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Cover and table of contents

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, 2023


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number 001-37702

Amgen Inc.

(Exact name of registrant as specified in its charter)


Delaware						95-3540776
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)
One Amgen Center Drive						91320-1799
Thousand Oaks
California
(Address of principal executive offices)						(Zip Code)

(805) 447-1000

(Registrant’s telephone number, including area code)

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, $0.0001 par value	AMGN	The Nasdaq Stock Market LLC
2.00% Senior Notes due 2026	AMGN26	The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ý 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 ý

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or Section 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 ý 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 ý 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.


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. ☒

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act) Yes ☐ No ý

The approximate aggregate market value of voting and non-voting stock held by non-affiliates of the registrant was $118,556,278,405 as of June 30, 2023.(A)

(A)Excludes 901,685 shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, at June 30, 2023. Exclusion of shares held by any person should not be construed to indicate that such person possesses the power, directly or indirectly, to direct or cause the direction of the management or policies of the registrant, or that such person is controlled by or under common control with the registrant.

535,918,901

(Number of shares of common stock outstanding as of February 9, 2024)

DOCUMENTS INCORPORATED BY REFERENCE

Specified portions of the registrant’s Proxy Statement with respect to the 2024 Annual Meeting of Stockholders to be held on May 31, 2024, are incorporated by reference into Part III of this annual report.

INDEX


		Page No.
	DEFINED TERMS AND PRODUCTS	ii
PART I		1
Item 1.	BUSINESS	1
	Significant Developments	1
	Marketing, Distribution and Selected Marketed Products	2
	Reimbursement	10
	Manufacturing, Distribution and Raw Materials	11
	Government Regulation	13
	Research and Development and Selected Product Candidates	17
	Business Relationships	22
	Human Capital Resources	24
	Information about our Executive Officers	27
	Geographic Area Financial Information	28
	Investor Information	28
Item 1A.	RISK FACTORS	29
Item 1B.	UNRESOLVED STAFF COMMENTS	54
Item 1C.	CYBERSECURITY	54
Item 2.	PROPERTIES	56
Item 3.	LEGAL PROCEEDINGS	57
Item 4.	MINE SAFETY DISCLOSURES	57
PART II		58
Item 5.	MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES	58
Item 6.	RESERVED	59
Item 7.	MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	60
Item 7A.	QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	80
Item 8.	FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA	82
Item 9.	CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE	82
Item 9A.	CONTROLS AND PROCEDURES	83
Item 9B.	OTHER INFORMATION	85
Item 9C.	DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS	85
PART III		85
Item 10.	DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE	85
Item 11.	EXECUTIVE COMPENSATION	85
Item 12.	SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS	86
Item 13.	CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE	86
Item 14.	PRINCIPAL ACCOUNTANT FEES AND SERVICES	86
PART IV		87
Item 15.	EXHIBITS AND FINANCIAL STATEMENT SCHEDULES	87
Item 16.	FORM 10-K SUMMARY	93
SIGNATURES		94

Defined Terms and Products

Defined terms

We use several terms in this Form 10-K, including but not limited to those that are finance, regulation and disease-state related as well as names of other companies, which are given below.


Term			Description

2017 Tax Act			Tax Cuts and Jobs Act of 2017
AbbVie			AbbVie Inc.
ALL			acute lymphoblastic leukemia
Amended 2009 Plan			Amended and Restated 2009 Equity Incentive Plan

AOCI			accumulated other comprehensive income (loss)
ASCVD			atherosclerotic cardiovascular disease
ASR			Accelerated Share Repurchase
AstraZeneca			AstraZeneca plc
BeiGene			BeiGene, Ltd.
Bergamo			Laboratorio Quimico Farmaceutico Bergamo Ltda
BiTE®			bispecific T-cell engager
BLA			Biologics License Application
BPCIA			Biologics Price Competition and Innovation Act of 2009
CCPA			California Consumer Privacy Act of 2018
CDT			Cybersecurity & Digital Trust
Celgene			Celgene Corporation
CGRP			calcitonin gene-related peptide
ChemoCentryx			ChemoCentryx, Inc.
chemotherapy			anticancer medicines
CHMP			Committee for Medicinal Products for Human Use
CIO			Chief Information Officer
CISO			Chief Information Security Officer
CMS			Centers for Medicare & Medicaid Services
COSO			Committee of Sponsoring Organizations of the Treadway Commission
COVID-19			coronavirus disease 2019
CRC			colorectal cancer
CRCC			Corporate Responsibility and Compliance Committee
CV			cardiovascular
DLL3			delta-like ligand 3
DOJ			U.S. Department of Justice
DTI			Digital, Technology & Innovation
EC			European Commission
Eczacıbaşı			EIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş.
EMA			European Medicines Agency
EPS			earnings per share
ESG			environmental, social and governance
EU			European Union
FASB			Financial Accounting Standards Board
FCPA			U.S. Foreign Corrupt Practices Act
FDA			U.S. Food and Drug Administration
FDCA			Federal Food, Drug, and Cosmetic Act
Fitch			Fitch Ratings, Inc.
Five Prime			Five Prime Therapeutics, Inc.


Term			Description
FTC			Federal Trade Commission
GAAP			U.S. generally accepted accounting principles
GDPR			General Data Protection Regulation
GEJ			gastroesophageal junction
Gensenta			Gensenta İlaç Sanayi ve Ticaret A.Ş.
HHS			U.S. Department of Health & Human Services
Horizon			Horizon Therapeutics plc
IGF-1R			insulin-like growth factor-1 receptor
IL			interleukin
IND			Investigational New Drug Application
IPR&D			in-process research and development
IRA			Inflation Reduction Act
IRS			Internal Revenue Service
Janssen			Janssen Biotech, Inc.

