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)

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 $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

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 Regulation12
Research and Development and Selected Product Candidates16
Business Relationships21
Human Capital Resources22
Information about our Executive Officers24
Geographic Area Financial Information25
Investor Information26
Item 1A.RISK FACTORS26
Item 1B.UNRESOLVED STAFF COMMENTS50
Item 2.PROPERTIES51
Item 3.LEGAL PROCEEDINGS51
Item 4.MINE SAFETY DISCLOSURES51
PART II52
Item 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES52
Item 6.RESERVED53
Item 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS54
Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK73
Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA75
Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE75
Item 9A.CONTROLS AND PROCEDURES76
Item 9B.OTHER INFORMATION78
PART III78
Item 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE78
Item 11.EXECUTIVE COMPENSATION78
Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS79
Item 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS AND DIRECTOR INDEPENDENCE80
Item 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES80
PART IV81
Item 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES81
Item 16.FORM 10-K SUMMARY87
SIGNATURES88

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.
ACAAffordable Care Act
aHUSatypical hemolytic uremic syndrome
ALLacute lymphoblastic leukemia
AMDage-related macular degeneration
Amended 2009 PlanAmended and Restated 2009 Equity Incentive Plan
ANDAAbbreviated New Drug Application
AOCIaccumulated other comprehensive income (loss)
AstraZenecaAstraZeneca plc
BAFFB-cell activating factor
BeiGeneBeiGene, Ltd.
BiTE®bispecific T-cell engager
BLABiologics License Application
BMSBristol Myers Squibb Company
BPCIABiologics Price Competition and Innovation Act of 2009
CelgeneCelgene Corporation
CGRPcalcitonin gene-related peptide
chemotherapyanticancer medicines
CHMPCommittee for Medicinal Products for Human Use
CITchemotherapy-induced thrombocytopenia
CKDchronic kidney disease
CMSCenters for Medicare & Medicaid Services
COSOCommittee of Sponsoring Organizations of the Treadway Commission
COVID-19coronavirus disease 2019
CVcardiovascular
DaVitaDaVita Inc.
DLL3delta-like ligand 3
DOJU.S. Department of Justice
DoRduration of response
ECEuropean Commission
EMAEuropean Medicines Agency
EPSearnings per share
ERGemployee resource group
ESAerythropoiesis-stimulating agent
ESGenvironmental, social and governance
ESRDend-stage renal disease
EUEuropean Union
FASBFinancial Accounting Standards Board
FCPAU.S. Foreign Corrupt Practices Act
FDAU.S. Food and Drug Administration
FDCAFederal Food, Drug, and Cosmetic Act
FGFR2bfibroblast growth factor receptor 2b
FitchFitch Ratings, Inc.

ii

TermDescription
Five PrimeFive Prime Therapeutics, Inc.
FOMBPRFinancial Oversight and Management Board for Puerto Rico
FTCFederal Trade Commission
GAAPU.S. generally accepted accounting principles
GDPRGeneral Data Protection Regulation
GEJgastroesophageal junction
HeFHheterozygous familial hypercholesterolemia
HER2human epidermal growth factor receptor 2
HGRACHuman Genetic Resources Administration of China
HHSU.S. Department of Health & Human Services
HLEhalf-life extended
HoFHhomozygous familial hypercholesterolemia
ICOSLinducible costimulatory ligand
ILinterleukin
INDInvestigational New Drug Application
IPR&Din-process research and development
IRPinternational reference pricing
IRSInternal Revenue Service
ITPimmune thrombocytopenia
J&JJohnson & Johnson
JanssenJanssen Biotech, Inc.
K-AKirin-Amgen, Inc.
KirinKirin Holdings Company, Limited
KKCKyowa Kirin Co., Ltd.
LDL-Clow-density lipoprotein cholesterol
LIBORLondon Interbank Offered Rate
LillyEli Lilly and Company
mCRPCmetastatic castrate-resistant prostate cancer
MD&Amanagement’s discussion and analysis
MFNmost favored nation
Moody’sMoody’s Investors Service, Inc.
MRDminimal residual disease
NeumoraNeumora Therapeutics, Inc.
NOLnet operating loss
NovartisNovartis Pharma AG
NSCLCnon-small cell lung cancer
NuevolutionNuevolution AB
OECDOrganization for Economic Co-operation and Development
OIGOffice of Inspector General
ORRobjective response rate
PBMpharmacy benefit manager
PCSK9proprotein convertase subtilisin/kexin type 9
PDE4phosphodiesterase 4
PDUFAPrescription Drug User Fee Act
PFSprogression-free survival
PNHparoxysmal nocturnal hemoglobinuria
Profit Sharing PlanAmgen Profit Sharing Plan for Employees in Ireland
PROMESAPuerto Rico Oversight, Management, and Economic Stability Act

iii

TermDescription
PTABPatent Trial and Appeal Board
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
sNDAsupplemental New Drug Application
SoCstandard of care
SOFRSecured Overnight Financing Rate
SREskeletal-related event
TakedaTakeda Pharmaceutical Company Limited
TDAPAtransitional drug add-on payment adjustment
TeneobioTeneobio, Inc.
TNFtumor necrosis factor
TPO-RAthrombopoietin receptor agonist
U.S. TreasuryU.S. Department of Treasury
UCLAUniversity of California, Los Angeles
USPTOU.S. Patent and Trademark Office
UTBunrecognized tax benefit
VEGFRvascular 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.

TermDescription
AcapatamabAcapatamab (formerly AMG 160)
AimovigAimovig® (erenumab-aooe)
AMGEVITAAMGEVITA™ (adalimumab)
AMJEVITAAMJEVITA™ (adalimumab-atto)
AranespAranesp® (darbepoetin alfa)
AutoTouchAutoTouch®
AVSOLAAVSOLA® (infliximab-axxq)
BLINCYTOBLINCYTO® (blinatumomab)
Efavaleukin alfaEfavaleukin alfa (formerly AMG 592)
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)
PavurutamabPavurutamab (formerly AMG 701)
ProliaProlia® (denosumab)
RepathaRepatha® (evolocumab)
RIABNIRIABNI™ (rituximab-arrx)
Rozibafusp alfaRozibafusp alfa (formerly AMG 570)
Sensipar/MimparaSensipar®/Mimpara™ (cinacalcet)
SureClickSureClick®
TarlatamabTarlatamab (formerly AMG 757)
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®, 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

Next: Item 1. BUSINESS