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Item 9A. Controls and Procedures

2026-02-13 compared with 2025-02-14 · 572 added, 478 removed, 1780 unchanged (37% of the section changed)

CONTROLS AND PROCEDURES

We maintain “disclosure controls and procedures,” as such term is defined under the Securities Exchange Act Rule 13a-15(e), that are designed to ensure that information required to be disclosed in Amgen’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is 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.

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 is 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 is 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, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2024.

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 December 31, 2025.

Management determined that as of December 31, 2025, there were no changes in our internal control over financial reporting that occurred during the fiscal quarter then ended that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

Management’s Report on Internal Control over Financial Reporting

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) under the Securities Exchange Act of 1934.

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) under the Securities Exchange Act of 1934.

The Company’s internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP in the United States.

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Information about our insider trading policies and procedures is incorporated by reference from the section entitled COMPENSATION DISCUSSION AND ANALYSIS—COMPENSATION POLICIES AND PRACTICES—Insider Trading Policies and Procedures in our Proxy Statement.

A copy of our Insider Trading Policy and our securities transactions pre-clearance practices and procedures are filed with this Annual Report on Form 10-K as Exhibits 19.1 and 19.2, respectively.

A copy of our Insider Trading Policy and our securities transactions pre-clearance practices and procedures are incorporated by reference to this Annual Report on Form 10-K as Exhibits 19.1 and 19.2, respectively.

Information about our executive officers is contained in the discussion entitled Part I, Item 1.

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EXECUTIVE COMPENSATION

Information about director and executive compensation is incorporated by reference from the sections entitled COMPENSATION DISCUSSION AND ANALYSIS, EXECUTIVE COMPENSATION TABLES, DIRECTOR COMPENSATION and CORPORATE GOVERNANCE—Pay Ratio in our Proxy Statement.

Information about compensation committee matters is incorporated by reference from the sections entitled CORPORATE GOVERNANCE—Compensation and Management Development Committee and CORPORATE GOVERNANCE—Compensation Committee Report in our Proxy Statement.

Information about compensation committee matters is incorporated by reference from the sections entitled CORPORATE GOVERNANCE—Compensation and Management Development Committee and COMPENSATION COMMITTEE REPORT in our Proxy Statement.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

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All other schedules are omitted because they are not applicable, not required or because the required information is included in the consolidated financial statements or notes thereto.

2.1 Agreement and Plan of Merger, dated July 27, 2021, by and among Amgen Inc., Teneobio, Inc., Tuxedo Merger Sub, Inc., and Fortis Advisors 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 September 30, 2021 on November 3, 2021 and incorporated herein by reference.)

2.2 Agreement and Plan of Merger, dated as of August 3, 2022, among ChemoCentryx, Inc., Amgen Inc.

and Carnation Merger Sub, Inc.

(Filed as an exhibit to Form 8-K on August 4, 2022 and incorporated herein by reference.)

2.3 Transaction Agreement, dated as of December 11, 2022, by and among Amgen Inc., Pillartree Limited and Horizon Therapeutics plc.

(Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.)

2.4 Appendix 3 to the Rule 2.7 Announcement, dated as of December 12, 2022 (Conditions Appendix).

(Filed as an exhibit to Form 8-K on December 12, 2022 and incorporated herein by reference.)

3.1 Restated Certificate of Incorporation of Amgen Inc.

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(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.)

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.)

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.)

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.)

10.19.6* 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.)

10.19.7* 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.)

10.20 Guarantee, dated as of October 31, 2019, made by and among BeiGene, Ltd.

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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.)

10.22.6 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 License and Collaboration Agreement, dated June 1, 2021, by and between Amgen Inc.

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(Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2021 on August 4, 2021 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.)

21* Subsidiaries of the Company.

23 Consent of the Independent Registered Public Accounting Firm.

The consent is set forth on page 96 of this Annual Report on the 10-K.

The consent is set forth on page 96 of this Annual Report on Form 10-K.

24 Power of Attorney.

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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.

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+ = 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.

2 See Significant Developments for additional information regarding the termination of our collaboration agreement with Kyowa Kirin.

FORM 10-K SUMMARY

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We have audited the accompanying consolidated balance sheets of Amgen Inc.

(the Company) as of December 31, 2024 and 2023, the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2024, and the related notes and the financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”).

(the Company) as of December 31, 2025 and 2024, the related consolidated statements of income, comprehensive income, stockholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes and financial statement schedule listed in the Index at Item 15(a)2 (collectively referred to as the “consolidated financial statements”).

In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S.

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As of December 31, 2025, the Company accrued $4.4 billion of gross unrecognized tax benefits.

Auditing the assessment of the technical merits and measurement of the Company’s unrecognized tax benefits is challenging due to the high degree of estimation and management judgement, given the ultimate resolution is dependent on uncontrollable factors such as the resolution of audit disputes with the IRS and results of the U.S.

Auditing the assessment of the technical merits and measurement of the Company’s unrecognized tax benefits is challenging due to the high degree of estimation and management judgment, given the ultimate resolution is dependent on uncontrollable factors such as the resolution of audit disputes with the IRS and results of the U.S.

Tax Court case.

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This included testing controls over management’s review of the inputs, calculations, assumptions and methods selected to measure the amount of tax benefits that qualify for recognition.

We involved tax controversy and transfer pricing specialists to assist in assessing the technical merits and measurement of certain of the Company’s unrecognized tax benefits.

We involved tax controversy and transfer pricing subject matter professionals to assist in assessing the technical merits and measurement of certain of the Company’s unrecognized tax benefits.

Depending on the nature of the specific tax position and, as applicable, developments with the relevant tax authorities, our procedures included obtaining and reviewing the Company’s correspondence with such tax authorities and evaluating certain third-party advice to support the Company’s evaluations and recorded positions.

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Interest expense, net ( 2,755 ) ( 3,155 ) ( 2,875 )

Other income (expense), net 506 2,833 ( 814 )

Other income, net 2,651 506 2,833

Income before income taxes 8,976 4,609 7,855

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Net income $ 7,711 $ 4,090 $ 6,717

Other comprehensive income (loss), net of reclassification adjustments and taxes:

(Losses) gains on foreign currency translation adjustments ( 76 ) 50 496

Gains (losses) on cash flow hedges 309 ( 150 ) 67

Other comprehensive (loss) income, net of reclassification adjustments and taxes:

Gains (losses) on foreign currency translation adjustments 172 ( 76 ) 50

(Losses) gains on cash flow hedges ( 377 ) 309 ( 150 )

Other 13 ( 10 ) 42

Other comprehensive income (loss), net of reclassification adjustments and taxes 223 ( 58 ) 565

Other comprehensive (loss) income, net of reclassification adjustments and taxes ( 192 ) 223 ( 58 )

Comprehensive income $ 7,519 $ 4,313 $ 6,659

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Net income — — 6,717 — 6,717

Other comprehensive income, net of taxes — — — 565 565

Other comprehensive loss, net of taxes — — — ( 58 ) ( 58 )

Dividends declared on common stock ($ 8.64 per share)

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Stock-based compensation expense — 454 — — 454

Equity awards issued for Horizon acquisition, net

— 141 — — 141

Tax impact related to employee stock-based compensation expense

— ( 134 ) — — ( 134 )

Repurchases of common stock ( 26.1 ) — ( 6,310 ) — ( 6,310 )

Balance as of December 31, 2023 535.4 33,070 ( 26,549 ) ( 289 ) 6,232

Net income — — 4,090 — 4,090

Other comprehensive loss, net of taxes — — — ( 58 ) ( 58 )

Other comprehensive income, net of taxes — — — 223 223

Dividends declared on common stock ($ 9.13 per share)

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Stock-based compensation expense — 530 — — 530

Equity awards issued for Horizon acquisition, net — 141 — — 141

Tax impact related to employee stock-based compensation expense

— ( 256 ) — — ( 256 )

Repurchases of common stock ( 0.7 ) — ( 200 ) — ( 200 )

Balance as of December 31, 2024 536.9 33,533 ( 27,590 ) ( 66 ) 5,877

Net income — — 7,711 — 7,711

Other comprehensive income, net of taxes — — — 223 223

Other comprehensive loss, net of taxes — — — ( 192 ) ( 192 )

Dividends declared on common stock ($ 9.66 per share)

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— ( 195 ) — — ( 195 )

Repurchases of common stock ( 0.7 ) — ( 200 ) — ( 200 )

Balance as of December 31, 2025 538.8 $ 34,023 $ ( 25,107 ) $ ( 258 ) $ 8,658

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Depreciation, amortization and other 5,167 5,592 4,071

Impairment of intangible assets 1,200 159 851

Stock-based compensation expense 494 530 431

Deferred income taxes ( 721 ) ( 1,228 ) ( 1,273 )

Adjustments for equity method investments ( 10 ) 11 891

Loss on divestiture — — 567

Losses (gains) on equity securities

(Gains) losses on equity securities

( 2,064 ) 159 ( 1,565 )

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Cash paid for acquisitions, net of cash acquired ( 53 ) — ( 26,989 )

Purchases of marketable securities — ( 1 ) ( 2,587 )

Proceeds from sales of marketable securities — — 1,123

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Net cash (used in) provided by financing activities ( 10,859 ) ( 9,415 ) 21,048

Increase (decrease) in cash and cash equivalents 1,029 3,315 ( 360 )

(Decrease) increase in cash and cash equivalents ( 2,844 ) 1,029 3,315

Cash and cash equivalents at beginning of year 11,973 10,944 7,629

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Principles of consolidation

The consolidated financial statements include the accounts of Amgen as well as its majority-owned subsidiaries.

The 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.

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Amgen is subject to current U.S.

minimum tax on foreign subsidiaries.

Based on our election beginning in 2022, we have established deferred taxes with respect to the U.S.

minimum tax on the earnings of our foreign subsidiaries.

This requires us to recognize deferred taxes for temporary basis differences expected to reverse as global intangible low-taxed income in future years.

These are ongoing adjustments that are likely to occur in the future.

tax on the earnings of our foreign subsidiaries.

We previously established deferred taxes related to this U.S.

tax, which requires us to recognize deferred taxes for temporary basis differences expected to reverse and be subject to this tax in future years.

These are ongoing adjustments that are likely to occur in future periods.

We first determine whether a set of assets acquired constitutes a business and should be accounted for as a business combination.

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IPR&D projects with no alternative future use are recorded in R&D expense upon acquisition, and contingent consideration obligations incurred in connection with an asset acquisition are recorded when it is probable that they will occur and they can be reasonably estimated.

See Note 4, Acquisitions and divestitures, and Note 18, Fair value measurement.

See Note 4, Acquisition, and Note 18, Fair value measurement.

Cash equivalents

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See Note 12, Property, plant and equipment.

Cloud computing arrangements

We capitalize qualifying implementation costs under cloud computing arrangements (CCA).

Capitalized CCA implementation costs are allocated between Other current assets and Other noncurrent assets in the Consolidated Balance Sheets.

As of December 31, 2025 and 2024, capitalized CCA implementation costs totaled $ 272 million and $ 227 million, respectively.

For critical software-as-a-service (SaaS) platforms, amortization is recorded over an established four-year period, and for all other arrangements, amortization is recorded over the expected term of the related contract.

Goodwill and other intangible assets

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Marketable and nonmarketable equity securities

Investments in publicly traded equity securities with readily determinable fair values are recorded at quoted market prices for identical securities, with changes in fair value recorded in Other income (expense), net, in the Consolidated Statements of Income.

Investments in equity securities without readily determinable fair values are recorded at cost less impairment, if any, adjusted for changes resulting from observable price changes in orderly transactions for identical or similar securities.

Such adjustments are recorded in Other income (expense), net, in the Consolidated Statements of Income.

Such adjustments are recorded in Other income, net, in the Consolidated Statements of Income.

Equity method investments

Equity investments that give us the ability to exert significant influence, but not control, over an investee for which we have not elected the fair value option are accounted for under the equity method of accounting.

In concluding whether we have the ability to exercise significant influence over an investee, we consider factors such as our ownership percentage, voting and other shareholder rights, board of directors representation and the existence of other collaborative or business relationships.

The equity method of accounting requires us to allocate the difference between the fair value of securities acquired and our proportionate share of the carrying value of the underlying assets (the basis difference) to various items and amortize such differences over their useful lives.

Our share of investees’ earnings or losses and amortization of basis differences, if any, are recorded one quarter in arrears in Other income (expense), net, in the Consolidated Statements of Income.

We record impairment losses on our equity method investments if we deem the impairment to be other-than-temporary.

We deem an impairment to be other-than-temporary based on various factors, including, but not limited to, the length of time the fair value is below the carrying value, volatility of the security price and our intent and ability to retain the investment to allow for a recovery in fair value.

For equity method investments for which we have elected the fair value option, changes in fair value are recorded in Other income (expense), net, in the Consolidated Statements of Income.

Equity investments that give us the ability to exert significant influence, but not control, over an investee are accounted for under the equity method of accounting, unless we have elected the fair value option.

For equity method investments for which the fair value option has been elected, changes in fair value are recorded in Other income, net, in the Consolidated Statements of Income.

Additionally, we hold investments in limited partnerships, which primarily invest in early-stage biotechnology companies.

As a practical expedient, such limited partnership investments are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships, with such changes included in Other income (expense), net, in the Consolidated Statements of Income.

Recently adopted accounting pronouncements

In November 2023, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures, to improve reportable segment disclosure requirements through enhanced disclosures about significant segment expenses and additional interim segment reporting disclosures, including for companies with a single reportable segment.

The standard is effective for public business entities such as Amgen for annual periods beginning after December 15, 2023, and interim periods beginning after December 15, 2024, with retrospective application required for all prior periods presented.

We adopted this standard in fiscal year 2024, which resulted in incremental segment disclosures.

See Note 2, Segment and other information.

Recent accounting pronouncements not yet adopted

In December 2023, the FASB issued ASU No.

2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures, to improve income tax disclosure requirements by requiring more detailed information on several income tax

disclosures, such as enhancing disclosure of income taxes paid and requiring disaggregation of the effective income tax rate reconciliation.

Improvements to Income Tax Disclosures, to improve income tax disclosure requirements by requiring more detailed information in several income tax disclosures, such as enhancing disclosure of income taxes paid and requiring disaggregation of the effective income tax rate reconciliation.

The standard is effective for public business entities such as Amgen for annual periods beginning after December 15, 2024.

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.

We prospectively adopted this standard in fiscal year 2025, which resulted in incremental income taxes disclosures.

See Note 7, Income taxes.

Recent accounting pronouncements not yet adopted

In November 2024, the FASB issued ASU No.

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We are currently evaluating the impact of adopting this standard on our consolidated financial statements and related disclosures.

In September 2025, the FASB issued ASU No.

2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):

Targeted Improvements to the Accounting for Internal-Use Software, to modernize the accounting for software costs, including updating guidance on the recognition and measurement of costs incurred in connection with development and implementation activities related to internal-use software.

The standard is effective for all entities for annual periods beginning after December 15, 2027, and interim periods within those annual periods.

Early adoption is permitted, and entities may apply the standard prospectively or retrospectively.

We evaluated the impact of adopting this new standard on our consolidated financial statements and related disclosures and do not expect the adoption to have a material impact.

Segment and other information

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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 Consolidated Statements of Income.

The CODM uses net income to allocate resources on a consolidated basis, which enables the CODM to assess both the overall level of resources available and optimize distribution of resources across functions, therapeutic areas, regions and research and development programs in line with our long-term corporate-wide strategic goals.

The CODM uses net income to allocate resources on a consolidated basis, which enables the CODM to assess both the overall level of resources available and optimize 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 non-recurring.

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See Note 10, Investments, for further information regarding equity method investments, and Net cash used in investing activities in the Consolidated Statements of Cash Flows for further information regarding capital expenditures.

The following table provides segment revenues, significant segment expenses, other segment items, reported segment net income and a reconciliation of segment net income to the Company’s total consolidated net income for the years ended December 31, 2024, 2023 and 2022 (in millions):

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 years ended December 31, 2025, 2024 and 2023 (in millions):

Years ended December 31,

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( 931 ) 252 ( 729 )

Equity in (income) loss of equity method investments

( 10 ) 14 667

Interest income

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(1) During the years ended December 31, 2025, 2024 and 2023, we recognized amortization expense on our intangible assets of $ 4.3 billion, $ 4.8 billion and $ 3.2 billion, respectively.