Kyowa Kirin			Kyowa Kirin Co., Ltd.
KRAS			Kirsten rat sarcoma viral oncogene
LDL-C			low-density lipoprotein cholesterol
LIBOR			London Interbank Offered Rate
Lilly			Eli Lilly and Company
Lp(a)			lipoprotein(a)

MAA			Marketing Authorisation Application
mCRC			metastatic colorectal cancer
MD&A			management’s discussion and analysis
Moody’s			Moody’s Investors Service, Inc.
mOS			median overall survival
mPFS			median progression-free survival
MRD			minimal residual disease
Neumora			Neumora Therapeutics, Inc.
NOL			net operating loss
Novartis			Novartis Pharma AG
NSCLC			non-small cell lung cancer
OECD			Organisation for Economic Co-operation and Development
OIG			Office of Inspector General

ORR			objective response rate
PBM			pharmacy benefit manager
PCSK9			proprotein convertase subtilisin/kexin type 9
PDAB			Prescription Drug Affordability Board
PDE4			phosphodiesterase 4
PDUFA			Prescription Drug User Fee Action
PFS			progression-free survival


PSUs			performance share units
R&D			research and development
RANKL			receptor activator of nuclear factor kappa-B ligand
RAR			Revenue Agent Report
RAS			Rat sarcoma viral oncogene
REMS			risk evaluation and mitigation strategy
ROU			right-of-use
ROW			rest of world

iii


Term			Description
RSUs			restricted stock units
S&P			Standard & Poor’s Financial Services LLC
SCLC			small cell lung cancer
SEC			U.S. Securities and Exchange Commission
SG&A			selling, general and administrative
siRNA			small interfering RNA
SOFR			Secured Overnight Financing Rate
TED			thyroid eye disease
Teneobio			Teneobio, Inc.
U.S. Treasury			U.S. Department of Treasury
USPTO			U.S. Patent and Trademark Office
UTB			unrecognized tax benefit

Products

The brand names of our products, our delivery devices and certain of our product candidates and their associated generic names are given below.


Term			Description

ACTIMMUNE			ACTIMMUNE® (interferon gamma-1b)(1)
Aimovig			Aimovig® (erenumab-aooe)
AMJEVITA/AMGEVITA			AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab)
Aranesp			Aranesp® (darbepoetin alfa)
AutoTouch			AutoTouch®
AVSOLA			AVSOLA® (infliximab-axxq)
BEKEMV			BEKEMV™ (eculizumab)
BLINCYTO			BLINCYTO® (blinatumomab)

BUPHENYL			BUPHENYL® (sodium phenylbutyrate)(1)
Corlanor			Corlanor® (ivabradine)


DUEXIS			DUEXIS® (ibuprofen and famotidine)(1)
ENBREL			Enbrel® (etanercept)
ENBREL Mini			ENBREL Mini®
EPOGEN			EPOGEN® (epoetin alfa)
EVENITY			EVENITY® (romosozumab-aqqg)
IMLYGIC			IMLYGIC® (talimogene laherparepvec)
KANJINTI			KANJINTI® (trastuzumab-anns)
KRYSTEXXA			KRYSTEXXA® (pegloticase)(1)
KYPROLIS			KYPROLIS® (carfilzomib)
LUMAKRAS/LUMYKRAS			LUMAKRAS®/LUMYKRAS™ (sotorasib)
Maridebart cafraglutide			Maridebart cafraglutide (formerly AMG 133)
MVASI			MVASI® (bevacizumab-awwb)
Neulasta			Neulasta® (pegfilgrastim)
NEUPOGEN			NEUPOGEN® (filgrastim)
Nplate			Nplate® (romiplostim)

Onpro			Onpro®

Otezla			Otezla® (apremilast)
Parsabiv			Parsabiv® (etelcalcetide)
PENNSAID			PENNSAID® 2% (diclofenac sodium topical solution)(1)
PROCYSBI			PROCYSBI® (cysteamine bitartrate)(1)
Prolia			Prolia® (denosumab)
Pushtronex			Pushtronex®
QUINSAIR			QUINSAIR® (levofloxacin)(1)
RAVICTI			RAVICTI® (glycerol phenylbutyrate)(1)
RAYOS			RAYOS® (prednisone)(1)
Repatha			Repatha® (evolocumab)
RIABNI			RIABNI® (rituximab-arrx)


Sensipar/Mimpara			Sensipar®/Mimpara™ (cinacalcet)
SureClick			SureClick®

TAVNEOS			TAVNEOS® (avacopan)
TEPEZZA			TEPEZZA® (teprotumumab-trbw)(1)


Term			Description
TEZSPIRE			TEZSPIRE® (tezepelumab-ekko)
UPLIZNA			UPLIZNA® (inebilizumab-cdon)(1)
Vectibix			Vectibix® (panitumumab)
Wezlana			WEZLANA™ (ustekinumab-auub)
Xaluritamig			Xaluritamig (formerly AMG 509)
XGEVA			XGEVA® (denosumab)

(1) Products were acquired from our Horizon acquisition on October 6, 2023.

Products referenced in this report that are not included in the above list are trademarks of their respective owners. They are Avastin®, BESPONSA®, Cosentyx®, DARZALEX®, ERBITUX®, EYLEA®, Herceptin®, HUMIRA®, KEYTRUDA®, LEQVIO®, POMALYST®/IMNOVID®, PRALUENT®, PROCRIT®, PROMACTA®/REVOLADE™, Remicade®, REVLIMID®, RINVOQ®, Rituxan®/MabThera®, Skyrizi®, SOLIRIS®, SOTYKTU®, STELARA®, Taltz®, Teribone™, Tremfya®, VELCADE® and Xeljanz®.

PART I

Next: Item 1. BUSINESS