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, 2021
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 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. ☒
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 $137,531,019,585 as of June 30, 2021.(A)
(A)Excludes 811,415 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, 2021. 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.
557,029,370
(Number of shares of common stock outstanding as of February 11, 2022)
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant’s Proxy Statement with respect to the 2022 Annual Meeting of Stockholders to be held May 17, 2022, 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 | ||||||||||||||||
| AbbVie | AbbVie Inc. | ||||||||||||||||
| ACA | Affordable Care Act | ||||||||||||||||
| aHUS | atypical hemolytic uremic syndrome | ||||||||||||||||
| ALL | acute lymphoblastic leukemia | ||||||||||||||||
| AMD | age-related macular degeneration | ||||||||||||||||
| Amended 2009 Plan | Amended and Restated 2009 Equity Incentive Plan | ||||||||||||||||
| ANDA | Abbreviated New Drug Application | ||||||||||||||||
| AOCI | accumulated other comprehensive income (loss) | ||||||||||||||||
| AstraZeneca | AstraZeneca plc | ||||||||||||||||
| BAFF | B-cell activating factor | ||||||||||||||||
| BeiGene | BeiGene, Ltd. | ||||||||||||||||
| BiTE® | bispecific T-cell engager | ||||||||||||||||
| BLA | Biologics License Application | ||||||||||||||||
| BMS | Bristol Myers Squibb Company | ||||||||||||||||
| BPCIA | Biologics Price Competition and Innovation Act of 2009 | ||||||||||||||||
| Celgene | Celgene Corporation | ||||||||||||||||
| CGRP | calcitonin gene-related peptide | ||||||||||||||||
| chemotherapy | anticancer medicines | ||||||||||||||||
| CHMP | Committee for Medicinal Products for Human Use | ||||||||||||||||
| CIT | chemotherapy-induced thrombocytopenia | ||||||||||||||||
| CKD | chronic kidney disease | ||||||||||||||||
| CMS | Centers for Medicare & Medicaid Services | ||||||||||||||||
| COSO | Committee of Sponsoring Organizations of the Treadway Commission | ||||||||||||||||
| COVID-19 | coronavirus disease 2019 | ||||||||||||||||
| CV | cardiovascular | ||||||||||||||||
| DaVita | DaVita Inc. | ||||||||||||||||
| DLL3 | delta-like ligand 3 | ||||||||||||||||
| DOJ | U.S. Department of Justice | ||||||||||||||||
| DoR | duration of response | ||||||||||||||||
| EC | European Commission | ||||||||||||||||
| EMA | European Medicines Agency | ||||||||||||||||
| EPS | earnings per share | ||||||||||||||||
| ERG | employee resource group | ||||||||||||||||
| ESA | erythropoiesis-stimulating agent | ||||||||||||||||
| ESG | environmental, social and governance | ||||||||||||||||
| ESRD | end-stage renal disease | ||||||||||||||||
| 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 | ||||||||||||||||
| FGFR2b | fibroblast growth factor receptor 2b | ||||||||||||||||
| Fitch | Fitch Ratings, Inc. |
ii
| Term | Description | ||||||||||||||||
| Five Prime | Five Prime Therapeutics, Inc. | ||||||||||||||||
| FOMBPR | Financial Oversight and Management Board for Puerto Rico | ||||||||||||||||
| FTC | Federal Trade Commission | ||||||||||||||||
| GAAP | U.S. generally accepted accounting principles | ||||||||||||||||
| GDPR | General Data Protection Regulation | ||||||||||||||||
| GEJ | gastroesophageal junction | ||||||||||||||||
| HeFH | heterozygous familial hypercholesterolemia | ||||||||||||||||
| HER2 | human epidermal growth factor receptor 2 | ||||||||||||||||
| HGRAC | Human Genetic Resources Administration of China | ||||||||||||||||
| HHS | U.S. Department of Health & Human Services | ||||||||||||||||
| HLE | half-life extended | ||||||||||||||||
| HoFH | homozygous familial hypercholesterolemia | ||||||||||||||||
| ICOSL | inducible costimulatory ligand | ||||||||||||||||
| IL | interleukin | ||||||||||||||||
| IND | Investigational New Drug Application | ||||||||||||||||
| IPR&D | in-process research and development | ||||||||||||||||
| IRP | international reference pricing | ||||||||||||||||
| IRS | Internal Revenue Service | ||||||||||||||||
| ITP | immune thrombocytopenia | ||||||||||||||||
| J&J | Johnson & Johnson | ||||||||||||||||
| Janssen | Janssen Biotech, Inc. | ||||||||||||||||
| K-A | Kirin-Amgen, Inc. | ||||||||||||||||
| Kirin | Kirin Holdings Company, Limited | ||||||||||||||||
| KKC | Kyowa Kirin Co., Ltd. | ||||||||||||||||
| LDL-C | low-density lipoprotein cholesterol | ||||||||||||||||
| LIBOR | London Interbank Offered Rate | ||||||||||||||||
