Cover and table of contents

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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, 2024

or

☐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)

Delaware95-3540776
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
One Amgen Center Drive91320-1799
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 classTrading Symbol (s)Name of each exchange on which registered
Common stock, $0.0001 par valueAMGNThe Nasdaq Global Select Market
2.00% Senior Notes due 2026AMGN26The Nasdaq Global Select Market

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 filerAccelerated filerNon-accelerated filerSmaller reporting companyEmerging 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 $167.6 billion as of the last business day of the registrant’s most recently completed second fiscal quarter.(A)

(A)Excludes 948,404 shares of common stock held by directors and executive officers, and any stockholders whose ownership exceeds ten percent of the shares outstanding, as of the last business day of the registrant’s most recently completed second fiscal quarter. 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.

537,204,943

(Number of shares of common stock outstanding as of February 11, 2025)

DOCUMENTS INCORPORATED BY REFERENCE

Specified portions of the registrant’s Proxy Statement with respect to the 2025 Annual Meeting of Stockholders to be held on May 23, 2025, are incorporated by reference into Part III of this annual report.

INDEX

Page No.
DEFINED TERMS AND PRODUCTSii
PART I1
Item 1.BUSINESS1
Significant Developments1
Marketing, Distribution and Selected Marketed Products2
Reimbursement10
Manufacturing, Distribution and Raw Materials12
Government Regulation13
Research and Development and Selected Product Candidates17
Business Relationships23
Human Capital Resources24
Information about our Executive Officers26
Geographic Area Financial Information27
Investor Information27
Item 1A.RISK FACTORS28
Item 1B.UNRESOLVED STAFF COMMENTS54
Item 1C.CYBERSECURITY54
Item 2.PROPERTIES57
Item 3.LEGAL PROCEEDINGS58
Item 4.MINE SAFETY DISCLOSURES58
PART II59
Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES59
Item 6.RESERVED60
Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS61
Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK81
Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA83
Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE83
Item 9A.CONTROLS AND PROCEDURES83
Item 9B.OTHER INFORMATION85
Item 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS85
PART III85
Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE85
Item 11.EXECUTIVE COMPENSATION85
Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS86
Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE87
Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES87
PART IV88
Item 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES88
Item 16.FORM 10-K SUMMARY94
SIGNATURES95

i

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.

TermDescription
2017 Tax ActTax Cuts and Jobs Act of 2017
340B ProgramFederal 340B Drug Pricing Program
Amended 2009 PlanAmended and Restated 2009 Equity Incentive Plan
AOCIaccumulated other comprehensive income (loss)
ASRAccelerated Share Repurchase
AstraZenecaAstraZeneca plc
ASUAccounting Standards Update
ATMOSAmgen Technology and Medical Organizations
B-ALLB-cell precursor acute lymphoblastic leukemia
BeiGeneBeiGene, Ltd.
BiTE®bispecific T-cell engager
BLABiologics License Application
BPCIABiologics Price Competition and Innovation Act of 2009
CCPACalifornia Consumer Privacy Act of 2018
CDTCybersecurity & Digital Trust
CGRPcalcitonin gene-related peptide
ChemoCentryxChemoCentryx, Inc.
chemotherapyanticancer medicines
CHMPCommittee for Medicinal Products for Human Use
CIOChief Information Officer
CISOChief Information Security Officer
CMSCenters for Medicare & Medicaid Services
COSOCommittee of Sponsoring Organizations of the Treadway Commission
CRCCCorporate Responsibility and Compliance Committee
DLL3delta-like ligand 3
DOJU.S. Department of Justice
ECEuropean Commission
EczacıbaşıEIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş.
EMAEuropean Medicines Agency
EPOEuropean Patent Office
EPSearnings per share
ESGenvironmental, social and governance
EUEuropean Union
FASBFinancial Accounting Standards Board
FCPAU.S. Foreign Corrupt Practices Act
FDAU.S. Food and Drug Administration
FDCAFederal Food, Drug, and Cosmetic Act
FitchFitch Ratings, Inc.
FTCFederal Trade Commission
GAAPU.S. generally accepted accounting principles
GDPRGeneral Data Protection Regulation
GensentaGensenta İlaç Sanayi ve Ticaret A.Ş.

