What changed in this filing

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Item 1. Financial Statements

2025-05-02 compared with 2024-10-31 · 267 added, 419 removed, 515 unchanged (57% of the section changed)

FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)

(In millions, except per-share data)

Three months ended

September 30, Nine months ended

September 30,

2024 2023 2024 2023

Product sales $ 7,873 $ 7,118

10 unchanged sentences

Interest expense, net ( 723 ) ( 824 )

Other income, net 1,830 685 1,288 2,431

Income before income taxes 3,101 1,947 3,827 7,003

Other income (expense), net 1,518 ( 235 )

Income (loss) before income taxes 1,973 ( 68 )

Provision for income taxes 243 45

Net income $ 2,830 $ 1,730 $ 3,463 $ 5,950

Earnings per share:

Net income (loss) $ 1,730 $ ( 113 )

Earnings (loss) per share:

Basic $ 3.22 $ ( 0.21 )

Diluted $ 3.20 $ ( 0.21 )

Weighted-average shares used in calculation of earnings per share:

Weighted-average shares used in calculation of earnings (loss) per share:

Basic 538 536

1 unchanged sentence

See accompanying notes.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In millions)

Three months ended

September 30, Nine months ended

September 30,

2024 2023 2024 2023

Net income $ 2,830 $ 1,730 $ 3,463 $ 5,950

Net income (loss) $ 1,730 $ ( 113 )

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

Foreign currency translation adjustments

71 ( 44 ) 32 ( 5 )

Cash flow hedges ( 253 ) 181 ( 76 ) 73

Gains (losses) on foreign currency translation adjustments 57 ( 24 )

(Losses) gains on cash flow hedges ( 223 ) 126

Other 1 ( 3 )

Other comprehensive (loss) income, net of reclassification adjustments and taxes ( 165 ) 99

Comprehensive income $ 2,649 $ 1,884 $ 3,416 $ 6,055

Comprehensive income (loss) $ 1,565 $ ( 14 )

See accompanying notes.

1 unchanged sentence

(In millions, except per-share data)

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Current assets:

35 unchanged sentences

deficit Accumulated

comprehensive

comprehensive loss Total

Balance as of December 31, 2024

536.9 $ 33,533 $ ( 27,590 ) $ ( 66 ) $ 5,877

Net loss — — ( 113 ) — ( 113 )

Other comprehensive income, net of taxes — — — 99 99

Dividends declared on common stock ($ 2.25 per share)

— — ( 1,208 ) — ( 1,208 )

Issuance of common stock in connection with equity award programs

1.0 34 — — 34

Stock-based compensation expense — 103 — — 103

Tax impact related to employee stock-based compensation expense

— ( 125 ) — — ( 125 )

Balance as of March 31, 2024

536.4 33,082 ( 27,870 ) ( 190 ) 5,022

Net income — — 1,730 — 1,730

Other comprehensive income, net of taxes — — — 35 35

Issuance of common stock in connection with equity award programs

0.8 65 — — 65

Stock-based compensation expense — 157 — — 157

Tax impact related to employee stock-based compensation expense

— ( 100 ) — — ( 100 )

Balance as of June 30, 2024

537.2 33,204 ( 27,124 ) ( 155 ) 5,925

Net income — — 2,830 — 2,830

Other comprehensive loss, net of taxes — — — ( 165 ) ( 165 )

6 unchanged sentences

— ( 82 ) — — ( 82 )

Balance as of September 30, 2024

Balance as of March 31, 2025

537.7 $ 33,578 $ ( 27,140 ) $ ( 231 ) $ 6,207

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)

(In millions, except per-share data)

paid-in capital Accumulated

3 unchanged sentences

535.4 $ 33,070 $ ( 26,549 ) $ ( 289 ) $ 6,232

Net income — — 2,841 — 2,841

Other comprehensive loss, net of taxes — — — ( 37 ) ( 37 )

Dividends declared on common stock ($ 2.13 per share)

— — ( 1,138 ) — ( 1,138 )

Issuance of common stock in connection with equity award programs

0.3 11 — — 11

Stock-based compensation expense — 47 — — 47

Tax impact related to employee stock-based compensation expense

— ( 37 ) — — ( 37 )

Balance as of March 31, 2023

534.3 32,535 ( 26,919 ) ( 268 ) 5,348

Net income — — 1,379 — 1,379

Other comprehensive loss, net of taxes — — — ( 12 ) ( 12 )

Issuance of common stock in connection with equity award programs

0.6 16 — — 16

Stock-based compensation expense — 119 — — 119

Tax impact related to employee stock-based compensation expense

— ( 69 ) — — ( 69 )

Balance as of June 30, 2023

534.9 32,601 ( 25,540 ) ( 280 ) 6,781

Net income — — 1,730 — 1,730

Net loss — — ( 113 ) — ( 113 )

Other comprehensive income, net of taxes — — — 99 99

6 unchanged sentences

— ( 125 ) — — ( 125 )

Balance as of September 30, 2023

Balance as of March 31, 2024

536.4 $ 33,082 $ ( 27,870 ) $ ( 190 ) $ 5,022

2 unchanged sentences

(In millions)

Nine months ended

September 30,

Three months ended

Cash flows from operating activities:

Net income $ 3,463 $ 5,950

Noncash adjustments to reconcile net income to net cash provided by operating activities:

Net income (loss) $ 1,730 $ ( 113 )

Noncash adjustments to reconcile net income (loss) to net cash provided by operating activities:

Depreciation, amortization and other 1,387 1,399

Impairment of intangible assets 800 68

Stock-based compensation expense 85 103

Deferred income taxes ( 250 ) ( 401 )

Adjustments for equity method investments ( 11 ) ( 17 )

Gains on equity securities

( 717 ) ( 1,304 )

(Gains) losses on equity securities ( 1,295 ) 515

Other items, net ( 50 ) ( 190 )

11 unchanged sentences

Cash flows from investing activities:

Proceeds from sales of marketable securities — 1,125

Proceeds from maturities of marketable securities — 550

Purchases of property, plant and equipment ( 411 ) ( 230 )

Net cash (used in) provided by investing activities ( 644 ) 885

Other ( 36 ) 13

Net cash used in investing activities ( 447 ) ( 217 )

Cash flows from financing activities:

Net proceeds from issuance of debt — 23,781

Extinguishment of debt ( 301 ) ( 410 )

2 unchanged sentences

Other ( 27 ) ( 90 )

Net cash (used in) provided by financing activities ( 8,008 ) 18,294

(Decrease) increase in cash and cash equivalents ( 1,933 ) 27,112

Net cash used in financing activities ( 4,107 ) ( 1,708 )

Decrease in cash and cash equivalents ( 3,163 ) ( 1,236 )

Cash and cash equivalents at beginning of period 11,973 10,944

2 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2024

March 31, 2025

Summary of significant accounting policies

(including its consolidated subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) is a global biotechnology pioneer that discovers, develops, manufactures and delivers innovative human therapeutics.

