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Merck & Co., Inc As filed with the Securities and Exchange Commission on February 25, 2021 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D. C. 20549 _________________________________ FORM 10-K (MARK ONE) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Fiscal Year Ended December 31, 2020 OR ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 1-6571 _________________________________ Merck & Co., Inc. 2000 Galloping Hill Road Kenilworth New Jersey 07033 (908) 740-4000 New Jersey 22-1918501 (State or other jurisdiction of incorporation) (I.R.S Employer Identification No.) Securities Registered pursuant to Section 12(b) of the Act: Title of Each Class Trading Symbol(s) Name of Each Exchange on which Registered Common Stock ($0.50 par value) MRK New York Stock Exchange 1.125% Notes due 2021 MRK/21 New York Stock Exchange 0.500% Notes due 2024 MRK 24 New York Stock Exchange 1.875% Notes due 2026 MRK/26 New York Stock Exchange 2.500% Notes due 2034 MRK/34 New York Stock Exchange 1.375% Notes due 2036 MRK 36A New York Stock Exchange Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2021: 2,530,315,668. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2020 based on closing price on June 30, 2020: $195,461,000,000. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No ☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check One): Large accelerated filer ☒ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☒ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒ Documents Incorporated by Reference: Document Part of Form 10-K Proxy Statement for the Annual Meeting of Shareholders to be held May 25, 2021, to be filed with the Part III Securities and Exchange Commission within 120 days after the close of the fiscal year covered by this report Table of Contents Table of Contents Page Part I Item 1. Business 1 Item 1A. Risk Factors 26 Cautionary Factors that May Affect Future Results 41 Item 1B. Unresolved Staff Comments 42 Item 2. Properties 42 Item 3. Legal Proceedings 43 Item 4. Mine Safety Disclosures 43 Executive Officers of the Registrant 44 Part II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 45 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 47 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 78 Item 8. Financial Statements and Supplementary Data 79 (a) Financial Statements 79 Notes to Consolidated Financial Statements 83 Report of Independent Registered Public Accounting Firm 136 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 138 Item 9A. Controls and Procedures 138 Management’s Report 138 Item 9B. Other Information 139 Part III Item 10. Directors, Executive Officers and Corporate Governance 140 Item 11. Executive Compensation 140 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 141 Item 13. Certain Relationships and Related Transactions, and Director Independence 141 Item 14. Principal Accountant Fees and Services 141 Part IV Item 15. Exhibits and Financial Statement Schedules 142 Item 16. Form 10-K Summary 146 Signatures 147 Table of Contents PART I Item 1. Business. Merck & Co., Inc. (Merck or the Company) is a global health care company that delivers innovative health solutions through its prescription medicines, vaccines, biologic therapies and animal health products. The Company’s operations are principally managed on a products basis and include two operating segments, which are the Pharmaceutical and Animal Health segments, both of which are reportable segments. The Pharmaceutical segment includes human health pharmaceutical and vaccine products. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells these human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Human health vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices. The Company sells these human health vaccines primarily to physicians, wholesalers, physician distributors and government entities. The Animal Health segment discovers, develops, manufactures and markets a wide range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all major livestock and companion animal species. The Company also offers an extensive suite of digitally connected identification, traceability and monitoring products. The Company sells its products to veterinarians, distributors and animal producers. The Company previously had a Healthcare Services segment that provided services and solutions focused on engagement, health analytics and clinical services to improve the value of care delivered to patients. The Company divested the remaining businesses in this segment in the first quarter of 2020. The Company previously had an Alliances segment that primarily included activity from the Company’s relationship with AstraZeneca LP related to sales of Nexium and Prilosec, which concluded in 2018. All product or service marks appearing in type form different from that of the surrounding text are trademarks or service marks owned, licensed to, promoted or distributed by Merck, its subsidiaries or affiliates, except as noted. All other trademarks or services marks are those of their respective owners. Planned Spin-Off of Women’s Health, Biosimilars and Established Brands into a New Company In February 2020, Merck announced its intention to spin-off (the Spin-Off) products from its women’s health, biosimilars and established brands businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders. The distribution is expected to qualify as tax-free to the Company and its shareholders for U.S. federal income tax purposes. The established brands included in the transaction consist of dermatology, non-opioid pain management, respiratory, and select cardiovascular products including Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin), as well as the rest of Merck’s diversified brands franchise. Merck’s existing research pipeline programs will continue to be owned and developed within Merck as planned. Organon will have development capabilities initially focused on late-stage development and life- cycle management, and is expected over time to develop research capabilities in selected therapeutic areas. The Spin-Off is expected to be completed late in the second quarter of 2021, subject to market and certain other conditions. See “Risk Factors - Risks Related to the Proposed Spin-Off of Organon.” 1 Table of Contents Product Sales Total Company sales, including sales of the Company’s top pharmaceutical products, as well as sales of animal health products, were as follows: ($ in millions) 2020 2019 2018 Total Sales $ 47,994 $ 46,840 $ 42,294 Pharmaceutical 43,021 41,751 37,689 Keytruda 14,380 11,084 7,171 Januvia/Janumet 5,276 5,524 5,914 Gardasil/Gardasil 9 3,938 3,737 3,151 ProQuad/M-M-R II/Varivax 1,878 2,275 1,798 Bridion 1,198 1,131 917 Pneumovax 23 1,087 926 907 Isentress/Isentress HD 857 975 1,140 Simponi 838 830 893 RotaTeq 797 791 728 Alliance revenue - Lynparza(1) 725 444 187 Implanon/Nexplanon 680 787 703 Zetia/Vytorin 664 874 1,355 Alliance revenue - Lenvima(1) 580 404 149 Animal Health 4,703 4,393 4,212 Livestock 2,939 2,784 2,630 Companion Animals 1,764 1,609 1,582 Other Revenues(2) 270 696 393 (1) Alliance revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.
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