Amgen Inc 10-Q for FY2026 Q3
Amgen Inc (AMGN)
10-Q
2026-11-04
For: 2026-09-30
View Original
Added on
November 04, 2026
About this 10-Q
Amgen Inc filed this 10-Q on November 4, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $10.37B
- up 8.5% from $9.56B a year earlier
- Net income
- $3.86B
- up 20.1% from net income of $3.22B a year earlier
- Diluted EPS
- $7.08
- up 19.4% from $5.93 a year earlier
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, 2026
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
Commission File Number: 001-37702
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | |||||||
| (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 | ||||||
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.
| ☑ | 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 29, 2026, the registrant had 540,911,490 shares of common stock, $0.0001 par value, outstanding.
AMGEN INC.
INDEX
| Page No. | ||||||||
| Item 1. | ||||||||
| Item 2. | ||||||||
| Item 3. | ||||||||
| Item 4. | ||||||||
| Item 1. | ||||||||
| Item 1A. | ||||||||
| Item 2. | ||||||||
| Item 5. | ||||||||
| Item 6. | ||||||||
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 provided below.
| Term | Description | ||||||||||||||||
| 2017 Tax Act | Tax Cuts and Jobs Act of 2017 | ||||||||||||||||
| 340B Program | Federal 340B Drug Pricing Program | ||||||||||||||||
| AAV | anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis | ||||||||||||||||
| AOCI | accumulated other comprehensive income (loss) | ||||||||||||||||
| AstraZeneca | AstraZeneca plc | ||||||||||||||||
| BeOne | BeOne Medicines Ltd. (formerly BeiGene, Ltd.) | ||||||||||||||||
| CDER | FDA’s Center for Drug Evaluation and Research | ||||||||||||||||
| ChemoCentryx | ChemoCentryx, Inc. | ||||||||||||||||
| CMS | Centers for Medicare & Medicaid Services | ||||||||||||||||
| DILI | drug-induced liver injury | ||||||||||||||||
| DSC | Drug Safety Communication | ||||||||||||||||
| EMA | European Medicines Agency | ||||||||||||||||
| EPS | earnings per share | ||||||||||||||||
| EU | European Union | ||||||||||||||||
| FDA | U.S. Food and Drug Administration | ||||||||||||||||
| Fitch | Fitch Ratings, Inc. | ||||||||||||||||
| GAAP | U.S. generally accepted accounting principles | ||||||||||||||||
| GENEROUS | GENErating cost Reductions fOr U.S. Medicaid | ||||||||||||||||
| HHS | U.S. Department of Health and Human Services | ||||||||||||||||
| IPR&D | in-process research and development | ||||||||||||||||
| IRA | Inflation Reduction Act of 2022 | ||||||||||||||||
| IRS | Internal Revenue Service | ||||||||||||||||
| July MFN Letter | Letter dated July 31, 2025, by the Administration to certain pharmaceutical manufacturers, including Amgen | ||||||||||||||||
| Later-Stage Clinical Programs | R&D expenses incurred in or related to phase 2 and phase 3 clinical programs intended to result in registration of a new product or a new indication for an existing product primarily in the United States or the EU | ||||||||||||||||
| MD&A | management’s discussion and analysis | ||||||||||||||||
| MFN | Most-Favored-Nation | ||||||||||||||||
| MFN EO | Most-Favored-Nation Prescription Drug Pricing Executive Order | ||||||||||||||||
| Moody’s | Moody’s Investors Service, Inc. | ||||||||||||||||
| NIH | National Institutes of Health | ||||||||||||||||
| OB3 | P.L. 119-21, commonly known as The One Big Beautiful Bill Act signed into law on July 4, 2025 | ||||||||||||||||
| OECD | Organisation for Economic Co-operation and Development | ||||||||||||||||
| PBM | pharmacy benefit manager | ||||||||||||||||
| PDAB | Prescription Drug Affordability Board | ||||||||||||||||
| R&D | research and development | ||||||||||||||||
| RANKL | receptor activator of nuclear factor kappa-B ligand | ||||||||||||||||
| RAR | Revenue Agent Report | ||||||||||||||||
| Research and Early Pipeline | R&D expenses incurred in activities substantially in support of early research through the completion of phase 1 clinical trials, including drug discovery, toxicology, pharmacokinetics and drug metabolism and process development | ||||||||||||||||
| 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 | ||||||||||||||||
| SOFR | Secured Overnight Financing Rate | ||||||||||||||||
| U.S. Treasury | U.S. Department of the Treasury | ||||||||||||||||
ii
| Term | Description | ||||||||||||||||
| UTB | unrecognized tax benefit | ||||||||||||||||
| VBDS | vanishing bile duct syndrome | ||||||||||||||||
iii
Products
The brand names of our products, our delivery devices and certain of our product candidates and their associated generic names are provided below.
| Term | Description | ||||
| ACTIMMUNE | ACTIMMUNE® (interferon gamma-1b) | ||||
| Aimovig | Aimovig® (erenumab-aooe) | ||||
| AMJEVITA/AMGEVITA | AMJEVITA® (adalimumab-atto)/AMGEVITA™ (adalimumab) | ||||
| Aranesp | Aranesp® (darbepoetin alfa) | ||||
| AVSOLA | AVSOLA® (infliximab-axxq) | ||||
| BKEMV/BEKEMV | BKEMV® (eculizumab-aeeb)/BEKEMV™ (eculizumab) | ||||
| BLINCYTO | BLINCYTO® (blinatumomab) | ||||
| BUPHENYL | BUPHENYL® (sodium phenylbutyrate) | ||||
| Corlanor | Corlanor® (ivabradine) | ||||
| ENBREL | Enbrel® (etanercept) | ||||
| EPOGEN | EPOGEN® (epoetin alfa) | ||||
| EVENITY | EVENITY® (romosozumab-aqqg) | ||||
| IMDELLTRA/IMDYLLTRA | IMDELLTRA® (tarlatamab-dlle)/IMDYLLTRA™ (tarlatamab) | ||||
| IMLYGIC | IMLYGIC® (talimogene laherparepvec) | ||||
| KANJINTI | KANJINTI® (trastuzumab-anns) | ||||
| KRYSTEXXA | KRYSTEXXA® (pegloticase) | ||||
| KYPROLIS | KYPROLIS® (carfilzomib) | ||||
| LUMAKRAS/LUMYKRAS | LUMAKRAS®/LUMYKRAS™ (sotorasib) | ||||
MariTide | Maridebart cafraglutide (MariTide™) | ||||
| MVASI | MVASI® (bevacizumab-awwb) | ||||
| Neulasta | Neulasta® (pegfilgrastim) | ||||
| NEUPOGEN | NEUPOGEN® (filgrastim) | ||||
| Nplate | Nplate® (romiplostim) | ||||
| Otezla | Otezla® (apremilast) | ||||
| Parsabiv | Parsabiv® (etelcalcetide) | ||||
| PAVBLU | PAVBLU® (aflibercept-ayyh) | ||||
| PENNSAID | PENNSAID® (diclofenac sodium topical solution) 2% | ||||
| PROCYSBI | PROCYSBI® (cysteamine bitartrate) | ||||
| Prolia | Prolia® (denosumab) | ||||
| QUINSAIR | QUINSAIR® (levofloxacin) | ||||
| RAVICTI | RAVICTI® (glycerol phenylbutyrate) | ||||
| RAYOS | RAYOS® (prednisone) | ||||
| Repatha | Repatha® (evolocumab) | ||||
| RIABNI | RIABNI® (rituximab-arrx) | ||||
| Sensipar/Mimpara | Sensipar®/Mimpara™ (cinacalcet) | ||||
| TAVNEOS | TAVNEOS® (avacopan) | ||||
| TEPEZZA | TEPEZZA® (teprotumumab-trbw) | ||||
| TEZSPIRE | TEZSPIRE® (tezepelumab-ekko) | ||||
| UPLIZNA | UPLIZNA® (inebilizumab-cdon) | ||||
| Vectibix | Vectibix® (panitumumab) | ||||
| WEZLANA/WEZENLA | WEZLANA® (ustekinumab-auub)/WEZENLA™ (ustekinumab) | ||||
| XGEVA | XGEVA® (denosumab) | ||||
Products referenced in this report that are not included in the above list are the properties of their respective owners.
iv
PART I—FINANCIAL INFORMATION
| Item 1. | FINANCIAL STATEMENTS | ||||
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(In millions, except per-share data)
(Unaudited)
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Revenues: | |||||||||||||||||||||||
| Product sales | $ | $ | $ | $ | |||||||||||||||||||
| Other revenues | |||||||||||||||||||||||
| Total revenues | |||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of sales | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| Selling, general and administrative | |||||||||||||||||||||||
| Other | |||||||||||||||||||||||
| Total operating expenses | |||||||||||||||||||||||
| Operating income | |||||||||||||||||||||||
| Other income (expense): | |||||||||||||||||||||||
| Interest expense, net | ( | ( | ( | ( | |||||||||||||||||||
| Other income, net | |||||||||||||||||||||||
| Income before income taxes | |||||||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
| Earnings per share: | |||||||||||||||||||||||
| Basic | $ | $ | $ | $ | |||||||||||||||||||
| Diluted | $ | $ | $ | $ | |||||||||||||||||||
| Weighted-average shares used in calculation of earnings per share: | |||||||||||||||||||||||
| Basic | |||||||||||||||||||||||
| Diluted | |||||||||||||||||||||||
See accompanying notes.
1
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(In millions)
(Unaudited)
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Net income | $ | $ | $ | $ | |||||||||||||||||||
| Other comprehensive (loss) income, net of reclassification adjustments and taxes: | |||||||||||||||||||||||
| Gains (losses) on foreign currency translation adjustments | ( | ||||||||||||||||||||||
| (Losses) gains on cash flow hedges | ( | ( | |||||||||||||||||||||
| Other | ( | ( | |||||||||||||||||||||
| Other comprehensive (loss) income, net of reclassification adjustments and taxes | ( | ( | |||||||||||||||||||||
| Comprehensive income | $ | $ | $ | $ | |||||||||||||||||||
See accompanying notes.
2
AMGEN INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In millions, except per-share data)
| September 30, 2026 | December 31, 2025 | ||||||||||
| (Unaudited) | |||||||||||
| ASSETS | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Trade receivables, net | |||||||||||
| Inventories | |||||||||||
| Other current assets | |||||||||||
| Total current assets | |||||||||||
| Property, plant and equipment, net | |||||||||||
| Intangible assets, net | |||||||||||
| Goodwill | |||||||||||
| Other noncurrent assets | |||||||||||
| Total assets | $ | $ | |||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | $ | |||||||||
| Accrued liabilities | |||||||||||
| Current portion of long-term debt | |||||||||||
| Total current liabilities | |||||||||||
| Long-term debt | |||||||||||
| Long-term deferred tax liabilities | |||||||||||
| Long-term tax liabilities | |||||||||||
| Other noncurrent liabilities | |||||||||||
Contingencies and commitments (see Note 13) | |||||||||||
Common stock and additional paid-in capital; $ | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Accumulated other comprehensive loss | ( | ( | |||||||||
| Total stockholders’ equity | |||||||||||
| Total liabilities and stockholders’ equity | $ | $ | |||||||||
See accompanying notes.
3
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(In millions, except per-share data)
(Unaudited)
| Three months ended September 30, 2026 | |||||||||||||||||||||||||||||
| Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
| Balance as of June 30, 2026 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Net income | — | — | — | ||||||||||||||||||||||||||
| Other comprehensive loss, net of taxes | — | — | — | ( | ( | ||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with equity award programs | — | — | |||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
| Balance as of September 30, 2026 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Nine months ended September 30, 2026 | |||||||||||||||||||||||||||||
| Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
| Balance as of December 31, 2025 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Net income | — | — | — | ||||||||||||||||||||||||||
| Other comprehensive income, net of taxes | — | — | — | ||||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with equity award programs | — | — | |||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
| Balance as of September 30, 2026 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
4
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)
(In millions, except per-share data)
(Unaudited)
| Three months ended September 30, 2025 | |||||||||||||||||||||||||||||
| Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
| Balance as of June 30, 2025 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Net income | — | — | — | ||||||||||||||||||||||||||
| Other comprehensive income, net of taxes | — | — | — | ||||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with equity award programs | — | — | |||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
| Balance as of September 30, 2025 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Nine months ended September 30, 2025 | |||||||||||||||||||||||||||||
| Number of shares of common stock | Common stock and additional paid-in capital | Accumulated deficit | Accumulated other comprehensive loss | Total | |||||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
| Net income | — | — | — | ||||||||||||||||||||||||||
| Other comprehensive loss, net of taxes | — | — | — | ( | ( | ||||||||||||||||||||||||
Dividends declared on common stock ($ | — | — | ( | — | ( | ||||||||||||||||||||||||
Issuance of common stock in connection with equity award programs | — | — | |||||||||||||||||||||||||||
| Stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||
Tax impact related to employee stock-based compensation expense | — | ( | — | — | ( | ||||||||||||||||||||||||
| Balance as of September 30, 2025 | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
See accompanying notes.
5
AMGEN INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In millions)
(Unaudited)
| Nine months ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net income | $ | $ | |||||||||
| Noncash adjustments to reconcile net income to net cash provided by operating activities: | |||||||||||
| Depreciation, amortization and other | |||||||||||
| Impairment of intangible assets | |||||||||||
| Stock-based compensation expense | |||||||||||
| Deferred income taxes | ( | ( | |||||||||
| Gain on equity securities | ( | ( | |||||||||
| Other items, net | ( | ||||||||||
| Changes in operating assets and liabilities, net of acquisitions: | |||||||||||
| Trade receivables, net | ( | ( | |||||||||
| Inventories | ( | ||||||||||
| Other assets | ( | ( | |||||||||
| Accounts payable | |||||||||||
| Accrued income taxes, net | ( | ||||||||||
| Long-term tax liabilities | |||||||||||
| Accrued liabilities | ( | ( | |||||||||
| Accrued sales incentives and allowance | |||||||||||
| Other liabilities | ( | ( | |||||||||
| Net cash provided by operating activities | |||||||||||
| Cash flows from investing activities: | |||||||||||
| Purchases of property, plant and equipment | ( | ( | |||||||||
| Other | ( | ( | |||||||||
| Net cash used in investing activities | ( | ( | |||||||||
| Cash flows from financing activities: | |||||||||||
| Net proceeds from issuance of debt | |||||||||||
| Extinguishment of debt | ( | ( | |||||||||
| Repayment of debt | ( | ( | |||||||||
| Dividends paid | ( | ( | |||||||||
| Other | ( | ( | |||||||||
| Net cash used in financing activities | ( | ( | |||||||||
| Increase (decrease) in cash and cash equivalents | ( | ||||||||||
| Cash and cash equivalents at beginning of period | |||||||||||
| Cash and cash equivalents at end of period | $ | $ | |||||||||
See accompanying notes.
6
AMGEN INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2026
(Unaudited)
1. Summary of significant accounting policies
Business
Amgen Inc. (including its consolidated subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics. We operate our business in one operating segment: human therapeutics. See Note 2, Segment and other information.
Basis of presentation
The interim unaudited financial information for the three and nine months ended September 30, 2026 and 2025, has been prepared in accordance with GAAP and includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated) that Amgen considers necessary for a fair presentation, in all material respects, of its condensed consolidated results of operations for those periods. Interim results are not necessarily indicative of results for the full fiscal year.
The condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2025, and with the condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026.
Principles of consolidation
The condensed consolidated financial statements include the accounts of Amgen and its majority-owned subsidiaries. In determining whether we are the primary beneficiary of a variable interest entity, we consider whether we have both the power to direct activities of the entity that most significantly impact the entity’s economic performance and the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. We do not have any significant interests in any variable interest entities of which we are the primary beneficiary. All material intercompany transactions and balances have been eliminated in consolidation. Certain reclassifications have been made to prior periods in the condensed consolidated financial statements and accompanying notes to conform with the current presentation.
Use of estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results may differ from those estimates.
Property, plant and equipment, net
Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $9.6 billion and $11.1 billion as of September 30, 2026 and December 31, 2025, respectively.
Recent accounting pronouncements not yet adopted
In November 2024, the Financial Accounting Standards Board issued Accounting Standards Update No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to improve disclosures about a public business entity’s expenses by requiring disaggregated disclosures of certain types of expenses, including purchases of inventory, employee compensation, depreciation, intangible amortization and depletion, as applicable, for each income statement caption that includes those expenses. In addition, the standard will require entities to define and disclose total selling expenses. The standard is effective for public business entities such as Amgen for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027. Early adoption is permitted, and entities may apply the standard prospectively or retrospectively. We are currently evaluating the impact of adopting this standard on our consolidated financial statements and related disclosures.
7
2. Segment and other information
We operate our business in one operating segment, which also represents one reportable segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting.
The human therapeutics segment is engaged in the discovery, development, manufacturing and delivery of innovative medicines to fight some of the world’s toughest diseases. The Company’s Chief Executive Officer has been identified as the chief operating decision maker (CODM). The CODM manages and allocates resources on a consolidated basis. The determination of a single segment is consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance and allocating resources, which is reviewed on a consolidated basis.
As the Company’s CODM evaluates the financial performance of the Company’s human therapeutics segment on a consolidated basis, the measure of segment performance is net income, as reflected in the Condensed Consolidated Statements of Income. The CODM uses net income to allocate resources on a consolidated basis, which enables the CODM to both assess the overall level of resources available and optimize the distribution of resources across functions, therapeutic areas, regions and R&D programs in line with our long-term corporate-wide strategic goals. In addition, the CODM may also evaluate financial performance based on net income adjusted for certain items that are unusual and nonrecurring. As the Company manages its assets on a consolidated basis, the measure of segment assets is total assets, as reflected in the Condensed Consolidated Balance Sheets. See Note 6, Investments, for further information regarding equity method investments, and Net cash used in investing activities in the Condensed Consolidated Statements of Cash Flows for further information regarding capital expenditures.
8
The following table provides segment revenues, significant segment expenses, other segment items and reported segment net income for the Company’s one reportable segment, as well as a reconciliation of segment net income to the Company’s total consolidated net income for the three and nine months ended September 30, 2026 and 2025 (in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Revenues: | ||||||||||||||||||||||||||
| Product sales | $ | $ | $ | $ | ||||||||||||||||||||||
| Other revenues | ||||||||||||||||||||||||||
| Total revenues | ||||||||||||||||||||||||||
| Less: | ||||||||||||||||||||||||||
Manufacturing cost of sales(1)(2) | ||||||||||||||||||||||||||
Profit share and royalties in cost of sales(1) | ||||||||||||||||||||||||||
Research and development(1) | ||||||||||||||||||||||||||
Sales and marketing(1) | ||||||||||||||||||||||||||
General and administrative(1) | ||||||||||||||||||||||||||
Other segment items(3) | ( | ( | ( | ( | ||||||||||||||||||||||
| Interest income | ( | ( | ( | ( | ||||||||||||||||||||||
| Interest expense, net | ||||||||||||||||||||||||||
| Provision for income taxes | ||||||||||||||||||||||||||
| Segment net income | ||||||||||||||||||||||||||
| Reconciliation of profit or loss | ||||||||||||||||||||||||||
| Adjustments and reconciling items | ||||||||||||||||||||||||||
| Consolidated net income | $ | $ | $ | $ | ||||||||||||||||||||||
____________
(1) During the three months ended September 30, 2026 and 2025, amortization of our finite-lived intangible assets was $889 million and $1.1 billion, respectively. During the nine months ended September 30, 2026 and 2025, amortization of our finite-lived intangible assets was $2.7 billion and $3.4 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income. In addition, during the three months ended September 30, 2026 and 2025, we recognized depreciation and right-of-use asset amortization of $233 million and $232 million, respectively. During the nine months ended September 30, 2026 and 2025, we recognized depreciation and right-of-use asset amortization of $675 million and $661 million, respectively.
(2) Manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $307 million during the nine months ended September 30, 2026, compared to $338 million and $1.0 billion during the three and nine months ended September 30, 2025, respectively.
(3) Other segment items included in Segment net income primarily consisted of fair value adjustments on equity securities (see Note 6, Investments) and net impairment charges on intangible assets (see Note 8, Goodwill and other intangible assets).
9
3. Revenues
We operate our business in one operating segment, which also represents one reportable segment: human therapeutics. Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Revenues by product and by geographic area, based on customers’ locations, are presented below. A substantial portion of ROW product sales relates to products sold in Europe.