ii

TermDescription
HHSU.S. Department of Health & Human Services
HorizonHorizon Therapeutics plc
IGF-1Rinsulin-like growth factor-1 receptor
INDInvestigational New Drug Application
IPR&Din-process research and development
IRAInflation Reduction Act of 2022
IRSInternal Revenue Service
KRASKirsten rat sarcoma viral oncogene
Kyowa KirinKyowa Kirin Co., Ltd.
LDL-Clow-density lipoprotein cholesterol
LillyEli Lilly and Company
MAAMarketing Authorisation Application
MD&Amanagement’s discussion and analysis
Moody’sMoody’s Investors Service, Inc.
MRDminimal residual disease
NeumoraNeumora Therapeutics, Inc.
NOLnet operating loss
NSCLCnon-small cell lung cancer
OECDOrganisation for Economic Co-operation and Development
OIGOffice of Inspector General
PBMpharmacy benefit manager
PCSK9proprotein convertase subtilisin/kexin type 9
PDABPrescription Drug Affordability Board
PDE4phosphodiesterase 4
R&Dresearch and development
RANKLreceptor activator of nuclear factor kappa-B ligand
RARRevenue Agent Report
RASRat sarcoma viral oncogene
RegeneronRegeneron Pharmaceuticals, Inc.
REMSRisk Evaluation and Mitigation Strategy
ROUright-of-use
ROWrest of world
RSUsrestricted stock units
S&PStandard & Poor’s Financial Services LLC
SECU.S. Securities and Exchange Commission
SG&Aselling, general and administrative
SOFRSecured Overnight Financing Rate
TEDthyroid eye disease
TeneobioTeneobio, Inc.
U.S. TreasuryU.S. Department of Treasury
USPTOU.S. Patent and Trademark Office
UTBunrecognized tax benefit

iii

Products

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

TermDescription
ACTIMMUNEACTIMMUNE® (interferon gamma-1b)
AimovigAimovig® (erenumab-aooe)
AMJEVITA/AMGEVITAAMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab)
AranespAranesp® (darbepoetin alfa)
AutoTouchAutoTouch®
AVSOLAAVSOLA® (infliximab-axxq)
BKEMV/BEKEMVBKEMV™ (eculizumab-aeeb)/BEKEMV™ (eculizumab)
BLINCYTOBLINCYTO® (blinatumomab)
BUPHENYLBUPHENYL® (sodium phenylbutyrate)
ConfiPenConfiPen™
CorlanorCorlanor® (ivabradine)
DUEXISDUEXIS® (ibuprofen and famotidine)
ENBRELEnbrel® (etanercept)
ENBREL MiniENBREL Mini®
EPOGENEPOGEN® (epoetin alfa)
EVENITYEVENITY® (romosozumab-aqqg)
IMDELLTRA/IMDYLLTRAIMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA® (tarlatamab)
IMLYGICIMLYGIC® (talimogene laherparepvec)
KANJINTIKANJINTI® (trastuzumab-anns)
KRYSTEXXAKRYSTEXXA® (pegloticase)
KYPROLISKYPROLIS® (carfilzomib)
LUMAKRAS/LUMYKRASLUMAKRAS®/LUMYKRAS™ (sotorasib)
MariTideMaridebart cafraglutide (formerly AMG 133)
MVASIMVASI® (bevacizumab-awwb)
NeulastaNeulasta® (pegfilgrastim)
NEUPOGENNEUPOGEN® (filgrastim)
NplateNplate® (romiplostim)
OnproOnpro®
OtezlaOtezla® (apremilast)
ParsabivParsabiv® (etelcalcetide)
PAVBLUPAVBLU™ (aflibercept-ayyh, formerly ABP 938)
PENNSAIDPENNSAID® (diclofenac sodium topical solution) 2%
PROCYSBIPROCYSBI® (cysteamine bitartrate)
ProliaProlia® (denosumab)
PushtronexPushtronex®
QUINSAIRQUINSAIR® (levofloxacin)
RAVICTIRAVICTI® (glycerol phenylbutyrate)
RAYOSRAYOS® (prednisone)
RepathaRepatha® (evolocumab)
RIABNIRIABNI® (rituximab-arrx)
Sensipar/MimparaSensipar®/Mimpara™ (cinacalcet)
SureClickSureClick®

iv

TermDescription
TAVNEOSTAVNEOS® (avacopan)
TEPEZZATEPEZZA® (teprotumumab-trbw)
TEZSPIRETEZSPIRE® (tezepelumab-ekko)
UPLIZNAUPLIZNA® (inebilizumab-cdon)
VectibixVectibix® (panitumumab)
WEZLANA/WEZENLAWEZLANA™ (ustekinumab-auub) / WEZENLA™ (ustekinumab)
XGEVAXGEVA® (denosumab)

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®, DUPIXENT®, ERBITUX®, EYLEA®, FASENRA®, Herceptin®, HUMIRA®, HYRIMOZ®, KEYTRUDA®, LEQVIO®, Nucala®, POMALYST®/IMNOVID®, PRALUENT®, PROCRIT®, PROMACTA®/REVOLADE™, Remicade®, REVLIMID®, RINVOQ®, Rituxan®/MabThera®, Skyrizi®, SOLIRIS®, SOTYKTU®, STELARA®, Taltz®, Teribone™, Tremfya®, VELCADE®, Xeljanz® and XOLAIR®.

v

PART I

Next: Item 1. BUSINESS