Amortization of intangible assets is included primarily in Cost of sales in the Consolidated Statements of Income.

Amortization of intangible assets is primarily included in Cost of sales in the Consolidated Statements of Income.

In addition, during the years ended December 31, 2025, 2024 and 2023, we recognized depreciation and ROU asset amortization expense of $ 887 million, $ 805 million and $ 824 million, respectively.

(2) During the years ended December 31, 2024, 2023 and 2022, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 2.4 billion, $ 656 million and $ 30 million, respectively.

(2) During the years ended December 31, 2025, 2024 and 2023, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 1.3 billion, $ 2.4 billion and $ 656 million, respectively.

(3) Other segment items included in Segment net income primarily consists of:

(i) fair value adjustments on equity securities (see Note 10, Investments) and (ii) net impairment charges on intangible assets (see Note 13, Goodwill and other intangible assets).

For the year ended December 31, 2023, other segment items also included expenses related to our restructuring plan that was both initiated and substantially completed in 2023.

For the year ended December 31, 2022, other segment items also included a loss on the divestiture of Gensenta (see Note 4, Acquisitions and divestitures).

We operate our business in one operating segment:

(i) fair value adjustments on equity securities (see Note 10, Investments);

(ii) net impairment charges on intangible assets (see Note 13, Goodwill and other intangible assets);

and (iii) expenses related to restructuring and cost-savings initiatives.

We operate our business in one operating segment, which also represents one reportable segment:

human therapeutics.

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Revenues by product and by geographic area, based on customers’ locations, are presented below.

The majority of ROW product sales relates to products sold in Europe.

A substantial portion of ROW product sales relates to products sold in Europe.

Revenues were as follows (in millions):

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Prolia $ 2,978 $ 1,436 $ 4,414 $ 2,885 $ 1,489 $ 4,374 $ 2,733 $ 1,315 $ 4,048

1,663 1,353 3,016 1,139 1,083 2,222 793 842 1,635

Otezla 1,839 426 2,265 1,699 427 2,126 1,777 411 2,188

ENBREL 2,199 27 2,226 3,288 28 3,316 3,650 47 3,697

EVENITY 1,600 500 2,100 1,131 432 1,563 809 351 1,160

XGEVA 1,355 729 2,084 1,507 718 2,225 1,527 585 2,112

1,758 145 1,903 1,835 16 1,851 441 7 448

Otezla 1,699 427 2,126 1,777 411 2,188 1,886 402 2,288

BLINCYTO 1,049 510 1,559 800 416 1,216 566 295 861

Nplate 1,027 497 1,524 970 486 1,456 996 481 1,477

1,478 — 1,478 972 — 972 567 — 567

EVENITY 1,131 432 1,563 809 351 1,160 533 254 787

KYPROLIS 913 499 1,412 948 555 1,503 921 482 1,403

Nplate 970 486 1,456 996 481 1,477 848 459 1,307

Aranesp 416 973 1,389 386 956 1,342 452 910 1,362

BLINCYTO 800 416 1,216 566 295 861 336 247 583

KRYSTEXXA (1)

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Vectibix 604 571 1,175 519 526 1,045 461 523 984

TEZSPIRE 972 — 972 567 — 567 170 — 170

Other products (3)

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(1) TEPEZZA and KRYSTEXXA were acquired from the acquisition of Horizon on October 6, 2023, and include product sales in the periods after the acquisition date.

(2) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.

(3) Consists of product sales of our non-principal products.

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Our total allowance for doubtful accounts as of December 31, 2025 and 2024, was not material.

Acquisitions and divestitures

Acquisition of Horizon Therapeutics plc

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Horizon is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs of patients impacted by rare, autoimmune and severe inflammatory diseases.

The acquisition, which was accounted for as a business combination, aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s leading rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for thyroid eye disease, KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder.

The acquisition, which was accounted for as a business combination, aligns with Amgen’s core strategy of delivering innovative medicines that make a significant difference for patients suffering from serious diseases and strengthens Amgen’s leading rare disease portfolio by adding first-in-class, early-in-lifecycle medicines, including TEPEZZA for TED, KRYSTEXXA for chronic refractory gout and UPLIZNA for neuromyelitis optica spectrum disorder.

Upon its acquisition, Horizon became a wholly owned subsidiary of Amgen, and its operations have been included in our consolidated financial statements commencing on the acquisition date.

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In addition, the unaudited pro forma financial information is not a projection of future results of operations of the combined company, nor does it reflect the expected realization of any synergies or cost savings associated with the acquisition.

Acquisition of ChemoCentryx, Inc.

On October 20, 2022, we acquired all of the outstanding stock of ChemoCentryx, a publicly traded biotechnology company focused on orally administered therapeutics to treat autoimmune diseases, inflammatory disorders and cancer, for $ 52.00 per share in cash, representing a total consideration of $ 3.9 billion.

The acquisition, which was accounted for as a business combination, includes TAVNEOS, an orally administered selective complement 5a receptor inhibitor that was approved by the FDA in October 2021 as an adjunctive therapy for adults with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis).

TAVNEOS is commercialized by us in the United States;

for markets outside the United States, TAVNEOS is commercialized by a collaboration partner, and Amgen is entitled to royalties and milestones based on future sales of the product.

Upon its acquisition, ChemoCentryx became a wholly owned subsidiary of Amgen, and its operations became included in our consolidated financial statements commencing on the acquisition date.

Measurement-period adjustments during the year ended December 31, 2023, included changes in the purchase price allocation and total consideration, resulting in a net decrease of approximately $ 18 million to goodwill.

The adjustments did not have a significant impact on Amgen’s results of operations during the year ended December 31, 2023, and would not have had a significant impact on prior-period results if the adjustments had been made as of the acquisition date.

The following table summarizes the final total consideration and allocated acquisition date fair values of assets acquired and liabilities assumed, inclusive of measurement-period adjustments (in millions):

Cash and cash equivalents $ 86

Marketable securities 235

Inventories 41

Finite-lived intangible assets—developed-product-technology rights

Other liabilities, net ( 83 )

Deferred tax liability, net ( 502 )

Total assets acquired, net of liabilities assumed

The $ 3.9 billion total consideration consisted of (i) a $ 3.7 billion cash payment to outstanding common stockholders of ChemoCentryx and (ii) a $ 181 million cash payment to equity award holders of ChemoCentryx for services rendered prior to the acquisition date of October 20, 2022, under the ChemoCentryx equity award plans.

The developed-product-technology rights acquired relates to TAVNEOS, which is approved in the United States and the EU for ANCA-associated vasculitis.

The estimated fair value of $ 3.5 billion was determined by using a multi-period excess earnings income approach that discounts expected future cash flows to present value by applying a discount rate that represents the estimated rate that market participants would use to value the intangible assets.

The developed-product-technology rights are being amortized on a straight-line basis over a weighted-average period of approximately 11 years from the acquisition date using the straight-line methodology.

The estimated fair value of the acquired inventory of $ 41 million was determined using the comparative sales method, which uses actual or expected selling prices of inventory as the base amount to which adjustments for selling effort and a profit on the buyer’s effort are applied.

The inventory fair value adjustment was amortized as inventory turned over, which we estimated to be approximately 13 months from the acquisition date.

A net deferred tax liability of $ 502 million was recognized on the temporary differences related to the book bases and tax bases of the acquired identifiable assets and assumed liabilities, primarily driven by the intangible assets acquired.

The excess of the acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $ 649 million was recorded as goodwill, which is not deductible for tax purposes.

The goodwill value is primarily attributable to the expected synergies from the TAVNEOS asset.

Divestiture of Gensenta İlaç Sanayi ve Ticaret A.Ş.

On November 2, 2022, we sold our shares in Gensenta, a subsidiary in Turkey, to Eczacıbaşı for net cash proceeds of approximately $ 130 million.

The transaction was accounted for as a sale of a business and did not meet the criteria to be classified as discontinued operations.

Upon closing of this transaction, net assets related to Gensenta of $ 86 million were divested, and during the year ended December 31, 2022, we recognized a loss on divestiture of $ 567 million recorded in Other operating expenses in the Consolidated Statements of Income, primarily due to the reclassification of $ 615 million of cumulative foreign currency translation losses from AOCI into earnings.

See Note 17, Stockholders’ equity.

Stock-based compensation

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Our RSU and stock option grants provide for accelerated or continued vesting in certain circumstances as defined in the plans and related grant agreements, including upon death, disability, termination in connection with a change in control and the retirement of employees who meet certain service and/or age requirements.

RSUs and stock options generally vest in equal amounts on the second, third and fourth anniversaries of the grant date.

For awards granted prior to April 1, 2025, RSUs and stock options generally vest in equal amounts on the second, third and fourth anniversaries of the grant date.

Effective for awards granted on or after April 1, 2025, RSUs and stock options generally vest in equal amounts on the first, second, third and fourth anniversaries of the grant date.

RSUs accrue dividend equivalents, which are typically payable in shares only when and to the extent the underlying RSUs vest and are issued to the recipient.

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The grant date fair value of an RSU equals the closing price of our common stock on the grant date, as RSUs accrue dividend equivalents during their vesting period, except with respect to certain holders of Horizon unvested RSUs who were granted replacement Amgen RSUs in 2023 under the original terms of the awards in connection with the Horizon acquisition based on the terms of the transaction.

See Note 4, Acquisitions and divestitures.

See Note 4, Acquisition.

Subsequent to the Horizon acquisition, $ 42 million of the RSUs were accelerated and cash settled in 2023.

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As of December 31, 2022, we elected to establish deferred taxes with respect to the U.S.

minimum tax on the earnings of our foreign subsidiaries for the reversal of temporary items in future years.

tax on the earnings of our foreign subsidiaries for the reversal of temporary items in future years.

Significant components of our deferred tax assets and liabilities were as follows (in millions):

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The Company has determined that unremitted foreign earnings are not considered indefinitely reinvested to the extent foreign earnings can be distributed without a significant tax cost.

For the amount considered to be indefinitely reinvested, it is not practicable to determine the amount of the related deferred income tax liability due to the complexities of the tax laws and assumptions we would have to make.

Valuation allowances are provided to reduce the amounts of our deferred tax assets to an amount that is more likely than not to be realized based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts.

The valuation allowance increased in 2024, primarily driven by the Company’s expectation that certain state R&D credits will expire unused.

The valuation allowance increased in 2025, primarily driven by the Company’s expectation that certain foreign amortization deductions are expected to expire unutilized.

As of December 31, 2025, we had $ 109 million of federal tax credit carryforwards available to reduce future federal income taxes and have provided a $ 31 million valuation allowance on those federal tax credit carryforwards.

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the remainder begin to expire between 2027 and 2033.

We had $ 957 million of state NOL carryforwards available to reduce future state income taxes and have provided a valuation allowance for

$ 822 million of those state NOL carryforwards.

We had $ 1.1 billion of foreign NOL carryforwards available to reduce future foreign income taxes and have provided a valuation allowance for $ 164 million of those foreign NOL carryforwards.

We had $ 971 million of state NOL carryforwards available to reduce future state income taxes and have provided a valuation allowance for $ 836 million of those state NOL carryforwards.

We had $ 1.4 billion of foreign NOL carryforwards available to reduce future foreign income

taxes and have provided a valuation allowance for $ 239 million of those foreign NOL carryforwards.

For the foreign NOLs with no valuation allowance provided, $ 120 million have no expiration;

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During the years ended December 31, 2025, 2024 and 2023, we recognized $ 264 million, $ 282 million and $ 287 million, respectively, of interest and penalties through the income tax provision in the Consolidated Statements of Income.

The decrease in interest expense for the year ended December 31, 2024, was primarily due to an IRS advance deposit of $ 800 million paid during the first quarter of 2024.

The decrease in interest expense for the year ended December 31, 2025, was primarily due to lower interest rates in 2025 compared to those in 2024.

As of December 31, 2025 and 2024, accrued interest and penalties associated with UTBs were $ 1.9 billion and $ 1.6 billion, respectively.

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate were as follows:

Years ended December 31,

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate for 2025 were as follows (in millions, except percentages):

Year ended December 31, 2025

Effective Tax Rate

Federal statutory tax rate

$ 1,885 21.0 %

Foreign tax effects:

Tax rate differential

Valuation allowance

Tax rate differential

Act 52 - withholding tax

Act 52 - income tax

( 968 ) ( 10.8 ) %

Tax incentive grant

( 122 ) ( 1.4 ) %

Pillar Two minimum tax 147 1.6 %

( 29 ) ( 0.3 ) %

Other foreign jurisdictions

Effect of cross-border tax laws:

tax on foreign subsidiaries (net of credits and deferred taxes)

( 545 ) ( 6.0 ) %

Foreign-derived intangible income

( 222 ) ( 2.5 ) %

( 18 ) ( 0.2 ) %

Credit on foreign taxes imposed on U.S.

( 456 ) ( 5.0 ) %

Research and development tax credits

( 272 ) ( 3.0 ) %

Other adjustments

Changes in unrecognized tax benefits (primarily interest)

Effective tax rate

$ 1,265 14.1 %

The reconciliations between the federal statutory tax rate applied to income before income taxes and our effective tax rate for 2024 and 2023 were as follows:

Years ended December 31,

Federal statutory tax rate 21.0 % 21.0 %

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The effective tax rates for the years ended December 31, 2025, 2024 and 2023, differ from the federal statutory rate primarily due to impacts of the jurisdictional mix of income and expenses.

Substantially all of the benefit to our effective tax rate from foreign earnings results from locations where 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.

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.

Additionally, the Company’s operations conducted in Singapore are subject to a tax incentive grant through 2036.

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 10.5% and to the OECD’s 15% global minimum tax in jurisdictions where enacted.

Beginning on January 1, 2023, we were no longer subject to a 4% excise tax in the U.S.

territory of Puerto Rico on the gross intercompany purchase price of goods and services from our manufacturer in Puerto Rico.

We qualify for and are subject to the alternative income tax rate on industrial development income of our Puerto Rico affiliate.

In the United States, this income tax qualifies for foreign tax credits.

Both this income tax and the associated foreign tax credits are generally recognized in our provision for income taxes.

We accounted for the 2022 excise tax that was capitalized in Inventories as an expense in Cost of sales when the related products were sold in the first half of 2023, and a foreign tax credit was not recognized with respect to the excise tax expense in 2023.

We did not have this excise tax exposure in 2024.

Income taxes paid during the years ended December 31, 2024, 2023 and 2022, were $ 2.9 billion, $ 3.4 billion and $ 2.4 billion, respectively.

tax at a reduced rate of 10.5%.

Income taxes paid (net of refunds received) included the following (in millions):

Year ended December 31, 2025

payments (federal and state) $ 3,390

Puerto Rico payments 610

Other foreign payments 300

Total income taxes paid (net of refunds received) $ 4,300

Income taxes paid (net of refunds received) during the years ended December 31, 2024 and 2023, were $ 2.9 billion and $ 3.4 billion, respectively.

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.

The legislation has multiple effective dates, with certain provisions effective in 2026 and beyond.

The impact of these changes was recorded in 2025.

One or more of our legal entities file income tax returns in the U.S.

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territory of Puerto Rico.

We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution.

In July 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 that we received in May and July 2021, which seek to increase our U.S.

We disagreed with the proposed adjustments and calculations, and in 2021, 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 on our foreign earnings.

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 pursued resolution with the IRS appeals office but were unable to reach resolution.

In July 2022, we filed a petition in the U.S.

Tax Court to contest a Notice for the years 2013–2015 that we previously reported receiving in April 2022 that 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.

In addition, the Notice 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 on our foreign earnings.

We disagreed with the proposed adjustments and calculations, and in 2022, 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 are contesting the 2010–2012 and 2013–2015 Notices through the judicial process.

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 on December 19, 2022.

Tax Court in 2022.

The trial began on November 4, 2024 and concluded on January 17, 2025.

With the conclusion of the trial, the parties will file post-trial briefs and make closing arguments in 2025.

The Company expects a decision from the Tax Court no earlier than 2026.

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.

The Company expects a decision from the U.S.

Tax Court no earlier than the second half of 2026.