Revenues were as follows (in millions):
| Three months ended September 30, | ||||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||||||||||||||
| U.S. | ROW | Total | U.S. | ROW | Total | |||||||||||||||||||||||||||||||||
| Repatha | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
| Prolia | ||||||||||||||||||||||||||||||||||||||
| EVENITY | ||||||||||||||||||||||||||||||||||||||
| TEPEZZA | ||||||||||||||||||||||||||||||||||||||
| ENBREL | ||||||||||||||||||||||||||||||||||||||
| Otezla | ||||||||||||||||||||||||||||||||||||||
| BLINCYTO | ||||||||||||||||||||||||||||||||||||||
TEZSPIRE(1) | ||||||||||||||||||||||||||||||||||||||
| Nplate | ||||||||||||||||||||||||||||||||||||||
| KRYSTEXXA | ||||||||||||||||||||||||||||||||||||||
| XGEVA | ||||||||||||||||||||||||||||||||||||||
| UPLIZNA | ||||||||||||||||||||||||||||||||||||||
| Aranesp | ||||||||||||||||||||||||||||||||||||||
| KYPROLIS | ||||||||||||||||||||||||||||||||||||||
| Vectibix | ||||||||||||||||||||||||||||||||||||||
| IMDELLTRA/IMDYLLTRA | ||||||||||||||||||||||||||||||||||||||
Other products(2) | ||||||||||||||||||||||||||||||||||||||
Total product sales(3) | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||
| Other revenues | ||||||||||||||||||||||||||||||||||||||
| Total revenues | $ | $ | ||||||||||||||||||||||||||||||||||||
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| Nine months ended September 30, | ||||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||||||||||||||
| U.S. | ROW | Total | U.S. | ROW | Total | |||||||||||||||||||||||||||||||||
| Repatha | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||
| Prolia | ||||||||||||||||||||||||||||||||||||||
| EVENITY | ||||||||||||||||||||||||||||||||||||||
| TEPEZZA | ||||||||||||||||||||||||||||||||||||||
| ENBREL | ||||||||||||||||||||||||||||||||||||||
| Otezla | ||||||||||||||||||||||||||||||||||||||
| BLINCYTO | ||||||||||||||||||||||||||||||||||||||
TEZSPIRE(1) | ||||||||||||||||||||||||||||||||||||||
| Nplate | ||||||||||||||||||||||||||||||||||||||
| KRYSTEXXA | ||||||||||||||||||||||||||||||||||||||
| XGEVA | ||||||||||||||||||||||||||||||||||||||
| UPLIZNA | ||||||||||||||||||||||||||||||||||||||
| Aranesp | ||||||||||||||||||||||||||||||||||||||
| KYPROLIS | ||||||||||||||||||||||||||||||||||||||
| Vectibix | ||||||||||||||||||||||||||||||||||||||
| IMDELLTRA/IMDYLLTRA | ||||||||||||||||||||||||||||||||||||||
Other products(2) | ||||||||||||||||||||||||||||||||||||||
Total product sales(3) | $ | $ | $ | $ | ||||||||||||||||||||||||||||||||||
| Other revenues | ||||||||||||||||||||||||||||||||||||||
| Total revenues | $ | $ | ||||||||||||||||||||||||||||||||||||
_______
(1) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.
(2) Consists of product sales of our non-principal products.
(3) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2026 and 2025.
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4. Income taxes
The effective tax rates for the three and nine months ended September 30, 2026 were 17.5 % and 15.5 %, respectively, compared with 18.0 % and 14.5 %, respectively, for the corresponding periods in the prior year.
The decrease in our effective tax rate for the three months ended September 30, 2026, was primarily due to the change in earnings mix, including lower net unrealized gains on equity investments (see Note 6, Investments), partially offset by net favorable items in the prior-year period as compared to the current-year period. The increase in our effective tax rate for the nine months ended September 30, 2026, was primarily due to the prior year Otezla intangible asset impairment charges and net unfavorable items in the current-year period as compared to the prior-year period, partially offset by the change in earnings mix, including lower net unrealized gains on equity investments (see Note 6, Investments) and lower amortization expense from acquisition related assets. The effective tax rates differ from the federal statutory rate primarily due to the impact of the jurisdictional mix of income and expenses. Substantially all of the benefit to our effective tax rate from foreign earnings results from locations in which the Company has significant manufacturing operations, including Singapore, Ireland and Puerto Rico, a territory of the United States that is treated as a foreign jurisdiction for U.S. tax purposes. Our operations in Puerto Rico are subject to tax incentive grants through 2050 and the Company’s operations in Singapore are subject to a tax incentive grant through 2036. Effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement. Additional countries, including Singapore, enacted the minimum tax agreement effective January 1, 2025. Singapore’s enactment of the agreement applies irrespective of the Company’s incentive grant. Due to the currently enacted scope of the agreement, the Company and its subsidiaries are now subject to a 15% minimum tax rate on adjusted financial statement income. Our foreign earnings are also subject to U.S. tax at a reduced rate of 12.6%, as of January 1, 2026.
On July 4, 2025, OB3 was enacted in the United States. OB3 has various provisions, including the permanent extension of certain expiring provisions of the 2017 Tax Act and modifications to the international tax framework, including the tax rate changes on foreign earnings noted above. The legislation has multiple effective dates, with most provisions effective as of January 1, 2026.
One or more of our legal entities file income tax returns in the U.S. federal jurisdiction, various U.S. state jurisdictions and certain foreign jurisdictions. Our income tax returns are routinely examined by tax authorities in those jurisdictions. Significant disputes can arise and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts. Tax authorities, including the IRS, are becoming more aggressive and are particularly focused on such matters.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations, and in 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012. The Notices seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued and paid on our foreign earnings.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012. We disagreed with the proposed adjustments and calculations, and in 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015. The Notice seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest, and asserts penalties of approximately $2.0 billion. Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued and paid on our foreign earnings.
We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We continue to contest the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court in 2022. The trial began on November 4, 2024 and concluded on January 17, 2025. The parties filed opening post-trial briefs on June 13, 2025, and the Court held oral argument on July 16, 2025. The parties filed post-trial reply briefs on October 10, 2025. On March 16, 2026, the Court ordered supplemental closing briefs, which were filed on May 20, 2026. The Company expects a decision from the U.S. Tax Court no earlier than late 2026 or early 2027.
We are currently under examination by the IRS for the years 2016–2018. In April 2026, we received a draft notice of proposed adjustment (NOPA) from the IRS for years 2016–2018, which is similar to the proposed adjustments for years 2010–
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2015 and relates primarily to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. In May and July 2026, the IRS reissued the NOPA in substantially the same form. We have informed the IRS audit team that its methodology is inconsistent with certain positions asserted by the IRS in the Tax Court, which positions were more favorable to Amgen than those previously taken by the audit team. In September 2026, we received a draft NOPA from the IRS asserting penalties for years 2016-2018 substantially similar to those the IRS asserted for years 2013-2015. If sustained in full, these proposed adjustments and penalties could have a material impact on our financial statements. We disagree with the proposed adjustments and penalties and intend to contest them. The IRS began its audit for years 2019–2022 in the second quarter of 2026, and we believe that it may seek to continue to audit similar issues related to the allocation of income between the United States and our foreign jurisdictions. In addition, we are under examination by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements.
During the three and nine months ended September 30, 2026, the gross amounts of our UTBs increased by $45 million and $125 million, respectively, as a result of tax positions taken during the current year. Substantially all of the UTBs as of September 30, 2026, if recognized, would impact our effective tax rate.
5. Earnings per share
The computation of basic EPS is based on the weighted-average number of our common shares outstanding. The computation of diluted EPS is based on the weighted-average number of our common shares outstanding and dilutive potential common shares, which primarily include shares that may be issued under our stock option, restricted stock and performance unit award programs (collectively, dilutive securities), as determined by using the treasury stock method.
The computations for basic and diluted EPS were as follows (in millions, except per-share data):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Income (Numerator): | |||||||||||||||||||||||
| Net income for basic and diluted EPS | $ | $ | $ | $ | |||||||||||||||||||
| Shares (Denominator): | |||||||||||||||||||||||
| Weighted-average shares for basic EPS | |||||||||||||||||||||||
| Effect of dilutive securities | |||||||||||||||||||||||
| Weighted-average shares for diluted EPS | |||||||||||||||||||||||
| Basic earnings per share | $ | $ | $ | $ | |||||||||||||||||||
| Diluted earnings per share | $ | $ | $ | $ | |||||||||||||||||||
For the three and nine months ended September 30, 2026 and 2025, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not
13
6. Investments
Available-for-sale investments
The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are classified as available for sale, by type of security were as follows (in millions):
| Types of securities as of September 30, 2026 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair values | ||||||||||||||||||||||
| U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
| Money market mutual funds | ||||||||||||||||||||||||||
| Other short-term interest-bearing securities | ||||||||||||||||||||||||||
| Total interest-bearing securities | $ | $ | $ | $ | ||||||||||||||||||||||
| Types of securities as of December 31, 2025 | Amortized cost | Gross unrealized gains | Gross unrealized losses | Fair values | ||||||||||||||||||||||
| U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
| Money market mutual funds | ||||||||||||||||||||||||||
| Other short-term interest-bearing securities | ||||||||||||||||||||||||||
| Total interest-bearing securities | $ | $ | $ | $ | ||||||||||||||||||||||
The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):
| Condensed Consolidated Balance Sheets locations | September 30, 2026 | December 31, 2025 | ||||||||||||
| Cash and cash equivalents | $ | $ | ||||||||||||
| Total interest-bearing securities | $ | $ | ||||||||||||
Cash and cash equivalents in the above table excludes bank account cash of $569 million and $604 million as of September 30, 2026 and December 31, 2025, respectively.
All interest-bearing securities as of September 30, 2026 and December 31, 2025, mature in one year or less. For the three months ended September 30, 2026 and 2025, interest income on these investments was $125 million and $99 million, respectively. For the nine months ended September 30, 2026 and 2025, interest income on these investments was $351 million and $311 million, respectively.
For the three and nine months ended September 30, 2026 and 2025, realized gains and losses on interest-bearing securities were not material and were recorded in Other income, net, in the Condensed Consolidated Statements of Income. The cost of securities sold is based on the specific-identification method.
The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
Equity securities
BeOne Medicines Ltd.
As of September 30, 2026 and December 31, 2025, our ownership interest in BeOne was approximately 17 6.9 billion and $5.8 billion, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three months ended September 30, 2026 and 2025, we recorded unrealized gains of $1.5 billion and $1.9 billion, respectively. During the nine months ended September 30, 2026 and 2025, we recorded unrealized gains of $1.2 billion and $3.0 billion, respectively. These unrealized gains were recognized in Other income, net, in the Condensed Consolidated Statements of Income.
14
Subject to certain exceptions or otherwise agreed to by BeOne, while Amgen holds at least 5.0 % of BeOne’s outstanding common stock, (A) we may only sell our BeOne equity investment via: (i) a registered public offering, (ii) a sale under Rule 144 of the Securities Act of 1933 (the “Securities Act”) or (iii) a private sale exempt from registration requirements under the Securities Act, and (B) we may not sell more than 5.0 % of BeOne’s outstanding common stock in any rolling 12-month period.
Other equity securities
Excluding our equity investment in BeOne (discussed above), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $398 million and $389 million as of September 30, 2026 and December 31, 2025, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three months ended September 30, 2026 and 2025, net unrealized gains and losses on these other publicly traded securities were not not 246 million during the nine months ended September 30, 2025. Additionally, net realized gains and losses on sales of these other publicly traded securities for the three and nine months ended September 30, 2026 and 2025, were not
We held investments of $314 million and $362 million in equity securities without readily determinable fair values as of September 30, 2026 and December 31, 2025, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. During the three and nine months ended September 30, 2026 and 2025, upward and downward adjustments on these securities were not not
Equity method investments
Limited partnerships
We held limited of $330 million and $253 million as of September 30, 2026 and December 31, 2025, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets. These investments, which are primarily investment funds of early-stage biotechnology companies, are accounted for by using the equity method of accounting and are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient. These investments are typically redeemable only through distributions upon liquidation of the underlying assets. As of September 30, 2026, we had $142 million of unfunded additional commitments to be made for these investments during the next several years. For the three and nine months ended September 30, 2026 and 2025, net unrealized gains and losses recognized from our limited partnership investments were not
15
7. Inventories
Inventories consisted of the following (in millions):
| September 30, 2026 | December 31, 2025 | ||||||||||
| Raw materials | $ | $ | |||||||||
| Work in process | |||||||||||
| Finished goods | |||||||||||
| Total inventories | $ | $ | |||||||||
8. Goodwill and other intangible assets
Goodwill
The change in the carrying amount of goodwill was as follows (in millions):
Balance at December 31, 2025 | $ | ||||
Foreign currency translation adjustments | ( | ||||
Balance at September 30, 2026 | $ | ||||
Other intangible assets
Other intangible assets consisted of the following (in millions):
| September 30, 2026 | December 31, 2025 | ||||||||||||||||||||||||||||||||||
| Gross carrying amounts | Accumulated amortization | Other intangible assets, net | Gross carrying amounts | Accumulated amortization | Other intangible assets, net | ||||||||||||||||||||||||||||||
| Finite-lived intangible assets: | |||||||||||||||||||||||||||||||||||
| Developed-product-technology rights | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
| Licensing rights | ( | ( | |||||||||||||||||||||||||||||||||
| Research and development technology rights | ( | ( | |||||||||||||||||||||||||||||||||
| Marketing-related rights | ( | ( | |||||||||||||||||||||||||||||||||
| Total finite-lived intangible assets | ( | ( | |||||||||||||||||||||||||||||||||
| Indefinite-lived intangible assets: | |||||||||||||||||||||||||||||||||||
| In-process research and development | — | — | |||||||||||||||||||||||||||||||||
| Total other intangible assets | $ | $ | ( | $ | $ | $ | ( | $ | |||||||||||||||||||||||||||
Developed-product-technology rights consists of rights related to marketed products acquired in business combinations. Licensing rights primarily consists of contractual rights to receive future milestone, royalty and profit-sharing payments; capitalized payments to third parties for milestones related to regulatory approvals to commercialize products; and upfront payments associated with royalty obligations for marketed products. R&D technology rights pertains to technologies used in R&D that have alternative future uses. Marketing-related rights primarily consists of rights related to the sale and distribution of marketed products.
IPR&D consists of R&D projects acquired in a business combination that are not complete at the time of acquisition due to remaining technological risks and/or lack of receipt of required regulatory approvals. We review IPR&D projects for impairment annually, whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable and upon the establishment of technological feasibility or regulatory approval.
16
TAVNEOS developed-product-technology rights
The developed-product-technology rights intangible asset related to TAVNEOS in the U.S. market has a carrying value of $2.2 billion as of September 30, 2026. The product, acquired by the Company in connection with our acquisition of ChemoCentryx in 2022, was approved by the FDA in 2021. On April 27, 2026, CDER issued a proposal to withdraw approval of TAVNEOS. The proposal follows the FDA’s March 2026 DSC in which it alerted patients and health care professionals about serious liver injury cases, including fatal cases, of DILI associated with TAVNEOS. The proposal alleges that there is new information indicating lack of substantial evidence of effectiveness for the drug and that ChemoCentryx’s application that resulted in FDA approval contained untrue statements of material facts. On April 30, 2026, the FDA posted a notice in the Federal Register that proposes to withdraw approval of TAVNEOS and announced an opportunity for ChemoCentryx to request a hearing on this proposal. On June 1, 2026, we requested a hearing on this proposal and subsequently submitted information supporting our request on July 23, 2026, including additional real-world evidence data and data from an independent, blinded re-adjudication of certain study data that supported the FDA’s approval of TAVNEOS. CDER has not yet responded to our July submission. We expect that once CDER responds, we would have an opportunity to make an additional submission. The FDA may issue a decision on the proposal without granting a hearing. Decisions on the proposal and whether to grant a hearing are appealable to the United States Court of Appeals. If ultimately withdrawal of the U.S. TAVNEOS marketing authorization is required, it would be subject to a date specified by the FDA Commissioner. The Company has engaged with regulatory authorities, continues to believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile, and intends to follow the appropriate process to support its position. As the FDA’s statement reporting its proposal indicates, TAVNEOS will remain on the market during the pendency of this process. Future changes to estimated TAVNEOS cash flows could unfavorably impact the Company’s ability to recover the carrying value of the related U.S. intangible asset.
Otezla developed-product-technology rights
In January 2025, as part of the IRA, the Company’s product Otezla was selected by CMS for Medicare price setting that will be applicable beginning on January 1, 2027. The earlier than anticipated selection resulted in a decrease in the estimated future cash flows for the product in the United States. This selection represented a triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment. In the first quarter of 2025, the Company utilized a discounted cash flow analysis based on Level 3 inputs, including estimated product sales, operating expenses and a discount rate, that resulted in an intangible asset fair value of $4.0 billion, which was lower than the carrying value of $4.8 billion, and a partial impairment of $800 million. In the third quarter of 2025, new facts and circumstances, primarily from the CMS price setting process, indicated a further triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment. A subsequent discounted cash flow analysis, prepared using the same Level 3 input framework and updated assumptions, resulted in a revised intangible asset fair value of $3.0 billion, which was lower than the carrying value of $3.4 billion, and an additional impairment of $400 million. The impairment charges of $400 million and $1.2 billion for the three and nine months ended September 30, 2025, respectively, were recorded in Other operating expenses in the Condensed Consolidated Statements of Income. See Note 11, Fair value measurement.
Amortization of finite-lived intangible assets
During the three months ended September 30, 2026 and 2025, we recognized amortization of our finite-lived intangible assets of $889 million and $1.1 billion, respectively. During the nine months ended September 30, 2026 and 2025, we recognized amortization of our finite-lived intangible assets of $2.7 billion and $3.4 billion, respectively. Amortization of intangible assets is primarily included in Cost of sales in the Condensed Consolidated Statements of Income. As of September 30, 2026, the total estimated future amortization of our finite-lived intangible assets for the remaining three months ending December 31, 2026, and the years ending December 31, 2027, 2028, 2029, 2030 and 2031, was $0.9 billion, $3.5 billion, $2.8 billion, $2.2 billion, $2.1 billion and $2.1 billion, respectively.
17
9. Financing arrangements
Our borrowings consisted of the following (in millions):
| September 30, 2026 | December 31, 2025 | ||||||||||
| $ | $ | ||||||||||
| Term loan due October 2026 | — | ||||||||||
18
| September 30, 2026 | December 31, 2025 | ||||||||||
| Other notes due 2097 | |||||||||||
Total principal amount of debt | |||||||||||
| Unamortized bond discounts, premiums and issuance costs, net | ( | ( | |||||||||
| Fair value adjustments | ( | ( | |||||||||
| Other | |||||||||||
| Total carrying value of debt | |||||||||||
| Less current portion | ( | ( | |||||||||
| Total long-term debt | $ | $ | |||||||||
There are no material differences between the effective interest rates and coupon rates of our notes, except for the 4.563 % 2048 Notes, the 4.663 % 2051 Notes and the 2.77 % 2053 Notes, which have effective interest rates of 6.3 %, 5.6 % and 5.2 %, respectively.
Debt issuances
During the nine months ended September 30, 2026, we issued $4.0 billion of debt consisting of $1.0 billion of the 4.20 % 2031 Notes, $1.75 billion of the 4.85 % 2036 Notes, $500 million of the 5.50 % 2046 Notes and $750 million of the 5.65 % 2056 Notes. There were no debt issuances during the three months ended September 30, 2026 or during the three and nine months ended September 30, 2025.
Debt repayments
During the three months ended September 30, 2026, we repaid $3.1 billion of debt, consisting of repayments in full of the $1.8 1.25 billion aggregate principal amount of the 2.60 % 2026 Notes, compared to $1.5 billion of debt repayments during the three months ended September 30, 2025.
During the nine months ended September 30, 2026, we repaid $3.9 billion of debt, consisting of repayments in full of the $1.8 1.25 billion aggregate principal amount of the 2.60 % 2026 Notes and the €750 million aggregate principal amount of the 2.00 % 2026 euro Notes ($833 million upon settlement of the related cross-currency swap), compared to $5.0 billion of debt repayments during the nine months ended September 30, 2025.
Debt extinguishment
During the three months ended September 30, 2026, we did not have any debt extinguishments. During the three months ended September 30, 2025, we repurchased an aggregate principal amount of our debt of $119 million, including portions of the 2.80 % 2041 Notes, 3.375 % 2050 Notes and 3.00 % 2052 Notes, for an aggregate cost of $81 million, which resulted in a $36 million gain on extinguishment of debt.
During the nine months ended September 30, 2026, we repurchased an aggregate principal amount of our debt of $324 million, including portions of the 2.80 % 2041 Notes, 3.375 % 2050 Notes and 3.00 % 2052 Notes, for an aggregate cost of $233 million, which resulted in a $90 million gain on extinguishment of debt. During the nine months ended September 30, 2025, we repurchased an aggregate principal amount of our debt of $1.0 billion, including portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes, for an aggregate cost of $683 million, which resulted in a $264 million gain on extinguishment of debt. Gains and losses on extinguishments of debt are recorded in Other income, net, in the Condensed Consolidated Statements of Income.
Interest rate swap contracts
See Note 12, Derivative instruments, for a discussion of interest rate swap contracts related to certain of our notes.
Shelf registration statement and other facilities
In the first quarter of 2026, we filed a shelf registration statement with the SEC that allows us to issue unspecified amounts of debt securities, common stock, preferred stock, warrants to purchase securities (including debt securities, common stock, preferred stock or depositary shares), rights to purchase common stock or preferred stock, securities purchase contracts, securities purchase units, and depositary shares. Under this shelf registration statement, all of the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance. This shelf registration statement expires in February 2029. Also in the first quarter of 2026, we extended the term of our $4.0 billion syndicated, unsecured,
19
revolving credit facility by one year to March 2029. As of September 30, 2026 and December 31, 2025, no
10. Stockholders’ equity
Stock repurchase program
During the nine months ended September 30, 2026 and 2025, we did not repurchase shares under our stock repurchase program. As of September 30, 2026, $6.8 billion of authorization remained available under the stock repurchase program.
Dividends
In December 2025, March 2026 and July 2026, our Board of Directors declared quarterly cash dividends of $2.52 2.52 per share, which will be paid in December 2026.
Accumulated other comprehensive income (loss)
The components of AOCI were as follows (in millions):
Foreign currency translation adjustments | Cash flow hedges | Other | AOCI | ||||||||||||||||||||||||||
Balance as of June 30, 2026 | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||
| Foreign currency translation adjustments | |||||||||||||||||||||||||||||
| Unrealized losses | ( | ( | |||||||||||||||||||||||||||
Reclassification adjustments into earnings | ( | ( | |||||||||||||||||||||||||||
| Other | ( | ( | |||||||||||||||||||||||||||
| Income taxes | |||||||||||||||||||||||||||||
Balance as of September 30, 2026 | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||
Foreign currency translation adjustments | Cash flow hedges | Other | AOCI | ||||||||||||||||||||||||||
| Balance as of December 31, 2025 | $ | ( | $ | ( | $ | $ | ( | ||||||||||||||||||||||
| Foreign currency translation adjustments | ( | ( | |||||||||||||||||||||||||||
| Unrealized gains | |||||||||||||||||||||||||||||
Reclassification adjustments into earnings | |||||||||||||||||||||||||||||
| Other | ( | ( | |||||||||||||||||||||||||||
| Income taxes | ( | ( | |||||||||||||||||||||||||||
Balance as of September 30, 2026 | $ | ( | $ | $ | $ | ( | |||||||||||||||||||||||
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Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):
| Three months ended September 30, | Condensed Consolidated Statements of Income locations | |||||||||||||||||||
| Components of AOCI | 2026 | 2025 | ||||||||||||||||||
| Cash flow hedges: | ||||||||||||||||||||
| Foreign currency forward contract gains (losses) | $ | $ | ( | Product sales | ||||||||||||||||
| Cross-currency swap contract gains (losses) | ( | Other income, net | ||||||||||||||||||
| ( | Income before income taxes | |||||||||||||||||||
| ( | Provision for income taxes | |||||||||||||||||||
| $ | $ | ( | Net income | |||||||||||||||||
| Nine months ended September 30, | Condensed Consolidated Statements of Income locations | |||||||||||||||||||
| Components of AOCI | 2026 | 2025 | ||||||||||||||||||
| Cash flow hedges: | ||||||||||||||||||||
| Foreign currency forward contract (losses) gains | $ | ( | $ | Product sales | ||||||||||||||||
| Cross-currency swap contract (losses) gains | ( | Other income, net | ||||||||||||||||||
| ( | Income before income taxes | |||||||||||||||||||
| ( | Provision for income taxes | |||||||||||||||||||
| $ | ( | $ | Net income | |||||||||||||||||
11. Fair value measurement
To estimate the fair values of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximize the use of observable inputs and minimize the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing an asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is divided into three levels based on the sources of inputs as follows:
| Level 1 | — | Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access | ||||||
| Level 2 | — | Valuations for which all significant inputs are observable either directly or indirectly—other than Level 1 inputs | ||||||
| Level 3 | — | Valuations based on inputs that are unobservable and significant to the overall fair value measurement | ||||||
The availability of observable inputs can vary among different types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, inputs used for measuring fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level of input used that is significant to the overall fair value measurement.
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The fair values of each major class of the Company’s financial assets and liabilities measured at fair value on a recurring basis were as follows (in millions):
| Quoted prices in active markets for identical assets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||||||||||||
| Fair value measurement as of September 30, 2026, using: | Total | |||||||||||||||||||||||||
| Assets: | ||||||||||||||||||||||||||
| Available-for-sale securities: | ||||||||||||||||||||||||||
| U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
| Money market mutual funds | ||||||||||||||||||||||||||
| Other short-term interest-bearing securities | ||||||||||||||||||||||||||
| Equity securities | ||||||||||||||||||||||||||
| Derivatives: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | ||||||||||||||||||||||||||
| Total assets | $ | $ | $ | $ | ||||||||||||||||||||||
| Liabilities: | ||||||||||||||||||||||||||
| Derivatives: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | $ | $ | $ | $ | ||||||||||||||||||||||
| Cross-currency swap contracts | ||||||||||||||||||||||||||
| Interest rate swap contracts | ||||||||||||||||||||||||||
Contingent consideration obligations | ||||||||||||||||||||||||||
| Total liabilities | $ | $ | $ | $ | ||||||||||||||||||||||
| Quoted prices in active markets for identical assets (Level 1) | Significant other observable inputs (Level 2) | Significant unobservable inputs (Level 3) | ||||||||||||||||||||||||
| Fair value measurement as of December 31, 2025, using: | Total | |||||||||||||||||||||||||
| Assets: | ||||||||||||||||||||||||||
| Available-for-sale securities: | ||||||||||||||||||||||||||
| U.S. Treasury bills | $ | $ | $ | $ | ||||||||||||||||||||||
| Money market mutual funds | ||||||||||||||||||||||||||
| Other short-term interest-bearing securities | ||||||||||||||||||||||||||
| Equity securities | ||||||||||||||||||||||||||
| Derivatives: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | ||||||||||||||||||||||||||
| Cross-currency swap contracts | ||||||||||||||||||||||||||
| Total assets | $ | $ | $ | $ | ||||||||||||||||||||||
| Liabilities: | ||||||||||||||||||||||||||
| Derivatives: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | $ | $ | $ | $ | ||||||||||||||||||||||
| Cross-currency swap contracts | ||||||||||||||||||||||||||
| Interest rate swap contracts | ||||||||||||||||||||||||||
Contingent consideration obligations | ||||||||||||||||||||||||||
| Total liabilities | $ | $ | $ | $ | ||||||||||||||||||||||
22
Interest-bearing and equity securities
The fair values of our U.S. Treasury bills are determined by utilizing third-party pricing services, which obtain pricing data from active market makers and brokers. The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investment in BeOne, as of September 30, 2026 and December 31, 2025, are based on quoted market prices in active markets, with no valuation adjustment.
Derivatives
All of our foreign currency forward contracts, cross-currency swap contracts and interest rate swap contracts are with counterparties that have minimum credit ratings of A– or equivalent by S&P, Moody’s or Fitch. We estimate the fair values of these contracts by taking into consideration valuations obtained from a third-party valuation service that uses an income-based industry-standard valuation model for which all significant inputs are observable either directly or indirectly. These inputs, as applicable, include foreign currency exchange rates, SOFR, swap rates, obligor credit default swap rates and cross-currency basis swap spreads. Certain inputs, when applicable, are at commonly quoted intervals. See Note 12, Derivative instruments.
Contingent consideration obligations
Our contingent consideration obligations are recorded at their fair values by using probability-adjusted discounted cash flows, and we revalue these obligations each reporting period until the related contingencies have been resolved. Significant unobservable inputs used in measuring these obligations relate to licensing rights and product candidates acquired through business development activity and include, as applicable, estimated probabilities and the timing of achieving specified development, regulatory and commercial milestones as well as estimated annual sales. Significant changes that increase or decrease the probabilities of achieving the related development, regulatory and commercial events or that shorten or lengthen the time required to achieve such events or that increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of the obligations, as applicable. Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Condensed Consolidated Statements of Income.
Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||
| Beginning balance | $ | $ | $ | $ | ||||||||||||||||||||||
| Additions | ||||||||||||||||||||||||||
| Payments | ( | ( | ( | ( | ||||||||||||||||||||||
| Net changes in valuations | ( | |||||||||||||||||||||||||
| Ending balance | $ | $ | $ | $ | ||||||||||||||||||||||
As of September 30, 2026 and December 31, 2025, the balances of our contingent consideration obligations were $367 million and $161 million, respectively, and primarily resulted from our acquisition of Teneobio, Inc. in October 2021 and other business development activity in 2025 and 2026.
Summary of the fair values of other financial instruments
Cash equivalents
The fair values of cash equivalents are approximated at their carrying values due to the short-term nature of such financial instruments.
Borrowings
We estimate the fair values of our fixed-rate debt by using Level 2 inputs. As of September 30, 2026 and December 31, 2025, the aggregate fair values of our fixed-rate debt were $49.0 billion and $51.0 billion, respectively, and the carrying values of our fixed-rate debt were $54.0 billion and $52.8 billion, respectively. The estimate of the fair value of our Term loan was approximated at its carrying value as of December 31, 2025, as this debt instrument, which was repaid in full in the third quarter of 2026, bore interest at a floating rate.
During the nine months ended September 30, 2026 and 2025, there were no transfers of assets or liabilities between fair value measurement levels. Except with respect to the partial impairments of the Otezla intangible asset in the first and third quarters of 2025 as discussed in Note 8, Goodwill and other intangible assets, there were no material remeasurements of the fair values of assets and liabilities that are not measured at fair value on a recurring basis.
23
12. Derivative instruments
The Company is exposed to foreign currency exchange rate and interest rate risks related to its business operations. To reduce our risks related to such exposures, we use or have used certain derivative instruments, including foreign currency forward, foreign currency option, cross-currency swap, forward interest rate and interest rate swap contracts. We have designated certain of our derivatives as cash flow and fair value hedges; we also have derivatives not designated as hedges. We do not use derivatives for speculative trading purposes.
Cash flow hedges
We are exposed to possible changes in the values of certain anticipated foreign currency cash flows resulting from changes in foreign currency exchange rates primarily associated with our euro-denominated international product sales. The foreign currency exchange rate fluctuation exposure associated with cash inflows from our international product sales is partially offset by corresponding cash outflows from our international operating expenses. To further reduce our exposure, we enter into foreign currency forward contracts to hedge a portion of our projected international product sales up to a maximum of three years into the future; and at any given point in time, a higher percentage of nearer-term projected product sales is being hedged than in successive periods.
As of September 30, 2026 and December 31, 2025, we had outstanding foreign currency forward contracts with aggregate notional amounts of $8.1 billion and $7.8 billion, respectively. We have designated these foreign currency forward contracts, which are primarily euro and Japanese yen based, as cash flow hedges. Accordingly, we record the unrealized gains and losses on these contracts in AOCI in the Condensed Consolidated Balance Sheets, and we reclassify them to Product sales in the Condensed Consolidated Statements of Income in the same periods during which the hedged transactions affect earnings.
To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term debt denominated in foreign currencies, we enter into cross-currency swap contracts. Under the terms of such contracts, we paid euros and pounds sterling and received U.S. dollars for the notional amounts at the inception of the contracts; and based on these notional amounts, we exchange interest payments at fixed rates over the terms of the contracts by paying U.S. dollars and receiving euros and pounds sterling. In addition, we will pay U.S. dollars to and receive euros and pounds sterling from the counterparties at the maturities of the contracts for these same notional amounts. The terms of these contracts correspond to the related hedged debt, thereby effectively converting the interest payments and principal repayment on the debt from euros and pounds sterling to U.S. dollars. We have designated these cross-currency swap contracts as cash flow hedges. Accordingly, the unrealized gains and losses on these contracts are recorded in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other income, net, in the Condensed Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.
The notional amounts and interest rates of our cross-currency swaps as of September 30, 2026, were as follows (notional amounts in millions):
| Foreign currency | U.S. dollars | |||||||||||||||||||||||||
| Hedged notes | Notional amounts | Interest rates | Notional amounts | Interest rates | ||||||||||||||||||||||
| £ | % | $ | % | |||||||||||||||||||||||
| £ | % | $ | % | |||||||||||||||||||||||
During the first quarter of 2026, our 2.00 % 2026 euro Notes matured and the related cross-currency swaps were settled.
In connection with the anticipated issuance of long-term fixed-rate debt, we occasionally enter into forward interest rate contracts in order to hedge the variability in cash flows due to changes in the applicable U.S. Treasury rate between the time we enter into these contracts and the time the related debt is issued. Gains and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI in the Condensed Consolidated Balance Sheets and are amortized into Interest expense, net, in the Condensed Consolidated Statements of Income over the terms of the associated debt issuances. Amounts recognized in connection with forward interest rate contracts during the nine months ended September 30, 2026 and 2025, and amounts expected to be recognized during the next 12 months were not material.
24
Unrealized gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||
| Derivatives in cash flow hedging relationships | 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||
| Foreign currency forward contracts | $ | ( | $ | $ | $ | ( | ||||||||||||||||||||
| Cross-currency swap contracts | ( | ( | ||||||||||||||||||||||||
| Forward interest rate contracts | ( | |||||||||||||||||||||||||
| Total unrealized (losses) gains | $ | ( | $ | $ | $ | ( | ||||||||||||||||||||
Fair value hedges
To achieve a desired mix of fixed-rate and floating-rate debt, we enter into interest rate swap contracts that qualify for and are designated as fair value hedges. These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate SOFR-based coupons over the terms of the related hedge contracts. As of September 30, 2026 and December 31, 2025, we had interest rate swap contracts with aggregate notional amounts of $7.4 billion and $6.7 billion, respectively, that hedge certain portions of our long-term debt. During the nine months ended September 30, 2026, we entered into $2.0 billion of interest rate swap contracts to hedge portions of our 4.85 % 2036 Notes and 5.60 % 2043 Notes. Also during the nine months ended September 30, 2026, $1.25 billion of our interest rate swaps were terminated in connection with the repayment of the 2.60 % 2026 Notes (see Note 9, Financing arrangements).
For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of Income the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk. If a hedging relationship involving an interest rate swap contract is terminated, the gain or loss realized on contract termination is recorded as an adjustment to the carrying value of the debt and amortized into Interest expense, net, over the remaining term of the previously hedged debt.
The hedged liabilities and related cumulative-basis adjustments for fair value hedges of those liabilities were recorded in the Condensed Consolidated Balance Sheets as follows (in millions):
Carrying amounts of hedged liabilities(1) | Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities(2) | |||||||||||||||||||||||||
| Condensed Consolidated Balance Sheets locations | September 30, 2026 | December 31, 2025 | September 30, 2026 | December 31, 2025 | ||||||||||||||||||||||
| Current portion of long-term debt | $ | $ | $ | $ | ||||||||||||||||||||||
| Long-term debt | $ | $ | $ | ( | $ | ( | ||||||||||||||||||||
____________
(1) Current portion of long-term debt includes $36 million and $47 million of carrying value with discontinued hedging relationships as of September 30, 2026 and December 31, 2025, respectively. Long-term debt includes $158 million and $185 million of carrying value with discontinued hedging relationships as of September 30, 2026 and December 31, 2025, respectively.
(2) Current portion of long-term debt includes $36 million and $47 million of hedging adjustments on discontinued hedging relationships as of September 30, 2026 and December 31, 2025, respectively. Long-term debt includes $58 million and $85 million of hedging adjustments on discontinued hedging relationships as of September 30, 2026 and December 31, 2025, respectively.
25
Impact of hedging transactions
The following tables summarize the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):
| Three months ended September 30, 2026 | Nine months ended September 30, 2026 | |||||||||||||||||||||||||||||||||||||
| Product sales | Other income, net | Interest expense, net | Product sales | Other income, net | Interest expense, net | |||||||||||||||||||||||||||||||||
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income | $ | $ | $ | ( | $ | $ | $ | ( | ||||||||||||||||||||||||||||||
| The effects of cash flow and fair value hedging: | ||||||||||||||||||||||||||||||||||||||
| Gains (losses) on cash flow hedging relationships reclassified out of AOCI: | ||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | $ | $ | — | $ | — | $ | ( | $ | — | $ | — | |||||||||||||||||||||||||||
| Cross-currency swap contracts | $ | — | $ | $ | — | $ | — | $ | ( | $ | — | |||||||||||||||||||||||||||
| Gains (losses) on fair value hedging relationships—interest rate swap agreements: | ||||||||||||||||||||||||||||||||||||||
Hedged items(1) | $ | — | $ | — | $ | $ | — | $ | — | $ | ||||||||||||||||||||||||||||
| Derivatives designated as hedging instruments | $ | — | $ | — | $ | ( | $ | — | $ | — | $ | ( | ||||||||||||||||||||||||||
| Three months ended September 30, 2025 | Nine months ended September 30, 2025 | |||||||||||||||||||||||||||||||||||||
| Product sales | Other income, net | Interest expense, net | Product sales | Other income, net | Interest expense, net | |||||||||||||||||||||||||||||||||
Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income | $ | $ | $ | ( | $ | $ | $ | ( | ||||||||||||||||||||||||||||||
| The effects of cash flow and fair value hedging: | ||||||||||||||||||||||||||||||||||||||
| (Losses) gains on cash flow hedging relationships reclassified out of AOCI: | ||||||||||||||||||||||||||||||||||||||
| Foreign currency forward contracts | $ | ( | $ | — | $ | — | $ | $ | — | $ | — | |||||||||||||||||||||||||||
| Cross-currency swap contracts | $ | — | $ | ( | $ | — | $ | — | $ | $ | — | |||||||||||||||||||||||||||
| (Losses) gains on fair value hedging relationships—interest rate swap agreements: | ||||||||||||||||||||||||||||||||||||||
Hedged items(1) | $ | — | $ | — | $ | ( | $ | — | $ | — | $ | ( | ||||||||||||||||||||||||||
| Derivatives designated as hedging instruments | $ | — | $ | — | $ | $ | — | $ | — | $ | ||||||||||||||||||||||||||||
__________
(1) Gains (losses) on hedged items do not exactly offset losses (gains) on the related designated hedging instruments due to amortization of the cumulative amounts of fair value hedging adjustments included in the carrying amount of the hedged debt for discontinued hedging relationships and the recognition of gains on terminated hedges when the corresponding hedged item was paid down in the period.
No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness. As of September 30, 2026, the amount of net loss on our foreign currency forward and cross-currency swap contracts expected to be reclassified out of AOCI and recognized into earnings during the next 12 months was not material.
Derivatives not designated as hedges
To reduce our exposure to foreign currency fluctuations in certain assets and liabilities denominated in foreign currencies, we enter into foreign currency forward contracts that are not designated as hedging transactions. Most of these exposures are hedged on a month-to-month basis. As of September 30, 2026 and December 31, 2025, the total notional amounts of these foreign currency forward contracts were $546 million and $240 million, respectively. Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three and nine months ended September 30, 2026 and 2025.
26
Fair values of derivatives
The fair values of derivatives included in the Condensed Consolidated Balance Sheets were as follows (in millions):
| Derivative assets | Derivative liabilities | |||||||||||||||||||||||||
| September 30, 2026 | Condensed Consolidated Balance Sheets locations | Fair values | Condensed Consolidated Balance Sheets locations | Fair values | ||||||||||||||||||||||
Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | Other current assets/ Other noncurrent assets | $ | Accrued liabilities/ Other noncurrent liabilities | $ | ||||||||||||||||||||||
| Cross-currency swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
| Interest rate swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Total derivatives designated as hedging instruments | ||||||||||||||||||||||||||
Derivatives not designated as hedging instruments: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | Other current assets | Accrued liabilities | ||||||||||||||||||||||||
Total derivatives not designated as hedging instruments | ||||||||||||||||||||||||||
| Total derivatives | $ | $ | ||||||||||||||||||||||||
| Derivative assets | Derivative liabilities | |||||||||||||||||||||||||
| December 31, 2025 | Condensed Consolidated Balance Sheets locations | Fair values | Condensed Consolidated Balance Sheets locations | Fair values | ||||||||||||||||||||||
Derivatives designated as hedging instruments: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | Other current assets/ Other noncurrent assets | $ | Accrued liabilities/ Other noncurrent liabilities | $ | ||||||||||||||||||||||
| Cross-currency swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
| Interest rate swap contracts | Other current assets/ Other noncurrent assets | Accrued liabilities/ Other noncurrent liabilities | ||||||||||||||||||||||||
Total derivatives designated as hedging instruments | ||||||||||||||||||||||||||
Derivatives not designated as hedging instruments: | ||||||||||||||||||||||||||
| Foreign currency forward contracts | Other current assets | Accrued liabilities | ||||||||||||||||||||||||
Total derivatives not designated as hedging instruments | ||||||||||||||||||||||||||
| Total derivatives | $ | $ | ||||||||||||||||||||||||
For additional information, see Note 11, Fair value measurement.
Our derivative contracts that were in liability positions as of September 30, 2026, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change in control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change in control. If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions. In such circumstances, the counterparties could request immediate settlement of these contracts for amounts that approximate the then current fair values of the contracts. In addition, our derivative contracts are not subject to any type of master netting arrangement, and amounts due either to or from a counterparty under the contracts may be offset against other amounts due either to or from the same counterparty only if an event of default or termination, as defined, were to occur.
27
The cash flow effects of our derivative contracts in the Condensed Consolidated Statements of Cash Flows are primarily included in Net cash provided by operating activities, except for certain circumstances, including the settlement of notional amounts of cross-currency swaps, which are included in Net cash used in financing activities.
13. Contingencies and commitments
Contingencies
In the ordinary course of business, we are involved in various legal proceedings, government investigations and other matters that are complex in nature and have outcomes that are difficult to predict. See our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1A. Risk Factors—Our business may be affected by litigation and government investigations. We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025; and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026.
We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. We evaluate, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of the liability that has been accrued previously.
Our legal proceedings involve various aspects of our business and a variety of claims, some of which present novel factual allegations and/or unique legal theories. The outcomes of these proceedings are inherently uncertain and depend on a variety of factors, including the development of the factual record, judicial or administrative rulings, and, in certain cases, the outcome of appellate review. Further, certain of the matters pending against us are at earlier stages of the legal process, which in complex proceedings of the sort we face often extend for several years, and have not progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate. Accordingly, except for amounts accrued, in each of the matters described in this filing in which we could incur a liability, our opponents seek an award of a not-yet-estimable amount of damages or an amount that is not material. While it is not possible to accurately predict or determine the eventual outcomes of these matters, an adverse determination in one or more of these matters currently pending could have a material adverse effect on our consolidated results of operations, financial position or cash flows.
Certain recent developments concerning our legal proceedings and other matters are discussed below.
Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation
Amgen Inc. et al. v. Amneal Pharmaceuticals, Inc. et al.; Amgen Inc. et al. v. Dr. Reddy’s Laboratories Ltd., et al.; and Amgen Inc. et al. v. Alkem Laboratories Ltd., et al.
A claim construction hearing will be scheduled after November 19, 2027, and the joint pretrial order is due September 15, 2028. A trial date has not yet been set.
On October 2, 2026 and October 5, 2026, Amgen Inc. and Amgen Manufacturing Limited LLC filed Supplemental Complaints asserting infringement of U.S. Patent No. 12,679,865 in addition to the other asserted patents in the actions filed against Dr. Reddy’s Laboratories Ltd., et al. and Alkem Laboratories Ltd., et al., respectively. On October 23, 2026, the defendants in Dr. Reddy’s Laboratories Ltd., et al. responded to the Supplemental Complaint asserting counterclaims for declaratory judgment of non-infringement and invalidity and affirmative defenses. On October 26, 2026, the defendants in Alkem Laboratories Ltd., et al. responded to the Supplemental Complaint asserting affirmative defenses and counterclaims.
PAVBLU® (aflibercept-ayyh) Patent Litigation
United States
Regeneron Pharmaceuticals, Inc. v. Amgen Inc. (action filed January 10, 2024) (the 2024 Action)
On August 6, 2026, Regeneron Pharmaceuticals, Inc. (Regeneron) filed a motion to strike certain of Amgen’s counterclaims pled in response to Regeneron’s complaint, including the counterclaims for Sherman Act monopolization and attempted monopolization.
On August 11, 2026, the U.S. District Court for the Northern District of West Virginia (the West Virginia District Court) denied Amgen’s motion for a suggestion of remand to the U.S. District Court for the Central District of California (the California Central District Court) for the 2024 Action.
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On August 20, 2026, Amgen filed its opposition brief and a conditional motion for leave to amend the pleadings. On August 27, 2026, Regeneron filed its reply brief and opposition brief to Amgen’s conditional motion. Amgen filed its reply brief in support of its conditional motion for leave to amend the pleadings on September 3, 2026.
On October 27, 2026, the West Virginia District Court entered a stipulation and order dismissing with prejudice Regeneron’s claims concerning U.S. Patent Nos. 9,816,110 and 11,788,102, and dismissing without prejudice Amgen’s counterclaims and affirmative defenses concerning those same patents.
The West Virginia District Court rescheduled the claim construction hearing from November 23, 2026 to December 1, 2026.
Regeneron Pharmaceuticals, Inc. v. Amgen Inc. (action filed June 17, 2025) (the 2025 Action)
On August 11, 2026, the West Virginia District Court also denied Amgen’s motion for a suggestion of remand to the California Central District Court for the 2025 Action.
On August 18, 2026, Amgen filed a motion for reconsideration of the West Virginia District Court’s July 7, 2026 Opinion and Order granting in part Regeneron’s motion to strike certain affirmative defenses and dismiss certain counterclaims related to U.S. Patent No. 12,331,099 and, in the alternative, a motion for leave to file a First Amended Answer to Complaint and Counterclaims. Regeneron filed its opposition brief on September 1, 2026, and Amgen filed its reply brief on September 8, 2026.
The West Virginia District Court rescheduled the claim construction hearing from November 23, 2026 to December 1, 2026.
KYPROLIS® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation
Onyx Therapeutics, Inc. v. Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited.
On October 6, 2026, the U.S. District Court for the District of Delaware (the Delaware District Court) entered a claim construction order adopting Onyx’s proposed construction of the lone patent claim term in dispute. The trial is scheduled to begin on July 28, 2027.
TAVNEOS® (avacopan) Abbreviated New Drug Application (ANDA) Patent Litigation
ChemoCentryx, Inc. v. Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited; ChemoCentryx, Inc. v. Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited
On July 29, 2026, pursuant to a joint stipulation, the U.S. District Court for the District of New Jersey ordered a stay of the consolidated action in its entirety pending the FDA Commissioner’s decision on whether to withdraw approval of TAVNEOS. On August 4, 2026, pursuant to its stay order, the court administratively terminated the consolidated action without prejudice.
ABP 206 (nivolumab) Patent Litigation
Bristol-Myers Squibb Company (“BMS”), E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd., v. Amgen Inc.
On September 8, 2026, Bristol-Myers Squibb Company (BMS), E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd., filed a lawsuit in the Delaware District Court alleging Amgen’s infringement of seven patents by Amgen’s submission of an application under the BPCIA for FDA licensure of ABP 206 as a biosimilar to BMS’s OPDIVO® (nivolumab) and also seeking declaratory judgment of infringement of the same seven patents. Amgen’s response to BMS’s complaint is due on November 13, 2026.
Antitrust Class Actions
Ventura County, California Antitrust Actions
On August 17, 2026, the California Superior Court for the County of Ventura granted Amgen’s demurrers to the complaints filed by Centene Corporation, Humana, Inc., and Molina Healthcare, Inc., with leave to amend the complaints, finding that based on the allegations Immunex and Roche did not “perdure” as separate entities following the exclusive license as required under California’s Cartwright Act. The court did not reach the other arguments Amgen raised in its demurrers. The plaintiffs have sought dismissal of these matters with prejudice; following dismissal by the court, the plaintiffs can appeal the court’s demurrer ruling.
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U.S. Tax Litigation and Related Matters
Securities Class Action Litigation (Roofers Local No. 149 Pension Fund)
Following the parties’ agreement to settle this matter, on October 21, 2026 the U.S. District Court for the Southern District of New York granted preliminary approval of the class action settlement. A hearing to consider final approval of the settlement is scheduled for March 2, 2027.
ChemoCentryx, Inc. Securities Matters
No objections to the settlement were submitted by the September 21, 2026 deadline established by the U.S. District Court for the Northern District of California in its preliminary approval order. On October 29, 2026, the court entered final judgment that approved the settlement and dismissed the action and all claims against the defendants with prejudice.
Opt-Out Cases
On September 14, 2026, defendants ChemoCentryx and its former Chief Executive Officer, Dr. Thomas Schall, entered into a settlement agreement with RA Capital Healthcare Fund, LP (RA Capital) to settle both cases. On October 19, 2026, RA Capital dismissed both the state and federal case pursuant to the terms of the settlement agreement.
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| Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | ||||
The following MD&A is intended to assist the reader in understanding Amgen’s business. MD&A is provided as a supplement to, and should be read in conjunction with, the consolidated financial statements and accompanying notes of our Annual Report on Form 10-K for the year ended December 31, 2025, and the condensed consolidated financial statements and accompanying notes of this Quarterly Report on Form 10-Q and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026. Our results of operations discussed in MD&A are presented in conformity with GAAP. Amgen operates in one operating segment: human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
Forward-looking statements
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases, written statements or our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Such words as “expect,” “anticipate,” “outlook,” “could,” “target,” “project,” “intend,” “plan,” “believe,” “seek,” “estimate,” “should,” “may,” “assume” and “continue” as well as variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance, and they involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in Item 1A. Risk Factors in Part II herein and in Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2025, and in Part II, Item 1A. Risk Factors of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026. We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources, trends, planned dividends, stock repurchases, and collaborations. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.
Overview
Amgen Inc. (including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. We focus on areas of high unmet medical need and leverage our expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease. We helped launch the biotechnology industry more than 45 years ago and have grown to be one of the world’s leading independent biotechnology companies. Our robust pipeline includes potential first-in-class medicines at all stages of development.
Our principal products are Repatha, Prolia, EVENITY, TEPEZZA, ENBREL, Otezla, BLINCYTO, TEZSPIRE, Nplate, KRYSTEXXA, XGEVA, UPLIZNA, Aranesp, KYPROLIS, Vectibix and IMDELLTRA/IMDYLLTRA. We also market a number of other products, including but not limited to PAVBLU, Neulasta, AMJEVITA/AMGEVITA, MVASI, TAVNEOS, LUMAKRAS/LUMYKRAS, Parsabiv, Aimovig, PROCYSBI and WEZLANA/WEZENLA.
Macroeconomic and other challenges
Uncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates and financial system instability, together with rising healthcare costs, evolving tariffs and trade protection measures, and geopolitical conflict continue to pose challenges to our business. The geopolitical conflict has increased volatility in the energy and transportation markets and disrupted global supply chains. Additionally, with public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, resulting in net price declines.
Moreover, provisions of the IRA, as well as the expanded utilization of the 340B Program from broadened application of 340B discounts, have negatively affected, and are likely to continue to negatively affect, our business. For example, CMS has selected ENBREL and Otezla for Medicare price setting beginning in 2026 and 2027, respectively. In addition to the IRA, other recent and proposed U.S. policy actions focus on drug pricing, including the Most-Favored-Nation Prescription Drug Pricing Executive Order (MFN EO) and the July MFN Letter that was delivered to a number of pharmaceutical companies, including Amgen. In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN
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Letter, including the Administration’s MFN pricing requests. We also announced the expansion of our direct-to-patient program. As part of the Administration’s MFN pricing initiative, CMS also announced the GENEROUS Model, under which we and other participating manufacturers will provide additional supplemental rebates for certain drugs to participating state Medicaid programs designed to align Medicaid net prices with prices paid in select other countries for drugs covered under the model. In September 2026, CMS announced that all 50 states, the District of Columbia and the U.S. territory of Puerto Rico had applied to participate in the GENEROUS Model. While these developments reflect ongoing engagement on pricing policy, the ultimate effects on our pricing, reimbursement, net sales and profitability remain uncertain in light of such evolving regulatory and policy expectations. See Part II, Item 1A. Risk Factors—Changing U.S. federal coverage and reimbursement policies and practices have affected, and are likely to continue to affect, access to, pricing of, and sales of our products, of this Quarterly Report on Form 10-Q for further discussion.
Numerous tariffs and trade protection measures have been proposed, and in a number of cases, implemented by the United States and other countries. Further, there have been previous proposals for sector-specific tariffs on our industry. In April 2026, the Administration issued a proclamation imposing Section 232 tariffs on certain patented pharmaceuticals and associated active pharmaceutical ingredients. However, in December 2025, in recognition of our capital investments in U.S. manufacturing, we received relief from Section 232 tariffs for approximately the next three years from that date. Given the many uncertainties and variables, tariffs and trade protection measures may adversely affect our business and results of operations.
Finally, wholesale and end-user buying patterns can affect our product sales. These buying patterns can cause fluctuations in quarterly product sales, but have generally not been significant to date when comparing full-year product performance to the prior year. For additional discussion of these and other risks, see Part II, Item 1A. Risk Factors, of this Quarterly Report on Form 10-Q.
Significant developments
The following is a summary of select significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026.
Products/pipeline
TEZSPIRE
In August 2026, we and our collaboration partner AstraZeneca announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. Additionally, detailed results were presented in October 2026 at international medical congresses.
Repatha
In August 2026, the European Commission approved an expanded indication for the use of Repatha in adults with established or at high risk for atherosclerotic cardiovascular disease (ASCVD) to reduce cardiovascular (CV) risk by lowering low-density lipoprotein cholesterol (LDL-C) levels, as an adjunct to correction of other risk factors, based on results from the Phase 3 VESALIUS-CV trial.
IMDELLTRA/IMDYLLTRA
In September 2026, we announced results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA/IMDYLLTRA in combination with AstraZeneca’s IMFINZI® (durvalumab) compared to IMFINZI alone. This study tested IMDELLTRA/IMDYLLTRA as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment with IMFINZI, platinum-based chemotherapy and etoposide. The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA/IMDYLLTRA in combination with IMFINZI. Overall, the safety profile of IMDELLTRA/IMDYLLTRA in combination with IMFINZI was consistent with the known safety profiles of the individual medicines. No new or unexpected safety signals were identified in DeLLphi-305. Additionally, detailed results were presented in October 2026 at an international medical congress.
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Dazodalibep
In September 2026, we announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at week 48, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Improvements in ESSDAI were observed as early as week 4 with treatment with dazodalibep, which were sustained through week 48 of the study. The most common adverse events (>/= 5% incidence, reported at a higher rate in dazodalibep compared with placebo) were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, and were generally mild to moderate in nature. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups. No imbalance in the incidence of thromboembolic events or opportunistic infections was observed across treatment arms. Additionally, in October 2026 we released further detail of these results.
ABP 206
In September 2026, we announced submission of our Biologics License Application and its acceptance for review by the FDA for ABP 206, our biosimilar candidate to OPDIVO® (nivolumab).
ABP 234
In September 2026, we announced completion of the primary analysis of a pharmacokinetic/comparative clinical study of ABP 234, our biosimilar candidate to KEYTRUDA® (pembrolizumab), which met both primary and secondary endpoints.
Selected financial information
The following is an overview of our results of operations (in millions, except percentages and per-share data):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Product sales | |||||||||||||||||||||||||||||||||||
| U.S. | $ | 7,259 | $ | 6,751 | 8 | % | $ | 20,022 | $ | 18,737 | 7 | % | |||||||||||||||||||||||
| ROW | 2,624 | 2,386 | 10 | % | 7,616 | 7,044 | 8 | % | |||||||||||||||||||||||||||
| Total product sales | 9,883 | 9,137 | 8 | % | 27,638 | 25,781 | 7 | % | |||||||||||||||||||||||||||
| Other revenues | 482 | 420 | 15 | % | 1,399 | 1,104 | 27 | % | |||||||||||||||||||||||||||
| Total revenues | $ | 10,365 | $ | 9,557 | 8 | % | $ | 29,037 | $ | 26,885 | 8 | % | |||||||||||||||||||||||
| Operating expenses | $ | 6,655 | $ | 7,031 | (5) | % | $ | 19,147 | $ | 20,525 | (7) | % | |||||||||||||||||||||||
| Operating income | $ | 3,710 | $ | 2,526 | 47 | % | $ | 9,890 | $ | 6,360 | 56 | % | |||||||||||||||||||||||
| Net income | $ | 3,864 | $ | 3,216 | 20 | % | $ | 8,058 | $ | 6,378 | 26 | % | |||||||||||||||||||||||
| Diluted EPS | $ | 7.08 | $ | 5.93 | 19 | % | $ | 14.79 | $ | 11.77 | 26 | % | |||||||||||||||||||||||
| Diluted shares | 546 | 542 | 1 | % | 545 | 542 | 1 | % | |||||||||||||||||||||||||||
In the following discussion of changes in product sales, any reference to volume growth or decline refers to changes in purchases of our products by healthcare providers (such as physicians or their clinics), dialysis centers, hospitals and pharmacies. In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and, in certain circumstances, end users (such as pharmacies) as may be noted.
Total product sales increased 8% for the three months ended September 30, 2026, driven by volume growth. Total product sales increased 7% for the nine months ended September 30, 2026, driven by volume growth of 10%, partially offset by lower net selling price.
For the three months ended September 30, 2026, U.S. volume grew 8% and ROW volume grew 16%, driven by certain brands, including Repatha, UPLIZNA, EVENITY, IMDELLTRA/IMDYLLTRA, TEZSPIRE and PAVBLU.
For the nine months ended September 30, 2026, U.S. volume grew 8% and ROW volume grew 12%, driven by certain brands, including Repatha, UPLIZNA, EVENITY, IMDELLTRA/IMDYLLTRA, PAVBLU and TEZSPIRE.
Other revenues increased 15% and 27% for the three and nine months ended September 30, 2026, respectively, driven by higher royalty income and corporate partner revenue.
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Operating expenses decreased 5% and 7% for the three and nine months ended September 30, 2026, respectively, reflecting lower amortization expense from acquisition-related assets and the impact of the Otezla intangible asset impairment charges recorded in 2025, partially offset by higher spend in Research and Early Pipeline, higher profit share expense and changes in our sales mix. See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements, for additional information related to the Otezla intangible asset impairment charges recorded in 2025.
For the remainder of 2026, we expect volume growth from certain brands to be partially offset by net selling price declines.
Uncertain macroeconomic conditions, including geopolitical conflict and rising geopolitical tensions, changes in the healthcare ecosystem, and potential government policy actions, including MFN pricing or similar drug pricing reforms and tariffs or trade protection measures, have the potential to introduce variability into product sales. Furthermore, product sales continue to be impacted by actions from governments and other entities to address macroeconomic challenges; provisions of the IRA; expanded utilization of the 340B Program from broadened application of 340B discounts; reductions in federal Medicaid spending; and an increase in the number of people without health insurance. See Part I, Item 1. Business—Reimbursement, and Part I, Item 1A. Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2025; and Part II, Item 1A. Risk Factors, of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
Results of operations
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Repatha | $ | 1,085 | $ | 794 | 37 | % | $ | 2,914 | $ | 2,146 | 36 | % | |||||||||||||||||||||||
| Prolia | 632 | 1,139 | (45) | % | 2,118 | 3,360 | (37) | % | |||||||||||||||||||||||||||
| EVENITY | 751 | 541 | 39 | % | 2,027 | 1,501 | 35 | % | |||||||||||||||||||||||||||
| TEPEZZA | 526 | 560 | (6) | % | 1,592 | 1,446 | 10 | % | |||||||||||||||||||||||||||
| ENBREL | 611 | 580 | 5 | % | 1,511 | 1,694 | (11) | % | |||||||||||||||||||||||||||
| Otezla | 481 | 585 | (18) | % | 1,403 | 1,640 | (14) | % | |||||||||||||||||||||||||||
| BLINCYTO | 496 | 392 | 27 | % | 1,383 | 1,146 | 21 | % | |||||||||||||||||||||||||||
TEZSPIRE(1) | 538 | 377 | 43 | % | 1,367 | 1,004 | 36 | % | |||||||||||||||||||||||||||
| Nplate | 472 | 457 | 3 | % | 1,314 | 1,139 | 15 | % | |||||||||||||||||||||||||||
| KRYSTEXXA | 419 | 320 | 31 | % | 1,074 | 905 | 19 | % | |||||||||||||||||||||||||||
| XGEVA | 288 | 539 | (47) | % | 1,051 | 1,637 | (36) | % | |||||||||||||||||||||||||||
| UPLIZNA | 451 | 155 | * | 1,048 | 422 | * | |||||||||||||||||||||||||||||
| Aranesp | 329 | 357 | (8) | % | 992 | 1,056 | (6) | % | |||||||||||||||||||||||||||
| KYPROLIS | 330 | 359 | (8) | % | 974 | 1,061 | (8) | % | |||||||||||||||||||||||||||
| Vectibix | 335 | 284 | 18 | % | 960 | 856 | 12 | % | |||||||||||||||||||||||||||
| IMDELLTRA/IMDYLLTRA | 406 | 178 | * | 952 | 393 | * | |||||||||||||||||||||||||||||
Other products(2) | 1,733 | 1,520 | 14 | % | 4,958 | 4,375 | 13 | % | |||||||||||||||||||||||||||
| Total product sales | $ | 9,883 | $ | 9,137 | 8 | % | $ | 27,638 | $ | 25,781 | 7 | % | |||||||||||||||||||||||
* Change in excess of 100%
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(1) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.
(2) Consists of product sales of our non-principal products.
Future sales of our products will depend in part on the factors discussed below and in the following sections of this report: (i) Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Selected financial information; and (ii) Part II, Item 1A. Risk Factors, and in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2025: (i) Part I, Item 1. Business—Marketing, Distribution and Selected Marketed
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Products; (ii) Part I, Item 1. Business—Reimbursement; (iii) Part I, Item 1A. Risk Factors; and (iv) Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Results of operations—Product sales, as well as in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026: (i) Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of operations—Product sales; and (ii) Part II, Item 1A. Risk Factors.
Repatha
Total Repatha sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Repatha — U.S. | $ | 666 | $ | 442 | 51 | % | $ | 1,641 | $ | 1,146 | 43 | % | |||||||||||||||||||||||
| Repatha — ROW | 419 | 352 | 19 | % | 1,273 | 1,000 | 27 | % | |||||||||||||||||||||||||||
| Total Repatha | $ | 1,085 | $ | 794 | 37 | % | $ | 2,914 | $ | 2,146 | 36 | % | |||||||||||||||||||||||
The increases in global Repatha sales for the three and nine months ended September 30, 2026 were primarily driven by volume growth.
For a discussion of litigation, including associated settlements, related to Repatha, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Prolia
Total Prolia sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Prolia — U.S. | $ | 409 | $ | 806 | (49) | % | $ | 1,348 | $ | 2,271 | (41) | % | |||||||||||||||||||||||
| Prolia — ROW | 223 | 333 | (33) | % | 770 | 1,089 | (29) | % | |||||||||||||||||||||||||||
| Total Prolia | $ | 632 | $ | 1,139 | (45) | % | $ | 2,118 | $ | 3,360 | (37) | % | |||||||||||||||||||||||
Global Prolia sales for the three and nine months ended September 30, 2026 decreased 45% and 37%, respectively, as multiple biosimilars have launched in the United States and ROW.
The decrease in global Prolia sales for the three months ended September 30, 2026 was driven by lower volume of 23%, with the remainder driven equally by lower net selling price and changes to estimated sales deductions.
The decrease in global Prolia sales for the nine months ended September 30, 2026 was primarily driven by lower volume of 20% and lower net selling price of 13%.
For the remainder of 2026, we expect continued sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.
As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.
For a discussion of litigation, including associated settlements, related to Prolia, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
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EVENITY
Total EVENITY sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| EVENITY — U.S. | $ | 557 | $ | 417 | 34 | % | $ | 1,538 | $ | 1,132 | 36 | % | |||||||||||||||||||||||
| EVENITY — ROW | 194 | 124 | 56 | % | 489 | 369 | 33 | % | |||||||||||||||||||||||||||
| Total EVENITY | $ | 751 | $ | 541 | 39 | % | $ | 2,027 | $ | 1,501 | 35 | % | |||||||||||||||||||||||
The increases in global EVENITY sales for the three and nine months ended September 30, 2026 were driven by volume growth.
TEPEZZA
Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| TEPEZZA — U.S. | $ | 441 | $ | 518 | (15) | % | $ | 1,385 | $ | 1,349 | 3 | % | |||||||||||||||||||||||
| TEPEZZA — ROW | 85 | 42 | * | 207 | 97 | * | |||||||||||||||||||||||||||||
| Total TEPEZZA | $ | 526 | $ | 560 | (6) | % | $ | 1,592 | $ | 1,446 | 10 | % | |||||||||||||||||||||||
* Change in excess of 100%
The decrease in global TEPEZZA sales for the three months ended September 30, 2026 was driven by lower inventory.
The increase in global TEPEZZA sales for the nine months ended September 30, 2026 was primarily driven by higher net selling price of 6% and higher inventory.
ENBREL
Total ENBREL sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| ENBREL — U.S. | $ | 605 | $ | 574 | 5 | % | $ | 1,493 | $ | 1,675 | (11) | % | |||||||||||||||||||||||
| ENBREL — Canada | 6 | 6 | — | % | 18 | 19 | (5) | % | |||||||||||||||||||||||||||
| Total ENBREL | $ | 611 | $ | 580 | 5 | % | $ | 1,511 | $ | 1,694 | (11) | % | |||||||||||||||||||||||
The increase in ENBREL sales for the three months ended September 30, 2026 was driven by favorable changes to estimated sales deductions of 15% and higher inventory of 8%, partially offset by lower net selling price of 14% reflecting the ongoing impact of U.S. Medicare Part D price setting effective in 2026 under the IRA, and lower volume.
The decrease in ENBREL sales for the nine months ended September 30, 2026 was driven by lower net selling price of 19% reflecting the ongoing impact of U.S. Medicare Part D price setting effective in 2026 under the IRA, as well as an increase in 340B Program mix, partially offset by favorable changes to estimated sales deductions.
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Otezla
Total Otezla sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Otezla — U.S. | $ | 428 | $ | 473 | (10) | % | $ | 1,211 | $ | 1,328 | (9) | % | |||||||||||||||||||||||
| Otezla — ROW | 53 | 112 | (53) | % | 192 | 312 | (38) | % | |||||||||||||||||||||||||||
| Total Otezla | $ | 481 | $ | 585 | (18) | % | $ | 1,403 | $ | 1,640 | (14) | % | |||||||||||||||||||||||
The decrease in global Otezla sales for the three months ended September 30, 2026 was driven by lower volume of 13%, unfavorable changes to estimated sales deductions of 9% and lower net selling price of 4%, partially offset by higher inventory.
The decrease in global Otezla sales for the nine months ended September 30, 2026 was driven by lower net selling price of 10% and lower volume of 8%.
Otezla ROW sales were unfavorably impacted for the three and nine months ended September 30, 2026 by generic competition following loss of exclusivity in certain European countries during the first quarter of 2026.
In January 2025, Otezla was selected by CMS for Medicare price setting that will be applicable beginning in 2027. As a result, we expect further declines in net selling price driven by Medicare price setting beginning in 2027. See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements, for additional information related to the Otezla intangible asset impairment charges recorded in 2025.
BLINCYTO
Total BLINCYTO sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| BLINCYTO — U.S. | $ | 269 | $ | 236 | 14 | % | $ | 775 | $ | 779 | (1) | % | |||||||||||||||||||||||
| BLINCYTO — ROW | 227 | 156 | 46 | % | 608 | 367 | 66 | % | |||||||||||||||||||||||||||
| Total BLINCYTO | $ | 496 | $ | 392 | 27 | % | $ | 1,383 | $ | 1,146 | 21 | % | |||||||||||||||||||||||
The increases in global BLINCYTO sales for the three and nine months ended September 30, 2026 were primarily driven by volume growth.
TEZSPIRE
Total TEZSPIRE sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
TEZSPIRE — U.S. | $ | 538 | $ | 377 | 43 | % | $ | 1,367 | $ | 1,004 | 36 | % | |||||||||||||||||||||||
The increases in TEZSPIRE sales for the three and nine months ended September 30, 2026 were driven by volume growth.
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Nplate
Total Nplate sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Nplate — U.S. | $ | 347 | $ | 333 | 4 | % | $ | 905 | $ | 762 | 19 | % | |||||||||||||||||||||||
| Nplate — ROW | 125 | 124 | 1 | % | 409 | 377 | 8 | % | |||||||||||||||||||||||||||
| Total Nplate | $ | 472 | $ | 457 | 3 | % | $ | 1,314 | $ | 1,139 | 15 | % | |||||||||||||||||||||||
Global Nplate sales for the three months ended September 30, 2026 increased 3% and included U.S. government orders of $65 million and $90 million for the three months ended September 30, 2026 and 2025, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 11% for the three months ended September 30, 2026, primarily driven by volume growth.
Global Nplate sales for the nine months ended September 30, 2026 increased 15% and included U.S. government orders of $125 million and $90 million for the nine months ended September 30, 2026 and 2025, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 13% for the nine months ended September 30, 2026, driven by volume growth of 11% and higher net selling price.
KRYSTEXXA
Total KRYSTEXXA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
KRYSTEXXA — U.S. | $ | 419 | $ | 320 | 31 | % | $ | 1,073 | $ | 905 | 19 | % | |||||||||||||||||||||||
KRYSTEXXA — ROW | — | — | N/A | 1 | — | N/A | |||||||||||||||||||||||||||||
Total KRYSTEXXA | $ | 419 | $ | 320 | 31 | % | $ | 1,074 | $ | 905 | 19 | % | |||||||||||||||||||||||
N/A = not applicable
The increases in KRYSTEXXA sales for the three and nine months ended September 30, 2026 were primarily driven by higher net selling price.
XGEVA
Total XGEVA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| XGEVA — U.S. | $ | 170 | $ | 357 | (52) | % | $ | 585 | $ | 1,064 | (45) | % | |||||||||||||||||||||||
| XGEVA — ROW | 118 | 182 | (35) | % | 466 | 573 | (19) | % | |||||||||||||||||||||||||||
| Total XGEVA | $ | 288 | $ | 539 | (47) | % | $ | 1,051 | $ | 1,637 | (36) | % | |||||||||||||||||||||||
Global XGEVA sales for the three and nine months ended September 30, 2026 decreased 47% and 36%, respectively, as multiple biosimilars have launched in the United States and ROW.
The decreases in global XGEVA sales for the three and nine months ended September 30, 2026 were primarily driven by lower volume of 32% and 24%, respectively, and lower net selling price of 11% and 10%, respectively.
For the remainder of 2026, we expect continued sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.
As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.
38
For a discussion of litigation, including associated settlements, related to XGEVA, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
UPLIZNA
Total UPLIZNA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| UPLIZNA — U.S. | $ | 352 | $ | 146 | * | $ | 915 | $ | 360 | * | |||||||||||||||||||||||||
| UPLIZNA — ROW | 99 | 9 | * | 133 | 62 | * | |||||||||||||||||||||||||||||
| Total UPLIZNA | $ | 451 | $ | 155 | * | $ | 1,048 | $ | 422 | * | |||||||||||||||||||||||||
* Change in excess of 100%
The increases in global UPLIZNA sales for the three and nine months ended September 30, 2026 were primarily driven by volume growth.
Aranesp
Total Aranesp sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Aranesp — U.S. | $ | 95 | $ | 103 | (8) | % | $ | 266 | $ | 301 | (12) | % | |||||||||||||||||||||||
| Aranesp — ROW | 234 | 254 | (8) | % | 726 | 755 | (4) | % | |||||||||||||||||||||||||||
| Total Aranesp | $ | 329 | $ | 357 | (8) | % | $ | 992 | $ | 1,056 | (6) | % | |||||||||||||||||||||||
The decrease in global Aranesp sales for the three months ended September 30, 2026 was primarily driven by lower volume.
The decrease in global Aranesp sales for the nine months ended September 30, 2026 was driven by lower net selling price of 3% and lower volume.
KYPROLIS
Total KYPROLIS sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| KYPROLIS — U.S. | $ | 209 | $ | 225 | (7) | % | $ | 628 | $ | 673 | (7) | % | |||||||||||||||||||||||
| KYPROLIS — ROW | 121 | 134 | (10) | % | 346 | 388 | (11) | % | |||||||||||||||||||||||||||
| Total KYPROLIS | $ | 330 | $ | 359 | (8) | % | $ | 974 | $ | 1,061 | (8) | % | |||||||||||||||||||||||
The decreases in global KYPROLIS sales for the three and nine months ended September 30, 2026 were primarily driven by lower volume.
For a discussion of ongoing litigation related to KYPROLIS, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
39
Vectibix
Total Vectibix sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Vectibix — U.S. | $ | 182 | $ | 162 | 12 | % | $ | 485 | $ | 441 | 10 | % | |||||||||||||||||||||||
| Vectibix — ROW | 153 | 122 | 25 | % | 475 | 415 | 14 | % | |||||||||||||||||||||||||||
| Total Vectibix | $ | 335 | $ | 284 | 18 | % | $ | 960 | $ | 856 | 12 | % | |||||||||||||||||||||||
The increases in global Vectibix sales for the three and nine months ended September 30, 2026 were primarily driven by volume growth.
IMDELLTRA/IMDYLLTRA
Total IMDELLTRA/IMDYLLTRA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| IMDELLTRA — U.S. | $ | 224 | $ | 144 | 56 | % | $ | 645 | $ | 330 | 95 | % | |||||||||||||||||||||||
| IMDYLLTRA — ROW | 182 | 34 | * | 307 | 63 | * | |||||||||||||||||||||||||||||
| Total IMDELLTRA/IMDYLLTRA | $ | 406 | $ | 178 | * | $ | 952 | $ | 393 | * | |||||||||||||||||||||||||
* Change in excess of 100%
The increases in global IMDELLTRA/IMDYLLTRA sales for the three and nine months ended September 30, 2026 were driven by volume growth.
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Other products
Other product sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| PAVBLU — U.S. | $ | 294 | $ | 212 | 39 | % | $ | 850 | $ | 437 | 95 | % | |||||||||||||||||||||||
| PAVBLU — ROW | 6 | 1 | * | 17 | 5 | * | |||||||||||||||||||||||||||||
| Neulasta — U.S. | 178 | 72 | * | 491 | 244 | * | |||||||||||||||||||||||||||||
| Neulasta — ROW | 17 | 20 | (15) | % | 48 | 59 | (19) | % | |||||||||||||||||||||||||||
| AMJEVITA — U.S. | 64 | 16 | * | 131 | 20 | * | |||||||||||||||||||||||||||||
AMGEVITA — ROW | 127 | 138 | (8) | % | 388 | 403 | (4) | % | |||||||||||||||||||||||||||
MVASI — U.S. | 128 | 156 | (18) | % | 330 | 436 | (24) | % | |||||||||||||||||||||||||||
MVASI — ROW | 40 | 57 | (30) | % | 141 | 147 | (4) | % | |||||||||||||||||||||||||||
| TAVNEOS — U.S. | 105 | 101 | 4 | % | 362 | 281 | 29 | % | |||||||||||||||||||||||||||
| TAVNEOS — ROW | — | 6 | (100) | % | 12 | 26 | (54) | % | |||||||||||||||||||||||||||
LUMAKRAS — U.S. | 55 | 57 | (4) | % | 166 | 164 | 1 | % | |||||||||||||||||||||||||||
LUMYKRAS — ROW | 47 | 39 | 21 | % | 141 | 107 | 32 | % | |||||||||||||||||||||||||||
| Parsabiv — U.S. | 38 | 42 | (10) | % | 135 | 143 | (6) | % | |||||||||||||||||||||||||||
| Parsabiv — ROW | 44 | 42 | 5 | % | 135 | 121 | 12 | % | |||||||||||||||||||||||||||
| Aimovig — U.S. | 83 | 90 | (8) | % | 232 | 239 | (3) | % | |||||||||||||||||||||||||||
| Aimovig — ROW | 6 | 5 | 20 | % | 19 | 16 | 19 | % | |||||||||||||||||||||||||||
| PROCYSBI — U.S. | 63 | 62 | 2 | % | 181 | 174 | 4 | % | |||||||||||||||||||||||||||
| PROCYSBI — ROW | 1 | 1 | — | % | 5 | 5 | — | % | |||||||||||||||||||||||||||
| WEZLANA — U.S. | 8 | — | N/A | 12 | 123 | (90) | % | ||||||||||||||||||||||||||||
| WEZENLA — ROW | 52 | 44 | 18 | % | 156 | 106 | 47 | % | |||||||||||||||||||||||||||
Other — U.S.(1) | 332 | 310 | 7 | % | 872 | 956 | (9) | % | |||||||||||||||||||||||||||
Other — ROW(1) | 45 | 49 | (8) | % | 134 | 163 | (18) | % | |||||||||||||||||||||||||||
| Total other products | $ | 1,733 | $ | 1,520 | 14 | % | $ | 4,958 | $ | 4,375 | 13 | % | |||||||||||||||||||||||
| Total U.S. — other products | $ | 1,348 | $ | 1,118 | 21 | % | $ | 3,762 | $ | 3,217 | 17 | % | |||||||||||||||||||||||
| Total ROW — other products | 385 | 402 | (4) | % | 1,196 | 1,158 | 3 | % | |||||||||||||||||||||||||||
| Total other products | $ | 1,733 | $ | 1,520 | 14 | % | $ | 4,958 | $ | 4,375 | 13 | % | |||||||||||||||||||||||
* Change in excess of 100%
N/A = not applicable
____________
(1) Consists of product sales from KANJINTI, AVSOLA, RAVICTI, BKEMV/BEKEMV, RIABNI, EPOGEN, IMLYGIC, NEUPOGEN, ACTIMMUNE, RAYOS, QUINSAIR, BUPHENYL, Sensipar/Mimpara, DUEXIS, Corlanor and PENNSAID.
41
Operating expenses
Operating expenses were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | ||||||||||||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||||||||||||||
| Cost of sales | $ | 2,788 | $ | 3,082 | (10) | % | $ | 8,343 | $ | 9,061 | (8) | % | |||||||||||||||||||||||
| % of product sales | 28.2 | % | 33.7 | % | 30.2 | % | 35.1 | % | |||||||||||||||||||||||||||
| % of total revenues | 26.9 | % | 32.2 | % | 28.7 | % | 33.7 | % | |||||||||||||||||||||||||||
| Research and development | $ | 2,111 | $ | 1,900 | 11 | % | $ | 5,698 | $ | 5,130 | 11 | % | |||||||||||||||||||||||
| % of product sales | 21.4 | % | 20.8 | % | 20.6 | % | 19.9 | % | |||||||||||||||||||||||||||
| % of total revenues | 20.4 | % | 19.9 | % | 19.6 | % | 19.1 | % | |||||||||||||||||||||||||||
| Selling, general and administrative | $ | 1,680 | $ | 1,720 | (2) | % | $ | 5,027 | $ | 5,098 | (1) | % | |||||||||||||||||||||||
| % of product sales | 17.0 | % | 18.8 | % | 18.2 | % | 19.8 | % | |||||||||||||||||||||||||||
| % of total revenues | 16.2 | % | 18.0 | % | 17.3 | % | 19.0 | % | |||||||||||||||||||||||||||
| Other | $ | 76 | $ | 329 | (77) | % | $ | 79 | $ | 1,236 | (94) | % | |||||||||||||||||||||||
| Total operating expenses | $ | 6,655 | $ | 7,031 | (5) | % | $ | 19,147 | $ | 20,525 | (7) | % | |||||||||||||||||||||||
Cost of sales
Cost of sales decreased to 26.9% of total revenues for the three months ended September 30, 2026, driven by lower amortization expense from acquisition-related assets and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix.
Cost of sales decreased to 28.7% of total revenues for the nine months ended September 30, 2026, driven by lower amortization expense from acquisition-related assets, partially offset by higher profit share expense and changes in our sales mix.
Research and development
The increase in R&D expense for the three months ended September 30, 2026, was driven by higher spend in Research and Early Pipeline, including business development activity.
The increase in R&D expense for the nine months ended September 30, 2026, was driven by higher spend in Research and Early Pipeline, including business development activity, and Later-Stage Clinical Programs, primarily those related to MariTide.
Selling, general and administrative
The decreases in SG&A expense for the three and nine months ended September 30, 2026, were driven by lower general and administrative expenses, partially offset by higher commercial product-related expenses.
Other
Other operating expenses for the three and nine months ended September 30, 2026, included intangible asset impairment charges, and for the nine months ended September 30, 2026, also included certain items associated with legal proceedings.
Other operating expenses for the three and nine months ended September 30, 2025, included the Otezla intangible asset impairment charges of $400 million and $1.2 billion, respectively, following its selection for price setting under the IRA. See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements.
42
Nonoperating expenses/income and income taxes
Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Interest expense, net | $ | (653) | $ | (685) | $ | (1,983) | $ | (2,102) | |||||||||||||||
| Other income, net | $ | 1,629 | $ | 2,080 | $ | 1,631 | $ | 3,204 | |||||||||||||||
| Provision for income taxes | $ | 822 | $ | 705 | $ | 1,480 | $ | 1,084 | |||||||||||||||
| Effective tax rate | 17.5 | % | 18.0 | % | 15.5 | % | 14.5 | % | |||||||||||||||
Interest expense, net
Interest expense, net, remained relatively unchanged for the three months ended September 30, 2026. Interest expense, net, decreased for the nine months ended September 30, 2026, primarily due to lower average debt outstanding.
Other income, net
Other income, net, decreased for the three and nine months ended September 30, 2026, primarily due to lower net unrealized gains on equity investments, primarily BeOne. See Note 6, Investments, to the condensed consolidated financial statements.
Income taxes
The decrease in our effective tax rate for the three months ended September 30, 2026, was primarily due to the change in earnings mix, including lower net unrealized gains on equity investments, partially offset by prior-year period net favorable items as compared to the current-year period. The increase in our effective tax rate for the nine months ended September 30, 2026, was primarily due to the prior year Otezla intangible asset impairment charges and net unfavorable items in the current-year period as compared to the prior-year period, partially offset by the change in earnings mix, including lower net unrealized gains on equity investments and lower amortization expense from acquisition-related assets.
In 2021, the OECD reached an initial agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries. Select individual countries, including the United Kingdom, EU member countries and Singapore, have enacted the global minimum tax agreement that took effect starting in 2024. Singapore’s enactment of the agreement effective 2025 applies irrespective of the Company’s incentive grant. On January 5, 2026, the OECD issued administrative guidance related to the global minimum tax agreement that, when fully enacted, will exempt U.S. companies from extra territorial minimum taxes effective January 1, 2026. Countries have begun to enact, or have announced intentions to enact, the new guidance, and we continue to monitor the potential impact to our 2026 tax rate.
On July 4, 2025, OB3 was enacted in the United States. OB3 has various provisions, including the permanent extension of certain expiring provisions of the 2017 Tax Act and modifications to the international tax framework, including tax rate changes on foreign earnings. The legislation has multiple effective dates, with most provisions effective as of January 1, 2026.
In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations, and in 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010–2012. The Notices seek to increase our U.S. taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued and paid on our foreign earnings.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010–2012. We disagreed with the proposed adjustments and calculations, and in 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013–2015. The Notice seeks to increase our U.S. taxable income for the years 2013–2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest, and asserts penalties of approximately $2.0 billion. Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued and paid on our foreign earnings.
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We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit. We continue to contest the 2010–2012 and 2013–2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court in 2022. The trial began on November 4, 2024 and concluded on January 17, 2025. The parties filed opening post-trial briefs on June 13, 2025, and the Court held oral argument on July 16, 2025. The parties filed post-trial reply briefs on October 10, 2025. On March 16, 2026, the Court ordered supplemental closing briefs, which were filed on May 20, 2026. The Company expects a decision from the U.S. Tax Court no earlier than late 2026 or early 2027.
We are currently under examination by the IRS for the years 2016–2018. In April 2026, we received a draft notice of proposed adjustment (NOPA) from the IRS for years 2016–2018, which is similar to the proposed adjustments for years 2010–2015 and relates primarily to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico. In May and July 2026, the IRS reissued the NOPA in substantially the same form. We have informed the IRS audit team that its methodology is inconsistent with certain positions asserted by the IRS in the Tax Court, which positions were more favorable to Amgen than those previously taken by the audit team. In September 2026, we received a draft NOPA from the IRS asserting penalties for years 2016-2018 substantially similar to those the IRS asserted for years 2013-2015. If sustained in full, these proposed adjustments and penalties could have a material impact on our financial statements. We disagree with the proposed adjustments and penalties and intend to contest them. The IRS began its audit for years 2019–2022 in the second quarter of 2026, and we believe that it may seek to continue to audit similar issues related to the allocation of income between the United States and our foreign jurisdictions. In addition, we are under examination by a number of state and foreign tax jurisdictions.
Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements.
See Part I, Item 1A. Risk Factors—We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, including OB3. Such tax liabilities could adversely affect our profitability and results of operations of our Annual Report on Form 10-K for the year ended December 31, 2025 and Note 4, Income taxes, to the condensed consolidated financial statements of this Quarterly Report on Form 10-Q for further discussion.
Financial condition, liquidity and capital resources
Selected financial data were as follows (in millions):
| September 30, 2026 | December 31, 2025 | ||||||||||
| Cash and cash equivalents | $ | 13,190 | $ | 9,129 | |||||||
| Total assets | $ | 96,048 | $ | 90,586 | |||||||
| Current portion of long-term debt | $ | 2,398 | $ | 4,599 | |||||||
| Long-term debt | $ | 51,609 | $ | 50,005 | |||||||
| Stockholders’ equity | $ | 14,352 | $ | 8,658 | |||||||
Cash and cash equivalents
Our balance of cash and cash equivalents was $13.2 billion as of September 30, 2026. The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
Capital allocation
Consistent with the objective to optimize our capital structure, we deploy our accumulated cash balances in a strategic manner and consider a number of alternatives, including investments in innovation both internally and externally (including investments that expand our portfolio of products in areas of therapeutic interest), capital expenditures, repayment of debt, payment of dividends and stock repurchases.
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We intend to continue investing in our business while returning capital to stockholders through the payment of cash dividends and stock repurchases. This reflects our desire to optimize our cost of capital and our confidence in the future cash flows of our business. The timing and amount of future dividends and stock repurchases will vary based on a number of factors, including future capital requirements for strategic transactions, debt levels and debt service requirements, our credit rating, availability of financing on acceptable terms, changes to applicable tax laws or corporate laws, changes to our business model and periodic determination by our Board of Directors that cash dividends and/or stock repurchases are in the best interests of stockholders and are in compliance with applicable laws and the Company’s agreements. In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.
In December 2025, March 2026 and July 2026, our Board of Directors declared quarterly cash dividends of $2.52 per share of common stock for the first, second and third quarters of 2026, respectively, an increase of 6% over the same periods in the prior year, which were paid in March 2026, June 2026 and September 2026, respectively. In October 2026, our Board of Directors declared a quarterly cash dividend of $2.52 per share, which will be paid in December 2026.
During the nine months ended September 30, 2026, we did not repurchase shares under our stock repurchase program. As of September 30, 2026, $6.8 billion of authorization remained available under the stock repurchase program.
As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of September 30, 2026 and December 31, 2025. Our accumulated deficit is not anticipated to affect our future ability to operate, repurchase stock, pay dividends or repay our debt given our expected continued profitability and strong financial position.
During the nine months ended September 30, 2026, we issued $4.0 billion of debt consisting of $1.0 billion of the 4.20% 2031 Notes, $1.75 billion of the 4.85% 2036 Notes, $500 million of the 5.50% 2046 Notes and $750 million of the 5.65% 2056 Notes. There were no debt issuances during the nine months ended September 30, 2025.
During the nine months ended September 30, 2026, we repaid $3.9 billion of debt, consisting of repayments in full of the $1.8 billion Term loan, the $1.25 billion aggregate principal amount of the 2.60% 2026 Notes and the €750 million aggregate principal amount of our 2.00% 2026 euro Notes ($833 million upon settlement of the related cross-currency swap), compared to $5.0 billion of debt repayments during the nine months ended September 30, 2025. We periodically consider the repurchase of our debt when conditions are favorable. During the nine months ended September 30, 2026 and 2025, we repurchased aggregate principal amounts of our debt of $324 million and $1.0 billion, respectively, for aggregate costs of $233 million and $683 million, respectively, which resulted in the recognition of gains on extinguishment of debt of $90 million and $264 million, respectively, recorded in Other income, net, in the Condensed Consolidated Statements of Income.
We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements, as well as our plans to pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities. We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets. See Part II, Item 1A. Risk Factors—Global economic conditions may negatively affect us and may magnify certain risks that affect our business, of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
In the first quarter of 2026, we filed a shelf registration statement with the SEC that allows us to issue unspecified amounts of debt securities, common stock, preferred stock, warrants to purchase securities (including debt securities, common stock, preferred stock or depositary shares), rights to purchase common stock or preferred stock, securities purchase contracts, securities purchase units, and depositary shares. Under this shelf registration statement, all of the securities available for issuance may be offered from time to time with terms to be determined at the time of issuance. This shelf registration statement expires in February 2029. Also in the first quarter of 2026, we extended the term of our $4.0 billion syndicated, unsecured, revolving credit facility by one year to March 2029. As of September 30, 2026 and December 31, 2025, no amounts were outstanding under this facility.
Certain of our financing arrangements contain nonfinancial covenants. In addition, our revolving credit agreement and term loan credit agreement include a financial covenant that requires us to maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (consolidated earnings before interest, taxes, depreciation and amortization) to (ii) Consolidated Interest Expense, each as defined and described in the respective agreements. We were in compliance with all applicable covenants under these arrangements as of September 30, 2026.
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Cash flows
Our summarized cash flow activity was as follows (in millions):
| Nine months ended September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Net cash provided by operating activities | $ | 10,432 | $ | 8,355 | |||||||
| Net cash used in investing activities | $ | (1,934) | $ | (1,250) | |||||||
| Net cash used in financing activities | $ | (4,437) | $ | (9,633) | |||||||
Operating
Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds. Cash provided by operating activities during the nine months ended September 30, 2026, increased as compared to the same period in the prior year primarily due to the final $1.8 billion repatriation tax payment in the second quarter of 2025 and higher net income in the current-year period after adjustments for noncash items, partially offset by the timing of working capital items.
Investing
Cash used in investing activities during the nine months ended September 30, 2026 and 2025, was primarily due to capital expenditures of $1.8 billion and $1.2 billion, respectively, including construction costs for new plants and expansion of manufacturing capacity. We currently estimate full year 2026 investments in capital projects to be approximately $2.6 billion.
Financing
Cash used in financing activities during the nine months ended September 30, 2026, was primarily due to the repayment and extinguishment of debt of $3.9 billion and $233 million, respectively, and the payment of dividends of $4.1 billion, partially offset by $4.0 billion of net proceeds from long-term debt issuances. Cash used in financing activities during the nine months ended September 30, 2025, was primarily due to the repayment and extinguishment of debt of $5.0 billion and $683 million, respectively, and the payment of dividends of $3.8 billion. See Note 9, Financing arrangements, and Note 10, Stockholders’ equity, to the condensed consolidated financial statements for further discussion.
Critical accounting policies and estimates
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies and estimates is presented in Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2026.
Recently issued accounting standards
For a discussion of recently issued accounting standards, see Note 1, Summary of significant accounting policies, to the condensed consolidated financial statements.
| Item 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | ||||
Information about our market risk is disclosed in Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the year ended December 31, 2025, and is incorporated herein by reference. There were no material changes during the nine months ended September 30, 2026, to the information provided in Part II, Item 7A. Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the year ended December 31, 2025.
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| Item 4. | CONTROLS AND PROCEDURES | ||||
We maintain “disclosure controls and procedures,” as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports gets recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. These controls and procedures are also designed to ensure that such information gets accumulated and communicated to Amgen’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, Amgen’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, Amgen’s management is required to apply its judgment in evaluating the cost–benefit relationship of possible controls and procedures. We have carried out an evaluation under the supervision and with the participation of our management, including Amgen’s Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of Amgen’s disclosure controls and procedures. Based upon their evaluation and subject to the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2026.
Management determined that as of September 30, 2026, no changes in our internal control over financial reporting had occurred during the fiscal quarter then ended that materially affected or are reasonably likely to materially affect our internal control over financial reporting.
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PART II — OTHER INFORMATION
| Item 1. | LEGAL PROCEEDINGS | ||||
See Part I—Note 13, Contingencies and commitments, to the condensed consolidated financial statements included in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026, for discussions that are limited to certain recent developments concerning our legal proceedings. Those discussions should be read in conjunction with Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025.
| Item 1A. | RISK FACTORS | ||||
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management’s assumptions. These statements are not guarantees of future performance and involve certain risks, uncertainties and assumptions that are difficult to predict. You should carefully consider the risks and uncertainties our business faces. The risks described below are not the only ones we face. Our business is also subject to the risks that affect many other companies, such as employment relations, general economic conditions, geopolitical events and international operations. Further, additional risks not currently known to us or that we currently believe are immaterial may in the future materially and adversely affect our business, operations, liquidity and stock price.
Below we provide in supplemental form the material changes to our risk factors that occurred during the past quarter. Our risk factors disclosed in Part I, Item 1A, of our Annual Report on Form 10-K for the year ended December 31, 2025, provide additional disclosure for these supplemental risks and are incorporated herein by reference.
Our sales depend on coverage and reimbursement from government and commercial third-party payers, and pricing and reimbursement pressures have affected, and are likely to continue to affect, our profitability.
Sales of our products depend on the availability and extent of coverage and reimbursement from third-party payers, including government healthcare programs and private insurance plans. Governments and private payers continue to pursue initiatives to manage drug utilization and contain costs. Payers are increasingly focused on costs, which has resulted, and is expected to continue to result, in lower reimbursement rates for our products and/or narrower patient populations for which payers will reimburse. Continued intense public scrutiny of the price of drugs and other healthcare costs, together with payer dynamics, have limited, and are likely to continue to limit, our ability to set or adjust the price of our products based on their value, which can have a material adverse effect on our business. In the United States, a number of legislative and regulatory proposals have been introduced and/or signed into law to lower drug prices. These include the IRA that enables the U.S. government to set prices for certain drugs in Medicare, redesigns Medicare Part D benefits to shift a greater proportion of the costs to manufacturers and health plans, and enables the U.S. government to impose penalties if drug prices are increased at a rate faster than inflation (IRA Inflation Penalties). On July 4, 2025, OB3 was enacted and included several changes to Medicare, Medicaid and Affordable Care Act policies, including provisions affecting eligibility, that, when implemented, are expected to adversely affect coverage and reimbursement for our products. On May 12, 2025, the Administration issued the Most-Favored-Nation (MFN) Prescription Drug Pricing Executive Order (MFN EO) aimed at using price benchmarks from other developed countries to set U.S. pricing targets. Subsequently, on July 31, 2025, the Administration sent letters to many pharmaceutical manufacturers, including Amgen (the July MFN Letter) as further described below, outlining steps that such manufacturers could take to advance actions consistent with elements of the MFN EO. In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests. Further, the Administration has called on Congress to enact legislation that would codify the terms that the Administration arrived at with recipients of the July MFN Letter (the MFN Terms). The details of such a legislative framework are unknown and, if enacted, such legislation could apply to a broader range of products, payers or pricing arrangements for a longer period than those resulting from the MFN Terms. Additional proposals focused on drug pricing continue to be debated, and additional executive orders or regulatory initiatives focused on drug pricing and competition may be adopted and implemented in some form. It remains unclear what further policies, legislation and/or actions the Administration, Congress, or state governments will advance with respect to other drug pricing proposals or other healthcare regulations affecting pharmaceuticals, including the MFN EO, IRA and OB3 implementation, trade policies, or state laws affecting the 340B Program or Medicaid reimbursement that could ultimately be adopted more broadly. To the extent such actions reduce or modify coverage or reimbursement for our products, increase rebates or other costs, constrain pricing decisions, or otherwise limit product use, they would have an adverse effect on our business and results of operations.
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—Changing U.S. federal coverage and reimbursement policies and practices have affected, and are likely to continue to affect, access to, pricing of, and sales of our products
A substantial proportion of our U.S. business relies on reimbursement from federal government healthcare programs and commercial insurance plans regulated by federal and state governments. See Part I, Item 1. Business—Reimbursement, of our Annual Report on Form 10-K for the year ended December 31, 2025. Our business has been, and will continue to be, affected by legislative actions changing U.S. federal reimbursement policy. For example, the IRA includes provisions requiring mandatory pricing in Medicare for certain drugs under Parts B and D (starting with 10 drugs effective January 1, 2026, adding 15 in 2027 and 2028, and adding 20 in 2029 and subsequent years such that, by 2031, approximately 100 drugs would be subject to such set prices). CMS has set Medicare Part D prices for ENBREL, effective January 1, 2026, and Otezla, effective January 2027, in each case at significantly lower levels. Such pricing for ENBREL has negatively impacted, and is expected to continue to negatively impact, its profitability, and such pricing for Otezla is expected to negatively impact its profitability beginning in January 2027. See Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of operations—Product sales. Depending on the growth and success of our medicines, other of our medicines may also be subject to selection by CMS in the next, or in a future, cycle of mandatory Medicare price setting, and we may be required to accept a price set by the government for Medicare using the process that was applied to ENBREL and Otezla. For example, Repatha may be a candidate for such Medicare price setting as early as January 2029. Further, CMS has issued policies that allow for the re-setting of prices for drugs for which it previously set a price. On April 15, 2025, the Administration issued an executive order (the April 2025 EO) that, among other directives, directs HHS to work with Congress to align the treatment of small molecule drugs and biologics in the Medicare price setting program under the IRA. It is currently unclear how such modifications would affect the timeframe in which Medicare price setting becomes applicable for selected drugs or biologics. Also under the IRA, Medicare Part D was redesigned to cap beneficiary out-of-pocket costs and reduce Federal reinsurance in the catastrophic phase; increasing cost-sharing obligations for Part D plans and manufacturers, including by requiring manufacturer discounts. Further, the IRA inflation penalties allow CMS to collect rebates from manufacturers if Medicare price increases outpace inflation, and several of our products have been subject to such IRA inflation rebates. The IRA’s Medicare price setting and Medicare redesign have had, and are likely to have, an adverse effect on our sales, our business and our results of operations, and such impact is expected to increase through the end of the decade and will depend on factors including the extent of our portfolio’s exposure to Medicare reimbursement, the rate of inflation over time, the number of our products selected for Medicare price setting and the timing of market entry of generic or biosimilar competition. Further, following the enactment of the IRA, the environment remains dynamic, and U.S. policymakers continue to demonstrate interest in health care and drug pricing changes as well as potential changes affecting intellectual property. For example, starting in 2025, CMS policy changes gave Part D plans more flexibility to substitute biosimilars for innovator products on their formularies. Implementation of OB3 also may impact access to and reimbursement of our products. For example, the Congressional Budget Office has projected that the OB3 will result in significant reductions in federal Medicaid spending over the next decade and an increase in the number of people without health insurance. These developments would place greater stress on state budgets and hospital finances, and could result in reduced access to medicines, additional pressure to further discount medicines and further growth of 340B Program utilization. The MFN EO directs HHS to pursue pricing policies that align U.S. drug prices with the prices available in certain comparably developed countries and directs a range of actions to advance that objective, including through regulatory, trade and other policy measures. In July 2025, the Administration delivered the July MFN Letter to us and a number of other manufacturers that called for drug manufacturers to: 1) extend MFN pricing to Medicaid; 2) guarantee MFN pricing to Medicaid, Medicare and commercial payers on all newly launched drugs; 3) use future increased revenues from outside the United States to lower U.S. drug prices; and 4) participate in direct-to-patient models to provide MFN pricing for certain drugs. Since the issuance of the July MFN Letter, the recipients have announced that they have reached agreement with the Administration to address the matters described in the letter. In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests. We also announced the expansion of our direct-to-patient program. As part of the Administration’s MFN pricing initiative, CMS announced the GENEROUS Model, under which we and other participating manufacturers will provide additional supplemental rebates for certain drugs to participating state Medicaid programs designed to align Medicaid net prices with prices paid in select other countries for drugs covered under the model. The effect of the GENEROUS Model on our business will depend on a number of factors, including the extent of state participation, the products subject to the model, the applicable international pricing benchmarks and the manner in which the model is implemented and administered. While these developments reflect ongoing engagement on pricing policy, the ultimate effects on our pricing, reimbursement, net sales and profitability remain uncertain in light of evolving regulatory and policy expectations.
We also face risks related to the reporting of pricing data that affect reimbursement of and discounts provided for our products. U.S. government price reporting regulations are complex and may require biopharmaceutical manufacturers to update certain previously submitted data. If our submitted pricing data are incorrect, we may become subject to substantial fines and penalties or other government enforcement actions, which could have a material adverse effect on our business and results of
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operations. In addition, as a result of restating previously reported price data, we may be required to pay additional rebates and provide additional discounts.
—Changing reimbursement and pricing actions in various states have negatively affected, and may continue to negatively affect, access to and sales of our products
At the state level, legislation, government actions and ballot initiatives can also affect how our products are covered and reimbursed and/or create additional pressure on our pricing decisions. Existing and proposed state pricing laws, which may move forward more rapidly than similar efforts at the federal level, have added complexity to the pricing of drugs. A number of states have adopted, and a number of other states continue to consider, PDABs, drug importation programs, reference pricing schemes and other drug pricing actions, including proposals designed to require biopharmaceutical manufacturers to report to the state proprietary pricing information or provide advance notice of certain price increases.
States continue to pursue laws related to price controls, referencing the IRA and seeking to regulate and prohibit restrictions on the 340B Program. For example, following the passage of the IRA, bills have been proposed in multiple states that would apply the drug price caps set by HHS for Medicare to drug prices in an individual state, and such references to IRA price caps have also been included in PDAB legislation. For Medicaid patients, states have established a Medicaid drug spending cap (New York) and implemented a new review and supplemental rebate negotiation process (Massachusetts). Seven states (Colorado, Maine, New Jersey, Maryland, Minnesota, Oregon and Washington) currently use PDABs to identify drugs that pose affordability challenges, and four such states include authority for the state PDABs to set upper payment limits on certain drugs for in-state patients, payers and providers. The seven states with enacted PDAB laws are in various phases of implementation, with Colorado’s PDAB being the furthest along. The Colorado PDAB deemed three of five drugs “unaffordable,” including ENBREL, and in 2025 the Colorado PDAB established an Upper Payment Limit (UPL) substantially lower than the wholesale acquisition cost of ENBREL that would be generally applicable to all formulations of ENBREL, effective no earlier than January 1, 2027, and will be reviewed annually. Although implementation of the ENBREL UPL is preliminarily enjoined, the matter remains subject to ongoing litigation and potential appeal, and similar state actions could adversely affect access to, pricing of and sales of our products. On July 16, 2025, Washington state’s PDAB selected ENBREL for one of its first affordability reviews, and on September 16, 2026, it also selected Otezla for affordability review. Following the timeline and process established by the state for such affordability review, the manufacturer and the PDAB will undertake a number of required interactions. However, the Washington state PDAB may not establish a UPL for any prescription drug before January 1, 2027. Further, inappropriate expanded utilization of the 340B Program from broadened application of the 340B discounts has had, and is expected to continue to have, a negative impact on the Company’s product sales, business and results of operations including by increasing the risk of duplicate discounts and/or the application of 340B discounts to ineligible patients or settings. Use of the 340B Program has continued to grow, and increased purchases of our products through this program have resulted, and are expected to continue to result, in additional discounts applicable to our products, affecting our net sales and results of operations. While we have expanded our efforts to obtain pharmacy and medical claims-level data that support 340B rebate payments and the Health Resources and Services Administration (HRSA) approved our participation in its one-year 340B rebate pilot program beginning January 2027 with respect to ENBREL and Otezla, these efforts may not fully address the adverse effects of duplicate discounts and other improper 340B utilization. Twenty-three states (Louisiana, Arkansas, West Virginia, Minnesota, Mississippi, Missouri, Maryland, Kansas, North Dakota, South Dakota, Utah, Nebraska, New Mexico, Colorado, Tennessee, Oregon, Vermont, Hawaii, Oklahoma, Rhode Island, Maine, Washington and Illinois) have enacted laws with mandates on manufacturers participating in the 340B Program, and, in 2026, no fewer than 17 states have introduced similar legislation. These bills vary, but typically include provisions restricting a manufacturer’s ability to direct drugs in 340B channels, requiring manufacturers to recognize or provide access to 340B contract pharmacies, and prohibiting manufacturers from requiring the inclusion of 340B claims modifiers. With OB3’s reductions to federal Medicaid funding to states, increased pressure is anticipated for providers to find and preserve existing revenue sources at the state level, which may result in increased use of 340B contract pharmacy mandates. In Genesis Health Care, Inc. v. Becerra, the U.S. District Court for the District of South Carolina issued an order in November 2023 enjoining the HRSA from enforcing a more restrictive interpretation against Genesis Health Care as to who qualifies as a patient under the 340B Program, which could, if adopted more broadly, affect the scope of eligibility for 340B discounts. Since this decision, various courts have reached differing conclusions on challenges to state laws regulating aspects of the 340B Program, with some courts declining to enjoin such laws and others granting relief to challengers. Certain appellate courts have issued decisions both upholding certain state 340B statutes and affirming the denial of preliminary injunctive relief to manufacturers, while litigation and appeals concerning the validity, interpretation, and enforcement of these laws remain ongoing.
The Administration has also taken steps to streamline the drug importation program and ease the process for states to obtain FDA authorization. In June 2026, the FDA authorized Colorado’s drug importation program. Maine, New Hampshire, New Mexico, Texas and Vermont have also enacted state importation laws, and some have submitted plans for approval to the FDA. Other states could adopt similar approaches or could pursue different policy changes in a continuing effort to reduce their costs. Previously, in 2024, the FDA authorized Florida to move forward with its importation program proposal, though the state
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has not yet completed any significant steps towards importation within the two-year authorization window. While under federal law biologics remain exempt from such state importation activities, our small molecule products could be impacted by these initiatives.
Ultimately, existing or future state government actions or ballot initiatives may also have a material adverse effect on our product sales, business and results of operations.
—U.S. commercial payer actions have affected, and may continue to affect, access to and sales of our products
Payers, including healthcare insurers, PBMs, integrated healthcare delivery systems (vertically-integrated organizations built from consolidations of healthcare insurers and PBMs) and group purchasing organizations, are continuing to seek ways to further reduce their costs. With increasing frequency, payers are adopting benefit plan changes that shift a greater proportion of drug costs to patients. Such measures include more limited benefit plan designs, high deductible plans, higher patient co-pay or coinsurance obligations and more significant limitations on patients’ use of manufacturer commercial co-pay assistance programs. Further, government regulation of payers may affect these trends. Payers, including PBMs, have sought, and continue to seek, price discounts or rebates in connection with the placement of our products on their formularies or those they manage, and also impose restrictions on access to, or usage of, our products (such as Step Therapy), require that patients receive the payer’s prior authorization before covering the product, and/or to exclude certain indications for which our products are approved.
Further, significant consolidation in the health insurance industry has resulted in a few large insurers and PBMs, which places greater pressure on pricing and usage negotiations with biopharmaceutical manufacturers, significantly increasing discount and rebate requirements and limiting patient access and usage. See our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1A. Risk Factors—Concentration of sales at certain of our wholesaler distributors and consolidation of private payers, such as insurers and PBMs, have negatively affected, and may continue to negatively affect, our business. This high degree of consolidation among insurers, PBMs and other payers, including integrated healthcare delivery systems and/or with specialty or mail-order pharmacies and pharmacy retailers, has increased the negotiating leverage such entities have over us and other biopharmaceutical manufacturers and has resulted in greater price discounts, rebates and service fees realized by those payers from our business. Our business is also affected by policies implemented by private healthcare entities that process Medicare claims, including Medicare Administrative Contractors. Each of CVS, Express Scripts and UnitedHealth Group (among the top six integrated health plans and PBMs) has Rebate Management Organizations that further increase their leverage to negotiate deeper discounts on their behalf and for the benefit of their other customers. Federal actions to reform PBM practices have accelerated, and as these actions collectively curtail rebate-driven economics, PBMs may respond by increasing explicit service fees to offset lost revenue and adopting more restrictive formulary design and utilization management to prioritize lowest net cost. Ultimately, additional discounts, rebates, fees, coverage changes, plan changes, restrictions or exclusions imposed by these commercial payers could have a material adverse effect on our product sales, business and results of operations. See our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1A. Risk Factors—Concentration of sales at certain of our wholesaler distributors and consolidation of private payers, such as insurers and PBMs, have negatively affected, and may continue to negatively affect, our business.
—Government and commercial payer actions outside the United States have affected and will continue to affect access to and sales of our products
Outside the United States, we expect countries will continue to take actions to reduce their drug expenditures and to reduce intellectual property protections. See Part I, Item 1. Business—Reimbursement, of our Annual Report on Form 10-K for the year ended December 31, 2025. Pressures to decrease drug expenditures may intensify as governments take actions to address budgets strained by high inflation and weak economic conditions, including in Europe, where sustained fiscal pressures continue to challenge public healthcare systems. In addition, policies under consideration or adopted in the United States that reference or tie drug prices to those paid in foreign jurisdictions, including through most-favored-nation or similar pricing approaches, could increase the significance of pricing decisions in such foreign jurisdictions. Further, the EU is currently undergoing a review and revision of its general pharmaceutical legislation that, while full implementation is not expected before 2027, has led to proposals that would reduce intellectual property protection for new products (including potentially shortening the duration of regulatory data exclusivity and orphan drug exclusivity protections), as well as change the reimbursement and regulatory landscape. International reference pricing has been widely used by many countries outside the United States to control costs. International reference pricing policies can change quickly and frequently and may not reflect differences in the burden of disease, indications, market structures or affordability across countries or regions. Other expenditure control practices, including the use of revenue clawbacks, rebates and caps on product sales, are also used in various foreign jurisdictions. In addition, countries may refuse to reimburse, or may restrict the reimbursed population for a product, when their national health technology assessments do not consider a medicine to demonstrate sufficient clinical benefit beyond existing therapies or to meet certain cost-effectiveness thresholds. For example, despite the EMA’s approval of Repatha for the treatment of patients with established atherosclerotic disease, prior to 2020, the reimbursement of Repatha in France was
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limited to a narrower patient population (such as those with homozygous familial hypercholesterolemia (HoFH)) following a national health technology assessment. Many countries decide on reimbursement between potentially competing products through national or regional tenders that often result in one product receiving most, or all of, the sales in that country or region. Failure to obtain coverage and reimbursement for our products, a deterioration in their existing coverage and reimbursement, or a decline in the timeliness or certainty of payment by payers to hospitals and other providers, has negatively affected, and may further negatively affect, the ability or willingness of healthcare providers to prescribe our products for their patients and otherwise negatively affect the use of our products or the prices we realize for them. Such failures and changes have had, and could in the future have, a material adverse effect on our product sales, business and results of operations.
Our current products and products in development cannot be sold without regulatory approval.
Our business is subject to extensive regulation by numerous state and federal government authorities in the United States, including the FDA, and by foreign regulatory authorities, including the EMA. We are required to obtain approval from regulatory authorities in the United States and other regions and countries before we, or our partners and affiliates, may manufacture, market or sell our products in those jurisdictions. Once our products are approved, the FDA and other U.S. and ex-U.S. regulatory agencies have substantial authority to require additional testing and reporting, perform inspections, change product labeling or mandate withdrawals of our products. Failure to comply with applicable regulatory requirements may subject us to administrative and/or judicially imposed sanctions or monetary penalties as well as reputational and other harms. The sanctions could include the FDA’s or ex-U.S. regulatory authorities’ refusals to approve pending applications, delays in obtaining or withdrawals of approvals, delays or suspensions of clinical trials, warning letters, product recalls or seizures, total or partial suspensions of our operations, injunctions, fines, civil penalties and/or criminal prosecutions.
Obtaining and maintaining regulatory approvals have been, and will continue to be, increasingly difficult, time-consuming and costly. Legislative bodies or regulatory agencies could enact new laws or regulations, change existing laws or regulations or change their interpretations of laws or regulations at any time, which could affect our ability to obtain or maintain approval of our products or product candidates. The rate and degree of change in existing laws and regulations and regulatory expectations have accelerated in established markets, and regulatory expectations continue to evolve in emerging markets. We are unable to predict whether and when any further changes to laws or regulatory policies affecting our business could occur, such as changes to laws or regulations governing manufacturer communications concerning drug products and drug product candidates and whether such changes could have a material adverse effect on our product sales, business and results of operations. Further, we are reliant on regulators having the resources necessary to evaluate and approve our products. In the United States, federal government shutdowns have occurred and such shutdowns have disrupted certain regulatory activities. Any future government shutdowns or workforce constraints may delay or disrupt regulatory activities, including those with respect to our ongoing clinical programs, the manufacture of our products and product candidates and product approvals.
Recent initiatives to reduce the size and budgets of government agencies, including the HHS, FDA and NIH, may adversely impact our operations. In particular, reductions in staffing and resources at the FDA could result in delays in regulatory review timelines and marketing application and supplement approvals. Changes in leadership at the FDA may also result in shifts in perspectives on the drug approval process and regulatory priorities. Further, implementation of new policy initiatives without guidance or rulemaking has reduced transparency and increased uncertainty with respect to agency actions. Additionally, funding reductions and caps on research overhead costs imposed on the NIH and its programs may result in grant funding cutbacks for scientific and disease-related research at academic institutions and research centers, and such reductions, over the longer term, may slow the overall discovery and development of new therapies and/or slow or interrupt the flow of innovation into the pharmaceutical development pipeline. These developments and others associated with the reduction of personnel and budgets at the regulatory agencies that oversee our industry and operations may adversely affect our business activities, including our ongoing and future clinical research and drug development programs, research collaborations, manufacturing activities and regulatory submissions.
Regulatory authorities have questioned, and may in the future question, the sufficiency for approval of the endpoints we select for our clinical trials. A number of our products and product candidates have been evaluated in clinical trials using surrogate endpoints that measure an effect that is known to correlate with an ultimate clinical benefit. For example, a therapeutic oncology product candidate may be evaluated for its ability to reduce or eliminate minimal residual disease (MRD), or to extend the length of time during and after the treatment that a patient lives without the disease worsening, measured by progression-free survival (PFS). Demonstrating that the product candidate induces MRD-negative responses or produces a statistically significant improvement in PFS does not necessarily mean that the product candidate will show a statistically significant improvement in overall survival or the time that the patients remain alive. In the cardiovascular setting, a heart disease therapeutic candidate may be evaluated for its ability to reduce low-density lipoprotein cholesterol (LDL-C) levels, as an elevated LDL-C level has been a surrogate endpoint for cardiovascular events such as death, heart attack and stroke. The use of surrogate endpoints such as PFS and LDL-C reduction, in the absence of other measures of clinical benefit, may not be sufficient for broad usage or approval even when such results are statistically significant. Regulatory authorities could also add
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new requirements, such as the completion of enrollment in a confirmatory study or the completion of an outcomes study or a meaningful portion of an outcomes study, as conditions for obtaining approval or obtaining an indication. For example, despite demonstrating that Repatha reduced LDL-C levels in a broad patient population, only after our large phase 3 outcomes study evaluating the ability of Repatha to prevent cardiovascular events met certain of its primary composite endpoint and key secondary composite endpoint did the FDA grant a broader approval of Repatha to reduce the risk of certain cardiovascular events. There may also be situations in which demonstrating the efficacy and safety of a product candidate may not be sufficient to gain regulatory approval unless superiority to other existing treatment options can be shown. The imposition of additional requirements or our inability to meet them in a timely fashion, or at all, has delayed, and may in the future delay, our clinical development and regulatory filing efforts, delay or prevent us from obtaining regulatory approval for new product candidates or new indications for existing products, or prevent us from maintaining our current product labels.
Some of our products have been approved by U.S. and ex-U.S. regulatory authorities on an accelerated or conditional basis with full approval conditioned upon fulfilling the requirements of regulators. For example, the FDA has approved LUMAKRAS under accelerated approval for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Following our submission of the LUMAKRAS/LUMYKRAS CodeBreaK 200 Phase 3 confirmatory data in March 2023 to the FDA and EMA, we received a Complete Response Letter from the FDA and a new postmarketing requirement for an additional confirmatory study to support full approval. Regulatory authorities are placing greater focus on whether the sponsors of products originally approved on an accelerated or conditional basis have met the conditions of the accelerated or conditional approvals. If we are unable to fulfill the regulators’ requirements that were conditions of a product’s accelerated or conditional approval and/or if regulators reevaluate the data or risk-benefit profile of our product, the conditional approval may not result in full approval or may be revoked or not renewed. Alternatively, we may be required to change the product’s labeled indications, conduct an additional confirmatory clinical trial, or even withdraw the product from the market.
Regulatory authorities may also revisit, reanalyze or reinterpret data underlying the approval of our products, including data previously reviewed during the approval process and/or postmarketing safety information, and such reassessments may lead to different conclusions regarding a product’s benefit-risk profile than those reached at the time of approval. For example, we have had ongoing interactions with the FDA regarding TAVNEOS, a product the Company acquired in connection with its acquisition of ChemoCentryx in 2022, following its approval by the FDA in October 2021. TAVNEOS is indicated for the adjunctive treatment of adult patients with severe AAV in combination with standard therapy including glucocorticoids. Hepatotoxicity is a known risk of TAVNEOS treatment for AAV and has been a subject of ongoing dialogue with the FDA. Throughout this period and up to today, the U.S. label includes a warning about hepatotoxicity and guidance for monitoring patients. In 2024, the Company provided an analysis of serious postmarketing cases of hepatotoxicity to the FDA and proactively submitted a proposed update to add VBDS to the TAVNEOS label. On January 16, 2026, the FDA requested that we voluntarily withdraw TAVNEOS from the U.S. market based on questions regarding aspects of the analysis and adjudication of certain study data that supported the original FDA approval of TAVNEOS. On January 28, 2026, following the FDA regulatory processes, we informed the FDA that we did not intend to withdraw TAVNEOS from the market as we are confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On March 31, 2026, the FDA issued a DSC in which it alerted patients and health care professionals about serious liver injury cases, including fatal cases, of DILI associated with TAVNEOS. The DSC is based on data available through October 9, 2024 and provides information about DILI and VBDS associated with TAVNEOS. Since approval in 2021, cases of VBDS have been reported, largely from Japan and none from the United States. Most patients who had VBDS were aged 65 years and older, and most cases occurred within 90 days of starting TAVNEOS. VBDS has been fatal in some of these patients. On April 29, 2026, the Company submitted a CBE-30 supplement to the FDA and, in May 2026, the U.S. label was updated to amend the hepatotoxicity warning language in the label to provide more information on cases of VBDS that have been observed in the postmarketing setting, including that cases with fatal outcomes have been reported, and modified the language regarding liver panel testing and treatment discontinuation rules. On April 27, 2026, CDER issued a proposal to withdraw approval of TAVNEOS, alleging that there is new information indicating lack of substantial evidence of effectiveness for the drug and that ChemoCentryx’s application that resulted in FDA approval contained untrue statements of material facts. On April 30, 2026, the FDA posted a notice in the Federal Register that proposes to withdraw approval of TAVNEOS and announced an opportunity for ChemoCentryx to request a hearing on this proposal. On June 1, 2026, we requested a hearing on this proposal and subsequently submitted information supporting our request on July 23, 2026, including additional real-world evidence data and data from an independent, blinded re-adjudication of certain study data that supported the FDA’s approval of TAVNEOS (the ADVOCATE data). CDER has not yet responded to our July submission. We expect that once CDER responds, we would have an opportunity to make an additional submission. The FDA may issue a decision on the proposal without granting a hearing. Decisions on the proposal and whether to grant a hearing are appealable to the United States Court of Appeals. If ultimately withdrawal of the U.S. TAVNEOS marketing authorization is required, it would be subject to a date specified by the FDA Commissioner. We cannot predict whether, or the extent to which, the FDA will consider the information we submitted sufficient to address its stated concerns regarding the reliability of the ADVOCATE data or the evidence supporting TAVNEOS’s effectiveness. In addition,
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in August 2026, the European Commission revoked the marketing authorization for TAVNEOS held by a licensee of ChemoCentryx in the EU. In a number of other jurisdictions, with respect to TAVNEOS, regulators have initiated reviews, advised against initiating treatment in new patients, or ordered or announced actions to revoke marketing authorizations, and pending applications and marketing authorizations have been voluntarily withdrawn. These developments could lead to additional adverse regulatory actions in other jurisdictions. The Company has engaged with regulatory authorities, continues to believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile, and intends to follow the appropriate process to support its position. As the FDA’s statement reporting its proposal indicates, TAVNEOS will remain on the market during the pendency of this process. We cannot predict the outcome of these interactions with the FDA on this matter, and the FDA may require additional actions, including further labeling changes, warnings, monitoring, restrictions on use, postmarketing commitments or studies, and any such action or any withdrawal of regulatory approval for TAVNEOS could adversely affect our product sales of TAVNEOS, business and results of operations, including by adversely affecting us in connection with existing or future litigation, government investigations or other legal proceedings.
Regulatory authorities can also impose postmarketing pediatric study requirements. Failure to fulfill such requirements may result in regulatory or enforcement action, including financial penalties or the invalidation of a product’s marketing authorization.
Safety problems or signals can arise as our products and product candidates are evaluated in clinical trials, including investigator-sponsored studies, or as our marketed products are used in clinical practice. We are required continuously to collect and assess adverse events reported to us and to communicate to regulatory agencies these adverse events and safety signals regarding our products. Regulatory agencies periodically perform inspections of our pharmacovigilance processes, including our adverse event reporting. In the United States, for our products with approved Risk Evaluation and Mitigation Strategies (REMS, see our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1. Business—Government Regulation—Post-approval Phase), we are required to submit periodic assessment reports to the FDA to demonstrate that the goals of the REMS are being met. REMS and other risk management programs are designed to help ensure that a drug’s benefits outweigh the risks and vary in the elements they contain. If the FDA is not satisfied with the results of the periodic assessment reports we submit for any of our REMS, the FDA may also modify our REMS or take other regulatory actions, such as implementing revised or restrictive labeling. The drug delivery devices approved for use in combination with our products are also subject to regulatory oversight and review for safety and malfunctions. See our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1A. Risk Factors—Some of our products are used with drug delivery or companion diagnostic devices that have their own regulatory, manufacturing and other risks. If regulatory agencies determine that we or other parties (including our clinical trial investigators, those operating our patient support programs or licensees of our products) have not complied with the applicable reporting, other pharmacovigilance or other safety or quality assessment requirements, we may become subject to additional inspections, warning letters or other enforcement actions, including fines, marketing authorization withdrawal and other penalties. Our product candidates and marketed products can also be affected by safety, efficacy or other clinical findings relating to product candidates or products that are similar to ours, target the same biological pathway or mechanism, or otherwise raise questions regarding an entire class of products or therapeutic approach. Such findings, including results from clinical trials conducted by third parties, may affect regulatory expectations, our clinical development strategies, or perceptions of the likelihood of success of our product candidates. Further, as a result of clinical trials, including sub-analyses or meta-analyses of earlier clinical trials (a meta-analysis involves the use of various statistical methods to combine results from previous separate but related studies) performed by us or others, concerns may arise about the sufficiency of the data or studies underlying a product’s approved label. Such actual or perceived safety problems or concerns can lead to:
•revised or restrictive labeling for our products, or the potential for restrictive labeling that has resulted, and may in the future result, in our decision not to commercialize a product candidate;
•requirements for risk management or minimization activities or other regulatory agency compliance actions related to the promotion and sale of our products;
•postmarketing commitments, mandated postmarketing requirements or pharmacovigilance programs for our approved products;
•product recalls of our approved products;
•required changes to the processes used in the manufacture of our products, which could increase our manufacturing costs and affect the availability of contract manufacturers we may utilize to assist in such manufacturing;
•revocation of approval for our products from the market completely, or within particular therapeutic areas or patient types;
•increased timelines or delays in being approved by the FDA or other regulatory bodies; and/or
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•treatments or product candidates not being approved by regulatory bodies.
For example, after an imbalance in positively adjudicated cardiovascular serious adverse events was observed in one of the phase 3 clinical trials for EVENITY but not in another, larger phase 3 study, in April 2019 the FDA approved EVENITY for the treatment of osteoporosis in postmenopausal women at high risk for fracture, along with a postmarketing requirement. The requirement includes a five-year observational feasibility study that could be followed by a comparative safety study or trial.
Regulatory authorities also require that our products are tested and controlled for impurities. Impurities exceeding established limits may lead to delayed product approvals or disrupt the manufacture and distribution of our products. For example, certain jurisdictions and regulatory agencies, including the FDA and EMA, require risk assessments, and if applicable, testing, for the presence of nitrosamine impurities in certain small molecule drugs, and we are following the established process of evaluating potentially impacted small molecule products.
In addition to our innovative products, we are working to develop and commercialize biosimilar versions of a number of products currently manufactured, marketed and sold by other pharmaceutical companies. In some markets outside the United States and EU, there is not yet a legislative or regulatory pathway for the approval of biosimilars. In the United States, the Biologics Price Competition and Innovation Act provides for such a pathway. Discussions within the FDA and other regulatory authorities, and between regulatory authorities and sponsors, continue as to the evidence needed to demonstrate biosimilarity or interchangeability for specific products. See our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1A. Risk Factors—We currently face competition from biosimilars and generics and expect to face increasing competition from biosimilars and generics in the future. Delays or uncertainties in the development or implementation of such pathways, or changes in existing regulatory pathways, including degradation of regulatory standards, could result in delays or difficulties in getting our biosimilar products approved by regulatory authorities, subject us to unanticipated development costs or otherwise reduce the value of the investments we have made in the biosimilars area. Further, we cannot predict the extent to which any potential legislative or policy initiatives would affect the biosimilar pathway or have a material adverse effect on our development of biosimilars, on our marketed biosimilars or on our pursuit of interchangeability designations for any biosimilar. In addition, if we are unable to bring our biosimilar products to market on a timely basis and secure “first-to-market” or other advantageous positions, our future biosimilar sales, business and results of operations could be materially and adversely affected.
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| Item 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | ||||
During the three months ended September 30, 2026, we had one outstanding stock repurchase program, under which we had no repurchase activity.
| Period | Total number of shares purchased | Average price paid per share | Total number of shares purchased as part of publicly announced program | Maximum dollar value that may yet be purchased under the program | ||||||||||||||||||||||
| July 1–31 | — | — | $ | 6,779,253,902 | ||||||||||||||||||||||
| August 1–31 | — | — | $ | 6,779,253,902 | ||||||||||||||||||||||
| September 1–30 | — | — | $ | 6,779,253,902 | ||||||||||||||||||||||
| Total | — | — | ||||||||||||||||||||||||
| Item 5. | OTHER INFORMATION | ||||
Rule 10b5-1 trading arrangements
During the three months ended September 30, 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted terminated
| Item 6. | EXHIBITS | ||||
Reference is made to the Index to Exhibits included herein.
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INDEX TO EXHIBITS
| Exhibit No. | Description | |||||||
| 3.1 | Restated Certificate of Incorporation of Amgen Inc. (As Restated March 6, 2013.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 on May 3, 2013 and incorporated herein by reference.) | |||||||
| 3.2 | Amended and Restated Bylaws of Amgen Inc. (As Amended and Restated February 15, 2016.) (Filed as an exhibit to Form 8-K on February 17, 2016 and incorporated herein by reference.) | |||||||
| 4.1 | Form of stock certificate for the common stock, par value $.0001 of the Company. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1997 on May 14, 1997 and incorporated herein by reference.) | |||||||
| 4.2 | Form of Indenture, dated January 1, 1992. (Filed as an exhibit to Form S-3 Registration Statement filed on December 19, 1991 and incorporated herein by reference.) | |||||||
| 4.3 | Agreement of Resignation, Appointment and Acceptance dated February 15, 2008. (Filed as an exhibit to Form 10-K for the year ended December 31, 2007 on February 28, 2008 and incorporated herein by reference.) | |||||||
| 4.4 | First Supplemental Indenture, dated February 26, 1997. (Filed as an exhibit to Form 8-K on March 14, 1997 and incorporated herein by reference.) | |||||||
| 4.5 | 8-1/8% Debentures due April 1, 2097. (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) | |||||||
| 4.6 | Officer’s Certificate of Amgen Inc., dated April 8, 1997, establishing a series of securities entitled “8 1/8% Debentures due April 1, 2097.” (Filed as an exhibit to Form 8-K on April 8, 1997 and incorporated herein by reference.) | |||||||
| 4.7 | Indenture, dated August 4, 2003. (Filed as an exhibit to Form S-3 Registration Statement on August 4, 2003 and incorporated herein by reference.) | |||||||
| 4.8 | Corporate Commercial Paper - Master Note between and among Amgen Inc., as Issuer, Cede & Co., as Nominee of The Depository Trust Company, and Citibank, N.A., as Paying Agent. (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 1998 on May 13, 1998 and incorporated herein by reference.) | |||||||
| 4.9 | Officers’ Certificate of Amgen Inc., dated May 30, 2007, including form of the Company’s 6.375% Senior Notes due 2037. (Filed as an exhibit to Form 8-K on May 30, 2007 and incorporated herein by reference.) | |||||||
| 4.10 | Officers’ Certificate of Amgen Inc., dated May 23, 2008, including form of the Company’s 6.90% Senior Notes due 2038. (Filed as exhibit to Form 8-K on May 23, 2008 and incorporated herein by reference.) | |||||||
| 4.11 | Officers’ Certificate of Amgen Inc., dated January 16, 2009, including form of the Company’s 6.40% Senior Notes due 2039. (Filed as exhibit to Form 8-K on January 16, 2009 and incorporated herein by reference.) | |||||||
| 4.12 | Officers’ Certificate of Amgen Inc., dated March 12, 2010, including form of the Company’s 5.75% Senior Notes due 2040. (Filed as exhibit to Form 8-K on March 12, 2010 and incorporated herein by reference.) | |||||||
| 4.13 | Officers’ Certificate of Amgen Inc., dated September 16, 2010, including form of the Company’s 4.95% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on September 17, 2010 and incorporated herein by reference.) | |||||||
| 4.14 | Officers’ Certificate of Amgen Inc., dated June 30, 2011, including form of the Company’s 5.65% Senior Notes due 2042. (Filed as an exhibit to Form 8-K on June 30, 2011 and incorporated herein by reference.) | |||||||
| 4.15 | Officers’ Certificate of Amgen Inc., dated November 10, 2011, including form of the Company’s 5.15% Senior Notes due 2041. (Filed as an exhibit to Form 8-K on November 10, 2011 and incorporated herein by reference.) | |||||||
| 4.16 | Officers’ Certificate of Amgen Inc., dated December 5, 2011, including form of the Company’s 5.50% Senior Notes due 2026. (Filed as an exhibit to Form 8-K on December 5, 2011 and incorporated herein by reference.) | |||||||
| 4.17 | Officers’ Certificate of Amgen Inc., dated May 15, 2012, including form of the Company’s 5.375% Senior Notes due 2043. (Filed as an exhibit to Form 8-K on May 15, 2012 and incorporated herein by reference.) | |||||||
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10.3+ | Form of Restricted Stock Unit Agreement for the Amgen Inc. Second Amended and Restated 2009 Equity Incentive Plan. (As Amended and Restated on December 8, 2025.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2025 on February 13, 2026 and incorporated herein by reference.) | |||||||
10.4+ | Amgen Inc. 2009 Performance Award Program. (As Amended and Restated on May 31, 2024.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2024 on August 7, 2024 and incorporated herein by reference.) | |||||||
10.5+ | Form of Performance Unit Agreement for the Amgen Inc. 2009 Performance Award Program (As Amended and Restated on December 8, 2025.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2025 on February 13, 2026 and incorporated herein by reference.) | |||||||
10.6+ | Amgen Inc. 2009 Director Equity Incentive Program. (As Amended and Restated on May 31, 2024.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2024 on August 7, 2024 and incorporated herein by reference.) | |||||||
10.7+ | Form of Restricted Stock Unit Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (As Amended and Restated on May 31, 2024.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2024 on August 7, 2024 and incorporated herein by reference.) | |||||||
10.8+ | Form of Cash-Settled Restricted Stock Unit Agreement for the Amgen Inc. 2009 Director Equity Incentive Program. (As Amended and Restated on May 31, 2024.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2024 on August 7, 2024 and incorporated herein by reference.) | |||||||
| 10.9+ | Amgen Inc. Supplemental Retirement Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | |||||||
| 10.9.1+ | First Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.) | |||||||
| 10.9.2+ | Second Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 23, 2019. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | |||||||
| 10.9.3+ | Third Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2021. (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | |||||||
| 10.9.4+ | Fourth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective October 20, 2022. (Filed as an exhibit to Form 10-K for the year ended December 31, 2022 on February 9, 2023 and incorporated herein by reference.) | |||||||
| 10.9.5+ | Fifth Amendment to the Amgen Inc. Supplemental Retirement Plan, effective January 1, 2024. (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.10+ | Amended and Restated Amgen Change of Control Severance Plan. (As Amended and Restated effective December 9, 2010 and subsequently amended effective March 2, 2011.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2011 on May 10, 2011 and incorporated herein by reference.) | |||||||
| 10.11+ | Amgen Inc. Executive Incentive Plan. (As Amended and Restated effective January 1, 2022.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2022 on April 28, 2022 and incorporated herein by reference.) | |||||||
| 10.12+ | Amgen Nonqualified Deferred Compensation Plan. (As Amended and Restated effective October 16, 2013.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2013 on February 24, 2014 and incorporated herein by reference.) | |||||||
| 10.12.1+ | First Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective October 14, 2016. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2016 on October 28, 2016 and incorporated herein by reference.) | |||||||
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| 10.12.2+ | Second Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective January 1, 2020. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | |||||||
| 10.12.3+ | Third Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective January 1, 2022. (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | |||||||
| 10.12.4+ | Fourth Amendment to the Amgen Nonqualified Deferred Compensation Plan, effective January 1, 2024. (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.13+ | Aircraft Time Sharing Agreement, dated December 3, 2021, by and between Amgen Inc. and Robert A. Bradway. (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | |||||||
| 10.14+ | Agreement between Amgen Inc. and James Bradner, dated December 13, 2023. (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.15+ | Employment Offer Agreement between Amgen (Europe) GmbH and Thomas Dittrich, dated May 16, 2026. (Filed as an exhibit to Form 8-K on May 19, 2026 and incorporated herein by reference.) | |||||||
| 10.16+ | Expatriate Assignment Letter of Understanding between Amgen Inc. and Thomas Dittrich, dated May 16, 2026. (Filed as an exhibit to Form 8-K on May 19, 2026 and incorporated herein by reference.) | |||||||
| 10.17 | Third Amended and Restated Credit Agreement, dated as of March 9, 2023, among Amgen Inc., the Banks therein named, Citibank, N.A., as Administrative Agent, and JPMorgan Chase Bank, N.A., as Syndication Agent. (Filed as an exhibit to Form 8-K on March 9, 2023 and incorporated herein by reference.) | |||||||
| 10.18 | Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited dated May 10, 2002 (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) and Amendment No. 1, effective June 9, 2003, to Collaboration and License Agreement between Amgen Inc. and Celltech R&D Limited (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.18.1 | Amendment No. 2 to Collaboration and License Agreement, effective November 14, 2016, between Amgen Inc. and Celltech R&D Limited. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.19 | Letter Agreement, dated June 25, 2019, by and between Amgen Inc. and UCB Celltech (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2019 on July 31, 2019 and incorporated herein by reference.) | |||||||
| 10.20 | Collaboration Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly-owned subsidiary of BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | |||||||
| 10.20.1 | First Amendment to Collaboration Agreement, dated April 20, 2022, by and between Amgen Inc. and BeiGene Switzerland GmbH, and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | |||||||
60
| 10.20.2 | Second Amendment to Collaboration Agreement, entered into as of February 26, 2023, by and between Amgen Inc. and BeiGene Switzerland GmbH, and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2023 on April 28, 2023 and incorporated herein by reference.) | |||||||
| 10.20.3 | Letter Agreement, dated May 9, 2025, by and between Amgen Inc. and BeiGene Switzerland GmbH, a wholly owned subsidiary of BeiGene, Ltd.1 (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2025 on August 5, 2025 and incorporated herein by reference.) | |||||||
| 10.20.4 | Letter Agreement, dated August 11, 2025, by and between Amgen Inc. and BeOne Medicines I GmbH and BeOne Medicines Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2025 on November 5, 2025 and incorporated herein by reference.) | |||||||
| 10.20.5 | Letter Agreement, dated October 1, 2025, by and between Amgen Inc. and BeOne Medicines I GmbH and BeOne Medicines Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2025 on February 13, 2026 and incorporated herein by reference.) | |||||||
| 10.20.6 | Third Amendment to Collaboration Agreement, dated October 31, 2025, by and among Amgen Inc., BeOne Medicines I GmbH, and BeOne Medicines Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2025 on February 13, 2026 and incorporated herein by reference.) | |||||||
| 10.20.7 | Fourth Amendment to Collaboration Agreement, dated November 11, 2025, by and among Amgen Inc., BeOne Medicines I GmbH, and BeOne Medicines Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2025 on February 13, 2026 and incorporated herein by reference.) | |||||||
| 10.20.8* | Letter Agreement, dated July 10, 2026, by and between Amgen Inc. and BeOne Medicines I GmbH and BeOne Medicines Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) | |||||||
| 10.21 | Guarantee, dated as of October 31, 2019, made by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-K for the year ended December 31, 2019 on February 12, 2020 and incorporated herein by reference.) | |||||||
| 10.22 | Share Purchase Agreement, dated October 31, 2019, by and between Amgen Inc. and BeiGene, Ltd. (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed). (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.) | |||||||
| 10.22.1 | Amendment No. 1 to Share Purchase Agreement, dated December 6, 2019, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Schedule 13D on January 8, 2020 and incorporated herein by reference.) | |||||||
| 10.22.2 | Restated Amendment No. 2 to Share Purchase Agreement, dated September 24, 2020, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2020 on October 29, 2020 and incorporated herein by reference.) | |||||||
| 10.22.3 | Amendment No. 3 to Share Purchase Agreement, dated January 30, 2023, by and among BeiGene, Ltd. and Amgen Inc. (Filed as an exhibit to Form 8-K on January 31, 2023 and incorporated herein by reference.) | |||||||
| 10.23 | Collaboration Agreement dated March 30, 2012 by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, a wholly owned subsidiary of AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | |||||||
| 10.23.1 | Amendment No. 1 to the Collaboration Agreement, dated October 1, 2014, by and among Amgen Inc., AstraZeneca Collaboration Ventures, LLC and AstraZeneca Pharmaceuticals LP (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2022 on August 5, 2022 and incorporated herein by reference.) | |||||||
61
| 10.23.2 | Amendment Nos. 2 through 6 to the March 30, 2012 Collaboration Agreement between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC, dated May 2 and 27 and October 2, 2016, January 31, 2018, and May 15, 2020, respectively (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2020 on July 29, 2020 and incorporated herein by reference.) | |||||||
| 10.23.3 | Amendment No. 7 to the Collaboration Agreement, dated December 17, 2020, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) would be competitively harmful if publicly disclosed.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2020 on February 9, 2021 and incorporated herein by reference.) | |||||||
| 10.23.4 | Amendment No. 8 to the Collaboration Agreement, dated November 19, 2021, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2021 on February 16, 2022 and incorporated herein by reference.) | |||||||
| 10.23.5 | Letter Agreement Regarding the Collaboration Agreement, dated as of December 1, 2023, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-K for the year ended December 31, 2023 on February 14, 2024 and incorporated herein by reference.) | |||||||
| 10.23.6 | Amendment No. 9 to the Collaboration Agreement, dated May 20, 2025, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2025 on August 5, 2025 and incorporated herein by reference.) | |||||||
| 10.23.7 | Amendment No. 10 to the Collaboration Agreement, dated June 23, 2026, by and between Amgen Inc. and AstraZeneca Collaboration Ventures, LLC. (portions of the exhibit have been omitted because they are both (i) not material and (ii) is the type of information that the Company treats as private or confidential.) (Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2026 on August 4, 2026 and incorporated herein by reference.) | |||||||
| 19.1 | Amgen Inc. Insider Trading Policy. (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.) | |||||||
| 19.2 | Amgen Inc. Securities Transactions Blackout and Pre-Clearance Practices and Procedures. (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.) | |||||||
| 31* | ||||||||
| 32** | ||||||||
| 97 | Policy Relating to Recovery of Erroneously Awarded Compensation. (Filed as an exhibit to Form 10-K for the year ended December 31, 2024 on February 14, 2025 and incorporated herein by reference.) | |||||||
| 101.INS | Inline XBRL Instance Document - The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document. | |||||||
| 101.SCH* | Inline XBRL Taxonomy Extension Schema Document. | |||||||
| 101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | |||||||
| 101.DEF* | Inline XBRL Taxonomy Extension Definition Linkbase Document. | |||||||
| 101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document. | |||||||
| 101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | |||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). | |||||||
________________________________________
(* = filed herewith)
(** = furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended)
(+ = management contract or compensatory plan or arrangement)
(1 In May 2025, BeiGene, Ltd. changed its name to BeOne Medicines Ltd., and BeiGene Switzerland GmbH changed its name
to BeOne Medicines I GmbH.)
62
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Quarterly Report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Amgen Inc. | ||||||||||||||
| (Registrant) | ||||||||||||||
| Date: | November 3, 2026 | By: | /S/ THOMAS J.W. DITTRICH | |||||||||||
| Thomas J.W. Dittrich | ||||||||||||||
| Executive Vice President and Chief Financial Officer | ||||||||||||||
| (Principal Financial Officer) | ||||||||||||||
63
Exhibit 10.20.8
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
July 10, 2026
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, California 91320-1799
United States
One Amgen Center Drive
Thousand Oaks, California 91320-1799
United States
Attention: Corporate Secretary
Re: Waiver of Certain Rights Related to [*]-Targeting Molecules Under the Collaboration Agreement
Dear Sir or Madam:
Reference is made to the Collaboration Agreement, dated as of October 31, 2019, as amended (the “Collaboration Agreement”), by and among Amgen Inc. (“Amgen”), BeOne Medicines I GmbH (f/k/a BeiGene Switzerland GmbH) (“BeOne”) and, solely with respect to Section 13.6, BeOne Medicines Ltd. (f/k/a BeiGene, Ltd.). Capitalized terms used but not defined herein have the meanings ascribed to them in the Collaboration Agreement.
Amgen has notified BeOne that Amgen is undergoing discussions with a potential counterparty (“Counterparty”) regarding a [*] combination study (the “[*] Study”) with Amgen’s IMDELLTRA® and the Counterparty’s [*] (the “Counterparty [*] Product”).
In accordance with Section 15.16 (Waivers and Modifications) of the Collaboration Agreement, this letter serves to document BeOne’s and Amgen’s agreement that, with respect to the Counterparty [*] Product, the Distracting Program Restrictions under Article IX of the Collaboration Agreement are hereby irrevocably waived with respect to the [*] Study and all research, development (including any bridging study or other clinical trial), regulatory, manufacturing, and commercialization activities relating to the combination of IMDELLTRA® and the Counterparty [*] Product, in and outside of the Collaboration Territory, excluding any Excluded Activity. “Excluded Activity” means any arrangement, agreement or transaction pursuant to which Amgen or any of its Affiliates (a) sells, distributes, invoices or books revenue for the Counterparty [*] Product or (b) receives revenue, profit, royalty, milestone or other sales-based economics or payments in respect of the Counterparty [*] Product. For avoidance of
doubt, Excluded Activity does not include (i) any co-promotion of IMDELLTRA® and the Counterparty [*] Product in combination, (ii) any activities related solely to IMDELLTRA® or (iii) any economics derived solely from sales of IMDELLTRA®.
Please acknowledge your agreement and consent to the foregoing by counter-signing this letter agreement in the space provided below and returning a copy to us.
[Signature Page Follows]
Yours sincerely,
BEONE MEDICINES I GMBH
/s/ Michael Schoen
By: Michael Schoen
Title: Managing Director
BEONE MEDICINES LTD.
/s/ Chan Lee
By: Chan Lee
Title: SVP, General Counsel and Corporate
Secretary
Acknowledged and agreed:
AMGEN INC.
/s/ Rachna Khosla
By: Rachna Khosla
Title: SVP, Business Development
BeOne Medicines I GmbH
Aeschengraben 27
Aeschengraben 27
4051 Basel, Switzerland
BeOneMedicines.com
Exhibit 31
CERTIFICATIONS
I, Robert A. Bradway, Chairman of the Board, Chief Executive Officer and President of Amgen Inc., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.;
2.Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3.Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and
(d)Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| November 3, 2026 | /s/ ROBERT A. BRADWAY | ||||
| Robert A. Bradway | |||||
| Chairman of the Board, | |||||
| Chief Executive Officer and President | |||||
1
CERTIFICATIONS
I, Thomas J.W. Dittrich, Executive Vice President and Chief Financial Officer of Amgen Inc., certify that:
1.I have reviewed this Quarterly Report on Form 10-Q of Amgen Inc.;
2.Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
3.Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this quarterly report based on such evaluation; and
(d)Disclosed in this quarterly report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| November 3, 2026 | /s/ THOMAS J.W. DITTRICH | ||||
Thomas J.W. Dittrich | |||||
| Executive Vice President and Chief Financial Officer | |||||
2
Exhibit 32
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Amgen Inc. (the “Company”) hereby certifies that:
(i)the accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2026 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii)information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| November 3, 2026 | /s/ ROBERT A. BRADWAY | ||||
| Robert A. Bradway | |||||
| Chairman of the Board, | |||||
| Chief Executive Officer and President | |||||
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (“Section 906”), or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Amgen Inc. and will be retained by Amgen Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
1
Certification of Chief Financial Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Amgen Inc. (the “Company”) hereby certifies that:
(i)the accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2026 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii)information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| November 3, 2026 | /s/ THOMAS J.W. DITTRICH | ||||
| Thomas J.W. Dittrich | |||||
| Executive Vice President and Chief Financial Officer | |||||
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (“Section 906”), or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Amgen Inc. and will be retained by Amgen Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
2