| Lilly | Eli Lilly and Company | ||||||||||||||||
| mCRPC | metastatic castrate-resistant prostate cancer | ||||||||||||||||
| MD&A | management’s discussion and analysis | ||||||||||||||||
| MFN | most favored nation | ||||||||||||||||
| Moody’s | Moody’s Investors Service, Inc. | ||||||||||||||||
| MRD | minimal residual disease | ||||||||||||||||
| Neumora | Neumora Therapeutics, Inc. | ||||||||||||||||
| NOL | net operating loss | ||||||||||||||||
| Novartis | Novartis Pharma AG | ||||||||||||||||
| NSCLC | non-small cell lung cancer | ||||||||||||||||
| Nuevolution | Nuevolution AB | ||||||||||||||||
| OECD | Organization 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 | ||||||||||||||||
| PDE4 | phosphodiesterase 4 | ||||||||||||||||
| PDUFA | Prescription Drug User Fee Act | ||||||||||||||||
| PFS | progression-free survival | ||||||||||||||||
| PNH | paroxysmal nocturnal hemoglobinuria | ||||||||||||||||
| Profit Sharing Plan | Amgen Profit Sharing Plan for Employees in Ireland | ||||||||||||||||
| PROMESA | Puerto Rico Oversight, Management, and Economic Stability Act |
iii
| Term | Description | ||||||||||||||||
| PTAB | Patent Trial and Appeal Board | ||||||||||||||||
| R&D | research and development | ||||||||||||||||
| RANKL | receptor activator of nuclear factor kappa-B ligand | ||||||||||||||||
| RAR | Revenue Agent Report | ||||||||||||||||
| 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 | ||||||||||||||||
| siRNA | small interfering RNA | ||||||||||||||||
| sNDA | supplemental New Drug Application | ||||||||||||||||
| SoC | standard of care | ||||||||||||||||
| SOFR | Secured Overnight Financing Rate | ||||||||||||||||
| SRE | skeletal-related event | ||||||||||||||||
| Takeda | Takeda Pharmaceutical Company Limited | ||||||||||||||||
| TDAPA | transitional drug add-on payment adjustment | ||||||||||||||||
| Teneobio | Teneobio, Inc. | ||||||||||||||||
| TNF | tumor necrosis factor | ||||||||||||||||
| TPO-RA | thrombopoietin receptor agonist | ||||||||||||||||
| U.S. Treasury | U.S. Department of Treasury | ||||||||||||||||
| UCLA | University of California, Los Angeles | ||||||||||||||||
| USPTO | U.S. Patent and Trademark Office | ||||||||||||||||
| UTB | unrecognized tax benefit | ||||||||||||||||
| VEGFR | vascular endothelial growth factor receptor | ||||||||||||||||
iv
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 | |||||||
| Acapatamab | Acapatamab (formerly AMG 160) | |||||||
| Aimovig | Aimovig® (erenumab-aooe) | |||||||
| AMGEVITA | AMGEVITA™ (adalimumab) | |||||||
| AMJEVITA | AMJEVITA™ (adalimumab-atto) | |||||||
| Aranesp | Aranesp® (darbepoetin alfa) | |||||||
| AutoTouch | AutoTouch® | |||||||
| AVSOLA | AVSOLA® (infliximab-axxq) | |||||||
| BLINCYTO | BLINCYTO® (blinatumomab) | |||||||
| Efavaleukin alfa | Efavaleukin alfa (formerly AMG 592) | |||||||
| ENBREL | Enbrel® (etanercept) | |||||||
| ENBREL Mini | ENBREL Mini® | |||||||
| EPOGEN | EPOGEN® (epoetin alfa) | |||||||
| EVENITY | EVENITY® (romosozumab-aqqg) | |||||||
| IMLYGIC | IMLYGIC® (talimogene laherparepvec) | |||||||
| KANJINTI | KANJINTI® (trastuzumab-anns) | |||||||
| KYPROLIS | KYPROLIS® (carfilzomib) | |||||||
| LUMAKRAS/LUMYKRAS | LUMAKRAS® / LUMYKRAS™ (sotorasib) | |||||||
| MVASI | MVASI® (bevacizumab-awwb) | |||||||
| Neulasta | Neulasta® (pegfilgrastim) | |||||||
| NEUPOGEN | NEUPOGEN® (filgrastim) | |||||||
| Nplate | Nplate® (romiplostim) | |||||||
| Olpasiran | Olpasiran (formerly AMG 890) | |||||||
| Onpro | Onpro® | |||||||
| Ordesekimab | Ordesekimab (formerly AMG 714) | |||||||
| Otezla | Otezla® (apremilast) | |||||||
| Parsabiv | Parsabiv® (etelcalcetide) | |||||||
| Pavurutamab | Pavurutamab (formerly AMG 701) | |||||||
| Prolia | Prolia® (denosumab) | |||||||
| Repatha | Repatha® (evolocumab) | |||||||
| RIABNI | RIABNI™ (rituximab-arrx) | |||||||
| Rozibafusp alfa | Rozibafusp alfa (formerly AMG 570) | |||||||
| Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | |||||||
| SureClick | SureClick® | |||||||
| Tarlatamab | Tarlatamab (formerly AMG 757) | |||||||
| TEZSPIRE | TEZSPIRE™ (tezepelumab-ekko) | |||||||
| Vectibix | Vectibix® (panitumumab) | |||||||
| 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®, Cosentyx®, DARZALEX®, DARZALEX FASPRO®, EYLEA®, Fulphila®, Herceptin®, HUMIRA®, POMALYST®/IMNOVID®, PRALUENT®, PROCRIT®, PROMACTA®/REVOLADE™, Remicade®, REVLIMID®, RINVOQ®, Rituxan®/MabThera®, Skyrizi®, SOLIRIS®, STELARA®, Taltz®, Tremfya®, UDENYCA®, VELCADE® and Xeljanz®.
v
PART I