We are currently under examination by the IRS for the years 2016–2018 with respect to issues similar to those for the 2010 through 2015 period.

We believe that the IRS may also seek to continue to audit similar issues related to the allocation of income between the United States and the U.S.

territory of Puerto Rico for years beyond 2018.

We expect that the IRS will begin its audit of 2019-2022 in the first half 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;

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 consolidated financial statements.

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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):

The computations for basic and diluted earnings per share were as follows (in millions, except per-share data):

Years ended December 31,

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Income (Numerator):

Net income for basic and diluted EPS $ 4,090 $ 6,717 $ 6,552

Net income for basic and diluted earnings per share $ 7,711 $ 4,090 $ 6,717

Shares (Denominator):

Weighted-average shares for basic EPS 537 535 538

Weighted-average shares for basic earnings per share 538 537 535

Effect of dilutive securities 4 4 3

Weighted-average shares for diluted EPS 541 538 541

Basic EPS $ 7.62 $ 12.56 $ 12.18

Diluted EPS $ 7.56 $ 12.49 $ 12.11

Weighted-average shares for diluted earnings per share 542 541 538

Basic earnings per share $ 14.33 $ 7.62 $ 12.56

Diluted earnings per share $ 14.23 $ 7.56 $ 12.49

For each of the three years ended December 31, 2025, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

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Amgen manufactures and supplies TEZSPIRE worldwide.

During the years ended December 31, 2024, 2023 and 2022, global profit and loss share expenses were $ 412 million, $ 310 million and $ 119 million, respectively, and were recorded in Cost of sales in the Consolidated Statements of Income.

During the years ended December 31, 2025, 2024 and 2023, global profit and loss share expenses were $ 587 million, $ 412 million and $ 310 million, respectively, and were recorded primarily in Cost of sales in the Consolidated Statements of

Net costs due to AstraZeneca for global development and commercialization were not material during the years ended December 31, 2025, 2024 and 2023.

TEZSPIRE launched in the United States in January 2022.

We are in a collaboration with UCB for the development and commercialization of EVENITY.

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Amgen manufactures and supplies EVENITY worldwide.

During the years ended December 31, 2024, 2023 and 2022, global profit and loss share expenses were $ 547 million, $ 396 million and $ 255 million, respectively, and were recorded in Cost of sales in the Consolidated Statements of Income.

During the years ended December 31, 2025, 2024 and 2023, global profit and loss share expenses were $ 721 million, $ 547 million and $ 396 million, respectively, and were recorded primarily in Cost of sales in the Consolidated Statements of Income.

Net costs recovered from and due to UCB during the years ended December 31, 2025, 2024 and 2023, were not material.

BeiGene, Ltd.

In January 2020, we acquired an equity stake in BeiGene for approximately $ 2.8 billion in cash as part of a collaboration to expand our oncology presence in China.

For additional information regarding our equity investment in BeiGene, see Note 10, Investments.

Under the collaboration, BeiGene began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the initial product-specific commercialization periods;

thereafter, product rights may revert to Amgen, and Amgen would pay royalties to BeiGene on sales in China of such products for a specified period.

Amgen manufactures and supplies the collaboration products to BeiGene.

In addition, we jointly develop a portion of our oncology portfolio with BeiGene, which shares in global R&D costs by providing cash and development services of up to $ 1.25 billion.

Upon regulatory approval, BeiGene will assume commercialization rights in China for a specified period, and Amgen and BeiGene will share profits and losses equally until certain of these product rights revert to Amgen.

Upon return of the product rights, Amgen will pay royalties to BeiGene on sales in China for a specified period.

For product sales outside China, Amgen also pays royalties to BeiGene.

During the years ended December 31, 2024, 2023 and 2022, net costs recovered from BeiGene for oncology product candidates were $ 122 million, $ 109 million and $ 199 million, respectively, and were recorded as an offset to R&D expense in the Consolidated Statements of Income.

During the years ended December 31, 2024, 2023 and 2022, product sales from Amgen to BeiGene under the collaboration were $ 259 million, $ 125 million and $ 64 million, respectively, and were recorded in Product sales in the Consolidated Statements of Income.

Profit and loss share expenses related to the initial product-specific commercialization period were not material during the years ended December 31, 2024, 2023 and 2022.

BeOne Medicines Ltd.

In January 2020, we acquired an equity stake in BeOne for approximately $ 2.8 billion in cash as part of a collaboration agreement to expand our oncology presence in China.

For additional information regarding our equity investment in BeOne, see Note 10, Investments.

Under the collaboration, BeOne began selling XGEVA in 2020, BLINCYTO in 2021 and KYPROLIS in 2022 in China, and Amgen shares profits and losses equally during the product-specific commercialization periods.

Following entry into an amendment by Amgen and BeOne on November 11, 2025, BeOne will retain the right to commercialize XGEVA, BLINCYTO and KYPROLIS in China for so long as such products are sold in China.

Amgen manufactures and supplies the collaboration products to BeOne.

In addition, we jointly develop a portion of our oncology portfolio with BeOne, which shares in global R&D costs by providing cash and development services of up to $ 1.25 billion.

Upon regulatory approval, BeOne will assume commercialization rights in China for a specified period, and Amgen and BeOne will share profits and losses equally until certain of these product rights revert to Amgen.

Upon return of the product rights, Amgen will pay royalties to BeOne on sales in China for a specified period.

For product sales outside China, Amgen also pays royalties to BeOne.

During the years ended December 31, 2025, 2024 and 2023, net costs recovered from BeOne for oncology product candidates were $ 181 million, $ 122 million and $ 109 million, respectively, and were recorded as an offset to R&D expense in the Consolidated Statements of Income.

During the years ended December 31, 2025, 2024 and 2023, product sales from Amgen to BeOne under the collaboration were $ 266 million, $ 259 million and $ 125 million, respectively, and were recorded in Product sales in the Consolidated Statements of Income.

Profit and loss share expenses related to the product-specific commercialization period were not material during the years ended December 31, 2025, 2024 and 2023.

Royalties on product sales of oncology portfolio products outside of China were not material for the years ended December 31, 2025, 2024 and 2023.

Kyowa Kirin Co., Ltd.

We are in a collaboration and licensing agreement with Kyowa Kirin to jointly develop and commercialize rocatinlimab, an anti-OX40 fully human monoclonal antibody, worldwide, except in Japan.

Since 2021, we have been in a collaboration agreement with Kyowa Kirin to jointly develop and commercialize rocatinlimab, an anti-OX40 fully human monoclonal antibody, worldwide, except in Japan.

Rocatinlimab is for the treatment of atopic dermatitis, with potential for treatment of other autoimmune diseases.

Under the terms of the agreement, we lead the global development, manufacture and commercialization of rocatinlimab, except in Japan.

Kyowa Kirin will co-promote rocatinlimab with Amgen in the United States and have opt in rights to co-promote rocatinlimab in various other markets outside the United States, including in Europe and Asia.

We made an upfront payment of $ 400 million to Kyowa Kirin that was recognized in R&D expense in the third quarter of 2021.

Amgen and Kyowa Kirin share equally the global development costs, except in Japan, and the U.S.

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We will also pay Kyowa Kirin significant double-digit royalties on global sales, except in Japan.

In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In February 2026, we received such regulatory clearance.

In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.

During the years ended December 31, 2025, 2024 and 2023, net costs recovered from Kyowa Kirin were $ 117 million, $ 166 million and $ 93 million, respectively, and were recorded as an offset to R&D expense in the Consolidated Statements of Income.

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All interest-bearing securities as of December 31, 2025 and 2024, mature in one year or less.

For the years ended December 31, 2024, 2023 and 2022, interest income on these investments was $ 510 million, $ 1.2 billion and $ 127 million, respectively.

For the years ended December 31, 2024, 2023 and 2022, realized gains and losses on interest-bearing securities were not material.

Realized gains and losses on interest-bearing securities are recorded in Other income (expense), net, in the Consolidated Statements of Income.

For the years ended December 31, 2025, 2024 and 2023, interest income on these investments was $ 408 million, $ 510 million and $ 1.2 billion, respectively.

For the years ended December 31, 2025, 2024 and 2023, realized gains and losses on interest-bearing securities were not material and were recorded in Other income, net, in the Consolidated Statements of Income.

The cost of securities sold is based on the specific-identification method.

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Equity securities

BeiGene, Ltd.

On January 2, 2020, we acquired a 20.5 % ownership interest in BeiGene for $ 2.8 billion, substantially all of which was attributed to the fair value of equity securities, and we began using the equity method of accounting for this investment.

Since the fair value of equity securities acquired exceeded our proportionate share of the carrying value of BeiGene’s underlying net assets, we began amortizing the intangible assets that gave rise to this basis difference over their useful lives.

Effective January 30, 2023, we relinquished our right to appoint a director to BeiGene’s Board of Directors.

We no longer have the ability to exert significant influence over BeiGene.

As a result, in the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, which is carried at fair value with changes in fair value recorded in Other income (expense), net, in the Consolidated Statements of Income.

BeOne Medicines Ltd.

As of December 31, 2025 and 2024, our ownership interest in BeOne was approximately 17.1 % and 17.8 %, respectively, and the fair values of our investment were $ 5.8 billion and $ 3.5 billion, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets.

We account for our ownership interest as an equity security with a readily determinable fair value, which is carried at fair value with changes in fair value recorded in Other income, net, in the Consolidated Statements of Income.

See Note 18, Fair value measurement.

During the years ended December 31, 2024 and 2023, we recognized unrealized gains of $ 82 million and $ 1.2 billion, respectively, in Other income (expense), net, in the Consolidated Statements of Income.

As of December 31, 2024 and 2023, the fair values of our investment in BeiGene were $ 3.5 billion and $ 3.4 billion, respectively, and were included in Other noncurrent assets in the Consolidated Balance Sheets.

During the year ended December 31, 2022, under the equity method of accounting, the carrying value of the investment was reduced by our share of BeiGene’s net losses of $ 394 million and amortization of the basis difference of $ 190 million, with such amounts recognized in Other income (expense), net.

In addition, during the year ended December 31, 2022, the carrying value increased by $ 11 million from the impact of other BeiGene ownership transactions.

For information on a collaboration agreement we entered into with BeiGene in connection with this investment, see Note 9, Collaborations.

Subject to certain exceptions or otherwise agreed to by BeiGene, while Amgen holds at least 5.0 % of BeiGene’s outstanding common stock, (A) we may only sell our BeiGene 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 BeiGene’s outstanding common stock in any rolling 12-month period.

During the years ended December 31, 2025, 2024 and 2023, we recognized unrealized gains of $ 2.3 billion, $ 82 million, and $ 1.2 billion respectively, in Other income, net, in the Consolidated Statements of Income.

For information on a collaboration agreement we entered into with BeOne in connection with this investment, see Note 9, Collaborations.

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 investments in BeiGene (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 314 million and $ 494 million as of December 31, 2024 and 2023, respectively, which are included in Other noncurrent assets in the Consolidated Balance Sheets.

For the years ended December 31, 2024, 2023 and 2022, net unrealized gains and losses on publicly traded securities resulted in a net loss of $ 21 million , a net gain of $ 98 million and a net loss of $ 165 million , respectively.

Excluding our equity investments in BeOne (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 326 million and $ 314 million as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets.

For the years ended December 31, 2025, 2024 and 2023, net unrealized gains and losses on publicly traded securities resulted in a net gain of $ 109 million , a net loss of $ 21 million and a net gain of $ 98 million , respectively.

Realized gains and losses on publicly traded securities for the years ended December 31, 2025, 2024 and 2023, were not material.

We held investments of $ 319 million and $ 309 million in equity securities without readily determinable fair values as of December 31, 2024 and 2023, respectively, which are included in Other noncurrent ass ets in the Consolidated Balance Sheets.

We held investments of $ 362 million and $ 319 million in equity securities without readily determinable fair values as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent ass ets in the Consolidated Balance Sheets.

For the years ended December 31, 2025, 2024 and 2023 , gains due to upward adjustments and gains realized upon dispositions of these securities were not material.

For the years ended December 31, 2025, 2024 and 2023 downward adjustments were not material.

For the year ended December 31, 2022, down ward adjustments to the carrying values of these securities were $ 67 million.

Adjustments were based on observable price transactions.

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Neumora Therapeutics, Inc.

As of December 31, 2024 and 2023, our ownership interests in Neumora were approximately 21.9 % and 23.2 %, respectively, and the fair values of our investment were $ 375 million and $ 603 million, respectively, which are included in Other noncurrent assets in the Consolidated Balance Sheets.

As of December 31, 2025 and 2024, our ownership interest in Neumora was approximately 21.2 % and 21.9 %, respectively, and the fair values of our investment were $ 63 million and $ 375 million, respectively, which were included in Other noncurrent assets in the Consolidated Balance Sheets.

Although our equity investment qualifies us for the equity method of accounting, we have elected the fair value option to account for our investment.

See Note 18, Fair value measurement.

Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other income (expense), net, in the Consolidated Statements of Income each reporting period.

Under the fair value option, changes in the fair value of the investment are recognized through earnings in Other income, net, in the Consolidated Statements of Income each reporting period.

We believe the fair value option best reflects the economics of the underlying transaction.

During the years ended December 31, 2024, 2023 and 2022 , we recognized unrealized losses of $ 228 million and unrealized gains of $ 238 million and $ 105 million, respectively, for the change in fair values in Other income (expense), net, in the Consolidated Statements of Income.

On January 2, 2025, Neumora released results of a Phase 3 study of navacaprant, and Neumora’s stock price declined.

During the years ended December 31, 2025, 2024 and 2023 , we recognized unrealized losses of $ 312 million and $ 228 million and an unrealized gain of $ 238 million, respectively, for the change in fair values in Other income, net, in the Consolidated Statements of Income.

We are contractually restricted from selling more than 5.0 % of Neumora’s outstanding common stock in any rolling 12-month period for as long as we hold at least 10.0 % of their outstanding common stock, subject to certain exceptions or otherwise agreed to by Neumora.

Limited partnerships

We held limited partnership investments of $ 262 million and $ 251 million as of December 31, 2024 and 2023, respectively, which are included in Other noncurrent assets in the Consolidated Balance Sheets.

We held limited partnership investments of $ 253 million and $ 262 million as of December 31, 2025 and 2024, respectively, which were included in Other noncurrent assets in the 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 December 31, 2024, unfunded additional commitments to be made for these investments during the next several years were $ 133 million .

As of December 31, 2025, we had $ 134 million of unfunded additional commitments to be made for these investments during the next several years.

For the years ended December 31, 2025, 2024 and 2023, net gains and losses recognized from our limited partnership investments were not material.

For the year ended December 31, 2022, net losses recognized from our limited partnership investments were $ 284 million .

Inventories consisted of the following (in millions):

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$ 6,225 $ 6,998

(1) The decrease to Inventories during the year ended December 31, 2024, was primarily due to amortization of the inventory step-up to fair value related to acquired inventory from the Horizon acquisition.

See Note 4, Acquisitions and divestitures.

Property, plant and equipment

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(1) For 2024, changes to Goodwill consisted of measurement-period adjustments related to our Horizon acquisition.

For 2023, changes to Goodwill primarily consisted of goodwill resulting from our Horizon acquisition.

See Note 4, Acquisitions and divestitures.

Other intangible assets

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Licensing rights 3,917 ( 3,522 ) 395 3,875 ( 3,392 ) 483

Marketing-related rights 1,202 ( 1,202 ) — 1,339 ( 1,264 ) 75

R&D technology rights 1,425 ( 1,305 ) 120 1,374 ( 1,235 ) 139

Marketing-related rights 1,203 ( 1,203 ) — 1,202 ( 1,202 ) —

Total finite-lived intangible assets 54,350 ( 32,784 ) 21,566 55,062 ( 28,423 ) 26,639

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Total other intangible assets $ 55,060 $ ( 32,784 ) $ 22,276 $ 56,122 $ ( 28,423 ) $ 27,699

Developed-product-technology rights consists of rights related to marketed products acquired in acquisitions.

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;

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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.

R&D technology rights pertain to technologies used in R&D that have alternative future uses.

The Company monitors intangible assets for impairment on a quarterly basis.

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 aggregate impairment charges of $ 1.2 billion during the year ended December 31, 2025 were recognized in Other operating expenses in the Consolidated Statements of Income.