We operate in one business segment:

We operate our business in one operating segment:

human therapeutics.

See Note 2, Segment and other information.

Basis of presentation

The interim unaudited financial information for the three and nine months ended September 30, 2024 and 2023, has been prepared in accordance with GAAP and includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated) that Amgen considers necessary for a fair presentation, in all material respects, of its condensed consolidated results of operations for those periods.

The interim unaudited financial information for the three months ended March 31, 2025 and 2024, has been prepared in accordance with GAAP and includes all adjustments (consisting of only normal, recurring adjustments unless otherwise indicated) that Amgen considers necessary for a fair presentation, in all material respects, of its condensed consolidated results of operations for those periods.

Interim results are not necessarily indicative of results for the full fiscal year.

The condensed consolidated financial statements should be read in conjunction with our consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2023, and with our condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

The condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2024.

Principles of consolidation

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

The condensed consolidated financial statements include the accounts of Amgen and its majority-owned subsidiaries.

In determining whether we are the primary beneficiary of a variable interest entity, we consider whether we have both the power to direct activities of the entity that most significantly impact the entity’s economic performance and the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity.

6 unchanged sentences

Property, plant and equipment, net

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization, of $ 10.3 billion and $ 9.8 billion as of September 30, 2024 and December 31, 2023, respectively.

Recent accounting pronouncements

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $ 10.6 billion and $ 10.4 billion as of March 31, 2025 and December 31, 2024, respectively.

Recent accounting pronouncements not yet adopted

In December 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (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.

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

Early adoption is permitted, and entities may apply the standard prospectively or may elect retrospective application.

We are currently evaluating the impact of adopting this new standard on our related disclosures.

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.

In November 2024, the FASB issued ASU No.

2023-07, Segment Reporting (Topic 280):

Improving 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 for annual periods beginning after December 15, 2023 and interim periods beginning after December 15, 2024.

Early adoption is permitted, and the standard requires retrospective application to all prior

periods presented.

We expect the adoption of this new standard to result in incremental disclosures to the notes to our financial statements.

Acquisition of Horizon Therapeutics plc

On October 6, 2023, Amgen completed its acquisition of Horizon by acquiring all of the outstanding shares of Horizon for $ 116.50 per share in cash, representing a total consideration of approximately $ 27.8 billion.

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.

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.

During the nine months ended September 30, 2024, the purchase price allocation of the acquisition was completed and measurement period adjustments were finalized, which included changes to the purchase price allocation that resulted in a net increase of approximately $ 25 million to goodwill.

The measurement period adjustments resulted primarily from adjustments to acquired assets and liabilities, including deferred tax attributes, based on facts and circumstances that existed as of the acquisition date and did not result from events subsequent to the acquisition date.

The adjustments did not have a significant impact on Amgen’s results of operations during the nine months ended September 30, 2024, 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 $ 681

Inventories 5,014

Property, plant and equipment, net 318

Finite-lived intangible assets – developed-product-technology rights 19,590

Goodwill 3,136

Deferred tax asset 795

Deferred tax liability ( 2,488 )

Other assets and liabilities, net ( 273 )

Total assets acquired, net of liabilities assumed

The $ 27.8 billion total consideration for this transaction consisted of (i) cash consideration transferred to common shareholders of $ 26.7 billion;

(ii) cash consideration transferred to vested and outstanding stock options, outstanding restricted stock unit (RSU) awards and outstanding performance stock unit (PSU) awards of $ 523 million;

(iii) the fair value of Amgen replacement awards (based on conversion of outstanding employee RSU awards) of $ 180 million representing noncash consideration;

and (iv) a portion of Horizon’s debt, settled by Amgen on the acquisition closing date, of $ 382 million.

Amgen issued 1.7 million replacement equity awards with the original vesting conditions, the fair value of which was determined based on the acquisition date fair value based on the conversion calculation.

The estimated fair values of $ 20.7 billion for the developed-product-technology rights and IPR&D intangible assets were determined 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 projected cash flows were based on certain assumptions attributable to the respective intangible asset, including estimates of future revenues and expenses, the time and resources needed to complete development and the probabilities of obtaining marketing approval from the FDA and other regulatory agencies.

The developed-product-technology rights are being amortized on a straight-line basis over a weighted-average period of approximately 10 years from the acquisition date using the straight-line methodology.

The estimated fair value of the acquired inventory of $ 5.0 billion 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 is being amortized using a weighted-average inventory turnover, which we estimate to approximate 27 months from the acquisition date.

A deferred tax liability of $ 2.5 billion 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, as well as an associated deferred tax asset for anticipatory foreign tax credits of $ 795 million.

The excess of the acquisition date consideration over the fair values assigned to the assets acquired and the liabilities assumed of $ 3.1 billion was recorded as goodwill, which is not deductible for tax purposes.

The goodwill value represents expected synergies from the marketed products acquired and other benefits.

Supplemental Pro Forma Financial Information

The following table presents the unaudited supplemental pro forma results of a hypothetical combined Amgen and Horizon entity for the three and nine months ended September 30, 2023, as if the acquisition of Horizon had occurred on January 1, 2022 (in millions):

Three months ended September 30, 2023 Nine months ended September 30, 2023

2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses, to improve disclosures about a public business entity’s expenses by requiring disaggregated disclosures of certain types of expenses, including purchases of inventory, employee compensation, depreciation, intangible amortization and depletion, as applicable, for each income statement caption that includes those expenses.

In addition, the standard will require entities to define and disclose total selling expenses.

The standard is effective for public business entities such as Amgen for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027.

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

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

Segment and other information

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

human therapeutics.

Therefore, results of our operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting.

The human therapeutics segment is engaged in the discovery, development, manufacturing and delivery of innovative medicines to fight some of the world’s toughest diseases.

The Company’s Chief Executive Officer has been identified as the chief operating decision maker (CODM).

The CODM manages and allocates resources on a consolidated basis.

The determination of a single segment is consistent with the financial information regularly reviewed by the CODM for purposes of evaluating performance and allocating resources, which is reviewed on a consolidated basis.

As the Company’s CODM evaluates the financial performance of the Company’s human therapeutics segment on a consolidated basis, the measure of segment performance is net income, as reflected in the Condensed Consolidated Statements of Income (Loss).

The CODM uses net income to allocate resources on a consolidated basis, which enables the CODM to both assess the overall level of resources available and optimize the distribution of resources across functions, therapeutic areas, regions and research and development 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.

As the Company manages its assets on a consolidated basis, the measure of segment assets is total assets, as reflected in the Condensed Consolidated Balance Sheets.

See Note 6, Investments, for further information regarding equity method investments, and Net cash used in investing activities in the Condensed Consolidated Statements of Cash Flows for further information regarding capital expenditures.

