCIAL LIABILITIES (61) Financial liabilities 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. ACCOUNTING AND MEASUREMENT PRINCIPLES APPLIED IN THE PREVIOUS YEAR (IAS 39) 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. DERECOGNITION 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. Changes in the fair value of equity instruments held for trading are recognized through profit or loss (other operating income/ expenses). 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. Equity instruments are subsequently measured at fair value. Equity instruments 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. Notes to the Consolidated Financial Statements Consolidated Financial Statements 308 Financial result Other operating income or other Other operating income operating expenses Financial result or other operating expenses Financial result (62) Derivatives and hedge accounting Interest income Financial result (applying the effective interest method) Financial result (applying the effective interest method) Financial result (applying the effective interest method) Depending on the category of debt instrument, at initial recognition Merck recognizes either the credit losses expected to occur over the entire lifetime or the 12-month expected credit losses. Except debt instruments with subsequent measurement through profit or loss, the impairment model of IFRS 9 is applied to all debt instruments. Merck uses the simplified impairment model for trade accounts receivable and contract assets pursuant to which any credit losses expected to occur over the entire lifetime of an asset are taken into account. In order to measure expected credit risks, the assets are grouped on the basis of the existing credit risk structure and the respective maturity structure. The customer groups with comparable default risks to be taken into account are determined at Merck in accordance with the business sectors and location of the respective customers. The default rates used in the simplified impairment model are derived on the basis of historical experience and current macro- economic expectations by taking into account country-specific ratings. These country ratings are aggregated to three separate rating groups. In this context, historical default rates generally also represent the best approximation for future expected defaults to the extent that a country's rating remains unchanged. Accordingly, when a country's rating changes, the historical default rates of the rating group to which the respective country has been re-allocated have to be applied, rather than the historical default rates of the previous rating group. Further information on the impairment of financial assets can be found in Note (38) "Management of financial risks". or expenses Parent Company Germany Germany Germany 100.00 100.00 Gernsheim Merck Holding GmbH Germany 100.00 Darmstadt Merck Healthcare KGaA Germany 100.00 100.00 Darmstadt Merck Healthcare Holding GmbH Merck International GmbH Germany 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 Darmstadt 100.00 100.00 Germany 100.00 Wiesbaden Merck Performance Materials GmbH Germany 100.00 Darmstadt Merck Performance Materials Germany GmbH Germany 100.00 Darmstadt Merck Patent GmbH Germany 100.00 100.00 Darmstadt Merck Life Science Holding GmbH Germany Merck Internationale Beteiligungen GmbH Darmstadt 100.00 Germany Merck Life Science Germany GmbH 100.00 Darmstadt Germany Merck Life Science GmbH Eppelheim 100.00 100.00 Germany 100.00 100.00 Darmstadt Merck Consumer Health Holding Germany GmbH Merck 12. Allgemeine Beteiligungs-GmbH Germany 100.00 100.00 Greifswald Litec-LLL GmbH Germany 100.00 Gernsheim Emedia Export Company mbH Germany 100.00 100.00 Darmstadt Chemitra GmbH Germany 100.00 AB Allgemeine Pensions GmbH & Co. KG Allergopharma GmbH & Co. KG Zossen 100.00 100.00 Reinbek 100.00 Darmstadt Germany Darmstadt 100.00 100.00 Germany Biochrom GmbH Berlin Allergopharma Verwaltungs GmbH Darmstadt 100.00 Germany Germany 100.00 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 21. Allgemeine Beteiligungs-GmbH Merck 13. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 Germany Germany Germany 100.00 Merck 15. Allgemeine Beteiligungs-GmbH Merck 16. Allgemeine Beteiligungs-GmbH Merck 20. Allgemeine Beteiligungs-GmbH 100.00 Darmstadt 100.00 Darmstadt 100.00 Germany Darmstadt Shanghai 100.00 China Alexandria Allergopharma USA, 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 100.00 100.00 100.00 Burlington Aldrich Chemical Co. LLC Natrix Separations, Inc. Sigma-Aldrich Canada Co. United States Canada Canada 100.00 Toronto Millipore (Canada) Ltd. Canada 100.00 Mississauga Oakville EMD Inc. United States Wilmington Country United States Notes to the Consolidated Financial Statements Consolidated Financial Statements 316 100.00 Wilmington EMD Finance LLC 100.00 Burlington EMD Digital Inc. United States United States 100.00 Rockland BioControl Systems, Inc. EMD Accounting Solutions & Services America, Inc. 100.00 Round Rock Cerilliant Corporation United States 100.00 Rocklin Cell Marque Corporation United States 100.00 Rockville BioReliance Corporation United States 100.00 United States Canada 100.00 Toronto Feltham Millipore (U.K.) Ltd. United Kingdom United Kingdom United Kingdom 100.00 Feltham Merck Serono Ltd. United Kingdom 100.00 London Merck Serono Europe Ltd. United Kingdom 100.00 Feltham 100.00 Merck Performance Materials Services UK Ltd. 100.00 Feltham Merck Investments Ltd. United Kingdom 100.00 Feltham Merck Holding Ltd. United Kingdom 100.00 Gillingham Merck Chemicals Ltd. United Kingdom 100.00 United Kingdom Millipore UK Holdings LLP Feltham 100.00 EMD Crop BioScience Canada Inc. Canada 100.00 Toronto EMD Chemicals Canada Inc. Canada North America 100.00 Gillingham Sigma-Genosys Limited United Kingdom Merck Management Consulting (Shanghai) Co., Ltd. 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 United Kingdom United Kingdom 100.00 Gillingham SAFC Biosciences Limited United States Company EMD Holding Corp. EMD Millipore Corporation 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 St. Louis United States 100.00 St. Louis Sigma-Aldrich Foreign Holding Co. United States 100.00 St. Louis Sigma-Aldrich Corporation United States 100.00 St. Louis Sigma-Aldrich Co. LLC United States Sigma-Aldrich Manufacturing LLC Sigma-Aldrich, Inc. Milwaukee 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 Sydney Merck Serono Australia Pty. Ltd. Australia 100.00 Bayswater Merck Pty. Ltd. Australia (APAC) Asia-Pacific 100.00 Bellefonte Supelco, Inc. United States 100.00 The Woodlands Sigma-Genosys of Texas LLC United States Merck Serono SIA Gillingham St. Louis United States 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 100.00 EMD Serono Research & Development Institute, Inc. 100.00 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 United States United States Millipore UK Holdings I, LLC Wilmington 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. United States United States United States United States 100.00 Cleveland 100.00 San Diego 100.00 Wilmington Research Organics, LLC Millipore UK Holdings II, LLC United States Ormet Circuits, Inc. United States United States 100.00 Sigma Redevelopment Corporation Epichem Group Limited United Kingdom 100.00 Schiphol-Rijk 100.00 100.00 Veldhoven 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. 100.00 Merck Holding Netherlands B. V. Netherlands Netherlands Netherlands Netherlands Netherlands 100.00 Schiphol-Rijk Merck B. V. Netherlands 100.00 Nieuwerkerk Ad Ijssel 100.00 Pietà Merck Chemicals B. V. Netherlands Sigma-Aldrich B. V. Zwijndrecht 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.o. Poland 100.00 Wroclaw Merck Business Solutions Europe Sp.z.o.0. Poland 100.00 Oslo Sigma-Aldrich Norway AS Norway 100.00 Oslo Merck Life Science AS Norway 100.00 Zwijndrecht Sigma-Aldrich Chemie N. V. Netherlands 100.00 100.00 Portugal Pietà Merck Capital Ltd. 100.00 Luxembourg Merck Holding S. a. r. l. Luxembourg 100.00 Luxembourg Merck Finanz S. a. r. l. Luxembourg 100.00 Luxembourg Merck Finance S. a. r.l. Luxembourg 100.00 Luxembourg Luxembourg Luxembourg 100.00 Luxembourg Mats Finance S. a. r. l. Luxembourg 100.00 Luxembourg AZ Electronic Materials S. a. r.l. Luxembourg 100.00 Vilnius Merck Serono, UAB Lithuania Merck Chemicals Holding S. a.r.l. Merck Invest SCS Luxembourg 100.00 Merck Capital Holding Ltd. Netherlands Malta Malta 100.00 Luxembourg Sigma-Aldrich S. a. r. l. 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 Luxembourg Millilux S. a. r.l. Luxembourg 100.00 100.00 Luxembourg Merck Re S. A. Luxembourg BioControl Systems B. V. 100.00 Merck, S.A. 100.00 Switzerland 100.00 Buchs Sigma-Aldrich (Switzerland) Holding AG Switzerland 100.00 Coinsins SeroMer Holding SA Switzerland 100.00 Coinsins Merck Serono SA Switzerland Switzerland 100.00 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 Coinsins Switzerland Turkey United Kingdom Sigma-Aldrich Chemie GmbH London BioReliance U.K. Acquisition Limited United Kingdom 100.00 Aberdeen BioReliance Limited United Kingdom 100.00 London BioControl Systems Limited United Kingdom 100.00 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 Algés Thereof: Merck KGaA (%) Aubonne 100.00 Ljubljana Merck d.o.o. Slovenia 100.00 Bratislava Sigma-Aldrich, spol. s r.o. Slovakia 100.00 Bratislava Merck spol. s r.o. Slovakia 100.00 Spain Belgrade Moscow Sigma-Aldrich Rus LLC Merck d.o.o. Beograd Russia Serbia 100.00 Moscow Merck LLC Russia 100.00 Bucharest Merck Romania S. R. L. Romania 100.00 Merck Chemicals and Life Science S. A. U. Madrid 100.00 Therwil Registered office Stockholm Ares Trading SA Switzerland Allergopharma AG Sigma-Aldrich Sweden AB Company Switzerland Sweden Country 315 Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 Solna Merck Chemicals and Life Science AB Sweden 100.00 Solna Merck AB Sweden 100.00 Madrid Sigma-Aldrich Quimica S. L. Spain 100.00 Madrid Merck, S. L. U. Spain Equity interest (%) Australia 100.00 100.00 Sigma-Aldrich Pty. Ltd. Castle Hill 100.00 China Beijing Skywing Technology Co., Ltd. Beijing China 100.00 Merck Chemicals (Shanghai) Co., Ltd. Shanghai 100.00 China Merck Display Materials (Shanghai) Co., Ltd. Shanghai China Merck Electronic Materials (Suzhou) Ltd. 100.00 100.00 Hong Kong 100.00 Nantong Merck Life Science Technologies (Nantong) Co., Ltd. Merck Ltd. China China 100.00 Hong Kong Suzhou Merck Life Science Ltd. 100.00 Shanghai Merck Holding (China) Co., Ltd. China China 100.00 < 0.5 Darmstadt Darmstadt 100.00 < 0.5 Ho Chi Minh City 100.00 100.00 Germany Germany Germany Germany Germany Germany Germany 100.00 Germany 100.00 Germany Merck 24. Allgemeine Beteiligungs-GmbH Merck 25. Allgemeine Beteiligungs-GmbH Merck 26. Allgemeine Beteiligungs-GmbH Merck 27. Allgemeine Beteiligungs-GmbH Merck 28. Allgemeine Beteiligungs-GmbH Merck 29. Allgemeine Beteiligungs-GmbH Merck 30. Allgemeine Beteiligungs-GmbH Merck 31. Allgemeine Beteiligungs-GmbH Merck 36. Allgemeine Beteiligungs-GmbH Merck 37. Allgemeine Beteiligungs-GmbH Merck 38. Allgemeine Beteiligungs-GmbH Darmstadt 100.00 100.00 < 0.5 <0.5 Darmstadt Germany Germany 100.00 Darmstadt 100.00 <0.5 Germany Germany Germany Merck 40. Allgemeine Beteiligungs-GmbH Merck 41. Allgemeine Beteiligungs-GmbH Merck Foundation gGmbH Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Other European F-Star Alpha Limited Canbex Therapeutics Ltd. Artios Pharma Limited United Kingdom United Kingdom United Kingdom United Kingdom ObsEva SA Inthera Bioscience AG Switzerland Switzerland Galecto Biotech AB 100.00 < 0.5 Darmstadt Germany 100.00 100.00 <0.5 Darmstadt 100.00 100.00 <0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 < 0.5 Darmstadt 100.00 100.00 <0.5 Darmstadt 100.00 100.00 < 0.5 Merck 39. Allgemeine Beteiligungs-GmbH 100.00 Zossen AB Pensionsverwaltung GmbH 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 100.00 318 Consolidated Financial Statements Notes to the Consolidated Financial Statements Country Middle East and Company Africa (MEA) Egypt Merck Ltd. 100.00 Santiago de Chile 100.00 Santiago de Chile Sigma-Aldrich Brasil Ltda. Chile Merck S.A. Chile Sigma-Aldrich Quimica Ltda. Colombia Merck S. A. Merck C. A. Merck, S.A. Ecuador Guatemala Merck Biopharma Distribution S.A. de C. V. Merck, S. A. de C. V. Sigma-Aldrich Quimica, S. de R.L. de C. V. Mesofarma Corporation Mexico Israel Mexico Panama Peru Merck Peruana S.A. Uruguay ARES Trading Uruguay S.A. Buenos Aires 100.00 Buenos Aires 100.00 Rio de Janeiro 100.00 São Paulo 100.00 Mexico Sweden Inter-Lab Ltd. InterPharm Laboratories Ltd. Herzliya Pituach 100.00 Yavne 90.00 Jerusalem 100.00 Rehovot 100.00 Nairobi 100.00 Halfway House 100.00 Kempton Park 100.00 Tunis 100.00 Tunis 100.00 Dubai 100.00 Thereof: Merck KGaA (%) Registered office Equity interest (%) Thereof: Merck KGaA (%) Fair value (€ million) Germany Germany 100.00 Yavne 100.00 Yavne Israel Merck Serono Ltd. Israel PMatX Ltd. Israel Israel Kenya South Africa South Africa QLight Nanotech Ltd. Sigma-Aldrich Israel Ltd. Merck Healthcare and Life Science Limited Merck (Pty) Ltd. Israel Sigma-Aldrich (Pty) Ltd. Tunisia Merck Promotion SARL Merck SARL United Arab Emirates Merck Serono Middle East FZ-Ltd. Country Company II. Companies not consolidated due to secondary importance Equity interest Registered office (%) Cairo 100.00 Tunisia SynAffix B. V. Abacus Diagnostica OY DNA Script S.A. S. 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 <0.5 100.00 Merck Pension Trustees Ltd. United Kingdom <0.5 100.00 Feltham Merck Ltd. United Kingdom <0.5 100.00 Feltham Merck Cross Border Trustees Ltd. Feltham Gillingham 100.00 <0.5 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 A) 100.00 Gillingham Wessex Biochemicals Ltd. United Kingdom <0.5 100.00 Gillingham Webnest Ltd. United Kingdom <0.5 100.00 Gillingham United Kingdom <0.5 100.00 Gillingham Russia <0.5 100.00 Moscow MedChem Limited Russia < 0.5 100.00 Moscow Chemical Trade Limited LLC Russia < 0.5 100.00 Amsterdam Merck Europe B. V. Netherlands < 0.5 100.00 Arklow SAFC Arklow Ltd. Ireland < 0.5 100.00 Athens Sigma-Aldrich (OM) Ltd. SAF-LAB LLC Biochrom Australia Pty. Ltd. Moscow < 0.5 Fluka Chemicals Ltd. United Kingdom <0.5 100.00 Gillingham <0.5 100.00 Gillingham A) 73.60 Plan-les-Ouates Fair value (€ million) Merck KGaA (%) Thereof: Equity interest (%) Registered office B-Line Systems Limited Bristol Organics Ltd. iOnctura SA Company United Kingdom United Kingdom Switzerland Country 319 Notes to the Consolidated Financial Statements Consolidated Financial Statements 100.00 Bayswater 100.00 <0.5 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 Notes to the Consolidated Financial Statements Consolidated Financial Statements 320 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. B) 50.58 B) 38.32 St. Louis St. Louis Prolog Healthy Living Fund II, L.P. Germany United States Alcan Systems GmbH Germany Aveni S. A. S. Forendo Pharma OY Netherlands Netherlands France France Finland Merck S. A. Finland ReWind Therapeutics N.V. Belgium Austria f-star Biotechnologische Forschungs- und Entwicklungsgesellschaft mbH countries Other European PharmLog Pharma Logistik GmbH PrintCity GmbH & Co. KG pharma mall Gesellschaft für Electronic Commerce mbH Germany Germany Germany IOmx Therapeutics AG Germany Inuru GmbH Germany Azelis Deutschland Kosmetik GmbH InfraServ GmbH & Co. Wiesbaden KG Germany Mosa Meat B. V. Prolog Healthy Living Fund, L.P. North America Merck S. A. Venezuela Latin America III. Non-controlled companies majority-owned <0.5 100.00 <0.5 100.00 Casablanca Lagos Merck Pharmaceutical and Life Sciences Ltd. Merck Maroc S.A.R.L. <0.5 100.00 Santo Domingo Nigeria Morocco Africa (MEA) Middle East and Merck Dominicana, S.R.L. Dominican Republic Latin America <0.5 100.00 Guangzhou Merck Innovation Hub (Guangdong) Co., Ltd. Venezuela United States Representaciones MEPRO S.A. Caracas Caracas A) 22.06 Basel Vaximm AG 2 39.11 Muttenz CAMAG Chemie-Erzeugnisse und Adsorptionstechnik AG Switzerland Switzerland A) 25.35 Lausanne Asceneuron SA Switzerland A) 38.81 Amsterdam Calypso Biotech B. V. Netherlands countries Other European <0.5 100.00 <0.5 100.00 IV. Associates not included at equity due to secondary importance Sigma-Aldrich de Argentina S. r. I. countries Brazil Australia (APAC) Asia-Pacific A) < 20.00 Cambridge Translate Bio, Inc. United States <0.5 < 20.00 < 20.00 San Diego Tioga Pharmaceuticals, Inc. United States A) < 20.00 Durham A) < 20.00 Cambridge Raze Therapeutics, Inc. Ribometrix Inc. United States United States A) < 20.00 Middle East and Menlo Park Immutep Limited < 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 Sydney Progyny, Inc. United States A) 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 London A) CLEARink Displays, Inc. United States Indi Molecular, Inc. United States < 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 Israel Company 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. Fremont Culver City Germantown Intrexon Corporation Country < 20.00 Metabomed Ltd. < 20.00 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. The financial statement risk 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. 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. The financial statement risk 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 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. ⚫ 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. 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. 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. • otherwise appears to be materially misstated. In connection with our audit, our responsibility is to read the other information and, in so doing, to consider whether the other information is materially inconsistent with the consolidated financial state- ments, with the combined management report or our knowledge obtained in the audit, or • 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. 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. 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 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. S. ma Stefan Oschmann 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. 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. Yavne 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. 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 Opinions Brompton-on-Swale A) < 20.00 Japan Merck Serono Co., Ltd. Tokyo 100.00 Japan Sigma-Aldrich Japan G.K. Tokyo 100.00 Malaysia Malaysia New Zealand New Zealand Merck Sdn Bhd Sigma-Aldrich (M) Sdn Bhd. Merck Ltd. Sigma-Aldrich New Zealand Co. Petaling Jaya Kuala Lumpur 100.00 100.00 Palmerston North 100.00 Christchurch 100.00 Philippines 100.00 Merck Business Solutions Asia Inc. Tokyo Japan Merck Specialities Pvt. Ltd. Sigma-Aldrich Chemicals Private Limited Mumbai 100.00 Mumbai 100.00 Mumbai 100.00 Bangalore 100.00 Indonesia Indonesia P.T. Merck Chemicals and Life Sciences P.T. Merck Tbk. Jakarta 100.00 Jakarta 86.65 Japan BioReliance K.K. Tokyo 100.00 Japan Merck Ltd. Tokyo 100.00 Merck Performance Materials Ltd. Bonifacio Global City 99.99 Philippines 100.00 Taiwan Merck Ltd. Taipei 100.00 Taiwan Merck Performance Materials Ltd. Taipei 100.00 Taiwan Vietnam Thailand SAFC Hitech Taiwan Co. Ltd. Merck Ltd. Merck Vietnam Ltd. Kaohsiung 100.00 Bangkok 45.11 Greece 100.00 Latin America Argentina Argentina Brazil Yongin City Sigma-Aldrich Korea Ltd. South Korea 100.00 Merck Inc. Bonifacio Global City 100.00 Singapore Merck Performance Materials Pte. Ltd. Singapore 100.00 Singapore Singapore Merck Pte. Ltd. Sigma-Aldrich Pte. Ltd. Singapore Merck Performance Materials Pvt. Ltd. 100.00 100.00 South Korea Merck Electronic Materials Ltd. Seoul 100.00 South Korea Merck Ltd. Seoul 100.00 South Korea Merck Performance Materials Ltd. Pyeongtaek-shi Singapore Merck Life Science Pvt. Ltd. India India Maastricht A) < 20.00 Paris A) < 20.00 Massy A) < 20.00 Turku <0.5 < 20.00 Turku A) < 20.00 Leuven-Heverlee A) < 20.00 Vienna <0.5 < 20.00 < 20.00 Neuried 3 < 20.00 < 20.00 A) Nijmegen < 20.00 Windsor A) < 20.00 Cambridge A) < 20.00 Cambridge A) < 20.00 Cambridge A) < 20.00 < 20.00 London < 20.00 London A) < 20.00 Cologny A) 23.28 Schlieren A) < 20.00 Lund A) A) Merck S.A. Bönen < 20.00 Registered office (%) Merck KGaA (%) China Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Beijing 100.00 China Merck Serono Co., Ltd. Beijing 100.00 China SAFC Hitech (Shanghai) Co., Ltd. Shanghai 100.00 China Sigma-Aldrich (Shanghai) Trading Co., Ltd. Shanghai 100.00 China Sigma-Aldrich (Wuxi) Life Science & Technology Co., Ltd. Wuxi 100.00 India India Company Country Thereof: Equity interest Sankt Augustin A) < 20.00 Martinsried < 0.5 < 20.00 Berlin 2 < 20.00 Wiesbaden 2 < 20.00 1 < 20.00 A) < 20.00 Darmstadt A) 7.75 69.00 Peratech HoldCo Limited Storm Therapeutics Limited F-Star Beta Limited F-Star Delta Limited Macrophage Pharma Limited United Kingdom United Kingdom United Kingdom United Kingdom Consolidated Financial Statements Notes to the Consolidated Financial Statements 317 Moers Druckfein Trade accounts receivable We exercise professional judgment and maintain professional skep- ticism throughout the audit. We also: 2015 2016 2017¹ 2018 in % 11,363 12,845 15,024 14,517 14,836 2.2% 1,762 1,843 2,481 2,423 2014 change Business Development 2014-2018 4 Proposal on the appropriation of profits for 2018. Financial liabilities Non-current Current Liquidity Investments in intangible assets³ Investments in property, plant and equipment³ Business free cash flow² 1,727 Net financial debt² Equity ratio (in %)² Research and development costs Dividend per share (in €) Employees (number as of December 31) 1 Fiscal 2017 has been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 2 Not defined by International Financial Reporting Standards (IFRSS). 3 According to the consolidated cash flow statement. Other key data -28.7% 15.5% 14.3% > 100.0% 3,388 3,630 4,490 4,246 3,800 -10.5% -272 29.8% 29.9% 29.3% 25.6% 1,557 1,487 2,154 2,129 28.3% Equity -82 -276 16.5% 16.7% 11.6% FINANCIAL CALENDAR for 2019 3,123 3,354 4,415 -75 4,164 -15.3% 27.5% 26.1% 29.4% 28.7% 23.8% -265 3,528 Cash and cash equivalents March 3/7/2019 Inventories 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 327 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. Independent Auditor's Report August 8/8/2019 Half-yearly Financial Report April 4/26/2019 Annual General Meeting November 11/14/2019 Quarterly Statement Q3 May 5/14/2019 Annual Press Conference Quarterly Statement Q1 Reasonable assurance is a high level of assurance, but is not a guar- antee that an audit conducted in accordance with Section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this combined management report. Identify and assess the risks of material misstatements of the con- solidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresenta- tions, or the override of internal controls. 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. German Public Auditor Responsible for the Engagement on the combined management report. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. • Evaluate the overall presentation, structure and content of the consolidated financial statements, including the disclosures, and whether the consolidated financial statements present the under- lying transactions and events in a manner that the consolidated financial statements give a true and fair view of the assets, liabil- ities, financial position and financial performance of the Group in compliance with IFRSS as adopted by the EU and the additional requirements of German commercial law pursuant to Section 315e (1) HGB. concern. • 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 • 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 1,461 E 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). Margin (% of net sales)² Adjustments² EBITDA pre² Margin (% of net sales)2 Profit before income tax Profit after tax Earnings per share (in €) EBITDA² Assets and liabilities Non-current assets of which: Goodwill Other intangible assets Property, plant and equipment Current assets of which: Total equity and liabilities 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. Margin (% of net sales)² Net sales The German Public Auditor responsible for the engagement is Bodo Rackwitz. Frankfurt am Main, February 15, 2019 KPMG AG Wirtschaftsprüfungsgesellschaft [Original German version signed by:] Braun Wirtschaftsprüfer [German Public Auditor] Operating result (EBIT)² Rackwitz [German Public Auditor] 330 Business Development 2014-2018 Business Development 2014-2018 This overview may include historically adjusted values in order to ensure comparability with 2018. € million Results of operations Wirtschaftsprüfer Other Legal and Regulatory Requirements - 31.4% 1,124 2,766 3,318 3,193 2,508 -21.4% 559 12,654 11,513 10,144 6,701 -33.9% 45.4% 33.8% 36.7% 39.5% 2,605 -0.9% 910 919 -16.8% 2,076 4,097 3,788 2,790 2,215 -20.6% 46.7% 143 132 392 106 -72.9% 481 514 716 179 1,704 1.00 1,709 1,976 Published on March 7, 2019 by Merck KGaA, Group Communications Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 Fax: +49 6151 72-5577 E-Mail: service@merckgroup.com Website: www.merckgroup.com CONCEPT AND DESIGN 3st kommunikation GmbH, Mainz www.3st.de PHOTOS You can order all publications from Group Communications, Merck KGaA, 64271 Darmstadt, service@merckgroup.com. Getty (pages 1, 10-11, 18-19, 20, 23, 26, 27, 33) Konstantin Eckert (pages 12-17) Rüdiger Nehmzow (pages 44, 48-49) Unsplash, Frank V. (pages 28-29) TRANSLATION Leinhäuser Language Services GmbH PRINTING AC medienhaus GmbH PAPER Mosa Meat (pages 34-35) 6,681 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. Information and Service 2,108 2,225 5.6% 1.05 1.20 1.25 1,254 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. 39,639 50,348 52,880 51,713 -2.2% 331 332 Information and Service 49,613 8,033 8,809 9,616 -1.8% 5,694 14,492 15,015 13,582 13,764 1.3% 27,652 5,702 9,980 8,317 7,237 -13.0% 2,990 4,008 4,231 10,930 4,512 28,166 30,737 1,633 2,615 3,396 2.66 2.56 3.75 5.99 30,589 7.76 26,010 38,081 38,258 35,621 36,888 3.6% 15,530 29.9% 29.5% 1,165 4,811 10,480 589 2,170 > 100.0% 11,801 12,855 14,050 14,066 939 17,233 5,637 13,713 12,597 10,823 8,896 -17.8% 3,561 22.5% 6.6% 832 0.3% 7,344 7,670 7,455 9,236 23.9% 1,660 2,610 2,879 2,609 2,764 5.0% 2,220 2,738 2,889 2,923 2,931 2,632 Further Information pursuant to Article 10 of the EU Audit Regulation "Syntropy aims to help researchers collaborate securely Sometimes, a needle prick can also physiology Bioling, a portfolio company of the Merck venture capital arm M Ventures, is on the edge of a breakthrough that could not only significantly improve the lives of people suffering from diabetes, but medical diagnostics as a whole. Would you prick yourself with a needle 100 times to maintain your own health? And what about 1,000 times? Or tens of thousands of times? That's a lifetime's number of needle pricks for many of the 380 million people suffering from diabetes. Yet the concentration of blood sugar, or glucose, must be monitored regularly in order to minimize the long- term complications of diabetes, such as increased atherosclerosis and nerve disorders. And so far, moni- toring requires a drop of blood - every single time. So most patients prick themselves several times a day, their entire lives. Over time, this is not only extremely bothersome; it also has a negative effect on their quality of life. So the new development from Bioling - a U.S.-based company backed by M Ventures, Merck's venture capital arm - could improve the lives of many people. Nectar, the name of this revolutionary product, looks like a patch the size of a euro 50-cent coin. It contains tiny sensors that, when applied to the skin, analyze what is known as the interstitial fluid directly beneath the top layer of the skin. This fluid is not within skin cells or other cells, but in the space between cells. The sensors currently measure glu- cose, but in the future could measure a number of things, such as lactate and ketone levels. Studies have shown that measuring glucose in the interstitial fluid leads to even more precise results than inter- stitial fluid from the subcutaneous tissue, where tradi- tional Continuous Glucose Monitors (CGMs) operate. Moreover, Nectar is not only affordable, it is also easy to use. It is completely pain-free, can remain on the skin for more than seven days, and sends the data wirelessly to a smartphone. The app that goes along with it is also easy to use. "Bioling is on the verge of improving and simplifying the lives of millions of people living with diabetes with just a small patch," explains Edward Kliphuis, Bioling Board Member and Investment Director of M Ven- tures. The needle-free sensor BEYOND TOMORROW 31 "Bioling is on the verge of improving and simplifying the lives of millions of people living with diabetes with just a small patch." EDWARD KLIPHUIS Investment Director of M Ventures and Bioling Board Member 221 Mg/dl 8 Mg/dl 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. 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 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 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. Ketone Lactat Glukose Semiconductors as a new driver of growth VIBRANT CHINA 27 CONTINUOUS TECHNOLOGICAL ADVANCES HELP SHAPE THE INDUSTRY Technology megatrends such as big data, the Inter- net of Things and artificial intelligence call for in- creasingly smaller but more powerful microchips. These technology megatrends are also driving the growth of the materials market. If China evolves into a leading microchip manufacturer and in- creases its domestic IC production, demand for high- tech materials will continue to rise. Merck is regar- ded as the global technology leader for many of these high-tech products. Its portfolio includes, among other things, high-precision materials and solutions based on colloidal silicon dioxide as well as process and deposition materials. Merck has developed ma- terials in which polymers arrange themselves along the conductive structure to address the miniatur- ization process. This directed self-assembly (DSA) technology, as it's called, is used in the computer chips of tomorrow. Winnie Hui sees the development of local production as a key prerequisite for maintaining successful business relationships with national and international customers in China in the future as well. This is only logical, since Merck focuses on long-term part- nerships in its business and will continue to supply specialized materials and customized solutions that require a great deal of technical expertise. - According to Winnie Hui, partners who set up local production operations are our most important customers, yet regulatory institutions are also key, since they have and exert a lot of regional influence in shaping requirements from central government. She also expects to see mergers between local companies: "If we want to stay suc- cessful in this competitive environment, we have to be agile and maintain our high pace." High-tech materials from Merck are essential for the manufacture of powerful microchips. The Chinese government intends to invest as much 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? If you want to actively shape the future, you need to ask the right questions. 30 BEYOND TOMORROW The needle-free sensor The needle- free sensor 8 BEYOND TOMORROW A platform for the fight against cancer Syntropy will drive the creation of new knowledge and accelerate scien- tific discovery. 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. If, one day, there is a clear global demand for "clean" meat that does not require killing animals... If, as a developer of "clean" meat, you could make one wish... Mark Post (61) is the founder of Mosa Meat. He and his team have big plans. In the following four short scenarios, he looks at a future with "clean" hamburger meat. MARK POST If, in ten years' time, the aim is for 100 million people all around the world to eat Mosa Meat's ground beef... not ensure that a greater share of the world's meat is produced without large-scale livestock farming... If, in the near future, we do IF 35 A platform for the fight against cancer Real meat without the side effects 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. Burger with patty made by Mosa Meat and cultivate them in a bioreactor, allowing them to proliferate until there are trillions of cells. Second, when researchers stop feeding the cells, they naturally merge to form myofibers. Under specific conditions, these pri- mary myofibers increasingly put on bulk and lengthen, until these strands of muscle tissue naturally - without genetic tricks - form the shape of what we intend to produce: meat. This process is not automated yet, so the price of the cultured ground beef is still expensive. Furthermore, fetal bovine serum is traditionally used to feed the cells, and the process to extract it is not in line with stan- dards of the developers at Mosa Meat. For this reason, Mosa Meat is research- ing sustainable solutions that would eliminate animal products from the production process. In light of this, the M Ventures investment could also lead to a strategic partnership: Merck has immense expertise in cultivating cells and developing bioreactors, and could help Mosa Meat master these challenges. But how can you produce real meat without slaughtering animals? There are two key steps: First, researchers take animal muscle cells which have the function of creating new muscle tissue when the muscle is injured, When Mark Post eats a juicy prototype hamburger from his own manufacture, it's not just because it tastes good: he also sinks his teeth in for scientific reasons. For nearly 13 years, Post, who is Professor of Pharmacology at the University of Maastricht, has been conducting research on meat for which no animal has to die. This was the idea behind the company Mosa Meat, which Post founded in 2015 and in which Merck's venture capital fund M Ventures has an equity stake. And the idea is now on the verge of a breakthrough: In 2021, Post is aiming for the market launch of his ground beef made from cultured meat. Al- though there are still challenges to overcome, Mark Post is optimistic: "We intend to fulfill our mission of making meat more sustainable, healthy, and animal-friendly." Meat consumption around the world continues to rise, with negative consequences for animals, the earth's climate, and the environment. Should meat be banned? That's unrealistic. A better solution is to develop meat for which no animals have to be slaughtered. Mosa Meat is working on that. It won't be long before the Dutch company introduces the first cultured hamburger to the market. Delicious, affordable - and "clean". side effects without the Real Meat Real meat without the side effects BEYOND TOMORROW 34 ALEXANDER KARP Palantir Technologies co-founder and CEO to realize the value of scientific data, driving discoveries that will deliver better treatments to patients faster." THEN ...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 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. 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. ...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. DATA ACROSS THE GLOBE IS PACKAGED DIFFERENTLY 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. 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- "We are committed to tailoring Syntropy to meet the precise needs of cancer researchers and clinical doctors." STEFAN OSCHMANN Chairman of the Merck Executive Board - wide in a structured form and could be the source of a great knowl- edge and developmental boost in modern medicine. SYNTROPY IS EXPECTED TO TAKE RESEARCH TO A NEW LEVEL 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 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. BEYOND TOMORROW A platform for the fight against cancer ...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. 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 36 BEYOND TOMORROW 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, EXTERNAL AND IN-HOUSE DATA WILL BE AGGREGATED 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. 33 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. 1 Excluding the Consumer Health business divested in 2018. 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. 2 MSCI European Pharma Index. 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. 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. 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. 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. 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. To Our Shareholders 3 Dow Jones European Chemical Index. GROWTH HAS ITS PRICE Chairman of the Executive Board and CEO 44 Fundamental Information about the Group 55 Merck 61 Strategy 68 Internal Management System 72 Corporate Responsibility 81 Research and Development 91 People at Merck 50 Merck Shares 99 101 Macroeconomic and 104 111 - - - Sector-Specific Environment Review of Forecast against Actual Business Developments Course of Business and Economic Position Merck Group Healthcare Life Science Report on Economic Position The Executive Board 48 55 New heroes wanted BEYOND TOMORROW 37 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? 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. AN OPPORTUNITY FOR VISIONARY IDEAS 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. 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 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. http://futureinsightprize.merckgroup.com Future Insight Prize Merck plans to support courageous projects over the next years in the following areas: 2019 Pandemic Protector - Protection against newly emerging pathogens and identification of an active substance for the treatment or prevention of disease (category: health) 2020 Multi-drug resistance breaker - Solving the problem of antibacterial resistance to multiple antibacterials (category: health) 2021 Letter from Stefan Oschmann 43 41-52 53-162 Combined Management Report* Shareholders Performance Materials To Our Table of Contents TABLE OF CONTENTS ANNUAL REPORT 38 CO2-to-fuel converter - Generating fuel through photocatalytic conversion of atmospheric CO2 (category: energy) 2022 Food generator - Technology to help feed the world's growing population (category: nutrition) Annual Report Stefan Oschmann Corporate and Other Report on Risks and Opportunities Business Development 2014-2018 332 Information and Service Financial Calendar for 2019 * 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. 39 TABLE OF CONTENTS ANNUAL REPORT TO OUR SHAREHOLDERS 41-52 TO OUR SHAREHOLDERS 43 Letter from Stefan Oschmann 48 The Executive Board 50 Merck Shares Letter from Stefan Oschmann To Our Shareholders In the Performance Materials business sector, we have developed a new strategy and restructured our organization. With the help of our multi-year "Bright Future" transformation program, we will implement our new strategy and create the basis for future profitable growth beyond 2019. Our goals in taking this step are to sharpen our focus on our customers' needs as well as to centrally decide on the assessment of projects and the related use of resources as part of an integrated approach to research and development. Growth in our Life Science business sector continued to perform above the market. We have further expanded our position as the most profitable technology and solutions supplier in the life science industry. We recorded particularly strong sales growth in our Process Solutions area, where we offer leading-edge processing technologies for biotech and pharmaceutical companies as well as products critical to the advancement of cell and gene therapy. Moreover, our e-commerce platform made a significant contribution to business growth. . • 330 • 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). 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. Dear shareholders, dear of March, dear friends 43 Letter from Stefan Oschmann To Our Shareholders 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. 137 Independent Auditor's Report 322 150 Report on Expected Developments 154 Report in accordance with Section 315a (1) of the German Commercial Code (HGB) 156 Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Corporate TABLE OF CONTENTS ANNUAL REPORT Consolidated Financial Statements 197-321 Consolidated Income Statement Governance 200 201 Responsibility Statement 163-196 165 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 193 Comprehensive Income 204 166 Consolidated Cash Flow Statement 203 Consolidated Balance Sheet 201 Capital Structure and Corporate Bodies of Merck KGaA Statement on Corporate Governance Consolidated Statement of 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. 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. - Healthcare Merck Shares To Our Shareholders Key share price data¹ MERCK SHARES 52 Source: Bloomberg (closing rates). Dec. Nov. Oct. Sept. 2018 Aug. June May Apr. Mar. Feb. Jan. Share price high December 3, 2018 → € 99.82 MSCI European Pharma Index Dow Jones European Chemical Index • Merck • DAX® Share price low March 26, 2018 → € 74.80 July 2017 Dividend² Share price high Market value of authorized shares5 (at year-end) 39,021 39,121 € million 473,740 583,653 number 89.75 89.98 € 87.90 74.80 € 114.40 99.82 € 1.25 1.25 € Market capitalization (at year-end) Daily average number of Merck shares traded³ Year-end share price Share price low гори € million -20 -15 Executive Board and CEO Chairman of the Stefan Oschmann Chief Financial Officer Marcus Kuhnert Member of the Executive Board CEO Life Science Member of the Executive Board Udit Batra The Executive Board The Executive Board Kai Beckmann Member of the Executive Board CEO Performance Materials To Our Shareholders 47 Chairman of the Executive Board and CEO Dr. Stefan Oschmann Stefan Suman Sincerely, 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. 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. 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. 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. Letter from Stefan Oschmann 48 Belén Garijo Member of the Executive Board CEO Healthcare - 10 -5 0 5 10 15 in % Share price development from January 1, 2018 to December 31, 2018 MERCK SHARES 51 Merck Shares To Our Shareholders The average daily trading volume of our shares increased by 23% from approximately 474,000 in 2017 to over 584,000 in 2018. The North America region continued to dominate: its proportion of the free float increased to around 36% (2017: 29%). By investor type, growth and value investors dominated, as in the previous year. In 2018, growing interest could be seen among value investors, who now hold approximately 28% of the free float. At the end of 2018, the top five investors held around 28% of the free float (2017: 19%). In 2018, the Merck Executive Board and the Investor Relations team gave in-depth briefings to more than 660 investors at investor con- ferences as well as during roadshows and conference calls. The performance of Merck shares was, on the whole, characterized by volatility in 2018: Following a downswing in the first quarter amid a market setting that came under visible pressure, the share price staged a recovery by the year-end. The Merck share price remained almost unchanged over the previous year at +0.26%, finishing the year at € 89.98. The shares substantially outperformed the relevant reference indices, which all recorded a downswing during the same period. When compared with the DAX® reference index, which fell by around 18% during the period as a whole, the Merck shares performed just under 19 percentage points better. Their outperformance vis-à-vis the relevant chemical industry index, which fell by almost 16% in 2018, was around 16 percentage points. The pharmaceutical industry index declined by around 3% in 2018, thus underperforming Merck shares by 3 percentage points in the same period. At a glance Merck Shares To Our Shareholders Merck Shares 50 49 The Executive Board To Our Shareholders thin 11,629 11,599 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. Fundamental Information about the Group 55 Merck Fundamental Information about the Group 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 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. 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 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. Additional Information on Merck KGaA in accordance with the German Commercial Code (HGB) Merck 156 154 Report on Expected Developments 150 Report on Risks and Opportunities 137 - Corporate and Other People at Merck 91 - Performance Materials - Life Science Report in accordance with Section 315a (1) of the German Commercial Code (HGB) We are Merck, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. Our work makes a positive difference in millions of people's lives every day. In Healthcare, we discover unique ways to treat the most chal- lenging diseases such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Performance Materials, we develop science that sits inside technologies and changes the way we access and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. 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. 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. 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. 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. 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 Fundamental Information about the Group Combined Management Report 56 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. 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"). 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. 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. 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. BIOPHARMA 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. 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 Healthcare 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 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. 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. Research and Development 81 - Merck Group Course of Business and Economic Position 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 United Kingdom 14.8% Rest of World 7.0% German Retail/Undisclosed 16.2% Identified investors by region as of December 2018 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). Source: Nasdaq Shareholder Identification. To Our Shareholders 1% Other 17% GARP (Growth At Reasonable Price) 111 Review of Forecast against Actual Business Developments 104 Macroeconomic and Sector-Specific Environment 101 Report on Economic Position 99 Corporate Responsibility 72 Internal Management System 68 Strategy 61 Merck 55 about the Group Fundamental Information 55 REPORT* COMBINED MANAGEMENT 53-162 REPORT* COMBINED MANAGEMENT 32% Growth 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 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. 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%. 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. purposefully to the requirements of end customers. On top of this, decisions on the evaluation of projects and the allocation of resources are to be made centrally, and the business sector aims to push ahead with integrated and interdisciplinary R&D. - Merck Fundamental Information about the Group Combined Management Report 60 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. 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 Our Performance Materials business sector comprises the specialty chemicals business of Merck and supplies solutions for displays, com- puter chips and surfaces of all kinds. Effective April 1, 2018, Performance Materials comprises three business units: Display Solutions, Semi- conductor Solutions and Surface Solutions. If we compare Performance Materials with a smartphone, Display Solutions represents the user interface, Semiconductor Solutions the intelligence and Surface Solutions the aesthetics. Performance Materials We will continue to actively manage our comprehensive portfolio by tapping into innovation and placing it in the best hands to con- tinuously drive value for customers. In October, we announced an agreement to sell our AmnisⓇ Flow Cytometry and Guava® Technologies businesses to Luminex Corpo- ration for € 63 million. The transaction transferred our flow cytometry platforms Amnis and Guava as well as the associated reagents under those brands. This included a portfolio of leading technologies serving the research space. In 2018, we served as the exclusive sponsor of TeleScience, a new online platform for Seeding Labs, an organization that provides scientists in developing countries with lab equipment, training and opportunities to collaborate with experts in their field. To date, our partnership with Seeding Labs has enabled the organization to equip 65 universities in 34 developing countries with 77 shipments (con- taining nearly 200 tons) of equipment, providing access to the global scientific community and helping to accelerate scientific research. 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. 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. 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. 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. 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 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. THE ROADMAP Strategically, what we have achieved is the transformation of a classic chemicals and pharmaceuticals supplier into the vibrant sci- ence and technology company with leading positions in Healthcare, Life Science and Performance Materials. To further achieve our stra- tegic goals from 2011-2017, we completed a transformation and growth program known as "Fit for 2018", primarily targeting organi- zational effectiveness and process optimization, and in the later years new initiatives such as the commencement of our Merck Innovation Center in Darmstadt, new product innovations and the new Merck brand. helped us further diversify our product portfolio that was strongly driven by liquid crystals. THE TRANSFORMATIONAL JOURNEY SINCE 2007 Throughout the past years, Merck has grown significantly through a series of strategic moves that have enabled us to develop into the vibrant science and technology company we are today. We have systematically and continuously strengthened and focused our port- folio of innovative science and technology throughout our business sectors. In Healthcare we divested our Generics business (2007) to focus on highly specialized products and acquired Serono (2007) to expand our pipeline and strengthen our business. This focused approach has continued until today with the divestments of the Bio- similars business (2017) and Consumer Health business (2018), so that we can increase our efforts on our Oncology, Immuno-oncology and Immunology franchises. Within Life Science, we have signifi- cantly transformed to become a diversified industry leader through the acquisition of Millipore (2010) and Sigma-Aldrich (2015). We continue to leverage the Sigma-Aldrich e-commerce platform to expand our reach and leadership in the industry as well as investing in strategic initiatives such as Gene Editing & Novel Modalities and End-to-End Bioprocessing. During this time, Performance Materials has continued to deliver profitable growth and a significant cash contribution, and we evolved this business further into attractive science and technology areas such as semiconductor materials through the acquisition of AZ Electronic Materials (2014), which also Group Strategy 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. 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. 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. 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. 61 Fundamental Information about the Group _ Strategy Combined Management Report Strategy On October 26, the Surface Solutions business unit announced that it would align itself even more closely with the needs of its markets. The future business areas of Surface Solutions will be auto- motive coatings, cosmetic solutions and industrial solutions. In the Surface Solutions business unit our goal is to help custom- ers with our materials and solutions to make innovative surfaces of all kinds more beautiful, more resistant or even more intelligent. Our pearlescent pigments enable striking automotive coatings, fascinating cosmetics, extraordinary packaging, innovative product design and even unique food creations. With our functional solutions we serve a large number of innovative applications, from dirt-repellent and easy- care surfaces to laser markings of plastic parts and cables. Materials for Directed Self Assembly (DSA) provide cost-effective patterning solutions which enable further chip scaling. DSA combines bottom-up with conventional top-down patterning. DSA uses a vari- ety of different materials, in particular so-called block copolymers (BCP) that consist of two continuous, linked strands of different polymers. These BCPs have the ability to arrange themselves in even shapes along the conductive structure under certain conditions. They form the basis for the extremely fine transistors and printed circuit paths for the computer chips of the future. Our technological com- petence in combination with a strengthened supply chain have con- tributed to this growth. General principles 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. 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. 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. 58 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. 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. ALLERGOPHARMA 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. CONSUMER HEALTH 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. Combined Management Report 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. 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. 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. 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. 57 Merck Fundamental Information about the Group Combined Management Report 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. 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. Fundamental Information about the Group - 59 Merck Fundamental Information about the Group Combined Management Report 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 In October, we also opened a new, 1,000-square-meter M Lab™ Collaboration Center in São Paulo, Brazil, to serve the Latin America region. The lab, which is one of nine such centers around the world, includes a non-good manufacturing practice (non-GMP) pilot and bench scale labs for customers. This allows customers to engage in process development support, troubleshooting, demonstrations and hands-on training to explore new ways to increase productivity, improve processes and mitigate risks. In the second half of 2018, we opened a € 13 million (SG $ 20 million), 3,800-square-meter laboratory in Singapore, the only lab of its kind in Singapore and outside of the United States and the United Kingdom. The lab will focus on biologics testing, which is a major step in the drug development process. Merck 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 first quarter of 2018, we made the first of several invest- ment announcements. In February, we invested €40 million in Asia, which included an integrated cell culture facility in Songdo, Incheon, Korea; a new manufacturing and distribution center near Mumbai, India; and a single-use manufacturing facility in Wuxi, China. Our e-commerce platform, sigmaaldrich.com, continues to grow and connect customers in nearly every country with the products needed to advance their research, development and production efforts. In 2018, we implemented initiatives to optimize how our customers search and find our products, engage with our content and make purchasing decisions. With our teams' technical expertise and dedica- tion to customer service, we continued to experience growth in both user sessions and revenue. This was recognized with three external awards. 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). In Life Science, our purpose is to solve the toughest problems in life science by collaborating with the global scientific community. Since acquiring the chemical and technology company Sigma-Aldrich in 2015, we have put a strategy in place that we continue to execute today: complete the integration of Sigma-Aldrich; strengthen our core businesses by delivering a broad and relevant portfolio to our customers and establishing new pillars of growth in scientific areas like cell and gene therapy and continuous bioprocessing. As ranked by sales, the Life Science business sector of Merck has achieved a top-three ranking in the global life science industry. In Life Science, we are a leading, global supplier of tools, high-grade chemicals, and equipment for academic labs, biotech and biophar- maceutical manufacturers, as well as the industrial sector. We make scientific discovery easier and faster with technologies like CRISPR for gene-editing; and we provide drug manufacturers with process development expertise that make medicines safer and more effective for patients. We offer both testing kits and services to ensure that our food is safe to eat and water is clean to drink. Life Science 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. 62 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. Fundamental Information about the Group _ Strategy 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 1. Ensure operational excellence by focusing on creating value, building a strong organization and implementing consistent processes To sustain our leadership for the future, Life Science has estab- lished a strategy based on three key pillars: Our aspiration remains to reinforce our leadership position as a tools and equipment supplier that is solving the toughest problems in life science. This has allowed us to achieve quality growth with a well-leveraged balance sheet. The Life Science business sector is executing an ambitious strat- egy to capture near-term opportunities and to invest for future growth. Our integration is on track, and we have consistently outperformed the market during the largest integration in our history and that of the industry. 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. 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. On December 1, 2018, we announced the completion of the sale of our Consumer Health business to Procter & Gamble. The divest- ment of Consumer Health was aligned with our strategy of focusing on our pipeline of innovative medicines. In this context, strategic collaborations are an integral part of delivering on our commitment to transforming the lives of patients living with serious unmet medical needs. We recognize the value of collaboration in the research and development of breakthrough therapies, as well as in strengthening our current portfolio. Here, we focus on balancing the right blend of internal capabilities and exter- nal partnerships, building strong collaborations with other leaders in the industry. success. The third pillar of our aspiration is innovation: to develop high- quality, first-to-market and best-in-class therapies, and to build a portfolio in each of our franchises. We have streamlined our pipeline and expanded our innovation capabilities with strong investigational drug candidates. In order to maximize the output of our R&D invest- ments and increase our chances of success in discovering and devel- oping new therapies, we focus our expertise on specific franchises and are exploiting synergies in disease mechanisms and biological pathways. We are investing in digital technologies as well as person- alized and translational medicine in order to drive continued pipeline The second pillar of our strategy is the focus on specialty medi- cine franchises. Here, we expect oncology, immuno-oncology and immunology markets to remain highly attractive in terms of size, growth prospects, and profitability. Within each specialty franchise, our approach is to develop deep internal expertise and insight from internal research to commercialization, augmented by external talent sourcing, strategic partnering and asset acquisitions. Fertility and Endocrinology offer significant opportunities to bring value to patients, with high profitability and growth potential; maximizing the commer- cial potential of these areas will remain important. The first pillar of our strategy is to reinforce our global footprint, e.g. bringing the innovation of our pipeline to patients and grow our presence in the United States and in China. The emerging markets and China are expected to be the largest growth driver for our established products in the future. Managing the balance between delivery of innovative medicines while expanding reach and ensur- ing profitable growth of the existing business will be one of the strategic challenges. bringing high value to patients and consumers. Therefore, we con- tinue to invest in research and development to discover new treat- ment options and improve existing ones. Together with our stake- holders and partners, we want to ensure that people can access the medicines they need to stay healthy and live longer. LIFE SCIENCE 65 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. Combined Management Report 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% • Focus on the attractive electronics market to achieve long-term organic growth perspective of 2-3% per year (CAGR) 66 Our priorities are: We have a solid foundation: a strong global customer network, a proven track record of delivering high-tech solutions, an efficient production infrastructure and the highest quality standards through- out the industry. Our innovative solutions allow us to establish inti- mate and long-term customer relationships, and understand the changing requirements of end customers in markets as diverse as consumer electronics, automotive and cosmetics. Within the electronics market, we are active in the field of semi- conductor and display solutions, targeting a material market of about € 85 billion. We are already one of the largest players in this field, while operating in selected and highly attractive market seg- ments. In coming years, we expect that the market for liquid crystal materials for TVs - still our largest business and one of the most attractive - will continue to decline. For us, after 2019, this devel- opment is expected to be more than offset by growth in OLED mate- rials and photoresists as well as in semiconductor materials and our solutions for surfaces. As a result, we want to achieve an attractive average sales growth of 2-3% after 2019 and to generate EBITDA pre margins of around 30%, substantially above the specialty chem- icals industry average. The remaining 20% of our sales relate to the automotive and cosmetics market served by Surface Solutions. We expect demand in these segments to likewise benefit from global trends such as increasing affluency in developing countries. Performance Materials targets attractive end markets that are driven by megatrends: digitalization, urbanization, mobility and affluency will drive advanced electronic systems with semiconductors at their heart. As a result, electronics demand is expected to grow for the foreseeable future. Roughly 80% of our sales are currently linked to the electronics market, which of course includes our Semiconductor Solutions and Display Solutions business units, but also parts of Surface Solutions. PERFORMANCE MATERIALS Strategy Combined Management Report 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). Fundamental Information about the Group Strategy Fundamental Information about the Group 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 China is a major innovation hotspot and one of our strategically most important growth markets. Cornerstones of our strategy are further localization via our Healthcare and Life Science production sites in Nantong and the OLED application center in Shanghai, the engagement of key stakeholders in the local environment and tap- ping into the Chinese innovation ecosystem via our future innovation hubs in Shanghai and Guangzhou. The establishment of both these hubs is already well underway, with scheduled openings in the second half of 2019. Together they will create a strong platform for us and our partners to drive innovation, while also significantly contributing to the range of our activities and general footprint in China. The focus of Performance Materials is on bringing the business back to a 2-3% organic sales growth trajectory from 2020 onwards, implementing our 5-year "Bright Future" transformation program and ensuring efficient resource allocation to foster the EBITDA pre margin of around 30%. We aim to further strengthen Performance Material's position as a leading electronics solutions provider, ensure a stronger focus on existing end market needs and implement a rigorous innovation and project prioritization process. Despite a decline in sales and profits at Performance Materials in 2018, we remain a market leader in this sector. In parallel we embarked on a transformation program to deliver on our strategy of becoming a leading electronics solutions provider and established a new R&D framework. 63 Fundamental Information about the Group _ Strategy 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. People 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. Our priority area "Performance" includes all activities that create sustainable, profitable growth. We have defined a strategic roadmap until 2022 to meet our ambition. Our primary aim is to deliver accel- erated profitable growth through sustained core business delivery and selective portfolio strengthening. Performance We aim to keep an attractive financial profile, regain our financial flexibility through stringent deleveraging and sustain our strong investment-grade rating. It is of utmost importance to us that we meet our obligations at all times through our diversified and profitable businesses as the basis for sustained cash flow generation. We are aiming to achieve sustained organic profitable growth, while targeted acquisition remains a growth option. We pursue a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current dividend represents the minimum level for future dividend proposals. In addition, our Group Strategy is always aimed at delivering our ambition of becoming the vibrant science and technology company, and be an innovation leader within our fields of activity. We will therefore strive to achieve our strategy by con- tinuing to focus on our three core priorities: "Performance", "People" and "Technology". We expect the Performance Materials business sector to generate an EBITDA pre margin of around 30% after 2019. The business sector initiated the "Bright Future" transformation program. Besides the ambition to get back to organic top-line growth, the program focuses on resource allocation, process excellence and active port- folio management. In more detail, it is our goal to continue to accelerate organic growth, expand our market footprint and sustain our leadership posi- tions within our science and technology specialty areas. We have clearly defined goals, such as generating annual sales of at least € 2 billion by 2022 with products from our Healthcare R&D pipeline - products that we launched recently or expect to bring to market soon. In addition, we aim to double our Group sales in China. Health- care shall contribute significantly to our growth ambition with the main drivers being new product launches and stable base business delivery. We expect Life Science to continuously target above-market growth with Process Solutions contributing significantly to this. From now until 2022, we categorize our strategy as a period of growth and expansion, with all business sectors contributing to our growth ambition. In order to achieve our strategic ambition by 2022, we want to work on ensuring strong and innovative, specialty-focused pillars with strong positions in our priority growth areas, such as Oncology, Immuno-oncology and Immunology, Bioprocessing, and Semiconductor Solutions. Combined Management Report 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. 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. 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. 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. 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. 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. HEALTHCARE Business strategies 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. 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. 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. This could enable faster and more accurate (remote) health moni- toring and treatment. Technology Fundamental Information about the Group _ Strategy Combined Management Report 64 In the context of the "People Strategy" we also want to look at new forms of cooperation and experiment with methods that result in better decision-making. For example, pilot initiatives focus on expanding the "Merck Science Network" further. Through this project we are promoting the establishment of a science community within the company to accelerate the exchange of innovative ideas and improve the collaboration between all employees in the Research and Development sector. In the Healthcare sector, we have begun to deepen the awareness of unbiased decision-making. We want to support leaders to help them reflect on their decision-making pro- cesses and take unbiased decisions. We place great importance on the continuous advanced training and further development of our managers. This is essential for them to address the diverse needs of their team members and the chang- ing requirements of the businesses and of digitalization. Our leaders are responsible for pushing our strategy ahead by building up the right competences, thereby fostering innovation. As part of this, they take calculated risks, set clear and inspiring direction to their employ- ees and provide the requisite structures and resources. 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. -46 -24.4% Gains (-)/losses (+) on the divestment of businesses -310 Acquisition-related adjustments > 100.0% 188 335 25 142 > 100.0% -24.6% -15 61 46 -15.3% -636 58 3,528 2 -1 4,164 Integration expenses/IT expenses 63 BUSINESS FREE CASH FLOW (BFCF) -97.2% Business free cash flow¹,2 58 Change 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 Fundamental Information about the Group _ Internal Management System Combined Management Report 70 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. -10.5% -446 4,246 3,800 EBITDA pre² -28.1% -23 81 58 Other adjustments -61 1 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. 