See Note 18, Fair value measurement.

The developed-product-technology rights intangible assets related to TAVNEOS have a carrying value of $ 2.5 billion as of December 31, 2025 with $ 2.4 billion related to the U.S.

On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S.

Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile.

On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market.

Amgen is evaluating next steps with the FDA to determine a path forward.

Future changes to estimated TAVNEOS cash flows could unfavorably impact the Company’s ability to recover the carrying value of the related intangible asset.

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.

All IPR&D projects have major risks

and uncertainties associated with the timely and successful completion of the development and commercialization of product candidates, including our ability to confirm safety and efficacy based on data from clinical trials, our ability to obtain necessary regulatory approvals and our ability to successfully complete these tasks within budgeted costs.

All IPR&D projects have major risks and uncertainties associated with the timely and successful completion of the development and commercialization of product candidates, including our ability to confirm safety and efficacy based on data from clinical trials, our ability to obtain necessary regulatory approvals and our ability to successfully complete these tasks within budgeted costs.

We are not permitted to market a human therapeutic without obtaining regulatory approvals, and such approvals require the completion of clinical trials that demonstrate that a product candidate is safe and effective.

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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.

During the year ended December 31, 2023, the development of AMG 340 acquired in connection with our Teneobio acquisition was terminated, resulting in an impairment charge of $ 783 million, which was recognized in Other operating expenses in the Consolidated Statements of Income and included in Other items, net, in the Consolidated Statements of Cash Flows.

See Note 18, Fair value measurement, for the impact on the related contingent consideration liability.

The Company monitors intangible assets for impairment on a quarterly basis.

The Developed-product-technology rights intangible asset related to Otezla has a carrying value of $ 5.2 billion as of December 31, 2024.

In January 2025, Otezla was selected by CMS for Medicare price setting under the IRA that will be applicable beginning on January 1, 2027.

Future changes to the Company’s estimates of the impact of the price negotiations under the IRA, as well as regulatory, market and competitive developments, could unfavorably impact the Company’s ability to recover the carrying value of the related intangible asset.

During the years ended December 31, 2024, 2023 and 2022, we recognized amortization associated with our finite-lived intangible assets of $ 4.8 billion, $ 3.2 billion and $ 2.6 billion, respectively.

Amortization of intangible assets is included primarily in Cost of sales in the Consolidated Statements of Income.

The total estimated amortization for our finite-lived intangible assets for the years ending December 31, 2025, 2026, 2027, 2028 and 2029, is $ 4.5 billion, $ 3.9 billion, $ 3.9 billion, $ 2.9 billion and $ 2.2 billion, respectively.

During the second quarter of 2025, the FDA approved UPLIZNA for the IgG4-RD indication, and commercialization commenced in the United States.

As a result, the Company reclassified the related intangible asset with a gross carrying value of $ 350 million from IPR&D to developed-product-technology rights and began amortizing it on a straight-line basis over its estimated useful life of approximately 11 years from the date placed in service.

During the years ended December 31, 2025, 2024 and 2023, we recognized amortization of our finite-lived intangible assets of $ 4.3 billion, $ 4.8 billion and $ 3.2 billion, respectively.

Amortization of intangible assets is primarily included in Cost of sales in the Consolidated Statements of Income.

As of December 31, 2025, the total estimated future amortization of our finite-lived intangible assets for the years ending December 31, 2026, 2027, 2028, 2029 and 2030, was $ 3.6 billion, $ 3.5 billion, $ 2.8 billion, $ 2.3 billion and $ 2.2 billion, respectively.

We lease certain facilities and equipment related primarily to R&D, administrative and commercial activities.

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Present value of lease liabilities $ 831

(1) Includes future rental commitments for abandoned leases of $ 51 million.

We expect to receive total future rental income of $ 54 million related to noncancellable subleases for abandoned facilities.

(1) Includes future rental commitments for properties that have been subleased in the amount of $ 99 million.

We expect to receive total future rental income of $ 54 million related to noncancellable subleases.

The weighted-average remaining lease terms and weighted-average discount rates were as follows:

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Prepaid expenses $ 2,945 $ 2,139

Corporate partner receivables 521 502

Tax receivables 198 172

Other 1,188 1,138

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Sales deductions $ 10,606 $ 8,405

Income taxes payable 2,583 1,664

Employee compensation and benefits 1,437 1,329

Dividends payable 1,358 1,278

Accrued interest payable 867 936

Income taxes payable 379 2,583

Other 4,743 4,046

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3.125 % notes due 2025 ( 3.125 % 2025 Notes)

Term loan due April 2025 — 2,000

3.125 % notes due 2025 ( 3.125 % 2025 Notes)

2.00 % € 750 million notes due 2026 ( 2.00 % 2026 euro Notes)

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Certain of the redeemable notes do not require the payment of make-whole amounts if redeemed during a specified period of time immediately prior to the maturity of the notes.

Such time periods range from one month to six months prior to maturity, except for the 5.507 % 2026 Notes, which may be redeemed without payment of the make-whole amount if redemption occurs after two years prior to maturity.

Such time periods range from one month to six months prior to maturity.

Debt issuances and acquisition-related financing

We did not issue debt securities during the year ended December 31, 2024.

In March 2023, in connection with the acquisition of Horizon (see Note 4, Acquisitions and divestitures —Acquisition of Horizon Therapeutics plc ), we issued the following series of notes (in millions):

We did not issue debt securities during the years ended December 31, 2025 and 2024.

In March 2023, in connection with the acquisition of Horizon (see Note 4, Acquisition), we issued the following series of notes (in millions):

Principal Amount

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As of December 31, 2025, we had $ 1.8 billion of borrowings outstanding under the term loan credit agreement, which has an interest rate of three-month SOFR plus 1.225 % and is due in October 2026.

In 2022, we issued $ 7.0 billion of debt consisting of $ 750 million of the 3.00 % 2029 Notes, $ 1.25 billion of the 4.05 % 2029 Notes, $ 1.0 billion of the 3.35 % 2032 Notes, $ 750 million of the 4.20 % 2033 Notes, $ 1.0 billion of the 4.20 % 2052 Notes, $ 1.0 billion of the 4.875 % 2053 Notes and $ 1.25 billion of the 4.40 % 2062 Notes.

The 3.00 % 2029 Notes were issued and used to finance eligible projects that met specified criteria to reduce our impact on the environment.

Debt extinguishment

In 2024, we repurchased an aggregate principal amount of our debt of $ 875 million, including portions of the 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 $ 659 million, which resulted in a $ 215 million gain on extinguishment of debt recorded in Other income (expense), net, in the Consolidated Statements of Income.

In 2023, we repurchased an aggregate principal amount of our debt of $ 881 million, 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 $ 647 million, which resulted in a $ 225 million gain on extinguishment of debt recorded in Other income (expense), net, in the Consolidated Statements of Income.

In 2022, we repurchased an aggregate principal amount of our debt of $ 378 million, including portions of the 2.20 % 2027 Notes, 1.65 % 2028 Notes, 2.00 % 2032 Notes, 2.80 % 2041 Notes and 3.00 % 2052 Notes, for an aggregate cost of $ 297 million, which resulted in a $ 78 million gain on extinguishment of debt recorded in Other income (expense), net, in the Consolidated Statements of Income.

In 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 recorded in Other income, net, in the Consolidated Statements of Income.

cost of $ 659 million, which resulted in a $ 215 million gain on extinguishment of debt recorded in Other income, net, in the Consolidated Statements of Income.

Debt repayments

In 2024, we repaid the full $ 2.0 billion aggregate principal amount on the term loan due April 2025, $ 200 million of the aggregate principal amount on the term loan due October 2026 and the full $ 1.4 billion aggregate principal amount of the 3.625 % 2024 Notes.

In 2023, we repaid the full $ 750 million aggregate principal amount of the 2.25 % 2023 Notes and the full CHF 700 million aggregate principal amount ($ 704 million upon settlement of the related cross-currency swap) of the 0.41 % 2023 Swiss franc Bonds.

In 2022, no debt was repaid or redeemed.

In 2025, debt repayments totaled $ 5.0 billion, including repayments in full of the $ 500 million aggregate principal amount of the 1.90 % 2025 Notes, $ 2.0 billion aggregate principal amount of the 5.25 % 2025 Notes, $ 1.0 billion aggregate principal amount of the 3.125 % 2025 Notes and $ 1.5 billion aggregate principal amount of the 5.507 % 2026 Notes.

In 2024, debt repayments totaled $ 3.6 billion, including the full $ 2.0 billion aggregate principal amount on the term loan due April 2025, $ 200 million of the aggregate principal amount on the term loan due October 2026 and the full $ 1.4 billion aggregate principal amount of the 3.625 % 2024 Notes.

In 2023, debt repayments totaled $ 1.5 billion, including the full $ 750 million aggregate principal amount of the 2.25 % 2023 Notes and the full CHF 700 million aggregate principal amount ($ 704 million upon settlement of the related cross-currency swap) of the 0.41 % 2023 Swiss franc Bonds.

Interest rate swaps

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Shelf registration statement and other facilities

As of December 31, 2024, we have a commercial paper program that allows us to issue up to $ 2.5 billion of unsecured commercial paper to fund our working-capital needs.

As of December 31, 2025, we have a commercial paper program that allows us to issue up to $ 4.0 billion of unsecured commercial paper to fund working capital needs.

As of December 31, 2025 and 2024, we had no amounts outstanding under our commercial paper program.

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preferred stock;

warrants to purchase debt securities, common stock, preferred stock or depositary

warrants to purchase debt securities, common stock, preferred stock or depositary shares;

rights to purchase common stock or preferred stock;

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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 2026.

This shelf registration statement expired in February 2026, and our Board has approved a new shelf registration statement to replace it.

Certain of our financing arrangements contain nonfinancial covenants.

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Interest costs capitalized for the years ended December 31, 2025, 2024 and 2023, were not material.

Interest paid, including the ongoing impact of interest rate and cross-currency swap contracts, during the years ended December 31, 2024, 2023 and 2022 was $ 3.3 billion, $ 2.4 billion and $ 1.2 billion, respectively.

Interest paid, net of amounts capitalized and including the ongoing impact of interest rate and cross-currency swap contracts, during the years ended December 31, 2025, 2024 and 2023 was $ 2.9 billion, $ 3.3 billion and $ 2.4 billion, respectively.

Stockholders’ equity

Stock repurchase program

During the years ended December 31, 2025 and 2023, we did not repurchase shares under our stock repurchase program.

During the year ended December 31, 2024, we repurchased 0.7 million shares of our common stock for a total cost of $ 200 million under our stock repurchase program.

During the year ended December 31, 2023, we did not repurchase any shares of our common stock under our stock repurchase program.

During the year ended December 31, 2022, we repurchased 26.1 million shares of our common stock under our stock repurchase program, consisting primarily of 24.8 million shares received under ASR agreements, for a total cost of $ 6.3 billion.

As of December 31, 2024, $ 6.8 billion remained available under our stock repurchase program.

As of December 31, 2025, $ 6.8 billion of authorization remained available under the stock repurchase program.

Our Board of Directors declared quarterly dividends per share of $ 2.38 , $ 2.25 and $ 2.13 , which were paid in each of the four quarters of 2025, 2024 and 2023, respectively.

Historically, we have declared dividends in December of each year, which were paid in the first quarter of the following fiscal year and in March, July and October, which were paid in the second, third and fourth quarters, respectively, of the same fiscal year.

Additionally, on December 10, 2024, the Board of Directors declared a quarterly cash dividend of $ 2.38 per share of common stock, which will be paid in March 2025, to all stockholders of record as of the close of business on February 14, 2025.

Additionally, in December 2025, the Board of Directors declared a quarterly cash dividend of $ 2.52 per share of common stock, which will be paid in March 2026, to all stockholders of record as of the close of business on February, 13 2026.

Accumulated other comprehensive loss

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Unrealized gains — 28 — 28

Reclassification adjustments to earnings

Reclassification adjustments into earnings — ( 222 ) — ( 222 )

Income taxes — 44 — 44

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Unrealized gains — 506 — 506

Reclassification adjustments to earnings

Reclassification adjustments into earnings — ( 117 ) — ( 117 )

— — ( 10 ) ( 10 )

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Foreign currency translation adjustments 172 — — 172

Unrealized gains — 506 — 506

Reclassification adjustments to earnings

— ( 117 ) — ( 117 )

— — ( 10 ) ( 10 )

Unrealized losses — ( 250 ) — ( 250 )

Reclassification adjustments into earnings — ( 231 ) — ( 231 )

Income taxes — 104 — 104

Balance as of December 31, 2025 $ ( 202 ) $ ( 90 ) $ 34 $ ( 258 )

With respect to the table above, income tax expenses or benefits for unrealized gains and losses and the related reclassification adjustments to earnings for cash flow hedges were a $ 105 million expense and a $ 25 million benefit in 2024, a $ 6 million expense and a $ 50 million benefit in 2023 and a $ 19 million expense and a $ 0 million benefit in 2022, respectively.

With respect to the table above, income tax expenses or benefits for unrealized gains and losses and the related reclassification adjustments to earnings for cash flow hedges were a $ 53 million benefit and a $ 51 million benefit in 2025, a $ 105 million expense and a $ 25 million benefit in 2024, and a $ 6 million expense and a $ 50 million benefit in 2023, respectively.

Reclassifications out of AOCI and into earnings were as follows (in millions):

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Cash flow hedges:

Foreign currency contract gains $ 192 $ 180 $ 231 Product sales

Cross-currency swap contract (losses) gains ( 75 ) 42 ( 233 ) Other income (expense), net

Foreign currency forward contract gains $ 10 $ 192 $ 180 Product sales

Cross-currency swap contract gains (losses) 221 ( 75 ) 42 Other income, net

231 117 222 Income before income taxes

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Fair value measurement

To estimate the fair value of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available.

To estimate the fair values of our financial assets and liabilities, we use valuation approaches within a hierarchy that maximizes the use of observable inputs and minimizes 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.

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Cross-currency swap contracts — 48 — 48

Interest rate swap contracts — — — —

Total assets $ 13,539 $ 1,374 $ — $ 14,913

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Foreign currency forward contracts — 420 — 420

Cross-currency swap contracts — — — —

Interest rate swap contracts — — — —

Total assets $ 14,542 $ 1,552 $ — $ 16,094

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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 investments in BeiGene and Neumora, as of December 31, 2024 and 2023, are based on quoted market prices in active markets, with no valuation adjustment .

The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeOne and Neumora, as of December 31, 2025 and 2024, are based on quoted market prices in active markets, with no valuation adjustment .

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.

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Contingent consideration obligations

As a result of our business acquisitions, we have incurred contingent consideration obligations as discussed below.

As a result of business development activity, we have incurred contingent consideration obligations as discussed below.

The 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.

The fair value measurements of these obligations are based on significant unobservable inputs related to licensing rights and product candidates acquired in business combinations, and they are reviewed quarterly by management in our R&D and commercial sales organizations.

The fair value measurements of these obligations are based on significant unobservable inputs related to licensing rights and product candidates acquired through business development activity, and they are reviewed quarterly by management in our R&D and commercial sales organizations.

The inputs include, as applicable, estimated probabilities and the timing of achieving specified development, regulatory and commercial milestones as well as estimated annual sales.

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Years ended December 31,

2024 2023 2022

Beginning balance $ 106 $ 96

Additions 68 —

Payments ( 7 ) ( 8 )

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Ending balance $ 161 $ 106

As of December 31, 2024 and 2023, our contingent consideration obligations are primarily the result of our acquisition of Teneobio in October 2021, which obligates us to make payments to the former shareholders upon achievement of separate development and regulatory milestones with regard to various R&D programs.

In 2023, the development of AMG 340 was terminated, resulting in a decrease of the related contingent consideration liability.

During the year ended December 31, 2023, the remeasurement of our contingent consideration liability of $ 165 million, which was primarily related to the termination of AMG 340, was recognized in Other operating expenses in the Consolidated Statements of Income and included in Other items, net, in the Consolidated Statements of Cash Flows.

See Note 13, Goodwill and other intangible assets, for the impact on the related IPR&D asset.

As of December 31, 2025 and 2024, our contingent consideration obligations were primarily the result of our acquisition of Teneobio in October 2021, which obligates us to make payments to the former shareholders upon achievement of separate development and regulatory milestones with regard to various R&D programs, and other business development activity in 2025.