The following table provides segment revenues, significant segment expenses, other segment items, reported segment net income (loss) and a reconciliation of segment net income (loss) to the Company’s total consolidated net income (loss) for the three months ended March 31, 2025 and 2024 (in millions):

Three months ended

Product sales $ 7,873 $ 7,118

Other revenues 276 329

Total revenues 8,149 7,447

Manufacturing cost of sales (1)(2)

Profit share and royalties in cost of sales (1)

Research and development (1)

Sales and marketing (1)

General and administrative (1)

Other segment items (3)

Equity in loss (income) of equity method investments 11 ( 27 )

Interest income

( 126 ) ( 153 )

Net income $ 902 $ 3,518

The unaudited supplemental pro forma combined financial information was prepared using the acquisition method of accounting and was based on the historical financial information of Amgen and Horizon.

In order to reflect the occurrence of the acquisition on January 1, 2022, the unaudited supplemental pro forma financial information includes adjustments to reflect the following:

(i) incremental amortization expense based on the fair values of the identifiable intangible assets and inventory step-up;

(ii) the additional interest expense associated with the issuance of debt to finance the acquisition;

and (iii) the income tax impact using an estimated effective tax rate applied to the combined entity.

The unaudited supplemental pro forma financial information is not necessarily indicative of what the condensed consolidated results of operations would have been had the acquisition been completed on January 1, 2022.

In addition, the unaudited supplemental 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.

We operate in one business segment:

Interest expense, net 723 824

Provision for income taxes

Segment net income (loss) 1,730 ( 113 )

Reconciliation of profit or loss:

Adjustments and reconciling items — —

Consolidated net income (loss) $ 1,730 $ ( 113 )

(1) During both the three months ended March 31, 2025 and 2024, amortization of our finite-lived intangible assets was $ 1.2 billion, which was primarily included in Cost of sales in the Condensed Consolidated Statements of Income (Loss).

In addition, during the three months ended March 31, 2025 and 2024, we recognized depreciation and right-of-use asset amortization of $ 209 million and $ 201 million, respectively.

(2) During the three months ended March 31, 2025 and 2024, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 363 million and $ 693 million, respectively.

(3) Other segment items included in Segment net income (loss) primarily consisted of fair value adjustments on equity securities (see Note 6, Investments) and net impairment charges on intangible assets (see Note 8, Goodwill and other intangible assets).

We operate our business in one operating segment:

human therapeutics.

1 unchanged sentence

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

The majority of ROW revenues relates to products sold in Europe.

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

Revenues were as follows (in millions):

Three months ended September 30,

Three months ended March 31,

ROW Total U.S.

Prolia $ 720 $ 379 $ 1,099 $ 657 $ 342 $ 999

ENBREL 817 8 825 1,026 9 1,035

XGEVA 373 168 541 374 145 519

Repatha 343 313 656 273 244 517

Otezla 460 104 564 462 105 567

482 6 488 — — —

EVENITY 289 110 399 214 93 307

KYPROLIS 238 140 378 231 118 349

Nplate 345 111 456 322 97 419

Aranesp 105 232 337 107 216 323

KRYSTEXXA (1)

310 — 310 — — —

BLINCYTO 237 90 327 147 73 220

Vectibix 132 150 282 116 136 252

269 — 269 161 — 161

Other products (3)

958 405 1,363 675 329 1,004

Total product sales (4)

$ 5,979 $ 2,172 8,151 $ 4,691 $ 1,857 6,548

Other revenues 352 355

Total revenues $ 8,503 $ 6,903

Nine months ended September 30,

ROW Total U.S.

Prolia $ 2,110 $ 1,099 $ 3,209 $ 1,987 $ 954 $ 2,941

ENBREL 2,280 21 2,301 2,645 37 2,682

XGEVA 360 206 566 366 195 561

Repatha 824 792 1,616 592 626 1,218

Otezla 1,185 317 1,502 1,251 308 1,559

1,379 12 1,391 — — —

ENBREL 504 6 510 561 6 567

EVENITY 320 122 442 236 106 342

Otezla 343 94 437 293 101 394

TEPEZZA 365 16 381 419 5 424

BLINCYTO 273 97 370 153 91 244

Aranesp 91 249 340 100 249 349

KYPROLIS 216 108 324 234 142 376

Nplate 201 112 313 190 127 317

Aranesp 296 738 1,034 345 698 1,043

KRYSTEXXA (1)

285 — 285 173 — 173

BLINCYTO 555 280 835 418 202 620

Vectibix 135 132 267 120 127 247

676 — 676 390 — 390

KRYSTEXXA 236 — 236 235 — 235

Other products (2)

4 unchanged sentences

Total revenues $ 8,149 $ 7,447

(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.

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

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

(4) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2024 and 2023.

The effective tax rates for the three and nine months ended September 30, 2024, were 8.7 % and 9.5 %, respectively, compared with 11.1 % and 15.0 %, respectively, for the corresponding periods in the prior year.

The decrease in our effective tax rate for the three months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets), partially offset by the quarter-to-date unrealized gains on our strategic equity investments (primarily BeiGene).

(3) Hedging gains and losses, which are included in product sales, were not material for the three months ended March 31, 2025 and 2024.

The effective tax rate for the three months ended March 31, 2025 was 12.3 % compared with ( 66.2 )% for the prior year period.

The increase in our effective tax rate for the three months ended March 31, 2025, was primarily due to the change in earnings mix as a result of net unrealized gains in the first quarter of 2025 compared to net unrealized losses in the first quarter of 2024 on equity investments (primarily BeiGene).

See Note 6, Investments —BeiGene, Ltd.

The decrease in our effective tax rate for the nine months ended September 30, 2024, was primarily due to the earnings mix as a result of the inclusion of the Horizon business (including the amortization of Horizon acquired assets).

The effective tax rates differ from the federal statutory rate primarily due to the impact of the jurisdictional mix of income and expenses.

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

Our legal entities in such countries, along with their direct and indirect 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%.

Additionally, effective January 1, 2024, selected individual countries, including the United Kingdom and EU member countries, have enacted the global minimum tax agreement.

Our legal entities in such countries, along with their direct and indirect subsidiaries, are now subject to a 15% minimum tax rate on adjusted financial statement income.

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 do not have this excise tax exposure in 2024.

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

2 unchanged sentences

Our income tax returns are routinely examined by tax authorities in those jurisdictions.

Significant disputes can and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts.

Significant disputes can arise and have arisen with tax authorities involving issues regarding the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and relevant facts.

Tax authorities, including the IRS, are becoming more aggressive and are particularly focused on such matters.

1 unchanged sentence

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.

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

In July 2021, we filed a petition in the U.S.

4 unchanged sentences

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.

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

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

7 unchanged sentences

Tax Court on December 19, 2022.

The trial is currently scheduled to begin on November 4, 2024.

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 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.

In addition, we are under examination by a number of state and foreign tax jurisdictions.

2 unchanged sentences

however, due to the complexity of the provision for income taxes and uncertain resolution of these matters, the ultimate outcome of any tax matters may result in payments substantially greater than amounts accrued and could have a material adverse impact on our condensed consolidated financial statements.

