As filed with the Securities and Exchange Commission on February 26, 2020 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, 2019 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, 2020: 2,536,268,760. Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2019 based on closing price on June 30, 2019: $215,106,000,000. 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 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 26, 2020, 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 WorldReginfo - 2a1bf3bf-0a0d-41b6-8d0c-5aaedbe33f5e Table of Contents Table of Contents Page Part I Item 1. Business 1 Item 1A. Risk Factors 20 Cautionary Factors that May Affect Future Results 32 Item 1B. Unresolved Staff Comments 33 Item 2. Properties 33 Item 3. Legal Proceedings 34 Item 4. Mine Safety Disclosures 34 Executive Officers of the Registrant 35 Part II Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 36 Item 6. Selected Financial Data 38 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 39 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 69 Item 8. Financial Statements and Supplementary Data 70 (a) Financial Statements 70 Notes to Consolidated Financial Statements 74 Report of Independent Registered Public Accounting Firm 124 (b) Supplementary Data 126 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 127 Item 9A. Controls and Procedures 127 Management’s Report 127 Item 9B. Other Information 128 Part III Item 10. Directors, Executive Officers and Corporate Governance 129 Item 11. Executive Compensation 129 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 130 Item 13. Certain Relationships and Related Transactions, and Director Independence 130 Item 14. Principal Accountant Fees and Services 130 Part IV Item 15. Exhibits and Financial Statement Schedules 131 Item 16. Form 10-K Summary 135 Signatures 136 WorldReginfo - 2a1bf3bf-0a0d-41b6-8d0c-5aaedbe33f5e 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 four operating segments, which are the Pharmaceutical, Animal Health, Healthcare Services and Alliances 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 Healthcare Services segment provides services and solutions that focus on engagement, health analytics and clinical services to improve the value of care delivered to patients. The Company has recently sold certain businesses in the Healthcare Services segment and is in the process of divesting the remaining businesses. While the Company continues to look for investment opportunities in this area of health care, the approach to these investments has shifted toward venture capital investments in third parties as opposed to wholly-owned businesses. The Alliances segment primarily includes activity from the Company’s relationship with AstraZeneca LP related to sales of Nexium and Prilosec, which concluded in 2018. The Company was incorporated in New Jersey in 1970. 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, Legacy Brands and Biosimilars into a New Company In February 2020, Merck announced its intention to spin-off (the Spin-Off) products from its women’s health, trusted legacy brands and biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company (NewCo) through a distribution of NewCo’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 legacy brands included in the transaction consist of dermatology, pain, respiratory, and select cardiovascular products including Zetia and Vytorin, 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. NewCo 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 in the first half of 2021, subject to market and certain other conditions. See “Risk Factors - Risks Related to the Proposed Spin-Off of NewCo.” 1 WorldReginfo - 2a1bf3bf-0a0d-41b6-8d0c-5aaedbe33f5e 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) 2019 2018 2017 Total Sales $ 46,840 $ 42,294 $ 40,122 Pharmaceutical 41,751 37,689 35,390 Keytruda 11,084 7,171 3,809 Januvia/Janumet 5,524 5,914 5,896 Gardasil/Gardasil 9 3,737 3,151 2,308 ProQuad/M-M-R II/Varivax 2,275 1,798 1,676 Bridion 1,131 917 704 Isentress/Isentress HD 975 1,140 1,204 Pneumovax 23 926 907 821 NuvaRing 879 902 761 Zetia/Vytorin 874 1,355 2,095 Simponi 830 893 819 Animal Health 4,393 4,212 3,875 Livestock 2,784 2,630 2,484 Companion Animals 1,609 1,582 1,391 Other Revenues(1) 696 393 857 (1) Other revenues are primarily comprised of Healthcare Services segment revenue, third-party manufacturing sales, and miscellaneous corporate revenues, including revenue hedging activities.