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Cover and table of contents

As filed with the Securities and Exchange Commission on February 25, 2022

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, 2021

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
KenilworthNew Jersey07033

(908) 740-4000

New Jersey22-1918501
(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 ClassTrading Symbol(s)Name of Each Exchange on which Registered
Common Stock ($0.50 par value)MRKNew York Stock Exchange
0.500% Notes due 2024MRK 24New York Stock Exchange
1.875% Notes due 2026MRK/26New York Stock Exchange
2.500% Notes due 2034MRK/34New York Stock Exchange
1.375% Notes due 2036MRK 36ANew York Stock Exchange

Number of shares of Common Stock ($0.50 par value) outstanding as of January 31, 2022: 2,527,733,606.

Aggregate market value of Common Stock ($0.50 par value) held by non-affiliates on June 30, 2021 based on closing price on June 30, 2021: $196,870,000,000.

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:
DocumentPart of Form 10-K
Proxy Statement for the Annual Meeting of Shareholders to be held May 24, 2022, to be filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year covered by this reportPart III

Table of Contents

Table of Contents

Page
Part I
Item 1.Business1
Item 1A.Risk Factors27
Cautionary Factors that May Affect Future Results41
Item 1B.Unresolved Staff Comments43
Item 2.Properties43
Item 3.Legal Proceedings43
Item 4.Mine Safety Disclosures43
Executive Officers of the Registrant44
Part II
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities46
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations48
Item 7A.Quantitative and Qualitative Disclosures About Market Risk78
Item 8.Financial Statements and Supplementary Data79
(a)Financial Statements79
Notes to Consolidated Financial Statements83
Report of Independent Registered Public Accounting Firm140
(b)Supplementary Data142
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure143
Item 9A.Controls and Procedures143
Management’s Report143
Item 9B.Other Information144
Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections144
Part III
Item 10.Directors, Executive Officers and Corporate Governance145
Item 11.Executive Compensation145
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters146
Item 13.Certain Relationships and Related Transactions, and Director Independence146
Item 14.Principal Accountant Fees and Services146
Part IV
Item 15.Exhibits and Financial Statement Schedules147
Item 16.Form 10-K Summary151
Signatures152

Table of Contents

PART I

Next: Item 1. Business.