During the three and nine months ended September 30, 2024, the gross amounts of our UTBs increased by $ 40 million and $ 120 million, respectively, as a result of tax positions taken during the current year.

Substantially all of the UTBs as of September 30, 2024, if recognized, would affect our effective tax rate.

During the three months ended March 31, 2025, the gross amounts of our UTBs increased by $ 40 million as a result of tax positions taken during the current year.

Substantially all of the UTBs as of March 31, 2025, if recognized, would affect our effective tax rate.

Earnings per share

1 unchanged sentence

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 (loss) per share were as follows (in millions, except per-share data):

Three months ended

September 30, Nine months ended

September 30,

2024 2023 2024 2023

Income (Numerator):

Net income for basic and diluted EPS $ 2,830 $ 1,730 $ 3,463 $ 5,950

Net income (loss) for basic and diluted earnings (loss) per share $ 1,730 $ ( 113 )

Shares (Denominator):

Weighted-average shares for basic EPS 537 535 537 535

Weighted-average shares for basic earnings (loss) per share 538 536

Effect of dilutive securities 3 —

Weighted-average shares for diluted EPS 542 538 541 538

Basic EPS $ 5.27 $ 3.23 $ 6.45 $ 11.12

Diluted EPS $ 5.22 $ 3.22 $ 6.40 $ 11.06

For the three and nine months ended September 30, 2024 and 2023, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

Weighted-average shares for diluted earnings (loss) per share 541 536

Basic earnings (loss) per share $ 3.22 $ ( 0.21 )

Diluted earnings (loss) per share $ 3.20 $ ( 0.21 )

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

For the three months ended March 31, 2024, 5 million shares of employee stock-based awards were excluded from the computation of diluted loss per share because the effect would have been antidilutive due to the Company’s net loss during that period.

Available-for-sale investments

The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are considered available-for-sale, by type of security were as follows (in millions):

Types of securities as of September 30, 2024 Amortized

The amortized cost, gross unrealized gains, gross unrealized losses and fair values of interest-bearing securities, which are classified as available for sale, by type of security were as follows (in millions):

Types of securities as of March 31, 2025 Amortized

Treasury bills $ 997 $ — $ — $ 997

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The fair values of interest-bearing securities by location in the Condensed Consolidated Balance Sheets were as follows (in millions):

Condensed Consolidated Balance Sheets locations September 30, 2024 December 31, 2023

Condensed Consolidated Balance Sheets locations March 31, 2025 December 31, 2024

Cash and cash equivalents $ 8,302 $ 11,486

Total interest-bearing securities $ 8,302 $ 11,486

Cash and cash equivalents in the above table excludes bank account cash of $ 435 million and $ 540 million as of September 30, 2024 and December 31, 2023, respectively.

All interest-bearing securities as of September 30, 2024 and December 31, 2023, mature in one year or less.

For the three and nine months ended September 30, 2024 and 2023, realized gains and losses on interest-bearing securities were not material.

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

Cash and cash equivalents in the above table excludes bank account cash of $ 508 million and $ 487 million as of March 31, 2025 and December 31, 2024, respectively.

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

For the three months ended March 31, 2025 and 2024, interest income on these investments was $ 126 million and $ 153 million, respectively.

For the three months ended March 31, 2025 and 2024, realized gains and losses on interest-bearing securities were not material and were recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income (Loss).

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

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BeiGene, Ltd.

Our ownership interest in BeiGene was approximately 18 % as of both September 30, 2024 and December 31, 2023, and the fair values of our investment were $ 4.3 billion and $ 3.4 billion, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

In the first quarter of 2023, we began to account for our ownership interest as an equity security with a readily determinable fair value, with changes in fair value recorded in Other income, net, in our Condensed Consolidated Statements of Income.

See Note 11, Fair value measurement.

During the three months ended September 30, 2024 and 2023, we recognized unrealized gains of $ 1.6 billion and $ 30 million, respectively, recorded in Other income, net, in our Condensed Consolidated Statements of Income.

During the nine months ended September 30, 2024 and 2023, we recognized unrealized gains of $ 836 million and $ 1.2 billion, respectively, recorded in Other income, net, in our Condensed Consolidated Statements of Income.

As of March 31, 2025 and December 31, 2024, the fair values of our investment in BeiGene were $ 5.2 billion and $ 3.5 billion, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended March 31, 2025 and 2024, we recognized an unrealized gain of $ 1.7 billion and an unrealized loss of $ 454 million, respectively, in Other income (expense), net, in the Condensed Consolidated Statements of Income (Loss).

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:

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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 $ 336 million and $ 494 million as of September 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and nine months ended September 30, 2024 and 2023, net unrealized gains and losses on these publicly traded securities were not material.

Additionally, net realized gains and losses on sales of publicly traded securities for the three and nine months ended September 30, 2024 and 2023, were not material.

We held investments of $ 318 million and $ 309 million in equity securities without readily determinable fair values as of September 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and nine months ended September 30, 2024 and 2023, upward and downward adjustments on these securities were not material.

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 $ 291 million and $ 314 million as of March 31, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended March 31, 2025 and 2024, net unrealized gains and losses on these publicly traded securities were not material.

Additionally, net realized gains and losses on sales of publicly traded securities for the three months ended March 31, 2025 and 2024, were not material.

We held investments of $ 326 million and $ 319 million in equity securities without readily determinable fair values as of March 31, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended March 31, 2025 and 2024, upward and downward adjustments on these securities were not material.

Adjustments were based on observable price transactions.

Net realized gains and losses on sales of securities without readily determinable fair values for the three and nine months ended September 30, 2024 and 2023, were not material.

Net realized gains and losses on sales of securities without readily determinable fair values for the three months ended March 31, 2025 and 2024, were not material.

Equity method investments

Neumora Therapeutics, Inc.

As of September 30, 2024 and December 31, 2023, our ownership interests in Neumora were approximately 22.1 % and 23.2 %, respectively, and the fair values of our investment were $ 467 million and $ 603 million, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

As of March 31, 2025 and December 31, 2024, our ownership interests in Neumora were approximately 21.8 % and 21.9 %, respectively, and the fair values of our investment were $ 35 million and $ 375 million, respectively, which were included in Other noncurrent assets in the Condensed 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.

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

See Note 11, Fair value measurement.

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

During the three months ended September 30, 2024 and 2023, we recognized unrealized gains of $ 119 million and $ 153 million, respectively, and during the nine months ended September 30, 2024 and 2023, we recognized $ 136 million of unrealized losses and $ 134 million of unrealized gains, respectively.

During the three months ended March 31, 2025, we recognized an unrealized loss of $ 340 million, compared to an unrealized loss of $ 117 million for the same period in the prior year.

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 $ 272 million and $ 251 million as of September 30, 2024 and December 31, 2023, respectively, which are included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

These investments, 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.

We held limited partnership investments of $ 252 million and $ 262 million as of March 31, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

These investments, which are primarily investment funds of early-stage biotechnology companies, are accounted for by using the equity method of accounting and are measured by using our proportionate share of the net asset values of the underlying investments held by the limited partnerships as a practical expedient.

