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, 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)

Delaware95-3540776
(State or other jurisdiction of incorporation or organization)(I.R.S. Employer Identification No.)
One Amgen Center Drive91320-1799
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 classTrading Symbol (s)Name of each exchange on which registered
Common stock, $0.0001 par valueAMGNThe Nasdaq Stock Market LLC
2.00% Senior Notes due 2026AMGN26The 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 filerAccelerated filerNon-accelerated filerSmaller reporting companyEmerging 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 $129,940,091,621 as of June 30, 2022.(A)

(A)Excludes 818,128 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, 2022. 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.

533,976,238

(Number of shares of common stock outstanding as of February 6, 2023)

DOCUMENTS INCORPORATED BY REFERENCE

Specified portions of the registrant’s Proxy Statement with respect to the 2023 Annual Meeting of Stockholders to be held May 19, 2023, are incorporated by reference into Part III of this annual report.

INDEX

Page No.
DEFINED TERMS AND PRODUCTSii
PART I1
Item 1.BUSINESS1
Significant Developments1
Marketing, Distribution and Selected Marketed Products3
Reimbursement9
Manufacturing, Distribution and Raw Materials11
Government Regulation13
Research and Development and Selected Product Candidates16
Business Relationships22
Human Capital Resources23
Information about our Executive Officers26
Geographic Area Financial Information27
Investor Information27
Item 1A.RISK FACTORS27
Item 1B.UNRESOLVED STAFF COMMENTS51
Item 2.PROPERTIES52
Item 3.LEGAL PROCEEDINGS52
Item 4.MINE SAFETY DISCLOSURES52
PART II53
Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES53
Item 6.RESERVED54
Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS55
Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK75
Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA77
Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE77
Item 9A.CONTROLS AND PROCEDURES78
Item 9B.OTHER INFORMATION80
PART III80
Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE80
Item 11.EXECUTIVE COMPENSATION80
Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS81
Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE82
Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES82
PART IV83
Item 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES83
Item 16.FORM 10-K SUMMARY89
SIGNATURES90

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.

TermDescription
2017 Tax ActTax Cuts and Jobs Act of 2017
AbbVieAbbVie Inc.
Amended 2009 PlanAmended and Restated 2009 Equity Incentive Plan
ANDAAbbreviated New Drug Application
AOCIaccumulated other comprehensive income (loss)
ASCVDatherosclerotic cardiovascular disease
ASRAccelerated Share Repurchase
AstraZenecaAstraZeneca plc
BeiGeneBeiGene, Ltd.
BergamoLaboratorio Quimico Farmaceutico Bergamo Ltda
BiTE®bispecific T-cell engager
BPCIABiologics Price Competition and Innovation Act of 2009
CCPACalifornia Consumer Privacy Act of 2018
CelgeneCelgene Corporation
CGRPcalcitonin gene-related peptide
ChemoCentryxChemoCentryx, Inc.
chemotherapyanticancer medicines
CHMPCommittee for Medicinal Products for Human Use
CMSCenters for Medicare & Medicaid Services
COSOCommittee of Sponsoring Organizations of the Treadway Commission
COVID-19coronavirus disease 2019
CVcardiovascular
DLL3delta-like ligand 3
DOJU.S. Department of Justice
ECEuropean Commission
EczacıbaşıEIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş.
EMAEuropean Medicines Agency
EPSearnings per share
ESGenvironmental, social and governance
EUEuropean Union
FASBFinancial Accounting Standards Board
FCPAU.S. Foreign Corrupt Practices Act
FDAU.S. Food and Drug Administration
FDCAFederal Food, Drug, and Cosmetic Act
FitchFitch Ratings, Inc.
Five PrimeFive Prime Therapeutics, Inc.
FTCFederal Trade Commission
GAAPU.S. generally accepted accounting principles
GDPRGeneral Data Protection Regulation
GEJgastroesophageal junction
GensentaGensenta İlaç Sanayi ve Ticaret A.Ş.
HHSU.S. Department of Health & Human Services
HorizonHorizon Therapeutics plc