Summary of the fair values of other financial instruments

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The fair values of cash equivalents are approximated at their carrying values due to the short-term nature of such financial instruments.

We estimate the fair values of our fixed-rate notes by using Level 2 inputs.

As of December 31, 2024 and 2023, the aggregate fair values of our fixed-rate notes were $ 54.9 billion and $ 59.2 billion, respectively, and the carrying values of our fixed-rate notes were $ 58.3 billion and $ 60.6 billion, respectively.

The estimates of the fair values of our term loans approximate their carrying values as of December 31, 2024 and 2023 as these debt instruments bear interest at floating rates.

During the years ended December 31, 2024 and 2023, there were no transfers of assets or liabilities between fair value measurement levels, and except with respect to the IPR&D intangible impairment of AMG 340 in 2023 as disclosed in Note 13, Goodwill and other intangible assets, there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

We estimate the fair values of our fixed-rate debt by using Level 2 inputs.

As of December 31, 2025 and 2024, the aggregate fair values of our fixed-rate debt were $ 51.0 billion and $ 54.9 billion, respectively, and the carrying values of our fixed-rate debt were $ 52.8 billion and $ 58.3 billion, respectively.

The estimate of the fair value of our term loan is approximated at its carrying value as of December 31, 2025 and 2024, as this debt instrument bears interest at a floating rate.

During the years ended December 31, 2025 and 2024, 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 2025 and the IPR&D intangible impairment of AMG 340 in 2023 as disclosed in Note 13, 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.

Derivative instruments

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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 December 31, 2024, 2023 and 2022, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.2 billion, $ 6.6 billion and $ 6.0 billion, respectively.

As of December 31, 2025 and 2024, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.8 billion and $ 7.2 billion, respectively.

We have designated these foreign currency forward contracts, which are primarily euro based, as cash flow hedges.

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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 Consolidated Balance Sheets and reclassified to Other income (expense), net, in the Consolidated Statements of Income in the same periods during which the hedged debt affects earnings.

Accordingly, the unrealized gains and losses on these contracts are recorded in AOCI in the Consolidated Balance Sheets and reclassified to Other income, net, in the 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 December 31, 2025, were as follows (notional amounts in millions):

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Gains and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI in the Consolidated Balance Sheets and are amortized into Interest expense, net, in the Consolidated Statements of Income over the terms of the associated debt issuances.

Amounts expected to be recognized during the subsequent 12 months on forward interest rate contracts are not material.

The unrealized gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):

In 2025, we entered into forward interest rate contracts with an aggregate notional amount of $ 500 million.

Amounts recognized in connection with forward interest rate contracts during the years ended December 31, 2025, 2024 and 2023, and amounts expected to be recognized during the next 12 months on forward interest rate contracts were not material.

Unrealized gains and losses recognized in AOCI for our derivative instruments designated as cash flow hedges were as follows (in millions):

Years ended December 31,

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Forward interest rate contracts — — ( 31 )

Total unrealized gains $ 506 $ 28 $ 84

Total unrealized (losses) gains $ ( 250 ) $ 506 $ 28

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 were designated as 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 both December 31, 2024 and 2023, we had interest rate swap contracts with an aggregate notional amount of $ 6.7 billion that hedge certain portions of our long-term debt issuances.

During the year ended December 31, 2024, interest rate swap contracts with an aggregate notional amount of $ 1.4 billion matured in connection with the repayment of the 3.625 % 2024 Notes.

In addition, we entered into new interest rate swap contracts with respect to the 5.25 % 2033 Notes for an aggregate notional amount of $ 1.4 billion at an interest rate of SOFR plus 1.8 %.

As of both December 31, 2025 and 2024, we had interest rate swap contracts with an aggregate notional amount of $ 6.7 billion that hedge certain portions of our long-term debt.

In 2025, interest rate swap contracts with an aggregate notional amount of $ 1.0 billion matured in connection with the repayment of the 3.125 % 2025 Notes.

Also in 2025, we entered into $ 1.0 billion of new interest rate swap contracts to hedge a portion of our 5.25 % 2033 Notes.

As of December 31, 2025 and 2024, the interest rates on the portion of notes for which we have entered into interest rate swap contracts and the related notional amounts of these contracts were as follows (dollar amounts in millions):

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1,500 SOFR + 4.3 %

4.663 % 2051 Notes

1,500 SOFR + 4.3 %

Total notional amounts $ 6,650 $ 6,650

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Year ended December 31, 2025

Product sales Other income (expense), net Interest expense, net

Product sales Other income, net Interest expense, net

Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 35,148 $ 2,651 $ ( 2,755 )

The effects of cash flow and fair value hedging:

Gains (losses) on cash flow hedging relationships reclassified out of AOCI:

Gains on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ 10 $ — $ —

Cross-currency swap contracts $ — $ 221 $ —

Gains on fair value hedging relationships—interest rate swap agreements:

(Losses) gains on fair value hedging relationships—interest rate swap agreements:

Hedged items (1)

$ — $ — $ ( 182 )

Derivatives designated as hedging instruments $ — $ — $ 238

Year ended December 31, 2024

Product sales Other income (expense), net Interest expense, net

Product sales Other income, net Interest expense, net

Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 32,026 $ 506 $ ( 3,155 )

The effects of cash flow and fair value hedging:

Gains on cash flow hedging relationships reclassified out of AOCI:

Gains (losses) on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ 192 $ — $ —

Cross-currency swap contracts $ — $ ( 75 ) $ —

(Losses) gains on fair value hedging relationships—interest rate swap agreements:

Gains on fair value hedging relationships—interest rate swap agreements:

Hedged items (1)

$ — $ — $ ( 118 )

Derivatives designated as hedging instruments $ — $ — $ 40

Year ended December 31, 2023

Product sales Other income (expense), net Interest expense, net

Product sales Other income, net Interest expense, net

Total amounts recorded in income and (expense) line items presented in the Consolidated Statements of Income $ 26,910 $ 2,833 $ ( 2,875 )

The effects of cash flow and fair value hedging:

Gains (losses) on cash flow hedging relationships reclassified out of AOCI:

Gains on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ 180 $ — $ —

Cross-currency swap contracts $ — $ 42 $ —

Gains (losses) on fair value hedging relationships—interest rate swap agreements:

(Losses) gains on fair value hedging relationships—interest rate swap agreements:

Hedged items (1)

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No portions of our cash flow hedge contracts were excluded from the assessment of hedge effectiveness.

As of December 31, 2024, we expected to reclassify $ 170 million of net gains on our foreign currency and cross-currency swap contracts out of AOCI and into earnings during the next 12 months.

As of December 31, 2025, the amount of net losses 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 $ 120 million.

Derivatives not designated as hedges

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Most of these exposures are hedged on a month-to-month basis.

As of December 31, 2024, 2023 and 2022, the total notional amounts of these foreign currency forward contracts were $ 148 million, $ 457 million and $ 517 million, respectively.

As of December 31, 2025 and 2024, the total notional amounts of these foreign currency forward contracts were $ 240 million and $ 148 million, respectively.

Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the years ended December 31, 2025, 2024 and 2023.

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Total derivatives designated as hedging instruments

Derivatives not designated as hedging instruments:

Foreign currency forward contracts

Other current assets 1 Accrued liabilities 1

Total derivatives not designated as hedging instruments

Total derivatives $ 244 $ 827

7 unchanged sentences

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 $ 420 $ 1,022

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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 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.

The cash flow effects of our derivative contracts in the Consolidated Statements of Cash Flows are included in Net cash provided by operating activities, except for the settlement of notional amounts of cross-currency swaps, which are included in Net cash (used in) provided by financing activities.

The cash flow effects of our derivative contracts in the Consolidated Statements of Cash Flows are primarily included in Net cash provided by operating activities, except for the settlement of notional amounts of cross-currency swaps, which are included in Net cash (used in) provided by financing activities.

Contingencies and commitments

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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.

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-quantified amount of damages or an amount that is not material.

In addition, a number of the matters pending against us are at very early stages of the legal process, which in complex proceedings of the sort we face often extend for several years.

As a result, none of the matters described in this filing, in which we could incur a liability, have progressed sufficiently through discovery and/or the development of important factual information and legal issues to enable us to estimate a range of possible loss, if any, or such amounts are not material.

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.

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and Sanofi Winthrop Industrie S.A.

filed a joint opposition against Amgen’s patent, and each of Lilly, Regeneron Pharmaceuticals, Inc.

filed a joint opposition against Amgen’s patent, and each of Eli Lilly and Company, Regeneron Pharmaceuticals, Inc.

(Regeneron) and Strawman Ltd.

2 unchanged sentences

On October 29, 2020, the TBA upheld the validity of certain claims, including claims that protect Repatha, but ruled that broader claims encompassing PRALUENT ® were invalid.

As a result of the TBA’s decision, national litigations regarding PRALUENT in Germany are in the process of being resolved.

In Germany, Sanofi-Aventis Deutschland GmbH and Regeneron filed actions in the Regional Court of Munich seeking damages arising from the provisional enforcement of an injunction against PRALUENT that was lifted after the TBA’s October 2020 ruling.

On May 8, 2024, the Regional Court of Munich issued a preliminary decision and scheduled a further oral hearing on January 15, 2025.

On November 13, 2024, the Regional Court of Munich scheduled the next hearing in the matter for May 21, 2025.

On July 21, 2022, Sanofi Biotechnology SAS filed an action against Amgen GmbH and Amgen (Europe) B.V.

As a result of the TBA’s decision, any national litigations regarding infringement of the EP`124 Patent by PRALUENT ® were terminated.

In Germany, Sanofi-Aventis Deutschland GmbH and Regeneron filed actions in the Regional Court of Munich seeking damages arising from the provisional enforcement of an injunction against PRALUENT ® that was lifted after the TBA’s October 2020 ruling on the EP’124 Patent.

On May 8, 2024, the Regional Court of Munich issued a preliminary decision.

The case is still pending, but further proceedings were stayed on December 9, 2025.

Also in Germany, on July 21, 2022, Sanofi Biotechnology SAS filed an action against Amgen GmbH and Amgen (Europe) B.V.

before the Regional Court of Dusseldorf alleging that the marketing and sale of Repatha infringes European Patent No.

2,756,004 (the EP’004 Patent), which Sanofi Biotechnology SAS licensed from Regeneron.

Sanofi Biotechnology SAS is seeking

infringement damages and injunctive relief.

Sanofi Biotechnology SAS is seeking infringement damages and injunctive relief.

On May 13, 2024, the Regional Court of Dusseldorf stayed the hearing on Sanofi Biotechnology SAS’ infringement action pending the outcome of Amgen’s nullity action against the EP’004 Patent before the German Federal Patent Court.

On December 29, 2025, the Regional Court of Dusseldorf lifted the stay and scheduled an oral hearing on May 12, 2026 to address whether Amgen infringes the EP’004 Patent in Germany.

On August 3, 2023, Amgen GmbH filed a nullity action before the German Federal Patent Court seeking invalidation of Regeneron’s EP’004 Patent.

Regeneron filed a Statement of Defense on November 20, 2023.

On February 29, 2024, the German Federal Patent Court scheduled the main hearing for November 25, 2025.

On November 25, 2025, the German Federal Patent Court upheld the validity of Regeneron’s EP’004 Patent.

Unified Patent Court of the European Union

Actions concerning Amgen’s European Patent 3,666,797 (the EP’797 Patent)

On June 1, 2023, Amgen filed an action before the Munich Local Division of the Unified Patent Court (UPC) against Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A.

(collectively, Sanofi-Aventis), and Regeneron alleging that the importation, marketing, sale and use of PRALUENT infringes European Patent 3,666,797 (the EP’797 Patent) seeking an injunction and damages for past infringement.

(collectively, Sanofi-Aventis), and Regeneron alleging that the importation, marketing, sale and use of PRALUENT ® infringes Amgen’s EP’797 Patent seeking an injunction and damages for past infringement.

Regeneron filed counterclaims for revocation, but on February 5, 2024, the court transferred the counterclaims to the Central Division of the UPC that is presiding over Sanofi’s revocation action.

The Munich Local Division of the UPC scheduled the hearing on our EP’797 Patent infringement action to begin on October 16, 2024.

The Munich Local Division of the UPC scheduled the hearing on Amgen’s EP’797 Patent infringement action to begin on October 16, 2024.

On June 29, 2023, the Central Division of the UPC served Amgen with an action that was filed by Sanofi-Aventis that seeks revocation of the EP’797 Patent.

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Subsequently, on July 29, 2024, the Munich Local Division of the UPC stayed Amgen’s action against Sanofi-Aventis alleging that the importation, marketing, sale and use of PRALUENT ® infringes the EP’797 Patent.

On September 13, 2024, Amgen filed a Statement of Appeal with the Court of Appeals to the UPC to set aside the Central Division of the UPC’s decision to revoke the EP’797 Patent.

The Court of Appeals scheduled oral arguments to take place on May 22, 2025.

On January 10, 2024, Sanofi Biotechnologies SAS and Regeneron filed an action against Amgen Inc., Amgen Europe B.V., Amgen N.V., Amgen GmbH, Amgen B.V., Amgen SAS, and Amgen S.R.L before the Dusseldorf Local Division of the UPC, alleging infringement of EP 3,536,712 (the EP’712 Patent), which Sanofi Biotechnology SAS licensed from Regeneron.

On September 13, 2024, Amgen filed a statement of appeal with the Court of Appeals of the UPC to set aside the Central Division of the UPC’s decision to revoke the EP’797 Patent.

On August 12, 2025, the Court of Appeals of the UPC heard oral argument on Amgen’s appeal seeking to set aside the Central Division of the UPC’s decision to revoke Amgen’s EP’797 Patent and on November 25, 2025, the Court of Appeals of the UPC issued a decision upholding the validity of Amgen’s EP’797 Patent.

On January 26, 2026, Sanofi and Regeneron filed an application for rehearing and sought an order from the Court of Appeals of the UPC that the lodging of its application for rehearing suspends the UPC’s decision upholding the validity of the EP’797 Patent.

On January 29, 2026, the Court of Appeals of the UPC issued an order giving Amgen the opportunity to respond to the request for rehearing by February 26, 2026.

On February 5, 2026, Amgen filed its reply to Sanofi’s request for suspension.

On December 30, 2025, following on the Court of Appeals of the UPC’s decision finding the EP’797 Patent valid, the Munich Local Division of the UPC lifted the stay on Amgen’s case alleging that PRALUENT ® infringes Amgen’s EP’797 Patent.

The Court scheduled an interim conference to take place on June 26, 2026, and an oral argument to take place on November 19, 2026.

Actions concerning Regeneron’s European Patent 3,536,712 (the EP’712 Patent)

On January 10, 2024, Sanofi Biotechnologies SAS (Sanofi Biotechnologies) and Regeneron filed an action (the UPC Action Concerning the EP’712 Patent) against Amgen Inc., Amgen Europe B.V., Amgen N.V., Amgen GmbH, Amgen B.V., Amgen SAS, and Amgen S.R.L before the Dusseldorf Local Division of the UPC, alleging infringement of Regeneron’s EP’712 Patent, which Sanofi Biotechnology SAS licensed from Regeneron.

Sanofi and Regeneron are seeking an injunction against the sale, marketing, use, importation, or storage of Repatha for certain specified uses in Belgium, France, Germany, Italy and the Netherlands.

Amgen filed counterclaims for invalidity and non-infringement.

On September 25, 2024, Sanofi Biotechnologies SAS and Regeneron filed a brief seeking to expand the ongoing action before the Dusseldorf Local Division of the UPC, alleging that Amgen’s Repatha infringes a newly-issued patent, European Patent No.

4,252,857 (the EP’857 Patent), seeking an injunction against the marketing, use, or importation of Repatha in 18 countries (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia and Sweden) and damages for past infringement.

On December 13, 2024, the Dusseldorf Local Division of the UPC denied Sanofi and Regeneron’s request to extend the complaint and ordered that only the issues of infringement and validity of the EP’712 Patent are to be addressed at an oral hearing scheduled for February 25, 2025.

On February 4, 2025, the Dusseldorf Local Division of the UPC formally ordered separation of the EP’857 Patent from the ongoing litigation and ordered Sanofi and Regeneron to file a new Statement of Case by February 28, 2025.