These investments are typically redeemable only through distributions upon liquidation of the underlying assets.

As of September 30, 2024, unfunded additional commitments to be made for these investments during the next several years amounted to $ 139 million.

For the three and nine months ended September 30, 2024 and 2023, net unrealized gains and losses from our limited partnership investments were not material.

As of March 31, 2025, we had $ 147 million of unfunded additional commitments to be made for these investments during the next several years.

For the three months ended March 31, 2025 and 2024, net unrealized gains and losses recognized from our limited partnership investments were not material.

Inventories consisted of the following (in millions):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Raw materials $ 841 $ 818

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The change in the carrying amount of goodwill was as follows (in millions):

Balance at January 1, 2024

Adjustments to goodwill resulting from acquisitions (1)

Balance at December 31, 2024

Foreign currency translation adjustments

Balance at September 30, 2024

(1) For the nine months ended September 30, 2024, adjustments to goodwill consisted of measurement period adjustments related to our Horizon acquisition.

See Note 2, Acquisitions.

Balance at March 31, 2025

Other intangible assets

Other intangible assets consisted of the following (in millions):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

amounts Accumulated

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Total other intangible assets $ 55,348 $ ( 29,624 ) $ 25,724 $ 56,122 $ ( 28,423 ) $ 27,699

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

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

Licensing rights primarily consists of contractual rights to receive future milestone, royalty and profit-sharing payments;

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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.

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

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.

The Company utilized a discounted cash flow analysis based on Level 3 inputs, including estimated product sales, operating expenses and a discount rate.

The discounted cash flow analysis resulted in an intangible asset fair value of $ 4.0 billion as of March 31, 2025, which was lower than the carrying value of $ 4.8 billion and resulted in a partial impairment of both the gross and net carrying amounts.

See Note 11, Fair value measurement.

Based on the revised estimated cash flows, during the three months ended March 31, 2025, we recorded an intangible asset impairment charge of $ 800 million in Other operating expenses in the Condensed Consolidated Statements of Income (Loss).

IPR&D consists of R&D projects acquired in a business combination that are not complete at the time of acquisition due to remaining technological risks and/or lack of receipt of required regulatory approvals.

We review IPR&D projects for impairment annually, whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable and upon the establishment of technological feasibility or regulatory approval.

During the three months ended September 30, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $ 1.2 billion and $ 693 million, respectively.

During the nine months ended September 30, 2024 and 2023, we recognized amortization associated with our finite-lived intangible assets of $ 3.6 billion and $ 2.1 billion, respectively.

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

As of September 30, 2024, the total estimated amortization of our finite-lived intangible assets for the remaining three months ending December 31, 2024, and the years ending December 31, 2025, 2026, 2027, 2028 and 2029, are $ 1.2 billion, $ 4.5 billion, $ 3.9 billion, $ 3.9 billion, $ 2.9 billion and $ 2.2 billion, respectively.

During both the three months ended March 31, 2025 and 2024, we recognized amortization of our finite-lived intangible assets of $ 1.2 billion, which was primarily included in Cost of sales in the Condensed Consolidated Statements of Income (Loss).

As of March 31, 2025, the total estimated future amortization of our finite-lived intangible assets for the remaining nine months ending December 31, 2025, and the years ending December 31, 2026, 2027, 2028, 2029 and 2030, was $ 3.1 billion, $ 3.7 billion, $ 3.7 billion, $ 2.8 billion, $ 2.2 billion and $ 2.1 billion, respectively.

Financing arrangements

Our borrowings consisted of the following (in millions):

September 30, 2024 December 31, 2023

3.625 % notes due 2024 ( 3.625 % 2024 Notes)

March 31, 2025 December 31, 2024

1.90 % notes due 2025 ( 1.90 % 2025 Notes)

5.25 % notes due 2025 ( 5.25 % 2025 Notes)

Term loan due April 2025 — 2,000

3.125 % notes due 2025 ( 3.125 % 2025 Notes)

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4.40 % notes due 2062 ( 4.40 % 2062 Notes)

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

5.75 % notes due 2063 ( 5.75 % 2063 Notes)

Other notes due 2097 100 100

Total principal amount of debt

58,945 61,778

Unamortized bond discounts, premiums and issuance costs, net ( 1,345 ) ( 1,360 )

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Debt repayments

During the nine months ended September 30, 2024, we repaid the $ 2.0 billion aggregate principal amount on the Term loan due April 2025, $ 200 million aggregate principal amount of the Term loan due October 2026 and the $ 1.4 billion aggregate principal amount of the 3.625 % 2024 Notes.

During the three months ended March 31, 2025, debt repayments totaled $ 2.5 billion, compared to no debt repayments during the same period in the prior year.

Debt extinguishment

During the nine months ended September 30, 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 the recognition of a $ 215 million gain on extinguishment of debt recorded in Other income, net, in the Condensed Consolidated Statements of Income.

During the three months ended March 31, 2025, we repurchased an aggregate principal amount of our debt of $ 414 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 $ 301 million, which resulted in a $ 111 million gain on extinguishment of debt.

During the three months ended March 31, 2024, we repurchased an aggregate principal amount of our debt of $ 544 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 $ 410 million, which resulted in a $ 133 million gain on extinguishment of debt.

Gains and losses on extinguishments of debt are recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income (Loss).

Interest rate swap contracts

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Stock repurchase program

During the nine months ended September 30, 2024 and 2023, we did not repurchase shares under our stock repurchase program.

As of September 30, 2024, $ 7.0 billion of authorization remained available under our stock repurchase program.

In August 2024, March 2024 and December 2023, our Board of Directors declared quarterly cash dividends of $ 2.25 per share, which were paid in September 2024, June 2024 and March 2024, respectively.

In October 2024, our Board of Directors declared a quarterly cash dividend of $ 2.25 per share that will be paid in December 2024.

During the three months ended March 31, 2025 and 2024, we did not repurchase shares under our stock repurchase program.

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

In March 2025, our Board of Directors declared a quarterly cash dividend of $ 2.38 per share, which will be paid in June 2025.

In December 2024, our Board of Directors declared a quarterly cash dividend of $ 2.38 per share, which was paid in March 2025.

