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, 2022
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 |
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 August 1, 2022, the registrant had 534,930,850 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 given below.
| Term | Description | ||||||||||||||||
| 2017 Tax Act | Tax Cuts and Jobs Act of 2017 | ||||||||||||||||
| ANDA | Abbreviated New Drug Application | ||||||||||||||||
| AOCI | accumulated other comprehensive income (loss) | ||||||||||||||||
| ASR | accelerated share repurchase | ||||||||||||||||
| BeiGene | BeiGene, Ltd. | ||||||||||||||||
| Bergamo | Laboratorio Quimico Farmaceutico Bergamo Ltda | ||||||||||||||||
| ChemoCentryx | ChemoCentryx, Inc. | ||||||||||||||||
| CMS | Centers for Medicare & Medicaid Services | ||||||||||||||||
| COVID-19 | coronavirus disease 2019 | ||||||||||||||||
| Eczacıbaşı | EIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş. | ||||||||||||||||
| EMA | European Medicines Agency | ||||||||||||||||
| EPS | earnings per share | ||||||||||||||||
| FASB | Financial Accounting Standards Board | ||||||||||||||||
| FDA | U.S. Food and Drug Administration | ||||||||||||||||
| Fitch | Fitch Ratings, Inc. | ||||||||||||||||
| Five Prime | Five Prime Therapeutics, Inc. | ||||||||||||||||
| FTC | Federal Trade Commission | ||||||||||||||||
| GAAP | U.S. generally accepted accounting principles | ||||||||||||||||
| Gensenta | Gensenta İlaç Sanayi ve Ticaret A.Ş. | ||||||||||||||||
| HHS | U.S. Department of Health & Human Services | ||||||||||||||||
| IPR&D | in-process research and development | ||||||||||||||||
| IRP | international reference pricing | ||||||||||||||||
| IRS | Internal Revenue Service | ||||||||||||||||
| LIBOR | London Interbank Offered Rate | ||||||||||||||||
| Lp(a) | lipoprotein(a) | ||||||||||||||||
| MD&A | management’s discussion and analysis | ||||||||||||||||
| MFN | most-favored nation | ||||||||||||||||
| Moody’s | Moody’s Investors Service, Inc. | ||||||||||||||||
| Neumora | Neumora Therapeutics, Inc. | ||||||||||||||||
| OECD | Organisation for Economic Co-operation and Development | ||||||||||||||||
| PBM | pharmacy benefit manager | ||||||||||||||||
| PTAB | Patent Trial and Appeal Board | ||||||||||||||||
| R&D | research and development | ||||||||||||||||
| RAR | Revenue Agent Report | ||||||||||||||||
| 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 | ||||||||||||||||
| Teneobio | Teneobio, Inc. | ||||||||||||||||
| U.S. Treasury | U.S. Department of Treasury | ||||||||||||||||
| USPTO | U.S. Patent and Trademark Office | ||||||||||||||||
| UTB | unrecognized tax benefit | ||||||||||||||||
ii
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 | |||||||
| Aimovig | Aimovig® (erenumab-aooe) | |||||||
| AMGEVITA | AMGEVITA™ (adalimumab) | |||||||
| Aranesp | Aranesp® (darbepoetin alfa) | |||||||
| AVSOLA | AVSOLA® (infliximab-axxq) | |||||||
| BLINCYTO | BLINCYTO® (blinatumomab) | |||||||
| Corlanor | Corlanor® (ivabradine) | |||||||
| ENBREL | Enbrel® (etanercept) | |||||||
| 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® | |||||||
| Otezla | Otezla® (apremilast) | |||||||
| Parsabiv | Parsabiv® (etelcalcetide) | |||||||
| Prolia | Prolia® (denosumab) | |||||||
| Repatha | Repatha® (evolocumab) | |||||||
| RIABNI | RIABNI™ (rituximab-arrx) | |||||||
| Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | |||||||
| TEZSPIRE | TEZSPIRE® (tezepelumab-ekko) | |||||||
| Vectibix | Vectibix® (panitumumab) | |||||||
| XGEVA | XGEVA® (denosumab) |
iii
PART I — FINANCIAL INFORMATION
Next: Item 1. FINANCIAL STATEMENTS