AMGEN INC
For the period ended Dec 31, 2023. Filed Feb 14, 2024.
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FY2023 · Filed Feb 14, 2024
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DEFINED TERMS AND PRODUCTSii
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. |
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| 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 |
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| 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 |
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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) |
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| 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®.
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.