Accumulated other comprehensive income (loss)

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Foreign currency translation adjustments 57 — — 57

Unrealized gains — 178 — 178

Reclassification adjustments into earnings

— ( 20 ) — ( 20 )

Other — — ( 3 ) ( 3 )

Income taxes — ( 32 ) — ( 32 )

Balance as of March 31, 2024

( 322 ) 104 28 ( 190 )

Foreign currency translation adjustments ( 15 ) — — ( 15 )

Unrealized gains — 117 — 117

Reclassification adjustments into earnings

— ( 52 ) — ( 52 )

Other — — ( 1 ) ( 1 )

Income taxes — ( 14 ) — ( 14 )

Balance as of June 30, 2024

( 337 ) 155 27 ( 155 )

Foreign currency translation adjustments 71 — — 71

Unrealized losses — ( 146 ) — ( 146 )

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Income taxes — 62 — 62

Balance as of September 30, 2024

Balance as of March 31, 2025

$ ( 317 ) $ 64 $ 22 $ ( 231 )

Reclassifications out of AOCI and into earnings, including related income tax expenses, were as follows (in millions):

Three months ended September 30,

Components of AOCI 2024 2023 Condensed Consolidated

Statements of Income locations

Cash flow hedges:

Foreign currency contract gains $ 45 $ 33 Product sales

Cross-currency swap contract gains (losses) 121 ( 86 ) Other income, net

166 ( 53 ) Income before income taxes

( 36 ) 11 Provision for income taxes

$ 130 $ ( 42 ) Net income

Nine months ended September 30,

Three months ended March 31,

Components of AOCI 2025 2024 Condensed Consolidated

Statements of Income locations

Statements of Income (Loss) locations

Cash flow hedges:

Foreign currency contract gains $ 151 $ 121 Product sales

Cross-currency swap contract gains (losses) 87 ( 57 ) Other income, net

238 64 Income before income taxes

Foreign currency forward contract gains $ 56 $ 51 Product sales

Cross-currency swap contract gains (losses) 83 ( 31 ) Other income (expense), net

139 20 Income (loss) before income taxes

( 30 ) ( 4 ) Provision for income taxes

$ 187 $ 50 Net income

$ 109 $ 16 Net income (loss)

Fair value measurement

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

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

Observable inputs are inputs that market participants would use in pricing an asset or liability based on market data obtained from sources independent of the Company.

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(Level 2) Significant

Fair value measurement as of September 30, 2024, using:

Fair value measurement as of March 31, 2025, using:

Available-for-sale securities:

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Foreign currency forward contracts — 195 — 195

Cross-currency swap contracts — 4 — 4

Interest rate swap contracts — 9 — 9

Total assets $ 12,664 $ 1,315 $ — $ 13,979

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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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Interest-bearing and equity securities

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 September 30, 2024 and December 31, 2023, are based on quoted market prices in active markets, with no valuation adjustment.

The fair values of our U.S.

Treasury bills are determined by utilizing third-party pricing services, which obtain pricing data from active market makers and brokers.

The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeiGene and Neumora, as of March 31, 2025 and December 31, 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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See Note 12, Derivative instruments.

Contingent consideration obligations

As a result of our business acquisitions, 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 inputs include, as applicable, estimated probabilities and the timing of achieving specified development, regulatory and commercial milestones as well as estimated annual sales.

Significant changes that increase or decrease the probabilities of achieving the related development, regulatory and commercial events or that shorten or lengthen the time required to achieve such events or that increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of the obligations, as applicable.

Changes in the fair values of contingent consideration obligations are recognized in Other operating expenses in the Condensed Consolidated Statements of Income.

Changes in the carrying amounts of contingent consideration obligations were as follows (in millions):

Three months ended

September 30, Nine months ended

September 30,

2024 2023 2024 2023

Beginning balance $ 107 $ 248 $ 96 $ 270

Payments ( 2 ) ( 3 ) ( 6 ) ( 7 )

Net changes in valuations 7 ( 147 ) 22 ( 165 )

Ending balance $ 112 $ 98 $ 112 $ 98

As of September 30, 2024 and December 31, 2023, our contingent consideration obligations are primarily the result of our acquisition of Teneobio, Inc.

in October 2021, which obligates us to pay the former shareholders payments upon achieving separate development and regulatory milestones with regard to various R&D programs.

Summary of the fair values of other financial instruments

Cash equivalents

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

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

As of September 30, 2024 and December 31, 2023, the aggregate fair values of our fixed-rate notes were $ 58.0 billion and $ 59.2 billion, respectively, and the carrying values of this debt were $ 58.6 billion and $ 60.6 billion, respectively.

The estimate of the fair values of our Term loans is approximated as the carrying values as of September 30, 2024 and December 31, 2023 as these debt instruments bear interest at floating rates.

During the nine months ended September 30, 2024 and 2023, there were no transfers of assets or liabilities between fair value measurement levels, and there were no material remeasurements to the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

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

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

As of March 31, 2025 and December 31, 2024, the aggregate fair values of our fixed-rate debt were $ 53.0 billion and $ 54.9 billion, respectively, and the carrying values of our fixed-rate debt were $ 55.6 billion and $ 58.3 billion, respectively.

The estimates of the fair values of our term loans approximate their carrying values as of March 31, 2025 and December 31, 2024, as these debt instruments bear interest at floating rates.

During the three months ended March 31, 2025 and 2024, there were no transfers of assets or liabilities between fair value measurement levels.

Except with respect to the partial impairment of the Otezla intangible asset as discussed in Note 8, Goodwill and other intangible assets, there were no material remeasurements of the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

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 September 30, 2024 and December 31, 2023, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.1 billion and $ 6.6 billion, respectively.

As of March 31, 2025 and December 31, 2024, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.3 billion and $ 7.2 billion, respectively.

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

Accordingly, we report the unrealized gains and losses on these contracts in AOCI in the Condensed Consolidated Balance Sheets, and we reclassify them to Product sales in the Condensed Consolidated Statements of Income in the same periods during which the hedged transactions affect earnings.

Accordingly, we record the unrealized gains and losses on these contracts in AOCI in the Condensed Consolidated Balance Sheets, and we reclassify them to Product sales in the Condensed Consolidated Statements of Income (Loss) in the same periods during which the hedged transactions affect earnings.

To hedge our exposure to foreign currency exchange rate risk associated with certain of our long-term debt denominated in foreign currencies, we enter into cross-currency swap contracts.

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

The notional amounts and interest rates of our cross-currency swaps as of September 30, 2024, were as follows (notional amounts in millions):

Accordingly, the unrealized gains and losses on these contracts are recorded in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other income (expense), net, in the Condensed Consolidated Statements of Income (Loss) in the same periods during which the hedged debt affects earnings.

The notional amounts and interest rates of our cross-currency swaps as of March 31, 2025, were as follows (notional amounts in millions):

Foreign currency U.S.

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Treasury rate between the time we enter into these contracts and the time the related debt is issued.

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

Amounts recognized in connection with forward interest rate contracts during the nine months ended September 30, 2024, and amounts expected to be recognized during the subsequent 12 months are not material.

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

Amounts recognized in connection with forward interest rate contracts during the three months ended March 31, 2025 and 2024, and amounts expected to be recognized during the next 12 months are not material.

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

Three months ended

September 30, Nine months ended

September 30,

Derivatives in cash flow hedging relationships 2025 2024

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Cross-currency swap contracts 66 ( 24 )

Forward interest rate contracts — — — ( 31 )

Total unrealized (losses) gains $ ( 146 ) $ 178

Fair value hedges

To achieve a desired mix of fixed-rate and floating-rate debt, we entered into interest rate swap contracts that qualified for and were designated as fair value hedges.

