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)
| 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 Global Select Market | ||||||
| 2.00% Senior Notes due 2026 | AMGN26 | The 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 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 $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
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.
| Term | Description | ||||||||||||||||
| 2017 Tax Act | Tax Cuts and Jobs Act of 2017 | ||||||||||||||||
| 340B Program | Federal 340B Drug Pricing Program | ||||||||||||||||
| Amended 2009 Plan | Amended and Restated 2009 Equity Incentive Plan | ||||||||||||||||
| AOCI | accumulated other comprehensive income (loss) | ||||||||||||||||
| ASR | Accelerated Share Repurchase | ||||||||||||||||
| AstraZeneca | AstraZeneca plc | ||||||||||||||||
| ASU | Accounting Standards Update | ||||||||||||||||
| ATMOS | Amgen Technology and Medical Organizations | ||||||||||||||||
| B-ALL | B-cell precursor acute lymphoblastic leukemia | ||||||||||||||||
| BeiGene | BeiGene, Ltd. | ||||||||||||||||
| 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 | ||||||||||||||||
| 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 | ||||||||||||||||
| CRCC | Corporate Responsibility and Compliance Committee | ||||||||||||||||
| DLL3 | delta-like ligand 3 | ||||||||||||||||
| DOJ | U.S. Department of Justice | ||||||||||||||||
| EC | European Commission | ||||||||||||||||
| Eczacıbaşı | EIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş. | ||||||||||||||||
| EMA | European Medicines Agency | ||||||||||||||||
| EPO | European Patent Office | ||||||||||||||||
| 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. | ||||||||||||||||
| FTC | Federal Trade Commission | ||||||||||||||||
| GAAP | U.S. generally accepted accounting principles | ||||||||||||||||
| GDPR | General Data Protection Regulation | ||||||||||||||||
| Gensenta | Gensenta İlaç Sanayi ve Ticaret A.Ş. |
ii
| Term | Description | ||||||||||||||||
| HHS | U.S. Department of Health & Human Services | ||||||||||||||||
| Horizon | Horizon Therapeutics plc | ||||||||||||||||
| IGF-1R | insulin-like growth factor-1 receptor | ||||||||||||||||
| IND | Investigational New Drug Application | ||||||||||||||||
| IPR&D | in-process research and development | ||||||||||||||||
| IRA | Inflation Reduction Act of 2022 | ||||||||||||||||
| IRS | Internal Revenue Service | ||||||||||||||||
| KRAS | Kirsten rat sarcoma viral oncogene | ||||||||||||||||
| Kyowa Kirin | Kyowa Kirin Co., Ltd. | ||||||||||||||||
| LDL-C | low-density lipoprotein cholesterol | ||||||||||||||||
| Lilly | Eli Lilly and Company | ||||||||||||||||
| MAA | Marketing Authorisation Application | ||||||||||||||||
| MD&A | management’s discussion and analysis | ||||||||||||||||
| Moody’s | Moody’s Investors Service, Inc. | ||||||||||||||||
| MRD | minimal residual disease | ||||||||||||||||
| Neumora | Neumora Therapeutics, Inc. | ||||||||||||||||
| NOL | net operating loss | ||||||||||||||||
| NSCLC | non-small cell lung cancer | ||||||||||||||||
| OECD | Organisation for Economic Co-operation and Development | ||||||||||||||||
| OIG | Office of Inspector General | ||||||||||||||||
| PBM | pharmacy benefit manager | ||||||||||||||||
| PCSK9 | proprotein convertase subtilisin/kexin type 9 | ||||||||||||||||
| PDAB | Prescription Drug Affordability Board | ||||||||||||||||
| PDE4 | phosphodiesterase 4 | ||||||||||||||||
| R&D | research and development | ||||||||||||||||
| RANKL | receptor activator of nuclear factor kappa-B ligand | ||||||||||||||||
| RAR | Revenue Agent Report | ||||||||||||||||
| RAS | Rat sarcoma viral oncogene | ||||||||||||||||
| Regeneron | Regeneron Pharmaceuticals, Inc. | ||||||||||||||||
| REMS | Risk Evaluation and Mitigation Strategy | ||||||||||||||||
| ROU | right-of-use | ||||||||||||||||
| ROW | rest of world | ||||||||||||||||
| RSUs | restricted stock units | ||||||||||||||||
| S&P | Standard & Poor’s Financial Services LLC | ||||||||||||||||
| SEC | U.S. Securities and Exchange Commission | ||||||||||||||||
| SG&A | selling, general and administrative | ||||||||||||||||
| 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 | ||||||||||||||||
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.