On February 25, 2025, a hearing on the validity and infringement of the EP’712 Patent was held before the Dusseldorf Local Division of the UPC.

On May 13, 2025, the Dusseldorf Local Division of the UPC issued a decision that the EP’712 Patent is valid but not infringed by Amgen.

On July 11, Amgen filed its statement of appeal against the part of the Dusseldorf Local Division of the UPC’s decision finding that the EP’712 Patent is valid.

On July 14, 2025, Sanofi and Regeneron filed their statement of appeal against the decision of the Dusseldorf Local Division of the UPC finding the EP’712 Patent not infringed by Amgen.

On September 15, 2025, Amgen and Sanofi and Regeneron filed their respective grounds of appeal.

On December 15, 2025, the parties filed responses to the grounds of appeal.

Actions concerning Regeneron’s European Patent 4,252,857 (the EP’857 Patent)

On September 25, 2024, Sanofi Biotechnologies and Regeneron filed a brief seeking to expand the ongoing action before the Dusseldorf Local Division of the UPC concerning the EP’712 Patent, alleging that Amgen’s Repatha infringes a newly-issued patent, European Patent No.

4,252,857 (the EP’857 Patent) and seeking an injunction against the marketing, use, or importation of Repatha in 18 countries (Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Romania, Slovenia and Sweden) and damages for past infringement (the UPC Action Concerning the EP’857 Patent).

On December 13, 2024, the Dusseldorf Local Division of the UPC denied Sanofi and Regeneron’s request to extend the complaint.

On February 4, 2025, the Dusseldorf Local Division of the UPC formally ordered separation of the EP’857 Patent from the ongoing EP’712 Patent litigation.

On June 9, 2025, Sanofi filed a motion seeking to stay the UPC Action Concerning the EP’857 Patent, which Amgen opposed.

On August 6, 2025, the Dusseldorf Local Division of the UPC stayed the UPC Action Concerning the EP’857 Patent until the Court of Appeals of the UPC reaches a decision on the appeal from the UPC Action Concerning the EP’712 Patent.

European Patent Office

Proceedings concerning Amgen’s EP’797 Patent

On November 16, 2023 and February 29, 2024, Sanofi-Aventis and Regeneron each filed a notice of opposition against Amgen’s EP’797 Patent before the EPO’s Opposition Division.

An oral hearing has been scheduled for March 31 to April 4, 2025.

A hearing was held beginning on March 31, 2025 and on April 3, 2025, the Opposition Division determined the claims of the EP’797 Patent are valid.

On April 16, 2025, Sanofi-Aventis and Regeneron filed notices of appeal and requested expedited appeal proceedings.

The EPO TBA has scheduled a hearing on Sanofi’s and Regeneron’s appeals against the Opposition Division’s decision upholding the validity of Amgen’s EP’797 Patent to take place on April 13-15, 2026.

On January 26, 2026, Amgen filed its reply to Sanofi-Aventis’s and Regeneron’s grounds of appeal.

Proceedings concerning Regeneron’s EP’712 Patent

On February 29, 2024, Amgen filed a notice of opposition and grounds of opposition before the EPO against Regeneron’s EP’712 Patent.

On March 15, 2024, the EPO notified the parties that the opposition will be accelerated in view of the infringement action pending against Amgen on the EP’712 Patent in the Dusseldorf Local Division of the UPC.

An oral hearing has been scheduled for March 11 to 12, 2025.

On April 24, 2020, the Supreme Court of Japan declined to hear Sanofi K.K.’s appeals making final the High Court’s decisions that PRALUENT infringes Amgen’s valid patent rights in Japan.

On June 24, 2020, Amgen filed written answers to the invalidity trials initiated by Regeneron on February 12, 2020 before the Japan Patent Office seeking to invalidate Amgen’s Japanese patents that were previously held infringed by PRALUENT and valid over challenges filed by Sanofi K.K.

On April 15, 2021, the Japan Patent Office dismissed Regeneron’s invalidity trials, and in August 2021 Regeneron appealed the decisions to the High Court.

On January 26, 2023, the High Court found Amgen’s patent claims invalid for lacking adequate support and

Amgen appealed to the Supreme Court of Japan on March 13, 2023.

On March 12, 2025, following a hearing on Amgen’s opposition to Regeneron’s EP’712 Patent, the Opposition Division determined that the claims of the EP’712 Patent are valid, and issued its written decision on April 24, 2025.

On April 25, 2025, Amgen filed a notice of appeal and request for expedited appeal proceedings.

On June 2, 2025, the EPO TBA accelerated Amgen’s appeal from the EPO’s decision that Regeneron’s EP’712 Patent is valid and scheduled oral argument to take place on March 25, 2026.

Proceedings concerning Regeneron’s EP’857 Patent

On June 23, 2025, Amgen filed a notice of opposition and grounds of opposition before the EPO against Regeneron’s EP’857 Patent.

On July 7, 2025, the EPO notified the parties that the opposition proceedings concerning the EP’857 Patent have been accelerated due to the pending parallel proceedings before the UPC, and Regeneron’s response to Amgen’s grounds of opposition must accordingly be filed by October 7, 2025.

The EPO Opposition Division scheduled a hearing to take place on Amgen’s opposition against Regeneron’s EP’857 Patent on June 9-10, 2026.

On April 24, 2020, the Supreme Court of Japan declined to hear Sanofi K.K.’s appeals making final the Intellectual Property High Court’s (IP High Court) decisions that PRALUENT ® infringes Amgen’s valid patent rights in Japan.

On June 24, 2020, Amgen filed written answers to the invalidity trials initiated by Regeneron on February 12, 2020 before the Japan Patent Office (JPO) seeking to invalidate Amgen’s Japanese patents that were previously held infringed by PRALUENT ® and valid over challenges filed by Sanofi K.K.

On April 15, 2021, the JPO dismissed Regeneron’s invalidity trials, and in August 2021 Regeneron appealed the decisions to the IP High Court.

On January 26, 2023, the IP High Court found Amgen’s patent claims invalid for lacking adequate support and Amgen appealed to the Supreme Court of Japan on March 13, 2023.

On September 15, 2023, the Supreme Court of Japan declined to hear Amgen’s appeal.

The case was remanded to the Japan Patent Office for further proceedings.

Damages proceedings against Sanofi K.K.

are ongoing before the Tokyo District Court, where Sanofi K.K.

has initiated new validity challenges to Amgen patents in Japan.

The case was remanded to the JPO for further proceedings, however the case is currently stayed.

On March 31, 2021, Amgen initiated damages proceedings against Sanofi K.K.

and Sanofi K.K.

raised new validity challenges to Amgen patents.

On September 27, 2023, the Tokyo District Court found Amgen’s patent claims invalid and dismissed Amgen’s lawsuit for damages.

Amgen appealed the Tokyo District Court’s decision to the Intellectual Property High Court on December 28, 2023.

The Intellectual Property High Court rejected Amgen’s appeal and remanded the case to the Japan Patent Office.

Amgen sought amended patent claims before the Japan Patent Office.

The Japan Patent Office rejected Amgen’s amended patent claims, and Amgen filed an appeal brief with the Intellectual Property High Court on September 16, 2024 seeking to overturn the Japan Patent Office’s decision.

Amgen appealed the Tokyo District Court’s decision to the IP High Court on December 28, 2023.

The IP High Court rejected Amgen’s appeal and remanded the case to the JPO.

Amgen then sought amended patent claims before the JPO.

The JPO rejected Amgen’s amended claims, and Amgen appealed the JPO’s decision to the IP High Court on September 16, 2024.

On April 15, 2025, the IP High Court dismissed Amgen’s appeal and, on May 27, 2025, Amgen filed petition for acceptance of an appeal before the Supreme Court of Japan.

Prolia/XGEVA Biologics Price Competition and Innovation Act (BPCIA) Litigation

Celltrion Inc., et al.

On May 28, 2024, Amgen Inc.

Shanghai Henlius Biotech Inc.

On June 25, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the U.S.

District Court for the District of New Jersey (New Jersey District Court) against Celltrion Inc.

and Celltrion USA, Inc.

(collectively, Celltrion) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

District Court for the District of New Jersey (New Jersey District Court) against Shanghai Henlius Biotech Inc., Shanghai Henlius Biologics Co., Ltd,

Organon LLC and Organon & Co.

(collectively, the Shanghai Henlius and Organon Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

and 11,952,605 (collectively, the Asserted Patents against Celltrion).

Amgen seeks a judgment from the New Jersey District Court that Celltrion has infringed or will infringe one or more claims of each of the Asserted Patents against Celltrion and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Celltrion’s proposed denosumab biosimilar before expiration of each of the Asserted Patents against Celltrion found infringed.

and 12,084,686 (collectively, the Asserted Patents against the Shanghai Henlius and Organon Defendants).

Amgen seeks a judgment from the New Jersey District Court that the Shanghai Henlius and Organon Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Shanghai Henlius and Organon Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Shanghai Henlius and Organon Defendants before expiration of each of the patents found to be infringed.

Amgen also seeks monetary remedies for any past acts of infringement.

Celltrion responded to the complaint on July 11, 2024, denying infringement and asserting affirmative defenses including invalidity and non-infringement.

On November 25, 2024, the New Jersey District Court issued a Scheduling Order including a hearing on claim construction scheduled for February 14, 2025 and trial beginning on April 7, 2025.

On January 23, 2025, the New Jersey District Court issued a consent judgment and injunction finding the Asserted Patents against Celltrion valid, enforceable and infringed by the Celltrion biosimilar denosumab products in the United States.

The injunction prohibits Celltrion, its affiliates and any third party acting on behalf of or in active concert with Celltrion from making using, offering to sell, selling or importing Celltrion’s denosumab biosimilar products into the United States before June 1, 2025, except as specifically authorized by a confidential binding settlement term sheet and 35 U.S.C.

Specific financial terms remain confidential.

The parties’ remaining claims and counterclaims were dismissed with prejudice.

Samsung Bioepis Co.

On August 12, 2024, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Samsung Bioepis Co.

(Bioepis) and Samsung Biologics Co., Ltd., (Biologics, and collectively with Bioepis, Samsung) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

On June 25, 2025, this litigation became a member of In Re:

Denosumab Patent Litigation multi-district litigation with other cases involving Prolia/XGEVA biosimilars pending in the district.

On September 5, 2025, the Shanghai Henlius and Organon Defendants responded to the complaint, asserting counterclaims for invalidity and non-infringement and affirmative defenses.

On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses.

A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028.

A trial date has not yet been set.

Hikma Pharmaceuticals USA Inc.

On June 25, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Hikma Pharmaceuticals USA Inc., Gedeon Richter Plc., and Gedeon Richter USA, Inc.

(collectively, the Hikma and Gedeon Richter Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

and 11,946,085 (collectively, the Asserted Patents against Samsung).

Amgen seeks a judgment from the New Jersey District Court that Samsung has infringed or will infringe one or more claims of each of the Asserted Patents against Samsung and, based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Samsung’s proposed denosumab biosimilar before expiration of each of the Asserted Patents against Samsung found infringed.

and 12,084,686 (collectively, the Asserted Patents against the Hikma and Gedeon Richter Defendants).

Amgen seeks a judgment from the New Jersey District Court that the Hikma and Gedeon Richter Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Hikma and Gedeon Richter Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar before expiration of each of the patents found to be infringed.

Amgen also seeks monetary remedies for any past acts of infringement.

Bioepis filed its Answer and Counterclaims in response to the Complaint on October 1, 2024.

On November 12, 2024, Bioepis filed an Amended Answer and Counterclaims, and Amgen responded to the Amended Counterclaims on November 26, 2024.

Biologics’ response to the Complaint was submitted on October 28, 2024.

On June 25, 2025, this litigation became a member of In Re:

Denosumab Patent Litigation multi-district litigation with other cases involving Prolia/XGEVA biosimilars pending in the district.

A trial date has not yet been set.

Fresenius Kabi USA, LLC et al.

On October 4, 2024, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the U.S.

District Court for the Northern District of Illinois (Illinois District Court) against Fresenius Kabi USA, LLC, Fresenius SwissBiosim GmbH, Fresenius Kabi Deutschland, GmbH, and Fresenius Kabi Austria GmbH (collectively Fresenius) based on the submission to the

FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

On September 5, 2025, the Hikma and Gedeon Richter Defendants responded to the complaint, asserting counterclaims and affirmative defenses on September 5, 2025.

On October 10, 2025, Amgen responded to those counterclaims and asserted its affirmative defenses.

Pursuant to a consent order providing leave to amend, Amgen filed an Amended Complaint on November 14, 2025, adding Gedeon Richter (Schweiz) AG as a defendant to the litigation.

The parties entered into a settlement agreement that resolves the patent litigation related to the Hikma denosumab biosimilar products in the United States.

Accordingly, the New Jersey District Court entered a Consent Judgment and Injunction on November 24, 2025, finding the claims of Amgen’s U.S.

patents asserted against the Hikma and Gedeon Richter Defendants valid, enforceable and infringed by Hikma’s denosumab biosimilars in the United States and enjoining Defendants from importing, making, using, offering to sell or selling the Hikma denosumab biosimilar products in the United States before January 1, 2026, except as may be permitted by the agreement or by statue.

Amneal Pharmaceuticals, Inc.

On November 6, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals LLC, GH Genhelix S.A., Universal Farma S.L., and Mabxience Research S.L., (collectively, the Amneal and Mabxience Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

and 12,084,686 (collectively, the Asserted Patents against Fresenius).

Amgen seeks a judgment from the Illinois District Court that Fresenius has infringed or will infringe one or more claims of each of the Asserted Patents against Fresenius and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Fresenius’s proposed denosumab biosimilar before expiration of each of the Asserted Patents against Fresenius found infringed.

12,084,686 (collectively, the Asserted Patents against the Amneal and Mabxience Defendants).

Amgen seeks a judgment from the New Jersey District Court that the Amneal and Mabxience

Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Amneal and Mabxience Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused denosumab biosimilar by the Amneal and Mabxience Defendants before expiration of each of the patents found to be infringed.

Amgen also seeks monetary remedies for any past acts of infringement.

Fresenius responded to the complaint on December 4, 2024, denying infringement and asserting affirmative defenses including invalidity and non-infringement.

On February 6, 2025, the Judicial Panel on Multidistrict Litigation granted Amgen’s November 15, 2024 motion to transfer this case from the Illinois District Court to the New Jersey District Court for coordinated and consolidated pretrial proceedings with the other cases involving Prolia/XGEVA biosimilars pending in the district.

Accord et al.

On January 9, 2026 and January 23, 2026, respectively, the Amneal and Mabxience Defendants responded to the complaint asserting affirmative defenses.

This litigation is part of the In Re:

Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district.

A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028.

A trial date has not yet been set.

Reddy’s Laboratories Ltd., et al.

On November 6, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the U.S.

District Court for the Eastern District of North Carolina (North Carolina District Court) against Accord Biopharma, Inc., Accord Healthcare, Inc.

and Intas Pharmaceuticals, Ltd.

(collectively Accord) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Dr.

Reddy’s Laboratories Ltd., Dr.

Reddy’s Laboratories SA, Dr.

Reddy’s Laboratories Inc., Alvotech Hf, and Alvotech Swiss AG (collectively, the Dr.

Reddy’s and Alvotech Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

and 12,084,686 (collectively, the Asserted Patents against Accord).

Amgen seeks a judgment from the North Carolina District Court that Accord has infringed or will infringe one or more claims of each of the Asserted Patents against Accord and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Accord’s proposed denosumab biosimilar before expiration of each of the Asserted Patents against Accord found infringed.

12,084,686 (collectively, the Asserted Patents against the Dr.

Reddy’s and Alvotech Defendants).

Amgen seeks a judgment from the New Jersey District Court that the Dr.

Reddy’s and Alvotech Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Dr.

Reddy’s and Alvotech Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Dr.

Reddy’s and Alvotech Defendants before expiration of each of the patents found to be infringed.

Amgen also seeks monetary remedies for any past acts of infringement.

Accord responded to the complaint on January 10, 2025, denying infringement and asserting affirmative defenses including invalidity and non-infringement.

On February 6, 2025, the Judicial Panel on Multidistrict Litigation granted Amgen’s November 15, 2024 motion to transfer this case from the North Carolina District Court to the New Jersey District Court for coordinated and consolidated pretrial proceedings with the other cases involving Prolia/XGEVA biosimilars pending in the district.