These interest rate swap contracts effectively convert fixed-rate coupons to floating-rate coupons over the terms of the related hedge contracts.

As of both September 30, 2024 and December 31, 2023, we had interest rate swap contracts with aggregate notional amounts of $ 6.7 billion, that hedge certain portions of our long-term debt issuances.

During the nine months ended September 30, 2024, interest rate swaps 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 swaps 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 %.

For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of Income the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk.

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 March 31, 2025 and December 31, 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 issuances.

For interest rate swap contracts that qualify for and are designated as fair value hedges, we recognize in Interest expense, net, in the Condensed Consolidated Statements of Income (Loss) the unrealized gain or loss on the derivative resulting from the change in fair value during the period, as well as the offsetting unrealized loss or gain of the hedged item resulting from the change in fair value during the period attributable to the hedged risk.

If a hedging relationship involving an interest rate swap contract is terminated, the gain or loss realized on contract termination is recorded as an adjustment to the carrying value of the debt and amortized into Interest expense, net, over the remaining term of the previously hedged debt.

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Cumulative amounts of fair value hedging adjustments related to the carrying amounts of the hedged liabilities (2)

Condensed Consolidated Balance Sheets locations September 30, 2024 December 31, 2023 September 30, 2024 December 31, 2023

Condensed Consolidated Balance Sheets locations March 31, 2025 December 31, 2024 March 31, 2025 December 31, 2024

Current portion of long-term debt $ 1,051 $ 1,045 $ 51 $ 45

Long-term debt $ 5,244 $ 5,152 $ ( 298 ) $ ( 388 )

(1) Current portion of long-term debt includes $ 58 million and $ 69 million of carrying value with discontinued hedging relationships as of September 30, 2024 and December 31, 2023, respectively.

Long-term debt includes $ 245 million and $ 288 million of carrying value with discontinued hedging relationships as of September 30, 2024 and December 31, 2023, respectively.

(2) Current portion of long-term debt includes $ 58 million and $ 69 million of hedging adjustments on discontinued hedging relationships as of September 30, 2024 and December 31, 2023, respectively.

Long-term debt includes $ 145 million and $ 188 million of hedging adjustments on discontinued hedging relationships as of September 30, 2024 and December 31, 2023, respectively.

(1) Current portion of long-term debt includes $ 54 million and $ 56 million of carrying value with discontinued hedging relationships as of March 31, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 219 million and $ 232 million of carrying value with discontinued hedging relationships as of March 31, 2025 and December 31, 2024, respectively.

(2) Current portion of long-term debt includes $ 54 million and $ 56 million of hedging adjustments on discontinued hedging relationships as of March 31, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 119 million and $ 132 million of hedging adjustments on discontinued hedging relationships as of March 31, 2025 and December 31, 2024, respectively.

Impact of hedging transactions

The following tables summarize the amounts recorded in income and expense line items and the effects thereon from fair value and cash flow hedging, including discontinued hedging relationships (in millions):

Three months ended September 30, 2024 Nine months ended September 30, 2024

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

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income

Three months ended March 31, 2025

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

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income (Loss)

$ 7,873 $ 1,518 $ ( 723 )

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Derivatives designated as hedging instruments $ — $ — $ 112

Three months ended September 30, 2023 Nine months ended September 30, 2023

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

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income

Three months ended March 31, 2024

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

Total amounts recorded in income and (expense) line items presented in the Condensed Consolidated Statements of Income (Loss)

$ 7,118 $ ( 235 ) $ ( 824 )

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Hedged items (1)

$ — $ — $ 58 $ — $ — $ 63

Derivatives designated as hedging instruments $ — $ — $ ( 28 )

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

As of September 30, 2024, amounts expected to be recognized into earnings during the subsequent 12 months on our foreign currency and cross-currency swap contracts are not material.

As of March 31, 2025, the amount of net gains on our foreign currency forward and cross-currency swap contracts expected to be reclassified out of AOCI and recognized into earnings during the next 12 months was not material.

Derivatives not designated as hedges

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

As of September 30, 2024 and December 31, 2023, the total notional amounts of these foreign currency forward contracts were $ 82 million and $ 457 million, respectively.

Gains and losses recognized in earnings for our derivative instruments not designated as hedging instruments were not material for the three and nine months ended September 30, 2024 and 2023.

As of March 31, 2025 and December 31, 2024, the total notional amounts of these foreign currency forward contracts were $ 41 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 three months ended March 31, 2025 and 2024.

Fair values of derivatives

1 unchanged sentence

Derivative assets Derivative liabilities

September 30, 2024 Condensed Consolidated

March 31, 2025 Condensed Consolidated

Balance Sheets locations Fair values Condensed Consolidated

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For additional information, see Note 11, Fair value measurement.

Our derivative contracts that were in liability positions as of September 30, 2024, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change-in-control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change-in-control.

Our derivative contracts that were in liability positions as of March 31, 2025, contain certain credit-risk-related contingent provisions that would be triggered if (i) we were to undergo a change in control and (ii) our or the surviving entity’s creditworthiness deteriorates, which is generally defined as having either a credit rating that is below investment grade or a materially weaker creditworthiness after the change in control.

If these events were to occur, the counterparties would have the right, but not the obligation, to close the contracts under early-termination provisions.

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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 Condensed 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.

Contingencies and commitments

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Risk Factors— Our business may be affected by litigation and government investigations.

We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote;

in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

We describe our legal proceedings and other matters that are significant or that we believe could become significant in this footnote and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024.

We record accruals for loss contingencies to the extent that we conclude it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated.

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In each of the matters described in this filing;

in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024, 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.

and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024, 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 Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2023;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024, 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.

and in Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024, 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.

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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Repatha Patent Litigation

Patent Disputes in the International Region

On October 17, 2024 in Sanofi-Aventis Deutschland GmbH (Sanofi-Aventis) and Regeneron Pharmaceuticals, Inc.’s (Regeneron) actions seeking damages arising from the provisional enforcement of an injunction against PRALUENT ® , the Munich Regional Court scheduled a hearing for February 26, 2025.

Unified Patent Court of the European Union

Amgen filed a Statement of Appeal on September 13, 2024, asking the Court of Appeals to the Unified Patent Court (UPC) to set aside the decision of the UPC Central Division revoking Amgen’s European Patent No.

3,666,797 (EP ‘797).

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

4,252,857, 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.

Unified Patent Court of the European Union (UPC)

On February 25, 2025, a hearing on the validity and infringement of European Patent No.

3,536,712 (the EP’712 Patent), which Sanofi Biotechnology SAS licensed from Regeneron Pharmaceuticals, Inc.

(Regeneron), was held before the Dusseldorf Local Division of the UPC.

The parties await the decision of the court.

On February 28, 2025, Sanofi and Regeneron filed the Statement of Case on European Patent No.

On April 17, 2025, the Court of Appeals of the UPC canceled the oral hearing scheduled for May 22, 2025 on the appeal of the decision by the Central Division of the UPC to revoke Amgen’s European Patent No.