| Term | Description | ||||
| ACTIMMUNE | ACTIMMUNE® (interferon gamma-1b) | ||||
| Aimovig | Aimovig® (erenumab-aooe) | ||||
| AMJEVITA/AMGEVITA | AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) | ||||
| Aranesp | Aranesp® (darbepoetin alfa) | ||||
| AutoTouch | AutoTouch® | ||||
| AVSOLA | AVSOLA® (infliximab-axxq) | ||||
| BKEMV/BEKEMV | BKEMV™ (eculizumab-aeeb)/BEKEMV™ (eculizumab) | ||||
| BLINCYTO | BLINCYTO® (blinatumomab) | ||||
| BUPHENYL | BUPHENYL® (sodium phenylbutyrate) | ||||
| ConfiPen | ConfiPen™ | ||||
| Corlanor | Corlanor® (ivabradine) | ||||
| DUEXIS | DUEXIS® (ibuprofen and famotidine) | ||||
| ENBREL | Enbrel® (etanercept) | ||||
| ENBREL Mini | ENBREL Mini® | ||||
| EPOGEN | EPOGEN® (epoetin alfa) | ||||
| EVENITY | EVENITY® (romosozumab-aqqg) | ||||
| IMDELLTRA/IMDYLLTRA | IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA® (tarlatamab) | ||||
| IMLYGIC | IMLYGIC® (talimogene laherparepvec) | ||||
| KANJINTI | KANJINTI® (trastuzumab-anns) | ||||
| KRYSTEXXA | KRYSTEXXA® (pegloticase) | ||||
| KYPROLIS | KYPROLIS® (carfilzomib) | ||||
| LUMAKRAS/LUMYKRAS | LUMAKRAS®/LUMYKRAS™ (sotorasib) | ||||
| MariTide | 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) | ||||
| PAVBLU | PAVBLU™ (aflibercept-ayyh, formerly ABP 938) | ||||
| PENNSAID | PENNSAID® (diclofenac sodium topical solution) 2% | ||||
| PROCYSBI | PROCYSBI® (cysteamine bitartrate) | ||||
| Prolia | Prolia® (denosumab) | ||||
| Pushtronex | Pushtronex® | ||||
| QUINSAIR | QUINSAIR® (levofloxacin) | ||||
| RAVICTI | RAVICTI® (glycerol phenylbutyrate) | ||||
| RAYOS | RAYOS® (prednisone) | ||||
| Repatha | Repatha® (evolocumab) | ||||
| RIABNI | RIABNI® (rituximab-arrx) | ||||
| Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | ||||
| SureClick | SureClick® |
iv
| Term | Description | ||||
| TAVNEOS | TAVNEOS® (avacopan) | ||||
| TEPEZZA | TEPEZZA® (teprotumumab-trbw) | ||||
| TEZSPIRE | TEZSPIRE® (tezepelumab-ekko) | ||||
| UPLIZNA | UPLIZNA® (inebilizumab-cdon) | ||||
| Vectibix | Vectibix® (panitumumab) | ||||
| WEZLANA/WEZENLA | WEZLANA™ (ustekinumab-auub) / WEZENLA™ (ustekinumab) | ||||
| XGEVA | XGEVA® (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