ii

TermDescription
ILinterleukin
INDInvestigational New Drug Application
IPR&Din-process research and development
IRAInflation Reduction Act
IRSInternal Revenue Service
JanssenJanssen Biotech, Inc.
K-AKirin-Amgen, Inc.
KKCKyowa Kirin Co., Ltd.
KRASKirsten rat sarcoma viral oncogene
LDL-Clow-density lipoprotein cholesterol
LIBORLondon Interbank Offered Rate
LillyEli Lilly and Company
Lp(a)lipoprotein(a)
MD&Amanagement’s discussion and analysis
Moody’sMoody’s Investors Service, Inc.
MRDminimal residual disease
NeumoraNeumora Therapeutics, Inc.
NOLnet operating loss
NovartisNovartis Pharma AG
NSCLCnon-small cell lung cancer
OECDOrganisation for Economic Co-operation and Development
OIGOffice of Inspector General
OLEopen label extension
ORRobjective response rate
PBMpharmacy benefit manager
PCSK9proprotein convertase subtilisin/kexin type 9
PDE4phosphodiesterase 4
PFSprogression-free survival
PNHparoxysmal nocturnal hemoglobinuria
Profit Sharing PlanAmgen Profit Sharing Plan for Employees in Ireland
R&Dresearch and development
RANKLreceptor activator of nuclear factor kappa-B ligand
RARRevenue Agent Report
REMSrisk evaluation and mitigation strategy
ROUright-of-use
ROWrest of world
RSUsrestricted stock units
S&PStandard & Poor’s Financial Services LLC
SECU.S. Securities and Exchange Commission
SG&Aselling, general and administrative
siRNAsmall interfering RNA
SOFRSecured Overnight Financing Rate
TeneobioTeneobio, Inc.
U.S. TreasuryU.S. Department of Treasury
USPTOU.S. Patent and Trademark Office
UTBunrecognized 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.

TermDescription
AcapatamabAcapatamab (formerly AMG 160)
AimovigAimovig® (erenumab-aooe)
AMGEVITAAMGEVITA™ (adalimumab)
AMJEVITAAMJEVITA™ (adalimumab-atto)
AranespAranesp® (darbepoetin alfa)
AutoTouchAutoTouch®
AVSOLAAVSOLA® (infliximab-axxq)
BLINCYTOBLINCYTO® (blinatumomab)
CorlanorCorlanor® (ivabradine)
Efavaleukin alfaEfavaleukin alfa (formerly AMG 592)
EmirodatamabEmirodatamab (formerly AMG 427)
ENBRELEnbrel® (etanercept)
ENBREL MiniENBREL Mini®
EPOGENEPOGEN® (epoetin alfa)
EVENITYEVENITY® (romosozumab-aqqg)
IMLYGICIMLYGIC® (talimogene laherparepvec)
KANJINTIKANJINTI® (trastuzumab-anns)
KYPROLISKYPROLIS® (carfilzomib)
LUMAKRAS/LUMYKRASLUMAKRAS® / LUMYKRAS™ (sotorasib)
MVASIMVASI® (bevacizumab-awwb)
NeulastaNeulasta® (pegfilgrastim)
NEUPOGENNEUPOGEN® (filgrastim)
NplateNplate® (romiplostim)
OlpasiranOlpasiran (formerly AMG 890)
OnproOnpro®
OrdesekimabOrdesekimab (formerly AMG 714)
OtezlaOtezla® (apremilast)
ParsabivParsabiv® (etelcalcetide)
ProliaProlia® (denosumab)
RepathaRepatha® (evolocumab)
RIABNIRIABNI® (rituximab-arrx)
RocatinlimabRocatinlimab (formerly AMG 451)
Rozibafusp alfaRozibafusp alfa (formerly AMG 570)
Sensipar/MimparaSensipar®/Mimpara™ (cinacalcet)
SureClickSureClick®
TarlatamabTarlatamab (formerly AMG 757)
TAVNEOSTAVNEOS® (avacopan)
TEZSPIRETEZSPIRE® (tezepelumab-ekko)
VectibixVectibix® (panitumumab)
XGEVAXGEVA® (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®, EYLEA®, Fulphila®, Herceptin®, HUMIRA®, POMALYST®/IMNOVID®, PRALUENT®, PROCRIT®, PROMACTA®/REVOLADE™, Remicade®, REVLIMID®, RINVOQ®, Rituxan®/MabThera®, Skyrizi®, SOLIRIS®, STELARA®, Taltz®, Teribone™, Tremfya®, UDENYCA®, VELCADE® and Xeljanz®.

iv

PART I

Next: Item 1. BUSINESS