3,666,797 (the EP’797 Patent).

This hearing will be rescheduled, and the parties have been invited to comment on the written decision of the European Patent Office Opposition Division rejecting Sanofi-Aventis and Regeneron’s opposition and concluding that the claims of the EP’797 Patent are valid.

European Patent Office

The European Patent Office (EPO) Opposition Division will hear argument on Sanofi-Aventis and Regeneron’s opposition against Amgen’s EP ‘797 from March 31 to April 4, 2025.

In Amgen’s opposition before the EPO against Regeneron’s European Patent No.

3,536,712, the Opposition Division will hear argument on March 11 and 12, 2025.

On September 16, 2024, Amgen filed an appeal brief with the Japanese Intellectual Property High Court, seeking to overturn the Japanese Patent Office’s decision to reject Amgen’s amended patent claims following a remand of the case to the Japanese Patent Office from the Japanese Intellectual Property High Court.

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.

A hearing was held beginning on March 31, 2025 on Sanofi-Aventis and Regeneron’s opposition against Amgen’s EP’797 Patent.

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.

On April 15, 2025, the Intellectual Property High Court dismissed Amgen’s appeal in Amgen’s lawsuit against Sanofi K.K.

seeking monetary compensation for past patent infringement.

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

Samsung Bioepis Co.

On August 12, 2024, 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 Samsung Bioepis Co.

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

The complaint asserts infringement of the following 34 patents:

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

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 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 found 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.

Biologic’s response to the Complaint is due on October 28, 2024.

District Court for the District of New Jersey (the New Jersey District Court) scheduled a trial to begin on May 4, 2026.

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 (Northern 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.

The complaint asserts infringement of the following 33 patents:

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

Amgen seeks a judgment from the Northern Illinois District Court that Fresenius has infringed or will infringe one or more claims of each of the Asserted Patents 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 found infringed.

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

PAVBLU ™ (formerly ABP 938 (aflibercept-ayyh)) Patent Litigation

On September 23, 2024, the U.S.

District Court for the Northern District of West Virginia denied Regeneron’s motion for a preliminary injunction, and Regeneron filed a notice of appeal, a motion to expedite the appeal, and an emergency motion for an injunction pending resolution of the appeal and for an administrative stay with the U.S.

Court of Appeals for the Federal Circuit (the Federal Circuit Court).

On September 25, 2024, the Federal Circuit Court issued an order temporarily enjoining the launch of PAVBLU on an administrative basis while it considered Regeneron’s motion for an injunction pending appeal.

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.

Amgen’s response brief to the appeal is due on November 4, 2024, Regeneron’s reply brief is due on November 13, 2024 and oral arguments for the appeal will be scheduled for January 2025.

Antitrust Class Actions

Sensipar Antitrust Class Actions

On September 13, 2024, the putative class of direct purchasers of Sensipar (Sensipar Plaintiffs) filed their opening brief in its appeal of the dismissal of its claims by the U.S.

District Court for the District of Delaware (Delaware District Court).

Amgen has obtained an extension until November 14, 2024 to file its opposing brief.

The Sensipar Plaintiffs’ reply is due December 5, 2024.

The parties entered into a confidential settlement that resolves patent disputes related to Fresenius’ denosumab biosimilar products, including this litigation.

On March 3, 2025, the parties filed a joint stipulation, and on March 7, 2025, the New Jersey District court entered an order dismissing all claims and affirmative defenses asserted in this litigation without prejudice.

The confidential settlement allows Fresenius to launch its denosumab biosimilar products in the United States as early as June 30, 2025, and in Europe in November 2025.

Denosumab Patent Litigation (Multidistrict Litigations)

The New Jersey District Court scheduled a claim construction hearing for all actions subject to the multidistrict litigation for November 12, 2025.

PAVBLU ® (aflibercept-ayyh) Patent Litigation

On March 14, 2025, the U.S.

Court of Appeals for the Federal Circuit affirmed the denial by the U.S.

District Court for the Northern District of West Virginia of Regeneron’s motion for a preliminary injunction.

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

Onyx Therapeutics, Inc.

Somerset Therapeutics, LLC

On April 24, 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 (the Delaware District Court) against Somerset Therapeutics, LLC (Somerset) asserting infringement of U.S.

7,737,112 (the ’112 Patent) based on Somerset’s submission of an ANDA 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 the defendant’s ANDA effective no earlier than the expiration of the ’112 Patent.

Antitrust Actions

Regeneron Pharmaceuticals, Inc.

Antitrust Action

The trial before the Delaware District Court that had been set to begin on November 12, 2024 was taken off calendar.

A new date for the trial has not yet been set.

The Delaware District Court set a hearing on November 20, 2024 to hear Amgen’s motion for summary judgment and the parties’ motions to exclude expert testimony.

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.

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.

Amgen’s response to the complaint is due on November 4, 2024.

On April 10, 2025, the Delaware District Court denied Amgen’s motion for summary judgment.

Trial is scheduled to begin on May 5, 2025.

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 of Maryland, Inc., Group Hospitalization and Medical Services, Inc., and CareFirst BlueChoice, Inc.

See Antitrust Class Action—CareFirst of Maryland Antitrust Class Action in

Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024.

Tax Litigation and Related Matters

4 unchanged sentences

149 Pension Fund)

On September 30, 2024, the U.S.

District Court for the Southern District of New York denied Amgen’s motion to dismiss.

Amgen's response to the complaint is due on November 20, 2024.

Shareholder Derivative Litigation (Hamilton)

On October 16, 2024, David Hamilton filed a derivative action captioned David Hamilton v.

Bradway, et al., No.

2024-1063 (Del.

16, 2024), purportedly on behalf of Amgen, against Amgen, Robert Bradway, Peter Griffith and Amgen’s Board members during the relevant time period.

The action was filed in the Delaware Chancery Court.

The complaint in this matter alleges claims for breach of fiduciary duty and unjust enrichment.

The factual allegations that form the basis for these claims are fundamentally the same as those asserted by the Roofers Local No.

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).

Pursuant to the Case Management Plan and Scheduling Order set by the U.S.

District Court for the Southern District of New York, the last day to file summary judgment motions is August 12, 2026.

Shareholder Derivative Action (Sieveking)

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.

ChemoCentryx, Inc.

Securities Matters

On September 10, 2024, the U.S.

District Court for the Northern District of California granted an administrative motion to extend certain case schedule deadlines, including setting the expert discovery cutoff to December 20, 2024 and setting the deadlines for summary judgment motions on April 4, 2025, summary judgment oppositions on April 25, 2025, and summary judgment replies on May 9, 2025.

Trial is set for September 2025.

Under the current schedule set by the U.S.

District Court for the Northern District of California, the lead plaintiff’s summary judgment motion is due May 8, 2025.

That motion and ChemoCentryx’s cross-motion for summary judgment will be fully briefed by July 3, 2025.

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-Q

Item 1. Financial Statements