On December 30, 2024, the parties jointly filed a stipulation agreeing to a consent injunction, which was subsequently entered by the North Carolina District Court, providing that that the Accord biosimilar products at issue will not be made, used, sold, offered for sale or imported into the United States before October 1, 2025, except as permitted by 35 U.S.C.

On January 9, 2026, the Dr.

Reddy’s and Alvotech Defendants responded to the complaint asserting counterclaims for invalidity and non-infringement and affirmative defenses.

On January 30, 2026, Amgen responded to those counterclaims and asserted its affirmative defenses.

This litigation is part of the In Re:

Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district.

A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028.

A trial date has not yet been set.

v Alkem Laboratories Ltd., et al.

On November 14, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Alkem Laboratories Ltd., Ascend Laboratories, LLC, and Enzene Biosciences (collectively, the Alkem Defendants) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

12,084,686 (collectively, the Asserted Patents against the Alkem Defendants).

Amgen seeks a judgment from the New Jersey District Court that the Alkem Defendants have infringed or will infringe one or more claims of each of the Asserted Patents against the Alkem Defendants and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of the accused proposed denosumab biosimilar by the Alkem Defendants before expiration of each of the patents found to be infringed.

Amgen also seeks monetary remedies for any past acts of infringement.

On January 23, 2026, the Alkem Defendants responded to the complaint asserting affirmative defenses and counterclaims.

On February 12, 2026, the Alkem Defendants filed an amended answer asserting affirmative defenses and counterclaims.

This litigation is part of the In Re:

Denosumab Patent Litigation multi-district litigation with other patent cases involving Prolia/XGEVA biosimilars pending in the district.

A claim construction hearing will be scheduled after June 23, 2027, and the joint pretrial order is due April 28, 2028.

A trial date has not yet been set.

PAVBLU ® (aflibercept-ayyh) Patent Litigation

On January 10, 2024, Regeneron filed a lawsuit in the U.S.

District Court for the Central District of California (California Central District Court) against Amgen alleging infringement of 32 patents listed by Regeneron in the BPCIA exchange.

The lawsuit stems from Amgen’s submission of an application under the BPCIA for FDA licensure of PAVBLU as biosimilar to Regeneron’s EYLEA.

District Court for the Central District of California (California Central District Court) against Amgen alleging infringement of 32 patents listed by Regeneron in the BPCIA exchange (the 2024 Complaint).

The lawsuit stems from Amgen’s submission of an application under the BPCIA for FDA licensure of

PAVBLU as biosimilar to Regeneron’s EYLEA ® .

By its complaint, Regeneron seeks, among other remedies, an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of each of the patents found to be infringed.

On January 11, 2024, Regeneron filed a motion with the Judicial Panel on Multidistrict Litigation to transfer this case from the California Central District Court to the U.S.

District Court for the Northern District of West Virginia (West Virginia District Court).

Amgen responded to Regeneron’s complaint on February 2, 2024, denying infringement and asserting counterclaims seeking a declaratory judgment that the asserted patents are not infringed, invalid, and/or unenforceable.

On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted Regeneron’s motion to transfer Regeneron’s patent infringement lawsuit pending against Amgen in the California Central District Court to the West Virginia District Court for coordinated and consolidated pretrial proceedings with the five other cases involving EYLEA biosimilars pending in that district.

On June 7, 2024, Regeneron filed a motion for a preliminary injunction to prohibit Amgen from engaging in the manufacture, use, offer for sell or sale within the United States, or importation into the United States, of PAVBLU until resolution of this lawsuit or the entry of a permanent injunction, whichever comes first.

On April 11, 2024, the Judicial Panel on Multidistrict Litigation granted a motion filed by Regeneron requesting transfer of Regeneron’s patent infringement lawsuit pending against Amgen in the California Central District Court to the U.S.

District Court for the Northern District of West Virginia (West Virginia District Court) for coordinated and consolidated pretrial proceedings with the five other cases involving EYLEA ® biosimilars pending in that district.

On June 7, 2024, Regeneron filed a motion in the West Virginia District Court for a preliminary injunction to prohibit Amgen from engaging in the manufacture, use, offer for sell or sale within the United States, or importation into the United States, of PAVBLU until resolution of this lawsuit or the entry of a permanent injunction, whichever comes first.

Regeneron’s motion focused on U.S.

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On October 22, 2024, the Federal Circuit Court denied Regeneron’s motion for an injunction pending appeal and lifted the temporary injunction that was entered on September 25, 2024.

Oral arguments for the appeal were held on January 14, 2025.

Oral argument for the appeal was held on January 14, 2025.

On March 14, 2025, the U.S.

Court of Appeals for the Federal Circuit affirmed the denial by the West Virginia District Court of Regeneron’s motion for a preliminary injunction.

On June 17, 2025, Regeneron filed a second lawsuit in the California Central District Court against Amgen alleging infringement of U.S.

12,331,099 (the ’099 Patent), also a formulation patent.

By its complaint, Regeneron seeks, among other remedies, damages and an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of the ’099 Patent.

In July 2025, the Judicial Panel on Multidistrict Litigation issued an Order transferring the case from the California Central District Court to the West Virginia District Court for coordinated and consolidated pretrial proceedings with the other cases involving EYLEA ® biosimilars pending in the district, and on July 31, 2025 the case was opened in the West Virginia District Court.

On September 12, 2025, Amgen responded to Regeneron’s complaint asserting infringement of the ’099 Patent, denying infringement and asserting counterclaims seeking a declaratory judgment that the ’099 Patent is not infringed, invalid, and/or unenforceable, and counterclaims for Sherman Act (15 U.S.C.

§ 2) monopolization through Walker Process fraud, Sherman Act (15 U.S.C.

§ 2) attempted monopolization through Walker Process fraud, and unlawful and unfair practices under the California Unfair Competition Law.

By its counterclaims, Amgen seeks, among other remedies, damages and an injunction against conduct by Regeneron.

On September 29, 2025, the West Virginia District Court entered a scheduling order for the matters pending in the multidistrict litigation, including a claim construction hearing for November 23, 2026.

On November 12, 2025, Regeneron filed a motion to strike certain of Amgen’s affirmative defenses and to dismiss certain of Amgen’s counterclaims, including the counterclaim seeking a declaratory judgment that the ’099 Patent is unenforceable, the counterclaims for Sherman Act monopolization and attempted monopolization, and the counterclaim for unlawful and unfair practices under the California Competition Law.

On January 7, 2026, the West Virginia District Court entered a stipulation and order of dismissal that dismissed with prejudice Regeneron’s claims with respect to 15 of the patents asserted in the 2024 Complaint and dismissed without prejudice Amgen’s counterclaims and affirmative defenses with respect to those patents.

Also on January 7, 2026, the West Virginia District Court granted Regeneron’s motion for leave to amend the 2024 Complaint.

The 2024 Complaint as amended alleges infringement of 19 patents and seeks, among other remedies, damages and an injunction prohibiting the commercial manufacture, use, offer for sale or sale in the United States or import into the United States of PAVBLU before the expiration of each of the patents found to be infringed.

KYPROLIS ® (carfilzomib) Abbreviated New Drug Application (ANDA) Patent Litigation

Onyx Therapeutics, Inc.

Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited.

On September 4, 2025, Onyx Therapeutics, Inc.

(Onyx Therapeutics, a wholly-owned subsidiary of Amgen) filed a lawsuit in the U.S.

District Court for the District of Delaware (Delaware District Court) against Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited (collectively, Amneal), asserting infringement of U.S.

7,737,112 (the ’112 Patent) based on Amneal’s submission of an application pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking FDA approval to market a generic version of KYPROLIS.

Onyx Therapeutics seeks an order from the

Delaware District Court making any FDA approval of Amneal’s application effective no earlier than the expiration of the ’112 Patent.

On November 6, 2025, Amneal answered the complaint and counterclaimed, seeking a declaration of non-infringement, and filed a motion for judgment on the pleadings of non-infringement.

On December 8, 2025, Onyx answered Amneal’s counterclaim, and on December 11, 2025, Onyx opposed Amneal’s motion for judgment on the pleadings.

On February 3, 2026, the Delaware District Court denied Amneal’s motion for judgment on the pleadings.

TAVNEOS ® (avacopan) Abbreviated New Drug Application (ANDA) Patent Litigation

ChemoCentryx, Inc.

Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited

On January 16, 2026, ChemoCentryx, Inc.

(ChemoCentryx, a wholly-owned subsidiary of Amgen) filed a lawsuit in the New Jersey District Court against Zydus Pharmaceuticals (USA) Inc., Zydus Lifesciences Global FZE, and Zydus Lifesciences Limited (collectively, Zydus) asserting infringement of U.S.

11,603,356 (the ’356 Patent) and 11,951,214 (the ’214 Patent) based on Zydus’s submission of an ANDA seeking FDA approval to market a generic version of TAVNEOS.

ChemoCentryx seeks, among other things, an order from the New Jersey District Court making any FDA approval of Zydus’s ANDA effective no earlier than the expiration of the ’356 and ’214 Patents.

ChemoCentryx, Inc.

Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited

On February 9, 2026, ChemoCentryx filed a lawsuit in the New Jersey District Court against Annora Pharma Private Limited, Hetero USA Inc., and Hetero Labs Limited (collectively, Annora) asserting infringement of the ’356 Patent and the ’214 Patent based on Annora’s submission of an ANDA seeking FDA approval to market a generic version of TAVNEOS.

ChemoCentryx seeks, among other things, an order from the New Jersey District Court making any FDA approval of Annora’s ANDA effective no earlier than the expiration of the ’356 and ’214 Patents.

Antitrust Class Action

Sensipar Antitrust Class Actions

From February to April 2019, four plaintiffs filed putative class action lawsuits against Amgen and various entities affiliated with Teva Pharmaceuticals USA, Inc.

(Teva) alleging anticompetitive conduct in connection with settlements between Amgen and manufacturers of generic cinacalcet product.

Two of those actions were brought in the U.S.

District Court for the District of Delaware (Delaware District Court), captioned UFCW Local 1500 Welfare Fund v.

Amgen Inc., et al.

(February 21, 2019) (Local 1500) and Cesar Castillo, Inc.

Amgen Inc., et al.

(February 26, 2019) (Castillo).

The third action was brought in the New Jersey District Court, captioned Teamsters Local 237 Welfare Fund, et al.

Amgen Inc., et al.

(March 14, 2019) (Local 237) and the fourth action was brought in the U.S.

District Court for the Eastern District of Pennsylvania (Eastern Pennsylvania District Court), captioned KPH Healthcare Services, Inc.

a/k/a Kinney Drugs, Inc.

Amgen Inc., et al (April 10, 2019) (KPH).

Each of the lawsuits is brought on behalf of a putative class of direct or indirect purchasers of Sensipar and alleges that the plaintiffs have overpaid for Sensipar as a result of Amgen’s conduct that allegedly improperly delayed market entry by manufacturers of generic cinacalcet products.

The lawsuits focus predominantly on the settlement among Amgen, Watson Laboratories, Inc.

(Watson) and Teva of the parties’ patent infringement litigation.

Each of the lawsuits seeks, among other things, treble damages, equitable relief and attorneys’ fees and costs.

On April 10, 2019, the plaintiff in the KPH lawsuit filed a motion seeking to have the four lawsuits consolidated and designated as a multidistrict litigation (MDL) in the Eastern Pennsylvania District Court, and the plaintiff in the Local 1500 lawsuit filed a motion seeking to have the four lawsuits, along with Cipla Ltd.

, consolidated and designated as an MDL in the Delaware District Court.

On July 31, 2019, the MDL panel entered an order consolidating in the Delaware District Court the four class action lawsuits.

On September 13, 2019, the plaintiffs filed amended complaints, and on October 15, 2019, Amgen filed its motion to dismiss both the direct purchaser plaintiffs’ consolidated class action complaint and the indirect purchaser end payer plaintiffs’ complaint.

On December 6, 2019, the plaintiffs responded to Amgen’s motion to dismiss and, on January 10, 2020, Amgen filed its response.

On February 6, 2020, the motions in the class action lawsuits were transferred to the U.S.

Magistrate Judge for the District of Delaware (Magistrate Judge) for a recommendation.

The MDL panel certified its conditional transfer order on February 6, 2020 transferring the additional class action lawsuit brought in the U.S.

District Court for the Southern District of Florida, captioned MSP Recovery Claims v.

Amgen Inc., et al.

, to the Delaware District Court.

On July 22, 2020, the Magistrate Judge issued a recommendation to the Delaware District Court that the claims against Amgen be dismissed but leave be given to plaintiffs to amend their complaints.

On August 5, 2020, the plaintiffs filed objections to the Magistrate Judge’s report and recommendation.

On August 19, 2020, Amgen filed a response to the plaintiffs’ objections.

On November 30, 2020, the Delaware District Court adopted the Magistrate Judge’s recommendation in part and denied it in part, denying Amgen’s motion to dismiss on the grounds that plaintiffs adequately alleged reverse payment claims but granted Amgen’s motion to dismiss with respect to the other Federal antitrust claims.

On December 23, 2020, Teva, Watson and Actavis filed a motion for interlocutory appeal and for a stay pending appeal and Amgen filed its joinder (the 1292 Motion).

On January 5, 2021, a joint status report was filed advising the Delaware District Court that the defendants are still considering whether to withdraw the 1292 Motion and plaintiffs’ offer to stay discovery, pending further rulings on motions to dismiss the amended complaints.

On January 19, 2021, a joint status report was filed pursuant to the Delaware District Court’s January 6, 2021 order along with a stipulation to defer the 1292 Motion until after rulings on the amended complaints.

On February 16, 2021, the plaintiffs in the antitrust class action lawsuit brought on behalf of putative classes of direct or indirect purchasers of Sensipar filed their amended complaints.

On March 4, 2021, a stipulation and order regarding the filing of a second amended complaint were filed to add another plaintiff:

Teamsters Western Region & Local 177 Health Care Fund.

On March 17, 2021, a defendant, MSP Recovery Claims, Series LLC, filed its notice of voluntary dismissal.

On March 30, 2021, the remaining defendants, including Amgen, filed their motions to dismiss the second amended complaint.

On April 27, 2021, plaintiffs filed their oppositions to defendants’ (including Amgen’s) motion to dismiss, and defendants’ reply was filed on May 25, 2021.

A hearing on defendants’ motion to dismiss was held in the Delaware District Court on July 13, 2021.

On March 11, 2022, the Delaware District Court granted defendants’ (including Amgen’s) motion to dismiss except as to the reverse payment claim and various state law claims from ten of the states in which plaintiffs reside.

On May 11, 2022, the parties filed motions asking permission to seek interlocutory appeal.

The plaintiffs did not oppose Amgen’s motion and instead argued all issues should be appealed at this time.

Amgen filed its opposition to plaintiffs’ motion on June 10, 2022, and reply briefs were filed on June 24, 2022.

On February 16, 2023, the Delaware District Court denied Amgen’s motion for interlocutory appeal.

On March 2, 2023, Amgen filed a motion for reargument, which the Delaware District Court denied while also certifying a question regarding whether the current judge has the authority to certify a question decided by a predecessor judge.

On April 17, 2023, Amgen filed a petition with the U.S.

Court of Appeals for the Third Circuit (Third Circuit Court), seeking a grant of our request for interlocutory appeal of the certified question as well as the Delaware District Court’s denial of our motion to dismiss the reverse payment claim.

Amgen’s response to the class action complaints is due 30 days after resolution or denial of the interlocutory appeal.

On June 26, 2023, the Third Circuit Court entered an order granting defendants’ (including Amgen’s) petition for interlocutory appeal and denying plaintiffs’ cross-petition.

The questions certified are whether (1) the statute for interlocutory decisions authorizes a district court judge to certify for interlocutory appeal an order issued in the same case by a predecessor district court judge;

and (2) the settlement of a patent infringement claim that involves the forgiveness of damages associated with that patent’s alleged infringement, on its own or combined with an acceleration clause, constitutes a reverse payment.

On July 3, 2023, Amgen and Teva Pharmaceuticals USA, Inc.

filed a notice of appeal, and on October 17, 2023, Amgen submitted its initial brief in its appeal before the Third Circuit Court.

