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-Q
(Mark One)
| ☑ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2025
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 |
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.
| 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 ☑
As of July 31, 2025, the registrant had 538,361,851 shares of common stock, $0.0001 par value, outstanding.
AMGEN INC.
INDEX
i
Defined Terms and Products
Defined terms
We use several terms in this Form 10-Q, including but not limited to those that are finance, regulation and disease-state related, as well as names of other companies, which are provided below.
| Term | Description | ||||||||||||||||
| 2017 Tax Act | Tax Cuts and Jobs Act of 2017 | ||||||||||||||||
| 340B Program | Federal 340B Drug Pricing Program | ||||||||||||||||
| AOCI | accumulated other comprehensive income (loss) | ||||||||||||||||
| AstraZeneca | AstraZeneca plc | ||||||||||||||||
| BeOne | BeOne Medicines Ltd. (formerly BeiGene, Ltd.) | ||||||||||||||||
| BLA | Biologics License Application | ||||||||||||||||
| CMS | Centers for Medicare & Medicaid Services | ||||||||||||||||
| EMA | European Medicines Agency | ||||||||||||||||
| EPS | earnings per share | ||||||||||||||||
| EU | European Union | ||||||||||||||||
| FDA | U.S. Food and Drug Administration | ||||||||||||||||
| Fitch | Fitch Ratings, Inc. | ||||||||||||||||
| G7 | Group of Seven (Canada, France, Germany, Italy, Japan, the United Kingdom and the United States) | ||||||||||||||||
| GAAP | U.S. generally accepted accounting principles | ||||||||||||||||
| HHS | U.S. Department of Health and Human Services | ||||||||||||||||
| Horizon | Horizon Therapeutics plc | ||||||||||||||||
| IPR&D | in-process research and development | ||||||||||||||||
| IRA | Inflation Reduction Act of 2022 | ||||||||||||||||
| IRS | Internal Revenue Service | ||||||||||||||||
| Later-Stage Clinical Programs | R&D expenses incurred in or related to phase 2 and phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU | ||||||||||||||||
| Marketed Product Support | R&D expenses incurred in support of the Company’s marketed products that are authorized to be sold primarily in the United States or the EU. Includes clinical trials designed to gather information on product safety (certain of which may be required by regulatory authorities) and their product characteristics after regulatory approval has been obtained, as well as the costs of obtaining regulatory approval of a product in a new market after approval in either the United States or the EU has been obtained | ||||||||||||||||
| MD&A | management’s discussion and analysis | ||||||||||||||||
| MFN | Most-Favored-Nations | ||||||||||||||||
| MFN EO | Most-Favored-Nations Prescription Drug Pricing Executive Order | ||||||||||||||||
| Moody’s | Moody’s Investors Service, Inc. | ||||||||||||||||
| Neumora | Neumora Therapeutics, Inc. | ||||||||||||||||
| OBBBA | The One Big Beautiful Bill Act | ||||||||||||||||
| OECD | Organisation for Economic Co-operation and Development | ||||||||||||||||
| PBM | pharmacy benefit manager | ||||||||||||||||
| PDAB | Prescription Drug Affordability Board | ||||||||||||||||
| R&D | research and development | ||||||||||||||||
| RANKL | receptor activator of nuclear factor kappa-B ligand | ||||||||||||||||
| RAR | Revenue Agent Report | ||||||||||||||||
| Research and Early Pipeline | R&D expenses incurred in activities substantially in support of early research through the completion of phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism and process development |
ii
| Term | Description | ||||||||||||||||
| ROW | rest of world | ||||||||||||||||
| 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 | ||||||||||||||||
| U.S. Treasury | U.S. Department of the Treasury | ||||||||||||||||
| 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 provided below.
| Term | Description | ||||
| ACTIMMUNE | ACTIMMUNE® (interferon gamma-1b) | ||||
| Aimovig | Aimovig® (erenumab-aooe) | ||||
| AMJEVITA/AMGEVITA | AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) | ||||
| Aranesp | Aranesp® (darbepoetin alfa) | ||||
| AVSOLA | AVSOLA® (infliximab-axxq) | ||||
| BKEMV/BEKEMV | BKEMV™ (eculizumab-aeeb)/BEKEMV™ (eculizumab) | ||||
| BLINCYTO | BLINCYTO® (blinatumomab) | ||||
| BUPHENYL | BUPHENYL® (sodium phenylbutyrate) | ||||
| Corlanor | Corlanor® (ivabradine) | ||||
| ENBREL | Enbrel® (etanercept) | ||||
| 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 (MariTide™) | ||||
| MVASI | MVASI® (bevacizumab-awwb) | ||||
| Neulasta | Neulasta® (pegfilgrastim) | ||||
| NEUPOGEN | NEUPOGEN® (filgrastim) | ||||
| Nplate | Nplate® (romiplostim) | ||||
| Otezla | Otezla® (apremilast) | ||||
| Parsabiv | Parsabiv® (etelcalcetide) | ||||
| PAVBLU | PAVBLU® (aflibercept-ayyh) | ||||
| PENNSAID | PENNSAID® (diclofenac sodium topical solution) 2% | ||||
| PROCYSBI | PROCYSBI® (cysteamine bitartrate) | ||||
| Prolia | Prolia® (denosumab) | ||||
| QUINSAIR | QUINSAIR® (levofloxacin) | ||||
| RAVICTI | RAVICTI® (glycerol phenylbutyrate) | ||||
| RAYOS | RAYOS® (prednisone) | ||||
| Repatha | Repatha® (evolocumab) | ||||
| RIABNI | RIABNI® (rituximab-arrx) | ||||
| Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | ||||
| 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) |
iv
PART I—FINANCIAL INFORMATION
Next: Item 1. FINANCIAL STATEMENTS