1,743 14,836 2018 Net sales € million Net sales¹ MERCK GROUP Net sales are defined as the revenues from the sale of goods, services rendered to external customers, commission income and profit-sharing from collaborations, net of value added tax and after sales deductions such as rebates or discounts. Net sales are the main indicator of our business growth and therefore an important parameter of external as well as internal performance measurement. In addition, acquisition- and currency-adjusted sales are used for internal performance man- agement. Organic sales growth shows the percentage change in net sales versus a comparative period, adjusted for exchange rate and portfolio effects. Exchange rate effects may arise as a result of foreign exchange fluctuation between the functional non-euro currency of a consolidated company and the reporting currency (euro). By contrast, portfolio effects reflect sales changes due to acquisitions and divest- ments of consolidated companies or businesses. NET SALES The three key performance indicators of net sales, EBITDA pre and business free cash flow are the most important factors for assessing operational performance. Therefore, we refer to these KPIs in the Report on Economic Position, the Report on Risks and Opportunities, and in the Report on Expected Developments. As the most important indicators of financial business performance, the KPIs are key ele- ments of our performance management system. Key performance indicators of the Group and its businesses 69 Fundamental Information about the Group — Internal Management System Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRSS). M&A = Mergers & Acquisitions POS¹ = Probability of success eNPV¹ = expected Net present value IRR¹ = Internal rate of return Net present value € million ROCE¹ = Return on capital employed NPV¹ Change 2017 € million in % in % -28.7% -696 2,423 € million 2017 2018 1,727 Restructuring expenses EBITDA² Impairment losses/reversals of impairment losses Depreciation and amortization 1,742 Operating result (EBIT)² Change Reconciliation EBIT to EBITDA pre¹,2 MERCK GROUP projects, restructuring expenses, gains/losses on the divestment of businesses, acquisition expenses, and other adjustments. The classification of specific income and expenses as adjustments follows clear rules and underlies strict governance at Group level. Within the scope of internal performance management, EBITDA pre allows for the necessary changes or restructuring without penalizing the performance of the operating business. EBITDA pre is the main performance indicator measuring ongoing operational profitability and is used internally and externally. To provide an alternative understanding of the underlying operational performance, it excludes from the operating result depreciation and amortization, impairment losses and reversals of impairment losses as well as adjustments. These adjustments are restricted to the following categories: integration expenses, IT expenses for selected EBITDA PRE 1 Previous year's figures have been adjusted, see Note (49) "Effects from new accounting standards and other presentation and measurement changes" in the Notes to the Consolidated Financial Statements. 14,517 2.2% 319 € million 2018 1,198 EBITDA pre² 368 > 100.0% in % 29.5% € million 769 12 10 -57 -2,303 22 2017 2,605 3,374 2018 Change Earnings per share pre² (in €) Net income pre² Non-controlling interests to be adjusted Income taxes on the basis of the underlying tax rate² Adjustments² Amortization of acquired intangible assets Income tax Profit after tax from discontinued operation Non-controlling interests Net income -428 € million -2,246 796 > 100.0% 5.92 5.10 -13.8% -355 2,574 2,219 0.4% -3 -3 -9.0% 73 -814 -741 > 100.0% 264 64 327 -1.9% -23 BFCF¹ = Business free cash flow 1,175 > 100.0% 2017 RECONCILIATION OF NET INCOME TO NET INCOME PRE¹, 2 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, -123 -22 -145 2,508 Business free cash flow² Elimination first-time consolidation of BioControl Systems Changes in trade accounts receivable as well as receivables from royalties and licenses > 100.0% -197 -18 -214 Changes in inventories -7.9% 80 -1,012 -932 Investments in property, plant and equipment as well as software and advance payments for intangible assets in % -10.5% € million -446 4,246 3,800 > 100.0% 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. -2 3,193 NET INCOME, EARNINGS PER SHARE (EPS) AND EARNINGS PER SHARE PRE (EPS PRE)¹ Capital market-related parameters 71 Fundamental Information about the Group — Internal Management System Combined Management Report MEVA gives information about the financial value created in a period. Value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital require- ments and investors' expectations. MERCK VALUE ADDED (MEVA) An additional parameter to prioritize investments in property, plant and equipment as well as intangible assets is the payback period, which indicates the time in years after which an investment will generate positive net cash flow. PAYBACK PERIOD In addition to NPV and IRR, when looking at individual accounting periods, ROCE is an important metric for the assessment of invest- ment projects. It is calculated as the adjusted operating result (EBIT) pre divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable and trade accounts payable, as well as inventories. RETURN ON CAPITAL EMPLOYED (ROCE) The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including mark-ups. INTERNAL RATE OF RETURN (IRR) The main criterion for the prioritization of investment opportunities is net present value. It is based on the discounted cash flow method and is calculated as the sum of the discounted free cash flows over the projection period of a project. The weighted average cost of capital (WACC), representing the weighted average of the cost of equity and cost of debt, is used as the discount rate. Depending on the type and location of a project, different mark-ups are applied to the WACC. NET PRESENT VALUE Sustainable value creation is essential to secure the long-term success of the company. To optimize the allocation of financial resources, we use a defined set of parameters as criteria for the prioritization of investment opportunities and portfolio decisions. Investments and value management 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 2 MEVA¹ = Merck value added 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. EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments Healthcare systems NGOS Competitors Customers 74 Combined Management Report Community EPS Earnings per share 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 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 malaria and other infectious diseases while helping to build local capacity across the value chain and positioning our company as a leading and reliable partner. The 2018 Access to Medicine Index continues to rank us in fourth place. Every two years, this index assesses the world's leading pharmaceutical companies on activities and initiatives they have implemented to promote access to medicine in developing countries. We received particular recognition for leading practices such as establishing our Global Health Institute to accelerate research and development (R&D) targeting schistosomiasis, malaria and bacterial infections, strengthening commitment to open innovation and estab- lishing the Capacity Advancement Program to improve access to better diabetes, cancer, hypertension and fertility therapies in under- served regions. 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. Strengthen the availability of healthcare solutions Scientists Patients 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. -0.82 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 Employee represen- tatives Employees Merck family Share- holders Suppliers Federations & policy makers Merck Media 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. 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 Strategic sphere of activity: Sustainable Solutions Through our products, we are helping overcome global challenges such as climate impact and resource scarcity. In doing so, we are also supporting our customers in reducing the impacts of their own activities and achieving their own sustainability goals. Life Science: reducing environmental impacts throughout the product life cycle It is important to us that we improve the environmental impact of our products. This applies to the entire life cycle - from production and use through to the disposal of our products. With our Design for Sustainability (DFS) program, we have developed a comprehensive approach for more sustainable life science products. This keeps sus- tainability criteria in the foreground during product development or re-engineering, and documents them in a scorecard. When develop- ing a new product, our aim is to improve on as many of these criteria scores as possible. The objective is to lower environmental impacts of devices and instruments, also during use by customers. Beginning with the concept stage, product teams identify potential environmen- tal impacts and opportunities to make improvements. By the end of 2018, 27% of these product development projects met three or more sustainability criteria. In addition, our researchers are developing innovative solutions in line with the "12 Principles of Green Chemistry" developed by chem- ists Paul T. Anastas and John C. Warner. The objective is to permit research that is as environmentally compatible as possible, and to minimize adverse effects on human health. More than 750 greener alternatives to conventional products are available so far. With DOZNⓇ, we have developed a web-based quantitative Green Chem- istry analysis tool. To date, we have used this matrix to assess and improve more than 40 products. It is our goal to make this system available to our customers in 2019, so that they can measure the environmental impact of their research and make more environmen- tally conscious decisions. 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. Fundamental Information about the Group Corporate Responsibility - 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. 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. Combined Management Report 76 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. 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 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. 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. 73 Fundamental Information about the Group _ Corporate Responsibility Fundamental Information about the Group Corporate Responsibility Sustainable 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 Net sales, EBITDA pre, BFCF Combined Management Report The dividend policy is oriented towards the business development and earnings increase of the coming years. However, dividend growth could deviate, for example, within the scope of restructuring or in the event of significant global economic developments. We aim for a target corridor of 20% to 25% of earnings per share pre. We are pursuing a sustainable dividend policy. Provided that the economic environment develops in a stable manner, the current div- idend represents the minimum level for future dividend proposals. DIVIDEND POLICY cial policy, as it safeguards access to capital markets at attractive financial conditions. Merck currently has a Baa1 rating from Moody's, an A rating from Standard & Poor's (S&P), and an A- rating from Scope, each with a stable outlook. The rating of our creditworthiness by external rating agencies is an important indicator of the company's financial stability. A strong investment-grade rating is an important cornerstone of Merck's finan- STRONG INVESTMENT-GRADE RATING 68 Net Sales, EBITDA pre, BFCF Net income, EPS, Dividend ratio, Credit rating MEVA Abbreviations EBITDA pre margin, ROCE Payback period, NPV, IRR, Capex EBITDA pre margin, POS, ROCE EBITDA pre margin, EPS, ROCE, MEVA Combined Management Report Projects Licensing NPV, IRR, M&A EBITDA pre margin Net sales growth, ROCE, MEVA 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 eNPV, IRR, Fundamental Information about the Group Strategy 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 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. - - Responsibility Global Health CR Strategy Broad Minds License to Operate Solutions 67 Strategy and Management We take responsibility every day and have been doing so for 350 years. This commitment is codified in our corporate strategy and values. Responsible conduct with respect to employees, prod- ucts, the environment and society is a fundamental prerequisite for our business success. -13.9% Fundamental Information about the Group Corporate Responsibility Combined Management Report Corporate Responsibility 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). 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. 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. 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. CREDIT RATING 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). 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 Combined Management Report 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. DIVIDEND RATIO 72 Like music, literature is an important mediator between cultures. That is why we support five literary prizes around the world. The awards primarily recognize those authors who build bridges between cultures, as well as between literature and science. We awarded four of the prizes in 2018: The Johann Heinrich Merck Award for Literary Critique and Essay in Germany went to author and translator Martin Pollack. The Italian Premio Letterario Merck was awarded to natural scientist, author and professor Carl Safina, and to physicist and science historian Lucio Russo. The winners of the Japanese Merck- Kakehashi Literature Award were author Clemens J. Setz and his translator Ayano Inukai. The Merck Translation Award in Russia went to authors Nina Federowa, Ekaterina Aralova, Natalia Stillmark and Tatiana Zborovskaja. The Merck-Tagore Literature Award in India will once again be offered in 2019. Responsibility for our products The safety of our products is at the core of our corporate responsi- bility. When used properly, they must pose no risk to customers, patients, consumers or the environment. Our goal is to ensure a positive benefit/risk profile for our products, which is why we regu- larly examine safety across their entire life cycle and continuously take steps to minimize risks. We provide patients, consumers and customers with extensive informational material so that they can use our products in a safe, responsible and proper manner. In our pharmaceutical marketing activities, the focus is always on the health and well-being of patients because we want them to receive effective and high-quality treatment. All guidelines pertaining to marketing and advertising are part of our Group-wide compliance program, which is complemented by our internal guidelines and various voluntary commitments that, in many cases, far exceed the applicable statutory regulations. Combined Management Report Fundamental Information about the Group Corporate Responsibility 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 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 78 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. 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. 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 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. Strategic sphere of activity: Broad Minds 77 _ Corporate Responsibility Fundamental Information about the Group Combined Management Report 2,117 The Deutsche Philharmonie Merck Safety of our Healthcare products 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. Quality of our products Total energy consumption 2018 2017 2016 2015 In gigawatt hours ENERGY CONSUMPTION 1, 2 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. 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. 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 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. Environmental management system Responsibility for the environment 79 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 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 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. an ISO 14001 group certificate for the tenth consecutive year. This certificate covers 81 sites around the world. 2,194 Solid tumors 0.0 Electricity 1.1 1.1 0.4 0.0 Steam, heat, cold 0.0 0.0 0.0 0.0 ¹In line with the Greenhouse Gas Protocol, for all previous years (up to the 2006 baseline) the energy consumption has been calculated based on the corporate structure as of December 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 All reported environmental key figures do not include data on the Consumer Health business, since these operations were transferred to Procter & Gamble - effective December 1, 2018 - and have been classified as discontinued operations within the meaning of IFRS 5 since April 2018. 3 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel and gasoline. Combined Management Report 0.4 1.1 1.1 Total energy sold 122 Indirect energy consumption 2,873 2,833 3,150 3,276 Electricity Fundamental Information about the Group Corporate Responsibility 2,527 2,624 2,740 Steam, heat, cold 346 342 526 536 2,491 80 TOTAL GREENHOUSE GAS EMISSIONS (SCOPE 1 AND 2 OF THE GHG PROTOCOL) 1, 2 In metric kilotons 408 0 331 305 13 14 331 13 344 13 354 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. 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. 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. 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 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. Responsibility for society We see ourselves as part of society - both at our individual sites and worldwide. Taking responsibility towards society is an integral part of our entrepreneurial approach. We believe that we can make an important contribution to the community through our knowledge, our skills and our products. Our social responsibility activities are primarily focused on those areas in which we have problem-solving expertise stemming from our core businesses. We are thus engaged in health and 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. 3 Baseline for our emission targets is 2006. 4 eq = equivalent. 119 373 391 Total CO₂eq emissions thereof direct CO2eq emissions Indirect CO2eq emissions Biogenic CO2 emissions 2006³ 2015 384 2016 2018 786 722 689 704 698 378 2017 122 119 Biomass and self-generated renewable energy 33 34 Indirect energy consumption 798 787 875 910 34 Electricity 692 729 761 Steam, heat, cold 96 95 146 702 149 33 32 2,232 Phase I Direct energy consumption 1,343 1,330 1,319 1,322 Biomass and self-generated renewable energy Natural gas 1,260 1,254 1,256 Liquid fossil fuels³ 110 36 32 1,200 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. Total energy sold 0.3 7,898 8,035 Direct energy consumption 4,835 4,748 4,759 Natural gas 7,621 4,320 4,514 4,522 Liquid fossil fuels³ 396 130 115 115 4,536 0.3 7,708 2017 0.1 0.0 Electricity Steam, heat, cold 0.3 0.3 0.1 2018 0.0 0.0 0.0 0.0 In terajoules Total energy consumption 2015 2016 0.0 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. 4,788 Fundamental Information about the Group _ Research and Development Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Solid tumors Phase I Hematological malignancies Phase I Non-small cell lung cancer, 1st line Phase III Gastric cancer, 1st line maintenance Phase I Solid tumors Phase II Hepatocellular cancer M2698 (p70S6K and Akt inhibitor) M3814 (DNA-PK inhibitor) M6620 (VX-970, ATR inhibitor) M4344 (VX-803, ATR inhibitor) M3541 (ATM inhibitor) M8891 (MetAP2 inhibitor) M7583 (BTK inhibitor) Phase III Immuno-Oncology Indication Status Relapsing multiple sclerosis Multiple sclerosis Registration¹ Phase II Non-small cell lung cancer Phase II Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Ovarian cancer, 1st line Phase III² Avelumab (anti-PD-L1 mAb) M9241 (NHS-IL12, cancer immunotherapy) M7824 (anti-PD-L1/TGF-ẞ trap) Urothelial cancer Phase II³ Colorectal cancer, 1st line Phase II4 Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer, 1st line Solid tumors Phase I Hematological malignancies Phase I Combined Management Report Solid tumors Phase I Phase II Tepotinib (MET kinase inhibitor) M7824 (anti-PD-L1/TGF-ẞ trap) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Avelumab (anti-PD-L1 mAb) Phase III Phase III Avelumab (anti-PD-L1 mAb) Locally advanced head and neck cancer Phase III Abituzumab (pan-av integrin inhibiting mAb) Avelumab (anti-PD-L1 mAb) Phase II Avelumab (anti-PD-L1 mAb) Solid tumors Phase II³ Avelumab (anti-PD-L1 mAb) Non-small cell lung cancer Phase II³ Merkel cell carcinoma, 1st line Tepotinib (MET kinase inhibitor) Urothelial cancer, 1st line maintenance Renal cell cancer, 1st line 2,141 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. 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. 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 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 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. 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 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. 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. 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. 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 Combined Management Report Fundamental Information about the Group _ Research and Development 83 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. 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. 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. 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. Fundamental Information about the Group _ Research and Development Combined Management Report 82 81 Research and Development We conduct research and development (R&D) worldwide in order to develop new products and services designed to improve the quality of life of patients and to satisfy the needs of our customers. Further optimizing the relevance and efficiency of our research and devel- opment activities - either on our own or in cooperation with third parties - is one of our top priorities. Oncology 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. 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. 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. 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) 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. 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. 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. 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 cancers. 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. 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. 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. 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. Neurology & Immunology Fertility At the Grant for Fertility Innovation (GFI) ceremony at the annual meeting of the European Society of Human Reproduction and Embry- ology (ESHRE) in Barcelona, Spain, we confirmed our commitment to supporting potential breakthrough research projects in the field of fertility. With an amount of € 300,000, the GFI is again supporting the advancement of medical science, aiming to bring innovation to life. The two winners Louise Glover from Ireland and Cinzia Di Pietro from Italy - received their awards during the ceremony, which was also attended by Louise Brown, the world's first person to be conceived using in vitro fertilization (IVF), as well as IVF pioneer Professor Bruno Lunenfeld. - General Medicine & Endocrinology 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. 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. 86 85 Combined Management Report BIOPHARMA PIPELINE as of December 31, 2018 Cladribine tablets (lymphocyte-targeting agent) Evobrutinib (BTK inhibitor) 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. Neurology Therapeutic area Compound Fundamental Information about the Group _ Research and Development Fundamental Information about the Group _ Research and Development 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. 84 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. 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 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. 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. Combined Management Report Fundamental Information about the Group _ Research and Development Combined Management Report 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. 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). 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. 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. 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. 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). 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. 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. Electronics We help to create, im- prove and prolong lives. employees Share of net sales NN Share of EBITDA pre We are advancing digital living. Healthcare 39% Life Science women in leadership positions AT A GLANCE nationalities 141 Share of net sales 9 62,908 Together, we impact life and health with science. Share of EBITDA pre Asia-Pacific 44% 45% 13 Merck A strong team 22 Strategy Group 13 €6,936 million 18% 15% Share of EBITDA pre €737 million Middle East and Africa €1,331 million Latin America €6,037 million Europe 41% 38% €5,952 million North America Net sales per region Share of net sales 1 Not defined by International Financial Reporting Standards (IFRS). 8.49 2019 1 Not defined by International Financial Reporting Standards (IFRS). -11.2% -475 4,259 3,784 Operating cash flow -15.5% -1.56 10.05 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. Earnings per share pre (€)¹ -1.16 7.65 6.49 Earnings per share (in €) -15.1% 28 -505 3,339 2,834 -15.2% Merck Group Net sales € million 16,152 2019 5,201 2020 17,534 2020 6,103 2021 19,687 2021 6,849 2022 22,232 2022 5,879 2023 20,993 2023 € million EBITDA pre¹ Merck Group 4,385 Internal Management System 99 Research and Development 301 Report on Risks and Opportunities 77 Employees 290 Contingent Liabilities Corporate and Other 76 Operating Assets, Liabilities and Capital Structure, Investments and 267 249 Group Structure 242 General Disclosures 235 Electronics 73 Healthcare 69 Operating Activities Life Science 94 Financing Assets The Executive Board Profit after tax 8 Letter from Belén Garijo 6 To our shareholders Independent Auditor's Report Business Development 2019-2023 Financial Calendar 363 362 Report on Expected Developments 350 Other Information Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 155 Scope of Consolidation 339 Other Disclosures 336 Report in Accordance with Section 315a of the German Commercial Code (HGB) Non-Financial Statement 96 349 Responsibility Statement 35 65 55 Compensation Report 224 218 197 Fundamental Information about the Report Combined Management Merck Shares 9 Capital Structure and Corporate Bodies of Merck KGaA 196 8 164 Letter from Belén Garijo 6 To our Shareholders Corporate Governance Table of contents Report on Economic Position 48 The Executive Board Merck Group Statement on Corporate Governance Consolidated Financial Statements Notes to the Consolidated Financial Statements Consolidated Statement of Changes in Net Equity Position 235 Course of Business and Economic 55 Business Development 234 Review of Forecast against Actual Report of the Supervisory Board Objectives of the Supervisory Board with Respect to its Composition and Profile of Skills and Expertise 52 233 Environment Consolidated Balance Sheet 232 Macroeconomic and Sector-Specific 48 Comprehensive Income 231 Consolidated Statement of 230 Consolidated Income Statement Consolidated Cash Flow Statement 30.8% 321,232 Margin (% of net sales)¹ Apr. May June July Aug. Sept. Oct. Nov. Dec. Merck shares Mar. Key share price data¹ -3.35% -20.34% 2023 2022 Dividend² Share price high Share price low Year-end share price Daily average number of Merck shares traded³ 4.76% € Feb. -30% Share price development from January 1, 2023, to December 31, 2023, in % • Merck • DAX ® • MSCI European Pharma Index • Dow Jones European Chemical Index ⚫ PHLX Semiconductor Sector Index • S&P 500 Life Sciences Tools & Services Index 64.90% 20.31% 13.55% Jan. 80% 60% 50% 40% 30% 20% 10% 0% -10% -20% 70% Merck Shares 2.20 € 1 11 | | | 1.40 1.85 2.20 2.20* 2014¹ 2015 Dividend development since 2014 2016 2018 2019 2020 2021 2022 2023 1 Adjusted to the new number of shares after the share split (June 30, 2014). * 2023 dividend subject to approval by the Annual General Meeting. 9 2017 2.20 Merck Shares 4 Based on the theoretical number of shares (434.8 million). 201.10 222.90 € 135.45 156.10 € 144.10 180.90 Number 5 Based on the number of shares in free float (129.2 million). Source: Bloomberg, Thomson Reuters. 329,074 € million 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®. Market capitalization (at year-end) 28.0% Merck Shares 10 Net sales % € million 2022 2023 € million Change Merck Group KEY FIGURES 2023 20,993 Merck Annual Report To Our Shareholders Letter from Belén Garijo 6 Dear shareholders, dear friends of turck, 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. 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. 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. 2023 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. 22,232 3,609 -14.2% -970 6,849 5,879 EBITDA pre¹ 29.3% 26.1% Margin (% of net sales)¹ -15.6% Operating result (EBIT)¹ -1,015 5,489 EBITDA² 20.1% 17.2% Margin (% of net sales)¹ -19.3% -5.6% -1,239 -865 4,474 6,504 To Our Shareholders 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. CC Chair of the Executive Board and CEO Member of the Executive Board Member of the Executive Board Chief Financial Officer CEO Electronics CEO Healthcare CEO Life Science Short biographies More information can be found at our website. Member of the Executive Board To Our Shareholders 9 Merck shares At a glance The stock markets got off to a restrained start in 2023 before finishing strongly, with some indices hitting record levels in December as interest rate concerns eased. There was a significant level of sector divergence with subdued performance in Life Sciences and Pharma. Consequently, our share price performance was dampened during 2023. The resilience of our multi-industry business model was demonstrated with Healthcare largely offsetting market-driven challenges in Electronics and Life Science. Despite the financial results, our share price declined by around 20% in the course of the year. Merck shares underperformed compared with the DAX® index of German blue-chip companies, which rose by around 20% over the year. Our share performance correlated strongly to the share performance of the life sciences industry across the year and tracked the index (-3%) until the December evobrutinib announcement. In comparison, the index for the pharmaceutical industry outperformed Merck shares, rising by almost 5%. The semiconductor industry index rose by around 65% driven by a handful of chip developers and their products for artificial intelligence applications. Merck shares closed at € 144.10 on December 29, 2023 (2022: € 180.90). The first six months were heavily influenced by uncertainties tied to the continued economic recovery, inflation, rising interest rates and geopolitical tensions. The Covid-19 pandemic business continued to decline, which created a difficult environment in the life science market. Moreover, customers of the Life Science business sector mainly focused on cash preservation as well as working capital optimization, in light of high interest rates. While the semiconductor market is preparing for artificial intelligence fueled growth, it has not yet translated into volume growth for the materials sector. The existing portfolio of Healthcare had a strong year; however, the negative results of the Phase III trials of evobrutinib had a share price impact in December. Taken together, these factors explain why our share price underperformed the DAX® and relevant sector indices in 2023. At approximately 329,000 shares per day, the average daily trading volume of Merck shares in 2023 was up around 2% on the prior-year figure of around 321,000. This meant Merck shares bucked the general trend of lower turnover on German securities trading platforms in 2023 compared with the previous year. Our shareholder structure remained largely stable in 2023 compared with the previous year: Europe continues to account for the largest proportion of the free float at around half, followed by the United States with around 29%. Compared with 2022, the proportion of the value-oriented investors fell slightly in favor of growth oriented investors and GARP (growth at a reasonable price) investors. The top five investors held around 24% of the free float at the end of 2023, up around two percentage points on the previous year. 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. Merck Shares 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. Matthias Heinzel Belén Garijo We remain firmly positioned to return to growth in 2024 and generate long-term, sustainable value for our owners, shareholders, customers, patients, employees, and society. Belén Garijo To Our Shareholders Letter from Belén Garijo 7 Looking forward, we expect that global economic and geopolitical challenges will continue to adversely affect our activities through 2024. However, based on current forecasts, we anticipate a gradual return to organic sales growth during the year. We expect our Life Science business sector to recover in the course of the year with the expected end of the destocking phase within Process Solutions on the one hand and improving conditions in Science & Lab Solutions on the other hand. Within our Healthcare business sector, growth rates should begin to normalize and more closely align with our mid-term targets. And within our Electronics business sector, we expect to benefit from an upswing in customer demand for Semiconductor Solutions as the market gradually recovers. Looking beyond 2024, our Group remains firmly positioned for long-term growth and impact as a leading science and technology company with a clear purpose to advance human progress. In addition to favorable macrotrends such as the digital transformation of markets by generative AI and machine learning technologies, many other forces are expected to drive growth across each of our three sectors. They include novel drug modalities in Life Science, growing patient needs for cancer, neurological and immunological treatments in Healthcare, and AI-enabling chips and high-performance computing demanding more and novel materials in Electronics. Our teams are closely monitoring these and other trends to help us anticipate potential scenarios and adapt with speed and agility to protect or expand our competitive positions. We continue to make strategic investments, enter collaborations, and adapt our businesses in order to constantly improve our competitive position and anticipate emerging market needs even more proactively. In Germany, the United States, Switzerland, China, the United Kingdom, Korea, and other countries across our global network, we invested significantly in new and upgraded sites and capabilities. With these and other significant capital expenditure projects, we are striving to move even closer and become more responsive to customers and patients worldwide. We assume that this overall momentum in operational expenditure will continue through 2025 and beyond. However, we reserve the flexibility to respond to further market changes. Despite the disappointing news in December 2023 that the Phase III clinical trials of evobrutinib did not meet their primary endpoints, we remain confident in the position of our Healthcare business sector as a global specialty innovator. In addition to the continued resilience of our established product portfolio, we look forward to the progress of many investigational therapies within our Healthcare pipeline, such as xevinapant in oncology and enpatoran to treat autoimmune diseases such as systemic and cutaneous lupus erythematosus. Boosted by various in-licensing of external innovation, including those announced in 2023, such as with Hengrui and Abbisko, we aim to introduce one new product or major indication every 1.5 years on average. Finally, I am pleased by the significant strides being made to achieve our three core sustainability targets. By 2030, we aim to have fully integrated sustainability into our value chains and contributed to human progress for more than one billion people through sustainable science and technology. And by 2040, we expect to achieve climate-neutrality and significantly reduce our resource consumption. After entering into virtual power purchase agreements in 2023, renewable energy is expected to cover 100% of our current electricity purchases in Europe, more than 90% in North America, and 70% worldwide from 2025. As you continue to read this Annual Report, you will see that we remain firmly positioned to both return to growth in 2024 and generate long-term, sustainable value for our owners, shareholders, customers, patients, employees, and society. On behalf of the Executive Board, I thank you and all our other shareholders for your ongoing trust and support. Peter Guenter Sincerely, 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 Belén Garijo Merck Shares 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. Report on Risks and Opportunities The Executive Board is authorized to increase the company's share capital with the approval of the Supervisory Board and of E. Merck KG on one or more occasions, up to and including April 21, 2027, by a total of up to € 56,521,124.19 by issuing new no-par value bearer shares in exchange for cash and/or non-cash contributions (Authorized Capital 2022). Limited liability shareholders are generally granted statutory rights to subscribe to the new shares. However, the Executive Board is authorized, with the approval of the Supervisory Board, to exclude limited liability shareholders' subscription rights, either in full or in part, in the case of a capital increase in exchange for cash contributions pursuant to or by analogous application of section 186 (3) sentence 4 AktG, if the issue price of the new shares is not substantially lower than the stock exchange price of the company's shares already listed and if the new shares issued under exclusion of these subscription rights do not exceed a proportional amount of 10% of the share capital either at the time of Authorized Capital 2022 taking effect or being utilized. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) This restriction to 10% of the share capital shall include the proportional amount of the share capital that is attributable to shares that are issued under exclusion of subscription rights or sold during the term of Authorized Capital 2022, based on an authorization to issue new shares or sell own shares by direct or analogous application of section 186 (3) sentence 4 AktG. This restriction shall also include the proportional amount of the share capital that is attributable to shares which may or must be issued in order to service bonds carrying a conversion or option right or a conversion or option obligation, if the bonds are issued during the term of Authorized Capital 2022 under exclusion of limited liability shareholders' subscription rights by analogous application of section 186 (3) sentence 4 AktG. It is likewise possible to exclude the subscription rights of limited liability shareholders with the approval of the Supervisory Board in the case of capital increases in exchange for non-cash contributions, particularly for the purpose of acquiring enterprises, parts of enterprises, or interests in enterprises. In addition, with the approval of the Supervisory Board, limited liability shareholders' subscription rights can be excluded in order to enable E. Merck KG to exercise its right pursuant to article 32 (3) of the company's Articles of Association to participate in a capital increase by issuing shares or freely transferable share subscription rights. It is likewise possible to exclude, with the approval of the Supervisory Board, the subscription rights of limited liability shareholders in order to enable E. Merck KG to exercise its right pursuant to article 33 of the Articles of Association to convert its equity interest into share capital, either in full or in part. 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. Finally, with the approval of the Supervisory Board, the subscription rights of limited liability shareholders can be excluded in order to offset any fractional amounts resulting from a capital increase. The sum of shares issued on the basis of Authorized Capital 2022 under exclusion of limited liability shareholders' subscription rights must not exceed a proportional amount of 10% of the share capital, taking into account other shares of the company which, during the term of Authorized Capital 2022, are sold or issued under exclusion of subscription rights or which are to be issued under bonds issued after April 22, 2022, under exclusion of subscription rights; this limitation shall apply both at the time of this authorization taking effect and at the time of this authorization being exercised. To the extent that subscription rights are not excluded under the above provisions, they may also be granted to limited liability shareholders by way of indirect subscription rights pursuant to section 186 (5) AktG or, in part, by way of direct subscription rights, and otherwise by way of indirect subscription rights pursuant to section 186 (5) AktG. Furthermore, the Executive Board is authorized, with the approval of the Supervisory Board, to determine the additional details of the capital increase and its implementation, including the content of rights attached to the shares as well as the terms and conditions of the share issue. The Articles of Association also encompass contingent capital. The share capital is contingently increased by up to € 66,406,298.40 composed of 51,081,768 shares (Contingent Capital I). The contingent capital increase serves to grant exchange rights to E. Merck KG in accordance with article 33 of the Articles of Association to enable the conversion of its equity interest. The shares carry dividend rights from the beginning of the fiscal year following the year in which the conversion option is exercised. 46 97 Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 98 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 Articles of Association can be amended by a resolution at the Annual Meeting that requires the approval of the general partners. Notwithstanding any statutory provisions to the contrary, the resolutions of the Annual General Meeting are adopted by a simple majority of the votes cast. Where the law requires a capital majority in addition to the voting majority, resolutions are adopted by a simple majority of the share capital represented in the vote. The Articles of Association of the company encompass authorized and contingent capital. The company is not authorized to acquire its own shares. According to the Articles of Association of Merck, the general partners not holding an equity interest who form the Executive Board are admitted by E. Merck KG with the consent of a simple majority of the other general partners. A person may be a general partner not holding an equity interest only if he or she is also a general partner of E. Merck KG. In addition, at the proposal of E. Merck KG and with the approval of all general partners not holding an equity interest, further persons who are not general partners not holding an equity interest may be appointed to the Executive Board. The 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). Combined Management Report Report on Expected Developments 95 Net sales For fiscal 2024, we expect to return to organic sales growth, which is likely to be slight to moderate. The Healthcare business sector is expected to be the strongest growth driver, with MavencladⓇ and products from the Cardiovascular, Metabolism & Endocrinology franchise making the main contributions to growth. For Life Science, we assume that sales in the first half of the year will still be influenced by customer destocking of increased inventories and that the expected recovery will thus mainly set in during the second half of 2024. We do not expect any further significant contributions from demand for products in connection with Covid-19 in 2024. In the Electronics business sector, we forecast that the turnaround in the semiconductor materials market will come in the second half of the year, leading as expected to organic sales growth with products from the Semiconductor Materials business. The expected declining Display Solutions business will have a negative impact as will the project business within the Semiconductor Solutions business unit, which, as expected, is subject to stronger fluctuations owing to the dependency on major individual orders. Overall, we forecast foreign exchange effects of 0% to -3% for the Merck Group. EBITDA pre³ For Group EBITDA pre, we also forecast a slight to moderate organic increase, which is expected to be driven primarily by the Healthcare business sector. Apart from the expected sales growth, the termination of the alliance with Pfizer Inc., USA, effective June 30, 2023 and the subsequent regain of the exclusive rights to develop, manufacture and commercialize BavencioⓇ had a positive effect on EBITDA pre as did lower costs, especially in research and development, as a result of the failure of evobrutinib to meet its primary endpoint as demonstrated by the results of the clinical trials published on December 6, 2023. EBITDA pre of the Life Science business sector is expected to be adversely impacted by negative mix effects, which we will mitigate as far as possible with corresponding cost savings. In the Electronics business sector, a favorable mix effect on sales as well as positive effects from active cost management are expected; however, the sale of a portfolio of licenses and patents in fiscal 2023 will have an opposing effect. The rise in costs in Corporate and Other will be mainly attributable to lower foreign currency hedging gains. The forecast foreign exchange development is likely to lower Group EBITDA pre by between -1% and -4%. Operating cash flow 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. 3 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Combined Management Report __ Report in Accordance with Section 315a of the German Commercial Code (HGB) 96 96 Report in Accordance with section 315a of the German commercial code (HGB) 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. 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. 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. Non-Financial Statement Chemical industry's Responsible Care® Global Charter, • Company network Together for Sustainability (TFS), Pharmaceutical Supply Chain Initiative (PSCI), Initiative Chemie³, a collaboration between the German Chemical Industry Association (VCI), the German Employers' Federation of the Chemical Industry (BAVC), and the German Mining, Chemical and Energy Industrial Union (IG BCE). Strategic and organizational approach to sustainability The world is facing numerous challenges that also affect us as a company. These include climate change, international conflicts and economic crises, for instance. Our ambition is to leverage science and technology to achieve sustainable progress for mankind. We pursue three overarching sustainability goals. In 2023, we revised our sustainability strategy, which we had communicated in 2020. In particular, we sharpened the second goal. In 2030, we will achieve human progress for more than one billion people through sustainable science and technology. By 2030, we will fully integrate sustainability into our value chains. By 2040, we will achieve climate neutrality and reduce our resource consumption. 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". Measuring progress made with the sustainability strategy 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. Combined Management Report_ • Combined Management Report_ United Nations Global Compact, 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. 99 99 ** Non-Financial statement* 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. 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). Description of our business model Our business model as well as our Group structure, governance and strategy are described under “Fundamental Information about the Group". Governance The requirements we place on responsible corporate governance are derived from our company values on the one hand and from the regulations, external initiatives, and international guidelines to which we are committed on the other hand. We have integrated these requirements into our sustainability strategy and our Group- wide guidelines. These guidelines comprise charters and principles that are valid for the entire company as well as specific standards and procedures for individual business sectors and sites. Some examples: Our Human Rights Charter aligns with the UN Guiding Principles for Business and Human Rights. Our Group-wide Social and Labor Standards Policy reflects the labor standards of the International Labour Organization (ILO). Our EHS Policy (Corporate Environment, Health and Safety Policy) for environmental impact mitigation and health and safety forms the basis for implementing the chemical industry's Responsible Care® Global Charter within our company. Our standard entitled Corporate Chemicals Regulations Governance describes the processes and management structures required to ensure global compliance with the pertinent chemical and product safety regulations. We endeavor to comply with all applicable laws as a matter of principle. Where necessary, we review our internal guidelines, standards and instruction manuals on compliant behavior and adapt them to reflect changes in the regulatory landscape. ** The summarized non-financial statement was not subject to a content review as part of the audit of the financial statements but was subject to a separate limited assurance audit by Deloitte. Combined Management Report Non-Financial Statement Roles and responsibilities We support the following responsible governance initiatives: 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. 100 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. Likewise, complications with the changeover of IT systems could negatively impact the earnings situation. Close monitoring of critical IT projects serves to mitigate this risk. Despite the mitigation measures applied and functional continuity plans, the effects of cybercrime or the failure of business-critical IT applications and their influence on EBITDA pre and operating cash flow are considered to be possible and with a significant impact. Environmental, climate-related, and safety risks Risks arising from environment, climate as well as plant and equipment As a company with global production operations, we are exposed to risks of possible damage to personnel, goods and our reputation. These include physical risks stemming from exposure to droughts, storms, and floods. Mitigation measures such as audits, consultations and trainings on environmental protection, occupational health and safety minimize these risks to people as well as the environment. In order to ensure the continuity of plant and equipment, we monitor these risks both at our own sites as well as at suppliers and contract manufacturers. By adhering to high technical standards, our rules of conduct, and all legal requirements in environmental protection as well as occupational health and safety, we ensure the preservation of goods and assets. We have taken sufficient appropriate accounting measures for the environmental risks known to us. We monitor regulatory risks in connection with the transition to a low-carbon economy, which could materialize in the mid- and long-term through rising carbon prices through emissions trading systems, taxes or energy legislation. We mitigate those risks with our energy and CO2 management measures. Mainly, we classify these as possible risks with moderate impacts. However, a critical impact on EBITDA pre or operating cash flow cannot fully be ruled out. Risks due to climate change In 2022, we performed a qualitative climate risk and vulnerability assessment to identify transitional and physical climate-related risks that are material to our activities. In 2023, in accordance with TCFD recommendations, we conducted a quantitative climate scenario analysis to identify climate-related risks and opportunities. Consequently, we conducted an evaluation in relation to impacts of transition risks and the exposure related to physical hazards. 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 line with our ongoing dedication to risk mitigation, we continuously develop innovative and sustainable approaches. As a result, we foresee no significant deviations from our expectations regarding impacts on EBITDA pre or operating cash flow. For further details on climate-related risks, please see "Increased uncertainty due to climate risks" in the "Notes to the Consolidated Financial Statements". Combined Management Report_ Report on Risks and Opportunities 93 Overall view of the risk and opportunity situation and management assessment 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. 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. 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. 2 91 Fundamental assumptions Risks in connection with a settlement agreement concluded by the divested Generics group Citalopram: In connection with the generics business that was divested in 2007, Merck was accused of breaching EU antitrust law through agreements entered into by its former subsidiary Generics (UK) Ltd., United Kingdom, relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. The European Commission imposed a fine in June 2013. Appeals against the decision were unsuccessful. Following the payment of the fine of around € 18 million, British health authorities brought legal claims for damages against Merck and other companies in a mid-triple-digit million-euro amount in fiscal 2023 due to alleged infringements of competition law. In addition, there were further claimants from various other jurisdictions who have not yet quantified their claims. In response to the latest developments in the proceedings, the provision was adjusted as of December 31, 2023, and is now recognized in a high single-digit million-euro amount. A cash outflow within the next twelve months is considered possible. Product liability risks Operating in the chemical and pharmaceutical industries, we are exposed to product liability risks. Product liability risks can lead to considerable claims for damages, costs to avert damages, and potentially loss of reputation. In view of this, we have taken out standard liability insurance to mitigate such risks. However, it could be that the insurance coverage available is insufficient for individual cases. Although the occurrence of product liability claims in excess of the existing insurance coverage is considered improbable, individual cases could still have a critical effect. Human resources risks Our future growth is highly dependent on our innovative strength. Therefore, the expertise and engagement of employees in all business sectors in which we operate are crucial to our success. The markets relevant to the company are characterized by intense competition to recruit qualified specialists and talents, and by the challenge of being perceived by the public as an attractive employer. Fluctuation risks specific to countries and industries have to be identified ahead of time and specifically addressed in order to keep the skills and expertise critical to success and business within the company. Recruiting as well as retaining specialists and talent are therefore key priorities for the company and are managed through the targeted use of, for instance, employer branding initiatives, global talent, and succession management processes as well as competitive compensation packages. Nevertheless, employee-related risks that affect business activities are possible; even though their impact is difficult to assess we evaluated a potential impact on the qualitative rating scale as moderate. Information technology risks We use a variety of IT systems and processes to optimally support our globalization. Trends in information technology offer various opportunities but also harbor risks. Risks due to cybercrime and the failure of business-critical applications 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. Combined Management Report_ Report on Risks and Opportunities 92 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. 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. 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. • About stable organic development to moderate organic growth ⚫ About stable to slightly negative foreign exchange effect EBITDA pre¹ • Slight to moderate organic growth ⚫ Negative foreign exchange effect -1% to -4% ⚫ Moderate organic decline to slight organic growth ⚫ About stable to moderate negative foreign exchange effect • Slight to significant negative foreign exchange effect ⚫ Moderate organic decline to moderate organic growth About stable to moderate negative foreign exchange effect ⚫ Rise in costs due to lower currency hedging gains 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. ⚫ Moderate to strong growth Operating cash flow Organic growth in the low teens percentage range ⚫ Moderate to solid organic growth About stable to slightly negative foreign exchange effect Slight organic decline to slight organic growth 94 94 ⚫ About stable to slightly negative foreign exchange effect Combined Management Report Report on Expected Developments Report on Expected Developments The following report provides a forecast for the development of net sales and EBITDA pre for the Merck Group and the individual business sectors Life Science, Healthcare and Electronics as well as a forecast for Group operating cash flow in 2024. Net Sales . € million Electronics • Life Science Healthcare Slight to moderate organic growth Negative foreign exchange effect 0% to -3% Merck Group Corporate and Other 12.4 9.2 Wastewater discharged directly 2023 stress areas Water 2023 Merck Group 11.1 9.5 0.110 8.6 3.4 0.000 Wastewater discharged to third parties 4.1 3.8 3.8 0.100 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. Assessing our water management practices 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. 13.3 2022 2021 7.6 13.4 0.156 2022 6.7 2020 6.3 6.3 5.8 0.002 5.4 5.2 5.0 4.8 0.06 Total wastewater volume (millions of m³) 0.06 0.06 0.002 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. Using water more efficiently 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. 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 2020 2021 0.06 In GWh 2611 2023 2 2 2 Downstream leased assets (category 13) 42 234 23 End-of-life treatment of sold products (category 12) 1,137 138211 1,296 2 1,164 Processing of sold products (category 10)9 105 6 84 8 Downstream transportation & distribution (category 9) Upstream leased assets (category 8)8 767 99 94 0.002 Use of sold products (category 11)10 Franchises (category 14) 12 Investments (category 15) 0 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. 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. 8 Already covered under Scope 1 and 2 emissions. 7 We adjusted our calculation methodology to take into account the results of an internal employee survey on home office use. 6 We adjusted our calculation methodology to remove non-GHG relevant waste streams. 5 In 2023, we introduced a new and improved calculation methodology based on primary data from suppliers/logistics service providers and an energy- based bottom-up calculation approach. 4 Due to high efforts for data preparation, we reference 2020 data for 2021. 3 We updated environmentally extended input-output analysis (EEIO) factors, and we adjusted our emission calculation approach for service categories using primary supplier data. 1 In line with the Greenhouse Gas Protocol, for all previous years, greenhouse gas emissions were calculated based on the current corporate structure as of Dec. 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 The reported figures contain 95-97% of our total spend. The difference stems from smaller sites that are not integrated in our Group-wide purchase volume data. 2020 data are slightly over-reported (approx. 3%) as the currency conversion factor (USD to EUR) from 2021 was used. Non-categorized spends are distributed pro rate to category 1 and 2. 1 2 1 2023 1.4 950 1.9 0 Indirect energy consumption 1,113 1,142 1,138 1,092 10 Electricity 90 964 984 38 982 Steam, heat, cold 163 178 154 110 0 Total energy sold 0.2 0.1 0.01 0.00 10 36 38 35 2,382 2,463 2,432 2,337 78 Direct energy consumption 1,269 1,321 1,294 1,245 68 Natural gas 1,182 1,235 1,188 1,164 59 Liquid fossil fuels² 52 48 70 43 9 Biomass and self-generated renewable energy 0.0 1.8 Electricity 0.1 The cooling water used in our production processes generally runs in a circular system. Depending on regulatory standards and the energy footprint, we sometimes use freshwater for cooling in a once-through system. However, this is only done in regions with high freshwater availability. For certain applications, we treat production wastewater and reuse it. In 2023, we recycled a total of 20.5 million m³ of water (2022: 20.7). Water withdrawal millions of m³ Total water withdrawal Combined Management Report Non-Financial Statement Environmental Matters 110 Surface water (rivers, lakes) Groundwater Drinking water (from local suppliers) 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. Rain water and other sources 2021 2022 2023 Merck Group 2023 Water stress areas 14.0 13.5 13.2 12.1 0.162 1.8 2020 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. - 0.01 0.00 0.0 Steam, heat, cold 0.0 0.0 0.00 0.00 0.0 1 In line with the Greenhouse Gas Protocol, for all previous years energy consumption has been calculated based on the current corporate structure as of Dec. 31 of the reporting year and retroactively adjusted for acquisitions or divestments of (parts of) companies, or for changes in emission factors (portfolio-adjusted). 2 Light and heavy fuel oil, liquefied petroleum gas (LPG), diesel, biodiesel, gasoline and kerosene. We use photovoltaics to produce power at multiple sites. - We currently only record purchased secondary energy this is primarily electricity and, to a lesser extent, heat, steam and cold. Details on the local energy mix, including the respective percentage of primary energy, renewable energy, etc. are not available. Data on local energy efficiency in electricity or heat generation are not available either. Our production sites are located in countries with a widely varying energy mix. Combined Management Report Non-Financial Statement Environmental Matters 109 Water management To us, sustainable water management means obtaining freshwater or discharging treated wastewater without negatively impacting aquatic ecosystems. We are also concerned with addressing water scarcity. To determine whether a site is in a water-stressed area, we apply a risk factor of the Aqueduct Water Risk Atlas of the World Resources Institute (WRI). We want to reduce the environmental impact of our wastewater and make our processes more water efficient. In the medium term, we will also consider water-related risks in our supply chain when purchasing important raw materials. In the long term, we aim to transparently map water use and environmental impacts throughout the entire life cycle of our products. To this end, we have defined two targets: Firstly, we originally aimed to achieve a 10% reduction in our Merck Water Intensity Score by 2025 compared with the baseline of 2020. In 2023, we met and surpassed this target, successfully lowering the Merck Water Intensity Score by 25% in comparison with the baseline year 2020. Consequently, we have set a new target based on a new and more transparent calculation. By 2030, we strive to achieve a 50% reduction in our water efficiency ratio of water intake per revenues compared with the 2020 baseline. The new target covers the complete water intake of our company. Our 2020 baseline year was chosen to align this new target with other existing environmental goals. Our second objective focuses on mitigating our environmental impact. Specifically, we are committed to reducing potentially harmful residues in our wastewater to levels below the established no-effect threshold. Our regular EHS audits at our production and development facilities also review site-specific water management practices. Our water management efforts focus more heavily on our manufacturing sites than our administrative facilities as production generally poses a higher risk to aquatic ecosystems. Roles and responsibilities The Group function Corporate Sustainability, Quality and Trade Compliance is responsible for water management. At our sites, engineers work closely with our EHS managers to reduce water consumption and treat wastewater. Further information can be found under "Environmental protection". Our commitment: Standards and procedures Our Sustainable water management principles set the framework for three Group-wide standards that detail how we integrate mechanisms of sustainable water management into our management system: Sustainable Water Management Part 1 - Wastewater; Sustainable Water Management Part 2 - Water Use; and Sustainable Management Part 3 Water Risk Management. All three standards are based on the commitments we made under the Responsible Care® initiative. 0.2 Employee commuting (category 7) metric kilotons 78 ⚫ Plant, process and transport safety • Water management • Climate action • Environmental management Topic Social matters Employee-related matters Environmental matters Aspect The following topics achieved the relevance threshold for double materiality in 2023. They cover fiscal year 2023 and pertain to our entire Group. Any deviations from the reporting framework are indicated on a case-by- case basis. Pursuant to section 289c (3) and section 315c (2) of the German Commercial Code (HGB), we are obligated to review topics for their double materiality. The principle of double materiality requires companies to disclose non-financial information as soon as the following two criteria are met: Firstly, the information makes it possible to understand how the company's activities affect non-financial aspects. And secondly, the information is necessary to understand the course of business, results of operations and economic position of Merck KGaA and the Merck Group. In 2023, we examined the topics identified within the scope of a materiality analysis in accordance with the Global Reporting Initiative standards (GRI) for their double materiality. • Chemical product safety Topics for the non-financial statement 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. 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 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. 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 103 April 11, 2024 • Attracting and retaining talent Diversity, equity and inclusion - 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 Other topics Anti-corruption and anti-bribery Respect for human rights Digital ethics • ⚫ Bioethics ⚫ Clinical studies • Prices of medicines ⚫ Patient safety Responsible supply chain (including the mica supply chain) ⚫Health and safety ⚫ Data protection and cyber security Sustainability Report 2023 as of Will be published in the Water management ⚫ 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. Will be published in the SASB index within the Sustainability Report 2023 as of April 11, 2024 Sustainable innovation and technology Further details • Environment, Health and Safety (EHS) Incident Rate 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). • 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 Total energy consumption ⚫ People treated with our Healthcare products and pharma products enabled by our Life Science business sector¹ ⚫ Lost Time Injury Rate (LTIR) Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment¹ • Violations of Global Social and Labor Standards Policy 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 • Water Intensity Score² • Waste 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 Plant, process and transport safety Diversity, equity and inclusion Attracting and retaining talent Further details 1 The key indicator is used to determine the sustainability factor for the Merck Long-Term Incentive Plan (LTIP). The Chair of the Executive Board and CEO of our company is responsible for environmental protection, which also covers climate action, water management, waste and recycling, air emissions, biodiversity, and plant and process safety. Her duties include approving overarching Group-wide guidelines such as our Environment, Health and Safety (EHS) Policy. Furthermore, the Merck Sustainability Board (MSB) monitors the Group-wide implementation of environmental protection goals. The Group function Corporate Sustainability, Quality and Trade Compliance (SQ) is responsible for steering all the related measures globally. SQ senior leadership approves operational standards and regularly reports on environmental protection to the Merck Sustainability Board. Every year, SQ prepares a comprehensive environment, health and safety report covering topics such as climate action, water management and waste and recycling as well as plant and process safety. The Merck Sustainability Board uses this report to steer the strategic direction and provide verification for our ISO 14001 and ISO 45001 certifications. Across our business sectors, the Operations Leadership Committee (OLC) makes strategic decisions on issues pertaining to emissions, energy, water, and waste. This body comprises representatives from Life Science, Healthcare and Electronics as well as SQ. Decisions made by the OLC and any resulting actions are implemented by the respective business sector. Once per quarter, the OLC members update their leaders on matters relating to environmental protection and this information, if relevant, is then shared with the MSB. Our commitment: Standards and standard operating procedure Our approach to environmental management is founded on our Group EHS (Environment, Health and Safety) Policy, which has been approved by our Executive Board. Aligned with the requirements of the chemical industry's Responsible Care® Global Charter and the ISO 14001 environmental management standard, this policy underscores our leaders' responsibility for environmental protection and health and safety. It is also aimed at our suppliers, calling on them to likewise adopt high environmental sustainability and safety standards. Our EHS policy thus complements the Supplier Code of Conduct of our Group Procurement function. Through our Contractor EHS Management Standard, we aim to ensure that our contract partners also take environment, health and safety aspects into account. 6,680 5,799 5,103 Total gross other indirect emissions (metric kilotons CO2 equivalents) 2023 2022 2021 2020 Other relevant indirect greenhouse gas emissions (Scope 3 of the GHG Protocol)¹ 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. 7 We adapted the calculations to the complete Greenhouse Gas Protocol requirements. 4,594 6 The figures presented here have been calculated in accordance with the market-based method. 4 In 2023, we adjusted our Scope 1 and Scope 2 calculations to reflect minor data corrections. equivalent. 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 7 15 14 14 227 242 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. Purchased goods & services (category 1)² 3,040 3,572 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 388 291 293 Capital goods (Category 2)² 2,5173 4,200 325 15 86 1,236 1,626 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. We also aim to cover 80% of our purchased electricity with renewables by 2030. 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: Climate action 106 Environmental Matters Non-Financial Statement Combined Management Report 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. 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. 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. 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 ISO 14001:2015 Group certificate Roles and responsibilities Corporate Sustainability, Quality and Trade Compliance is responsible for overseeing all climate action efforts throughout the Group, with our individual sites and business sectors worldwide implementing the necessary measures at the local level. More information can be found under “Environmental protection”. Our commitment: Standards and legal frameworks 1,827 325 14 22 1,463 1,760 1,951 2,152 2023 Merck Group thereof: Merck KGaA 2022 2021 20203 2023 Biogenic CO2 emissions? indirect CO2eq emissions (Scope 2)6 direct CO2eq emissions (Scope 1)5 thereof: Total CO2eq³ emissions4 Total greenhouse gas emissions (Scope 1 and 2 of the GHG Protocol) 1,2 107 Environmental Matters Combined Management Report Non-Financial Statement 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. 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). 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). Emissions reduced further 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. 1,518 Merck Group thereof: Merck KGaA 2023 Environmental Matters Combined Management Report Non-Financial Statement 14.33 15.02 not applicable Asia-Pacific (APAC) 10.60 14.66 12.84 11.90 not applicable Latin America 11.40 12.95 13.38 13.19 not applicable Middle East and Africa (MEA) 11.80 16.57 13.04 15.63 not applicable Total number of leavers 4,721 6,354 6,358 6,336 152 by gender 9.79 North America 3.48 5.52 Women 8.22 11.00 9.93 9.76 3.87 Turnover rate by age group Up to 29 years old 11.30 16.64 15.91 14.39 5.79 30 to 49 years old Men 7.74 9.55 9.48 3.41 50 or older 7.52 9.22 8.05 8.49 2.62 Turnover rate by region Europe 5.64 6.00 5.91 10.05 3.24 2,697 3,673 152 1,281 2,078 2,182 2,305 not applicable Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) 1,394 2,015 1,905 1,824 not applicable 398 449 467 460 not applicable 158 211 164 187 not applicable 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. 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. 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. 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. Roles and responsibilities 1,560 1,640 1,601 1,490 3,639 87 2,024 2,779 2,685 2,697 65 Women by age group Up to 29 years old 974 1,451 1,542 1,358 3,575 32 2,677 3,545 3,569 3,624 82 50 or older 1,070 1,358 1,247 1,354 38 by region Europe North America 30 to 49 years old 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. 10.11 10.69 118 156 165 126 not applicable Rate of new employee hires¹ (%) 11 15 17 9 6 by age group² up to 29 years old 30 to 49 years old 479 43 41 40 39 77 50 51 51 54 21 7 8 7 2 Middle East and Africa (MEA) not applicable 445 460 3,016 4,101 4,569 2,493 3,653 4,859 6,113 2,997 89 131 2,160 2,567 3,015 2,028 50 or older 220 1,789 2,855 3,971 1,181 not applicable Asia-Pacific (APAC) 2,206 2,803 3,071 1,710 not applicable Latin America 396 579 North America 10.40 by gender² Men 8 not applicable 2 2 2 2 not applicable 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. 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. Staff turnover 1,2 Combined Management Report Non-Financial Statement Employee-Related Matters 116 2023 2023 20203 2021 2022 Merck Group thereof: Merck KGaA Total turnover rate 8.22 10.82 10.16 9.96 3.48 Turnover rate by gender Men 8.22 4 6 6 not applicable by region² Europe North America Asia-Pacific (APAC) Latin America Middle East and Africa (MEA) 45 46 43 45 40 55 54 57 Women 55 32 29 28 37 100 27 32 37 22 not applicable 33 31 29 31 60 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. Combined Management Report Non-Financial Statement Employee-Related Matters 60 60 60 53 thereof: number of employees in senior management (Role 6+) 68 63 58 65 19 thereof: number of employees in middle management (Role 4 & 5) 2,032 2,172 2,235 2,283 367 thereof: number of employees in low management (Role 3) 6,926 7,298 8,007 7,963 805 thereof: number of employees in "other employees (below Role 3)" 25,948 26,624 60 30 to 49 years old (%) 494 8,484 15 15 15 14 14 thereof: number of employees in senior management (Role 6+) 0 0 0 0 0 thereof: number of employees in middle management (Role 4 & 5) 28,124 6 12 8 2 thereof: number of employees in low management (Role 3) 199 241 263 249 39 thereof: number of employees in "other employees (below Role 3)" 8,365 8,880 9,651 8 Up to 29 years old (%) 27,697 50 years or older (%) 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 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%). Culture and ethnicity 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. 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. 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. 2 The sharp decline in comparison with the previous year (8,485 employees) is attributable to the fact that in addition to Healthcare KGaA, which was hived off in 2019, the two other business sectors, namely Life Science und Electronics, have now also been transferred to separate legal entities. 1 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. 10,481 10,382 25 25 25 26 33 thereof: number of employees in senior management (Role 6+) 125 131 133 135 29 thereof: number of employees in middle management (Role 4 & 5) 894 1,599 1,771 1,848 231 thereof: number of employees in low management (Role 3) 3,161 3,341 3,607 3,695 431 thereof: number of employees in "other employees (below Role 3)" 9,698 9,939 1,651 by age group Merck Group¹ thereof: Merck KGaA 2023 200 48 Middle management (Role 4 & 5) 3,637 3,831 4,018 4,139 600 Low management (Role 3) 10,286 10,880 11,877 11,907 1,275 Other employees (below Role 3) 44,011 45,443 48,157 46,662 2,001 % of women (total) 43 43 43 44 39 thereof: number of women in senior management (Role 6+) 42 191 194 193 Senior management (Role 6+) 117 Our commitment: Group-wide policies and guidelines 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 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. 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. A competitive compensation structure 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. 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. Strengthening our sustainability culture 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". Combined Management Report Non-Financial Statement Employee-Related Matters 118 Diversity, equity and inclusion 49 We are committed to promoting a strong sense of inclusion and belonging among our employees. Therefore, we approach diversity, equity and inclusion (DE&I) with the same purpose as our other global business objectives and aspirations. While we have always been a diverse organization we currently span 65 countries and have about 63,000 employees from 141 nationalities - we recognize that our success depends on our ability to foster equity and inclusion. In addition, our DE&I approach fuels our efforts to make positive impacts in the communities where we live and work. We expect our leaders and managers to be mindful and considerate in how they attract, hire, retain, and promote their people. We aim to help every employee maximize their potential, regardless of their gender identity, culture, ethnicity, race, religion or creed, sexual orientation, nationality, socioeconomic and family status, language, disability status, age, mindset, faiths, military service, or political conviction. Number of employees by hierarchical level 2023 2023 As of Dec. 31 2020 2021 2022 Merck Group¹ thereof: Merck KGaA Total employees 58,127 60,348 64,243 62,908 3,924 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. 51 58 15 management (Role 4 & 5) 2,353 2,418 2,468 2,517 386 thereof: number of men in low management (Role 3) 5,934 6,211 6,754 6,757 800 thereof: number of men in "other thereof: number of men in middle employees (below Role 3)" 25,500 27,090 26,083 1,168 Footnotes follow at the end of the table. As of Dec. 31 Combined Management Report Non-Financial Statement Employee-Related Matters 119 2020 2021 2022 2023 24,766 Europe 33 140 thereof: number of women in middle management (Role 4 & 5) 1,284 1,413 1,550 1,622 214 thereof: number of women in low management (Role 3) 4,352 4,669 5,123 5,150 475 142 thereof: number of women in "other 19,245 19,943 % of men (total) 57 57 21,067 57 20,579 833 56 61 thereof: number of men in senior management (Role 6+) 151 145 employees (below Role 3)" by region 15.44 Number of nationalities 11,218 2,301 831 thereof: women 16,798 3,084 7,565 857 4,562 1,203 384 50 or older 16,159 5,133 2,085 8,706 1,407 717 196 thereof: women 6,461 2,034 3,595 467 472 266 94 Average age 41.5 43.5 1,304 42.9 16,304 38,006 Non-Financial Statement Combined Management Report Before commissioning a plant, we draft a safety concept, which is subject to continuous review throughout the entire lifetime of the facility. It is updated as needed until the facility is decommissioned. This safety concept contains an overview of potential risks and specifies corresponding protective measures. In the event that alterations are made to a plant, we reassess the hazard and risk situation. Our Risk Management Process guides all our sites in identifying and assessing risks and serves to devise further measures to minimize them. We use internal EHS audits to complement the inspections conducted by our EHS and dangerous goods managers in order to ensure that our sites comply with process, plant, transport, and storage safety regulations. Normally, these audits are conducted every three years at production sites and every four years at warehouse and distribution sites. If major shortcomings are identified, we re-audit the respective site the following year. Conversely, we may decide to extend the period between audits at facilities where, based on the findings from previous audits, we deem the potential risk to be low. Our sites are required to rectify any deficiencies discovered during the audit, with the auditor subsequently checking whether the specified corrective actions have been taken. In 2023, we conducted 34 EHS audits (2022: 41) in accordance with our Group-wide EHS standards. Assessing potential risks Our Group Transport Safety Standard is based on the United Nations Recommendations on the Transport of Dangerous Goods. This guideline is especially important for sites in countries with inadequate local regulations covering the conveyance of hazardous materials. Our Group-wide EHS standards stipulate the safety levels for the storage of hazardous materials at our sites. Along with supplementary standard operating procedures and best practice documents, these EHS standards describe the technology, equipment and organizational infrastructure needed to achieve the appropriate safety levels. Contract warehouses must also adhere to our strict safety requirements. Before we sign a contract with an operator, they must submit a statement detailing how they meet our prerequisites. Our Group-wide EHS standards also define the technical and organizational requirements for such warehouses. To ensure safe operation throughout the lifetime of a plant, our Group-wide EHS standards contain specific rules for production plants and processes. These include specifications that determine how special risk analyses and hazard assessments are to be carried out. We have also defined measures for the event of accidental release of chemical substances and for fire protection. Our commitment: Internal standards and international rules Overriding responsibility for plant, process and transport safety lies with the Group function Corporate Sustainability, Quality and Trade Compliance (SQ), which coordinates plant and process safety for the company and defines Group-wide EHS standards and regulations. Roles and responsibilities 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. 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. Plant, process and transport safety 111 7,352 8,743 3,294 535 2,634 440 142 thereof: women 4,150 995 1,521 213 1,323 224 87 30 to 49 years old 2,233 Environmental Matters Total employees 14,718 66 66 New employees 77 30 66 66 12 2023 2023 As of Dec. 31 2020 2021 2022 66 Merck Group thereof: Merck KGaA 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 3,347 Total number of new employee hires 62,908 (Role 4 or above) 78 28,304 43.0 3,924 37.4 40.8 40.5 15,259 3,458 1,169 Combined Management Report Non-Financial Statement Employee-Related Matters 115 Internationality of employees As of Dec. 31 % of non-Germans in management positions 2023 2020 2021 2022 Merck Group thereof: Merck KGaA 141 142 139 141 70 Combined Management Report Number of nationalities in management positions (Role 4 or above) 75 79 2023 4,610 112 We track EHS performance indicators at all production and warehouse facilities, as well as at major research sites, including both accidents and near misses. We investigate each individual incident and then devise appropriate countermeasures in an effort to reduce the likelihood of such events reoccurring in the future. EHS performance indicator data are reported once a month within each business sector, with the Executive Board receiving reports on the topic once per year. Four indicators are particularly important to us: As of Dec. 31 Number of employees Worldwide North America Europe Merck KGaA Asia-Pacific (APAC) Middle East and Latin America Africa (MEA) 2022 Up to 29 years old 9,926 2,753 Employee age by region 3,530 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 1,181 16,216 2 The sharp decline in comparison with the previous year (8,485 employees) is attributable to the fact that in addition to Healthcare KGaA, which was hived off in 2019, the two other business sectors, namely Life Science und Electronics, have now also been transferred to separate legal entities. 1,537 Non-Financial Statement Employee-Related Matters 114 Employee-Related Matters Attracting and retaining talent 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. 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. Total number of employees As of Dec. 31 Total number of employees Men Women 2023 2023 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. thereof: 2021 2022 Merck Group¹ Merck KGaA² 58,127 60,348 64,243 33,204 24,923 34,274 26,074 36,452 27,791 62,908 35,499 3,924 2,387 27,409 2020 Keeping a close eye on safety 4,549 2,333 64,243 15,847 28,244 8,485 15,412 3,490 1,250 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. Up to 29 years old Product safety information Safe and sustainable by design implies that product safety starts during development. Therefore, at an early stage of our product development process, we analyze innovations in terms of their impacts on human health and the environment. We continuously evaluate the intrinsic hazards of both our existing and new products to create relevant product safety information in line with applicable rules. Safety analysis of our products In 2023, there was one incident of non-compliance with regulations concerning potential health and safety impacts and the labeling of our chemical products. Some information and the REACH registration number was missing on a safety data sheet which resulted in a fine in Italy. In this regard, to the best of our knowledge, there were no negative impacts on human health or the environment. Using the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) for hazard communication enables us to streamline our internal processes and provide consistent, harmonized and high- quality information to our customers. Total employees 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. 113 Environmental Matters Non-Financial Statement Combined Management Report This approach also applies to innovative fields of development such as nanomaterials, which we use with the greatest of care in line with the precautionary principle. Furthermore, our Group-wide Policy for Use and Handling of Nanomaterials provides the necessary guidance on the use of these materials. Our Group standard provides a framework for governing the setup of effective operational processes for product safety, hazard communication and chemical regulatory compliance throughout our business sectors. In addition, the Group Chemicals Regulations Council fosters cross-sectoral alignment of strategic regulatory activities required for existing and emerging chemicals regulations as well as sustainability and identifies potential impacts for our company. Our Life Science, Healthcare and Electronics business sectors have organizational structures in place to implement our product safety strategy in line with their respective business requirements and customer needs. This approach includes registering chemicals, classifying hazardous substances and highlighting risks using safety data sheets, labels and digital communication tools. Roles and responsibilities Product safety is one of our top priorities. During the product development phase, we investigate the potential adverse impacts of chemical substances. Along the entire value chain of our products - from raw materials to manufacture and commercialization – we provide relevant information on their hazardous properties and how to deal with them. These instructions facilitate the safe handling and use of our products in line with pertinent regulatory requirements. We publish this information primarily on the relevant digital channels. As paper safety data sheets are still common in some countries, we can also provide these upon request through our customer service. Chemical product safety For the Lost Time Injury Rate (LTIR) we set ourselves the goal of lowering our Group-wide LTIR to under 1.0 by 2025 (number of accidents Group-wide resulting in at least one missed day of work per million hours worked). In 2023, our LTIR was 1.3 (2022: 1.2). The EHS Leading Rate (EHS LR) reflects the number and the results of the analyses of near misses and hazardous conditions or behaviors, as well as other proactive safety activities such as risk assessments. The EHS IR also contains our Loss of Primary Containment (LoPC) indicator. In 2023, we did not record any significant incident-related releases of substances (2022: two). Under our EHS Incident Rate (EHS IR), we track and evaluate all major and minor accidents and incidents as well as further EHS-relevant incidents. The EHS IR covers both our own employees as well as those of contractors. To calculate it, we state the number of incidents and the severity of the event in relation to the number of hours worked. The lower the EHS Incident Rate, the safer the site is. In 2023, the ratio was 2.4 (2022: 2.8). Legal requirements and internal guidelines 11,174 40.3 37.3 890 thereof: women 16,909 3,278 7,528 1,664 4,498 1,196 409 50 or older 15,894 5,283 8,498 2,755 41.1 1,239 192 thereof: women 6,245 2,045 3,437 870 412 255 96 Average age 41.6 43.3 43.1 43.1 681 5,397 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. 45 Men Women by gender 50 or older 2,944 390 971 671 433 5 0 not applicable Middle East and Africa (MEA) 0 0 0 0 by gender Women 0 0 0 0 0 not applicable 0 Latin America 0 0 0 0 North America 0 0 0 0 not applicable Asia-Pacific (APAC) 0 0 0 0 not applicable 0 0 0 0 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 124 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. 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. Roles and responsibilities • 0 • Risk management process 0 Men 1 Including supervised temporary staff. 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. 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: 0 by region Europe Alongside this indicator, in the United States, we also use the Occupational Illness Rate to monitor work- related illnesses and their long-term effects. Work-related accidents¹ 2023 2023 2020 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 We use our EHS Incident Rate (EHS IR) to document incidents. 1.3 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. Accident rates Roles and responsibilities 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. 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. 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. 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. Health and safety 121 Employee-Related Matters Combined Management Report Non-Financial Statement 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 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: 0 1.6 2.4 0.6 0.6 not applicable Middle East and Africa (MEA) 0.4 0.0 1.1 0.4 not applicable Number of deaths 0 0 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. 0 0 0.4 Europe 0.8 not applicable 2.1 1.7 2.2 1.6 North America 0.8 1.2 1.7 1.4 not applicable Asia-Pacific (APAC) 0.1 0.1 0.3 0.1 Latin America 0 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 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 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". Risk analyses to determine human rights and environmental risks 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. 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 Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 128 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. 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. Identifying actual and potential impacts on human rights Creating awareness among our employees Our reporting practices 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 complaint mechanisms 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". 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. Human rights violations 2020 2021 2022 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. 2023 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 Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 126 Auditing our mica supply chain 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. 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. 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. Evaluating and tracking mica sources 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. 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 127 Human rights 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. 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. Roles and responsibilities 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. 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. 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. 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 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. Number of reported violations of Social and Labor Standards Policy 121 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 Medical Safety and Ethics Board 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 Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 130 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. Our commitment: Guidelines and statutory 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. 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. 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). 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. Applying our proactive safety strategy to benefit-risk assessments 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. Up-to-date labeling and product information 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. Internal and external training 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. 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. Inspections and audits for drug safety monitoring 108 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. 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. 136 184 Number of confirmed Violations of Social and Labor Standards Policy 29 41 68 60 thereof: number of incidents of discrimination 2 Roles and responsibilities 6 71 1 As of 2023, the incidents of discrimination also include cases of harassment as a specific form of discrimination. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 129 Patient safety 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. Continual monitoring of product safety risk profiles 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. 7 measures. 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. Mica is an important raw material for our effect pigments, which are used in automotive, cosmetic and industrial coatings as well as plastics. We procure the majority of our mica from the Indian states of Jharkhand and Bihar. We have special measures in place to comply with high social and environmental standards in our mica supply chain. Our commitment: Guidelines and standards 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 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. 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. Non-Financial Statement Social Matters and Respect for Human Rights 125 Combined Management Report Through the TfS initiative, suppliers are assessed either based on information obtained during audits or based on self-reported and publicly accessible information provided by EcoVadis, an independent rating agency. EcoVadis assesses suppliers from more than 175 countries and more than 200 sectors across the four categories of Environment, Labor and Human Rights, Ethics, and Sustainable Procurement. On top of the assessments, suppliers are also monitored through a 360-degree news watch. The results are shared among TfS member companies in compliance with all restrictions stipulated by antitrust law. Through the TfS initiative alone, we have access to 1,860 valid scorecards on the assessment of our suppliers (2022: 1,700), almost 1,790 of which completed a new assessment or re-assessment in 2023 (2022: 1,100). In some cases, these were initiated by us and in other cases by other TFS members. Supplier Decarbonization Program Our Supplier Decarbonization Program is a key element of achieving our Science Based Target. Through this ten-year program that was defined as part of the decarbonization strategy in 2021, we aim to reduce greenhouse gas emissions associated with purchased goods and services as well as capital goods. In order to manage the large quantities of data on the CO2 emissions of our suppliers, we have an automated carbon accounting tool in place to which we continuously add new functionalities. We offer our suppliers access to solutions to reduce their Scope 2 emissions. In addition, we joined the Energize program as a new sponsor. Energize is a collective initiative by a group of industry-leading pharmaceutical and fine chemical companies that have committed themselves to engaging their suppliers to support the adoption of renewable energy and reduce greenhouse gas emissions within their common supply chains. We offer all our suppliers the opportunity to join the program for free and to find out more about renewable electricity options leading to reduced Scope 2 emissions. Mica supply chain Together for Sustainability supplier assessments and audits Customer Privacy¹ 0 0 0 0 received from outside parties Total number of substantiated complaints 0 2022 4 3 3 Reported violations of Data Privacy Guidelines thereof: Merck KGaA Merck Group 0 7 Total number of complaints from regulatory bodies 0 Total number of identified leaks, thefts, or losses of customer data 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. Compliance management Anti-Corruption and Anti-Bribery 139 Anti-Corruption and Anti-Bribery Combined Management Report Non-Financial Statement 0 1 0 0 0 2021 0 0 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. 0 1 These data only reflect incidents classified as significant. о 2020 • Our Group Compliance function is responsible for our compliance portfolio, which consists of the following elements: 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 Our commitment: Guidelines and standards Whistleblowing and Investigations Standard 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. Supplier Code of Conduct 140 Anti-Corruption and Anti-Bribery Non-Financial Statement • Risk Assessment: Identifying internal and external critical risks in regular business operations • • • 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. 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 . Continuous Improvement: Based on and applicable to all compliance program elements 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. 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. Combined Management Report 2023 Roles and responsibilities 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. 2023 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: Combined Management Report • The Declaration of Helsinki, published by the World Medical Association, • Good Pharmacovigilance/Laboratory/Manufacturing/Distribution Practices (GVP/GLP/GMP/GDP), The International Ethical Guidelines for Health-related Research Involving Humans, published by the Council for International Organizations of Medical Sciences (CIOMS), Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 134 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. Conducting clinical studies responsibly The Good Clinical Practice (GCP) guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), 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. 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. 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. 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. Our commitment: Medicine price guidelines and principles 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. Value-based contracting models Diversity, equity and inclusion in clinical trials 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. Combined Management Report Non-Financial Statement Social Matters and Respect for Human Rights 132 Programs for low- and middle-income countries 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. 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. Clinical studies 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. 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. 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. Disclosure of clinical studies and publication of results 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. Enabling early access to new medicines 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 137 Developments in the field of generative AI, for instance ChatGPT, are growing in importance. All our business sectors are developing applications based on generative AI. To apply these innovative technologies responsibly and to the benefit of all, an ethical framework is currently being developed. The DEAP is intensively evaluating the guidelines. The aim is to roll out this framework company-wide in 2024. Ethical use of data and algorithms In June 2023, online training on the CODE was assigned to approximately 12,000 managers with personnel responsibility who can access the training in eight languages via our internal training platform. In addition, an advanced training course is available specifically for employees working in the fields of data science, AI and other digital areas of specialization. The course serves to illustrate the importance of the CODE and empowers participants to make responsible decisions concerning the ethical aspects of data use and algorithms in digital products and business models. Since 2022, we have been looking at potential ethical risks that could result from projects by the Life Science Data Intelligence and Analytics unit of our Life Science business sector with the aim of developing suitable processes. The unit analyzes data from the business sector in order to obtain insights for our business. Data privacy and cyber security The mandate and goal of our Group Data Privacy unit is to mitigate risks and create a global framework for data privacy-compliant business operations. This unit helps train our employees to handle data responsibly and with clear accountability. It safeguards our company by providing data privacy risk assurance and ensuring compliance with relevant data privacy laws globally. Group Data Privacy also contributes to creating value for the development of digital business models. It is of critical importance to our business to protect our information systems, their contents and our communication channels against any criminal or unwanted activities. These include e-crime and cyberattacks, such as unauthorized access, information leakage and misuse of data or systems. Our commitment: Guidelines and standards Roles and responsibilities 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. 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. Data Privacy 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. 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. 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. Roles and responsibilities Combined Management Report 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. 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. Non-Financial Statement Social Matters and Respect for Human Rights 135 Bioethics - Roles and responsibilities 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. 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. All employees may address their concerns to the Bioethics team via our compliance hotline and a dedicated e-mail address (accessible via the intranet). 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. 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. 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. 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. 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. Our commitment to policies and standards Stem cell research "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." 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. 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: Digital ethics 136 Non-Financial Statement Social Matters and Respect for Human Rights Combined Management Report This is complemented by further guidelines that form the ethical framework of our research and business activities. Our Stem Cell Principle sets the ethical boundaries for the use of human stem cells in our research. Our Fertility Principle regulates our fertility treatment and in-vitro fertilization research activities. Using genome-editing techniques Sustainable innovation and technology 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. 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 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. Other Topics 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. Combined Management Report Non-Financial Statement Other Topics 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. 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. 145 Our commitment: Aiming for circularity 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. 144 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 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. Other Topics Healthcare Ethical Guiding Principles Combined Management Report 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). Combined Management Report Moreover, we apply various specific internal rules and regulations: • Pharma Code for Conducting Pharmaceutical Business and Pharmaceutical Operations (Pharma Code) • • Non-Financial Statement Standard on Medical Activities • Policy on Interactions with Patients, Patient Opinion Leaders, and Patient Organizations Guideline Good Practice and Process Guidance: Engagement with Patients, Patient Opinion Leaders, and Patient Organizations Transparent reporting 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. Regular employee training 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. For the collaboration with patient organizations: Non-Financial Statement Other Topics Transport by motorbikes, passenger cars and light commercial vehicles (activity 6.5 of the Delegated Act on the "climate change mitigation" environmental objective), and Reporting in accordance with the EU Taxonomy Regulation 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 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). 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), 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). Combined Management Report Non-Financial Statement Other Topics 148 Determination of taxonomy alignment Technical screening criteria 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. Our commitment: Group-wide guidelines and industry standards • With respect to capital expenditure, the EU Taxonomy Regulation differentiates between three categories of capital expenditure: Manufacture of electrical and electronic equipment in the Life Science business sector (environmental objective "transition to a circular economy"). Manufacture of medical products in the Healthcare business sector (environmental objective "pollution prevention and control"), and Fundamentals 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: 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. 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. 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. 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. Approach 146 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. Combined Management Report Non-Financial Statement Other Topics 147 As a result of this process, taxonomy-eligible activities generating net sales were identified only in conjunction with the following economic activities: • Manufacture of energy-efficient building equipment in the Electronics business sector (environmental objective "climate change mitigation"), Manufacture of active pharmaceutical ingredients in the Healthcare and Life Science business sectors (environmental objective "pollution prevention and control"), 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. 143 2020 Combined Management Report Merck Group 2023 thereof: Merck KGaA Total number of reported compliance violations Number of reported compliance incidents Number of confirmed cases 81 79 79 106 9 41 42 28 32 1 2022 2021 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. 2023 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. Reporting potential compliance violations Confirmed cases by category 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. 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. Combined Management Report Non-Financial Statement Anti-Corruption and Anti-Bribery 142 Reported compliance violations 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. Non-Financial Statement Anti-Corruption and Anti-Bribery Bribery and corruption 1 Other violations of Merck values, internal guidelines or legal requirements 24 35 12 25 1 Compliance audits 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. 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. Interactions with health systems 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. 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. Roles and responsibilities 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. 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. 0 3 2 0 2 1 0 Violation of cartel laws and fair competition rules 0 0 1 6 0 Fraudulent actions against Merck 11 6 11 0 Other violations of the Merck Compliance Principles for the relations with business partners 0 0 Minimum safeguards Identification of taxonomy-eligible economic activities 149 Operating expenditure In order to exclude double counting, capital expenditure on products from taxonomy-aligned economic activities and individual measures that have already been checked under category A (i.e. capital expenditure that relates to assets or processes associated with taxonomy-aligned economic activities) are included under this category only. Against this background, capital expenditure for production buildings, for example, is subject to a taxonomy-eligibility check under category A only, while capital expenditure for administrative buildings is included under category C. changes in property, plant and equipment and intangible assets disclosed in the consolidated financial statements (see Note (20) "Property, Plant and Equipment” and Note (19) "Other Intangible Assets" in the Notes to the Consolidated Financial Statements). 150 Non-Financial Statement Other Topics Combined Management Report The share of capital expenditure on assets or processes associated with economic activities classified as taxonomy-eligible or taxonomy-aligned is determined as follows: Share of total capital expenditure that is taxonomy-eligible or taxonomy-aligned divided by total capital expenditure according to the EU Taxonomy Regulation. At Merck and within the meaning of the EU Taxonomy Regulation, capital expenditure in the reporting period comprises additions to property, plant and equipment (IAS 16), rights of use from leases (IFRS 16), and intangible assets (IAS 38) with the exception of goodwill. Apart from the additions, advance payments for the named assets are also included. The denominator also includes additions to property, plant and equipment and intangible assets resulting from business combinations. The additions can be seen in the Capital expenditure The net sales KPI represents the ratio of net sales from taxonomy-eligible or taxonomy-aligned economic activities in a fiscal year to the total net sales of the same fiscal year. The definition of relevant net sales for the purposes of the EU Taxonomy Regulation corresponds to the definition of net sales in the consolidated financial statements (see Note (9) "Net sales” in the Notes to the Consolidated Financial Statements). Net sales In the area of fossil gas, Merck operates a gas turbine and a co-generation facility to generate electricity and heat from fossil gaseous fuels. The facilities serve to generate our own power and heat. These activities in the area of electricity generation from fossil gaseous fuels as well as the operation of co-generation units with fossil gaseous fuels have been classified as not material. Additional activities in the field of nuclear energy and fossil gas are not performed or are performed to an insignificant extent only. The purchase or performance of contract manufacturing services for active pharmaceutical ingredients or medical products in the Healthcare and Life Science business sectors typically does not give rise to a taxonomy- eligible economic activity, as Merck does not control the circumstances under which the contract manufacturing is performed in many cases. To check the taxonomy eligibility of an economic activity, Merck applies an end-product oriented approach for manufacturing-related activities. This means that the end product must result from one of the economic activities specified in the Delegated Act in order to qualify as being taxonomy-eligible. In the case of organic basic chemicals, the corresponding economic activities qualify as taxonomy-eligible in the interpretation of Merck only if the manufacturing activities of the named chemical products involve a significant transformation process. In our interpretation, products that are merely passed on for sale, repackaged or mixed do not qualify as taxonomy-eligible within the meaning of the EU Taxonomy Regulation. Ancillary activities that are operationally necessary for our core business do not qualify as independent taxonomy-eligible economic activities. This applies, for example, to the transport of our products to our customers, research and development activities, and the acquisition or construction of production buildings in areas that cannot be allocated to a taxonomy-eligible target activity. Taxonomy eligibility The EU Taxonomy Regulation and the corresponding Delegated Acts contain wording and requirements which, even taking into account the supplementary publications of the EU Commission and the "EU Platform on Sustainable Finance", are subject to interpretation and/or for which clarifications have not yet been published in every case. The most significant interpretive issues and Merck's approach are presented below. The 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. Combined Management Report Non-Financial Statement Other Topics Accounting and measurement policies 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 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: 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 Climate change Water Pollution Circular economy Biodiversity Minimum safeguards activity activity al Criteria for a substantial contribution CapEx 2022 eligible aligned or taxonomy of Proportion Non-Financial Statement _ Other Topics Combined Management Report ("Do no significant harm") DNSH criteria enabling Category Category transition- Of which transitional Economic activities for buildings (A1) Manufacture of energy efficiency equipment A. TAXONOMY-ELIGIBLE ACTIVITIES A.1. Environmentally sustainable activities (taxonomy-aligned) CCM 3.5 1881 33 3 3 3 28 28.49 0.03 - 27.99 0.47 0.47 N/EL N/EL N/EL N/EL EL N/EL Turnover of environmentally sustainable N/EL N/EL N/EL N/EL N/EL N/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 EL; EL; EL; EL; activities (taxonomy-aligned) (A.1) Of which enabling Of which transitional 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 CE 1.2 EL N/EL N/EL EL N/EL N/EL 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 adaptation Climate change mitigation Biodiversity 548 -43.2 Personnel expenses -581 -1,256 675 -53.7 Depreciation, amortization, and write-downs -132 -1,269 -142 -7.5 Other operating expenses -821 -1,150 329 -28.6 Investment result 2,203 2,015 11 188 -721 -43.0 158 Business development and results of operations 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). 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. Results of operations Change € million Net sales 2023 Cost of materials 2022 % 1,628 3,180 -1,552 -48.8 Other income 105 184 -79 € million 9.3 Other financial result -685 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. Depreciation, amortization, and adjustments remained essentially unchanged as against the previous year. The transfer of operating activities did not have a material impact on the amount of fixed assets (see “Effects of material company agreements on the net assets, financial position, and results of operations"). The reduction in other operating expenses was due to the transfer of operating activities (see "Effects of material company agreements on the net assets, financial position, and results of operations") and mainly resulted from the lower level of external services for sales and advertising as well as other external services and procurements. Following the transfer of operating activities, the relevance of investment income as the largest income item is increasing. It increased by € 188 million to € 2,203 million (2022: € 2,015 million) on the back of higher income from profit and loss transfer agreements with subsidiaries in the Healthcare business sector. The general rise in interest rates also led to an increase in the profit transfer from the Group financing company, Merck Financial Services GmbH, Darmstadt. This was offset by lower dividends from other subsidiaries and higher expenses from profit and loss transfer agreements. 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 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. CapEx 2023 Proportion of CapEx 2023 Climate change mitigation Climate change adaptation Water Pollution Circular Economy 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. 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. 17.7 43 -414 -272 65.7 Profit before profit transfers and taxes 996 1,148 -152 -13.2 Profit transfers -696 -677 -18 2.7 Taxes -16 -228 213 -93.1 Profit after profit transfers and taxes 285 242 E Code Y Proportion of 649 67.1 0 0 78 74 4 968 5.5 25,680 171 0.7 Change Dec. 31, 2023 5,481 Dec. 31, 2022 5,479 25,851 1,617 -50.9 -64 969 107 11.0 22,808 22,804 3 0.0 1,708 1,641 68 4.1 29 546 -517 -94.7 62 126 € million % 2 0.0 308 -156 -50.5 14,848 686 4.6 10 25,851 11 -1 -12.1 25,680 171 0.7 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. Largely irrespective of the transfer of operating assets, one notable increase on the asset side of the balance sheet related to fixed assets (€ +99 million). This was mainly due to the investments in property, plant and equipment at the Darmstadt site. The 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%. 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. 152 15,534 1,076 -10.0 2,751 2,198 2,283 -85 -3.7 1,415 1,509 -94 -6.2 783 774 9 1.2 18,162 17,907 256 1.4 2,476 -275 -5.6 -11 192 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 Pollution of Criteria for a substantial contribution E Turnover 2023 Climate change adaptation Climate change Z mitigation Water (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N N/EL N/EL N/EL N/EL N/EL N/EL Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; % E Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Y Y Y Y T % Turnover 2023 Proportion DNSH criteria Provisions for pensions and other post-employment benefits Other provisions Liabilities Financial liabilities Trade accounts payable Other liabilities Deferred income Change Dec. 31, 2023 Dec. 31, 2022 € million % 24,065 23,965 99 0.4 181 Provisions ("Do no significant harm") Net equity Equity and liabilities Economic activities Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 160 Net assets and financial position Assets € million Fixed assets Intangible assets Tangible assets Financial assets Current assets Inventories Trade accounts receivable Other receivables and other assets Cash and cash equivalents Prepaid expenses € million Combined Management Report_ Y -195 Climate change Z OpEx 2023 Proportion of OpEx 2023 Code Economic activities % Climate z CCM 3.5 Y N/EL N/EL N/EL N/EL N/EL Y Y Y Y Y Y 0.00 0.02 change Water Pollution Minimum Biodiversity economy Circular Pollution Water Climate change change Climate Biodiversity % E T Y; N; Y; N; Y; N; Y; N; Y; N; Y; N; N/EL N/EL N/EL N/EL N/EL N/EL (b) (b) (b) (b) (b) (b) Y/N Y/N Y/N Y/N Y/N Y/N Y/N Circular Z Economy E safeguards CCM 7.2 Y N/EL N/EL N/EL N 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 0.00 EL N/EL N/EL EL; EL; EL; EL; EL; N/EL N/EL N/EL N/EL N/EL 0.00 0.16 N/EL N/EL N/EL N/EL EL N/EL 0.00 OpEx of taxonomy-eligible but not environmentally sustainable activities (not taxonomy-aligned activities) (A.2) A. OpEx of taxonomy eligible activities (A.1 + A.2) 2.02 0.02 0.00 0.00 1.83 0.16 0.00 97.98 2,817 100.00 CE 1.2 EL; N/EL (not taxonomy-aligned activities) sustainable activities Y Y Y Y Y Y 0.00 T 0.02 0.02 0.00 0.00 0.00 0.00 0.00 0.00 0.00 E 0.00 T 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 0.00 "60 7-0-869 eligible OpEx 2022 of 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 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 Y Y Y Y E 0.00 Y Y Y EL; 1,26 0.04 N/EL N/EL N/EL EL N/EL N/EL 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་ -0.8% 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 4.27 N/EL N/EL N/EL EL N/EL N/EL 0.00 Y taxonomy aligned or Y Y sustainable activities (not taxonomy-aligned activities) (A.2) A. CapEx of taxonomy eligible activities (A.1 + A.2) B. TAXONOMY-NON-ELIGIBLE ACTIVITIES CapEx of taxonomy-non-eligible activities (B) Total (A + B) 152 Criteria for a substantial contribution DNSH criteria Manufacture of medicinal products CapEx of taxonomy-eligible but not environmentally ("Do no significant harm") Non-Financial Statement _ Other Topics 153 Proportion Category Category transition- enabling al activity activity Combined Management Report. Manufacture of active pharmaceutical ingredients (API) or active substances Transport by motorbikes, passenger cars and light commercial vehicles (A.2) but not environmentally sustainable activities (not taxonomy-aligned activities) E 0.06 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 % A.2 Taxonomy-eligible, Y A. TAXONOMY-ELIGIBLE ACTIVITIES A.1 Environemtally sustainable activities (taxonomy-aligned) ཟླ་བ་སྐརྒྱལ་་ཞུ།། Renovation of existing buildings Total assets Equity and liabilities A. Net equity Subscribed capital General partner's equity Capital reserves Retained earnings Profit carried forward E. Merck KG Net retained profit: shareholders -0.8% 168 397 397 3,814 3,814 702 702 80 80 318 168 -195 25,680 25,485 76 126 -50 -39.8% Other receivables and other assets 1,347 968 379 39.2% Cash and cash equivalents 0 0 0.0% 1,448 1,641 -192 -11.7% C. Prepaid expenses 74 74 0.0% 318 Trade accounts receivable 5,479 0.0% Total equity and liabilities 2,751 2,751 222 308 -86 0.0% -28.0% 14,847 17,819 D. Deferred income 14,848 17,907 0.0% -87 -0.5% 11 11 -1.7% 25,485 25,680 Manufacture of energy efficiency equipment for buildings -1 Other liabilities Trade accounts payable Financial liabilities 0.0% 0.0% 0.0% 0.0% 0.0% 0.0% B. Provisions Provisions for pensions and other post-employment benefits 1,487 1,509 -22 -1.5% Other provisions 688 2,175 774 2,283 -86 -11.1% -108 -4.7% C. Liabilities 5,479 -95.4% Of which enabling 546 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. The financial statements of Merck KGaA have been prepared in accordance with the provisions of the German Commercial Code (HGB), the German Stock Corporation Act (AktG), and the supplementary requirements of the Articles of Association. The full version of the Annual Financial Statements of Merck KGaA together with the unqualified auditor's opinion has been submitted to the electronic company register and published there. Effects of material company agreements on the net assets, financial position, and results of operations Additional Information on Hive-down of the operating activities of the business sectors 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. Termination of the temporary business lease of the Life Science and Electronics business sectors Merck Life Science KGaA went live on January 1, 2023. It assumed the power of operational management for the Life Science operating business and ELP from Merck KGaA at this date. Merck KGaA therefore terminated the LS and ELP business lease agreements with effect from January 1, 2023. 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). - were 155 Combined Management Report_ OpEx of environmentally sustainable activities (taxonomy aligned) (A.1) Of which enabling Of which transitional environmentally B. TAXONOMY-NON-ELIGIBLE ACTIVITIES OpEx of taxonomy-non-eligible activities (B) Total (A + B) (a) (b) Combined Management Report. Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Non-Financial Statement 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 Circular Economy: CE Pollution Prevention and Control: PPC Biodiversity and ecosystems: BIO Y - Yes, Taxonomy-eligible and Taxonomy-aligned activity with the relevant environmental objective N-No, Taxonomy-eligible but not Taxonomy-aligned activity with the relevant environmental objective N/EL - not eligible, Taxonomy-non-eligible activity for the relevant environmental objective. Research and development expenses accounted for 2,445 Mio. € (2022:2,521 Mio. €) of the reported operating expenditure, with 1,657 Mio. € (2022: 1,694 Mio. €) of this being attributable to the Healthcare business sector. Other Topics 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. Water and Marine Resources: WTR 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 € million % 192 192 0.0% 961 969 -8 22,809 Merck KGaA 31.12.2022 22,804 0.0% 23,962 23,965 -3 0.0% B. Current assets Inventories 25 Additional transfers involving the Life Science business sector 5 Merck KGaA 01.01.2023 -0.8% Combined Management Report_ Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) 157 Change 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 Financial assets -521 2023 Compensation for fiscal 2023¹ - Chronological overview 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. ⚫ 1/3 of profit sharing 2023 (to be held in shares for 4 years) 2/3 of profit sharing 2023 (free disposal) • Service cost • Additional benefits • Base salary 23% 5,245 5,359 46% 0.3% 8.4% 23% 2023 - Non-performance-related Base salary 2021 Service cost 2024 2025 2026 2027 Three years performance cycle 2022 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 1,659 167 Determining the compensation of the Executive Board Profit sharing 2023 Performance-related Additional benefits Max - Summary Ø further EB members¹ 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. 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). 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. 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. 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. 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. 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. 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. Corporate Governance Compensation Report 22% 45% 1.3% 9.4% 22% 6,814 2023- 7,037 Min Max Min - Belén Garijo Summary of the compensation for the Executive Board members' performance up to December 31, 2023 (see page 8 below “Executive Board Compensation for 2023") For fiscal 2023, no payment will be made from the LTIP. In 2021, an LTIP was introduced, with a performance period of four years in total (previously three years). As a result, there is a one-time payout gap without bridging payments. The LTIP is therefore not considered in the following graphics below. As a result, the maximum values represent the sum of the base salary, additional benefits and service costs for fiscal 2023 as well as the maximum amount of profit sharing. 166 - Compensation for fiscal 2023 2,227 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: Base salary International peer group • Four-year performance period with three-year achievement period and subsequent one-year holding period • Absolute capped amount totaling 250% of the individual grant goals "Dedicated to human progress", "Partnering for sustainable business impact" and "Reducing our ecological footprint" Sustainability factor ranging from 0.8 to 1.2 based on the sustainability • • Key performance indicators: share price performance relative to the DAX® (50%), EBITDA pre margin (25%), organic sales growth (25%) • Performance Share Plan based on virtual shares (Merck Share Units) Merck Long-Term Incentive Plan • Individual, absolute capped amount • 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 • Key performance indicator: Three-year average of the profit after tax of the E. Merck Group Profit sharing Performance- related compensation Pension entitlement compensation Other components 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 addition, as compensation for the loss of entitlements to variable compensation from his previous employment relationship, Peter Guenter received upon the initial appointment in fiscal 2021 a commitment to compensation totaling € 1,500,000.00. The entitlement has been verified in the context of his initial appointment based on supporting documents and the amount has been determined accordingly. The compensation is to be paid in cash in four equal installments. The first installment was paid on July 1, 2021, the second installment was paid on July 1, 2022, and the third installment was paid on July 1, 2023. The final installment will be paid out on July 1, 2024, provided the employment relationship continues. The additional benefits mainly include company cars for personal use, contributions to insurance policies and expenses for personal protection. Additional benefits As base salary, the members of the Executive Board receive contractually fixed performance-independent amounts that are paid in the form of 12 equal monthly installments. There was no increase of the base salary in fiscal 2023. Base salary Performance-independent compensation In addition, the compensation for which the members of the Executive Board have provided the underlying service in full by December 31, 2023, but whose payment will be made in the following year, is disclosed on a voluntary basis. This enables transparent information and ensures the link between performance and compensation in the fiscal year. This year, the voluntary reporting only concerns profit sharing for 2023. The Personnel Committee has provisionally determined the payout amounts of the profit-sharing by resolution and informed the members of the Executive Board accordingly. The final amount will be paid to the members of the Executive Board after the consolidated financial statements of E. Merck KG have been released. After amending the compensation system of the Executive Board effective January 1, 2021, an additional one-year holding period was introduced for the LTIP, which applies for the first time to the LTIP Tranche 2021. Therefore, the performance period of the LTIP tranche 2021 will run until the end of fiscal 2024 and payout will be made in April 2025. The LTIP tranche 2020, however, ran until the end of fiscal 2022 and was paid out in April 2023. As a result, payout of the LTIP tranche 2021 can only be reported on a voluntary basis in the Compensation Report 2024. The obligation to report on the LTIP tranche 2021 applies for the first time in the Compensation Report 2025. Additional benefits 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). Executive Board compensation for 2023 170 Corporate Governance Compensation Report • Four-year holding period • Mandatory personal investment amounting to one third of the net payment of the profit sharing in Merck shares Share Ownership Guidelines • In the event of other grossly non-compliant or unethical behavior or behavior or actions that are contrary to our corporate values. 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. German peer group 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. Non- • Bayer • Sartorius • MSD • DuPont • AstraZeneca • Sanofi • Lonza • Danaher • Air Liquide + DAX® • Roche • Infineon • Bio-Rad ⚫ Agilent ⚫ Entegris • Biogen • GlaxoSmithKline • Novartis • Philips The following diagram provides an overview of all the elements of the compensation system for Executive Board members: 169 Corporate Governance Compensation Report The performance-related compensation elements - profit sharing and the Long-Term Incentive Plan on a multi-year performance period and as such are fully oriented toward the company's long-term development. In addition, there is a strong reference to the company's share price, to provide for special focus on our shareholders' interests. The key performance indicators selected for variable compensation are derived from the corporate strategy and form part of our central controlling system. In this way, the variable compensation of the Executive Board members is used as a strong steering tool to ensure a focus on our objective of long-term profitable growth accompanied by strong cost discipline. are based - Executive Board compensation includes three main components: base salary, profit sharing and the Long-Term Incentive Plan. It is complemented by contributions to the company pension plan as well as additional benefits. Additional compensation arrangements also exist for the members of the Executive Board, in particular malus and clawback provisions and a Share Ownership Guideline. performance- related Compensation components 168 Corporate Governance Compensation Report The Personnel Committee regularly reviews the amount and structure of the Executive Board compensation by referring to the peer groups described and with the assistance of an independent compensation consultant. Moreover, for the determination of the specific compensation amounts, the relations between Executive Board compensation, top management compensation and workforce compensation will be considered also based on a multi-year assessment. Top management is defined as senior levels of management below the Executive Board in Germany. The average compensation of an employee in full-time employment in Germany is considered in the determination of the compensation of the remaining staff. The international peer group was defined considering the size, business area and geographic location of the headquarters of the respective competitors. Overall, the peer group offers an appropriate ratio of companies headquartered in Europe and the United States as well as a balanced coverage of the Life Science, Healthcare and Electronics business sectors. Based on the size criteria of sales, number of employees and market capitalization, Merck positions itself around the median of this international peer group. • UCB Thermo Fisher Overview of the structure of the compensation system Compensation Report 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. Corporate Governance Compensation Report 3,085 2,615 2022 2023 Risks and opportunities Total Other Marketing and sales Logistics Research Production and site operations Administration Average number of employees during the year Personnel The average number of employees by functional area: Personnel For fiscal 2023, we are proposing to the Annual General Meeting the payment of a dividend of € 2.20 per share. Dividend Research and development (R&D) expenditure declined to € 69 million in fiscal 2023 (2022: € 289 million), largely as a result of the transfer of operating activities (see “Effects of material company agreements on the net assets, financial position, and results of operations"). Merck KGaA continues to recognize expenses for global R&D services. Research and development The reduction in provisions was due in particular to the lower level of pension provisions, which primarily resulted from pension payments and employees being transferred to other legal entities within the Merck Group. Merck KGaA is also financed via the Group financing company, Merck Financial Services GmbH, Darmstadt, which provides Merck KGaA with sufficient financial resources and hence ensures liquidity. Other liabilities rose by € 686 million and primarily relate to current loans and clearing account liabilities in respect of Merck Financial Services GmbH, Darmstadt, in the amount of € 14,476 million (2022: € 13,963 million). Financial liabilities of € 2,476 million relate to bonds issued in previous years to finance the acquisitions of Sigma-Aldrich and Versum Materials, Inc., United States, in particular. The € -275 million reduction in financial liabilities was attributable to the repayment of bonds, which resulted in an increase in other liabilities from intragroup financing. Additional information on the financing conditions and maturity structure of the bonds can be found in Note (21) "Financial liabilities" of the Notes to the Financial Statements in accordance with HGB. Merck KGaA was financed by equity in the amount of € 5,481 million (2022: € 5,479 million). This corresponds to an equity ratio of 21.2% (2022: 21.3%). Equity increased in particular as a result of the net income generated in fiscal 2023, which offset the dividend payments made during the year. 161 Additional Information on Merck KGaA in Accordance with the German Commercial Code (HGB) Combined Management Report_ 164 869 2,940 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”). 1,091 Skills and Expertise, and Qualification Matrix 341 224 Objectives of the Supervisory Board with Respect to its Composition, Profile of 218 Report of the Supervisory Board 197 Statement on Corporate Governance 196 Capital Structure and Corporate Bodies of Merck KGaA 164 Compensation Report No risks that could jeopardize the continued existence of the company have been identified. Merck Financial Services GmbH, Darmstadt, will provide the company with sufficient financial resources as needed and thus ensure liquidity. In line with the Group's development, we expect investment income to see moderate growth compared with the figure recorded in fiscal 2023. Accordingly, net income is forecast to be slightly higher than in 2023 overall. Forecast for 2024 Net income was above the forecast level due to higher investment income and lower taxes in particular. Taken together, these more than offset the higher level of other financial expenses. Net sales declined from € 3,180 million in the previous year to € 1,628 million, largely as a result of the € 1,813 million in sales from operating product and service business that were no longer recognized as anticipated following the transfer of operating activities. Sales in the reporting year relate solely to the intragroup on-charging of services. The increase in on-charged site and administrative services in particular meant that these were higher than the prior-year forecast of € 1,366 million. corporate Governance Deviations of actual business development in fiscal 2022 from the previously reported guidance 614 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. 43 523 122 4,008 74 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 66 0 is immediately available 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: x performance and sustainability goals (0.8 - 1.2) Profit sharing Maximum limit 2/3 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: 1.75 Three-year average of the profit after tax of the E. Merck Group (in € billion) 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. (€ million) for individual 2021 0.75 Adjustment factor Corporate Governance Compensation Report Belén Garijo 3,003 Contribution level Peter Guenter Kai Beckmann 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. 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. Pension obligations IAS 19 Present value of the pension obligation Service cost as of December 31 € thousand Payout in € 2022 Helene von Roeder (since July 1, 2023)4 2023 Considering the relevant three-year average of the E. Merck Group's profit after tax, the individual sharing rates and the performance factor, the profit sharing and the shareholding obligation for fiscal 2023 are as follows: Profit sharing 2023 summary Belén Garijo Kai Beckmann Peter Guenter Matthias Heinzel Marcus Kuhnert (until June 30, 2023)³ 2023 Three-year average profit after tax of the Average individual profit- E. Merck Group sharing rate 2023 (€ million) (in per mill)1 1.52 Performance factor for individual performance Payout amount (€ thousand) 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. 3,288 3,017 2,735 2,760 3,017 Three-year average Corporate Governance Compensation Report 174 Profit after tax of the E. Merck Group € million Profit after tax of the E. Merck Group 2020 1,915 2021 3,003 2022 3,288 2023 2,760 Three-year average profit after tax of the E. Merck Group (2020-2022) Three-year average profit after tax of the E. Merck Group (2021-2023) 2022 Helene von Roeder (Entry: July 1, 2023) 2022 • 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. 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. As regards profit sharing, an individual profit-sharing rate is contractually defined for the members of the Executive Board as a per mille rate of the three-year average of the consolidated profit after tax of E. Merck KG, Darmstadt, Germany. Fiscal 2023 and the two preceding fiscal years are included in the calculation. Profit sharing Performance-related compensation comprises profit sharing as well as the Long-Term Incentive Plan (LTIP). Performance-related compensation Corporate Governance Compensation Report • Violations of internal rules and regulations (for instance the Merck Code of Conduct), laws or other binding external requirements in the area of responsibility 172 ⚫ 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 ⚫ Failure to execute especially important projects or failing to achieve other exceptionally important objectives in the area of responsibility 4,587 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. ⚫ Clear failure to achieve targets for relevant key performance indicators in the area of responsibility Behaviors or actions that are contradictory to our company values 2023 1 The pension contribution for 2023 has been fully paid out into the pension account. 22,960 893 1,357 437 435 450 6,309 6,875 439 435 450 7,057 7,858 638 638 650 Matthias Heinzel 19,808 450 462 2,377 2,626 2,625 Total 268 268 225 4,717 5,197 401 396 400 Marcus Kuhnert (Left: June 30, 2023)¹ 832 1,405 454 FY 2023 thereof shareholding obligation (1/3) (€ thousand)² $1111 value Actual achieved Upper target corridor limit Target Lower target corridor limit LTIP 2020 target achievement 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. 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. Target Achievement Long-Term Incentive Plan 179 Corporate Governance Compensation Report 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. "Reducing our ecological footprint" 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. "Partnering for sustainable business impact" 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. Target achievement¹ "Dedicated to human progress" Share price performance relative to the DAX® EBITDA pre margin 11.1% 8.1% 131.7% 30.5% 31.6% 28.6% 25.6% 150.0% 58.6% 50.0% 0.0% -20.0% Total target achievement 5.1% (weighting: 25%) Organic sales growth (weighting: 25%) (weighting: 50%) 8.7% 805.0 965.0 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 Percentage of relevant suppliers (in terms of number and supplier spend) that are covered by a valid sustainability assessment People treated with our Healthcare products (including schistosomiasis 30% control program) and pharma products enabled by our Life Science business sector 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 Sustainability Goal/Key Indicator 875.0 Dedicated to human progress Minimum Greenhouse gas emissions in Scope 1+2 worldwide (in kt) 100% 92% 85% Relevant suppliers with a valid sustainability assessment (% of supplier spend) Reducing our ecological footprint 80% 73% 65% Relevant suppliers with a valid sustainability assessment (% of all relevant suppliers) Partnering for sustainable business impact Number of people treated with pharmaceutical products of Merck Life Science (in million) 650 609 555 Number of people treated as part of the schistosomiasis control program (in million) Maximum Target Number of people treated with Merck Healthcare products (in million) 110.0% 135.4% 1 Cap of 150% for the performance indicator "Share price performance relative to the DAX®" was reached. From profit sharing 2021 1,224 1,529 Share holding obligation based on SOG (in € thousand)¹ Helene von Roeder Marcus Kuhnert Matthias Heinzel Peter Guenter Belén Garijo Kai Beckmann Share Ownership Guideline 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. 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. 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. Share Ownership Guideline 180 Corporate Governance Compensation Report 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. From profit sharing 2022 2,939 From profit sharing 2023 1,463 1,529 1,111 Neither the malus provision nor the clawback provision were exercised in fiscal 2023. 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. Malus and clawback provisions 1 Gross amounts from profit sharing. Shareholding obligation is calculated on the respective net amounts. Total 4,216 3,126 3,476 3,216 2,405 2024 sharing for fiscal year 1,055 111 11 In % of Annual Base Salary Investment is made after 1,111 1,237 1,237 payout of profit 1,184 1,064 From profit sharing 2024 16,942 12,510 1,320 28,942 21,371 2,255 (until April 30, 2021) Stefan Oschmann Payout amount (€ thousand)¹ Reference Merck share price at the end (in €) MSUS Total target Final number of achievement Number of provisionally granted MSUS (in €) (€ thousand) beginning Grant amount Reference Merck share price at the LTIP 2020 summary The resulting final number of MSUs and the payout amounts of the LTIP tranche 2020 are shown in the following table. 2,226 Udit Batra (until July 13, 2020) 1,705 (until June 30, 2023) Marcus Kuhnert 3,910 25,284 18,670 1,970 Belén Garijo 3,406 • 19,637 1,530 Kai Beckmann 173.46 135.4% 105.53 633 21,883 16,159 14,500 Good measurability and operationalization 1,184 Internal and external influence of the sustainability key indicators by management 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. Long-Term Incentive tranche for fiscal 2023 Long-Term Incentive Plan (LTIP) 175 Corporate Governance Compensation Report 1 Payout amount of profit sharing in relation to the three-year average after tax. 2 Gross amount investment is based on net amount. 998 2,993 1.0 1.09 Marcus Kuhnert 1,184 3,552 1.0 1.30 1,184 3,552 Grant in € Reference Merck share 1.0 price at the beginning FY 2024 50% share price the Merck Performance of Financial targets (0% - 150%) MSUS provisionally granted Number of Reference Merck share price at the end 0% - 200% actually achieved (0% - 180%) Number of MSUS Sustainability factor (0.8 - 1.2) Holding period Target achievement cycle Performance cycle FY 2026 FY 2025 FY 2023 1.30 2,735 1,064 522 1,567 1.0 0.52 1,237 522 3,712 1,567 1.0 0.52 1.0 3,017 1,237 3,712 1.23 3,333 1.0 . 1.10 1 Payout amount of profit sharing in relation to the three-year average after tax. 2 Gross amount investment is based on net amount. 3 Pro-rated for January 1, 2023 until June 30, 2023. 4 Pro-rated for July 1, 2023 until December 31, 2023. 3,193 1.0 1.17 1,463 4,390 1.0 1.60 Matthias Heinzel "Dedicated to human progress" Belén Garijo Kai Beckmann Peter Guenter Payout amount (€ thousand) Performance factor for individual performance Average individual profit- sharing rate 2022 (in per mill)1 average profit after tax of the E. Merck Group (€ million) Three-year Profit sharing 2022 summary In fiscal 2023, the profit sharing for fiscal 2022 already explained in detail in the Compensation Report 2022 was paid out, which is thus reported as compensation awarded or due in fiscal 2023 in accordance with section 162 of the German Stock Corporation Act (AktG). Further details can be found in the following table from the previous year: The profit-sharing 2023 will be paid out in April 2024, while one-third must be held in shares of Merck KGaA, Darmstadt, Germany, for at least four years. Further details of the investment obligation can be found under "Share Ownership Guideline”. thereof share holding obligation (1/3) (€ thousand)² vs. the DAX® 1.23 sustainable 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. Based on the three financial performance indicators, the number of MSUs allocated may be between 0% and 150% of the provisionally granted MSUs. The resulting number of MSUs is then multiplied by the sustainability factor. The 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. 1,750 4,036 700 3,500 8,071 1,400 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. 4,750 Achievement 100% Relevance and influence of the sustainability key indicators on the three overarching sustainability goals of the sustainability strategy • "Partnering for 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 Target value Performance of the Merck share price vs. the DAX® 50% 0% -20% 0% 0% 100% 150% Achievement Corporate Governance Compensation Report 150% 10,954 -x% points +x% points Actual value of EBITDA pre margin or organic sales growth 173.46 Peter Guenter Kai Beckmann Belén Garijo LTIP Tranche 2023 allocation In fiscal 2023, the allocation of the LTIP tranche 2023 was made on the basis of the following parameters: Corporate Governance Compensation Report 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. Calculation of the MSUS Amount paid out in € (0% - 250% of the grant in €) target value relation to 25% EBITDA pre margin in relation to target value Organic sales "Reducing our ecological footprint" 1,900 business impact" Matthias Heinzel Marcus Kuhnert (until June 30, 2023)¹ growth in 1 Payout will be pro-rated based on the termination agreement. 4,750 10,954 Helene von Roeder (since July 1, 2023) 1,900 4,288 9,887 1,715 5,750 13,260 -25% (€ thousand) 2,300 Grant amount 176 (€ thousand) Reference Merck share price at the Number of provisionally granted MSUS beginning (in €) Maximum payout 396 44.8% 2,939 2,939 Others Compensation awarded or due pursuant to section 162 AktG Service cost 6,558 100.0% 3,300 Compensation for the fiscal year 2,193 7,158 Total compensation 7,180 1,044 522 LTI 2019 (2019 to 2021) 600 6,954 € thousand 26 € thousand 1,200 26 1,769 885 Profit sharing 2022 LTI 2020 (2020 to 2022) Payout in cash Investment (in shares; 4-year holding period) 998 1,995 998 Profit sharing 2023 Payout in cash Investment (in shares; 4-year holding period) Merck LTIP 1,995 30.4% 15.2% Member of the Executive Board 396 2,589 2023 2022 2023 € thousand 600 in % 98.5% € thousand For the fiscal year (voluntary disclosure) € thousand 1.5% 600 9 1,044 522 2022 € thousand 1,200 26 € thousand LTI 2020 (2020 to 2022) 9 401 7,581 (pursuant to section 162 AktG) In the fiscal year 401 7,559 Base salary Additional benefits Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) (since July 1, 2023) Profit sharing 2022 Investment (in shares; 4-year holding period) Profit sharing 2023 Payout in cash Investment (in shares; 4-year holding period) Merck LTIP LTI 2019 (2019 to 2021) Helene von Roeder Payout in cash 0.4% 1,590 795 in % 9.1% 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 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 Profit sharing 2021 Profit sharing Additional benefits € thousand 1,200 12 5,304 435 5,739 Others¹ 5,148 437 5,585 Matthias Heinzel Member of the Executive Board Service cost In the fiscal year (pursuant to section 162 AktG) 2023 2022 € thousand 1,200 16 in % 25.2% 0.3% (since April 1, 2021) 26 Total compensation 2023 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 Profit sharing 2021 Profit sharing Additional benefits Base salary € thousand 1,200 16 2,475 1,237 2022 € thousand 1,200 12 2,368 1,184 For the fiscal year (voluntary disclosure) 4,768 3,597 4,928 4,764 454 5,222 462 4,059 454 5,382 462 5,226 100.0% 953 2,131 609 Pension payments € thousand Karl-Ludwig Kley Bernd Reckmann 2023 2022 756 695 443 443 Payments to former members of the Executive Board and their surviving dependents 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 (December 31, 2022: € 123.1 million). Corporate Governance Compensation Report 189 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% 633 100.0% Merck LTIP LTI 2019 (2019 to 2021) Others Pension Compensation awarded or due pursuant to section 162 AKtG Compliance with the defined maximum compensation Walter Galinat 2023 € thousand 2022 in % € thousand 361 154 154 Member of the Executive Board (until September 30, 2018) Compensation awarded or due pursuant to section 162 AKtG 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. € 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. 9,500 Marcus Kuhnert (until June 30, 2023) 8,000 9,500 Helene von Roeder (since July 1, 2023) 8,000 9,500 Corporate Governance Compensation Report 190 Compensation for the Supervisory Board members in fiscal 2023 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. 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 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. 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. 5,198 8,000 Matthias Heinzel 9,500 8,000 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. 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. 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. Overall compensation limit Maximum limit for Direct Maximum compensation pursuant to section 87a € thousand The maximum compensation for the fiscal year is € 11,500,000 for the Chair of the Executive Board and Belén Garijo Peter Guenter Compensation AktG 9,800 11,500 8,000 9,500 Kai Beckmann Compensation awarded or due pursuant to section 162 AktG 2,131 100.0% Payout in cash Investment (in shares; 4-year holding period) LTIP LTI 2019 (2019 bis 2021) Marcus Kuhnert Member of the Executive Board (until June 30, 2023) 2023 2022 in Tsd. € 600 600 in % 100.0% 100.0% in Tsd. € Stefan Oschmann Chair of the Executive Board Profit sharing 2021 Profit sharing Compensation awarded or due pursuant to section 162 AKtG Others (waiting allowance) 100.0% Compensation for the fiscal year 3,128 Service cost 268 268 Total compensation (until April 30, 2021) 877 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 3,396 633 2023 2022 Merck LTIP LTI 2019 (2019 to 2021) LTI 2020 (2020 to 2022) Others Pension Corporate Governance Compensation Report Udit Batra Member of the Executive Board (until July 13, 2020) 2023 € thousand 188 2022 in % € thousand 10,189 100.0% 4,011 Compensation awarded or due pursuant to section 162 AktG in % € thousand 858 429 4,377 55.5% LTI 2020 (2020 bis 2022) € thousand 2,226 1,166 29.1% 3,953 Pensions 619 15.4% 572 Others 437 7.3% 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. 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 2,128 1,064 Compensation for the fiscal year Total compensation 435 8,255 439 8,334 4,555 435 4,990 7,814 439 8,253 Base salary Additional benefits Service cost LTI 2020 (2020 to 2022) LTI 2019 (2019 to 2021) Merck LTIP € thousand in % 1,200 22 15% 0.3% € thousand 1,200 16 € thousand € thousand 1,200 22 Base salary Additional benefits 1,200 16 Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) Profit sharing 2022 1,903 951 Payout in cash 2,128 Investment (in shares; 4-year holding period) Profit sharing 2023 1,064 27.2% 13.6% Payout in cash Investment (in shares; 4-year holding period) Corporate Governance Compensation Report Peter Guenter Member of the Executive Board (since January 1, 2021) In the fiscal year LTI 2020 (2020 to 2022) Others Compensation awarded or due pursuant to section 162 AktG Compensation for the fiscal year Service cost Total compensation Base salary 2,110 1,055 2,475 1,237 185 2022 € thousand 1,200 21 2,368 1,184 375 375 375 375 5,144 100.0% 4,761 435 5,579 LTI 2019 (2019 to 2021) 2022 Merck LTIP Payout in cash (pursuant to section 162 AktG) For the fiscal year (voluntary disclosure) 2023 2022 2023 € 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 46.0% 23.0% Investment (in shares; 4-year holding period) 2022 2023 For the fiscal year (voluntary disclosure) In fiscal year 2023 pursuant to section 162 AktG Base salary Additional benefits For fiscal year 2023 as voluntary disclosure Profit sharing for fiscal year 2022, payout in fiscal year 2023: - Payout in cash - Investment (in shares; 4-year holding period according to Share Ownership Guideline) LTIP tranche 2020 (Jan 1, 2020-Dec 31, 2022), payout was in fiscal year 2023 Profit sharing for fiscal year 2023, payout in fiscal year 2024: - Payout in cash - Investment (in shares; 4-year holding period according to Share Ownership Guideline) Other compensation The compensation of the current members of the Executive Board is shown in the following tables. Service cost as voluntary disclosure Compensation awarded or due Base salary Additional benefits Corporate Governance Compensation Report 184 Belén Garijo Chair of the Executive Board (since May 1, 2021; previously member of the Executive Board) In the fiscal year (pursuant to section 162 AktG) 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. To provide a complete picture of the total compensation of the Executive Board members, pension expense is also reported on a voluntary basis. 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. 181 Compensation-related transactions Contracts with the members of the Executive Board are usually concluded for a period of five years. If a contract begins during the year, the fixed compensation, profit sharing and individual LTIP tranches are paid on a pro rata basis. Should members of the Executive Board be held liable for financial losses while executing their duties, this liability risk is covered by a D&O insurance policy under certain circumstances. The D&O insurance policy has a deductible in accordance with the legal requirements. Obligations in connection with the termination of Executive Board membership The 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. 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 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. 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. During the fiscal year, no adjustments or changes were made to the employment contracts of the Executive Board. In particular, the terms of the termination agreement with Marcus Kuhnert did not result in any adjustments or changes to the original contract with Marcus Kuhnert. Corporate Governance Compensation Report 182 Post-contractual non-competition Post contractual non-competition clauses have been agreed with the members of the Executive Board except for Marcus Kuhnert. His contract provided for the option to agree on a post-contractual non-compete in the event of termination of his membership of the Executive Board. In general, the post-contractual non- competition clause involves the payment of compensation amounting to 50% of the member's average compensation within the last twelve months and is paid for a period of two years. Other earnings, pension payments and any severance payments are offset against this amount. Owing to his early termination, a post-contractual non-compete was agreed with Marcus Kuhnert with effect until July 31, 2024. As compensation, the post-contractual non-compete agreement provides for the payment of the fixed compensation as well as for the payment of the variable compensation until July 31, 2024, which means for the regular remaining term of his contract. Further compensation will not be granted. There was also a post-contractual non-competition agreement with Stefan Oschmann which came into force upon the termination of his membership of the Executive Board. The parties agreed on a monthly compensation of € 343,184 for the period from May 1, 2021, to April 30, 2023. The monthly pension of € 51,569 as well as further additional income has been offset against this amount. Loans, advances, payments by affiliates of Merck Group 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. Besides this, neither loans or advances were paid to other members of the Executive Board during fiscal 2023, nor any payments by affiliated companies. Corporate Governance Compensation Report 183 Individual Disclosure of the Compensation of the Executive Board Compensation awarded or due to current members of the Executive Board in fiscal 2023 2023 2023 2022 2023 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 9,891 Service cost Total compensation incl. service cost 638 10,527 638 10,529 638 6,814 638 10,529 1 Reduction of LTI 2019 and LTI 2020 payout due to maximum amount of direct compensation. Kai Beckmann Member of the Executive Board In the fiscal year (pursuant to section 162 AktG) For the fiscal year (voluntary disclosure) 3,058 1,529 Corporate Governance Compensation Report LTI 2020 (2020 to 2022) LTIP¹ € thousand 1,500 in % 15.2% 89 0.9% € thousand 1,500 91 € thousand 1,500 89 2022 € thousand 1,500 91 Profit sharing Profit sharing 2021 Payout in cash Investment (in shares; 4-year holding period) 2,447 1,224 Profit sharing 2022 Payout in cash 2,927 Investment (in shares; 4-year holding period) Profit sharing 2023 1,463 29.6% 14.8% 2,927 1,463 Payout in cash Investment (in shares; 4-year holding period) LTI 2019 (2019 to 2021) Merck Shares Identified investors by region as of November 2023 To Our Shareholders Net sales by region € million/in % of net sales 21% In the therapeutic area of SCCHN, we advanced our global Phase III development program for xevinapant, an IAP (inhibitor of apoptosis protein) inhibitor in 2023, with enrollment completed in the Trilynx study. The recruitment of patients in the XRay Vision study is ongoing (for further details see "Research and Development"). In 2023, we also continued to expand the availability of Tepmetko® (tepotinib), our oral MET inhibitor designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, with additional regulatory approvals. TepmetkoⓇ is now available in 43 markets globally. In September 2023, we received U.S. Food and Drug Administration approval of a supplemental Biologics Licensing Application for BavencioⓇ, converting the MCC indication from accelerated approval into full approval approximately four years earlier than anticipated. As a result, BavencioⓇ is the first MCC treatment to receive full approval in the U.S. market. BavencioⓇ is also approved in the first-line treatment of advanced renal cell carcinoma in combination with axitinib and it is a standard of care as a monotherapy in metastatic Merkel cell carcinoma (MCC), a rare form of skin cancer. Through our subsidiary Ares Trading SA, we regained exclusive worldwide rights to develop, manufacture and commercialize BavencioⓇ from Pfizer as of June 30, 2023. We have made progress in changing the standard of care globally for patients with locally advanced or metastatic urothelial carcinoma (UC) as we continue to obtain additional regulatory approvals and reimbursement decisions for our anti-PD-L1 antibody Bavencio® (avelumab) (for further details see "Research and Development"). BavencioⓇ is approved as a first-line maintenance treatment for advanced UC in 71 countries. It has become a standard of care in the treatment of this disease based on the results of the JAVELIN Bladder 100 trial, the only Phase III study of an immunotherapy to demonstrate a significant overall survival benefit in the first-line maintenance setting. Erbitux® (cetuximab) remains our best-selling cancer drug with € 1 billion in sales in 2023. The drug is a standard of care for patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer (mCRC) as well as both recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck (SCCHN). With more than 200 active clinical trials involving ErbituxⓇ, including more than 15 Phase III studies, we are also continuously advancing our broad-based lifecycle management strategy. Oncology In 2023, Healthcare generated 38% of Group sales and 41% of EBITDA pre (excluding Corporate and Other). Europe and North America generated 53% of Healthcare's net sales in 2023. In recent years, we have steadily expanded our presence in growth markets. In 2023, Asia-Pacific and Latin America accounted for 40% of sales. In Healthcare, we operate as a global specialty innovator in the Neurology & Immunology and Oncology franchises as well as in the therapeutic areas of fertility and cardiovascular, metabolic and endocrinological disorders. The Healthcare business sector discovers, develops, manufactures, and markets pharmaceutical and biological prescription drugs to treat cancer, multiple sclerosis (MS), infertility, and growth disorders as well as certain cardiovascular and metabolic diseases. Our R&D pipeline is focused on strengthening our position in the fields of oncology, neurology and immunology. 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 March, Life Science launched its open-source code library for Palantir Foundry on GitHub®. Our source code, "Foundry DevTools", was published under an open-source license in collaboration with Palantir. We have been partnering with Palantir since 2017 to build our data and analytics capabilities and contribute to the digital product portfolios of our Life Science, Healthcare and Electronics business sectors. The source code is freely accessible to all Foundry developers worldwide. Digitalization Four years after its inception in 2019, the SMASH Packaging plan has entered its next generation, called SMASH 2.0. So far, more than 100 packaging improvement projects have been completed or are underway, removing tens of thousands of metric tons of CO2 without sacrificing safety, quality, or performance. Key achievements include avoiding more than 300 metric tons of packaging and achieving a 23% reduction of expanded polystyrene (EPS), also known as Styrofoam. 72.5% of the paper-based materials sourced directly for packing and shipping products therefore aligns with the so-called zero deforestation standards. Sustainable packaging solutions* In November, we completed the second phase of our new € 29 million Biologics Testing Center in Shanghai, China, expanding our first biosafety laboratories, which we inaugurated in 2022, in this market. This expansion enables us to provide local access to a broad range of testing for cell line characterization and lot release, from preclinical development to commercialization. Since September, CTDMO can offer integrated services for all critical stages of mRNA development, manufacturing and commercialization, including products and testing, with the opening of two new GMP- grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The new sites are part of the company's ongoing € 1 billion investment to advance mRNA technologies and build its global mRNA network and capabilities in addition to key acquisitions such as AmpTec and Exelead. With this € 28 million investment, we can provide mRNA services at different scales and applications from preclinical to commercial. In July, Life Science announced a € 23 million expansion of its facility in Lenexa, Kansas, USA, adding lab space and production capacity to manufacture cell culture media. Cell culture media is used in processes as varied as vaccine manufacturing, gene therapy and monoclonal antibody manufacturing. The company's strategic investments to expand capacity in existing production facilities in the Lenexa, Kansas, USA, and Nantong, China, sites with dry powder media manufacturing lines will increase both local and global production capacity. 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"). € 70 million investment will enable large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers. 18 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. Denmark was chosen because of the existing recycling infrastructure in the country. Today, the four companies involved in this partnership account for around six million injection pens used in Denmark annually. The ambitious target for the first 12 months is for 25% of all injection pens distributed by the four companies in Denmark to be recycled, amounting to more than 25 metric tons of plastic. We are continuously taking action to further reduce the negative ecological impact of our operations on our planet with a holistic approach that includes our locations, products, logistics and patients. A portfolio-related activity to reduce the ecological footprint of our operations is the partnership we entered in May with Novo Nordisk, Eli Lilly and Sanofi to pioneer the world's first cross-industry solution for recycling materials from injection pens after use by patients. Minimizing the ecological footprint of our operations* In endocrinology, we build evidence in the digital health space and leverage technology to provide new solutions for patient engagement, partnership with healthcare practitioners and better payer value proposition. SaizenⓇ, containing the active ingredient somatropin, is our main endocrinology product and is indicated for the treatment of multiple growth hormone disorders in children and adults. SaizenⓇ can be delivered with the EasypodⓇ electromechanical injection device, the only growth hormone injection device able to wirelessly transfer data such as injection times, dates and doses to the web-based software system Growzen® Connect. AluettaⓇ (the SaizenⓇ pen) is now available in 67 countries with the objective of expanding the reach of SaizenⓇ, offering additional options for healthcare practitioners and patients and expanding our devices portfolio. GlucophageⓇ, containing the active ingredient metformin, is a drug for first-line treatment of type 2 diabetes and is available in more than 100 countries. In recent financial years, GlucophageⓇ has been approved by further health authorities for use in prediabetes when intensive lifestyle changes failed. EuthyroxⓇ, with the active ingredient levothyroxine, is a leading medicine for the treatment of hypothyroidism, a disease with high prevalence but still low diagnosis rates in most emerging markets. 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). 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. 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. Infertility is an increasing challenge globally due to demographic changes and lifestyle adjustments such as delayed childbearing. Based on the latest data from WHO, one in six people worldwide is affected by infertility. According to the latest data, more than five million babies have been born worldwide with the help of Gonal-f®, a therapeutic within our Fertility portfolio. It contains the active ingredient follitropin alfa (r-hFSH alfa), which is a recombinant form of the natural hormone FSH and is available in a convenient and ready-to-use pre-filled injection pen. Treatment with Gonal-f® can result in increased follicles, oocytes, and embryos compared to urinary gonadotropins, thereby improving the chances of pregnancy and live birth. Our Fertility franchise is a global market leader in fertility drugs and treatments. Fertility With evobrutinib, we had originally aimed to commercialize a first-in-class Bruton's tyrosine kinase (BTK) inhibitor for RMS. In December, we shared the outcome from the EVOLUTION clinical trials, which showed that the investigational drug did not meet its primary endpoint of annualized relapse rate for up to 156 weeks compared to oral teriflunomide. MavencladⓇ, a short-course oral therapy for the treatment of adults with various forms of highly active RMS, reached blockbuster status in fiscal 2023 with total net sales of more than US$ 1 billion, and is approved in 95 countries worldwide, including those of the European Union, Switzerland, Australia, Canada, and the United States. In Neurology & Immunology, we aim to provide transformative treatment solutions to support people living with neurological and immune-mediated conditions while significantly improving quality of life for them and their caregivers. With over two decades of experience in MS, our current portfolio includes two approved products for the treatment of relapsing MS (RMS) - Rebif® (interferon beta-1a) and MavencladⓇ (cladribine tablets). Rebif®, a disease-modifying drug, has been a standard treatment in RMS for over 20 years with more than 1.9 million patient-years of therapy since approval. Neurology & Immunology Within our DDR portfolio, we continue to advance the development of our potent and selective inhibitor of ataxia telangiectasia and Rad3-related (ATR), tuvusertib (M1774). We initiated the Phase Ib/IIa DDRiver NSCLC 322 study of tuvusertib in combination with cemiplimab in participants with non-squamous non-small cell lung cancer (NSCLC) (for further details see "Research and Development"). Combined Management Report Fundamental Information about the Group Merck In June, we announced the expansion of production capacity for highly purified reagents at the site in Nantong, China, a major transportation hub in the Yangtze River Delta region. The approximate Also in May, we signed a non-binding memorandum of understanding with the Korean Ministry of Trade, Industry and Energy and Daejeon City, Korea, for a new Asia-Pacific bioprocessing center aimed at supporting the region's healthcare ecosystem. The planned bioprocessing facility would support commercial manufacturing for biotech and pharmaceutical customers in this region. The investment includes a new facility in Glasgow, which will house molecular biology and sequencing services. Testing capacity in current buildings will be expanded to include biosafety testing, analytical development and viral clearance suites. The latest investment follows our recent testing expansions in Rockville, Maryland, USA, and Shanghai, China. With its BioRelianceⓇ testing services portfolio, Life Science performs more than 20,000 studies annually in the United Kingdom for more than 400 customers globally. BioRelianceⓇ contract testing services and the recently formed Millipore® CTDMO Services are part of the Life Science Services business unit. O 5,952 14,718 North America 28% 6,037 North America 23% Europe 29% 1,169 Latin America 3,458 737 Middle East and Africa (MEA) 5% Middle East and Africa (MEA) 2% 4% Employees by region as of December 31, 2023¹ Number/in % Merck Group 33% Asia-Pacific (APAC) 6,936 1,331 Latin America 6% 45% Europe 28,304 24% Asia-Pacific (APAC) 15,259 16 16 Merck Fundamental Information about the Group Combined Management Report In May, we announced an investment of € 35 million in biosafety testing facilities at our Glasgow and Stirling sites in Scotland. Biosafety testing is a step in the drug development and manufacturing process to ensure that drugs are safe, effective and compliant with regulatory requirements. Through the expansion, we plan to create nearly 500 new jobs, bringing our Life Science workforce to over 1,200 employees across the two sites. We have started building a new € 30 million expansion in Allentown, Pennsylvania, USA, which will join the existing facility to create a two-building "distribution campus". Investments to expand capabilities and production In March, we opened a lateral flow assay development lab in St. Louis, Missouri, USA, an innovative space where customers collaborate with our technical experts to troubleshoot point-of-care testing. The Science & Lab Solutions business unit serves customers in the pharmaceutical, biotech industries and other industries in production, testing and research, as well as public authorities and research institutions. We provide customers with access to a broad portfolio including reagents, consumables, devices, instruments, software, and services for scientific discovery in addition to lab water instruments, consumables and services, microbiology and biomonitoring products, test assays, analytical reagents, and flow cytometry kits and instruments. Science & Lab Solutions Electronics 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. The Process Solutions business unit continued to focus on delivering its product offering for the pharmaceutical development and manufacture of filtration devices, chromatography resins, single-use assemblies and systems, processing chemicals, and excipients. Process Solutions In 2023, Life Science generated 44% of Group sales and 45% of EBITDA pre (excluding Corporate and Other). In recent years, we have steadily expanded our presence in growth markets. Europe and North America generated 70% of Life Science's sales in 2023; Asia-Pacific and Latin America accounted for 29% of sales. nanomaterials. Across our Life Science business sector, we collaborate with the global scientific community to deliver innovations and to this end, we offer a broad and deep product portfolio as well as global Contract Testing Development Manufacturing Organization (CTDMO) services ranging from process development to commercialization. In 2023, we continued to execute our strategy as a diversified life science company to strengthen our three business units, Process Solutions, Life Science Services, and Science & Lab Solutions. Our R&D teams in the three business units have launched more than 8,500 products to respond to growth trends, including those launched through our "faucet program" for antibodies, reference materials and We are a leading global provider of products and services for a wide range of customers, including research labs, biotech and pharmaceutical companies, diagnostic labs, and the industrial sector. Life Science Fundamental Information about the Group Merck Combined Management Report 15 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 Services 11 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. Combined Management Report Merck Strategy Internal Management System 35 Research and Development 48 Report on Economic Position 48 Macroeconomic and Sector-Specific Environment 52 Review of Forecast against Actual Business Developments Course of Business and Economic Position Merck Group 55 55 65 Life Science 69 Healthcare 73 Electronics 76 Corporate and Other 77 Report on Risks and Opportunities 94 Report on Expected Developments 96 Report in Accordance with Section 315a HGB1 28 99 22 13 German Retail/ Undisclosed 4% Rest of World 0 19% Europe (ex-Germany/UK) 29% United States 17% United Kingdom Source: Nasdaq Shareholder Identification; Total Shares Outstanding: 129.2 million. Identified investors by type as of November 2023 3% Hedge 19% Index 19% Value Source: Nasdaq Shareholder Identification. 1% Others 33% Growth 25% GARP (Growth At Reasonable Price) Combined Management Report* Fundamental Information about the Group 13 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Non-Financial Statement Environmental Matters 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. Combined Management Report Fundamental Information about the Group Merck 14 14 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. 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". 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. Merck Group 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). Our Semiconductor Solutions business unit consists of the following business fields: Formulations, Thin Films, Specialty Gases and Delivery Systems & Services. Semiconductor Solutions is the largest business unit in terms of sales within Electronics. It comprises our product and service offering for the semiconductor industry. We are developing materials and solutions to make the next generation of devices - we help make chips smaller, faster, more powerful and more sustainable. Semiconductor Solutions supplies products for major production steps in wafer processing, including doping, patterning, deposition, planarization, etching, and cleaning. It also supplies delivery equipment for semiconductor manufacturing. Specialty cleans, photoresists, and conductive pastes for semiconductor packaging complement the portfolio. Intermolecular is our center for complex material solutions in Electronics, located in San Jose, California, USA. There, we explore, test, and develop combinations of different materials for next-generation electronics. Semiconductor Solutions Electronics accounted for 18% of Group sales in 2023, and its share of EBITDA pre (excluding Corporate and Other) was 15%. In 2023, Asia-Pacific generated 67% of Electronics' net sales, Europe and North America accounted for 30% of sales. In 2021, we started our "Level Up" growth program and are continuing to invest significantly more than € 3 billion in innovation and capacity expansion. Despite difficult market conditions in 2023, we plan to continue our "Level Up" growth program and will adjust the timeframe of our investments in line with market demand. The Electronics business sector consists of three business units: Semiconductor Solutions, Display Solutions and Surface Solutions. Three cross-functional boards support the business units: Technology Leadership Board, Supply Chain Leadership Board, and Commercial Leadership Board. They define cross-sector standards, steer portfolio management, drive forward the exchange on good practice, and promote transparency. 20 20 Fundamental Information about the Group Merck 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. 104 Ever since we were established in 1668, we have continuously reinvented ourselves and adopted a long-term mindset. This approach is rooted in responsibility, care and respect: for our work, our employees, our customers, patients, society, and our planet. We want to become the global 21st century science and technology pioneer and are committed to working towards a better future: sustainable progress for humankind. In 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. Employee-Related Matters Social Matters and Respect for Human Rights 114 123 139 144 Other Topics Anti-Corruption and Anti-Bribery 155 Additional Information on Merck KGaA in Accordance with HGB1 * The management report of Merck KGaA has been combined with the Group management report and published in the 2023 Merck Annual Report as well as in the annual financial statements of Merck KGaA. The management report also contains the combined non-financial (Group) statement of Merck KGaA, which we issue pursuant to sections 289b-289e and 315b-315c HGB. The 2023 Annual Report is an additional, non-official publication, which does not comply with the requirements of the European Single Electronic Format (ESEF). The official annual financial report for fiscal 2023, prepared in accordance with the ESEF format, has been filed with the electronic German Federal Gazette (elektronischer Bundesanzeiger) and is available on the website of the German company register. 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. In addition, our specialists also explore visionary new solutions at the interfaces of our three diversified business sectors. 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. 1 German Commercial Code. Combined Management Report Fundamental Information about the Group Merck 13 33 Fundamental Information about the Group Merck 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. 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. 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. 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. 9% Germany 7,158 7,180 Member of the Executive Board -77.80% 695 154 Walter Galinat (until September 30, 2018) -16.30% -19.40% -43.80% -70.30% 2,131 633 -11.30% 41.80% -47.00% -11.80% 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% 43.20% 17.00% -0.30% 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 -60.60% 22.30% -10.10% Karl-Ludwig Kley (until August 31, 2016) 89.3 Sascha Held 13.10% 2.10% 0.70% 112.0 112.8 Wolfgang Büchele Member of the Supervisory Board 0.50% 85.00% -66.00% 5.90% 6,999 7,409 Further former members -43.00% 6.70% -3.50% 443 443 Bernd Reckmann (until April 29, 2016) 67.10% 10.30% 8.80% 695 756 Other Matter - Formal Audit of the Compensation Report 88.5 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. 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. 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. 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. Corporate Governance 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. 197 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 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. 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. Corporate Governance Statement on Corporate Governance 199 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 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. 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." Darmstadt, February 2024 For the Executive Board signed Belén Garijo For the Supervisory Board signed Wolfgang Büchele Corporate Governance Statement on Corporate Governance The General Meeting of Merck KGaA Statement on Corporate Governance Corporate Governance Further information can be found under "Merck KGaA" in the "Statement on Corporate Governance". 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. Frankfurt am Main, Germany, February 16, 2024 Deloitte GmbH Wirtschaftsprüfungsgesellschaft Signed: Christoph Schenk Wirtschaftsprüfer (German Public Auditor) Signed: Daniel Weise Wirtschaftsprüfer (German Public Auditor) Corporate Governance Capital Structure and Corporate Bodies of Merck KGaA 196 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 MONITORING Supervisory board Annual General Meeting Shareholders hold share capital € 168,014,927.60 Board of Partners of E. Merck KG General partner E. Merck KG holds equity interest € 397,196,314.35 Intended Use of the Report 0.80% 2.70% 17.30% 11.00% -0.50% 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 3.90% Simon Thelen 25.40% 3.70% 1.20% 65.0 65.8 Daniel Thelen 1.50% 50.0 50.8 Helga Rübsamen-Schaeff 42.00% 50.80% 42.00% 8.90% 1.70% -2.20% 6.60% 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% 7.30% 59.40% -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% 6.10% -70.80% 80.0 23.4 50.0 50.8 Renate Koehler 45.30% 1.50% 50.0 50.8 Michael Kleinemeier 42.00% -1.40% 20.70% 10.50% 59.5 65.8 Jürgen Glaser 116.00% 23.5 50.8 Birgit Biermann (since July 14, 2022) 30.5 Barbara Lambert (since August 11, 2023) -1.60% 1.50% 50.0 50.8 Gabriele Eismann 110.00% 1.50% 200 42.00% 50.8 Helene von Roeder (until April 17, 2023) 42.00% 25.40% 3.70% 1.20% 65.0 65.8 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 45.30% 1.50% 50.0 Anne Lange We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion. Information on corporate governance practices 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. 7% 3.8 30.5 3% 0.8 37% ལྦ། །། T 47.0 93% 47.0 93% 47.0 93% 47.0 93% 47.0 93% Alexander Putz Dietmar Oeter Peter Emanuel Merck 50.8 22.0 Anne Lange 47.0 93% Kleinemeier Michael 72% 47.0 Jürgen Glaser 93% 47.0 14, 2022) (since July Birgit Biermann 60% Renate Koehler 23.5 23% 3.8 3.0 50.8 47.0 94% 7% 3.8 50.0 6% 3.0 94% 50.0 6% 94% 47.0 47.0 50.8 7% 50.8 7% 3.8 50.0 6% 50.8 47.0 94% 7% 3.8 59.5 5% 47.0 79% 65.8 6% 18.4 6% 2023) Barbara Lambert sand thou- thou- € thou- thou- thou- Total compen- sation Meeting fees € € € € in % € duties Compensation for committee Fixed compensation Total compen- sation Meeting fees 2022 Compensation for committee duties 2023 Fixed compensation Compensation awarded or due 191 Corporate Governance Compensation Report € in % sand in % 47.0 94% 50.8 7% 3.8 47.0 93% Gabriele Eismann 15.0 89.3 70.5 80% 4% 3.8 17% 79% 70.5 Sascha Held 15.0 84% 94.0 sand in % sand thousand 112.8 3% 3.8 13% 83% 94.0 Wolfgang Büchele (since August 11, Reporting 50.0 7% Change 2021/2020 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. 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 Comparative presentation of compensation and earnings development Corporate Governance Compensation Report 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. 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 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. 50.0 6% 3.0 65.0 5% 3.0 23% 50.0 192 Belén Garijo (Chair since May 1, 2021) 9,889 9,891 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. 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. 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 or 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 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. 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). 288.90% 32.60% 3,597 4,768 Matthias Heinzel (since April 1, 2021) Marcus Kuhnert (until June 30, 2023) Helene von Roeder (since July 1, 2023) 185.10% 8.00% 4,761 5,144 Peter Guenter (since January 1, 2021) -11.00% 37.90% 25.00% -0.90% 7,895 7,820 Kai Beckmann (since April 1, 2011) -6.90% 43.30% 22.20% 6% 3.0 47.0 94% 65.8 47.0 72% 15.0 50.8 47.0 94% 7% 88.5 3% 17% 112.0 3% 13% in % thousand in % € thou- ་།༄་། ་། ་། སྦྱོརྞྞཞཞ | འ ཀ། 9.5 16% 65.0 5% 3.0 15.0 23% 50.0 6% 50.0 6% 3.0 50.8 47.0 94% 50.8 47.0 94% 65.8 47.0 72% 6% 3.8 23% 3.8 7% 6% 3.8 50.0 47.0 72% 3.8 6% 3.8 23% 47.0 72% 15.0 47.0 93% Simon Thelen Daniel Thelen 50.8 7% 3.8 47.0 93% Schaeff Helga Rübsamen- 80.0 4% 3.0 38% 23.4 47.0 59% 30.0 3% 0.8 38% 59% 13.8 17, 2023) Roeder (until April Helene von Christian Raabe Audit Opinion 201 Corporate Governance Statement on Corporate Governance 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 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). 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%. Member Frankfurt am Main, Chair Kai Beckmann Darmstadt, CEO Electronics Peter Guenter 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) Belén Garijo 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. We also adopt environmental safety and protection targets with the aim of permanently improving our environmental protection and safety: 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. 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 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 (a) ⚫Bundesdruckerei GmbH, Berlin, Germany (not listed) ⚫ Bundesdruckerei Gruppe GmbH, Berlin, Germany (not listed) (b) • No board positions Member of the Supervisory Board since Jul. 1, 2009 of meeting of the Supervisory Board 5/5 Apr. 26, 2019 5/5 Sascha Held (Vice Chair of the Supervisory Board) Riedstadt, Application Consultant (full-time member and Chair of the Merck Joint Works Council) Birgit Biermann Bochum, Member of the Central Board of Executive Directors of the German Mining, Chemical and Energy Industrial Union (IG BCE), Hannover Gabriele Eismann Seeheim-Jugenheim, full-time member of the Works Council Jürgen Glaser Bingen, former Regional Director of the German Mining, Chemical and Energy Industrial Union (IG BCE), Darmstadt Michael Kleinemeier Heidelberg, Managing Director of e-mobiligence GmbH, Heidelberg Renate Koehler Darmstadt, Pharmacist and until January 02, 2024, Manager of Engel-Apotheke pharmacy, Darmstadt (Independent Shareholder Representative) Barbara Lambert ⚫ KNDS NV, Amsterdam, Netherlands (not listed) Systems, processes, templates • Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck, Germany (Chair) (not listed) ⚫ Merck Electronics KGaA, Darmstadt, Germany¹ (Chair) (not listed) Galapagos N.V., Mechelen, Belgium (listed) • Zentiva Group a.s., Prague, Czech Republic (not listed) No mandates (b) ⚫ Döhler Group SE, Darmstadt, Germany (not listed) No mandates The general partners with no equity interest (Executive Board) manage the business activities in accordance with the laws, the Articles of Association, and the rules of procedure. They are appointed by E. Merck KG with the approval of a simple majority of the other general partners. The members of the Executive Board are jointly responsible for the entire management of the company. Certain tasks are assigned to individual Executive Board members based on a responsibility distribution plan. Each Executive Board member promptly informs the other members of any important actions or operations in his or her respective business area. Among other things, the Executive Board is responsible for preparing the Annual Financial Statements of Merck KGaA and of the Merck Group as well as for approving the quarterly and half-year financial statements of the Merck Group. In addition, the Executive Board ensures that all legal provisions, official regulations, and the company's internal policies are observed, and works to achieve compliance with them by all the companies of the Merck Group. A Group-wide guideline defines in detail which transactions require prior approval by the Executive Board. 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) Memberships of (a) other statutory supervisory boards and (b) comparable German and foreign supervisory bodies of corporations (a) ⚫Gelita AG, Eberbach, Germany (Chair) (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) Programs & Tools Training & Awareness Appropriate training and additional measures to educate and keep awareness high processing activities internal & external reporting 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 Programs & Tools 5 4 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. related data; perform Based on a corporate culture that places the fundamental company values responsibility, respect, integrity, and transparency Tracking of Compliance- Monitoring & Reporting 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. 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 Identifying internal and external critical risks in regular business operations Case Management Timely response to reports of misconduct and implementation of corrective actions 8 1 7 2 Givrins (Switzerland), Supervisory and Administrative Board Member (Independent Shareholder Representative) - courage, achievement, 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 for information and data deletion by data subjects Policies & Procedures Global data privacy policies, standards and procedures Risk Assessment & Documentation Identify internal & external risks; records of Incident Management - Data Privacy Program Elements Continuous Improvement 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 assurance. 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. Corporate Governance Statement on Corporate Governance 204 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 Based on and applying to all (a) adidas AG, Herzogenaurach, Germany (listed) Berlin, CEO Healthcare (a) Deutsche Börse AG, Eschborn, Germany (listed) 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 Höchst, IT Business Partner Darmstadt Site Helene von Roeder Frankfurt am Main, at that time Member of the Executive Board (CTO) of Vonovia SE, Bochum (Independent Shareholder Representative) Memberships of 5/5 (a) other statutory supervisory boards and 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) (b) comparable German and foreign supervisory bodies of corporations Apr. 26, 2019 No board positions ⚫ UBS Switzerland AG / Credit Suisse AG (Group Mandate), Zurich, Switzerland (not listed) Jul. 14, 2022 5/5 No board positions May 09, 2014 5/5 (a) • SIRONA Dental Systems GmbH, Wals, Austria (not listed) Apr. 26, 2019 5/5 (b) ⚫ Merck BKK, Darmstadt, Germany (not listed) (a) Merck Life Science KGaA, Darmstadt, Germany¹ (Chair) (not listed) (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) ⚫ SRH Holding (SdbR), Heidelberg (not listed) No board positions Synlab AG, Munich, Germany (listed) (b) . Implenia AG, Opfikon, Switzerland (listed) 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. May 28, 2020 5/5 Michelstadt, Chemical Laboratory Assistant (full- time member of the Merck Joint Works Council) Christian Raabe Apr. 26, 2019 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) ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) 1 Internal board position. 2 Members delegated according to article 6 (5) of the Articles of Association. 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). 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 Corporate Governance Statement on Corporate Governance 210 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. The members of the Board of Partners of E. Merck KG and of the Supervisory Board may be convened to a joint meeting if so agreed by the chairpersons of the two boards. The Supervisory Board has adopted rules of procedure for its activities that are available on the company's website at: https://www.merckgroup.com/company/who-we-are/management-and-company- structure/supervisory-board/EN/Rules-of-Procedure-Supervisory-Board-EN.pdf. The rules of procedure prescribe that the Supervisory Board may form committees. The Supervisory Board has formed a Nomination Committee and an Audit Committee. No board positions 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. (a) 5/5 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. (b) E. Merck KG, Darmstadt, Germany¹ (not listed) Apr. 26, 2019 5/5 Apr. 26, 2019 1/1 until ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) Apr. 17, 2023 (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) Helga Rübsamen-Schaeff Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal (a) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) (a) Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) ⚫ Merck Life Science KGaA, Darmstadt, Germany¹ (not listed) • 4SC AG, Martinsried, Germany (listed) • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) (b) ⚫ E. Merck KG, Darmstadt, Germany¹ (not listed) 5/5 ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Daniel Thelen Cologne, Program Manager Infrastructure at DB InfraGO AG, Frankfurt am Main (Independent Shareholder Representative) Simon Thelen² May 09, 2014 1 This group makes up around 7% of the total workforce; see the description under "Diversity and management". In turn, the obligation to stipulate a target for the percentage of positions held by women on the Executive Board pursuant to section 111 (5) AktG and the minimum composition requirement for the Executive Board pursuant to section 76 (3a) AktG are not applicable to the legal form of a corporation with general partners (Kommanditgesellschaft auf Aktien), as a corporation with general partners neither has a management board comparable to that of a stock corporation, nor does the Supervisory Board have personnel authority over the Executive Board. Rather, the Executive Board of Merck KGaA consists of personally liable general partners (see also the description of Supervisory Board procedures). In line with its diversity policy, however, Merck also continues to pursue representation of both genders as an objective for the Executive Board. The statutory target of 30% pursuant to section 96 (2) AktG is already applied to the Supervisory Board of Merck KGaA; this eliminates the obligation to stipulate a further target for the percentage of positions held by women on the Supervisory Board (see section 111 (5) sentence 5 AktG). 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) Corporate Governance Statement on Corporate Governance 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. December 31, 2024, in order to implement the obligations under section 76 (4) AktG as follows: 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: 215 Internationality, global mindset 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 Industry knowledge Our diversity strategy Educational background 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. Diversity policy pursuant to section 289f (2) no. 6 of the German Commercial Code (HGB) On December 21, 2021, the Executive Board of Merck KGaA therefore set the new targets to be achieved by 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. 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) Corporate Governance 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 normally meets four times a year. The members of the Executive Board of Merck KGaA are invited to all meetings of the Board of Partners, unless the Board of Partners resolves otherwise in individual cases. The members of the Board of Partners may convene a joint meeting with the Supervisory Board of Merck KGaA if so agreed by the chairpersons of the two boards. 213 Corporate Governance Statement on Corporate Governance The Board of Partners supervises the Executive Board in its management of the company. It informs itself about the business matters of Merck KGaA and may inspect and examine the company's accounts, other business documents, and assets for this purpose. According to article 13 (4) of the Articles of Association of Merck KGaA, the Executive Board requires the approval of E. Merck KG for transactions that are beyond the scope of the Group's ordinary business activities. For such transactions, approval must first be obtained from the Board of Partners of E. Merck KG. The Board of Partners convenes as and when necessary; however, it (b) ⚫Travel Asset Group Ltd., London, United Kingdom (Chair) (not listed) (a) Merck KGaA, Darmstadt, Germany (listed) Cologne, Program Manager Infrastructure at DB InfraGO AG, Frankfurt am Main Daniel Thelen 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. Merck Electronics KGaA, Darmstadt, Germany (Vice Chair) (not listed) Merck Healthcare KGaA, Darmstadt, Germany (not listed) • Finance Committee The Finance Committee has four members: Wolfgang Büchele (Chair) since May 9, 2023, and Helene von Roeder (Chair) until April 2, 2023, Johannes Baillou, Daniel Thelen, and Simon Thelen. The Finance Committee holds at least four meetings a year, some of which are joint meetings with the Audit Committee of the Supervisory Board of Merck KGaA. At least one meeting is a joint meeting with the auditor of Merck KGaA. Further meetings are convened as and when necessary. Meetings of the Finance Committee are attended by the Chief Financial Officer of Merck KGaA. Other members of the Executive Board of Merck KGaA may attend the meetings upon request of the Finance Committee. These meetings regularly include the Chair of the Executive Board. Among other things, the Finance Committee is responsible for analyzing and discussing the Annual Financial Statements, the Consolidated Financial Statements, and the respective reports of the auditor, as well as the half-year financial report and the quarterly statements. In addition, the Finance Committee addresses Merck's net assets, financial position, results of operations, and liquidity, as well as accounting issues. Upon request of the Board of Partners, the Finance Committee examines investment projects that must be approved by the Board of Partners and provides recommendations pertaining thereto. It passes its resolutions with a simple majority. The Chair of the Committee regularly informs the Board of Partners of its activities. Research and Development Committee The Research and Development Committee has four members: Helga Rübsamen-Schaeff (Chair), Johannes Baillou, Katharina Kraft, and Simon Thelen. The Research and Development Committee is convened as and when necessary but holds at least two meetings a year. Meetings of the Research and Development Committee are attended by members of the Executive Board of Merck KGaA upon request of the Committee. These meetings regularly include the Chair of the Executive Board as well as the CEO Life Science, the CEO Healthcare, and the CEO Electronics. Among other things, the Research and Development Committee is responsible for reviewing and discussing the research activities of the Life Science, Healthcare, and Electronics business sectors. It passes its resolutions with a simple majority. The Chair of the Committee reports to the Board of Partners on the insights gained from the meetings. Corporate Governance Statement on Corporate Governance 214 Stipulations to promote the percentage of management positions held by women pursuant to section 76 (4) and section 111 (5) of the German Stock Corporation Act (AktG) Merck Life Science KGaA, Darmstadt, Germany (Vice Chair) (not listed) Statement on Corporate Governance 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. Age 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. Annual Financial Statements and Consolidated Financial Statements 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. • 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. For the Consolidated Financial Statements prepared in accordance with International Financial Reporting Standards and for the Combined Management Report, the auditors issued the unqualified auditor's report that is reproduced in the Annual Report of the Merck Group. The auditors issued an unqualified audit opinion on the Annual Financial Statements of Merck KGaA in accordance with German Auditing Standards. The Annual Financial Statements of Merck KGaA, the Consolidated Financial Statements of the Merck Group, and the Combined Management Report for Merck KGaA and the Merck Group, including the accounts, were audited by Deloitte GmbH Wirtschaftsprüfungsgesellschaft, Munich. 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. Cooperation with the Executive Board 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. Report of the supervisory Board 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 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 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. 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. Seven Supervisory Board members are university graduates and hold doctorates. 218 Corporate Governance Report of the Supervisory Board 216 (a) Fortas GmbH, Rösrath, Germany (Chairman) (not listed) 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. • 4SC AG, Martinsried, Germany (listed) • • • (a) ⚫Merck KGaA, Darmstadt, Germany (listed) ⚫ Merck Electronics KGaA, Darmstadt, Germany (not listed) (b) comparable German and foreign supervisory bodies of corporations (a) ⚫Merck Life Science KGaA, Darmstadt, Germany (not listed) (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 Merck Healthcare KGaA, Darmstadt, Germany (not listed) Merck Life Science KGaA, Darmstadt, Germany (not listed) (Chair of the Board of Partners) Member The Board of Partners has nine members. The Board of Partners was composed as follows in fiscal 2023: 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. 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. 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 • AiCuris Anti-Infective Cures AG, Wuppertal, Germany (not listed) Johannes Baillou Merck Electronics KGaA, Darmstadt, Germany (not listed) 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". (a) Merck KGaA, Darmstadt, Germany (listed) Merck Healthcare KGaA, Darmstadt, Germany (Chair) (not listed) • (a) (b) ⚫ AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) ⚫ Deutsche Wohnen SE, Berlin, Germany (listed) (a) • Merck KGaA, Darmstadt, Germany (listed) • 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) ⚫ KNDS NV, Amsterdam, Netherlands (not listed) Wegmann Unternehmens-Holding GmbH & Co. KG, Fürstenfeldbruck, Germany (Chair) (not listed) . (b) AVW Versicherungsmakler GmbH, Hamburg, Germany (not listed) Merck KGaA, Darmstadt, Germany (listed) Merck Electronics KGaA, Darmstadt, Germany (Chair) (not listed) • Gelita AG, Eberbach, Germany (Chair) (not listed) • Merck Life Science KGaA, Darmstadt, Germany (not listed) Michael Kleinemeier Heidelberg, Managing Director of e- mobiligence GmbH, Heidelberg Katharina Kraft ⚫ Merck Life Science KGaA, Darmstadt, Germany (not listed) Helene von Roeder (until April 2, 2023) Frankfurt am Main, at that time Member of the Executive Board (CFO) of Vonovia SE, Bochum Helga Rübsamen-Schaeff Mannheim, Senior Strategy Manager at BASF SE, Ludwigshafen Düsseldorf, Member of the Supervisory Board of AiCuris Anti-infective Cures AG, Wuppertal Frank Stangenberg-Haverkamp Darmstadt, Chair of the Executive Board and General Partner of E. Merck KG, Darmstadt Corporate Governance Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and Qualification Matrix The Supervisory Board shall have an appropriate number of independent shareholder representatives as members. In any case, at least five of the shareholder representatives on the Supervisory Board shall be independent. According to the Articles of Association of Merck KGaA, six members representing the shareholders are to be elected by the Annual General Meeting, and two members are to be delegated. Taking this and the special ownership structure of Merck KGaA into account, the shareholder representatives consider five shareholder representatives to be an appropriate number of independent members. In the opinion of the shareholder representatives, the objectives concerning independent members are met at the present time. The shareholder representatives consider the following members to be independent: Wolfgang Büchele, Michael Kleinemeier, Renate Koehler, Barbara Lambert, Peter Emanuel Merck, Helene von Roeder (until stepping down Independence Women on the Supervisory Board 226 The Supervisory Board shall have at least three members with business experience in the main sales markets of Merck KGaA. Currently, the main sales markets of Merck KGaA are Europe, America, and Asia-Pacific. The present composition of the Supervisory Board satisfies this objective. More than three Supervisory Board members have entrepreneurial experience in a wide range of European countries. More than three Supervisory Board members have experience in management positions in companies that operate globally. Internationality In accordance with recommendation C.1 of the German Corporate Governance Code in the version dated April 28, 2022, the Supervisory Board has specified the following objectives regarding its composition, and reports below on the status of implementation. Objectives of the Supervisory Board with Respect to its composition 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. 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. No material conflicts of interest 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. Moreover, no one shall be proposed for election to the Supervisory Board who simultaneously serves on a board of or advises a major competitor of the company, or who, owing to another function, such as advisor to major contractual partners of the company, could potentially become involved in a conflict of interest. No Supervisory Board member serves on a board of or advises a major competitor. Moreover, no Supervisory Board member performs a function that could lead to a lasting conflict of interest. Age limit As a rule, the members of the Supervisory Board shall not exceed the age of 75. This objective is met at the present time. 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 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. Qualification matrix 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. Regular limit on the length of Supervisory Board membership Employees Objectives of the Supervisory Board with Respect to its Composition, Profile of Skills and Expertise, and 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. 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 230 Consolidated Financial Statements Consolidated Income Statement Scope of Consolidation 339 Other Disclosures 336 Capital Structure, Investments and Financing Assets 301 Merck KGaA, including the compensation of the Executive Board and Supervisory Board, can be found in the Statement on Corporate Governance. 290 267 Operating Assets, Liabilities, and Contingent Liabilities Operating Activities 249 242 Group Structure General Disclosures 235 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 225 Wolfgang Büchele (Chair) • Birgit Biermann • • 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 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. Business Administration 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. Experience in other supervisory or control bodies 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 • Committees Data and Digital Adminis- tration Gabriele Eismann Jürgen Glaser Michael Kleinemeier Renate Koehler Barbara Lambert (from Aug. 11, 2023) Anne Lange Peter Emanuel Merck Dietmar Oeter Alexander Putz Christian Raabe Sascha Held (Vice Chair) Helene von Roeder Helga Rübsamen-Schaeff Daniel Thelen Simon Thelen Sector Knowledge (HC and LS/EL) Accounting incl. External Supervisory Business Management Sustainability Experience Reporting1,2 or Control Auditing2 Bodies³ Sustainability (until Apr. 17, 2023) The Supervisory Board of Merck KGaA had a Nomination Committee and an Audit Committee in fiscal year 2023. Initial situation 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. -2,445 12 Research and development costs -1,306 -1,392 40 -322 -277 3,484 4,287 Income tax 15 -650 -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 -2,521 Earnings per share (in €) Impairment losses and reversals of impairment losses on financial assets (net) -51 235 Notes to the Consolidated Financial Statements 7.65 6.49 7.65 6.49 Profit before income tax Finance costs 90 197 40 Finance income 4,474 3,609 Operating result (EBIT)¹ -1,170 -830 14 Other operating expenses 486 445 13 Other operating income -6 42 Audit Committee Basic 1 Not defined by International Financial Reporting Standard (IFRS). 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 Wolfgang Büchele The Supervisory Board of Merck KGaA Darmstadt, February 2024 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. 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. Composition, Diluted profile of 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. 17 Administration expenses -4,714 -4,510 11 Marketing and selling expenses 13,705 12,392 -8,527 -8,600 10 skills and Expertise, and qualification matrix 234 Consolidated Statement of Changes in Net Equity 20,993 9 2022 2023 Note Gross profit Cost of sales Net sales € million Consolidated Income Statement General notes on the composition of the Supervisory Board 22,232 22 16 Changes in remeasurement -1 -746 -1 -746 565 3,814 20,228 2,073 -746 26,680 26,754 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 235 Notes to the consolidated Financial statements 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 75 https://www.unternehmensregister.de. Shares in Merck KGaA are traded on the regulated market of the Frankfurt Stock Exchange and on other exchanges. 5 -300 26,005 2,824 2,824 10 2,834 -28 -1,013 -1,041 5 -2 2,796 -1,013 1,783 8 1,791 -284 -284 -16 -1,043 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. 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 November 19, 2021 Standard/ 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 Interpretation May 18, 2017 June 25, 2020 December 9, 2021 November 8, 2023 See below May 23, 2023 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 Disclosure of Accounting Policies Date of publication February 12, 2021 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 May 7, 2021 August 11, 2022 No material impact 78 Liabilities as Current or Non-Current 25,927 Total equity reserves Transactions with no change of control Change in scope of consolidation/Other Dec. 31, 2023 Equity attributable Gains/losses Capital E. Merck KG including changes in Equity capital Retained earnings recognized in equity to Merck KGaA shareholders Non- controlling interests Total equity 565 reserves 3,814 Profit transfer to/from Dividend payments Jan. 1, 2022 Profit after tax Gains/losses recognized in equity Comprehensive income Dividend payments Capital increases Profit transfer to/from E. Merck KG including changes in Capital increases reserves Change in scope of consolidation/Other Dec. 31, 2022 € million Jan. 1, 2023 Profit after tax Gains/losses recognized in equity Comprehensive income Transactions with no change of control 15,134 1,824 21,338 565 3,814 18,463 3,086 25,927 78 26,005 Equity attributable -868 Equity capital 565 3,814 Retained earnings 18,463 Gains/losses recognized in to Merck KGaA equity shareholders Non- controlling interests Capital reserves -868 -868 -251 78 21,416 3,326 3,326 14 3,339 1,109 1,261 2,370 -2 2,368 4,435 1,261 5,696 12 5,708 -239 -239 -11 3,086 January 23, 2020 July 15, 2020 December 19, 2023 January 1, 2024 No material impact 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. -15 -17 39 91 -2 -5 -5 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 Comprehensive income Changes recognized in equity Reclassification to profit or loss Changes taken directly to equity Currency translation difference Changes recognized in equity Tax effect Reclassification to assets Reclassification to profit or loss Other comprehensive income Fair value adjustments The most significant transition-related climate risks to the net assets, financial position, and results of operations are in the Electronics business sector, which is responsible for well in excess of half of the Group's direct (Scope 1) and indirect (Scope 2) greenhouse gas emissions. The majority of these greenhouse gas emissions take the form of process-related emissions resulting from the production of specialty gases for the semiconductor and electronics industries. In order to achieve the climate goals it has adopted, the Group intends to reduce the emissions in its business with these specialty gases by making technological improvements to the production process in particular. The recoverability of the assets recognized in connection with these products depends on the successful implementation of the technological improvements in production, as they could largely prevent the risk of long-term price rises due to the increased pricing of greenhouse gas emissions. Furthermore, based on the information currently available, the implementation of Merck's sustainability strategy is not expected to result in a significant decline in net sales in this business. There have been no indications of impairment of the assets concerned to date, nor has it been necessary to adjust their remaining useful lives. There is significant estimation uncertainty due to the long-term nature of the underlying analyses and the high degree of uncertainty concerning future development. Transition-related climate risks 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. Increased uncertainty due to climate risks 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 Transition-related climate risks describe the consequences for companies as a result of the transition to a more sustainable economic system. 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, energy efficiency measures, • reduced emissions in the supply chain (e.g. switching to sea transportation), and • recognition of a shadow price for the CO2 emissions of major projects. • Cost of cash flow hedge reserve Changes recognized in equity Tax effect 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 Profit after tax Changes recognized in equity Changes recognized in equity Equity instruments -236 1,440 48 -187 -300 1,140 34 Tax effect € million Consolidated Statement of Comprehensive Income Consolidated Financial Statements Consolidated Statement of Comprehensive Income 1,109 -28 -31 160 3 2 -34 158 Reclassification to assets 194 -95 Reclassification to profit or loss -98 98 Fair value adjustments 39 Cash flow hedge reserve Items of other comprehensive income that may be reclassified to profit or loss in subsequent periods 231 Impact of trade restrictions, sanctions, and supply chain bottlenecks The war in Ukraine has not had any material effects on the Merck Group's net assets, financial position, or results of operations owing to its limited business volume in Russia, Ukraine, Belarus, and the Republic of Moldova. In fiscal 2023 and 2022 alike, the total share of Group net sales generated in the aforementioned countries amounted to less than 1.5%. Furthermore, the conflict in the Middle East did not have a material impact on the Merck Group's net assets, financial position, and results of operations in the reporting period. In fiscal 2023 and 2022 alike, the share of Group net sales generated with customers in Israel was less than 1%. Direct impact of armed conflicts The higher interest rates also resulted in a rise in the discount rates applied in performing impairment testing and determining the fair values of financial and non-financial assets compared with the previous year (see Note (18) "Goodwill” and Note (43) “Information on fair value measurement” in particular). 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 Notes to the Consolidated Financial Statements General Disclosures 237 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%. 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. 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. Change in the recognition of liabilities and provisions For the same reason, liabilities in connection with wages and salaries have been reported in other non-financial liabilities rather than other financial liabilities since January 1, 2023. With regard to the comparative period (December 31, 2022), this resulted in the reclassification of € 127 million to other non-financial liabilities (of which € 121 million to other current non-financial liabilities). 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. 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. Allocation of taxing rights (Pillar I) Based on the information currently available, Merck expects the efforts to achieve international convergence on tax rules as part of the OECD's Inclusive Framework to have an impact on the Group's taxation. Although the tax rules apply to the ultimate parent company of the Group, E. Merck Kommanditgesellschaft, top-up taxes could be payable in a number of jurisdictions, and this could have an impact on the Merck Group. Impact of efforts to achieve international convergence on taxation Deferral of Effective Date Amendments to IAS 1 Non-current Liabilities 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 Expected to be effective for the first time for financial years beginning on or after Expected impact on the consolidated financial statements 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 Translation of financial statements into the reporting currency (Euro) Fair value adjustments 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. 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 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. Dec. 31, 2022 7.420 140.716 Increased uncertainty due to the macroeconomic situation Impact of inflation 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 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. Dec. 31, 2023 7.854 156.462 7.088 137.989 7.667 151.913 0.972 1,412.674 33.695 1.082 Consolidated Financial Statements Notes to the Consolidated Financial Statements General Disclosures 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 The exchange rates of the most significant currencies in these consolidated financial statements were as follows: € 1 = Chinese renminbi (CNY) Japanese yen (JPY) Swiss franc (CHF) South Korean won (KRW) Taiwan dollar (TWD) U.S. dollar (USD) Average rate Closing rate 2023 2022 Hyperinflation € million Tax effect Operating Cash Flow Payments for investments in property, plant and equipment Payments from the disposal of intangible assets Payments for investments in intangible assets 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 Payments from the disposal of property, plant and equipment 233 Payments for investments in financial assets Proceeds from the disposal of other financial assets Note 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 Dividend payments to non-controlling interests Proceeds from the disposal of non-financial assets Payments for the acquisition of non-financial assets Payments for acquisitions less acquired cash and cash equivalents (net) 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 38 Other current financial liabilities² 1,228 702 37 Current financial debt 372 575 27 Current provisions 81 83 33 Current provisions for employee benefits² Current liabilities¹ 1,005 1,153 Trade and other current payables¹ 30 9,514 8,699 48,495 Total equity and liabilities¹ 1,786 1,479 29 Other current non-financial liabilities² 2023 1,483 15 Current income tax liabilities 877 9 Refund liabilities 2,499 2,545 1,433 2022 2,834 3,339 -1,364 1,281 519 -1,613 -420 1,637 697 -716 -868 -11 -12 -239 -284 -2,743 -1,892 -1,893 41 -1,732 -1,555 For details see Note (34) "Equity". Equity Consolidated Statement of Changes in Net 234 Consolidated Financial Statements Consolidated Statement of Changes in Net Equity 2 The lines "Repayments of bonds" and "Repayments of other current and non-current financial debt" as well as "Proceeds from the issuance of bonds" and "Payments from new borrowings of other current and non-current financial debt", which were presented separately in the previous year, have been summarized to improve clarity. 1 Prior-year figures have been adjusted, see note (2) "Reporting principles". 23 1,854 35 1,899 1,854 -7 -31 -39 160 1,982 13,015 4 2,511 -72 -48 -150 -445 -755 279 188 101 -43 -413 -8 -604 -89 2,030 1,880 21 16 3,784 4,259 -1,075 -2,494 219 510 -854 -12 -364 1,077 -537 19 -1,531 -1,807 38 136 -275 -216 21 13,042 912 1,130 957 981 1,287 Other non-current financial assets 27 28 25 Non-current receivables 3 3 Investments accounted for using the equity method 8,204 9,056 20 Property, plant and equipment¹ Other non-current non-financial assets 22 115 99 Trade and other current receivables 4,632 4,637 24 Inventories Current assets 36,334 7,335 36,102 1,514 15 Deferred tax assets 10 9 15 Non-current income tax receivables 1,310 25 6,551 Other intangible assets¹ 5,708 1,791 2,368 -1,043 1,259 -1,015 1,157 -1,018 -71 -15 1,228 -1,003 11 5 10 thereof: attributable to Merck KGaA shareholders 1,783 5,696 thereof: attributable to non-controlling interests 18,389 17,845 18 Dec. 31, 2022 Dec. 31, 2023 Note Goodwill¹ 19 Non-current assets¹ Consolidated Balance Sheet 232 Consolidated Cash Flow Statement Consolidated Financial Statements. 12 8 34 € million 4,004 36 Contract assets 27 Other non-current provisions 2,030 2,192 33 Non-current provisions for employee benefits Non-current liabilities¹ 26,005 26,754 78 75 Non-controlling interests 3,086 25,927 2,073 26,680 Equity attributable to Merck KGaA shareholders 277 299 Non-current financial debt 37 15 Deferred tax liabilities¹ 38 39 15 Non-current income tax liabilities 19 Gains/losses recognized in equity 17 Other non-current non-financial liabilities² 141 147 4,114 Other non-current financial liabilities² 9,200 9,239 29 18,463 38 Retained earnings Cash and cash equivalents 446 473 15 Current income tax receivables 705 633 35 22 499 36 Other current financial assets 128 104 26 20,228 Other current non-financial assets 1,982 321 Assets held for sale 565 3,814 1,854 3,814 Capital reserves 565 34 Total equity Total assets¹ Equity capital 48,495 12,201 6 12,393 48,535 62 344 Investments in intangible plant and equipment Recognition and measurement of lease arrangements Inventories 1,435 397 Investments in property, 694 107 97 136 provisions (according to 256 20 275 assets6 Non-cash changes in 72 174 28 -22,521 3 274 13 48,535 (segment result)² -5,949 277 345 EBITDA pre 3,760 2,477 1,192 7,428 -579 6,849 EBITDA pre margin 36.2% 5,341 -16,571 31.6% 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 29.7% consolidated cash flow IFRS 16 1 Excluding intersegment sales. yes 6,551 Identification and measurement of intangible assets within the scope of business combinations Other intangible assets high IAS 36 18 yes 17,845 Determination of recoverable amount Goodwill 6, 19 Note Sensitivity Discretionary scope/ estimation uncertainty IFRS Carrying amount as of Dec. 31, 2023 in € million Accounting matter The accounting matters with the most significant discretionary decisions as well as the most comprehensive assumptions relating to the future and sources of estimation uncertainty are described below: Overview of significant discretionary decisions and sources of estimation uncertainty 241 Notes to the Consolidated Financial Statements General Disclosures Consolidated Financial Statements 6,504 analysis statement)? IFRS 3 In-licensing of intangible assets 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". 6 According to the consolidated cash flow statement. 7 Excluding provisions for pensions and other post-employment benefits. 500 Leases medium medium IAS 16 IAS 36 Identification of impairments or reversal of impairments high Determination of depreciation no 9,056 Property, plant, and equipment high IAS 36 Identification of impairments or reversal of impairments medium IAS 38 Determination of amortization medium IAS 38 20 -696 117 1,531 1,138 55 34 7,335 8,203 1 8,204 2,406 2,406 36,325 9 36,334 12,201 12,201 7,302 48,526 26,005 12,201 12,201 48,535 26,005 26,005 Non-current liabilities Other non-current provisions and liabilities 11,729 11,729 Deferred tax liabilities 1,279 26,005 18,389 -26 18,415 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. 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. Acquisition of Erbi Biosystems Inc., United States 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. 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. 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. Adjustments to the prior-year consolidated balance sheet to reflect the purchase price allocations completed in fiscal 2023 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 245 was shortly before the reporting date. The completion of the purchase price allocations for both companies in 2023 resulted in the following adjustments: € million Non-current assets Goodwill Intangible assets (excluding goodwill) Property, plant and equipment Other non-current assets Current assets Current assets Total assets Equity Equity Dec. 31, 2022 as reported Adjustments for Erbi and M Chemicals Dec. 31, 2022 adjusted 8 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. 1,287 8 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 Collaboration and licensing agreements As part of the accounting treatment of collaboration and licensing agreements, significant discretionary decisions have to be made in the following areas: Identification of an appropriate income recognition method and • Determination of the appropriate timing of income recognition. Estimates are to be made, especially when it comes to determining the transaction price and progress on the performance obligation. Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 247 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 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. 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. 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. 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. In-licensing agreement with Debiopharm International SA, Switzerland, on drug candidates for the treatment of head and neck cancer 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. 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 248 In-licensing agreement with Jiangsu Hengrui Pharmaceuticals Co. Ltd., China, on drug candidates for the treatment of metastatic colorectal cancer 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. 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. In-licensing agreement with Abbisko Therapeutics Co. Ltd., China, on drug candidates for the treatment of tenosynovial giant cell tumor 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). Collaboration agreements The accounting and measurement policies for the in-licensing of intellectual property are presented in Note (19) "Other intangible assets". In-licensing agreements 13,015 Current liabilities Trade payables and other liabilities 2,498 1 2,499 Other current liabilities Total equity and liabilities 7,016 7,016 9,513 1 9,514 48,526 9 48,535 21 Divestments Sale of shares in Calypso Biotech B.V., Netherlands 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 246 (7) Collaboration and licensing agreements Accounting and measurement policies Out-licensing agreements Merck primarily enters into material out-licensing agreements for intellectual property in the Healthcare business sector. The granting of a license typically constitutes a distinct performance obligation that must usually be recognized at a point in time. Due to the uncertainty of development results and regulatory events, contingent consideration is typically recognized when the event in question has occurred. Sales-based and usage-based royalties are recognized when the contract partner makes the corresponding sales or uses the intellectual property. As out-licensing transactions in the Healthcare business sector do not form part of ordinary activities and the licensees do not constitute customers within the meaning of IFRS 15, the corresponding income from upfront payments, milestone payments, and royalties is reported in other operating income (see Note (13) "Other operating income"). 13,007 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. 27, 28 Recognition and measurement of other provisions and IAS 37 contingent liabilities high Revenue recognition yes 9 Measurement of sales deductions and refund liabilities 877 IFRS 15 high no Income tax 15 Recognition and measurement of income tax liabilities 1,473 IAS 12 high Recognition and measurement of deferred taxes from temporary differences IAS 12 medium Recognition of deferred tax assets from tax loss carryforwards 67 IAS 12 high no medium IAS 19 4,787 852 medium 4,637 no 24 Identification of impairments or reversal of impairments Trade and other receivables IAS 2 medium 4,031 no 25, 42 Determination of loss allowance IFRS 9 medium Other financial assets yes 36, 43 Determination of fair values of contingent consideration 125 Determination of fair values of equity instruments 643 IFRS 13 IFRS 9, IFRS 13 high medium Provisions for employee benefits yes 33 Determination of present value of defined-benefit obligations Other provisions and contingent liabilities (4) Subsequent events 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. 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 243 (6) Acquisitions and divestments Accounting and measurement policies Business combinations 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: Customer relationships Technology Trademark Measurement method for determining fair value Multi-period excess earnings method Relief from royalty method Relief from royalty method Results from foreign currency hedging of expected business combinations, if they meet the requirements for hedge accounting, are offset against the carrying value of the net assets acquired. 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. Significant discretionary decisions and sources of estimation uncertainty Business combinations In particular, estimation uncertainty and discretionary decisions in conjunction with purchase price allocation relate to: planning of future cash flows; the customer churn rate, which indicates how existing customer relationships will change in the future; the license rate for technologies, which estimates royalty savings on the basis of comparable transactions of similar technologies; the discount factor, which is applied for maturity- and risk-based discounting of expected cash inflows; and the useful life and the degree of technical obsolescence which depend, among other things, on assumptions about technological developments. Divestments 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Group Structure 244 Acquisitions in the previous year Acquisition of Exelead Inc., United States 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"). 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). 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. 34 Group Structure 242 Group Structure (5) Scope of Consolidation Accounting and measurement policies Scope of Consolidation 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”). The scope of consolidation changed as follows in the reporting period: Fully consolidated companies as of Dec. 31, 2022¹ Additions Retirements 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 Non-consolidated subsidiaries as of Dec. 31, 2023 Companies established Acquisitions Materiality Liquidations/mergers Divestments Immateriality Loss of control 1 Previous year has been adjusted for better comparability with note (48) "List of shareholdings". 313 2 -9 306 2 2 31 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. 7,200 228 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. Operating Activities 181 35 216 assets5 Non-cash changes in provisions(according to 33 94 100 227 154 381 consolidated cash flow statement)6 1 Excluding intersegment sales. 2 Not defined by International Financial Reporting Standard (IFRS). 3 Without impairments on financial assets and inventories. Consolidated Financial Statements Notes to the Consolidated Financial Statements 58 69 54 6,222 48,495 Liabilities by business sector -1,843 -3,146 -636 -5,626 -16,115 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. -21,741 953 316 394 1,663 145 1,807 plant and equipment5 Investments in intangible Investments in property, 5 According to the consolidated cash flow statement. 6 Excluding provisions for pensions and other post-employment benefits. Information by business sector 2022 4,474 303 545 1,693 105 187 20 232 -801 1,798 232 Impairment losses³ Reversals of impairment losses EBITDA4 3,678 Adjustments² 82 2,385 92 Depreciation 42,273 5,275 1,895 € million Net sales¹ Intersegment sales Operating result (EBIT)² Total of reportable operating Life Science 10,380 61 2,808 845 24 572 Healthcare 7,839 segments Corporate and Other Group 4,013 22,232 22,232 61 -61 Electronics 10,275 Group 20,993 23,476 3,609 -77 -713 4,322 248 2,225 1,850 Impairment losses³ Depreciation Operating result (EBIT)² 77 77 yes 20,993 3,659 8,053 9,281 Intersegment sales 848 34 299 526 1,673 6,092 816 2,545 2,731 EBITDA4 losses 8,522 -6 Net sales¹ -6 Reversals of impairment 104 1 103 42 27 1,782 109 -6 segments Corporate and Other Healthcare 184 -603 206 5,489 390 EBITDA pre 2,820 (segment result)² 2,543 913 97 6,276 5,879 EBITDA pre margin 30.4% 31.6% 25.0% 28.0% (in % of net sales)² Assets by business sector -397 Electronics -1 249 Life Science € million operating Total of reportable 250 Operating Activities Adjustments² 88 - Information by business sector – 2023 The segment information is derived from the financial figures, which are based on the IFRSS applied in the Consolidated Financial Statements. Transfer prices for intragroup net sales were determined on an arm's-length basis for all of the business sectors. Fixed assets are allocated to the segments on the basis of the degree of utilization. Depreciation expenses are allocated on the same basis. Fixed assets are always recognized by the buyer at the amortized Group cost following intragroup transactions. Services performed by the Group functions are allocated on the basis of planning data. Any deviations in the actual costs incurred are not allocated to the reportable operating segments but continue to be recognized in the Corporate and Other column. Apart from net sales, the success of a segment is mainly determined by EBITDA pre (segment result). EBITDA pre is a key figure that is not defined by International Financial Reporting Standards (IFRS). However, it represents the most important variable used to steer the Merck Group. To permit a better understanding of operational performance, EBITDA pre excludes depreciation and amortization, impairment losses, and reversals of impairment losses in addition to specific adjustments presented below. In addition to the direct activities of the central Group functions, Corporate and Other includes income and expenses, assets, and liabilities, as well as cash flows that cannot be allocated to the reportable segments as they are managed at Group level in central Group functions. This relates in particular to expenses and income for the foreign currency hedging of transactions in operating business, financial expenses, and financial income, which include interest expenses and interest income, and income tax expenses and income. Financial liabilities, pension provisions and income tax assets and liabilities are also allocated to Corporate and Other. Moreover, the column serves as the reconciliation to the Group figures. 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities Consolidated Financial Statements Notes to the Consolidated Financial Statements Information by country and region 2023 251 Middle East and Africa Europe Goodwill and other intangible assets² 5,121 1,783 1,780 18,794 18,783 480 47 2 24,396 Property, plant and equipment 4,878 20,993 2,215 2,576 2,571 444 225 62 9,056 Research and development costs -2,004 -1,042 -827 -349 Number of employees 28,304 1,097 € million 535 2,477 thereof: thereof: Germany Switzerland North America thereof: Asia- thereof: Latin USA Pacific China America Group Net sales by customer location¹ 6,037 1,000 1,267 369 5,632 6,936 2,708 1,331 737 20,993 Net sales by company location¹ 6,334 1,420 512 6,198 5,911 6,658 5,952 1,315 941 10% 417 881 4% Services 804 8% 16 110 3% 930 4% License income 16 4 20 Commission income 1 Income from co- I commercialization agreements Total 10,380 100% 17 1 1 7,839 4% Equipment Total 9,281 100% 8,053 100% 3,659 100% 20,993 100% 2022 € million Net sales by nature of the products Life Science Healthcare Electronics Group Goods 9,097 88% 7,804 100% 3,481 87% 20,382 92% 463 100% 4,013 100% 25% 2,261 29% 2,901 72% 7,697 35% 353 3% 838 10% 40 1% 1,231 5% 116 10,380 1% 527 7% 53 2% 695 3% 100% 7,839 2,536 29% 6,361 16% 18 1 1 22,232 100% Net sales by region (customer location) Europe North America Asia-Pacific Latin America Middle East and Africa 4% Total 33% 2,433 31% 371 9% 6,248 28% 3,931 38% 1,781 23% 649 3,445 100% 737 75 8,074 87% 8,004 99% 2,952 81% 19,030 91% Equipment 411 5% 593 16% 1,004 5% Services 778 8% 33 1% 111 3% 922 4% License income Goods Commission income Group Healthcare Surface Solutions Total 2023 2022 2,479 68% 2,674 67% 770 21% 900 22% 411 11% 439 11% 3,659 100% 4,013 100% 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. 2023 € million Net sales by nature of the products Life Science Electronics Income from co- commercialization agreements Total 21% 5,952 28% Asia-Pacific 2,263 25% 2,232 28% 2,440 67% 6,936 33% Latin America 352 4% 12% 39 1% 1,331 6% Middle East and Africa 116 1% 546 7% 787 22% 1,793 36% 17 3 1 15 17 9,281 100% 8,053 100% 3,659 100% 20,993 2% 100% (customer location) Europe 3,178 34% 2,541 31% 318 9% 6,037 29% North America 3,372 Net sales by region Display Solutions 4,013 22,232 Marketing and selling expenses 1 Excluding amortization of internally generated or separately acquired software. 2023 2022 -950 -971 -923 -972 -515 -476 -1,061 -1,193 -596 -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 Other marketing and selling expenses 259 Royalty and license expenses Logistics 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 Accounting and measurement policies Cost of sales 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 Sales promotion Amortization of intangible assets¹ (12) Research and development costs Accounting and measurement policies 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 7 Reversal of impairment losses on non-financial asset 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". Currency effects from operating activities 105 53 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 816 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 100% Dec. 31, 2023 2 2,526 Disposals due to divestments/Reclassification to assets held for sale Utilizations -2,270 -1,739 -43 -29 -2,313 Cumulative increase (-)/decrease (+) in net sales -159 -147 -9 -6 -168 thereof: attributable to performance obligations satisfied in prior periods Currency translation Other Dec. 31, 2022 -118 -115 0 -118 29 31 40 2 56 2,470 100% 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 257 services in the Life Science business sector and net sales from the project business of the Semiconductor Solutions business unit in the Electronics business sector. 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). The following table shows the change in refund liabilities: 2022 € million Rebates/Bonus payments Rights of return Total thereof: United States 784 445 Total 55 thereof: United States Total 35 839 Jan. 1, 2022 Additions due to business combinations Other additions 1,902 2 31 -3 -2,485 -1,855 -60 -37 -2,545 Cumulative increase (-)/decrease (+) in net sales -121 -120 8 10 -113 thereof: attributable to performance -118 -116 9 10 -109 obligations satisfied in prior periods Currency translation -26 -18 -2 -2 -28 Other Utilizations Disposals due to divestments/Reclassification to assets held for sale 2,648 31 -3 850 492 62 43 912 2023 € million Jan. 1, 2023 Rebates/Bonus payments Rights of return Total 2 thereof: United States thereof: United States Total 850 492 62 43 912 Additions due to business combinations Other additions 2,596 1,945 52 Total Semiconductor Solutions 19 Operating Activities 2022 -249 -198 -118 -88 51 38 Acquisition-related adjustments -18 -29 2023 Other adjustments -68 Adjustments before impairment losses/reversals of impairment losses¹ -390 -345 Impairment losses² -88 -232 Reversals of impairment losses 1 Adjustments (total)¹ -56 -477 Gains (+)/losses (-) on the divestment of businesses Restructuring expenses 2022 6,276 7,428 -397 -579 5,879 6,849 -1,880 -2,030 -390 Integration expenses/IT expenses -345 4,474 -125 -187 3,484 256 Financial result Profit before income tax 1 Not defined by International Financial Reporting Standard (IFRS). Please refer to the following table for the components of the adjustments. The adjustments comprised the following: € million 3,609 -577 1 Not defined by International Financial Reporting Standard (IFRS). 2 Without impairments on financial assets and inventories. -110 -1 -6 -118 € million Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses Acquisition-related adjustments Other adjustments -1 Adjustments before impairment Impairment losses² Reversals of impairment losses Adjustments in the operating result (total)¹ 1 Not defined by International Financial Reporting Standards (IFRS). 2 Without impairments on financial assets and inventories. 2022 € million Restructuring expenses Integration expenses/IT expenses Gains (+)/losses (-) on the divestment of businesses losses/reversals of impairment losses¹ -249 -21 -6 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"). As in the previous year, integration and IT expenses in fiscal 2023 related to expenses for the enhancement of ERP systems. 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”). 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”). Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 253 The adjustments are reported in the consolidated income statement as part of the respective functional costs and allocated to them as follows: 2023 thereof: thereof: marketing and thereof: thereof: cost of sales selling administration expenses expenses thereof: research and development other operating income and expenses expenses Total -42 -44 -135 2023 Acquisition-related adjustments Operating result (EBIT)¹ Depreciation/amortization/impairment losses/reversals of impairment losses Net sales by customer location¹ 6,248 1,108 469 6,361 6,025 7,697 3,157 1,231 695 Group 22,232 location¹ 6,648 1,532 592 6,596 6,302 7,297 2,818 1,175 516 Net sales by company 22,232 Middle East and Africa thereof: China 13,531 2,648 14,718 -348 14,496 -63 -25 -18 -11 -2,445 15,259 Latin America 4,433 1,169 62,908 1 Excluding intersegment sales. 2 Goodwill and other intangible assets are allocated by currency area. Information by country and region – 2022 € million Europe thereof: thereof: Germany Switzerland North thereof: America USA Asia- Pacific 3,458 Goodwill and other intangible assets 2, 3 4,930 -372 15,847 15,634 -371 -69 -26 -17 -12 15,412 4,904 3,487 1,243 -835 2,574 -2,521 64,232 2 Goodwill and other intangible assets are allocated by currency area. 3 Previous-year figures have been adjusted, see note (6) "Acquisitions and divestments". No single customer accounted for more than 10% of the Group's total net sales in fiscal 2023 or 2022. Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 252 The following table presents the reconciliation of segment results of all operating businesses to the profit before income tax of the Merck Group: € million EBITDA pre of the operating businesses¹ Corporate and Other EBITDA pre of the Merck Group¹ 1 Excluding intersegment sales. 13,620 28,243 Number of employees 1,568 1,768 20,163 20,152 629 57 2 25,724 Property, plant and equipment³ 4,302 1,911 1,059 2,368 2,363 1,266 423 211 57 8,204 Research and development costs -2,051 -1,081 Adjustments¹ Other adjustments 4,287 51 22% thereof: ErbituxⓇ thereof: BavencioⓇ Neurology & Immunology thereof: MavencladⓇ 1,025 13% 1,023 13% 713 1,683 9% 8% 1,665 21% 1,743 22% 956 12% 856 11% thereof: RebifⓇ 611 709 22% 2022 4,898 47% Process Solutions 3,782 41% 4,540 44% Life Science Services 792 8% 1,819 943 Total 9,281 100% 10,380 100% 1 Prior-year figures have been adjusted owing to realignment in the Life Science business sector. Healthcare € million Oncology 2023 9% 9% 887 11% 7% 553 7% thereof: SaizenⓇ Other Adjustments before impairment 332 4% 266 3% 565 235 161 2% 8,053 100% 7,839 100% Electronics € million Consolidated Financial Statements Notes to the Consolidated Financial Statements 3% thereof: Euthyrox® 8% 590 Fertility 1,547 19% 1,446 18% thereof: Gonal-fⓇ 847 11% 825 11% Cardiovascular, Metabolism & Endocrinology 2,786 35% 2,805 36% thereof: GlucophageⓇ 882 11% 930 12% thereof: ConcorⓇ 571 7% 51% 4,706 Total -50 income and expenses expenses Total -27 -38 -74 -28 -198 2 operating -77 -12 -88 38 38 -22 -29 -68 -68 losses/reversals of impairment losses¹ -32 -1 -32 thereof: other thereof: administration expenses 2022 51 -18 -18 -56 -56 -43 -44 -246 -390 thereof: research and development -88 1 1 -43 -44 -246 -7 -138 -477 thereof: cost of sales thereof: marketing and selling expenses -88 -115 -32 -91 Determining the transaction price 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. 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. 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. 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). Contractual payment terms 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 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 255 fulfilled. The payment targets contractually agreed between Merck Group and its customers usually range between 30 and 60 days. Practical expedients Merck uses the practical expedient of IFRS 15 in which the promised amount of consideration is not adjusted for the effects of a significant financing component if the period between the fulfillment of a performance obligation and the payment by the customer only amounts to up to one year. Significant discretionary decisions and sources of estimation uncertainty Sales deductions The measurement of sales deductions and the corresponding refund liabilities requires extensive estimates. Uncertainties exist 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. Due to a lack of past experience, the estimation uncertainty referenced above is particularly relevant for product launches in the Healthcare business sector. -75 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. The following tables present a breakdown of net sales by key product lines/products: Life Science¹ € million Science & Lab Solutions 2023 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"). Any changes in estimates of the parameters listed above have a cumulative impact on the net sales for the respective adjustment period. 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. 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. Impairment losses² -232 -345 Reversals of impairment losses Adjustments in the operating result (total)¹ -32 -32 -115 -75 -232 -577 1 Not defined by International Financial Reporting Standards (IFRS). 2 Without impairments on financial assets. (9) Net sales -323 Consolidated Financial Statements Notes to the Consolidated Financial Statements Nature and timing of revenue recognition Operating Activities 254 Accounting and measurement policies scope of consolidation/ Changes in debited to income statement) (net) -1,261 Intangible assets equity Currency translation/ Expenses for miscellaneous services Deferred tax assets/liabilities (net) Assets Liabilities 235 -4 -11 € million Remaining other operating expenses Currency effects from operating activities -154 Other changes Deferred taxes credited/ 91 Deferred tax assets/liabilities -120 -305 91 369 -132 23 1,829 1,807 Offset deferred tax assets and liabilities -520 -520 Deferred taxes (consolidated 23 1,310 1,287 balance sheet) 1 Previous-year figures have been adjusted, please refer to Note (6) "Acquisitions and Divestments". Jan. 1, 2023 Dec. 31, 2023 Deferred taxes (consolidated -114 Consolidated Financial Statements -830 Deferred tax liabilities for planned dividend payments within the next twelve months of profits already generated are recognized. Significant discretionary decisions and sources of estimation uncertainty Income taxes 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 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. 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities existing tax planning of the respective Group company. 263 € million Current income taxes in the period Income taxes for previous periods Deferred taxes in the period thereof: from temporary differences thereof: from changes in tax rates thereof: from tax loss carryforwards Income taxes 2023 2022 offsetting) -1,140 -1,344 Income taxes in the consolidated income statement were broken down as follows: • results planning, and results history, -1,170 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"). 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). Currency effects from operating activities in the previous year primarily resulted from cash flow hedges in U.S. dollars. Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 262 (15) Income tax Accounting and measurement policies Current income taxes Current income taxes for the reporting period and, where applicable, for prior periods, are calculated in the amounts that the tax authorities are expected to demand or reimburse. The calculation is based on the company-specific tax rate applicable in the relevant tax year. Uncertain income tax assets and liabilities 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. Deferred taxes Deferred tax assets resulting from deductible temporary differences that exceed deferred tax liabilities relating to the same taxation authority and the same taxable entity are recognized if it is considered 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. The recognition of deferred tax assets requires an estimate of the probability of future use. The influencing factors considered as part of this assessment include the following: • temporary differences relating to the same taxation authority and the same taxable entity that will be subject to taxation in the future, Other operating expenses Deferred taxes (before -26 41 -275 -104 -232 -102 -68 -56 -67 -47 -171 -45 -67 -39 -45 -26 -16 -30 Expenses from Litigation Expenses from a donation to the World Health Organization -46 -23 2022 Infrastructure expenses 167 -3 Notes to the Consolidated Financial Statements Operating Activities 261 (14) Other operating expenses Accounting and measurement policies Other operating expenses 2023 Other operating expenses comprise all expenses that cannot be reasonably allocated to a functional cost type or finance costs. € million Profit share agreements Impairment losses on non-financial assets Non-income related taxes and expenses from tax audits Loss from hyperinflation accounting Premiums, fees and contributions Project expenses (including integration and IT projects) Non-allocable personnel expenses The breakdown of other operating expenses was as follows: -7 Expenses from claims -23 93 13 -2 122 170 49 liabilities Tax loss carryforwards 17 11 30 30 Tax refund claims/Other -57 -2 1 3 -55 19 Current and non-current provisions 51 -9 -20 -12 Restructuring expenses Expenses from fair value measurement of assets and liabilities at fair value -19 -8 Expenses from disposal of businesses and assets 51 66 15 receivables/Other assets Current and non-current 803 -37 -296 6 475 526 96 28 Current and non-current 369 23 Offset deferred tax assets and -627 -627 liabilities Deferred taxes (consolidated 385 1,514 offsetting) 1,130 -9 -48 -650 -948 18.7% 22.1% 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements balance sheet) Operating Activities 1,757 385 liabilities Tax loss carryforwards 30 40 -2 67 67 Tax refund claims/Other 2,142 -55 3 -57 117 174 Deferred taxes (before 323 42 -3 -5 264 Deferred taxes 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: -3 -129 39 1,374 168 Current and non-current -6 -4 -22 -59 -32 financial assets Inventories 737 84 2 823 846 23 32 -68 Property, plant and equipment 112 Jan 1, 2022 Dec. 31, 2022 Deferred tax assets/liabilities € million Intangible assets (net) Deferred taxes (consolidated income statement) Changes in scope of consolidation/ Deferred taxes credited/debited to equity Currency translation/ Deferred tax assets/liabilities Other changes¹ -1,428 302 -135 (net) -1,261 Assets Liabilities¹ 62 181 119 -6 4,287 31.7% 31.7% -1,105 -1,360 495 568 -7 3,484 -71 28 -103 -79 32 14 -129 47 -979 167 2022 2023 Tax ratio according to consolidated income statement 290 338 -7 12 40 19 -650 -948 Tax reconciliation The following table presents the reconciliation from the theoretical income tax expense to the income tax expense according to the consolidated income statement. The theoretical income tax expense is determined by applying the statutory tax rate of a corporation headquartered in Darmstadt of 31.7% (2022: 31.7%). € million Profit before income tax Tax rate Theoretical income tax expense Tax rate differences Tax effect of companies with a negative contribution to consolidated profit Income tax for previous periods Tax credits Tax effect on tax loss carryforwards Tax effect of non-deductible expenses/Tax-free income/Other tax effects Income tax expense according to consolidated income statement 111 323 1,090 -129 -1 59 92 33 receivables/Other assets Current and non-current 475 -10 9 50 510 633 122 provisions Current and non-current 122 -6 9 -6 51 Current and non-current 15 5 5 -119 103 222 Current and non-current -32 13 -17 -36 2 38 financial assets Inventories 823 42 -44 821 835 Property, plant and equipment -5 -27 156 Accounting and measurement policies (17) Earnings per share The change in other non-cash income and expenses contained the neutralization of revaluations of contingent consideration recognized in income (see Note (36) "Other financial assets"). The corresponding cash inflows are also recognized in the cash flow from investing activities. The item "Neutralization of gains/losses on disposal of fixed assets" included the effects recognized in income of the disposal of a non-strategic brand in the Healthcare business sector and a portfolio of licenses and patents in the Electronics business sector. The corresponding cash inflows are recognized in the cash flow from investing activities. The changes in provisions included a mid-double-digit million-euro amount for the recognition of restructuring provisions to align the Group functions more closely with the businesses, and a high double-digit million-euro amount for the recognition of provisions for acceptance and follow-on obligations in connection with the results of the two Phase III clinical trials to evaluate the efficacy and safety of evobrutinib (see Note (27) "Other provisions"). Interest paid totaled € 181 million (2022: € 185 million). Interest received amounted to € 77 million (2022: € 25 million). Tax payments made totaled € 1,053 million in fiscal 2023 (2022: € 1,344 million). Tax refunds received amounted to € 38 million (2022: € 145 million). Tax payments are reported in operating cash flow. Only significant transactions where the associated tax payments can be practically calculated are recognized in the relevant item of the consolidated cash flow statement. The option to recognize interest received and interest payments made is exercised to the extent that such transactions are recognized in cash flow from operating activities. • The operating cash flow is presented using the indirect method based on profit after taxes. • The operating cash flow is calculated and presented based on the following principles: Accounting and measurement policies (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. 184 Earnings per share 135 Basic earnings per share is calculated by dividing the profit after taxes attributable to the shareholders of Merck KGaA (net income) by the weighted average number of theoretical shares outstanding. The calculation of the theoretical number of shares is based on the fact that the general partner's equity is not represented by shares. Corresponding to the division of the subscribed capital of € 168 million into 129,242,252 shares (see Note (34) "Equity"), the general partner's equity of € 397 million equates to 305,535,626 theoretical shares. Overall, equity capital amounted to € 565 million or 434,777,878 theoretical shares outstanding. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Based on a combination of different estimating methods, for example, historical and implied stock yields Derived from the respective sector-specific peer group Derived from the returns of long-term government bonds based on the Svensson method Cost of debt and capital structure Market risk premium Beta factor 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. Method for impairment testing 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. 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 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. Derived from the market data of the respective peer group companies 49 106 Tax loss carryforwards for which a deferred tax asset is recognized 838 677 161 793 536 257 Total Outside Germany Germany Total Outside Germany Germany Tax loss carryforwards € million Dec. 31, 2022¹ Dec. 31, 2023 Tax loss carryforwards were structured as follows: Changes in tax loss carryforwards Deferred tax liabilities from outside basis differences for planned dividend payouts were recognized in the amount of € 157 million (December 31, 2022: € 79 million). Retained earnings of subsidiaries for which no deferred taxes were recognized amounted to € 10,627 million as of December 31, 2023 (December 31, 2022: € 10,249 million). The resulting temporary differences that will be taxable in future periods in the event of dividend payments would amount to € 603 million as of December 31, 2023 (December 31, 2022: € 582 million). As in the previous year, the item "Changes in scope of consolidation/Currency translation/Other changes" mainly comprised exchange rate effects for items translated from U.S. dollars to the reporting currency (euro). Furthermore, a non-recurring deferred tax income on intangible assets impacted in the amount of € 95 million. Given the positive earnings forecasts, it was assumed that it will be possible to realize recognized deferred tax assets of € 597 million (December 31, 2022: € 191 million), which exceeded deferred tax liabilities relating to the same taxation authority and the same taxable entity, even though there was a loss in the current or previous period. No deferred tax assets were recognized in the balance sheet for deductible temporary differences and other interest carryforwards in the amount of € 13,220 million (December 31, 2022: € 71 million). The increase in deductible temporary differences for which no deferred tax assets were recognized in the balance sheet is due to the change in the exercise of different tax-related options abroad compared with the previous year. The majority of these differences can only be utilized until 2029. Their utilization for tax purposes is not expected during this period. 265 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Activities 23 81 95 135 251 136 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 702 541 161 542 441 101 Tax loss carryforwards for which no deferred 136 The long-term growth rate after the detailed planning period is determined taking into account expected long- term growth and long-term inflation expectations. Operating cash flow 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%). Currency translation difference 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 for sale Disposals due to divestments/Reclassification to assets held Other additions Net carrying amounts, Jan. 1, 2022¹ € 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 Goodwill Electronics Life Science Electronics 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. 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. -544 17,845 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 Significant measurement assumptions 12,193 828 18,389 209 4,671 1,525 12,193 619 17,004 557 4,420 42 1,525 11,059 515 Total Healthcare > 2 1,525 > 2 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% 6.3% 0.00% 2.00% 1.00% 2.00% Electronics 7.5% 8.2% 2.00% 2.00% 2022 2023 2022 2023 in % tax Weighted cost of capital after Long-term growth rate The additional significant value-relevant assumptions underlying the goodwill impairment tests are quantified below. The calculation of the recoverable amount of the Electronics CGU included the expected average sales growth in the period until the transition to the terminal value at a higher single-digit percentage (2022: higher single-digit percentage). The sales expectation for the Electronics CGU is primarily based on the long-term growth trend in the market for semiconductor materials and positive sales contributions from the Level Up growth program with an initial investment volume exceeding € 3 billion by the end of 2025. Taking into account Group costs allocated on a pro rata basis, the EBITDA pre margin applied in the period until the transition to the terminal value in the impairment test for fiscal 2023 was around 29% (2022: around 30%). > 2 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%. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 269 Life Science Healthcare¹ Goodwill >10 > 2 Significant discretionary decisions and sources of estimation uncertainty >10 >2 >2 >2 > 10 > 10 Life Science Healthcare 2022 2023 2022 >2 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. 2022 2023 Increase in cost of capital after tax percentage points percentage points % Decrease in long-term growth rate 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. Decrease in net cash flows - 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. 2023 Disposals Disposals due to divestments/Reclassification to assets held for sale 1 Currency translation difference 1 Reversals of impairment losses -23 43 67 -9 77 233 Transfers 1 5 3 -12 1 88 -2 -4,319 -1 Dec. 31, 2023 -266 43 6,326 6,625 1,946 3,045 17,943 Accumulated depreciation and impairment losses as of Jan. 1, 2023 -2,588 -1,380 -21 -8,308 Depreciation -332 -389 -173 -895 Impairment losses -8 19 USA 106 Capacity expansion for drug safety testing Membrane factory Ireland Research center Germany Germany Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 277 (21) Leasing Accounting and measurement policies Leasing Scope of IFRS 16 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”). 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. Separation of lease and non-lease components 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. Depreciation of the right-of-use assets arising from leases 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”). Determining the incremental borrowing rate -37 Filling and logistics center 1 Life Science Life Science Dec. 31, 2023 Net carrying amounts as of Dec. 31, 2023 -2,820 3,506 -4,584 2,042 -1,454 -29 -8,887 492 3,016 9,056 1 Previous year's figures have been adjusted, see Note (6) "Acquisitions and divestments". The individual additions to construction in progress in fiscal 2023 with an investment volume of more than € 50 million each are presented below: Business sector Life Science Investment project Country Filtration plant Ireland Life Science Healthcare -27 Plant and machinery1 -119 -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 84 91 1 244 Transfers -6 11 Depreciation -1 -7,593 -1,287 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. 127 -930 -1 Currency translation difference 80 63 12 20 175 Dec. 31, 2022 5,976 6,228 1,879 2,429 16,513 Accumulated depreciation and impairment losses as of Jan. 1, 2022 -2,304 -3,987 -15 -5 -1 Currency translation difference 169 32 56 1,723 1,981 Reclassification to assets held for sale Disposals -85 -93 -82 -18 -278 Transfers 385 542 120 -1,053 -6 Currency translation difference Additions Changes in the scope of consolidation 16,513 2,429 -26 -35 -10 -70 Dec. 31, 2022 -2,588 -4,319 -1,380 -21 -84 -8,308 3,389 1,909 499 2,408 8,204 Cost as of Jan. 1, 2023 5,976 6,228 1,879 Net carrying amounts as of Dec. 31, 2022 Determining the lease term Income from subleasing right-of-use assets Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating cash flow Financing cash flow Total At the reporting date, the future lease payments were distributed over the following periods: December 31, 2023 € million Future lease payments Interest portion of future payments € million Present value of future lease payments € million Future lease payments Interest portion of future payments Present value of future lease payments 2023 2022 -147 -152 December 31, 2022 Interest expenses for lease liabilities Total Income from sale-and-lease-back transactions 512 -13 1 -1 -14 427 10 64 500 The net carrying amounts of other facilities, operating and office equipment mainly included the right-of-use assets for vehicles. 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 280 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: € million Right-of-use assets Depreciation Impairment losses Reversals of impairment losses Expenses for leasing low-value assets Expenses for leases with variable lease payments -11 -14 -14 -173 -13 256 137 513 After more than Within 1 year 132 1-5 years 281 5 years Total 111 524 -9 -17 -9 -35 123 264 101 488 120 -147 -47 -22 -179 2023 2022 -25 -26 -149 -150 -174 -176 After more than Within 1 year 1-5 years 5 years Total 130 278 152 560 -11 -15 -37 -2 -108 Changes in the scope of consolidation Additions Disposals Depreciation Impairment losses Reversal of impairment losses Other Dec. 31, 2022 € million Net carrying amounts as of Jan. 1, 2023 Changes in the scope of consolidation Additions Disposals Depreciation Impairment losses Reversal of impairment losses Other Dec. 31, 2023 Right-of-use assets Net carrying amounts as of Jan. 1, 2022 Land, land rights, € million Operating Assets, Liabilities, and Contingent Liabilities 279 Operating Assets, Liabilities, and Contingent Liabilities 278 Significant discretionary decisions and sources of estimation uncertainty Leasing Identification of a lease 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. Measurement of lease and non-lease components 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. Determining the lease term When determining the lease term, existing renewal and termination options must be evaluated to determine the probability that such options will be exercised. The assessment of the probability of exercise may be discretionary even though it relies on existing and material information on the general economic context, such as location strategies, leasehold improvements, or the degree of specificity. If the available information does not allow a reliable assessment, Merck uses historical experience for comparable situations. The largest 30 leases accounted for around 50% of total lease liabilities in fiscal 2023 and 2022. They are essentially for right-of-use assets for office, warehouse, and laboratory buildings. If options to renew these leases were exercised in future, which is not yet considered likely, this would result in additional potential undiscounted cash outflows of up to € 235 million (2022: € 219 million). 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. Determining the incremental borrowing rate Determining the risk-free interest rate and determining the risk surcharge are both discretionary. Initial measurement of the lease liability and the right-of-use asset In measuring the lease liability, there is discretionary scope and significant estimation uncertainty regarding measuring any payments in the course of promised residual value guarantees, and assessing the probability that existing purchase, termination, and renewal options will be exercised. 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 The reconciliation of net carrying amounts of right-of-use assets from leases was as follows: 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. and buildings Other facilities, operating and office equipment 8 58 481 Right-of-use assets Land, land rights, and buildings Plant and machinery Other facilities, operating and office equipment Total 415 8 58 481 157 4 45 206 -23 -1 -25 415 Plant and machinery -5 2 Total 382 9 56 447 7 7 160 43 203 -16 -1 -3 -19 -112 -3 -37 -152 -6 -1 290 Others -282 493 401 7,336 Consolidated Financial Statements Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 273 Cost as of Jan. 1, 2023 Additions due to business combinations Other additions Disposals due to divestments/Reclassification to assets Customer relationships, Marketing authorizations, Software and brands, and trademarks patents, licenses, similar rights, and other items software in development Total 10,391 11,302 793 1,379 5,648 -16,833 17 231 83 331 Transfers -14 15 -1 Currency translation -160 -36 -1 -13 -211 Dec. 31, 2022 -4,743 -10,509 -887 -695 Net carrying amounts as of Dec. 31, 2022 Other disposals 1,096 20 1,637 1,165 24,045 Accumulated depreciation and impairment losses as of Jan. 1, 2023 -4,743 -10,509 -887 -695 -16,833 Depreciation, amortization, and write-downs -581 -202 -104 -887 Impairment losses -26 -24 -31 -81 -482 24,169 -16 -112 11,200 284 Transfers 396 held for sale Other disposals 3 -25 -9 -13 -44 Transfers 16 -14 5 6 Currency translation -351 Dec. 31, 2023 10,043 -3 Reversals of impairment losses held for sale Reversals of impairment losses € million Cost as of Jan. 1, 2022 Additions due to business combinations Other additions Disposals due to divestments/Reclassification to assets held for sale Other disposals Transfers Currency translation Dec. 31, 2022 Customer relationships, brands, and trademarks Marketing authorizations, patents, licenses, similar rights, and other items Software and software in development Total Finite useful life1 Not yet available for use 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. 9,825 97 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). Determination of amortization Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 271 (19) Other intangible assets Accounting and measurement policies Recognition and initial measurement of purchased 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. 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 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. Subsequent measurement Subsequent measurement is at amortized cost. 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. 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. 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 272 Significant discretionary decisions and sources of estimation uncertainty Purchased intangible assets The identification and measurement of intangible assets acquired in the course of business combinations are subject to significant discretion and estimation uncertainty. 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. 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. Disposals due to divestments/Reclassification to assets 11,305 97 1,058 1,096 24,169 Accumulated amortization and impairment losses as of Jan. 1, 2022 -3,989 -10,443 -720 -659 -15,810 Depreciation, amortization, and write-downs -602 -229 -102 -932 Impairment losses -9 -18 -180 -3 -211 1,379 1,235 11,302 582 23,423 194 55 166 93 314 -17 -236 -11 -83 -347 0 23 -23 4 2 487 59 13 24 10,391 5 92 Disposals due to divestments/Reclassification to assets Not yet available for use 13 583 133 729 493 thereof from the following acquisition: Versum Materials, Inc. 135 102 115 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 Recognition and initial measurement 5 102 134 8 124 580 793 0.3-9.3 212 235 447 657 thereof from the following acquisitions: AZ Electronic Materials S.A. 0.3-9.3 87 87 170 Versum Materials, Inc. 0.8-2.8 107 107 164 2 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: 1,754 1,905 14,810 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 -6 5,687 243 5,464 progress Production buildings Administration buildings Plant and machinery Operating and office equipment, other facilities Useful life No more than 33 years No more than 40 years 6 to 25 years 3 to 10 years 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 Other facilities, € million Cost as of Jan. 1, 2022 Land, land rights, and buildings¹ operating and Construction in office equipment Total¹ 124 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. Patents, licenses, and similar rights 729 395 6,551 1 Previous year has been adjusted, please refer to Note (6) "Acquisitions and Divestments". Additions and disposals The additions from business combinations in the previous year resulted in particular from the acquisition of Exelead Inc., United States (see Note (6) "Acquisitions and divestments"). 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. 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. Loss allowances 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 274 Other significant information As in the previous year, the currency translation effects essentially resulted from the translation of other intangible assets denominated in U.S. dollars. Marketing authorizations, patents, licenses, similar rights, and other items not yet available for use involved ongoing development projects that were not yet in the commercialization phase and thus did not yet have a defined useful life. These primarily related to the Healthcare business sector. Overview of material other intangible assets The carrying amounts of customer relationships, brands, and trademarks, as well as marketing authorizations, patents, licenses, similar rights, and other items, were attributable to the business sectors as follows: Remaining useful life in Total 580 € million 4,847 265 -17,493 held for sale 213 -3 25 3 12 37 Transfers Currency translation - - 156 91 2 Dec. 31, 2023 -5,196 -10,619 -908 16 -770 Net carrying amounts as of Dec. 31, 2023 Customer relationships, brands, and trademarks Other disposals Electronics Dec. 31, 2023 1,672 2.5-3.5 170 170 239 Brands and trademarks thereof from the following acquisition: 0.5-3.9 296 9 305 432 Sigma-Aldrich Corporation Marketing authorizations, patents, licenses and 3.9 281 281 366 Finite useful life¹ years Life Science Healthcare 3,175 Millipore Corporation 1,798 similar rights, and other 1,545 1,545 4,847 5,648 Customer relationships 2.5-14.8 2,879 1,663 5,216 thereof from the following acquisitions: 4,542 12.8-13.8 2,608 118 2,726 3,048 Versum Materials, Inc. 2.8-14.8 Sigma-Aldrich Corporation Total Dec. 31, 2022 202 Contract liabilities 252 3 282 1 249 200 126 1 163 Liabilities from non-income-related taxes 127 5 121 3 4 122 164 285 1,479 29 Other additions Additions due to business combinations Payroll-related liabilities¹ Jan. 1 € million The following table shows the development of contract liabilities in the period under review: 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. 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles“. 1,805 19 1,786 1,496 17 Other non-financial liabilities¹ 36 10 26 38 8 Other accruals 1,156 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 916 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 Contingent liabilities Accounting and measurement policies Operating Assets, Liabilities, and Contingent Liabilities 288 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 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. Interest and penalties related to income taxes 1,290 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. (28) Contingent liabilities The identification and the measurement of contingent liabilities are both subject to considerable uncertainty. This applies with regard to assessing the likelihood of an outflow of resources as well as determining its amount. Contingent liabilities in the amount of € 204 million (December 31, 2022 (adjusted): € 231 million) related almost exclusively to litigation and tax matters. 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. 916 Accruals for personnel expenses¹ Total Non-current Current Total Non-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 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. 1,156 2023 Marketing and sales Current 11,938 22,086 24,105 2022 2023 290 Personnel expenses Compulsory social security contributions and other costs 11,886 Pension expenses € million Personnel expenses comprised the following: (32) Personnel expenses Average number of employees Other Supply chain Research and development Administration Wages and salaries 6,516 7,334 4,971 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. 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. 6,644 6,517 460 365 844 853 5,340 5,299 2022 2023 62,552 63,642 1,309 1,676 15,087 14,436 4,850 Production 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. (31) Number of employees Employees -1,194 -1,313 -1,313 Recognition of income/reversal Disposals due to divestments/Reclassification to assets held for sale 1,277 1 202 3 198 1 1,276 1,290 285 3 282 Total Non-current Current Total Non-current -1,195 2022 Cumulative catch-up adjustments to revenue Currency translation Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees Trade and other payables as of December 31, 2023, included accrued amounts of € 775 million (December 31, 2022: € 903 million) from outstanding invoices. Trade and other payables are subsequently measured at amortized cost. Trade and other payables Accounting and measurement policies (30) Trade and other payables a total of € 253 million (2022: € 181 million) was recognized through profit or loss in fiscal 2023. As of January 1, 2023, contract liabilities amounted to € 285 million (January 1, 2022: € 202 million), of which 285 3 282 252 3 249 Dec. 31 Other -11 1 -11 Reclassification from non-current to current 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. 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. 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. comprehensive Total Subsequently income measured at amortized cost Dec. 31, 2022 Subsequently measured at fair value through other Subsequently measured at fair value through other comprehensive Total 3,945 25 3,969 4,046 22 4,069 income Dec. 31, 2023 Subsequently measured at amortized cost Gross trade accounts receivable Gross other receivables 4,632 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". Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 283 (25) Trade and other receivables Accounting and measurement policies Trade and other receivables 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 accounts receivable that are potentially designated to be sold on account of a factoring agreement are measured at fair value through other comprehensive income. The measurement policies applied in determining loss allowances for trade and other receivables are shown in Note (42) "Management of financial risks” in the "Credit risks” section. Loss allowances and reversals of loss allowances are 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. Further information on the accounting and measurement policies governing financial assets can be found in Note (36) "Other financial assets”. Significant discretion and sources of estimation uncertainty Trade and other receivables Information on the significant discretion and estimation uncertainty concerning trade and other receivables can be found in Note (42) "Management of financial risks". Trade and other receivables were measured as follows: € million 160 Gross trade and other receivables 4,105 25 22 4,031 4,119 thereof: non-current 28 4,004 28 4,091 27 22 22 4,141 22 4,114 27 The reduction in trade and other receivables is mainly attributable to foreign exchange effects and general operational performance. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 284 (26) Contract assets 25 4,637 3,979 25 160 4,130 136 136 4,182 22 4,204 Loss allowances on trade accounts receivable -97 -97 -63 -63 Loss allowances on other receivables Net trade and other receivables -1 -1 -1 -1 4,007 thereof: current 2,139 2,045 1,418 346 3 349 Prepaid expenses 182 37 219 210 29 239 Assets from defined benefit plans 33 33 46 46 Remaining other assets 95 325 76 2 Receivables from non-income-related taxes Acceptance and follow-on obligations Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 281 (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 Total 323 Accounting and measurement policies 171 67 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. Since inventories are, for the most part, not manufactured within the scope of long-term production processes, borrowing costs are not included. Inventory prepayments are reported under other non-financial assets. Significant discretionary decisions and sources of estimation uncertainty Identification of impairments or reversal of impairments Discretionary decisions are required in the identification of impairment as well as in identifying the need to reverse impairment of inventories. There are estimation uncertainties with respect to the calculation of the net realizable value. In particular, changes in selling prices and expected costs of completion are considered in calculating this value. Inventories consisted of the following: € million Raw materials and supplies Work in progress Finished goods/goods for resale Inventories Dec. 31, 2023 Dec. 31, 2022 1,164 1,076 1,428 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. 103 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. Accounting and measurement policies 170 Other non-financial assets 633 115 748 705 99 804 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. 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. 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”). 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. 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"). 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 282 (24) Inventories Inventories Contract assets (23) Cash flow from investing activities The following table shows the change in contract assets: • the legal situation and current court rulings in comparable proceedings in the jurisdiction(s) in question. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 285 The following factors are also relevant in measuring provisions for litigation: • the duration of proceedings in pending legal disputes, • the validity of the arguments brought forward by the opposing party, and the applicable license rate plus an expected infringement surcharge, the usual damages and fines for comparable legal disputes, and • the discount factor to be used. Provisions for restructuring Merck uses formal restructuring plans and the expectations of the affected employees concerning the performance of the restructuring measures to assess the recognition obligation for provisions for restructuring projects and the amount of the expected outflow of resources. Provisions for environmental protection To assess a recognition obligation in relation to provisions for environmental protection and to quantify future outflows of resources, Merck draws on appraisals by independent external experts and the knowledge of in- house specialists. • • 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. thereof: current 42 139 19 166 127 82 575 thereof: non-current 17 71 130 15 45 277 Accounting and measurement policies Provisions for litigation The following are key parameters in calculating the present value of the future settlement amount of the provisions for environmental protection: the future settlement date, the extent of environmental damage, • Provisions for environmental protection 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. The estimation uncertainties relate in particular to the assessment of the timing and likelihood of a future outflow of resources and the extent of necessary remediation measures as well as the related calculation of the amount of the liability. Provisions for acceptance and follow-on obligations Estimation uncertainty regarding the provisions for acceptance and follow-on obligations primarily relates to determining the amount of the expected outflow of resources. Provisions for interest and penalties related to income taxes Estimation uncertainty concerning the provisions for interest and penalties related to income taxes mainly relates to the interpretation of tax codes and the effects of amended case law. Antitrust and other proceedings In connection with the generics business that was divested in 2007, Merck was accused of breaching EU antitrust law through agreements entered into by its former subsidiary Generics (UK) Ltd., United Kingdom, relating to the antidepressant Citalopram patented by Lundbeck A/S, Denmark. The European Commission imposed a fine in June 2013. Appeals against the decision were unsuccessful. Following the payment of the fine of around € 18 million, British health authorities brought legal claims for damages against Merck and other companies in a mid-triple-digit million-euro amount in fiscal 2023 due to alleged infringements of competition law. In addition, there were further claimants from various other jurisdictions who have not yet quantified their claims. In response to the latest developments in the proceedings, the provision was adjusted as of December 31, 2023, and is now recognized in a high-single-digit million-euro amount. A cash outflow within the next 12 months is considered possible. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 287 Restructuring The restructuring provisions recognized as of December 31, 2023, primarily relate to obligations for workforce reduction measures in connection with communicated restructuring plans. A program to continuously improve processes and align the Group functions more closely with the businesses was launched in 2023. The implementation of this program will take until at least the end of fiscal 2024. Provisions in a mid-double-digit million-euro amount were recognized for the program in the current fiscal year. Furthermore, additional programs to improve efficiency and increase customer focus in the Electronics and Healthcare business sectors were initiated during the current fiscal year. This resulted in the recognition of provisions in a mid-double- digit million-euro amount that are largely expected to be utilized within the next two years. 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. 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. 852 Provisions for restructuring Provisions for litigation the applicable remediation methods, • the associated future costs, and the discount factor. Provisions for acceptance and follow-on obligations The assessment of the recognition obligation for provisions for acceptance and follow-on obligations and the quantification of future outflows of resources is based on internal project plans as well as on the assessment of the respective matters by in-house and external specialists. The main parameters in determining the amount of the provision are: the ability to use or potential for modification of secured manufacturing capacities at third-party providers, particularly for pharmaceutical compounds, the number of affected patients and the expected duration of their continued treatment in clinical development programs, • the expected date or period of the outflow of resources, and • Provisions for interest and penalties related to income taxes Objective assessments are performed to determine the need to recognize provisions for interest and penalties related to income taxes not covered by IAS 12. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Operating Assets, Liabilities, and Contingent Liabilities 286 Significant discretion and sources of estimation uncertainty 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. 127 the expectations concerning future events influencing the obligations. 181 128 Contract assets resulted in particular from rendering services and manufacturing of products in the Life Science and Electronics business sectors. (27) Other provisions Other provisions developed as follows: Interest and € million Jan. 1, 2023 Additions Utilizations Release Interest effect Currency translation Litigation Restructuring Environmental protection Acceptance and follow-on obligations penalties related to income taxes 104 Other 1 -451 Jan. 1 € million 127 2023 2022 128 207 Additions due to business combinations 10 Other additions 339 360 thereof: attributable to performance obligations satisfied in prior periods Disposals due to divestments/Reclassification to assets held for sale Reclassification to trade accounts receivable 2 Currency differences Dec. 31 -361 -3 1 Total Other 134 -25 -51 -3 -59 -39 -29 -205 5 -1 -1 -2 -4 Changes in scope of consolidation/Other Dec. 31, 2023 85 59 149 -95 -22 6 -12 148 127 88 -1 91 672 10 173 3 210 -4 80 124 89 479 -45 -10 20222 2023 -5.6% Reconciliation EBITDA pre¹ -5.6% Merck Group 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. EBITDA pre 30 Combined Management Report_ Fundamental Information about the Group. Internal Management System Change € million Elimination of adjustments IFRS pre¹ IFRS Elimination of adjustments pre¹ 20,993 20,993 22,232 22,232 Cost of sales -8,600 Net sales pre¹ 29 € million -1,239 EBITDA pre-margin¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments in percent of the net sales. EPS = Earnings per share. EPS pre¹ = Earnings per share before adjustments. MEVA¹ = Merck value added. 43 OCF1 = Operating cash flow. ROCE¹ Return on capital employed. NPV1 = Net present value. IRR¹ Internal rate of return. eNPV1 = Expected net present value. POS¹ Probability of success. M&A Mergers and acquisitions. 1 Not defined by International Financial Reporting Standards (IFRS). % Combined Management Report_ Fundamental Information about the Group Internal Management System 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. Net sales 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. Merck Group Net sales € million Net sales Change 2023 2022 20,993 22,232 Key performance indicators of the Group and its businesses -8,558 -6 32 -2,521 75 -2,446 -0.3% -51 -51 0 -6 > 100.0% impairment losses on financial assets (net) Other operating income and -385 138 -247 -685 323 -361 -31.6% expenses Operating result (EBIT)¹ 3,609 Depreciation/amortization/ EBITDA pre¹ = Earnings before interest, income tax, depreciation and amortization as well as adjustments. 4,474 -2,438 7 -2,445 Research and development costs Impairment losses and reversal of -8,496 0.7% Gross profit 12,392 43 12,435 13,705 32 13,737 -9.5% Marketing and selling expenses -4,510 -8,527 44 -4,714 32 -4,681 -4.6% Administration expenses -1,392 246 -1,146 -1,306 115 -1,191 -3.8% -4,466 Abbreviations 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. NPV, IRR, 23 Combined Management Report Fundamental Information about the Group_ Strategy Business strategies Life Science Our strategy builds on the transformation we began last year, with a sharpened focus on differentiating both our core and high-growth portfolios and capitalizing on the unique capabilities of our company. We are doing this by leveraging our distinctive breadth of offerings to customers in academia, the biopharmaceutical industry and the industrial sector, including food & beverage, to advance leading edge science. We aspire to comprehensively address customers' scientific needs and serve as a partner across products and services with a focus on enabling novel modalities. We amplify customer value by proactively addressing future customer needs to create lasting differentiation beyond the breadth and performance of our offerings. Our multichannel commercial approach, e-commerce platform and focus on sustainability set us apart. We enhance competitiveness by pursuing operational and commercial excellence and building future-oriented capabilities and ways of working. This course we have set directs our focus and resources to pursuing opportunities that financially and technologically "move the needle" while deprioritizing those that may distract from our focused ambition to continue to be a global science & technology leader. For example, our Process Solutions business unit is optimizing its go-to-market approaches to address shifting customer behaviors, including expanding access to Process Solutions products via sigmaaldrich.com, our e-commerce platform. Our growing Life Science Services Contract Testing and Development Manufacturing Organization (CTDMO) business is building an end-to-end offering for novel modalities with a focus on anti-drug conjugates (ADCs), mRNA and viral vectors, where customers are seeking greater technical expertise and collaboration. The diverse customer and portfolio base of our Science and Lab Solutions business provides a stable foundation while continuing to build positions in higher-growth segments. Our Integrated Supply Chain Organization's evolution to become more agile, resilient, and customer-centric is an essential foundation for continued profitable growth. To this end, we have implemented new processes to more closely connect our sales and production plans, using digital tools to align with customers on lead times and other supply expectations, standardizing operations across sites and regionalizing our network - especially in Asia-Pacific (APAC) - to meet local needs and balance risk. We have also embedded sustainability criteria in R&D and operations, providing customers with an expanded range of greener alternatives and data, such as product carbon footprints, to help reach their sustainability goals. - Our strategy reflects our purpose - to impact life and health with science and allows us to deliver customer and shareholder value now and into the future. We are prepared to address short-term challenges and emerge from the post-Covid-19-pandemic era with deeper customer relationships, high-value innovations and a more resilient and cost-effective operating network. 24 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 * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 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. 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). Combined Management Report impairment losses/reversals of Fundamental Information about the Group Merck 21 In fiscal 2023, we integrated the chemical business of Mecaro Co. Ltd., which we acquired in 2022, into our Semiconductor Solutions business. We also strengthened our business in thin films technology and our footprint in Korea. In February 2023, we broke ground for a new integrated facility in Kaohsiung, Taiwan. Here we will produce a comprehensive portfolio of semiconductor materials in one single site. In April 2023, we announced our plans to expand manufacturing capacities at our site in Hometown, Pennsylvania, USA, thus increasing domestic production capacity for electronics components. The roughly € 300 million investment in the Hometown site is intended to further develop our largest integrated specialty gases facility. In June 2023, we commissioned a new production facility for DS&S in Chandler, Arizona, USA. Display Solutions Our Display Solutions business unit includes the businesses with liquid crystals (LC), display patterning materials (materials for surface treatment), organic light-emitting diodes (OLED), photoresists, reactive mesogens, smart antenna (LC-based antennas), and liquid crystal glazing (LC-based windows). We support our customers in developing novel display technologies for TV, IT, mobile devices, automotive, gaming, and other applications. Together with our customers we are working in the field of AR/VR to expand the application scenarios of LC & OLED materials and enhance the user experience in small and micro-sized displays. We are working very closely with leading panel makers to develop next-generation products with LCD (liquid crystal display) technology for the electronics market. 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. 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. With our OLED materials, we are also supporting our customers in making sustainable OLED structures, which are important for new OLED applications such as IT screens. In 2023, we developed deuterated materials for next-generation OLED displays. They have the potential to more than double the lifetime of OLED stacks without compromising on efficiency and voltage, enabling displays with higher brightness. Real estate investors use our product eyrise® s350 solar shading (sun protection at the touch of a button) to deliver on ESG (environment, social, governance) objectives. For example, a large real estate investor in Switzerland has already installed eyrise® on all facades of its flagship project in the center of Zurich. More commercial projects are currently in installation. Surface Solutions In our Surface Solutions business, we provide our customers with solutions that help them to create functional and decorative surfaces of all kinds. We focus on markets for automotive coatings, cosmetics, and, to a smaller extent, industrial applications. With our portfolio of active ingredients, we enable cosmetics manufacturers to enrich their skin care products with moisturizing, protecting and anti-aging effects. Moreover, our functional solutions serve many innovative applications, from dirt-repellent and easy-care surfaces to laser markings of plastic parts and cables. Despite the current challenging economic environment, Surface Solutions is continuing to implement its strategic transformation. We continued to invest in digitalizing and modernizing our production plants around the globe while adjusting our capacities to the changing demands in our different markets. Combined Management Report Fundamental Information about the Group_ Strategy 22 22 Strategy* Strategy fundamentals and ambition 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. 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 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. In the short term, AI alone cannot offset the current market decline in the electronics industry, which results from weak demand after the Covid-19 pandemic and associated excess inventory along the value chain. However, in the medium and long term, the fundamental growth drivers, such as AI, are expected to accelerate the market development through the next decade. To produce ever more powerful and energy-efficient chips, innovation in novel materials will be even more essential. To benefit from the strong electronics industry growth, we are continuously expanding our capacities and our capabilities. We are continuing to invest significantly more than € 3 billion in innovation and capacities, which are aligned with the customers and regions we serve. These investments are an essential part of our ongoing Level Up growth program, which we kicked off at the end of 2021. The investments are made in lockstep with the capacity expansions of our customers in order to support their growth and new fabs with a reliable supply of innovative materials and systems. We will continue to invest in our geographic proximity to our customers while boosting R&D and innovation. Electronics also seeks to exploit attractive external growth opportunities through acquisitions. Our ability to systematically use data and digital methods across the entire value chain differentiates in the market, enabling us to meet and exceed the increasing requirements regarding quality, speed and reliability. Furthermore, we are accelerating important initiatives to transform the industry towards sustainability and investing even further in safety. After substantial investments in improving our processes and expanding our production capacities in Surface Solutions, we remain confident of successfully implementing our strategic transformation within that business. 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. 28 Combined Management Report_ Fundamental Information about the Group. Internal Management System 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) for measuring performance is EBITDA pre¹. 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. Business Merck Group Projects M&A NPV, IRR, EBITDA pre margin, EPS, EPS pre, ROCE, MEVA Net Sales, EBITDA pre, OCF, Net income, EPS, EPS pre, Dividend ratio, Net financial debt, Credit rating, ROCE, MEVA Net sales, EBITDA pre, OCF Net sales growth, EBITDA pre margin ROCE, MEVA Licensing eNPV, IRR, EBITDA pre margin, POS, ROCE Capex Sustainable dividend policy In November 2023, our ratings were confirmed by Moody's (A3, stable outlook) and Standard & Poor's (A, stable outlook). We discontinued our Scope rating (previously: A, stable outlook) in December 2023. The rating of our creditworthiness by external rating agencies is an important indicator of financial stability. A strong investment-grade rating is an important cornerstone of our financial policy as it safeguards access to attractive financial conditions on the capital markets. 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. Data & Digital strategy 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 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. Combined Management Report Fundamental Information about the Group_ Strategy 26 26 Sustainability strategy Leveraging science and technology 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. 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. Payback period, EBITDA pre margin, ROCE 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. In 2023, we revised our sustainability strategy, which we had communicated in 2020. In particular, we sharpened the second goal: Under the new heading "Partnering for sustainable business impact", we want to strengthen our focus on the social aspects in our value chains and embed sustainability more comprehensively into our decision-making processes. Therefore, in addition to the existing focus area "Sustainable and transparent supply chain", we are now also working on the new focus areas "Sustainability in our ways of working and decision-making" and "Our people and communities; providing a diverse and inclusive environment". For the third goal, "Reducing our ecological footprint", we modified two of our key indicators for waste and water. The two new indicators, which are valid as of 2024, use more common metrics and also include circular economy criteria. We use 14 key indicators to record and assess our progress towards achieving our sustainability goals. Our annual Long-Term Incentive Plan (LTIP) for Executive Board members and senior executives contains a sustainability factor. We use it to measure performance over a period of three years based on selected key indicators for each of our three sustainability goals. Details on how this sustainability factor is calculated can be found in the "Compensation Report". In 2023, the company tied 15% of variable employee compensation to sustainability parameters for the first time. We are in the process of transforming the company and are integrating sustainability into the innovation process and all parts of the value chain. It is our aim to decouple the growth of our businesses from negative environmental impacts. More information on sustainability topics can be found in the "Non-Financial Statement", which is also part of the management report. 27 Combined Management Report Fundamental Information about the Group_ Strategy Strategic finance and dividend policy We pursue a conservative financial policy characterized by the following aspects: Financial flexibility and a conservative funding strategy We ensure that we meet our obligations at all times and adhere to a conservative and proactive funding strategy that involves the use of various financial instruments. Our diversified and profitable business activities form the basis for our strong and sustainable cash flow generation capacity. Moreover, we have several funding resources in place. A € 2.5 billion syndicated loan facility is in place until 2028 to cover unexpected cash needs. This credit line is a backup facility that is intended to be used in exceptional circumstances only. We also agreed upon several bilateral loan facilities. In addition, we have a commercial paper program with a volume of € 2.5 billion at our disposal. Within the scope of this program, we can issue short-term commercial paper with a maturity of up to one year. The bond market also represents an important source of financing. The most recent bond issue took place in June 2022 (€ 1.0 billion bond issue). The use of various instruments provides a broad financing basis and addresses different investor groups. Refining the sustainability strategy 1,880 Strong investment-grade rating 1,792 -18 29 -29 Other adjustments 56 -56 68 -68 5,879 5,879 6,849 6,849 thereof: organic growth¹ -14.2% -9.0% thereof: exchange rate effects -4.9% thereof: acquisitions/divestments -0.3% 1 Not defined by International Financial Reporting Standard (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. -87 18 Acquisition-related adjustments EBITDA pre¹ 38 divestment of businesses -232 1,798 -0.3% impairment losses EBITDA² 5,489 Restructuring expenses 249 -249 198 6,504 2,030 -198 51 -51 Gains (-)/losses (+) on the -88 -38 -118 118 Integration expenses/IT expenses 88 19 607 175 21 19 27 108 170 21 27 95 171 29 18 25 99 160 24 17 24 151 103 103 22 994 153 103 20 22 99 20 22 95 19 22 91 165 38 19 23 85 Total United Kingdom Other countries Switzerland Germany Expected payments of undiscounted benefits 133 22 The expected payments of undiscounted benefits under the plans were as follows: 26 594 2,040 2,848 646 2,202 Fair value of the plan assets 64 5 59 62 62 Other 64 64 61 61 Insurance contracts 344 204 140 439 2,634 Plan assets did not directly include financial instruments issued by Group companies or assets used by Group companies. 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. 21 88 Total Other countries United Kingdom Expected payments of undiscounted benefits Switzerland Germany 2028-2032 2027 2026 2025 17 2024 € million December 31, 2022 2029-2033 2028 2027 2026 2025 2024 € million December 31, 2023 2023 583 Release 116 10% -10% 10% Change in the DAX® Variation of Merck share price € million 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. Share-based payments 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 -10% 217 Increase (+)/decrease (-) of the provision Dec. 31, 2022 300 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees 40% "Reducing our ecological footprint" • 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, 2023 Dec. 31, 2023 Changes in scope of consolidation/Other -57 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 Accounting and measurement policies Other employee benefit provisions 298 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees The weighted duration of defined benefit obligations amounted to 17 years (2022: 16 years). 940 168 164 163 26 155 22223 130 392 Interest effect Currency translation Reclassification from non-current to current/liabilities¹ 32 -90 -9 -3 -5 2 2 -130 -89 -41 112 -125 -26 239 161 78 380 81 299 Total Current other employee benefit provisions¹ Non-current other employee benefit provisions -99 48 market 500 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 -4 -6 Other -1 1 -2 Other changes 296 -10 Present value of the defined benefit obligations -4,287 Interest income Gains (+) or losses Past service cost -168 123 -291 5 -3 89 -150 -109 -1,685 Net defined benefit liability Effects of asset ceilings -33 37 -37 -3 89 -150 2,634 -109 Fair value of the plan assets -6 -3 Currency translation recognized in equity 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 Dec. 31, 2022 1,731 299 217 2,192 Dec. 31, 2023 1,975 1 Previous year's figures have been adjusted, see Note (2) "Reporting principles". 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 Employees Consolidated Financial Statements Notes to the Consolidated Financial Statements 9 Provisions for pensions and other post-employment benefits Accounting and measurement policies Provisions for pensions and other post-employment benefits 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. 1 -1 Changes in the scope of consolidation 2022 2023 2022 2023 2022 2023 2022 Plan administration costs recognized in income 2023 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 Apart from the net balance of interest expense for the defined benefit obligations and interest income from the plan assets, which is reported in financial income and financial expenses, the expenses for defined benefit plans are allocated to the individual functional areas in the consolidated income statement. The other actuarial assumptions used as the basis for calculating the defined benefit obligation, such as rates of salary increases and pension trends, were determined on a country-by-country basis in line with the economic conditions prevailing in each country. The latest country-specific mortality tables are also applied (Germany: Heubeck 2018G; Switzerland: BVG 2020G; United Kingdom: S3PA). The discount rates for defined benefit pension plans are generally determined by reference to discount rates for similar durations and currencies calculated by external actuaries. This was based on bonds with ratings of at least "AA" or a comparable rating from at least one of the leading rating agencies as of the reporting date. The present value of the defined benefit obligation is determined by expert third parties according to the actuarial projected unit credit method. Other countries on settlement Currency effects recognized in income Other effects recognized in income 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 Covering the benefit obligations with financial assets represents a means of providing for future cash outflows, which are required by law in some countries (for example, Switzerland and the United Kingdom) and voluntarily in other countries (for example, Germany). The actual income from plan assets amounted to € 147 million in the year under review (2022: loss of € 395 million). -1,943 2,848 -4,787 December 31, 2023 5 16 -11 Other 1 market No quoted market price in an active market Quoted market price in an active Total 321 179 373 193 180 Real estate 968 968 1,219 1,219 -4 Debt instruments 636 620 620 58 58 74 74 Total No quoted market price in an active market 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. 636 Investment funds 5 4 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 arising from experience adjustments 10 Actuarial gains (+)/losses (-) arising from changes in financial assumptions -350 Actuarial gains (+)/losses (-) arising from changes in demographic assumptions 17 Actuarial gains (+)/losses (-) Remeasurements of defined benefit obligations Items recognized in income Actuarial gains (+)/losses (-) 29 29 -323 20 -16 Currency translation recognized in equity Changes in the scope of consolidation 142 -1 57 86 17 125 Other changes 21 57 -61 147 Payment transactions Employee contributions Employer contributions Pension payments -236 29 58 -22 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. Dec. 31, 2021 Performance cycle 3.76% 3.81% 4.49% 4.52% 4.95% 4.80% 2.15% 2.70% 1.34% 3.84% 2.76% 2.75% Future salary increases 3.74% 3.32% Discount rate In order to minimize fluctuations of the net defined benefit liability, Merck, in managing its plan assets, also pays attention to potential fluctuations in liabilities. The portfolio is structured in such a way that, in the ideal scenario, the impact of exogenous factors on the plan assets and the defined benefit obligations offset each other. Depending on the legal, economic, and fiscal circumstances prevailing in each country, different retirement benefit systems are provided for employees. Newly hired employees are only offered plans whose benefits are based on contributions and the return on their investments. Some of these plans require the employer to guarantee a minimum return on investment. Other plans are generally based on the employee's years of service and salary. Pension obligations comprise both obligations from current pensions and accrued benefits for pensions payable in the future. The value recognized in the consolidated balance sheet for pensions and other post-employment benefits was derived as follows: € million Present value of all defined benefit obligations Fair value of the plan assets Dec. 31, 2023 Future pension increases Duration Dec. 31, 2022 2.14% 0.02% Switzerland Germany Increase (+)/decrease (-) in present value of all defined benefit obligations if € million December 31, 2023 The following overview shows how the present value of all defined benefit obligations would have been impacted by changes to relevant actuarial assumptions: 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% 2.89% 15 2.90% 13 0.03% 15 16 17 19 2.14% 4,787 4,287 -2,848 Benefit based on final salary Annuity 2,429 1 354 Lump sum Installments 1 72 127 2,856 127 1 Benefit not based on final salary Annuity 613 1,060 59 1,732 Lump sum 10 29 Total Other countries United Kingdom Switzerland -2,634 Funded status Effects of the asset ceilings Net defined benefit liability 1,939 1,652 4 1,943 33 1,685 Assets from defined benefit plans United Kingdom 33 1,975 46 1,731 294 Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees The increase in provisions was mainly due to the reduction in the discount rates in the euro area and Switzerland. The defined benefit obligations were based on the following types of benefits provided by the respective plan: Dec. 31, 2023 € million Germany Provisions for pensions and other post-employment benefits 43 Other countries the discount rate were 50 basis points lower the discount rate were 50 basis points higher ☑ 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 5 Switzerland I 89 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 197 5 16 35 140 the expected rate of future pension increase were 50 basis points higher -148 -5 -12 -2 -128 the expected rate of future pension increase were 50 basis points lower 10 Germany Increase (+)/decrease (-) in present value of all defined benefit obligations if € million were 50 basis points higher 109 9 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 expected rate of future pension increase -141 -3 -8 293 Notes to the Consolidated Financial Statements Employees Consolidated Financial Statements December 31, 2022 10 27 109 the life expectancy were 1 year higher -10 -28 Total -110 were 50 basis points higher 212 5 9 44 155 the expected rate of future pension increase were 50 basis points lower -157 -5 the life expectancy were 1 year lower Installments 4 4 Actuarial gains (+)/losses (-) -429 -429 arising from experience adjustments Changes in the effects of the asset ceilings Actuarial gains (+)/losses (-) Actuarial gains (+)/losses (-) Pension payments Employer contributions Employee contributions Payment transactions -32 -32 1,901 -429 -32 1,440 140 -52 88 42 Remeasurements of plan assets 42 arising from experience adjustments 2,099 Currency effects recognized in income Other effects recognized in income Items recognized in income -30 30 1 -2 -306 59 -247 -1 Remeasurements of defined benefit obligations Actuarial gains (+)/losses (-) 7 7 arising from changes in demographic assumptions Actuarial gains (+)/losses (-) 2,099 arising from changes in financial assumptions Actuarial gains (+)/losses (-) -205 -205 -20 19 -1 Paid out 41,813 685,700 Forfeited Potential number offered for the first time in 2021 Potential number of MSU 13,722.30 173.46 3 Years 2023 tranche Jan. 1, 2023 - Dec. 31, 2025 15,684.57 12,995.23 DAX® value (60-day average of the DAX® prior to the start of the performance cycle) 212.16 3 Years 132.43 3 Years Reference price of Merck shares in € (60-day average Merck share price prior to the start of the performance cycle) Term 2022 tranche Jan. 1, 2022 - Dec. 31, 2024 2021 tranche Jan. 1, 2021 - Dec. 31, 2023 643,887 Potential number offered for the first time in 2022 509,033 Forfeited 120 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. 651,200 1,266 1,673 464,022 573,459 Dec. 31, 2023 19,901 22,829 26,455 2,016 Gains (+) or losses (-) on settlement Paid out 672,367 Potential number offered for the first time in 2023 488,524 601,930 Dec. 31, 2022 227 1,253 Paid out 20,282 40,704 Forfeited Past service cost -1 -1 E Annuity Lump sum Installments Other Medical plan obligations 2 555 4 5 Germany Switzerland Dec. 31, 2022 United Kingdom Other countries Total 1 327 72 2,586 130 130 2,186 Benefit not based on final salary Installments Lump sum Other 4 4 Medical plan 18 18 Present value of defined benefit obligations 3,058 1,061 358 2 310 Fair value of the plan assets 1,281 1,022 384 160 2,848 Present value of defined benefit € million Benefit based on final salary Annuity 4,787 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: 879 1,496 January 1, 2022 Current service cost Interest expense Interest income Plan administration costs recognized in income Present value of the defined benefit obligations Fair value of the plan assets Effects of asset ceilings Net defined benefit liability -5,995 2,999 -2,996 -203 -203 -73 -73 34 34 -3 -3 € 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. 33 41 5 5 5 22 22 2,752 881 332 62 323 Fair value of the plan assets 1,202 909 372 152 2,634 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. 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. Consolidated Financial Statements Notes to the Consolidated Financial Statements Employees 295 4,287 129 Dec. 31, 2022 <15 Subsequent measurement at Subsequent measurement at amortized cost Operational Asset type Category Measurement effects of debt instruments are reported in the consolidated balance sheet and the consolidated income statement as follows: Recognition Financial assets are derecognized if the claim for compensation is fulfilled by the other counterparty, if there is no longer a reasonable expectation that the counterparty will fulfill its contractual obligations, or if Merck transfers the contractual rights including all material risks and rewards of the financial asset to another counterparty. fair value through other comprehensive income Derecognition 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, Capital Structure, Investments, and Financing Activities 306 Financial Operational Impairment Financial income and expenses Other operating income or other operating expenses Foreign currency gains or losses Group equity (upon derecognition: reclassification to financial income and expenses) Other operating income or other operating expenses Financial income and expenses operating expenses) derecognition: reclassification to other operating income or other Financial income and expenses Group equity (upon Other operating income or other operating expenses Net gain and net loss on disposal/value adjustments Financial loss fair value through profit or Operational Subsequent measurement at Financial income and expenses Financial and reversals of impairment losses of financial assets (net) Financial income and expenses Impairment losses, losses/reversals of impairment losses Impairment losses, and reversals of impairment losses of financial assets (net) • • 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 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 (€ -90 million) and was paid to E. Merck KG in fiscal 2023. Merck & Cie KmG is a partnership under Swiss law that is controlled by Merck KGaA but distributes its operating result directly to E. Merck KG. This distribution is a payment to shareholders and is therefore also presented under changes in equity. Based on the proposed appropriation of profits, the profit transfer to E. Merck KG for fiscal 2023, including changes in reserves, amounted to € -746 million. This consisted of the profit/loss transfer to E. Merck KG (€ -692 million), the profit transfer to Merck KGaA (€ -4 million), the change in profit carried forward by E. Merck KG (€ 1 million) and the profit transfer from Merck & Cie KmG, Switzerland, to E. Merck KG (€ -52 million). In the previous year, the profit transfer to E. Merck KG including changes in reserves amounted to -868 million. This consisted of the profit transfer to E. Merck KG (€ -684 million), the profit transfer to Merck KGaA (€ 7 million), the change in profit carried forward by E. Merck KG (€ -100 million) and the profit transfer from Merck & Cie KmG to E. Merck KG withdrawal by E. Merck KG -801 -90 -682 -52 Profit transfer to E. Merck KG/ transfer adjusted for trade tax 23 -12 € million Other operating Cash, bank balances and cheques Cash and cash equivalents Detailed information on the measurement methods for financial assets measured at fair value are presented in Note (43) "Information on fair value measurement”. Financial assets are initially measured at fair value and recognized as of the settlement date. For financial assets not subsequently measured at fair value through profit or loss in subsequent periods, initial measurement also includes directly attributable transaction costs. Any difference between the fair value of a financial instrument on initial recognition (Level 2 and 3) and the transaction price is recognized in income using the straight-line method over the duration. Recognition and initial measurement This section does not cover the accounting and measurement policies for derivative financial instruments. They are presented separately in Note (39) "Derivative financial instruments”. Other financial assets Accounting and measurement policies (36) Other financial assets Capital Structure, Investments, and Financing Activities 305 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements € 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. 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 Short-term cash investments (up to 3 months) Result of E. Merck KG before reciprocal profit income or other operating expenses Other operating income or other operating expenses Financial income and expenses 517 80 842 644 198 Subsequent measurement at fair value through other comprehensive income 122 122 597 200 Other 4 4 4 4 1 Loans against third parties 126 200 Equity instruments 643 643 125 Contingent consideration 502 436 66 396 333 63 63 Subsequent measurement at fair value through profit and loss 81 1 80 199 1 198 Debt instruments 516 516 4 122 204 4 Results recognized directly in equity (value adjustments) Reclassification of the cumulative results previously recognized directly in equity in the retained earnings when asset is disposed Financial income Other operating Foreign currency gains and losses recognized directly in equity Dividend income gains or losses 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 Operational Asset type Foreign currency Subsequent measurement at fair value through other comprehensive income Category The following table provides details on the measurement effects of equity instruments on the consolidated balance sheet and the consolidated income statement: 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. Financial income and expenses Financial income and expenses Financial income and expenses (applying the effective interest method) Interest income or expenses Foreign currency gains and losses recognized directly in equity Financial income and expenses Financial income Operational 201 Subsequent measurement at amortized cost Total non-current current Total non-current current € million Dec. 31, 2022 Dec. 31, 2023 At the reporting date, other financial assets were composed as follows: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 307 Financial income Other operating income Other operating income or other operating expenses Financial income and expenses Financial income and expenses Financial Other operating income or other operating expenses Subsequent measurement at fair value through profit or loss 125 changes in reserves -778 E. Merck KG 2022 2023 Result of E. Merck KG before reciprocal profit transfer, adjusted for trade tax € million The reciprocal net profit/loss transfer between E. Merck KG and Merck KGaA as stipulated by the Articles of Association was as follows: The allocation of net profit/loss is based on the net income of both E. Merck KG and Merck KGaA, determined in accordance with the provisions of the German Commercial Code. These figures are adjusted for trade tax and/or corporation tax and create the basis for the allocation of net profit/loss. The adjustment for corporation tax is made to compensate for the difference in the tax treatment between the general partner and the limited liability shareholders. Corporation tax is only calculated on the income received by the limited liability shareholders. Its equivalent is the income tax applicable to the partners of E. Merck KG which must be paid by them directly. The adjustment thus ensures that the share in net profit corresponds to the respective interests held by the two shareholder groups. E. Merck KG and Merck KGaA engage in reciprocal net profit transfers. This makes it possible for E. Merck KG, the general partner of Merck KGaA, and the shareholders to participate in the net profit/loss of Merck KGaA in accordance with the ratio of the general partner's equity interest and the subscribed capital (70.274% or 29.726% of the equity capital). Merck KGaA 2,073 -7 -56 -5 -5 E. Merck KG's share of net profit Dec. 31, 2023 Tax effect Reclassification to assets 2,136 E. Merck KG Merck KGaA -12 partner's equity to equity capital) -684 684 -692 692 (70.274%) Profit transfer to E. Merck KG (ratio of general 974 23 985 -12 (100%) Basis for appropriation of profits 54 4 Corporation tax 919 980 Net income of Merck KGaA before reciprocal profit transfer -88 -920 -1,001 -15 -1,013 -71 16 194 1,117 1,230 -15 -98 1,261 1,159 11 91 1,824 1,992 -23 -145 equity difference recognized in Gains/losses 139 Profit/loss transfer to Merck KGaA (ratio of subscribed capital to equity capital) -5 5 -1,016 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 10 -868 (29.726%) -4 Merck & Cie KMG Total Merck KGaA KMG € million Merck & Cie 2022 2023 Merck KGaA Appropriation of profits and changes in reserves € 284 million (2022: € 284 million), the profit carried forward of the shareholders after the dividend payment would amount to € 34 million (2022: € 34 million). Based on the proposed dividend payment to the shareholders, E. Merck KG would be entitled to withdraw € 682 million (2022: € 801 million), meaning that E. Merck KG would be entitled to a profit brought forward of € 81 million (2022: € 80 million). A dividend of € 2.20 per share was distributed for fiscal 2022. The dividend proposal for fiscal 2023 is unchanged at € 2.20 per share. With the proposed dividend payment to shareholders amounting to 34 -284 318 34 -284 80 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 304 Total Profit transfer to E. Merck KG -52 -90 -746 -694 -52 Profit transfer to E. Merck KG including 7 -100 -100 1 1 Change in profit carried forward of E. Merck KG 7 -4 -4 Profit/loss transfer to Merck KGaA -774 -684 -90 -743 -692 -801 319 Profit carried forward of limited liability shareholders (preliminary) Dividend proposal 2022 2023 Net income € million The profit distribution to be resolved by shareholders also defines the amount of that portion of net profit/loss freely available to E. Merck KG. If the shareholders resolve to carry forward or to allocate to retained earnings a portion of Merck KGaA's net retained profit to which they are entitled, E. Merck KG shall be obliged to allocate to the profit carried forward/retained earnings of Merck KGaA a comparable sum determined according to the ratio of subscribed capital to general partner's equity. This ensures that the retained earnings and the profit carried forward by Merck KGaA correspond to the ownership ratios of the shareholders on the one hand and E. Merck KG on the other hand. Consequently, for distributions to E. Merck KG, the available amount is the amount that results from netting the profit transfer of Merck KGaA with the amount either allocated or withdrawn by E. Merck KG from retained earnings/profit carried forward. This amount corresponds to the sum paid as a dividend to the shareholders and reflects their pro rata shareholding in the company. Based on the profit transfer, the appropriation of profits by Merck KGaA was as follows: Appropriation of profits € 692 million to E. Merck KG (2022: € 684 million). In addition, an expense from corporation tax charges was reported in the amount of € 4 million (2022: expense of € 54 million). 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 303 242 700 285 683 Net income -54 -4 Corporation tax 7 -7 Portion limited 4 Portion liability shareholders 81 Profit carried forward E. Merck KG -682 Withdrawal by E. Merck KG Retained earnings limited liability shareholders Transfer to revenue reserves Withdrawal from revenue reserves Profit carried forward previous year 76 180 34 80 242 700 285 683 Portion limited liability shareholders E. Merck KG Portion E. Merck KG 14 235 250 797 Eurobond 2019/2031 € 500 2,375 July 2030 497 497 797 Eurobond 2022/2030 750 0.500 July 2028 747 748 Eurobond 2020/2028 € 600 € July 2031 0.875 800 June 20793 749 632 Hybrid bond 2019/2079 € 500 1.625 June 20792 498 499 Hybrid bond 2019/2079 € 500 3,375 Dec. 2074¹ 499 499 Hybrid bond 2014/2074 € 0.375 July 2027 598 598 702 Current financial debt 125 122 Lease liabilities (IFRS 16) transactions) 30 77 Liabilities from derivatives (financial 11 20 Loans from third parties and other financial debt 259 206 Liabilities to related parties 203 277 Bank loans 600 1,228 2.875 USD bond 2015/2025 1,498 Eurobond 2019/2027 € 500 1.875 July 2026 498 499 Eurobond 2022/2026 € 750 0.125 July 2025 747 748 Eurobond 2020/2025 USD 1,600 3.250 March 2025 1,444 Bonds (current) 750 Hybrid bond 2020/2080 2,500 375 financing commitments Interest Utilization Financing commitments from banks Utilization commitments from banks Bilateral credit agreement 2,500 Syndicated loan Financing Maturity of Dec. 31, 2022 Dec. 31, 2023 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: 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. 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. Capital management € million variable 2027 375 There were no indications that the availability of extended credit lines was restricted. 203 3,078 284 3,158 2027 fix 7 7 < 1 year variable 203 203 277 277 Various bank credit lines Project financing with banks <3 Jahre variable Information on liabilities to related parties can be found in Note (45) "Related party disclosures”. 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. 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%). A partial buyback of the nominal volume of € 275 million of hybrid bonds issued in 2019 and 2020 took place on November 20, 2023. transactions) Liabilities from derivatives (financial 48 47 Loans from third parties and other financial debt 660 990 Liabilities to related parties 7 Bank loans 8,126 7,802 Bonds (non-current) € 1,000 1.625 Sep. 20804 998 840 Lease liabilities (IFRS 16) € Non-current financial debt less: A partial buyback of the nominal volume of € 250 million of a hybrid bond issued in 2019 took place on September 9, 2022. 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. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 310 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). 4 Merck has the right to prematurely repay this hybrid bond issued in September 2020 for the first time in September 2026. 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. 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. 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. 247 8,328 1,854 1,982 459 7,500 Net financial debt6 Current financial assets5 Cash and cash equivalents 10,428 9,941 366 9,200 9,239 393 Financial debt € 600 0.005 Level 1 <50 Level 1 <50 Level 1 <50 Level 1 <50 <25 Level 3 Level 3 <50 422 436 Fair Value: hierarchy level IFRS 13 Fair value as of Fair Value: hierarchy level IFRS 13 Dec. 31, 2023 <50 Level 3 <50 Level 3 Level 3 <15 Level 3 <15 Storm Therapeutics Limited, UK Level 3 <50 Level 3 <25 Mosa Meat B.V., Netherlands Level 3 <15 Level 3 <25 Celestial AI Inc., United States Level 3 <25 Level 3 <25 Artios Pharma Limited, UK Wiliot Ltd., Israel Precigen, Inc., United States Vera Therapeutics, Inc., United States DNA Script S.A.S., France 7 50 47 3 Derivatives without a hedging relationship 16 16 16 27 27 182 154 28 194 161 33 32 Derivatives without a hedging relationship (financial transactions) Other debt instruments 46 Asceneuron SA, Switzerland 53 Derivatives with a hedging relationship M Ventures portfolio € million Fair value as of Equity interests with subsequent measurement at fair value through other comprehensive income mainly related to shares in the following companies in particular: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 308 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. 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. 1,278 957 321 1,480 981 499 53 53 37 37 Financial assets (operational) (operational) Level 3 <15 Level 3 18 Level 3 14 Level 1 Level 1 2 Level 3 10 Level 3 9 Level 3 22 Level 3 13 InfraServ GmbH & Co. Wiesbaden KG, Germany Level 3 10 Level 3 17 Level 3 Total 643 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 309 Dec. 2023 600 Eurobond 2019/2023 Currency million % Maturity € million € million Interest rate 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: The accounting and measurement policies for 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, financial debt is initially recognized at fair value and subsequently measured at amortized cost using the effective interest method. Financial debt/capital management Accounting and measurement policies (37) Financial debt/Capital management 516 Currency translation Other (no notation in an active market) Telios Pharma, Inc., United States Other (notation in an active market) Level 3 <15 Level 3 <15 Level 3 <15 Level 3 <15 Level 3 <15 Plexium Inc., United States Nouscom AG, Switzerland Formo Bio GmbH, Germany Level 3 <15 Level 3 <15 ElectronInks Inc., United States 1 Other (notation in an active market) Level 1 Level 1 IDRX, Inc., United States Level 1 34 Level 1 0 MoonLake Immunotherapeutics AG, Switzerland Level 1 0 Level 1 152 MoonLake Immunotherapeutics Ltd., Cayman Islands 94 207 Other minority interests Level 3 181 Level 3 200 Other (no notation in an active market) 4 Cost of cash flow hedge reserve 23 Cash flow hedge 16,610 -1,539 63 15,134 3,326 3,326 1,140 -31 1,109 3,326 1,140 -31 4,435 -239 -239 -868 Transactions with no change of control Change in scope of consolidation/Other Dec. 31, 2022 Jan. 1, 2023 Profit after tax earnings Retained for equity instruments plans reserve Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 301 Capital Structure, Investments, and Financing Activities (34) Equity Accounting 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 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. Equity capital/Capital reserves The equity capital of the company consisted of the subscribed capital composed of shares and the equity interest held by the general partner E. Merck KG (general partner's equity). As of the balance sheet date, the company's subscribed capital amounting to € 168 million was divided into 129,242,251 no-par value bearer shares plus one registered share. Each share therefore corresponded to € 1.30 of the subscribed capital. The amount resulting from the issue of shares by Merck KGaA exceeding the nominal amount was recognized in the capital reserves. The equity interest held by the general partner amounted to € 397 million. As in the previous year, there were no changes in subscribed capital in fiscal 2023. Retained earnings Gains/losses recognized in equity Retained earnings developed as follows: Jan. 1, 2022 Profit after tax Gains/losses recognized in equity Comprehensive income Dividend payments Capital increases Profit transfer to/from E. Merck KG including changes in reserves -868 Retained earnings/net retained profit Remeasurement Fair value reserve of defined benefit € million Comprehensive income Accounting and measurement policies -19 -1 -746 -1 Change in scope of consolidation/Other 31 Dec. 31, 2023 20,635 -4 -592 -27 186 Transactions with no change of control 20,228 Capital Structure, Investments, and Financing Activities 302 Gains/losses recognized in equity Gains/losses recognized in equity developed as follows (see also Note (39) “Derivative financial instruments"): € million Jan. 1, 2022 Profit after tax Gains/losses recognized in equity Reclassification to profit or loss Reclassification to assets Dividend payments Consolidated Financial Statements_ Notes to the Consolidated Financial Statements -746 Fair value adjustment Capital increases -2 Profit transfer to/from E. Merck KG including changes in reserves 21 18,811 -401 53 18,463 18,811 -401 53 18,463 Tax effect 2,824 2,824 -284 2,796 160 -284 2,824 -28 -187 160 -187 7,412 current non-current current non-current non-current current Currency Cash flow hedge € million Financial transactions Financial transactions Negative market values Positive market values current non-current December 31, 2023 The fair values of the derivatives were as follows: 1 The virtual power purchase agreements do not have fixed nominal amounts. 10,014 9,487 5,255 Transactions in operating business non-current No hedge accounting 5 47 40 5,255 27 agreements 18 2 47 3 37 Virtual power purchase 27 Currency 2 77 47 3 27 5 37 77 18 Other financial liabilities Other financial assets Financial debt 4,760 Derivatives without a hedging relationship Financial transactions Currency operating business hedging relationship Currency Derivatives with a cash flow Other financial assets Positive market values Virtual power purchase agreements Transactions in during the term Presentation on the balance sheet Market value item Type of Type of hedged collateral Hedging relationship Changes in fair value in the consolidated income statement and the consolidated statement of comprehensive income 77 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: Fair value Transactions in operating business Negative market values Positive market values Negative market values Positive market values Negative market values adjustments (in equity) Fair value adjustments (in equity) 2,075 4,760 2,075 current non-current current Virtual power purchase agreements¹ No hedge accounting Cash flow hedge € million Currency Currency Dec. 31, 2022 Dec. 31, 2023 The nominal amounts of the derivatives held by Merck at the respective reporting dates were as follows: Other operating income Other operating expenses Other financial assets Other financial liabilities Financial income and expenses Other operating expenses at maturity Other operating income 7,412 7 The following table presents the potential netting volume of the reported derivative assets and liabilities: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 123 -83 123 -83 Net presentation Netting presentation Gross -102 -102 114 Potential netting volume 114 presentation Gross Derivative liabilities Derivative assets € million December 31, 2022 Derivative liabilities Derivative assets € million Netting Net presentation December 31, 2023 due to master netting agreements Potential net amount of currency forwards options Time value of € million Spot component Intrinsic Cash flow hedge reserve Forward component Cost of cash flow hedge reserve due to financial collateral 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"): 63 60 -60 amount Potential net due to financial collateral due to master netting agreements Potential netting volume 74 -62 40 -40 -23 18 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. 19 current non-current current current non-current non-current current No hedge accounting Currency Cash flow hedge non-current € million Financial transactions business Financial transactions Transactions in operating Transactions in operating Negative market values Positive market values December 31, 2022 Capital Structure, Investments, and Financing Activities 313 business 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. 53 53 34 30 46 60 16 19 4 46 7 30 Virtual power purchase agreements 16 Currency 19 4 30 46 7 16 30 30 Capital Structure, Investments, and Financing Activities 312 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". 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. In this presentation, effects of cash flow hedges are taken into consideration in the equity of the Group. The net exposure of each of the above currencies consisted of the following components: planned cash flows in the next 12 months in the respective currency, less the nominal values of hedging instruments of these planned cash flows. The planned cash flows in the next 12 months are analyzed and divided into subsets in accordance with the risk management strategy. In the first subset, 25% of a regularly reviewed basket of currencies is hedged. The second subset hedges a more flexible basket of currencies selected on the basis of hedging costs and correlation with the euro. The hedging strategy achieves an economic hedge ratio of at least 40% across all hedging subsets. Depending on scenario analyses, this can be increased to up to 90% using a rule-based approach. As in the previous year, balance sheet items in the above currencies were economically hedged by derivatives in full if they did not correspond to the functional currency of the respective Group company. Accordingly, they do not affect the net exposure presented above. The impact of cash flow hedge accounting for forecast transactions in foreign currency was as follows for the major currencies: December 31, 2023 € million Notional amount CNY 141 JPY TWD USD 922 114 78 52 839 922 114 KRW 78 12 7 -59 100 16 22 15 87 -61 -9 -17 14 -15 Exchange rate +10% (depreciation vs. €) Consolidated income statement Equity (other comprehensive income) 59 -100 42 -16 -22 -15 -87 -182 Consolidated income statement Equity (other comprehensive income) 52 thereof: current January 2024 - December 2024 1:1 Change in value of outstanding hedging instruments since January 1, 2023 22 5 1 6 Change in value of hedged item used to determine hedge effectiveness since -22 -5 January 2024 - December 2024 1:1 -1 -6 January 1, 2023 Weighted average hedging rate 7.63 146.50 1,415.00 33.26 1.10 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. 0 839 1:1 January 2024 - December 2024 1:1 thereof: non-current Fair Value of the hedging instrument 22 5 1 6 thereof: positive market values 23 5 January 2024 - December 2024 1 8 thereof: negative market values -2 -2 January 2024 - Maturity profile December 2024 Hedge ratio¹ 1:1 1 Exchange rate -10% (appreciation vs. €) 867 151 47 thereof: interest accruals 861 861 732 1,241 122 1,119 1,127 47 129 Total Non-current Current Total Non-current Current thereof: liabilities to related parties Miscellaneous other financial liabilities¹ in Mio. € 998 732 Dec. 31, 2022 50 Liabilities from derivatives (operational) Merck only uses derivatives as hedging instruments. Merck uses the dollar offset method as well as regression analyses to measure hedge effectiveness. 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. Derivative financial instruments Accounting and measurement policies (39) Derivative financial instruments The liabilities to related parties primarily consist of liabilities to E. Merck KG. 1 Previous year has been adjusted, please refer to Note (2) "Reporting principles". 1,294 141 50 1,153 147 1,005 Other financial liabilities¹ 53 19 34 25 18 7 1,152 Dec. 31, 2023 Other financial liabilities comprised the following: Total -42 -2 77 9 7 5 52 December 31, 2022 € million -12 Net exposure CNY JPY KRW TWD USD -591 997 163 216 CHF -29 -3 -47 Other financial liabilities Accounting and measurement policies (38) Other financial liabilities 294 117 420 Consolidated income statement Equity (other comprehensive income) -59 47 3 29 12 42 2 -93 -10 -9 -6 -58 Consolidated income statement Equity (other comprehensive income) 59 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements value of options -12 swaps 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 (41) Financing cash flow Capital Structure, Investments, and Financing Activities 316 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements The currency result from equity instruments with subsequent measurement at fair value through other comprehensive income was recognized in other comprehensive income. 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. 31 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". 3 -5 29 1 79 -51 -27 -27 -18 -18 34 30 The change in financial debt was as follows: Cash financial liabilities Other current and non-current 1,195 -420 697 918 E. Merck Beteiligungen KG Financial liabilities to E. Merck KG and 2023 2023 Changes in scope of consoli- Dec. 31, dation Fair value adjust- ment effects Ex- change rate Change in lease liabilities Lease interest Cash Repay- inflows ments Jan. 1, 2023 € million Non-cash Other 9,510 30 1 2023 Subsequent measurement at fair 2 2 2022 Debt Instruments 2023 2022 thereof: investments held 95 2023 derecognized 2023 thereof: investments 2022 Equity Instruments 2023 income value through other comprehensive Subsequent measurement at fair 2022 1 95 2022 2022 Total 2023 2022 relationship (net) 2023 Derivatives without a hedging (without derivatives) 2022 value through profit or loss value through profit or loss Subsequent measurement at fair 2022 amortized cost 2023 Subsequent measurement at Financial debt (without derivatives) 30 30 2023 -5 Financial debt 519 -1,973 1,216 -2,394 Foreign exchange risks The Report on Risks and Opportunities included in the combined management report provides further information on the management of financial risks. Merck uses marketable forward exchange contracts, options and interest swaps as hedging instruments. The strategy to hedge interest rate and foreign exchange rate fluctuations arising from forecast transactions and transactions already recognized in the balance sheet is set by a risk committee, which meets on a regular basis. The use of derivatives is regulated by extensive guidelines and subject to ongoing risk controls by Group Treasury. Speculation is prohibited. The strict separation of functions between trading, settlement and control functions is ensured. Derivatives are only entered into with banks that have a good credit rating. Related default risks are continuously monitored. Market fluctuations with respect to foreign exchange and interest rates represent significant profit and cash flow risks for 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. (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. 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. 1 The previous year's figures have been adjusted, see consolidated cash flow statement. -691 711 -37 Derivative assets (current and non- current) 7 10,428 7 9,510 -13 -13 663 663 97 -16 187 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. . Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 319 -593 USD TWD KRW JPY CNY CHF Exchange rate +10% (depreciation vs. €) Foreign exchange risks from the following transactions are economically hedged through the use of foreign exchange contracts and currency options: Exchange rate -10% (appreciation vs. €) € 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. • intragroup financing in non-functional currency, and Net exposure 10,428 -12 187 Cash € million 2022 -27 -620 609 -16 Derivative assets (current and non- current) 9,941 Non-cash -15 -83 201 -14 8,746 -15 603 -83 201 -14 603 97 Changes Jan. 1, 2022 -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 Change Financial liabilities to E. Merck KG and in scope of consoli- dation Other Fair value adjust- ment effects Ex- change rate in lease liabilities Lease interest Repay- ments Cash inflows Dec. 31, 2022 1 -50 1 -46 -10 474 -7 -5 -4 -6 Dec. 31, 2023 Tax effect -56 Reclassification to assets -59 -36 22 22 98 67 31 -17 22 -95 Reclassification to profit or loss Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 314 Finance income and expenses were as follows: -319 Interest expense and similar expenses Finance income 90 197 2 19 7 Income from the change of the fair value of share-based compensation programs Other interest income (40) Finance income and expenses/Net gains and losses from financial instruments 10 1 1 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 69 153 2022 2023 Interest income and similar income € million 25 -235 -5 Fair value adjustment (directly 106 16 16 Reclassification to profit or loss -98 -26 -73 -15 -26 74 11 -145 -11 -93 -40 -23 -12 -11 Jan. 1, 2022 Total Fair value adjustment (directly recognized in equity) recognized in equity) 13 Reclassification to assets -54 -54 -5 -50 -4 -12 -11 -1 -50 194 -4 -11 -5 2 10 11 Jan. 1, 2023 31 Dec. 31, 2022 Tax effect -12 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 6 4 Other intangible assets 10 18 Property, plant and equipment 17 22 Capitalized borrowing costs for Interest income/expenses and similar income and expenses -30 -9 24 Other interest income/expenses and similar income and expenses -2 -5 Other non-current provisions -7 12 -50 25 39 153 69 -6 -51 -4 2022 amortized cost -3 2023 Subsequent measurement at Financial assets -319 Total Fair value adjustments Net gains and losses Impairment losses/reversal of impairment losses (net) Dividends Currency differences € million 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: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 315 -235 Disposal gains/losses Tax items -39 -61 Interest income 2022 2023 Subsequent measurement at fair value at amortized cost thereof: Financial assets Financial instruments € million Interest and similar income and expenses arose as follows: -187 Interest expenses -125 -322 -2 Financial result Finance costs Other interest expenses -26 -1 -2 Expenses from fair value changes of share-based compensation programs Currency differences from financing activities -277 Interest income Interest expenses 90 Pension provisions -13 -14 Leases -1 Subsequent measurement at fair value through profit or loss -155 -202 Subsequent measurement at fair value at amortized cost -2 11 14 Subsequent measurement at fair value through profit or loss thereof: Financial debt 1 Subsequent measurement at fair value through other comprehensive income -3 22 76 -161 33 -203 of currency Interest rate forwards December 31, 2022 Transactions in operating business Notional amount In financial terms, the most important agreement is the one concluded between Merck and a wind energy project developer in the United States for an installed capacity attributable to Merck of 68 megawatts. The wind farm was commissioned in fiscal 2022. The fair value of the agreement was € 44 million as of the end of the reporting period (2022: € 50 million). The electricity price of around 40% of the expected production volume under this virtual power purchase agreement is hedged by a separate hedging instrument. Consequently, the net effect of the fixed price for the virtual power purchase agreement is zero for this quantity. The accounting provisions on hedge accounting were not applicable. In total, the agreements including the hedging instrument resulted in a net gain on fair value measurement of € 3 million (2022: € 16 million) that was recognized in other operating income. A change in the material valuation parameters would have had the following impact on the fair value of the agreements excluding the hedging instrument: December 31, 2023 Change in expected future electricity Change in expected annual production prices volume 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. Change in cost of capital after tax percentage points percentage points € million +10 -10 +10 percentage points -10 Electricity price risks -100 basis points -17 1,778 855 The effects of a parallel shift in the yield curve by +100 or -100 basis points on the consolidated income statement, as well as on equity relative to all short-term or variable monetary deposits and monetary borrowings within the scope of IAS 32, except contingent considerations, are presented in the following table. In the event of a downward shift, the interest rate for instruments subject to a contractual interest rate floor of zero percent was limited accordingly: € million Change in market interest rate Effects on consolidated income statement Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 320 Effects on equity (other comprehensive income) 2022 +100 basis points 21 -100 basis points -21 +100 basis points 17 2023 2,083 -1,228 +1 Change in the fair value of the virtual power purchase agreements Change in cost of capital after tax percentage points +1 -1 9 -9 -10 5 -2 2 The risk that Merck cannot meet its payment obligations resulting from financial liabilities is limited by establishing the required financial flexibility and by Group-wide cash management. Information on issued bonds and other sources of financing can be found in Note (37) “Financial debt/Capital management”. Liquidity risks are monitored and reported to management on a regular basis. Capital Structure, Investments, and Financing Activities 311 € million -5 -1 +10 +10 19 -19 6 -6 -3 3 -10 December 31, 2022 Change in the fair value of the virtual power purchase agreements Liquidity risks Change in expected future electricity Change in expected annual production prices volume percentage points percentage points € million -625 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Dec. 31, 2023 2,403 3,408 8 2 -3 5 10 134 10 5 45 thereof: negative market values -2 -3 -34 2 Maturity profile 92 3,408 Dec. 31, 2022 thereof: current thereof: non-current Fair value of the hedging instrument thereof: positive market values CNY 933 JPY TWD USD 933 92 158 134 KRW January 2023 - December 2023 158 January 2023 - 3 -5 -10 Weighted average hedging rate 7.32 1,373.00 31.16 1.07 1 The hedging instruments and the corresponding hedged items were denominated in the same currency, therefore the hedge ratio was 1:1. In addition to the transactional foreign exchange risks described previously, currency translation risks resulted from the fact that many of Merck's subsidiaries are located outside the euro area and have functional currencies other than the reporting currency. Exchange differences resulting from translation of the assets and liabilities of these companies into euro, the reporting currency, are recognized in equity. Interest rate risks The Merck Group's net exposure to interest rate changes comprised the following: January 2023 - December 2023 Short-term or variable interest rate monetary deposits Short-term or variable interest rate monetary borrowings Net interest rate exposure € million -2 -8 136.00 10 2023 January 2023 – December 2023 January 2023 - December 2023 Hedge ratio¹ December 1:1 1:1 1:1 1:1 Change in value of outstanding hedging instruments since January 1, 2022 Change in value of hedged item used to determine hedge effectiveness since January 1, 2022 8 2 -3 5 1:1 Jan. 1 Additions Utilizations Reclassifica- tion within levels Effects of currency translation Changes in scope of consolidation Dec. 31 -59 (including current leasing receivables) 4 -2 -63 -23 thereof: Level 1/2 Trade and other receivables -7 € million 1 -99 -7 2 7 -20 -31 -50 11 Net -7 -74 -2 -3 -64 -51 11 -1 2 -1 Equity instruments thereof: Level 3 -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: 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. Fair value determined by official prices and quoted market values (Level 1) Subsequent measurement at fair value through other comprehensive income -31 Financial instruments concerned Description of the measurement technique Main input factors used to determine fair values Shares Financial assets -31 1 Purchased or originated credit-impaired receivables. Loss allowances for financial assets -34 -1 4 -1 -31 thereof: POCI¹ Contract Assets -1 -61 -2 thereof: Level 1/2 thereof: Level 3 Other Receivables (including non-current leasing receivables) thereof: Level 1 thereof: Level 2 thereof: Level 3 -1 -97 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. 11 64 64 4,069 5 1 3 27 36 -9 -4 -2 -12 -35 -63 -3 75 472 3,394 Total 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 -3 Loss allowances accounts receivable Not yet due 0.3% 0.8% Up to 90 days Up to 180 days past due past due 3.2% Up to 360 days past due 19.6% More than 360 days past due 54.6% thereof credit impaired trade 4 -26 Credit risks from other receivables thereof: Level 3 Loss allowances for financial assets 1 Purchased or originated credit-impaired receivables. 2022 Net Reclassifica- tion within Effects of Changes in Jan. 1 Additions Utilizations currency levels translation scope of consolidation Dec. 31 -63 -50 thereof: Level 2 thereof: Level 1 (including non-current leasing receivables) Other Receivables Gross other receivables amounted to € 160 million as of December 31, 2023 (December 31, 2022: € 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. Credit risks from other financial assets Bonds 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 -32 € million (including current leasing receivables) thereof: Level 1/2 thereof: Level 3 thereof: POCI¹ Contract Assets thereof: Level 1/2 thereof: Level 3 Trade and other receivables Derived from active market Derivatives (without a hedging and currency options Quoted prices in an active market Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Counterparty credit risk is taken into consideration for measurements of financial instruments at fair value. In the case of non-derivative financial instruments, such as other liabilities or interest-bearing securities, this is reflected using risk premiums on the discount rate, while discounts on market value (credit valuation adjustments and debit valuation adjustments) are used for derivatives. Transfers between the individual hierarchy levels at fair value are made at the end of the month in which the triggering event - for example an initial public offering - took place. Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 330 Assets from contingent considerations (Level 3) The fair values of assets from contingent considerations are calculated by weighting the expected future cash flows from milestone payments and royalties using their probability of occurrence and discounting them. The main parameters when determining contingent considerations are: • the estimated probability of reaching the individual milestone events, the underlying sales planning used to derive royalties, and . the discount factor used. When determining the probability of occurrence of the individual milestone events in connection with the development of drug candidates, the focus is on empirically available probabilities of success of development programs in comparable phases of clinical development in the relevant therapeutic areas. To determine the sales plan, internal sales plans and sales plans of external industry services are used. The discount rate (after tax) of 6.6% as of December 31, 2023 (December 31, 2022: 6.3% to 7.3%) was calculated using the weighted average cost of capital. Income and expenses from the discounting of probability-weighted future milestone payments and license fees and from changes in discount rates are reported in the financial result. Significant discretionary decisions and sources of estimation uncertainty Equity investments in unlisted companies Determining the parameters that are to be included in discounted cash-flow-methods and deriving the fair value from observable prices within the scope of equity refinancing are both subject to discretionary decisions and estimation uncertainty. Electricity future price curves, expected electricity production volumes, discount factors Discounting of probability- weighted future milestone payments and license fees Use of recognized actuarial methods Contingent considerations from the purchase of businesses Nominal value less factoring fees Discounting of expected future cash flows Discounting of probability- weighted future milestone payments and license fees Discounting of expected future cash flows Consideration of the fair value of companies in which the funds are invested Use of recognized actuarial methods Acquisition cost Nominal value of potentially sold trade accounts receivable, average fees for sales of trade accounts receivable Assets from contingent consideration Electricity future price curves, expected electricity production volumes, discount factors Net asset values of the fund interests Interest rates observable on the market Financial liabilities Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Hedging instrument for virtual power purchase agreements Contingent consideration Sales planning, milestone payments, probabilities of regulatory and commercial events, discount rates Expected cash flows from recent business planning, discount rates The calculation of the fair value of assets from contingent considerations is subject to significant discretionary judgment. The most significant contingent consideration was the future purchase price claim from the sale of the biosimilars business to a subsidiary of Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, Germany, on August 31, 2017. It was calculated by an external valuation expert on initial recognition in 2017 and continued on this basis. As of December 31, 2023, the carrying amount was € 118 million (December 31, 2022: € 219 million). If, in the context of determining the fair value of this contingent consideration at the balance sheet date, the probability of approval as well as the discount factor of the most important development programs had been estimated to be lower or higher, this would have led to the following changes in the measurement and the corresponding effects on the profit before income tax: Change in probability of regulatory approval € million -10% unchanged 10% 5.8% -18 3 3 6.3% Change of discount rate -21 20 (unchanged) 6.8% -24 24 Bonds with embedded settlement option for equity in an unlisted company -3 7.1% December 31, 2023 € million Change of discount rate December 31, 2022 Change in probability of regulatory approval -10% unchanged -8 10% -3 3 9 6.6% -6 6 (unchanged) 6.1% Other debt instruments Interests in unlisted funds Contingent considerations from the sale of businesses or shares in corporations Description of the measurement technique Forward exchange contracts Derivatives (without a hedging and currency options relationship) Interest rate swaps Derivatives (with a hedging relationship) Forward exchange contracts and currency options Financial liabilities Subsequent measurement at fair value through profit or loss Forward exchange contracts -78 relationship) Interest rate swaps Derivatives (with a hedging relationship) Financial instruments concerned Subsequent measurement at fair value through profit or loss Financial assets Fair value determined using input factors observable in the market (Level 2) Other short-term cash investments Subsequent measurement at fair value through profit or loss Other debt instruments Financial liabilities Subsequent measurement at amortized cost Forward exchange contracts and currency options Financial debt Derived from active market Bonds Derived from active market Quoted prices in an active market Quoted prices in an active market Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 328 Publicly-traded funds Other short-term cash investments Subsequent measurement at amortized cost Financial liabilities Liabilities to banks and other loan liabilities Description of the measurement technique Equity instruments Equity investments in unlisted companies Discounting of expected future cash flows Main input factors used to determine fair values Expected cash flows from recent business planning, average cost of capital, expected long-term growth rate Derived from observable prices within the scope of equity refinancing sufficiently close to the balance sheet date, considered risk allowances Financial instruments concerned Cost-based determination Trade and other receivables Subsequent measurement at fair value through profit or loss Derivatives (without a hedging relationship) Contingent consideration Other debt instruments Trade accounts receivable that are intended for sale due to a factoring agreement Virtual power purchase agreements Observable prices derived from equity refinancing Loans with variable repayments Subsequent measurement at fair value through other comprehensive income Fair value determined using input factors unobservable in the market (Level 3) Main input factors used to determine fair values Use of recognized actuarial methods Use of recognized actuarial methods Spot and forward rates observable on the market as well as exchange rate volatilities Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Financial assets Use of recognized actuarial methods Spot and forward rates observable on the market as well as exchange rate volatilities Interest rate curves available on the market Spot and forward rates observable on the market as well as exchange rate volatilities Discounting of future cash flows Interest rates observable on the market Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 329 Use of recognized actuarial methods -46 Trade accounts receivable before loss -4 Bonds and commercial paper¹ 8,726 -147 -600 -363 -5,352 -111 -2,801 Bank loans 203 -5 -203 Trade accounts payable² 2,499 -2,499 amortized cost Subsequent measurement at Repayment Interest -256 -5,885 -15 -113 -137 -2,521 1 For the hybrid bonds, repayment is assumed at the earliest possible date. December 31, 2022 Cash flows <1 year Liabilities to related parties Cash flows Cash flows >5 years Carrying € million amount Interest Repayment Interest Repayment 1-5 years -370 1,780 -1,121 53 -34 -4 -7 -12 relationship Derivatives with a hedging relationship Refund liabilities Finance lease liabilities 30 -30 912 -912 491 -9 4 Derivatives without a hedging Contingent considerations value through profit or loss -81 -110 -53 -550 Other financial liabilities² 376 -258 -25 -118 59 59 -5 -10 -10 -48 Subsequent measurement at fair Loans from third parties and other financial debt -6,127 -225 14,515 7,802 Bank loans 283 -164 -8 -1,000 -241 -277 -1 -4,888 -7 -63 -1,934 Trade accounts payable 2,545 -2,545 Liabilities to related parties Bonds and commercial paper¹ amortized cost Repayment Interest -3 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 1,928 Cash flows < 1 year Cash flows > 5 years Carrying amount Interest Repayment Interest Repayment Cash flows 1-5 years -37 -938 -97 -79 -8 -10 relationship Derivatives with a hedging relationship Refund liabilities 96 Lease liabilities -5 877 -877 515 -11 -120 -22 5 -123 Derivatives without a hedging 2 -550 -35 -440 Other financial liabilities 393 -266 -127 -2 Loans from third parties and other financial debt -5 -20 -9 -47 Subsequent measurement at fair value through profit or loss Contingent considerations 68 15,134 -191 -5,790 994 648 7 3,012 302 17 471 60 521 4 585 1,575 1,817 669 7 1,363 153 Group Other Electronics 565 10 2,838 280 15 454 66 4,069 2 1,484 1,892 582 10 3,969 Life Science Healthcare 676 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 325 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. Loss allowances based on expected credit losses for trade accounts receivable as of December 31, 2023, were as follows: 73 3,969 10 1 4 18 46 55 80 -3 -5 -22 -53 -97 -9 -1 -15 1,003 67 3,342 December 31, 2023 € million Expected loss rate allowances thereof: credit impaired Loss allowances thereof credit impaired trade 432 accounts receivable 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 Not yet due -18 1,260 158 Other 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. 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 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. Impairment of trade accounts receivable and contract assets -17 -471 -264 -5,904 -9 -173 -101 -3,463 1 For the hybrid bonds, repayment is assumed at the earliest possible date. Credit risks 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 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 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 regarding: the identification of customer groups with identical default risks, 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. Credit risks from trade accounts receivable The credit risk from trade accounts receivable is largely impacted by the specific circumstances of individual customers. Merck also 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. This is done in particular by analyzing the aging structure of trade accounts receivable. Merck continuously reviews and monitors the open positions of all its customers in the corresponding countries and takes steps to mitigate credit risks if necessary. The tables below contain an overview of the credit risk by business sector and country rating as established by leading rating agencies: 1 December 31, 2023 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 € million Group -1 -50 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: -7 € million of trade accounts receivable of contract assets of debt instruments subsequently measured at amortized cost 2023 2022 -51 -6 Impairment losses 609 17 Gernsheim 436 25 -5 -307 -3 -62 -20 710 of Dec. 31, 2023 Disposals during the reporting period related in particular to payments received in connection with the contingent consideration arising from the sale of the biosimilars business to Fresenius SE & Co. KGaA, Bad Homburg vor der Höhe, as well as trade accounts receivable under factoring agreements. The reclassification of the fair value of Calypso Biotech B.V., Netherlands, to assets held for sale is included in the "Other" line item. The gains and losses from Level 3 assets recognized in other comprehensive income were reported in the consolidated statement of comprehensive income under the item "Fair value adjustments". Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 335 The following equity instruments measured at fair value through other comprehensive income were disposed of in 2023 and 2022: € million 20231 50 Fair value on the date 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 income Transfer of the cumulative gains (+) or losses (-) within group equity to retained earnings 29 18 17 third parties Reasons for the disposal 125 95 Net carrying amounts as assets/liabilities held as of the balance sheet date 5 10 I 14 Gains (+)/losses (-) recognized in other 47 47 comprehensive income Currency translation -2 -3 -1 I difference Disposals -51 -11 Other into Level 1/Level 2 I -3 Partial sale Transfers out of Level 3 2 -69 -29 -2 -190 -21 3 thereof: attributable to 11 10 (%) Registered office Steinheim Sigma-Aldrich Biochemie GmbH Company Germany Country Equity interest 340 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. Grundstücksverwaltungsgesellschaft mbH A) 100.00 100.00 Darmstadt thereof: Merck KGaA (%) Germany 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 Hohenbrunn Merck Schuchardt OHG 100.00 100.00 Germany Sigma-Aldrich Chemie GmbH 10 Portfolio M Ventures Portfoliogesellschaften adjustment/restructuring and full acquisition by third parties Merck Chemicals and Life Science GesmbH Austria countries Other European 100.00 Darmstadt Versum Materials Germany GmbH Germany 100.00 100.00 Steinheim Sigma-Aldrich Verwaltungs GmbH Germany Steinheim 100.00 Germany Sigma-Aldrich Chemie Holding GmbH Taufkirchen 100.00 10 Germany Steinheim 100.00 Germany Sigma-Aldrich Logistik GmbH Steinheim 100.00 Sigma-Aldrich Grundstücks GmbH & Co. KG income and expenses) statement (financial 14 6 of the balance sheet date Gains (+)/losses (-) recognized in other -11 -11 comprehensive income Currency translation 2 2 -1 I -3 difference 1 Disposals -46 -4 -1 -68 10 -131 Transfers out of Level 3 I -11 I -11 into Level 1/Level 2 Other -7 -21 9 -4 assets/liabilities held as recognized in the consolidated income 17 15 30 30 -13 79 statement (other operating result) thereof: attributable to assets/liabilities held as 17 7 30 4 -13 thereof: attributable to income and expenses) statement (financial 16 -1 1 7 10 consolidated income recognized in the Gains (+)/losses (-) date of the balance sheet 44 -4 Net carrying amounts as 93 250 806 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 1 69 statement (other 10 5 consolidated income recognized in the Gains (+)/losses (-) date -23 of the balance sheet 1 16 10 assets/liabilities held as thereof: attributable to operating result) 16 Germany -4 415 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 The changes in financial assets and liabilities for each of the individual classes of financial instruments allocated to Level 3 and measured at fair value were as follows in fiscal 2023: 2023 Financial assets Financial liabilities Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss Other debt € million 53 250 93 Total Derivatives without a hedging relationship other Contingent receivables consideration 22 Trade and Derivatives without a hedging relationship Contingent consideration instruments Additions of Jan. 1, 2023 Net carrying amounts as Equity instruments Gains (+)/losses (-) 100.00 Darmstadt 0.2 0.4 1 The owner of Engel-Apotheke, Darmstadt, is a member of the Supervisory Board of Merck KGaA. As in the previous year, the liabilities of Group companies in respect of E. Merck KG primarily resulted from mutual profit transfers between Merck KGaA and E. Merck KG as well as the profit transfer by Merck & Cie KMG, Switzerland, to E. Merck KG. They included financial debt of € 94.7 million (December 31, 2022: € 258.0 million), subject to standard market interest rates. The financial debt in respect of E. Merck Beteiligungen KG in the amount of € 1,100.0 million (December 31, 2022: € 660.0 million) were also subject to standard market interest rates. There was no collateral or guarantees either in favor of or at the expense of Merck. Loss allowances on receivables from non-consolidated subsidiaries recognized in the reporting period and previous periods amounted to € 19.0 million in total as of December 31, 2023 (December 31, 2022: € 12.0 million). The expense from impairment losses recognized in 2023 amounted to € 7.0 million (2022: € 0.0 million). Information on pension funds that are classified as defined benefit plans in accordance with IAS 19 can be found in Note (33) "Provisions for employee benefits". Information on Executive Board and Supervisory Board compensation can be found in Note (46) "Executive Board and Supervisory Board compensation". Above and beyond this, no material activities between companies of the Merck Group and members of the Executive Board or the Supervisory Board of Merck KGaA, the Executive Board or the Board of Partners of E. Merck KG, or members of their immediate families took place in either fiscal 2023 or the previous year. 337 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures (46) Executive Board and Supervisory Board compensation 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: € million Fixed compensation Variable compensation 1.8 Other compensation Short-term benefits Post-employment benefits Other long-term benefits Termination benefits Share-based payments Total compensation pursuant to IAS 24.17 2023 2022 6.3 6.3 18.5 17.7 0.6 0.4 Additional benefits 2.9 0.6 0.6 Joint ventures 2.3 3.2 0.0 0.0 0.6 0.5 0.0 0.0 Associated companies 0.9 0.1 0.0 0.0 19.5 3.0 0.0 0.1 0.2 Non-consolidated subsidiaries companies 1.2 0.9 0.2 6.7 0.0 0.0 0.4 0.3 Majority interest in non-controlled 0.0 0.0 0.0 0.2 24.6 Total 2023 thereof: Deloitte GmbH Wirtschafts- prüfungs- gesellschaft, Group Germany 10.6 3.9 0.4 0.3 11.0 4.2 The expenses for other audit-related services to Deloitte GmbH Wirtschaftsprüfungsgesellschaft primarily arose for the audit of the non-financial statement and the sustainability report. Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures Other services 339 (48) List of shareholdings The shareholdings of Merck KGaA as of December 31, 2023, are presented below: Country Company I. Fully consolidated companies Equity interest Registered office (%) thereof: Merck KGaA (%) Germany Parent Germany Germany Merck KGaA Scope of Consolidation Audits of financial statements Other audit-related services Tax consultancy services € million 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: 2.6 2.4 0.7 0.0 0.0 0.0 3.8 5.8 32.7 32.7 The total compensation granted to members of the Executive Board as referred to by section 314 (1) no. 6 a) HGB amounted to € 30.1 million in fiscal 2023 (2022: € 30.4 million). In addition to the short-term benefits shown in the table above, this also includes compensation under the standalone long-term incentive plan for the Executive Board, the structure of which is essentially as described in Note (33) "Provisions for employee benefits", and other long-term benefits. On the basis of the long-term incentive plan, 57,164 virtual shares, also referred to as Merck Share Units (MSU), were made potentially available in fiscal 2023 (2022: 43,436 MSU). Payments to former members of the Executive Board and their surviving dependents in accordance with section 314 (1) no. 6 b) HGB were made as pension payments, as profit sharing, under the long-term incentive plan and waiting allowance for a post-contractual non-competition clause. These payments amounted to € 14.4 million in fiscal 2023 (2022: € 21.7 million). Provisions for defined benefit pension commitments carried by E. Merck KG amounted to € 123.8 million as of December 31, 2023 (December 31, 2022: € 123.1 million). The compensation of the Supervisory Board in accordance with section 314 (1) no. 6 a) HGB and IAS 24.17 was composed as follows: € thousand Fixed portion Meeting attendance fees Committee membership compensation Total compensation granted in the fiscal year (47) Auditor's fees 338 Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 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. 968 961 25.6 105 48 58 815 808 2022 2023 95 0.0 0.0 0.0 Darmstadt Merck International GmbH Germany 100.00 100.00 Gernsheim Merck Holding GmbH Germany 100.00 Darmstadt Merck Healthcare KGaA A) Germany 100.00 100.00 100.00 Darmstadt Germany 100.00 100.00 Weiterstadt Merck Healthcare Germany GmbH A) Germany 100.00 Darmstadt Merck Gernsheim Holding GmbH A) Germany 4 -19 -19 1 Disposals due to liquidations are not included. Merck Healthcare Holding GmbH 100.00 Germany Merck Internationale Beteiligungen GmbH Merck Real Estate GmbH A) Germany 100.00 100.00 Darmstadt Merck Performance Materials Holding GmbH Germany 100.00 Wiesbaden Merck Performance Materials GmbH Germany 100.00 Darmstadt Merck Patent GmbH A) Germany 100.00 100.00 Darmstadt 100.00 Germany Merck Life Science Holding GmbH Darmstadt 100.00 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. 100.00 Merck Life Science KGaA A) Darmstadt 100.00 Germany Merck LS RTU GmbH A) Darmstadt Germany (44) Other financial obligations Other financial obligations comprised the following: € million Receivables Liabilities € million 2023 2022 2023 2022 Dec. 31, 2023 Dec. 31, 2022 Dec. 31, 2023 Dec. 31, 2022 E. Merck KG 2.3 1.9 11.3 4.0 0.1 0.0 826.5 1,118.8 0.2 0.0 0.1 0.1 Engel-Apotheke, Darmstadt¹ 660.1 Expenses 1,100.1 0.0 0.6 32.4 0.5 0.4 E. Merck Beteiligungen KG 0.0 100.00 Income 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. Acquisition of intangible assets Acquisition of property, plant, and equipment Other financial obligations Dec. 31, 2023 1,431 Dec. 31, 2022 483 1,914 1,050 280 1,330 Obligations to acquire intangible assets existed in particular owing to contingent considerations within the scope of in-licensing and research and development collaborations. In these agreements, Merck has entered into an obligation to make milestone payments once specific targets have been reached. In the unlikely event that all of the milestones are achieved, Merck would be obligated to pay up to € 1,431 million (December 31, 2022: € 1,050 million) for the acquisition of intangible assets. The table above does not contain any other financial obligations from possible future sales-based license fees and milestone payments. 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. Dec. 31, 2023 Dec. 31, 2022 Related party disclosures Accounting and measurement policies (45) Related party disclosures Other Disclosures Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 336 Transactions were conducted with related parties as follows: 1,050 676 604 326 548 48 278 1,431 AmpTec GmbH A) Fair value changes Transfers into Level 3 from Carrying amount Fair value¹ Fair value determined by official prices and quoted market Fair value determined using input factors observable in the market (Level 2) Fair value determined using input factors not observable in the market (Level 3) Total Consoli- dated notes cost Current values Total (Level 1) Cash and cash equivalents 35 1,982 1,982 Trade and other receivables (excluding 25 3,973 25 3,998 leasing receivables) Other debt instruments Non- current Subsequent measurement at amortized Financial assets € million 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 December 31, 2023 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: Capital Structure, Investments, and Financing Activities 331 Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Vienna 100.00 36 Austria Vienna 100.00 Austria Sigma-Aldrich Handels GmbH Vienna 100.00 Merck Gesellschaft mbH Merck d.o.o. 201 204 194 98 95 194 Derivatives without a hedging 36, 39 30 47 77 relationship Derivatives with a hedging relationship 36, 39 37 37 161 WN 50 77 37 37 Lease receivables (measured in 25 6 3 9 accordance with IFRS 16)² Total 6,485 1,008 7,493 27 33 36 Other debt instruments Subsequent measurement at fair value through other comprehensive income Equity instruments Trade and other receivables Other debt instruments 323 36 643 643 207 436 643 25 25 25 25 25 125 125 125 125 36 Contingent considerations 4 through profit or loss 199 199 199 1 198 36 Subsequent measurement at fair value Zagreb 100.00 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 505 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. Lyon 99.86 France Merck Santé S.A.S. 100.00 Level 1/Level 2 65 1,300 833 1,174 Financial liabilities Subsequent measurement at amortized cost Trade accounts payable³ 30 2,499 2,499 Financial debt 37 1,073 8,834 9,907 7,989 70 1,188 Other financial liabilities4 38 1,119 118 1,237 Subsequent measurement at fair value through profit or loss Contingent consideration 38 4 4 4 4 Derivatives without a hedging 9,177 271 7,273 984 Other debt instruments 36 28 154 182 89 93 182 Derivatives without a hedging 36, 39 23 46 69 17 53 69 relationship 6,289 Total measured in accordance with IFRS 16)² 7 2 5 37, 38, 25 53 53 53 53 36,39 Derivatives with a hedging relationship Finance lease receivables (to be 250 34 53 Financial assets Financial liabilities Subsequent measurement at fair value through profit or loss Subsequent measurement at fair value through other comprehensive income Subsequent measurement at fair value through profit or loss Other debt € million instruments Contingent consideration Derivatives without a hedging relationship Trade and Equity instruments other Contingent receivables consideration Derivatives without a hedging relationship 2022 Total 78 271 24 345 20 -39 -10 689 of Jan. 1, 2022 Additions 27 87 70 184 Net carrying amounts as 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: Consolidated Financial Statements_ Notes to the Consolidated Financial Statements Capital Structure, Investments, and Financing Activities 333 4 Previous year's figures have been adjusted, see Note (2) "Reporting Principles". 30 23 53 relationship 39 Derivatives with a hedging relationship 38, 39 30 30 30 30 Refund liabilities 9 912 912 Finance lease liabilities (to be measured 37 3 Previous year's figures have been adjusted, see Note (6) "Acquisitions and Divestments". 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. 9,265 27 1,248 19 7,989 5,792 Total in accordance with IFRS 16)² 491 366 125 9,342 15,134 250 250 235 Derivatives with a hedging relationship 38, 39 5 5 5 2 2 20 96 5 Refund liabilities 9 877 877 20 Lease liabilities (measured in accordance with IFRS 16)² 122 393 515 Total 5,129 9,387 14,515 7,367 2,747 22 10,136 1 The simplification option under IFRS 7.29(a) was used for disclosures of certain fair values. IFRS 7.29(d) explicitly does not require disclosure of the fair value of lease liabilities. 2 Measurements within the scope of IFRS 16 are exempted from the requirements of IFRS 13 (IFRS 13.6(b)). Consolidated Financial Statements_ Notes to the Consolidated Financial Statements 37 39 relationship 77 Financial liabilities Subsequent measurement at amortized cost Trade payables and other liabilities 30 2,545 2,545 Financial debt 37 503 8,846 9,349 7,367 2,665 10,032 Other financial liabilities 38 96 18 79 37, 38, Derivatives without a hedging 2 Capital Structure, Investments, and Financing Activities 332 2 Contingent considerations through profit or loss Subsequent measurement at fair value 1,125 127 998 38 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 122 4 126 Subsequent measurement at fair value through other comprehensive income Equity instruments 36 516 516 102 415 516 Trade accounts receivable and other 25 22 22 22 14 36 Contingent consideration through profit or loss Subsequent measurement at fair value 81 36 81 1 80 36 Debt instruments receivable 22 81 731 Other debt instruments 4,112 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 (Level 3) Total quoted Consoli- dated market notes 25 4,087 100.00 receivable (excluding leasing Trade accounts receivable and other 1,854 receivables) 1,854 Cash and cash equivalents (Level 1) Total values Non- current Current 35 Darmstadt 25 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 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 Merck Consumer Health Holding Germany GmbH Darmstadt 100.00 Merck Financial Trading GmbH Germany 100.00 100.00 Darmstadt Merck Financial Services GmbH Germany 100.00 100.00 Germany Darmstadt Germany 100.00 Darmstadt Merck Electronics KGaA A) Germany 100.00 Darmstadt Merck Display Trading GmbH A) 100.00 Merck Export GmbH A) Germany Germany Germany Germany company Hamburg 100.00 Germany Darmstadt 100.00 Germany Biochrom GmbH A) Berlin 100.00 Germany AZ Electronic Materials GmbH A) Germany 100.00 100.00 Germany Emedia Export Company mbH Gernsheim 100.00 Germany Germany Germany Chemitra GmbH A) Buchs 100.00 Merck Serono SA Sigma-Aldrich Chemie GmbH Buchs Switzerland Sigma-Aldrich (Switzerland) Holding AG Switzerland 100.00 Eysins SeroMer Holding SA 100.00 Aubonne 100.00 Switzerland Footnotes follow at the end of the table. Sigma-Aldrich International GmbH 342 Buchs Epichem Group Limited BioReliance Limited Merck Ilac, Ecza Ve Kimya Ticaret Anonim Sirketi Sigma-Aldrich Production GmbH Switzerland Company Switzerland United Kingdom United Kingdom Türkiye Switzerland Country thereof: Equity interest Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 100.00 100.00 Merck Performance Materials (Suisse) SA Madrid 100.00 Sweden Merck AB Solna 100.00 Sweden Merck Life Science AB Solna 100.00 Switzerland Ares Trading SA Aubonne Registered office Buchs 100.00 Merck, S.L.U. Eysins Spain Madrid Switzerland 100.00 Zug Merck (Schweiz) AG Switzerland 51.63 51.63 Altdorf Merck & Cie KmG Switzerland Eysins Chord Therapeutics SA Switzerland Spain Merck Life Science S.L.U. 100.00 (%) Feltham 100.00 North America 100.00 Feltham Versum Materials UK Limited United Kingdom 100.00 Canada Gillingham United Kingdom 100.00 Gillingham SAFC Hitech Limited United Kingdom 100.00 Sigma-Aldrich Company Limited Canada EMD Crop BioScience Canada Inc. EMD Inc. Toronto 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 Mississauga 100.00 Gillingham SAFC Biosciences Limited United Kingdom 100.00 100.00 Feltham Merck Investments Ltd. United Kingdom 100.00 Feltham Merck Holding Ltd. United Kingdom 100.00 Gillingham 100.00 Aberdeen 100.00 Istanbul 100.00 United Kingdom Merck KGaA (%) Merck Life Science UK Limited 100.00 100.00 100.00 Feltham Millipore (U.K.) Limited Merck Serono Ltd. United Kingdom United Kingdom 100.00 Feltham Merck Serono Europe Limited United Kingdom 100.00 Feltham Merck Performance Materials Limited United Kingdom Gillingham Madrid Warsaw Spain Netherlands 100.00 Amsterdam Merck Chemicals B.V. Netherlands 100.00 Merck Europe B.V. Schiphol-Rijk Netherlands 100.00 100.00 Veldhoven 100.00 Pietà Merck B.V. Amsterdam 100.00 Netherlands 21.54 Schiphol-Rijk Serono Tri Holdings B.V. Netherlands 100.00 Amsterdam Merck Ventures B.V. Netherlands 100.00 Amsterdam Merck Life Science N.V. Netherlands 100.00 Schiphol-Rijk Merck Holding Netherlands B.V. eyrise B.V. Merck Capital Limited Netherlands Malta Luxembourg Merck Re S.A. Luxembourg 100.00 Luxembourg Merck Invest SCS Luxembourg 100.00 Luxembourg Merck Holding S.à r.l. Luxembourg 100.00 Luxembourg Merck Finanz S.à.r.l. Luxembourg 100.00 100.00 100.00 Millipore International Holdings S.à r.l. 50.29 100.00 Pietà Merck Capital Holding Limited Malta 100.00 Luxembourg Sigma-Aldrich S.a.r.l. Luxembourg 100.00 Luxembourg Sigma-Aldrich Global S.a.r.l. Luxembourg 100.00 Luxembourg Luxembourg Netherlands Sigma-Aldrich B.V. Amsterdam Moscow Merck LLC Merck Life Science LLC Russia Russia 100.00 Bucharest Merck Romania S.R.L. Romania 100.00 Algés Merck, S.A. Portugal 100.00 United States 100.00 Merck Sp. z o.o. Moscow Serbia 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 100.00 Merck Chemicals and Life Science S.A.U. Poland Poznan Versum Materials Netherlands B.V. Netherlands 100.00 Amsterdam Versum Materials International B.V. Netherlands 100.00 Amsterdam Versum Materials Holdings Nederland B.V. Netherlands 100.00 Amsterdam Versum Materials Asia B.V. Netherlands 100.00 Amsterdam 100.00 100.00 Netherlands Merck Life Science Sp. z o.o. Poland 100.00 Wroclaw Merck Business Solutions Europe Sp. z o.o. Poland 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 100.00 Aldrich-APL, LLC 100.00 100.00 New Zealand New Zealand Philippines Philippines Merck Ltd. Auckland 100.00 Sigma-Aldrich New Zealand Co. Auckland 100.00 Merck Business Solutions Asia Inc. Taguig 99.99 Merck Inc. Taguig 100.00 Republic of Korea Merck Performance Materials Hong Kong Ltd. Merck Pharmaceutical (HK) Ltd. China Kuala Lumpur China Versum Materials Malaysia Sdn Bhd Petaling Jaya Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures 344 Equity interest Country Japan Malaysia Merck Sdn Bhd Malaysia Malaysia Company Versum Materials Japan Inc. Sigma-Aldrich (M) Sdn Bhd Registered office (%) thereof: Merck KGaA (%) Tokyo 100.00 Petaling Jaya 100.00 100.00 100.00 Hong Kong 100.00 100.00 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 Bayswater 100.00 Macquarie Park 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 Footnotes follow at the end of the table. Guangzhou Shanghai 100.00 100.00 100.00 Shanghai 100.00 Shanghai 100.00 Macquarie Park 100.00 Australia 100.00 Sigma-Aldrich Japan G.K. Shanghai 100.00 Shanghai 100.00 China Sigma-Aldrich (Shanghai) Trading Co., Ltd. Shanghai 100.00 Sigma-Aldrich (Wuxi) Life Science & Technology Co., China Wuxi 100.00 Ltd. China Versum Materials (Dalian) Co., Ltd. Dalian 100.00 China Versum Materials (Shanghai) Co., Ltd. Merck Testing and Certification (Shanghai) Co., Ltd. SAFC Hitech (Shanghai) Co., Ltd. Shanghai China 100.00 Hong Kong 100.00 China China Merck Pharmaceutical Distribution (Jiangsu) Co., Ltd. Merck Pharmaceutical Manufacturing (Jiangsu) Co., Ltd. Nantong 100.00 Nantong 100.00 China Merck Serono (Beijing) Pharmaceutical Distribution Co., Ltd. Beijing 100.00 China China Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd. Merck Serono Co., Ltd. Beijing 100.00 Beijing China 100.00 India Merck Life Science Pvt. Ltd. Tokyo 100.00 Japan Merck Electronics Ltd. Tokyo 100.00 Japan Merck Holdings G.K. Tokyo 100.00 Japan Merck Ltd. Tokyo 100.00 Japan Merck Performance Materials G.K. Tokyo 100.00 Japan Merck Biopharma Co., Ltd. Japan 86.65 Jakarta Mumbai 100.00 India Merck Performance Materials Pvt. Ltd. Mumbai 100.00 India Merck Specialities Pvt. Ltd. Mumbai Tokyo 100.00 Sigma-Aldrich Chemicals Private Limited Bangalore 100.00 Indonesia P.T. Merck Chemicals and Life Sciences Jakarta 100.00 Indonesia P.T. Merck Tbk. India Urbana Australia Australia Exelead Inc. United States 100.00 Rockland EMD Serono, Inc. United States 100.00 Billerica EMD Serono Research & Development Institute, Inc. United States 100.00 Rockland EMD Serono Holding, Inc. United States 100.00 Wilmington EMD Performance Materials Corp. United States 100.00 Wilmington Burlington 100.00 United States 100.00 Wilmington 100.00 Glendale 100.00 Wilmington 100.00 Wilmington 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 United States United States EMD Millipore Corporation United States 100.00 West Trenton Electron Transfer Technologies, Inc. United States 100.00 Round Rock Cerilliant Corporation United States 100.00 Rocklin Cell Marque Corporation United States 100.00 Rockville BioReliance Corporation United States 100.00 Wilmington BioControl Systems, Inc. United States 100.00 United States EMD Accounting Solutions & Services America, Inc. Rockland Wilmington 100.00 Rockland EMD Invest LLC EMD Holding Corp. United States United States 100.00 Wilmington Wilmington EMD Group Holding, Inc. 100.00 Wilmington EMD Finance LLC United States 100.00 Burlington EMD Digital Inc. United States 100.00 United States Australia 100.00 100.00 100.00 The Woodlands 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. United States Sigma-Aldrich Research Biochemicals, Inc. Sigma-Aldrich RTC, Inc. Supelco, Inc. 100.00 100.00 Wilmington United States 100.00 Wilmington Versum Materials US, LLC United States 100.00 Wilmington Versum Materials US International, Inc. United States 100.00 Wilmington Versum Materials Technology LLC United States 100.00 Wilmington Versum Materials Manufacturing Company, LLC United States Bellefonte Sigma-Aldrich Missouri Insurance Company Sigma-Aldrich Manufacturing LLC Sigma-Aldrich Corporation Sigma Chemical Foreign Holding LLC United States 100.00 Rockland Serono Laboratories, Inc. United States 100.00 Madison 100.00 Carlsbad SAFC Carlsbad, Inc. SAFC, Inc. United States United States 100.00 Lenexa SAFC Biosciences, Inc. United States 100.00 Cleveland St. Louis 100.00 United States Sigma Redevelopment Corporation Company United States United States United States United States United States United States United States Country San Diego thereof: 343 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 100.00 St. Louis Sigma-Aldrich Co. LLC United States 100.00 St. Louis Equity interest Luxembourg CAM AG Chemie-Erzeugnisse und Luxembourg 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Darmstadt 100.00 100.00 Darmstadt Germany Germany Germany Germany GreenTech Accelerator Gernsheim GmbH Merck 25. Allgemeine Beteiligungs-GmbH Merck 26. Allgemeine Beteiligungs-GmbH Merck 27. Allgemeine Beteiligungs-GmbH Merck 28. Allgemeine Beteiligungs-GmbH Merck 29. Allgemeine Beteiligungs-GmbH Merck 37. Allgemeine Beteiligungs-GmbH Merck 38. Allgemeine Beteiligungs-GmbH Merck 39. Allgemeine Beteiligungs-GmbH Merck 40. Allgemeine Beteiligungs-GmbH Merck 41. Allgemeine Beteiligungs-GmbH Merck 42. Allgemeine Beteiligungs-GmbH Merck 43. Allgemeine Beteiligungs-GmbH Merck 44. Allgemeine Beteiligungs-GmbH Merck 45. Allgemeine Beteiligungs-GmbH Merck 46. Allgemeine Beteiligungs-GmbH Merck 47. Allgemeine Beteiligungs-GmbH Merck 48. Allgemeine Beteiligungs-GmbH Merck 49. Allgemeine Beteiligungs-GmbH Gernsheim 20.00 20.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 100.00 Germany Darmstadt 100.00 Leuven-Heverlee 25.72 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 100.00 100.00 Montrouge 21.69 Amsterdam 27.49 ReWind Therapeutics NV 100.00 Belgium 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 100.00 Darmstadt 100.00 Other European countries Amsterdam Germany Germany South Africa Merck (Pty) Ltd. Modderfontein 100.00 South Africa Merck Life Science (Pty) Ltd. Modderfontein 100.00 Tunisia Merck Promotion SARL Tunis 100.00 Tunisia Merck SARL Tunis 100.00 United Arab 100.00 Merck Serono Middle East FZ-Ltd. Riyadh Saudi Arabia 90.91 Israel QLight Nanotech Ltd. Jerusalem 100.00 Israel Sigma-Aldrich Israel Ltd. Rehovot 100.00 Israel Versum Materials Israel Ltd. Tel Aviv 100.00 Kenya Merck Healthcare and Life Science Limited Nairobi 100.00 MERCK Limited Germany Dubai Emirates III. Companies measured at fair value through other comprehensive income in accordance with IFRS 9 due to immateriality and other equity investments Germany Germany BEEoled GmbH Dresden 21.76 Germany Germany Germany Germany Germany Germany Germany Germany Germany Germany Germany thereof: Merck KGaA (%) 100.00 Equity interest (%) Company II. Companies accounted for using the equity method Other European countries United Kingdom MM Domain Holdco Limited London 50.00 50.00 North America United States Syntropy Technologies LLC Wilmington 50.00 Footnotes follow at the end of the table. Consolidated Financial Statements Notes to the Consolidated Financial Statements Other Disclosures 346 Country Registered office 32.41 Netherlands Russia Switzerland United States United States United States Country 347 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 24.99 Wilmington Polaris Electro-Optics, Inc United States 23.55 Los Angeles Pictor Labs, Inc. United States 20.67 Ann Arbor Asia-Pacific (APAC) 32.16 China Singapore Middle East and Africa (MEA) Dominican Republic Latin America 100.00 Singapore 35.00 Kawasaki 100.00 Shanghai Merck Testing (Shanghai) Co., Ltd. Resonac Versum Materials Co. LTD D) Merck Life Science Testing Services Pte. Ltd. 100.00 35.61 44.50 Equity interest (%) Registered office St. Louis St. Louis Wilmington Prolog Healthy Living Fund II, L.P. C) Prolog Healthy Living Fund, L.P. C) Surface Solutions, LLC Company Japan Algeria Wilmington Wilmington United Kingdom United Kingdom United Kingdom United Kingdom 100.00 Feltham Merck Ltd. United Kingdom 100.00 Feltham Merck Cross Border Trustees Ltd. United Kingdom 22.21 London Macrophage Pharma Limited Adsorptionstechnik AG 39.11 Muttenz Merck Pension Trustees Ltd. Outrun Therapeutics Limited Sigma Chemical Co. Ltd. Theolytics Ltd. 25.43 Feltham Dundee 100.00 Wilmington 50.00 Dover 21.65 Toronto Future Fertility Inc. Actithera Inc. EMD Biotech LLC ImmuneBridge Inc. Indi Molecular, Inc. MemryX Inc. United States United States North America Canada United States United States United States 23.80 Oxford 100.00 Gillingham 35.40 100.00 Israel Israel Nigeria Helene von Roeder Mikado Matthias Heinzel M. Henizel Peter Guenter Kai Beckmann Bohum Belén Garijo Darmstadt, February 14, 2024 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 Other Information Responsibility Statement 363 Financial Calendar 362 Business Development 2019-2023 350 Independent Auditor's Report 349 Responsibility Statement 350 other information Other Information Reproduction of the Independent Auditor's Report To Merck Kommanditgesellschaft auf Aktien, Darmstadt, Germany Switzerland United Kingdom Kivu BioScience B.V. Naarden 21.66 Chemical Trade Limited LLC Moscow 100.00 Asceneuron SA Lausanne Pursuant to section 322 (3) sentence 1 HGB, we declare that our audit has not led to any reservations relating to the legal compliance of the consolidated financial statements and of the combined management report. the accompanying combined management report as a whole provides an appropriate view of the Group's position. In all material respects, this combined management report is consistent with the consolidated financial statements, complies with German legal requirements and appropriately presents the opportunities and risks of future development. Our 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. 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 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 Reproduction of the Independent Auditor's Report 100.00 100.00 Helene von Roeder 20.00 Wilaya de Tipiza 100.00 Santo Domingo Representaciones MEPRO S.A. Merck S.A. Venezuela 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. Novapharm Production SARL Merck Dominicana, S.R.L. Lachish Darom 26.92 Yavne 98.37 Indaco Matthias Heinzel M. Heinzel Peter Guenter Kai Beckmann 1Bchmmmm Belén Garijo Darmstadt, February 14, 2024 Yavne D) This is an affiliate within the meaning of IFRS 11 (joint activity). 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 thereof: Merck KGaA (%) 100.00 Lagos C) Closed-end funds classified as debt instruments in accordance with IFRS 9. Merck Finance S.à r.l. PMatX Ltd. 100.00 Singapore Taiwan 100.00 Singapore 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 Singapore Pte. Ltd. Versum Materials SPC Korea Ltd. Singapore Merck 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 100.00 Kaohsiung 100.00 Taipei Merck Performance Materials Ltd. SAFC Hitech Taiwan Co., Ltd. Taiwan Taiwan 100.00 Taipei 100.00 Bangkok 100.00 100.00 341 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 100.00 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Siheung-Si 100.00 M Chemicals Inc. Siheung-si 100.00 Ansan-si 100.00 Ansan-si 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 Israel 45.11 Hong Kong 100.00 345 Consolidated Financial Statements. Notes to the Consolidated Financial Statements Other Disclosures Footnotes follow at the end of the table. 100.00 Montevideo Ares Trading Uruguay S.A. Herzliya Pituach Uruguay 100.00 Lima Merck Peruana S.A. Peru 100.00 Panama City 100.00 Panama City 100.00 Toluca 100.00 Country Mexico City Middle East and Israel Ho Chi Minh City Equity interest thereof: Registered office (%) Merck KGaA (%) Africa (MEA) Egypt Merck Ltd. Cairo 100.00 Israel Yavne Company 100.00 Israel InterPharm Laboratories Ltd. Yavne 100.00 Merck Serono Ltd. 100.00 Inter-Lab Ltd. Mesofarma Corporation 100.00 Santiago de Chile Merck S.A. Chile 100.00 Barueri Sigma-Aldrich Brasil Ltda. Brazil Chile 100.00 100.00 Buenos Aires Brazil Argentina 100.00 Buenos Aires 100.00 Mexico City Rio de Janeiro Sigma-Aldrich Quimica Ltda. Sigma-Aldrich de Argentina S.R.L. Merck S.A. 100.00 Sigma-Aldrich Quimica, S. de R.L. de C.V. Santiago de Chile Merck Biopharma Distribution S.A. de C.V. Merck, S.A. de C.V. Panama Merck, S.A. Panama Mexico Mexico Mexico 100.00 Ho Chi Minh City Merck, S.A. Guatemala City Merck S.A. Bogota 100.00 Ecuador Guatemala Colombia Quito 100.00 Merck C.A. 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. Other Information Reproduction of the Independent Auditor's Report 353 Other Information 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. the remuneration report pursuant to section 162 German Stock Corporation Act (AktG), • the report of the supervisory board, • • • • 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. The executive directors and/or the supervisory board are responsible for the other information. The other information comprises: the corporate governance statement pursuant to sections 289f and 315d HGB referred to in the combined management report, 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 Management Report all other parts of the annual report, but not the consolidated financial statements, not the audited content of the combined management report and not our auditor's report thereon. The supervisory board is responsible for the report of the supervisory board. The executive directors and the supervisory board are responsible for the statement according to section 161 AktG concerning the German Corporate Governance Code, which is part of the corporate governance statement, and for the remuneration report pursuant to section 162 AktG. Otherwise, the executive directors are responsible for the other information. Our audit opinions on the consolidated financial statements and on the combined management report do not cover the other information, and consequently we do not express an audit opinion or any other form of assurance conclusion thereon. 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: 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 otherwise appears to be materially misstated. 354 Other Information Reproduction of the Independent Auditor's Report Responsibilities of the Executive Directors and the Supervisory Board for the Consolidated Financial Statements and the Combined b) 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, • Our presentation of these key audit matters has been structured as follows: 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 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. 351 Other Information Reproduction of the Independent Auditor's Report Basis for the Audit Opinions We conducted our audit of the consolidated financial statements and of the combined management report in accordance with section 317 HGB and the EU Audit Regulation (No. 537/2014; referred to subsequently as "EU Audit Regulation”) and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW). Our responsibilities under those requirements and principles are further described in the "Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report" section of our auditor's report. We are independent of the group entities in accordance with the requirements of European law and German commercial and professional law, and we have fulfilled our other German professional responsibilities in accordance with these requirements. In addition, in accordance with Article 10 (2) point (f) of the EU Audit Regulation, we declare that we have not provided non-audit services prohibited under Article 5 (1) of the EU Audit Regulation. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinions on the consolidated financial statements and on the combined management report. 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. In the following we present the key audit matters we have determined in the course of our audit: 1. 2. Recoverability of goodwill in the Electronics business sector Completeness and measurement of income tax liabilities a) b) The disclosures of the executive directors on recognition and measurement of income tax liabilities can be found in note 15 in the notes to the consolidated financial statements. 1. 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) 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. 2. a) Completeness and measurement of income tax liabilities As at December 31, 2023, the amount recognized for income tax liabilities including liabilities for uncertain tax obligations is mEUR 1,473. a) 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. 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. Auditor's Responsibilities for the Audit of the Consolidated Financial Statements and of the Combined Management Report 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: To Merck Kommanditgesellschaft auf Aktien, Darmstadt/Germany (German Public Auditor) Christoph Schenk Signed: Wirtschaftsprüfungsgesellschaft Deloitte GmbH Frankfurt am Main, Germany, February 16, 2024 The German Public Auditor responsible for the engagement is Daniel Weise. German Public Auditor Responsible for the Engagement Other Information Reproduction of the Independent Auditor's Report Wirtschaftsprüfer 358 Our Engagement 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. Reconciliation of selected disclosures with the corresponding data in the consolidated financial statements and the annual financial statements and combined management report, Analytical procedures on selected information in the non-financial reporting, Identification of likely risks of material misstatement in the non-financial reporting, Inquiries of the executive directors and relevant employees involved in the preparation of the non-financial reporting about the preparation process, about the internal control related to this process and about disclosures in the non-financial reporting, Gaining an understanding of the structure of the Group's sustainability organization and stakeholder engagement, The procedures performed in a limited assurance engagement are less in extent than for a reasonable assurance engagement; consequently, the level of assurance obtained in a limited assurance engagement is substantially lower than the assurance that would have been obtained had a reasonable assurance engagement been performed. The choice of assurance work is subject to the practitioner's professional judgment. Within the scope of our assurance engagement, which we performed in the months from October 2023 to February 2024, we have, among other things, performed the following assurance procedures and other activities: We conducted our assurance engagement in accordance with the International Standard on Assurance Engagements (ISAE) 3000 (Revised): "Assurance Engagements other than Audits or Reviews of Historical Financial Information" issued by the IAASB. This standard requires that we plan and perform the assurance engagement to obtain limited assurance about whether any matters have come to our attention that cause us to believe that the Company's non-financial reporting - with the exception of the referenced remuneration report and sustainability report and of references to external sources of documentation and websites including their contents as well as of disclosures relating to prior periods - is not prepared, in all material respects, in accordance with section 289c to section 289e HGB, section 315c in conjunction with section 289c to section 289e HGB and the EU Taxonomy Regulation and the delegated acts adopted thereunder as well as the interpretation by the executive directors disclosed in the section "Reporting in accordance with the EU Taxonomy Regulation” of the non-financial reporting. Our responsibility is to express a conclusion with limited assurance on the non-financial reporting based on our assurance engagement. 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 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. Independence and Quality Assurance of the Audit Firm 360 Other Information Reproduction of the Independent Auditor's Report The preciseness and completeness of the environmental data in the non-financial reporting is subject to inherent restrictions resulting from the manner in which the data was collected and calculated as well as from assumptions made. The EU Taxonomy Regulation and the delegated acts adopted thereunder contain wording and terms that are still subject to considerable interpretation uncertainties and for which clarifications have not yet been published in every case. Therefore, the executive directors have disclosed their interpretation of the EU Taxonomy Regulation and the delegated acts adopted thereunder in the section "Reporting in accordance with the EU Taxonomy Regulation” of the non-financial reporting. They are responsible for the defensibility of this interpretation. Due to the immanent risk that indeterminate legal terms may be interpreted differently, the legal conformity of the interpretation is subject to uncertainties. This responsibility includes the selection and application of appropriate non-financial reporting methods and making assumptions and estimates about individual non-financial information of the Group that are reasonable in the circumstances. Furthermore, the executive directors are responsible for such internal control as the executive directors consider necessary to enable the preparation of a non-financial reporting that is free from material misstatement, whether due to fraud (i.e. fraudulent non-financial reporting) or error. The executive directors of the Company are responsible for the preparation of the non-financial reporting in accordance with section 289c to section 289e German Commercial Code (HGB), section 315c in conjunction with section 289c to section 289e HGB and Article 8 of Regulation (EU) 2020/852 of the Parliament and the Council of 18 June 2020 on the establishment of a framework to facilitate sustainable investment, and amending Regulation (EU) 2019/2088 ("EU Taxonomy Regulation") and the delegated acts adopted thereunder, as well as for making their own interpretation of the wording and terms contained in the EU Taxonomy Regulation and the delegated acts adopted thereunder, as set out in the section "Reporting in accordance with the EU Taxonomy Regulation" of the non-financial reporting. Responsibility of the Executive Directors We have complied with the German professional requirements on independence as well as other professional conduct requirements. - Our auditor's report must always be read together with the audited consolidated financial statements and the audited combined management report as well as with the audited ESEF documents. The consolidated financial statements and the combined management report converted into the ESEF format - including the versions to be submitted for inclusion in the Company Register are merely electronic reproductions of the audited consolidated financial statements and the audited combined management report and do not take their place. In particular, the ESEF report and our audit opinion contained therein are to be used solely together with the audited ESEF documents made available in electronic form. Use of the Auditor's Report Other Legal and Regulatory Requirements 356 Other Information Reproduction of the 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 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. 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. 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 the executive directors in the combined management report. On the basis of sufficient appropriate audit evidence we evaluate, in particular, the significant assumptions used by the executive directors as a basis for the prospective information, and evaluate the proper derivation of the prospective information from these assumptions. We do not express a separate audit opinion on the prospective information and on the assumptions used as a basis. There is a substantial unavoidable risk that future events will differ materially from the prospective information. evaluate 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. 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 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. evaluate the appropriateness of accounting policies used by the executive directors and the reasonableness of estimates made by the executive directors and related disclosures. obtain an understanding of internal control relevant to the audit of the consolidated financial statements and of arrangements and measures relevant to the audit of the combined management report in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an audit opinion on the effectiveness of these systems. identify and assess the risks of material misstatement of the consolidated financial statements and of the combined management report, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our audit opinions. The risk of not detecting a material misstatement resulting from fraud is higher than the risk of not detecting a material misstatement resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal controls. We exercise professional judgment and maintain professional skepticism throughout the audit. We also: 355 Other Information Reproduction of the Independent Auditor's Report Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in accordance with section 317 HGB and the EU Audit Regulation and in compliance with German Generally Accepted Standards for Financial Statement Audits promulgated by the Institut der Wirtschaftsprüfer (IDW) will always detect a material misstatement. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these consolidated financial statements and this group management report. 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. 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. Audit Opinion We have performed an audit in accordance with section 317 (3a) HGB to obtain reasonable assurance whether the electronic reproductions of the consolidated financial statements and of the combined management report (hereinafter referred to as "ESEF documents") prepared for publication, contained in the file, which has the SHA 256 value c114c083dc2ea03436431c301daa4137a7a71bd1b9fb0c7c074e316f288ebc8f, meet, in all material respects, the requirements for the electronic reporting format pursuant to section 328 (1) HGB ("ESEF format"). In accordance with the German legal requirements, this audit only covers the conversion of the information contained in the consolidated financial statements and the combined management report into the ESEF format, and therefore covers neither the information contained in these electronic reproductions, nor any other information contained in the file identified above. In our opinion, the electronic reproductions of the consolidated financial statements and of the combined management report prepared for publication contained in the file identified above meet, in all material respects, the requirements for the electronic reporting format pursuant to section 328 (1) HGB. Beyond this audit opinion and our audit opinions on the accompanying consolidated financial statements and on the accompanying combined management report for the financial year from January 1 to December 31, 2023 contained in the "Report on the Audit of the Consolidated Financial Statements and of the Combined Management Report" above, we do not express any assurance opinion on the information contained within these electronic reproductions or on any other information contained in the file identified above. - 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. 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. 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: 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 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. Basis for the Audit Opinion 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. Responsibility of the Independent Practitioner Evaluation of the presentation of the non-financial reporting, and Evaluation of the process to identify taxonomy-eligible and taxonomy-aligned economic activities and the corresponding disclosures in the non-financial reporting. 25.2% Current 0.4% 9,239 9,200 8,270 9,785 8,644 Non-current -4.7% 9,941 10,428 10,801 12,142 4,550 2,357 2,531 1,228 and equipment³ 1,807 1,531 Payments for investments in property, plant, -21.5% 216 13,194 275 150 208 Payments for investments in intangible assets³ Liquidity -42.9% 702 355 Financial liabilities 2.9% 26,005 Trade receivables and other current 0.1% 4,637 4,632 361 Other Information Reproduction of the Independent Auditor's Report receivables 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. 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. 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. Restriction of Use 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. Our responsibility is to the Company alone. We do not accept any responsibility to third parties. Our conclusion is not modified in this respect. Frankfurt am Main, Germany, February 16, 2024 Practitioner's Conclusion 813 4,114 3,488 21,416 17,017 17,914 Equity 6.9% 1,982 4,004 1,854 1,355 781 Cash and cash equivalents -2.7% 3,646 3,221 1,899 1,413 1,066 18.0% April 2024 7 Annual Press Conference March Financial calendar 4 Proposal on the appropriation of profits for 2023. 26 Annual General Meeting 3 According to the consolidated cash flow statement. 1 Not defined by International Financial Reporting Standards (IFRS). -2.1% 62,908 64,232 60,334 58,096 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. 57,036 2024 15 Quarterly Statement Q1 www.nexxar.com nexxar GmbH, Vienna DESIGN Frankfurter Strasse 250, 64293 Darmstadt, Germany Telephone: +49 6151 72-0 www.merckgroup.com Published on March 7, 2024 by Merck KGaA M May 2024 November Half-yearly Financial Report 2024 1 August 2024 14 Quarterly Statement Q3 Deloitte GmbH Employees (number as of December 31) 2.204 -9.9% 7,500 8,328 8,753 10,758 12,363 Other key data Net financial debt¹ 3,784 4,259 4,616 3,477 2,856 Operating cash flow³ -11.2% 0.0% Equity ratio (in %)¹ 40.7% 2.20 1.85 1.40 -3.0% 2,445 2,521 40.9% 2,426 2,268 1.30 Dividend per share (in €) Research and development costs 55.2% 53.6% 47.2% 2,288 Wirtschaftsprüfungsgesellschaft 26,754 Daniel Oehlmann -15.2% Assets and liabilities Total assets 43,808 41,796 45,362 6.49 48,535 -0.1% Non-current assets 34,805 32,516 34,380 36,334 48,495 36,102 7.65 4.57 2,630 3,924 4,287 3,484 -18.7% Profit after tax 7.03 1,324 3,065 3,339 2,834 -15.1% Earnings per share (in €) 3.04 1,994 1,735 Signed: Goodwill 9,056 10.4% Current assets 9,003 9,280 10,982 8,204 12,201 1.6% thereof: Inventories 3,342 3,294 3,900 12,393 thereof: 7,217 6,192 17,114 15,959 17,004 18,389 17,845 -3.0% 6,421 Other intangible assets 7,653 7,612 7,335 6,551 -10.7% Property, plant, and equipment 9,221 Profit before income tax -0.6% 30.8% -5.6% -19.3% 20,993 3,609 4,474 4,179 2,985 2,120 Operating result (EBIT)¹ 22,232 19,687 17,534 16,152 Net sales Results of operations 2022 2021 2020 2019 28.0% Wirtschaftsprüfer (German Public Auditor) Signed: Jan Joos Wirtschaftsprüfer Margin (% of net sales) 1 (German Public Auditor) 362 Business BUSINESS DEVelopment 2019-2023 This overview may include historically adjusted values in order to ensure comparability with the reporting period. € million Other Information Business Development 2019 - 2023 13.1% 2023 Change in % 4,385 345 390 13.1% EBITDA pre¹ 5,201 6,103 279 6,849 -14.2% Margin (% of net sales) 1 27.1% 29.7% 17.0% 31.0% 5,879 318 157 5,946 17.2% EBITDA² 4,066 4,923 Adjustments¹ 6,504 5,489 -15.6% Margin (% of net sales) 1 28.1% 30.2% 29.3% 26.1% 20.1% 21.2% thereof: Changes in trade accounts payable/refund liabilities³ -98.0% -144 101 405 -43 -413 -93 thereof: Changes in trade accounts receivable³ -85.3% 516 -604 -89 > 100.0% thereof: Changes in inventories³ -8 Changes in provisions³ 21 279 -84.7% -72 Other non-cash income and expenses³ > 100.0% -102 -48 188 -150 -32.5% 69.6% -310 -445 -755 Changes in other assets and liabilities³ -91 Neutralization of gains/losses on disposal of fixed assets and other disposals³ 776 31 -141 2023 Changes in working capital¹ Income tax² Finance result² Adjustments¹ EBITDA pre¹ 2022 € million Operating cash flow Merck Group Operating cash flow results from Merck's current business activities and describes the cash generated from operating activities. It is influenced mainly by EBITDA pre, income tax, the financial result and changes in net working capital. Operating cash flow (OCF) Combined Management Report_ Fundamental Information about the Group. Internal Management System > 100.0% Change € million % 5,879 -31.4% 298 -948 -650 -33.0% 62 -187 -125 13.1% -45 -345 -390 -14.2% -970 6,849 -917 Operating cash flow Internal rate of return (IRR) 4,259 Life Science Healthcare Electronics Corporate and Other Total Change 2023 2022 € million % 396 3,784 -3 -0.7% 1,657 297 94 2,445 1,694 -37 -2.2% 308 -11 -3.5% 119 -24 -20.5% 2,521 € million Research and Development Costs 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. 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. =4 Relevant non-financial performance measures Along with the indicators of the financial performance of the businesses, non-financial measures also play an important role in furthering the success of the company. High-Impact Culture 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. Sustainability 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. Diversity, equity and inclusion 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. 35 Combined Management Report Fundamental Information about the Group. Research and Development Research and Development -75 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. 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. With our Healthcare business sector's R&D pipeline, we aspire to make a positive difference for patients. Our main research areas include oncology and immunology, including multiple sclerosis. The main focus of our Electronics business sector's research is on developing innovative materials and technologies required for the manufacture of ever smaller, faster, more powerful, and more sustainable processors and memory chips. Furthermore, Electronics develops novel materials for next-generation displays and functional and decorative effect pigments for use in the automotive and cosmetics industries and other industrial applications. We are firmly convinced that science should not be conducted in silos. We believe that a modern, multidisciplinary approach to science will power the next wave of human progress. We call this approach "bioconvergence" because it leverages synergies across digital and material science as well as biotechnology. Success depends on the ability to combine a broad mix of competencies and technologies across several disciplines to create novel market solutions. We are a diversified science and technology company with leading positions across the life science, healthcare and electronics industries. Our goal is to harness synergies not only within our business sectors, but across them. Examples of opportunities we are developing at the intersection of our business sectors and converging technologies include: Continuing to build our automated design-make-test-analyze platform powered by state-of-the-art artificial intelligence (AI) and lab automation. This will accelerate the discovery of new and better drug candidates and in turn expedite timelines for new therapies to reach patients. Using our capabilities across the Group in messenger ribonucleic acid (mRNA) synthesis, lipid nanoparticle (LNP) synthesis and formulation and targeted delivery as well as AI to enable the development of "smarter" LNPs that can more effectively target different tissue types including hard-to-reach biological targets in various disease areas. 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. Combined Management Report Fundamental Information about the Group. Research and Development 36 Advanced microphysiological systems based on human cell culture models promise to deliver faster and more accurate drug testing results compared with today's two-dimensional approaches and might reduce animal testing. We are currently looking into this next generation of organoids based on chip technology, bringing our Life Science, Healthcare and Electronics colleagues together to work on this area of innovation. In our R&D, AI and machine learning have demonstrated their ability to predict the properties of new materials. However, our applications of AI and machine learning go beyond just internal use. One example of AI and machine learning being commercialized is the progress made on AIDDISON™. This AI- powered drug discovery software uses generative AI based on two decades of historic data. The software, which had been in development since 2020, was launched by Life Science in 2023. In addition to external commercialization, we also use it in our Healthcare business sector for internal early drug discovery. High-quality, interoperable data combined with analytics and AI offer unprecedented potential for new digital business models adjacent to our current product offering and unlock additional growth opportunities. Examples include Syntropy and Athinia™, which are partnerships with Palantir. 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). -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. Combined Management Report 39 Healthcare 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. Oncology* In Oncology, our scientific curiosity and dedication to patients are at the heart of our efforts to improve the future of people living with cancer. In this core focus area of our R&D portfolio, we aim to deliver transformative treatments. Translational research is embedded into the whole R&D process, with several projects addressing unmet needs in difficult-to-treat cancers through innovative treatment approaches and novel combinations. We are committed to bringing new standards of care for multiple tumor types to as many patients as possible worldwide. Therefore, in 2023 we continued to explore the impact of our marketed therapies through continued analysis of data from our pivotal studies and the generation of real-world evidence. We are assessing these treatments in new settings as well. BavencioⓇ To date, BavencioⓇ (avelumab), an anti-PD-L1 antibody, has been approved in 66 countries as a first-line maintenance treatment for locally advanced or metastatic urothelial carcinoma (UC) in adult patients whose disease has not progressed following platinum-based chemotherapy. At the 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, we presented long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. The data demonstrated median overall survival from start of chemotherapy of 29.7 months among patients receiving BavencioⓇ who did not progress on first-line platinum-based chemotherapy, thus establishing a new benchmark for treatment outcomes in clinical studies. We continue to evaluate whether optimization of first-line maintenance treatment by adding a novel therapy to avelumab could improve outcomes for patients with advanced UC whose disease did not progress with first-line platinum-based chemotherapy in the Phase II JAVELIN Bladder Medley study. Initiated in 2022, this randomized umbrella study is assessing avelumab monotherapy versus the combination of avelumab with our investigational anti-TIGIT antibody M6223, avelumab in combination with Nektar Therapeutics' interleukin-15 (IL-15) receptor agonist, NKTR-255, and avelumab in combination with Gilead Sciences' TrodelvyⓇ (sacituzumab govitecan-hziy). 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Ⓡ Fundamental Information about the Group. Research and Development 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 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. 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). 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 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. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 34 Combined Management Report 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. 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. In July, the MobiusⓇ iFlex Bioreactor was launched as the latest addition to the BioContinuum TM Production and Harvest Platform, our integrated solution for perfusion process development and manufacturing. Alongside our portfolio of EX-CELL® Advanced HD Perfusion, Mobius® Breez Microbioreactor and Cellicon® Cell Retention Solution, the MobiusⓇ iFlex Bioreactor enables customers to realize the efficiency gains and cost savings of production intensification and continuous monoclonal antibody (mAb) manufacturing. In March, Medicine Maker recognized the Process Solutions business unit with its Best Biopharma Equipment Company award. Life Science Services* 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. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. Life Science Services received three awards in 2023. In March, it was recognized at Life Science Leader's 2023 CDMO Leadership Awards in five categories: capabilities, compatibility, expertise, quality, and service. In September, it received the API Development Award for ChetoSensarTM at the 2023 CPHI Pharma Awards as well as the Best Biologics CMO Award at the 2023 Asia Pacific Biologics CMO Excellence Awards 2023. 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 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 Internal Management System 399 Credit rating Non-controlling interest 2023 2022 € million in % 2,824 3,326 -502 -15.1% 10 14 -3 -25.6% Income tax 650 -298 -31.4% Amortization of acquired intangible assets 783 830 -47 -5.6% Adjustments¹ 477 577 Net income € million Change Reconciliation net income to net income pre¹ -475 -11.2% 1 Not defined by International Financial Reporting Standard (IFRS). Adjustments according to definition above. 2 According to Consolidated Income Statement. 3 According to the Consolidated Cash Flow Statement. 4 As of January 1, 2023, the tranche of the Merck Long-Term Incentive Plan to be paid out in the months following the balance sheet date is disclosed under other current non-financial liabilities and no longer under current provisions for employee benefits. For better comparability, the previous year's figures have been adjusted. Combined Management Report_ Fundamental Information about the Group. Internal Management System 32 Investments and value management 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) -99 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. The internal rate of return is a further important criterion for the assessment of acquisition projects and investments in property, plant and equipment, as well as intangible assets. It is the discount rate that makes the present value of all future free cash flows equal to the initial investment or the purchase price of an acquisition. A project adds value if the internal rate of return is higher than the weighted cost of capital including markups. Return on capital employed (ROCE) In addition to NPV and IRR, return on capital employed is an important metric for the assessment of investment projects when looking at individual accounting periods. It is calculated as the adjusted operating result pre (EBIT pre) divided by the sum of property, plant and equipment, intangible assets, trade accounts receivable, trade accounts payable, and inventories. Payback period 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. Merck value added (MEVA) Merck value added gives information about the financial value created over a period of time. Added value is created when the return on capital employed (ROCE) of the company or the business is higher than the weighted average cost of capital (WACC). MEVA metrics provide us with a powerful tool to weigh investment and spending decisions against capital requirements and investors' expectations. Combined Management Report_ Fundamental Information about the Group. Internal Management System 33 Capital market-related parameters 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. 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. 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. -17.2% 948 -1,044 -15.6% Earnings per share pre¹ in € 8.49 Income tax on the basis of the underlying tax rate¹ 10.05 -1.56 -15.5% 1 Not defined by International Financial Reporting Standards (IFRS). Dividend ratio We pursue a reliable dividend policy with a target payout ratio based on EPS pre (see definition above) with the aim of ensuring an attractive return for our shareholders. -680 4,371 -1,310 266 -20.3% Non-controlling interests to be adjusted -10 -14 3 -25.6% Net income pre¹ 3,691 Systemic lupus erythematosus¹ Cutaneous lupus erythematosus¹ Phase Ia Phase Ib Phase Ib Phase II Phase III Phase III Pediatric schistosomiasis 10 Malaria Phase II Phase II Idiopathic inflammatory myopathies (DM and PM)² Phase II 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 Solid tumors? Status M9140 (anti-CEACAM5 Antibody drug conjugate) Solid tumors8 Indication Solid tumors⁹ Global Health Arpraziquantel (anthelmintic) M5717 (PeEF2 inhibitor) Solid tumors M9466 (HRS-1167; Selective PARPi) Fundamental Information about the Group. Research and Development 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. 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). 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. 7 Administered in combination with Tuvusertib/M1774 (ATRI). 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. 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 M6223 (anti-TIGIT mAb) Phase Ib 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). 8 Administered in combination, including combinations other than avelumab. 10 On 14 December, 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel for the treatment of schistosomiasis in children aged 3 months to 6 years. The application was submitted by Merck, on behalf of the Pediatric Praziquantel Consortium, under the EU-M4all procedure for high-priority medicines for human use intended for countries outside the European Union. ATM: ATM serine/threonine kinase 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 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 PD-L1: Programmed cell death ligand 1 Phase Ib: Dose escalation/expansion and signal seeking 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 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. M4076 (ATM inhibitor) Sustainable technologies and materials* Avelumab (anti-PD-L1 mAb) + combinations 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). 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. 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. Combined Management Report Fundamental Information about the Group. Research and Development 42 Neurology & Immunology* • 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. 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. 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. 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. 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 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). Tuvusertib/M1774 (ATR inhibitor) Highlights included: We shared additional new data for our marketed and investigational oncology medicines at major oncology congresses. Xevinapant (IAP inhibitor) Xevinapant (IAP inhibitor) Oncology Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) Enpatoran (TLR7/8 antagonist) Immunology As of December 31, 2023 Therapeutic area Compound 44 Research and Development Combined Management Report Fundamental Information about the Group. Our pipeline * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 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. Collaborations to strengthen AI-driven drug discovery* 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. 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. • Our declared aim is to bring more medicines to more patients faster. In 2023, we supported this aim by reaching key milestones for two transformational investments focusing on complementary therapeutic modalities: Investments to speed up the availability of new medicines* ConcorⓇ/Concor Cor®, containing bisoprolol, is a beta-blocker for treating hypertension and cardiovascular diseases such as coronary heart disease and chronic heart failure. In addition to ConcorⓇ/Concor CorⓇ, the ConcorⓇ franchise includes fixed-dose combinations such as Concor Plus®/Lodoz® (bisoprolol with hydrochlorothiazide) and ConcorⓇ AM (bisoprolol with amlodipine). ConcorⓇ AM has been registered in 71 countries. 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. 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. 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. Cardiovascular, Metabolism & Endocrinology* 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. 43 Combined Management Report Fundamental Information about the Group. Research and Development 41 Highlights of congress publications in 2023 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. 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. 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. 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. 7.8% 9.2% 7.7% 17.4% 35.8% 38.2% 14.5% 16.9% 4.2% -5.6% Change 2022 Change 2023¹ NF3 abatement 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. 49 Electronics Market for the treatment of colorectal cancer6 3.0 1 Figures for fiscal 2023 estimated Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment The development of selected sector specific environments was as follows: Life Science Growth in market for laboratory products² -2.3% Growth in global sales of biopharmaceutical drugs³ Early clinical monoclonal antibody (mAb) pipeline growth Healthcare Global pharmaceutical market Market for multiple sclerosis therapies Market for type 2 diabetes therapies5 Market for fertility treatment5 Share of biopharmaceutical sales in the global pharmaceutical market³ 2.5% 19.1% 18.1% 5 Growth rates based on market data in local currency, translated at a constant euro exchange rate. The IQVIA market data on the growth of indications are based on current figures, including the third quarter of 2023. Annual growth based on the values for the past 12 months. The type 2 diabetes market excludes the United States since this market is insignificant to Merck. 6 Growth rates based on market data stated in US dollars. Market data from Evaluate Pharma on the growth of indications are based on published company reports and are subject to exchange rate fluctuations. 7 Growth of display area is a pure volume indicator. Combined Management Report _ Report on Economic Position Macroeconomic and Sector-Specific Environment 50 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. 50 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. 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 Life Science 5.2 1 Predicted development. Final development rates for 2023 were not available for all industries when this report was prepared. 2 Global Market for Laboratory Products, October 2023, Frost & Sullivan. 10.1% 10.9% 4.2% -0.1% 4.5% Growth of wafer area for semiconductor chips -14.1% 7.1% 3.9% -1.5% -3.9% Global sales of cosmetics and care products 4.2% 12.2% Global number of produced light vehicles Growth of display surface area? China 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). 6.7 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. 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. 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). * 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 47 Display Solutions With the proliferation of multiple applications and display trends, the display industry's technological requirements are significantly expanding. Our display materials are enabling the fast-growing market of innovative displays for current and future applications such as foldable smartphones, flexible displays for automotive or AR/VR (augmented reality/virtual reality) devices. As our liquid crystals business remains a strong focus area, our R&D team is continuously working to develop new liquid crystal mixtures for our customers who need differentiated performance such as high transmittance, high contrast ratio, and high reliability to realize displays for new applications. We are working with our customers in the field of AR/VR to expand the application scenarios of liquid crystals and continue to enhance the user experience in small and micro-sized displays. We remain fully committed to advancing LCD technology and are working very closely with leading panel makers to develop next-generation products for the electronics market. In the display industry, OLED is regarded as state-of-the-art technology for its excellent visual experience. It is also considered as the technology of the future of displays as it enables the production of flexible, foldable, rollable, and even transparent displays. We introduced new barrier materials that offer superior flexibility, higher reliability and a longer lifetime in flexible OLED devices compared with existing solutions. Devices with fully flexible OLED displays are one of the fastest-growing trends in data-driven electronics. Our innovative ALD material won the "Display Component of The Year 2023" award from Society for Information Display (SID), the world's largest display association. In addition, our innovative deuterated material won the "Technology Innovation Award" from LG Displays in September 2023. Surface Solutions In our 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 cosmetics business, we are further developing our range of high-color intensity pigments with metallic optical effects entirely without the use of metals. These Ronaflux® pigments are based on an entirely new proprietary technology employing fluidized bed processes for depositing ultrathin and highly stable carbon layers onto pearlescent pigments - a major precondition for spectacular shine effects. The carbon layers intensify the colors of the effect pigments, thus enabling brilliant shades of blue and green without the addition of chrome oxides, Prussian blue or other colorants. This new offering enables manufacturers of eye makeup and lipsticks to meet the strict regulatory requirements while offering brilliant metallic blue and green shades that do not contain any metal-based pigments. To produce realistic color effects on electronic devices, we are focusing on methodologies to transfer coloristic measuring data into 3D visible effects. As a first step, we have introduced the first digital tool for visualizing car colors in various light conditions in a realistic way. Under controlled, calibrated conditions, color data, measured state-of-the-art technology, can be used to produce a realistic display. Euro Area Combined Management Report _ Report on Economic Position USA 7.2 Advanced Economics World 2022 20231 Annual change in % Business field Formulations (patterning and planarization) The development of gross domestic product (GDP) in selected countries and regions was as follows: 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 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. 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. 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. 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). 1.6 2.6 2.5 1.9 0.5 3.4 1.9 1.0 Emerging Markets and Developing Economies 4.1 4.1 Business field Specialty Gases 5.4 4.5 India 3.5 3.1 Emerging Markets and Developing Economies Asia PFAS Japan 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* 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. Academic research program Research and Development Semiconductor Solutions 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. Combined Management Report Fundamental Information about the Group. - Our Life Science business sector reported an organic decline in net sales of -7.9% in fiscal 2023. This was at the lower end of the forecast range of between -8% and -2%, which we adjusted in the second quarter and confirmed in the third quarter, meaning that Life Science fell below our original forecast of slight to moderate organic growth. All of the business units Process Solutions, Life Science Services and Science & Lab Solutions recorded a downturn in organic net sales. As expected, Process Solutions and Life Science Services saw the most pronounced organic decline in net sales, whereas the downturn in the Science & Lab Solutions business unit was only slight. All in all, net sales in the Life Science business sector fell by -10.6% to € 9,281 million including a negative exchange rate effect of -2.7% and a positive portfolio effect of 0.1%. This was in the lower half of the forecast range of € 9,100 million to € 9,950 million, which is consistent with the more specific forecast issued at the end of the third quarter (trending in the lower half of the forecast range). Healthcare EBITDA pre 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). Report on Economic Position Review of Forecast against Actual Business Developments 53 Electronics Life Science 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). Combined Management Report 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). Combined Management Report 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 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%). 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. 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 The net sales in the individual quarters as well as the respective organic growth rates in 2023 are presented in the following graph: 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). Net sales Life Science Operating cash flow Combined Management Report 3,339 2,834 Profit after tax 30.8% 28.0% Margin (% of net sales) 1 -14.2% -970 6,849 5,879 EBITDA pre¹ 29.3% 26.1% Margin (% of net sales)¹ -1,015 -505 -15.1% Earnings per share (€) 6.49 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. 1 Not defined by International Financial Reporting Standards (IFRS). -11.2% -475 4,259 3,784 6,504 Operating cash flow -1.56 10.05 8.49 Earnings per share pre (€)¹ -15.2% -1.16 7.65 -15.5% 5,489 EBITDA² 20.1% Merck Group Course of Business and Economic Position 55 Merck Group Report on Economic Position Course of Business and Economic Position Combined Management Report € 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. Merck Group 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 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 Electronics 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). Healthcare 54 54 Report on Economic Position Review of Forecast against Actual Business Developments 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%. 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). Key figures € million 17.2% Margin (% of net sales) 1 -19.3% -865 4,474 3,609 Operating result (EBIT) 1 Change -5.6% 22,232 20,993 Net sales % € million 2022 2023 -1,239 -15.6% thereof: Change 658 Current financial debt 702 Trade and other current payables/ 3,422 refund liabilities¹ Other current liabilities² 3,918 Total equity and liabilities¹ 2,030 299 9,200 1,486 162 Current provisions² -22 thereof: liabilities¹, 2 26 0.2% Equity Non-current liabilities¹ thereof: Non-current provisions for 2,192 employee benefits Other non-current 277 provisions Non-current financial debt 9,239 Other non-current 1,333 Current liabilities1 39 -153 8,699 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). Goodwill was down as against the previous year as a result of the depreciation of the U.S. dollar against the euro in particular. 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. 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). 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. 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. -0.1% -40 -504 17.9% 9,514 19.6% -815 -8.6% 48,495 100.0% 26.8% 453 3,411 4,422 48,535 100.0% 205 -526 11 1,228 13,015 26.9% 13,042 Property, plant and 9,056 8,204 equipment¹ Other non-current assets 2,650 2,406 -544 -784 852 244 Current assets 12,393 25.6% 12,201 7,335 6,551 Other intangible assets¹ 18,389 € million % € million % € million % Non-current assets¹ 25.1% 36,102 36,334 74.9% -232 -0.6% thereof: Goodwill1 17,845 74.4% Dec. 31, 2022 192 Merck Group -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% 178 1,854 1,280 321 Inventories 4,637 4,632 Trade and other current 4,004 4,114 5 1.6% -110 Other current financial 499 assets Other current assets 1,271 Cash and cash equivalents 1,982 receivables Net sales and organic growth¹ by quarter² 8.5% Q1 70% 57 557 396 Life Science 17% 297 Electronics 13% € million/% Research and development costs by business sector¹ - 2023 Merck Group Merck Group Course of Business and Economic Position_ Report on Economic Position Healthcare 1,657 1 Not presented: research and development costs of € 94 million allocated to Corporate and Other. There was a year-on-year decline in the operating result (EBIT) in fiscal 2023. This was largely due to the lower level of gross profit, which was only partially offset by a reduction in operating expenses. In particular, the year-on-year decline in the gross margin was due to lower sales of high-margin products in the Life Science business sector that had experienced strong demand in conjunction with the Covid-19 pandemic. In addition, as a result of the agreement terminating the strategic alliance with Pfizer Inc., United States, the cost of sales included royalties for the Bavencio® product for the first time from July 1, 2023, which in turn reduced the gross margin. Marketing and selling expenses declined on the back of lower logistics costs in particular. 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 Combined Management Report Report on Economic Position 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. Combined Management Report 56 56 1 Not defined by International Financial Reporting Standards (IFRS). Income tax -18.7% -33.0% 62 -803 -0.8% 19.3% -187 4,287 -0.6% 16.6% Profit after tax -125 3,484 Financial result -43.8% -19.3% 300 -865 -3.1% 20.1% € million/organic growth in % 17.2% 3,609 Profit before income tax 22 -650 2,834 -948 3,339 -15.1% -502 -25.6% 3 -0.1% 15.0% -14 3,326 13.5% -3.1% 13.5% 2,824 -10 Non-controlling interests -15.1% -505 -31.4% 298 -4.3% 15.0% Net income Operating result (EBIT)¹ Q2 Q4 3% 695 6.1% -2.7% 8.8% 4% 737 20,993 Merck Group Africa (MEA) Middle East and 5% 1,231 8.1% -10.5% 100.0% 100% -1.6% -4.1% 0.1% 20,993 % 2023 Cost of sales Net sales € million Change 18.6% Consolidated Income Statement The Consolidated Income Statement of the Merck Group is as follows: Net sales in the Life Science business sector decreased by € 1,100 million or -10.6% year-on-year to € 9,281 million (2022: € 10,380 million). This development was mainly attributable to organic effects, which amounted to € 821 million or -7.9%. Exchange rate effects of € 285 million or -2.7% also contributed to the downturn in net sales. The Life Science business sector accounted for the largest share of Group net sales at 44% (2022: 47%), followed by Healthcare at 38% (2022: 35%). Net sales in the Healthcare business sector increased by € 214 million or 2.7% year-on-year to € 8,053 million (2022: € 7,839 million). Negative exchange rate effects of -5.8% were offset by organic growth of 8.5%. The € 354 million decline in net sales in the Electronics business sector to € 3,659 million (2022: € 4,013 million) was driven by organic effects of -5.1% and exchange rate effects of -4.1%. This was offset by a positive effect of 0.3% from the acquisition of M Chemicals Inc., Korea. The percentage contribution of Electronics to Group net sales was unchanged year-on-year at 18%. Orders already received by the reporting date that will result in net sales in future periods amounted to around € 4 billion as of December 31, 2023 (December 31, 2022: around € 6 billion), of which around € 3 billion related to the Life Science business sector (December 31, 2022: around € 4 billion). In fiscal 2023, the Merck Group generated net sales of € 20,993 million (2022: € 22,232 million), representing a year-on-year decline of € 1,239 million or -5.6%. Negative exchange rate effects served to reduce net sales by € 902 million or -4.1% in fiscal 2023. These effects largely resulted from the exchange rate development of the Chinese renminbi, the US dollar, and the Argentinian peso. Net sales fell by € 357 million or -1.6% organically. Net sales in the Life Science and Electronics business sectors declined, while the Healthcare business sector recorded organic growth. The portfolio-related net sales increase of € 19 million mainly resulted from the acquisition of M Chemicals Inc., Korea. 1 Not defined by International Financial Reporting Standards (IFRS). 100% 22,232 -5.6% Merck Group Dec. 31, 2023 Balance sheet structure Merck Group Merck Group 2 Quarterly breakdown unaudited. 1 Not defined by International Financial Reporting Standards (IFRS). -12.8% -2.6% % 1,628 EBITDA pre¹ by business sector² - 2023 1,810 1,629 2022 1,293 1,446 1,553 1,587 2023 1,782 Q3 € million/% Electronics Net assets and financial position 59 Merck Group Course of Business and Economic Position_ Report on Economic Position Combined Management Report 2,543 15% Healthcare 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% -20.2% 2,820 45% Life Science 913 41% -1.8% -685 4,474 Other operating income and expenses 18% 4,013 -8.8% 0.3% -4.1% -5.1% 18% 3,659 Electronics 35% 7,839 47% 10,380 Share 2022 Merck Group 20,993 100% -1.6% Share 2023 -385 Net sales by region Merck Group In fiscal 2023, the Merck Group recorded the following regional sales performance: Merck Group Total change -10.6% 2.7% Course of Business and Economic Position Combined Management Report 1 Not defined by International Financial Reporting Standards (IFRS). 100% 22,232 -5.6% 0.1% -4.1% Report on Economic Position -5.8% 38% 8,053 -1.1% 0.8% % 5,660 5,806 5,568 5,198 -4.1% 2022 5,173 5,302 5,293 2023 Q4 Q3 Q2 5,225 Organic growth¹ -1.7% 2 Quarterly breakdown unaudited. Healthcare 0.1% -2.7% -7.9% 44% 9,281 Acquisitions/ divestments 1 Not defined by International Financial Reporting Standards (IFRS). Exchange rate effects Share 2023 Life Science € million Net sales by business sector Merck Group In fiscal 2023, the net sales by business sector developed as follows: Organic growth¹ Exchange rate effects € million Total change 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 Acquisitions/ divestments 13,705 59.0% -1,392 -6.6% -1,306 -5.9% losses on financial assets (net) > 100% -45 -6 -0.2% -51 Impairment losses and reversals of impairment 12,392 -3.0% -11.3% -2,521 -11.6% -2,445 Research and development costs 6.6% -86 75 Gross profit 61.6% -8,527 0.1% -2.7% -38.4% 28% 5,952 North America 28% -6.4% 6,248 -2.1% -1.3% 29% 6,037 Europe Share 2022 -3.4% 6,361 -3.8% Asia-Pacific (APAC) -41.0% -8,600 100.0% 29% 2022 22,232 6% 1,331 Latin America % 7,697 -9.9% 0.2% -5.8% -4.3% 33% 6,936 35% 100% 14% -4.0% 53% 14.9% 1 Not defined by International Financial Reporting Standards (IFRS). 23% 10% Share -12.8% 2.9% 2022 28.5% 4% 84 25% 353 3% 116 1% 0.1% -10.6% 10,380 100% 1 Not defined by International Financial Accounting Standards (IFRS). 1 The core business consists of "Net sales excluding the Covid-19 pandemic business". This is a financial indicator that is not defined by International Financial Reporting Standards (IFRS). It should not be taken into account in order to assess the performance of Merck in isolation or as an alternative to the financial indicators presented in the consolidated financial statements and determined in accordance with IFRS. Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science The following table presents the composition of EBITDA pre for 2023 in comparison with 2022. The International Financial Reporting Standards (IFRS) figures have been modified to reflect the elimination of adjustments included in the respective functional costs. Life Science Reconciliation EBITDA pre¹ 2,536 2023 -10.7% -0.3% -0.1% -7.9% -5.1% -5.6% Latin America 352 4% 10.3% -10.8% 0.1% Middle East and Africa (MEA) 116 1% 5.3% Life Science 9,281 100% -5.5% -2.7% 2022 Change € million Gross profit 5,044 6 5,050 6,100 7 6,107 -17.3% Marketing and selling expenses -2,245 12 -2,232 -2,400 16 -2,384 -10.6% -1.0% -4,273 7 -4,280 Net sales Cost of sales IFRS Elimination of adjustments -0.5% IFRS Elimination of adjustments 25% Pre¹ 9,281 9,281 10,380 10,380 -4,236 6 -4,230 Pre¹ 2,263 Asia-Pacific (APAC) 38% -2.3% -16.7% 4,540 44% Life Science Services Life Science 792 9,281 8% -14.6% -2.0% 0.6% 100% -7.9% -2.7% 0.1% -14.4% 41% 3,782 Process Solutions Acquisitions / € million 2023 Share growth¹ rate effects divestments Total change 20222 -15.9% -10.6% Share 4,706 51% -0.6% -3.3% -3.9% 4,898 47% Science & Lab Solutions -6.3% 943 10,380 North America 3,372 36% -12.0% Exchange rate effects -0.2% -2.3% Acquisitions/ divestments Total change 2022 Share -7.8% 3,445 33% 0.1% -14.2% 3,931 -7.6% 34% 3,178 Europe 100% 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 The Science & Lab Solutions business unit, which provides products and services to support life science research for pharmaceutical, biotechnology, academic research laboratories and researchers, and scientific and industrial laboratories, had organically stable sales in 2023. While the core business¹ generated organic growth in the first half of 2023, sales saw an organic decline in the second half of 2023 amid further decreasing pandemic-related demand as well as decreasing demand in China due to the current economic environment. Including an unfavorable foreign exchange effect of -3.3%, net sales decreased to € 4,706 million in 2023 (2022: € 4,898 million). Science & Lab Solutions accounted for 51% of Life Science net sales (2022: 47%). Geographically, Europe showed organic growth in 2023, while net sales in North America and Asia-Pacific (APAC) declined organically. 9% 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%). Net sales of the business sector by region developed as follows: Life Science Net sales by region € million 2023 Share Organic growth¹ 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). Administration expenses -425 53 1,006 976 % -2.9% -29.2% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 850 -37.0% -30.4% Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 69 Healthcare 927 2022 592 615 67 Combined Management Report Report on Economic Position Course of Business and Economic Position_ Life Science 68 The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: Life Science EBITDA pre¹ and change by quarter² Healthcare € million/change in % 22 Q2 Q3 Q4 2023 901 712 Q1 40 Key figures Net sales 24.2% 2,545 2,385 160 6.7% 31.6% 30.4% 2,543 2,477 66 2.7% 31.6% 31.6% 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 27.6% 17.4% 330 1,895 Operating result (EBIT)¹ Margin (% of net sales) 1 EBITDA² Margin (% of net sales)¹ EBITDA pre¹ Margin (% of net sales) 1 Change € million 2023 € million % 8,053 7,839 214 2.7% 2,225 2022 Exchange 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%). 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%). 48 -78 -85 61 -24 > 100.0% expenses Operating result (EBIT)¹ 1,850 2,808 Depreciation/amortization/ impairment losses/reversals of 881 -34 848 -126 Other operating income and -75.5% -9 -372 -400 22 -377 -1.4% Research and development costs -396 870 3 -399 -0 -399 -1.5% Impairment losses and reversals of impairment losses on financial assets (net) -2 -2 -393 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. -24 0.3% -18 Other adjustments EBITDA pre² 2,820 2,820 3,760 of which: organic growth¹ of which: exchange rate effects 3,760 -25.0% -21.4% -3.3% of which: acquisitions/ divestments 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. -0.3% 18 -6 6 Acquisition-related adjustments impairment losses EBITDA² 2,731 Restructuring expenses 30 -30 Integration expenses/IT expenses 845 53 3,678 41 -41 24 -24 Gains (-)/losses (+) on the divestment of businesses -53 Organic Net sales by business unit Life Science 201 187 Dividend payments/profit withdrawals² 1,164 967 -30 86 -258 -3 7,500 8,328 1 Not defined by International Financial Reporting Standards (IFRS). 2 As reported in the Consolidated Cash Flow Statement. Traditionally, the capital market represents a major source of financing for Merck, for instance via bond issues. As of December 31, 2023, there were liabilities of € 3.9 billion from a debt issuance program most recently renewed in fiscal 2023 (December 31, 2022: € 4.5 billion). Loan agreements represent a further source of financing for Merck. A € 2.5 billion syndicated loan facility is in place until 2028 to cover unexpected cash needs. This credit line is a backup facility that is intended to be used in exceptional circumstances only. Merck also agreed upon several bilateral loan facilities. December 31 Other Currency translation difference Change in lease liabilities 216 275 Payments from the disposal of intangible assets² -136 -38 Payments for investments in property, plant and equipment² 1,807 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. 1,531 -19 -21 Acquisitions² 12 854 Payments from divestments² -4 Payments from the disposal of property, plant and equipment² Payments for investments in intangible assets² Combined Management Report Course of Business and Economic Position 3.375% 1.625% 0.125% 3.250% 1.875% 1.625% 600 600 750 634 0.375% 2.875% 0.5% 2030 500 500 2.375% 2031 842 500 1,502 750 Merck Group 62 The maturities of our financial liabilities are aligned with our planned free cash flow. The repayment profile of the issued bonds was as follows: • Eurobond • USD Bond¹ • Hybridbond² 2024 Report on Economic Position 2025 2027 2028 2029 | | | 500 500 500 2026 800 -4,259 8,753 1 Not defined by International Financial Reporting Standards (IFRSS). Change Dec. 31, 2023 Dec. 31, 2022 € million % 7,802 8,726 -924 -10.6% 283 203 80 39.4% 1,196 Net financial debt¹ Other current financial assets² Cash and cash equivalents less: Combined Management Report Report on Economic Position Course of Business and Economic Position_ Merck Group 61 The composition and the development of net financial debt were as follows: Merck Group 919 Net financial debt¹ Bonds Bank loans Liabilities to related parties Loans from third parties and other financial debt Liabilities from derivatives (financial transactions) Lease liabilities Financial debt € million -3,784 276 68 212 85.9% 8,328 -828 -9.9% 2 Excluding current derivatives (operational) and contingent considerations, which are recognized in the context of business combinations according to IFRS 3. 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. Merck Group Reconciliation of net financial debt¹ € million January 1 Operating Cash Flow 2023 2022 8,328 247 6.9% 128 1,854 59 9 15.7% 77 30 47 > 100.0% 30.1% 515 24 5.0% 9,941 10,428 -487 -4.7% 1,982 459 7,500 491 The net sales in the individual quarters as well as the respective organic growth rates in 2022 are presented in the following graph: 0.875% 2 For the hybrid bonds, repayment is assumed at the earliest possible date. 1 Not defined by International Financial Reporting Standards (IFRS). Change 2023 2022 € million % 9,281 10,380 1,850 2,808 -1,100 -958 -10.6% -34.1% 19.9% 27.1% Margin (% of net sales) 1 EBITDA pre¹ Margin (% of net sales) 1 Margin (% of net sales)¹ EBITDA² Course of Business and Economic Position Merck Group Overall assessment of business performance and economic situation Despite the challenging macroeconomic environment and headwinds in individual markets, Merck can look back on a predominantly steady fiscal 2023 thanks to the diversified nature of its business sectors. As anticipated, Life Science business declined as a result of the forecast downturn in demand for products in connection with the Covid-19 pandemic and the slower than expected reduction in customer inventories in the Process Solutions business unit. Additionally, the economic slowdown in the semiconductor industry led to weak business performance in the Electronics business sector. However, Healthcare achieved strong organic growth that partially offset the negative development in the other business sectors. All in all, the Merck Group's net sales declined by -5.6% or € -1.2 billion to € 21 billion in fiscal 2023. Our most important key performance indicator, EBITDA pre, fell by -14.2% to € 5.9 billion. Earnings were adversely affected by the challenging market conditions and exchange rate effects. We will propose to the Annual General Meeting an unchanged dividend payment of € 2.20 per share for fiscal 2023. The solid financing policies of the Merck Group were reflected in its consistently good key balance sheet figures. The equity ratio remained at 55.2% as of December 31, 2023 (December 31, 2022: 53.6%). Net financial debt was reduced further, amounting to € 7.5 billion at the end of the fiscal year (2022: € 8.3 billion). Based on our solid net assets and financial position as well as our diversified operations, we view the economic situation of the Merck Group as positive overall. Thanks to our resilient business model and our clear positioning as a science and technology company, we are well positioned even in economically challenging times. 2,731 65 Report on Economic Position Course of Business and Economic Position_ Life Science Life Science Life Science Key figures € million Net sales Operating result (EBIT) 1 Combined Management Report Combined Management Report Report on Economic Position 3,678 -25.7% 2,354 2,191 2,249 2022 2,445 2,648 2,681 2,606 % 0.6% -8.7% -13.2% -9.7% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 2,487 2023 Q4 Q3 29.4% 35.4% 2,820 3,760 -940 -25.0% 30.4% -946 36.2% Development of sales and results of operations The development of sales in the individual quarters in comparison with 2022 as well as the respective organic growth rates are presented in the following graph: Life Science Net sales and organic growth¹ by quarter² € million/organic growth in % Q1 Q2 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 The nominal volumes of bonds denominated in U.S. dollars were converted into euros at the closing rate on December 31, 2023. 64 -19.1% 53.6% 47.2% 40.7% 40.9% Total assets Non-current assets Asset ratio¹ 74.4% 74.9% 75.8% 77.8% 79.4% Total assets Total equity Asset coverage¹ 55.2% Dec. 31, 2019 Dec. 31, 2020 Dec. 31, 2021 The capital market uses the assessments published by rating agencies to help lenders assess the risks of a financial instrument used by Merck. Merck is currently rated by Standard & Poor's and Moody's. Standard & Poor's has issued a long-term credit rating of A with a stable outlook, while Moody's has issued a rating of A3 with a stable outlook. An overview of the development of our rating in recent years is presented in the “Report on Risks and Opportunities”. The financial debt was not secured by liens or similar forms of collateral. The loan agreements do not contain any financial covenants. There were no indications that the availability of extended credit lines was restricted. Cash and cash equivalents included restricted cash amounting to € 404 million (December 31, 2022: € 456 million). We pursue a sustainable dividend policy and aim for a target corridor of 20% to 25% of earnings per share pre when determining the amount of the dividend. The average borrowing cost on December 31, 2023, was 2.1% (December 31, 2022: 1.9%). Combined Management Report Report on Economic Position Course of Business and Economic Position_ Merck Group 63 74.1% 83 Merck Group Key balance sheet figures % Total equity Equity ratio¹ Dec. 31, 2023 Dec. 31, 2022 The development of key balance sheet figures was as follows: 3.8% 71.6% 52.3% 840 852 % 1.5% 22 Q2 Q3 Q4 1,255 1,053 1,552 1,015 -27.0% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. 622 853 2023 Q1 51.5% Non-current assets Current liabilities Finance structure¹ 40.0% 42.2% 43.6% 62.3% 37.3% Liabilities (total) 1 Not defined by International Financial Reporting Standards (IFRS). In the area of financial risks and opportunities, Merck uses an active management strategy to reduce the effects of fluctuations in exchange and interest rates. This also includes the use of derivative financial instruments. Further details on liquidity, counterparty and financial market risks and opportunities are presented in the "Report on Risks and Opportunities” in the “Financial risks and opportunities" section. In fiscal 2023, operating cash flow, which is one of the three most important key performance indicators alongside net sales and EBITDA pre, decreased by -11.2% to € 3,784 million (2022: € 4,259 million). This was mainly due to the development of EBITDA pre. This was countered by a reduction in working capital and lower tax payments. Further information about the development of the operating cash flow can be found in the “Internal Management System” chapter in this Combined Management Report, under "Consolidated Cash Flow Statement" in the Consolidated Financial Statements and in Note (16) "Operating cash flow” in the Notes to the Consolidated Financial Statements. The distribution of operating cash flow across the individual quarters and the percentage changes in comparison with 2022 were as follows: Merck Group Operative cash flow¹ and change by quarter² € million/change in % 45.7% Healthcare Pre¹ € million/organic growth in % 3% Other 235 3% 161 2% Healthcare 266 8,053 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 100% 70 25.1% 35.7% 1.6% -4.9% -3.3% 590 8% thereof: EuthyroxⓇ 565 -10.6% 7% -3.2% 2.2% 553 7% thereof: SaizenⓇ 332 4% 5.4% 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. 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). Share € million Organic growth¹ Share € million Organic growth¹ 100% 41% 956 360 15.9% 3.4% GlucophageⓇ 490 23.2% 100% 38% 51% 2% 882 128 467 45% 20 -0.7% MavencladⓇ 54.4% 87 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. 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 1,025 421 10.9% 2.4% Asia-Pacific (APAC) 464 14.2% Latin America 7% 571 thereof: ConcorⓇ 12% 8% Neurology & Immunology 1,665 21% -0.9% -3.5% -4.5% 611 1,743 thereof: MavencladⓇ 956 12% 15.9% -4.3% 11.7% 856 22% 16.6% -6.8% 23.4% 2022 Share -9.2% 8.1% 1,683 22% thereof: Erbitux® 1,025 13% 10.9% -10.6% 0.3% 1,023 13% thereof: BavencioⓇ 713 9% 11% 9% 45 62.6% 5% 203 thereof: Rebif® 9% Cardiovascular, Metabolism & Endocrinology 2,786 35% 4.0% -4.6% -0.7% 11% 2,805 thereof: GlucophageⓇ 882 11% -0.5% -4.6% -5.1% 930 36% 825 2.7% -7.8% -17.2% -2.9% -20.1% 887 11% Fertility 1,547 19% 14.9% -7.8% 7.0% 1,446 18% thereof: Gonal-fⓇ 847 11% 10.5% 709 Middle East and Africa (MEA) 53 -12.8% 5% 41 Net sales and organic growth¹ by quarter² 9.2% Q1 Q2 Q3 Q4 2023 1,905 2,049 2,066 2,032 2022 1,795 2,089 2,030 % 5.3% 1,924 7.4% Exchange Organic growth¹ 17.3% 11.9% 1,819 Oncology Share 2023 22% Net sales by major product lines/products € million 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. rate effects Total change Net sales of the key product lines and products developed as follows in 2023: Healthcare 1,700 21 -20.7% Marketing and selling expenses -591 3 -588 -662 3 -659 1,721 -10.9% -147 440 12 > 100.0% Operating result (EBIT)¹ 248 572 Depreciation/amortization/ impairment losses/reversals of expenses 568 526 565 -20 545 -3.5% impairment losses EBITDA² 816 -42 Administration expenses -28 70 29 -118 -128 8 -120 -1.0% Research and development costs -297 26 1 Gross profit -308 2 -306 -3.2% Impairment losses and reversals of impairment losses on financial assets (net) Other operating income and -44 -297 1,364 Operating result (EBIT)¹ 1,138 100% 4,013 -8.8% 0.3% -4.1% -5.1% 100% 2% 53 42.4% 1% 1 Not defined by International Financial Reporting Standards (IFRS). 40 -1.6% -11.2% 53.6% 2% 75 3,659 Electronics Middle East and Africa (MEA) -2.3% 1% 39 Latin America 72% -3.9% 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. Electronics Reconciliation EBITDA pre¹ 0.1% -2,292 21 -2,314 -2,295 37 -2,332 Cost of sales -8.8% 4,013 4,013 3,659 3,659 Pre¹ Pre¹ Elimination of adjustments IFRS Pre¹ Elimination of adjustments IFRS Net sales € million Change 2022 2023 37 Restructuring expenses 60 -60 Report on Risks and Opportunities Combined Management Report_ 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. 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. 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. Group Accounting provides support to the local contacts and ensures a consistently high quality of reporting throughout the entire reporting process. 79 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. 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 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. Internal control system for the (Group) accounting process Internal control system Combined Management Report_ Report on Risks and Opportunities 78 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. Both the second and third line of defense functions regularly report to the Executive Board and the Audit Committee of the Supervisory Board. 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. Non-financial internal control system and overall evaluation* 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. 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. 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. 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. Risk and opportunity management 2,901 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. Combined Management Report_ 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. 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. The aim of our internal control system as the entirety of all systematically defined controls is therefore to prevent and reduce the probability of potential risks occurring as well as actively steer risks in business processes. Thereby, it helps to ensure the compliance of the company's activities with laws and regulations. The entire internal control system and the applied methods are continuously developed further. The responsibility for the effectiveness of the internal control system and the further development of the non- financial key metrics lies with the respective responsible senior leaders or risk and process owners. Additionally, the non-financial internal control system aligns with the sustainability strategy and ongoing projects for implementing sustainability reporting (e.g. CSRD). The goal is to continuously improve regulatory compliance pursuant to CSRD requirements through the implementation of organization-wide measures and controls. For fiscal 2023, the Group Legal & Compliance function provides the organizational framework for the non- financial internal control system. In line with the risk situation of the Group and to ensure regulatory compliance, non-financial topics such as sustainability, cyber security and supply chain are core areas of the internal control system. We base this on international standards, such as the framework for the governance of Group Cyber Security, which includes organizational, process-related, and technical measures for information security. The existing process of Cyber Security Risk Management is designed pursuant to ISO 27005:2018. In comparison with the previous year, a monthly Group Security Forum has been established, where new risks from the risk register are reported, and actions are tracked. 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. * The contents of this chapter or section are voluntary and therefore not audited. However, our auditor has read the text critically. 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. The second line of defense includes enabling functions at both Group and local level that control and monitor the operational business (first line of defense). This includes, among other things, the design and implementation of methods and procedures for risk management and the internal control system (financial and non-financial) as well as its regular monitoring. The 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. -696 -603 -11.0% 88 -801 -713 93 % 2022 2023 Change 1 Not defined by International Financial Reporting Standards (IFRS). EBITDA pre¹ EBITDA² € million -13.4% -397 -579 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: which Three Lines of Defense 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". 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. 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). 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. Report on Risks and opportunities 77 Report on Risks and Opportunities Combined Management Report_ 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. 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. -31.5% 182 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 of which: organic growth¹ of which: exchange rate effects 1,192 -23.4% -17.1% -5.6% -0.7% 1,192 of which: acquisitions/ divestments 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 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. 1 Not defined by International Financial Reporting Standards (IFRS). 913 913 EBITDA pre¹ 31 -31 Integration expenses/IT expenses 24 -24 13 -13 Gains (-)/losses (+) on the divestment of businesses Acquisition-related adjustments 13 -13 11 -11 Other adjustments 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. € million 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 -31.1% -33.1% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. Combined Management Report Report on Economic Position -10.7% Course of Business and Economic Position 76 Corporate and Other Corporate and Other comprises administrative expenses for central Group functions that cannot be directly allocated to the business sectors. Corporate and other Key figures 80 Corporate and Other 308 302 -18.0% € million/change in % Q2 Q3 Q4 208 206 Q1 22 2023 237 262 2022 289 293 % Electronics Report on Risks and Opportunities 1,327 901 Organic growth1 Exchange rate effects Acquisitions/ divestments Total change 2022 Share Semiconductor Solutions 2,479 68% -3.9% -3.9% 0.5% -7.3% 2,674 67% Display Solutions 770 21% -9.2% Share -5.3% 2023 -3.2% Q3 Q4 2023 Acquisition-related adjustments 899 916 943 2022 ― 957 996 1,036 % - -7.1% -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% € million Q2 -14.5% 22% The Surface Solutions business unit reported a moderate organic net sales decline in 2023. While the Cosmetics business continued to show strength again in 2023, especially in Asia and EMEA, these gains were more than offset by weaker demand for Industrials and Coatings across all regions. Net sales of the Electronics business sector by region developed as follows: Electronics Net sales by region € million 2023 Share Organic growth1 Europe 318 9% -13.6% Exchange rate effects -0.6% Acquisitions/ divestments Total change 2022 Share -14.2% 371 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. 900 74 Combined Management Report. _ Report on Economic Position Surface Solutions 411 11% -3.6% -2.9% -6.5% 439 11% Electronics 3,659 100% -5.1% -4.1% 0.3% -8.8% 4,013 100% 1 Not defined by International Financial Accounting Standards (IFRS). The Semiconductor Solutions business unit, which comprises two businesses, namely Semiconductor Materials and Delivery Systems & Services (DS&S), reported a moderate decline in net sales in organic terms in fiscal 2023. The cyclical slow-down in the semiconductor industry, which has significantly impacted the sales volumes of the Semiconductor Materials business, is proving to be both longer and more severe than the industry initially expected and affected every quarter of 2023. DS&S partially compensated for the decline in Semiconductor Materials due to the strong demand for equipment and projects throughout 2023 as our key customers continue to invest in long-term capacity increases. The portfolio effect was due to the acquisition of the chemical business of Mecaro Co. Ltd., Korea, trading as M Chemicals Inc., Korea, on December 30, 2022. Course of Business and Economic Position Electronics Q1 € million/organic growth in % Net sales and organic growth¹ by quarter² 2023 590 Q2 Q3 Q4 704 685 565 711 633 2022 529 604 % 11.4% 16.6% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Quarterly breakdown unaudited. -3.6% Q1 -10.8% € million/change in % Healthcare of which: organic growth¹ of which: exchange rate effects of which: acquisitions/ divestments 2,543 2,543 2,477 2,477 2.7% 17.1% -14.4% 1 Not defined by International Financial Reporting Standards (IFRS). 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Combined Management Report Report on Economic Position Course of Business and Economic Position Healthcare 72 Adjusted gross profit increased slightly in fiscal 2023, while the gross margin declined slightly to 74.8% (2022: 75.5%). Marketing and sales costs and administrative expenses were essentially unchanged year-on-year in the reporting period. The adjusted research and development costs increased slightly compared with the previous year, which was largely due to the provisions recognized for follow-on obligations in connection with the discontinuation of the development program for evobrutinib, a BTK inhibitor used in the treatment of relapsing multiple sclerosis (RMS). Net adjusted other operating expenses and income were negative but declined in fiscal 2023. This positive development was mainly driven by the end of the strategic alliance with Pfizer Inc., United States, on the co-development and co-commercialization of the oncology drug BavencioⓇ effective June 30, 2023. The royalties paid to Pfizer Inc., United States, instead of the profit share previously reported in other operating expenses have been reported in the cost of sales since July 2023, leading to a corresponding increase in this item. This development outweighed the year-on-year reduction in license income, meaning that the net figure improved as a result. The moderate increase in EBITDA pre in fiscal 2023 meant that the EBITDA pre margin amounted to 31.6% (2022: 31.6%). The development of EBITDA pre in the individual quarters in comparison with 2022 is presented in the following overview: EBITDA pre¹ and change by quarter² Combined Management Report _ Report on Economic Position Course of Business and Economic Position Electronics -325 -56.8% 6.8% 14.3% 816 1,138 -322 -28.3% 22.3% 28.3% 913 25.0% 1,192 -279 -23.4% 29.7% 2 Not defined by International Financial Reporting Standards (IFRS); EBITDA corresponds to operating result (EBIT) adjusted by depreciation, amortization, impairment losses, and reversals of impairment losses. Development of net sales and results of operations The net sales in the individual quarters as well as the respective organic growth rates in 2023 are presented in the following graph: Electronics 572 -8.8% -354 4,013 73 Electronics Electronics Key figures € million Net sales Operating result (EBIT)¹ Margin (% of net sales)¹ EBITDA² 9% Margin (% of net sales)¹ Margin (% of net sales) 1 1 Not defined by International Financial Reporting Standards (IFRS). Change 2023 2022 € million % 3,659 248 EBITDA pre¹ North America 787 21% Healthcare 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. 1 Not defined by International Financial Reporting Standards (IFRS). 100% 7,839 2.7% -5.8% 8.5% 7% 527 3.8% -1.3% 5.1% 7% 100% 8,053 Healthcare 546 Middle East and Africa (MEA) 10% Reconciliation EBITDA pre¹ 838 2023 Change -1,925 -2,030 -1 -2,029 2.7% 7,839 7,839 8,053 8,053 Pre¹ Pre¹ Elimination of adjustments IFRS Pre¹ Elimination of adjustments IFRS Cost of sales Net sales € million 2022 12.3% -10.8% 23.1% 31% 2,541 Europe Share 2022 Total change Acquisitions/ divestments Exchange rate effects Organic growth¹ Share 2023 € million Net sales by region Healthcare Net sales in the Healthcare business sector by region in 2023 developed as follows: 71 Healthcare Report on Economic Position Course of Business and Economic Position Combined Management Report 9.6% -5.1% 4.5% 2,433 12% 941 Latin America 29% 2,261 -1.3% -7.7% 6.4% 28% 4 2,232 23% 1,781 0.6% -3.2% 3.9% 22% 1,793 North America 31% Asia-Pacific (APAC) EBITDA pre¹ -1,921 Gross profit -20 20 Integration expenses/IT expenses -32 32 Restructuring expenses 2,545 EBITDA² impairment losses 2.3% 303 -187 490 310 -10 320 impairment losses/reversals of Depreciation/amortization/ 1,895 Gains (-)/losses (+) on the 2,225 -53 2,385 25.2% -3.8% 21.3% 649 16% Asia-Pacific (APAC) 2,440 67% -11.8% -4.5% 0.4% -15.9% divestment of businesses 15 -15 -16 16 -91 91 53 Operating result (EBIT)¹ expenses -18.7% -294 20 -314 Administration expenses 0.5% -1,631 13 -1,644 -1,639 29 -1,668 Marketing and selling expenses 1.8% 5,917 4 5,914 6,023 -1 6,024 -313 18 -296 -0.7% -198 172 -370 -161 -41 -120 Other operating income and > 100.0% 2 5.7% 2 -41 2.0% -1,622 73 -1,694 -1,655 2 -1,657 Research and development costs Impairment losses and reversals of impairment losses on financial assets (net) -41 Other adjustments 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. Combined Management Report_ Nevertheless, reputational risks could result, for instance through public dialogues on social media. On the qualitative rating scale, we thus rate this risk as significant. We and our employees are active on numerous social media platforms. The consistent and legally compliant use of such platforms and their content is important in terms of increasing awareness of our brand, among other things. We take all necessary precautions and have implemented processes to ensure awareness regarding the proper handling of social media as well as actively manage and control our publications and communication. Risks from the use of social media Overall, the threat resulting from product-related crime is likely with a moderate impact. As 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. Combined Management Report_ Report on Risks and Opportunities 88 Financial risks and opportunities We have commitments in connection with pension obligations. The present value of defined benefit obligations can be significantly increased or reduced by changes in the relevant valuation parameters, for example the interest rate or future salary increases. Pension obligations are regularly assessed as part of annual actuarial reports. The obligations are covered by the pension provisions reported in the balance sheet based on the assumptions as of the balance sheet date. Some of these obligations are funded by plan assets (further information can be found under "Provisions for pensions and other post-employment benefits" in the "Notes to the Consolidated Financial Statements"). Risks and opportunities from pension obligations The carrying amounts of individual balance sheet items are subject to the risk of changing market and business conditions and thus to changes in fair values as well. Necessary impairments could have a significant negative non-cash impact on earnings and affect the accounting ratios. This applies specifically to the high level of intangible assets including goodwill, which mainly derive from the purchase price allocations made in connection with past acquisitions (further information can be found under "Goodwill" and "Other intangible assets” in the "Notes to the Consolidated Financial Statements"). This qualitative risk might have a significant effect on reputation. 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. Risks and Opportunities in Life Science Financial market risks and opportunities The solvency and operational development of trading partners are regularly reviewed as part of the management of operational counterparty risks. Sovereign risks are also analyzed. The volume of receivables of each customer is capped in line with their credit ratings. Risk-mitigating measures, such as credit insurance, are utilized as appropriate. Nevertheless, defaults by isolated trading partners, even those with outstanding credit ratings, cannot be entirely ruled out, although rated as unlikely. As for counterparty risks from financial transactions, we review all central positions relating to trading partners and their credit ratings daily. We manage financial risks of default by diversifying our financial positions and through the related active management of our trading partners. Significant financial transactions involving credit risk are entered into with banks and industrial companies that have a good credit rating. Moreover, our large banking syndicate - the renewed syndicated loan facility of € 2.5 billion was syndicated among 15 banks in 2023 - reduces possible losses in the event of default. Counterparty risks arise from the potential default by a partner in connection with financial investments, loans, and financing commitments on the one hand and receivables in operating business on the other. Counterparty risks To ensure continued existence, we must be able to fulfill our commitments arising from operating and financial activities at any time. Therefore, to reduce potential liquidity risks, we have a central Group-wide liquidity management system in place, and a balanced maturity profile. The maturities of our financial liabilities are aligned with our planned free cash flow. Furthermore, we have a syndicated loan facility of € 2.5 billion with a term until 2028, which ensures continuing solvency if any liquidity bottlenecks occur. As our loan agreements do not contain any financial covenants, these agreed lines of credit can be accessed even if Merck's credit rating should deteriorate. Additionally, we have a commercial paper program with a maximum volume of € 2.5 billion. Liquidity risks 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. Counterparty risks are classified as possible risks and might have moderate effects. 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. 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. 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. 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 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". Our Science & Lab Solutions business unit serves customers in the pharmaceutical and biotech industries and other industries in production, testing and research, as well as public authorities and research institutions. Despite current headwinds - a complex macroeconomic environment, and softer market demand, especially in the United States and China the business unit is well-positioned to deliver long-term, profitable growth. We aim to offer our customers a streamlined experience and a comprehensive portfolio of offerings to facilitate their research and analytical processes. This includes several customer solutions in the area of innovative digitalization and automation. A faster recovery from the aforementioned macroeconomic adverse development as well as greater commercial success of our innovative digital and automation solutions could imply an increased potential compared to our latest plans. - == 84 Report on Risks and Opportunities Combined Management Report_ 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. Consequently, faster market growth driven by the aforementioned industry shifts can lead to a more positive development compared with our latest plan. 85 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. 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. Further details on the industry and market development can be found under "Macroeconomic and Sector- Specific Environment", e.g. on the market challenging environment in the life science industry. In today's dynamic business environment, we prioritize innovation and growth. Projects are essential for achieving our strategic objectives, driving expansion, and promoting sustainable development. To effectively support further business growth and enhance efficiency, we continuously invest in projects, such as IT systems, distribution centers, office buildings and other projects. However, project execution involves significant capital expenditures, making effective project management crucial to avoid delays and higher spending. Inadequate planning, execution errors, and ineffective change management can lead to inefficiencies and disruptions, resulting in increased costs and lower sales. Risks arising from project execution In fiscal 2023, we announced several new investments to expand capacity and product capabilities at facilities around the world. These include investments in biosafety testing, the expansion of our production for highly purified reagents and expanded lab space and production capability to manufacture cell culture media. Having the right capacity in the right place to ensure supply security, to bring new products to the market and to serve higher customer demand offers us the opportunity to capture higher market shares and can serve as a competitive advantage. However, market dynamics naturally influence our expansion activities as well as utilization. We therefore regularly review our expansion plans and adapt them accordingly. During the Covid-19 pandemic, supply chains experienced unprecedented disruption, with customers placing greater emphasis on supply security. In Life Science, we responded to this trend by actively diversifying our global presence by moving to a production network in the region and for the region to increase resiliency and meet the local needs of customers in North America, Europe and Asia-Pacific. We make targeted investments worldwide to expand our regional capacities and drive sustainable growth in all three of our business sectors. Opportunities arising from capacity expansion Risks and opportunities related to the quality and availability of products 86 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. Report on Risks and Opportunities 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. - Risks and opportunities of research and development Combined Management Report_ Assessment by independent rating agencies 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. Overview of Rating Development € 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. 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. 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. Combined Management Report_ Report on Risks and Opportunities 82 82 Business-related risks and opportunities Political and regulatory risks and opportunities 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 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 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. Risk of negative political and macroeconomic developments € 25 100 million € 100 500 million > € 500 million Degree of impact 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% 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. 1 - 5% 20 - 50% > 50% Explanation Highly improbable Improbable Possible Likely More likely than not Degree of impact 5 -20% 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 Combined Management Report_ Report on Risks and Opportunities 2019 2018 2017 2016 2015 2014 2013 2012 2020 2011 • Moody's • S&P BBB / Baa2 BBB+ / Baa1 A- / A3 A / A2 A+ / A1 S&P/Moody's BBB-/Baa3 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. 2021 2023 83 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. 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. 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. 2022 Legal risks 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 Combined Management Report_ Report on Risks and Opportunities 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". Risk of a temporary ban on products/production facilities or of non-registration of products due to non-compliance with quality standards