On January 12, 2024, Amgen reached an agreement in principle to settle with the putative class of indirect purchasers of Sensipar.

On February 17, 2024, Amgen and the indirect purchasers filed a stipulation in the Delaware District Court to dismiss the indirect purchasers’ claims.

On February 22, 2024, Amgen and the indirect purchasers filed a stipulation in the Third Circuit Court dismissing the portion of the Third Circuit Court’s appeal relating to the claims of the indirect purchasers.

Amgen and the direct purchasers filed a stipulation on April 12, 2024 in the Delaware District Court, dismissing with prejudice the direct purchasers’ claims that were at issue in the appeal and seeking entry of final judgment in Amgen’s favor.

On April 15, 2024, the Delaware District Court entered an order pursuant to the stipulation and closed the case.

On May 14, 2024, the putative class of direct purchasers of Sensipar appealed the claims that were dismissed with prejudice by the Delaware District Court.

On November 12, 2024, Amgen settled with the putative class of direct purchasers of Sensipar, and the remaining claims were dismissed on November 29, 2024.

Regeneron Pharmaceuticals, Inc.

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Amgen’s initial responsive pleading, a motion to dismiss, was filed on August 1, 2022.

On August 11, 2022, Amgen moved to stay the case pending the ultimate decision on the merits of the ongoing patent litigation between Amgen and Regeneron in Amgen Inc., et al.

Sanofi, et al.

On January 6, 2023, the Delaware District Court heard oral argument on the motion to stay and the motion to dismiss.

On February 10, 2023, the Delaware District Court denied Amgen’s motion to stay this action, and on March 21, 2023, the Delaware District Court denied Amgen’s motion to dismiss the complaint.

The Delaware District Court denied Amgen’s motion to dismiss the complaint.

On August 28, 2023, Regeneron filed its amended complaint, and on September 20, 2023, Amgen filed a counterclaim, alleging Regeneron’s own anticompetitive conduct with respect to formulary position for Regeneron’s drug, PRALUENT ® , at CVS.

Trial was originally scheduled to begin on November 12, 2024, but has been rescheduled for May 2, 2025.

On November 20, 2024 the Delaware District Court heard Amgen’s motion for summary judgment and the parties’ motions to exclude expert testimony, and the motions are currently under submission.

Amgen notified the Delaware District Court that it would not be pursuing its counterclaim on April 24, 2025.

A jury trial was held in the Delaware District Court from May 5, 2025 to May 14, 2025.

On May 15, 2025, the jury returned a verdict finding for Regeneron on its federal and state antitrust law and tortious interference claims but finding for Amgen on its below-cost pricing claim under California’s Unfair Practices Act.

The jury awarded Regeneron $ 135.6 million in compensatory damages on its antitrust claims (which are subject to trebling under applicable law), or in the alternative, in compensatory damages plus $ 271.2 million in punitive damages on its tortious interference claim, with such damages under either alternative claim totaling $ 406.8 million.

As Regeneron must elect between recovery under the antitrust or tortious interference claims, any potential damages award would be limited to one of these claims.

Although we cannot predict with certainty the ultimate outcome of this litigation, Amgen believes that the jury’s decision and amounts awarded are inconsistent with the law and evidence at trial.

Both parties have filed post-trial motions.

On June 12, 2025, Amgen filed a renewed motion for judgment as a matter of law or, in the alternative, for a new trial.

Also on June 12, 2025, Regeneron filed a motion for permanent injunctive relief, a constructive trust, and prejudgment interest.

Both motions were fully briefed and a hearing on the post-trial motions was held on August 27, 2025.

In assessing whether we should accrue a liability for this litigation in our consolidated financial statements, we considered various factors, including the legal and factual circumstances of the case, the jury’s award, the court’s post-trial proceedings, applicable law, and the likelihood that the jury’s award will be upheld after post-trial briefing and potentially on appeal.

result of this review, we have determined, in accordance with applicable accounting standards, that it is not probable that we will incur a loss as a result of this litigation, and we have therefore not recorded a liability for this matter.

The ultimate result of this litigation, however, is uncertain because it is reasonably possible that by settlement or final court judgment that none, some, or all of the jury’s verdict and other relief sought might ultimately be awarded but the size of an award, if any, is not estimable at this time.

CareFirst of Maryland Antitrust Class Action

On August 6, 2024, CareFirst of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc.

(collectively, CareFirst), filed a class action antitrust lawsuit against Amgen Inc., Amgen Manufacturing, Limited (corrected to Amgen Manufacturing Limited LLC in CareFirst’s amended complaint on October 11, 2024), and Immunex Corporation in the U.S.

District Court for the Eastern District of Virginia, alleging federal and state antitrust claims and state consumer protection claims.

The plaintiffs allege that, in 2004, Amgen entered into an anticompetitive agreement with certain F.

(collectively, CareFirst), filed a proposed class action lawsuit against Amgen Inc., Amgen Manufacturing, Limited (corrected to Amgen Manufacturing Limited LLC in CareFirst’s amended complaint on filed October 11, 2024), and Immunex Corporation in the U.S.

District Court for the Eastern District of Virginia (District Court for the Eastern District of Virginia), alleging federal and state antitrust claims and state consumer protection and unjust enrichment claims.

CareFirst alleges that, in 2004, Amgen entered into an anticompetitive agreement with certain F.

Hoffman-La Roche AG entities (Roche) and other parties that provided Amgen with rights to Roche’s patents in a manner that enabled Amgen to allegedly unlawfully extend the life of patents applicable to ENBREL and, thereby, delay biosimilar entry.

On November 4, 2024, Amgen filed a motion to dismiss, and plaintiffs thereafter filed an amended complaint on November 25, 2024.

On January 8, 2025, Amgen filed a motion to dismiss the amended complaint.

On November 4, 2024, Amgen filed a motion to dismiss, and CareFirst thereafter filed a second amended complaint on November 25, 2024.

On January 8, 2025, Amgen filed a motion to dismiss the second amended complaint.

On September 30, 2025, the District Court for the Eastern District of Virginia issued an order granting in part and denying in part Amgen’s motion to dismiss.

The court dismissed CareFirst’s antitrust claim under Puerto Rico law and its unjust enrichment claims under the laws of seven states and Puerto Rico, but otherwise permitted the claims to proceed.

On October 20, 2025, Amgen filed a motion asking the district court to certify its order on the motion to dismiss for interlocutory appeal to the U.S.

Court of Appeals for the Fourth Circuit.

On November 3, 2025, CareFirst filed its opposition to Amgen’s motion to certify for interlocutory appeal.

On November 7, 2025, Amgen filed its answer to the second amended complaint, and on November 10, 2025, Amgen filed its reply in support of its motion to certify for interlocutory appeal.

Antitrust Action

On April 11, 2025, Sandoz Inc.

(Sandoz) filed a complaint in the U.S.

District Court for the Eastern District of Virginia against Amgen Inc., Amgen Manufacturing Limited LLC, and Immunex Corporation claiming violations of the antitrust laws and tortious interference related to Amgen’s patent rights to ENBREL, and seeking damages, injunctive relief and attorneys’ fees.

The factual allegations that form the basis for the claims of Sandoz’s complaint are substantially similar to those asserted in the lawsuit filed against Amgen in the same court by CareFirst.

On June 20, 2025, Amgen filed a motion to dismiss the complaint.

Sandoz filed its opposition to the motion to dismiss on July 21, 2025, and on August 21, 2025, Amgen filed its reply in support of the motion to dismiss.

Other Similar Antitrust Actions

In July and August 2025, seven lawsuits were filed in the California Superior Court in Ventura County, each alleging state law antitrust, consumer protection, and unjust enrichment claims, based on allegations substantially similar to those in the CareFirst class action.

The cases were filed by:

Centene Corporation, WellCare Health Plans, Inc., New York Quality Healthcare Corporation d/b/a Fidelis Care, and Health Net, LLC (collectively, Centene) on July 29, 2025;

(Humana) on July 29, 2025;

Molina Healthcare, Inc.

(Molina) on July 29, 2025;

Blue Cross and Blue Shield of Florida, Inc.

and Health Options, Inc.

d/b/a Florida Blue HMO (collectively, BCBSFL) on July 29, 2025;

Blue Cross and Blue Shield of Kansas City (BCBSKC) on July 29, 2025;

Blue Cross and Blue Shield of Massachusetts, Inc.

and Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc.

(collectively, BCBSMA) on August 8, 2025;

and Health Care Services Corp.

(HCSC) on August 21, 2025.

Amgen subsequently removed the cases filed by BCBSFL, BCBSKC, BCBSMA, and HCSC to the California Central District Court.

On September 29, 2025, HCSC voluntarily dismissed its case without prejudice.

On October 1, 2025, BCBSFL, BCBSKC, and BCBSMA voluntarily dismissed their cases without prejudice.

On January 8, 2026, Amgen filed demurrers to the complaints filed by Centene, Humana, and Molina, seeking the dismissal of the claims in those complaints, with prejudice.

On February 2, 2026, the complaint in the Centene case was amended to join BCBSFL, BCBSKC, BCBSMA, and HCSC as additional plaintiffs.

Humana and Molina filed their opposition to Amgen’s demurrers on February 5, 2026, and Amgen’s replies are due on February 26, 2026.

On February 5, Amgen filed a demurrer to the amended Centene complaint;

Centene’s opposition to the demurrer was filed February 9, 2026 and Amgen’s reply is due February 26, 2026.

Tax Litigation and Related Matters

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On March 13, 2023, Roofers Local No.

149 Pension Fund filed a purported class action against Amgen, Robert Bradway and Peter Griffith in the U.S.

149 Pension Fund filed a purported class action (Roofers Securities Class Action) against Amgen, Robert Bradway and Peter Griffith in the U.S.

District Court for the Southern District of New York (Southern District Court of New York).

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On November 20, 2024, Amgen filed an answer to the amended complaint.

A Case Management Plan and Scheduling Order was entered on January 16, 2025.

Class certification briefing will be completed by December 23, 2025 and the last day to file summary judgment motions is August 12, 2025 but no briefing schedule has been set.

Pursuant to the Southern District Court of New York’s order on September 11, 2025, the class certification briefing is due by April 24, 2026.

The last day to file summary judgment motions is December 21, 2026, but no briefing schedule has been set and no trial date has been set.

On December 9, 2025, plaintiffs filed their motion for class certification.

Amgen’s opposition is due on March 9, 2026 and plaintiffs’ reply is due May 8, 2026.

Shareholder Derivative Actions (Martin, Clearwater and DM Cohen)

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2, 2023), purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members.

The action was filed in the Southern District Court of New York as related to the pending federal securities class action filed by Roofers Local No.

149 Pension Fund on March 13, 2023 (the Roofers securities class action).

The action was filed in the Southern District Court of New York as related to the pending Roofers Securities Class Action.

The complaint in this matter alleges claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment and waste of corporate assets.

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On January 16, 2024, the Southern District Court of New York consolidated the Martin Derivative Action and Clearwater Derivative Action (the Consolidated Action).

The Southern District Court of New York entered an Order staying the Consolidated Action until a final judgment is entered in the federal securities class action.

The Southern District Court of New York entered an Order staying the Consolidated Action until a final judgment is entered in the Roofers Securities Class Action.

On February 12, 2025, DM Cohen, Inc.

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The complaint asserts claims for violations of the Securities Exchange Act of 1934, breach of fiduciary duty, waste of corporate assets and unjust enrichment.

The factual allegations that form the basis for the claims in the Consolidated Action and the DM Cohen Derivative Action are essentially the same as the allegations asserted in the Roofers securities class action regarding purportedly false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls.

misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls.

On April 21, 2025, the Southern District Court of New York consolidated the derivative action filed by DM Cohen, Inc.

with the Consolidated Action.

The case is stayed pending entry of a final judgment in the Roofers Securities Class action.

Shareholder Derivative Actions (Hamilton, Blackburn, Bryla)

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149 Pension Fund on March 13, 2023 (alleging false and misleading statements and omissions made from July 29, 2020 through April 27, 2022 relating to Amgen’s tax liabilities, business and finances, and the adequacy and maintenance of its internal controls).

On April 9, 2025, the Delaware Court of Chancery consolidated the derivative actions filed by each of David Hamilton, Charles Blackburn and Robert Bryla purportedly on behalf of Amgen against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members.

The case is stayed pending entry of a final judgment in the Roofers Securities Class Action.

Shareholder Derivative Actions (Sieveking, Tierney)

On April 2, 2025, Carolyn Sieveking and James P.

Tierney filed a derivative action (the Sieveking Derivative Action) in the Delaware District Court purportedly on behalf of Amgen, against nominal defendant Amgen, Robert Bradway, Peter Griffith, Linda Louie and Amgen’s Board members during the relevant time period (the Sieveking Derivative Action).

The complaint alleges claims for violations of Section 10(b), Rule 10b5 and Section 20(a) of the Securities Exchange Act of 1934, and breach of fiduciary duty.

The factual allegations that form the basis for the claims in the Sieveking Derivative Action is fundamentally the same as those asserted by the Roofers Local No.

149 Pension Fund.

On June 9, 2025, the Delaware District Court stayed the case pending entry of a final judgment in the Roofers Securities Class Action.

ChemoCentryx, Inc.

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On February 23, 2023, the Northern District Court of California substantially denied ChemoCentryx’s motion to dismiss the matter in its entirety, while granting the motion to dismiss with respect to certain allegations of the plaintiffs.

On April 4, 2023, the parties submitted a case management statement to the Northern District Court of California, and on April 10, 2023, the Northern District Court of California entered an order setting dates for amendment of pleadings and briefing on class certification.

On April 27, 2023, ChemoCentryx submitted its answer to the complaint.

On August 25, 2023, the lead plaintiff moved to certify a class composed of all purchasers of ChemoCentryx stock between November 25, 2019 and May 6, 2021.

On March 6, 2024, the Northern District Court of California certified a class of all persons who purchased or otherwise acquired the common stock of ChemoCentryx between November 26, 2019 and May 6, 2021.

On March 20, 2024, ChemoCentryx filed a petition with the U.S.

Court of Appeals for the Ninth Circuit (Ninth Circuit Court), seeking permission to have the district court’s order on class certification heard on appeal.

The lead plaintiff’s response to ChemoCentryx’s petition was submitted on April 2, 2024, and on May 24, 2024, the Ninth Circuit Court denied ChemoCentryx’s petition to appeal the class certification order.

Under the current schedule for the class action in the district court, the parties’ motions to exclude experts will be fully briefed by March 20, 2025, and summary judgment will be fully briefed by May 9, 2025.

Trial is set for September 22, 2025.

The deadline for class members to opt out of the class action was January 14, 2025.

On August 15, 2025, the Northern District Court of California granted defendants’ motion for summary judgment in its entirety and denied lead plaintiff’s motion for partial summary judgment.

On September 12, 2025, the lead plaintiff filed a notice of appeal to the Ninth Circuit Court of Appeals, and filed its opening brief on January 5, 2026.

On January 27, 2026, the parties informed the Court of Appeals they had reached an agreement to settle the case on a class-wide basis, subject to approval by the district court.

Opt-Out Cases

Prior to the opt-out deadline, on May 2, 2024, RA Capital Healthcare Fund, LP filed two securities cases (which are similar to the class action), in the California Superior Court in Ventura County and in the Northern District Court of California, against ChemoCentryx and its former Chief Executive Officer, Dr.

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On July 2, 2024, the state court stayed the case pending an order on summary judgment in the federal class action.

Under the current schedule in the federal case, briefing on the defendants’ motion to dismiss the complaint will be complete by March 11, 2025, and a hearing on that motion is set for May 1, 2025.

Defendants, including ChemoCentryx, moved to dismiss the complaint, and on June 13, 2025, the court issued an order staying the federal case pending resolution of the class action.

The court did not reach the merits of defendants’ motion to dismiss.

Commitments – U.S.

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The final U.S.

repatriation tax payment of $ 1.8 billion will be made in 2025.

repatriation tax payment of $ 1.8 billion was made in 2025.

VALUATION AND QUALIFYING ACCOUNTS

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of period Additions

expenses Other

additions Deductions Balance

expenses Deductions

Other changes

$ 38 $ 1 $ — $ 4 $ 43

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures