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 September 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)

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

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 October 31, 2022, the registrant had 533,579,206 shares of common stock, $0.0001 par value, outstanding.

AMGEN INC.

INDEX

Page No.
DEFINED TERMS AND PRODUCTSii
PART I - FINANCIAL INFORMATION1
Item 1.FINANCIAL STATEMENTS1
CONDENSED CONSOLIDATED STATEMENTS OF INCOME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME2
CONDENSED CONSOLIDATED BALANCE SHEETS3
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS6
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS7
Item 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS30
Item 3.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK42
Item 4.CONTROLS AND PROCEDURES43
PART II - OTHER INFORMATION44
Item 1.LEGAL PROCEEDINGS44
Item 1A.RISK FACTORS44
Item 2.UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS48
Item 6.EXHIBITS49
INDEX TO EXHIBITS50
SIGNATURES57

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.

TermDescription
ANDAAbbreviated New Drug Application
AOCIaccumulated other comprehensive income (loss)
ASRaccelerated share repurchase
BeiGeneBeiGene, Ltd.
BergamoLaboratorio Quimico Farmaceutico Bergamo Ltda
ChemoCentryxChemoCentryx, Inc.
CMSCenters for Medicare & Medicaid Services
COVID-19coronavirus disease 2019
EczacıbaşıEIS Eczacıbaşı İlaç, Sınai ve Finansal Yatırımlar Sanayi ve Ticaret A.Ş.
EPSearnings per share
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
FitchFitch Ratings, Inc.
Five PrimeFive Prime Therapeutics, Inc.
FTCFederal Trade Commission
GAAPU.S. generally accepted accounting principles
GensentaGensenta İlaç Sanayi ve Ticaret A.Ş.
HHSU.S. Department of Health & Human Services
IPR&Din-process research and development
IRAInflation Reduction Act of 2022
IRPinternational reference pricing
IRSInternal Revenue Service
KKCKyowa Kirin Co., Ltd.
LIBORLondon Interbank Offered Rate
MD&Amanagement’s discussion and analysis
MFNmost-favored nation
Moody’sMoody’s Investors Service, Inc.
NeumoraNeumora Therapeutics, Inc.
OECDOrganisation for Economic Co-operation and Development
PBMpharmacy benefit manager
PDABPrescription Drug Affordability Board
PTABPatent Trial and Appeal Board
R&Dresearch and development
RARRevenue Agent Report
ROWrest of world
S&PStandard & Poor’s Financial Services LLC
SECU.S. Securities and Exchange Commission
SG&Aselling, general and administrative
TeneobioTeneobio, Inc.
U.S. TreasuryU.S. Department of Treasury
USPTOU.S. Patent and Trademark Office
UTBunrecognized 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.

TermDescription
AimovigAimovig® (erenumab-aooe)
AMGEVITAAMGEVITA™ (adalimumab)
AranespAranesp® (darbepoetin alfa)
AVSOLAAVSOLA® (infliximab-axxq)
BLINCYTOBLINCYTO® (blinatumomab)
CorlanorCorlanor® (ivabradine)
ENBRELEnbrel® (etanercept)
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)
OnproOnpro®
OtezlaOtezla® (apremilast)
ParsabivParsabiv® (etelcalcetide)
ProliaProlia® (denosumab)
RepathaRepatha® (evolocumab)
RIABNIRIABNI® (rituximab-arrx)
Sensipar/MimparaSensipar®/Mimpara™ (cinacalcet)
TEZSPIRETEZSPIRE® (tezepelumab-ekko)
VectibixVectibix® (panitumumab)
XGEVAXGEVA® (denosumab)

iii

PART I — FINANCIAL INFORMATION

Next: Item 1. FINANCIAL STATEMENTS