What changed in this filing

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Item 1. Financial Statements

2025-11-05 compared with 2025-08-06 · 246 added, 247 removed, 685 unchanged (42% of the section changed)

3 unchanged sentences

Three months ended

June 30, Six months ended

September 30, Nine months ended

September 30,

2025 2024 2025 2024

11 unchanged sentences

Interest expense, net ( 685 ) ( 776 ) ( 2,102 ) ( 2,408 )

Other (expense) income, net ( 394 ) ( 307 ) 1,124 ( 542 )

Other income, net 2,080 1,830 3,204 1,288

Income before income taxes 3,921 3,101 7,462 3,827

11 unchanged sentences

Three months ended

June 30, Six months ended

September 30, Nine months ended

September 30,

2025 2024 2025 2024

Net income $ 3,216 $ 2,830 $ 6,378 $ 3,463

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

Gains (losses) on foreign currency translation adjustments 86 ( 15 ) 143 ( 39 )

(Losses) gains on cash flow hedges ( 399 ) 51 ( 622 ) 177

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

Gains on foreign currency translation adjustments 11 71 154 32

Gains (losses) on cash flow hedges 110 ( 253 ) ( 512 ) ( 76 )

Other 1 1 2 ( 3 )

Other comprehensive (loss) income, net of reclassification adjustments and taxes ( 313 ) 35 ( 478 ) 134

Other comprehensive income (loss), net of reclassification adjustments and taxes 122 ( 181 ) ( 356 ) ( 47 )

Comprehensive income $ 3,338 $ 2,649 $ 6,022 $ 3,416

2 unchanged sentences

(In millions, except per-share data)

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Current assets:

33 unchanged sentences

(In millions, except per-share data)

Three months ended June 30, 2025

Three months ended September 30, 2025

paid-in capital Accumulated

1 unchanged sentence

comprehensive loss Total

Balance as of March 31, 2025 537.7 $ 33,578 $ ( 27,140 ) $ ( 231 ) $ 6,207

Balance as of June 30, 2025 538.3 $ 33,680 $ ( 25,708 ) $ ( 544 ) $ 7,428

Net income — — 3,216 — 3,216

Other comprehensive loss, net of taxes — — — ( 313 ) ( 313 )

Other comprehensive income, net of taxes — — — 122 122

Dividends declared on common stock ($ 2.38 per share)

— — ( 1,308 ) — ( 1,308 )

Issuance of common stock in connection with equity award programs

3 unchanged sentences

— ( 12 ) — — ( 12 )

Balance as of June 30, 2025 538.3 $ 33,680 $ ( 25,708 ) $ ( 544 ) $ 7,428

Six months ended June 30, 2025

Balance as of September 30, 2025 538.5 $ 33,841 $ ( 23,800 ) $ ( 422 ) $ 9,619

Nine months ended September 30, 2025

paid-in capital Accumulated

11 unchanged sentences

— ( 185 ) — — ( 185 )

Balance as of June 30, 2025 538.3 $ 33,680 $ ( 25,708 ) $ ( 544 ) $ 7,428

Balance as of September 30, 2025 538.5 $ 33,841 $ ( 23,800 ) $ ( 422 ) $ 9,619

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (continued)

(In millions, except per-share data)

Three months ended June 30, 2024

Three months ended September 30, 2024

paid-in capital Accumulated

1 unchanged sentence

comprehensive loss Total

Balance as of March 31, 2024 536.4 $ 33,082 $ ( 27,870 ) $ ( 190 ) $ 5,022

Balance as of June 30, 2024 537.2 $ 33,204 $ ( 27,124 ) $ ( 155 ) $ 5,925

Net income — — 2,830 — 2,830

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

Other comprehensive loss, net of taxes — — — ( 181 ) ( 181 )

Dividends declared on common stock ($ 2.25 per share)

— — ( 1,236 ) — ( 1,236 )

Issuance of common stock in connection with equity award programs

3 unchanged sentences

— ( 14 ) — — ( 14 )

Balance as of June 30, 2024 537.2 $ 33,204 $ ( 27,124 ) $ ( 155 ) $ 5,925

Six months ended June 30, 2024

Balance as of September 30, 2024 537.5 $ 33,393 $ ( 25,530 ) $ ( 336 ) $ 7,527

Nine months ended September 30, 2024

paid-in capital Accumulated

3 unchanged sentences

Net income — — 3,463 — 3,463

Other comprehensive income, net of taxes — — — 134 134

Other comprehensive loss, net of taxes — — — ( 47 ) ( 47 )

Dividends declared on common stock ($ 2.25 per share)

5 unchanged sentences

— ( 239 ) — — ( 239 )

Balance as of June 30, 2024 537.2 $ 33,204 $ ( 27,124 ) $ ( 155 ) $ 5,925

Balance as of September 30, 2024 537.5 $ 33,393 $ ( 25,530 ) $ ( 336 ) $ 7,527

See accompanying notes.

1 unchanged sentence

(In millions)

Six months ended

Nine months ended

September 30,

Cash flows from operating activities:

5 unchanged sentences

Deferred income taxes ( 702 ) ( 894 )

(Gains) losses on equity securities ( 741 ) 916

Gains on equity securities ( 2,712 ) ( 717 )

Other items, net ( 101 ) ( 139 )

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2025

September 30, 2025

Summary of significant accounting policies

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Basis of presentation

The interim unaudited financial information for the three and six months ended June 30, 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.

The interim unaudited financial information for the three and nine months ended September 30, 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 the consolidated financial statements and the notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2024, and with the condensed consolidated financial statements and the notes thereto contained in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

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, and with the condensed consolidated financial statements and the notes thereto contained in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.

Principles of consolidation

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Property, plant and equipment, net

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $ 10.8 billion and $ 10.4 billion as of June 30, 2025 and December 31, 2024, respectively.

Property, plant and equipment is recorded at historical cost, net of accumulated depreciation and amortization of $ 11.0 billion and $ 10.4 billion as of September 30, 2025 and December 31, 2024, respectively.

Recent accounting pronouncements not yet adopted

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

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

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

In November 2024, the FASB issued ASU No.

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

In September 2025, the FASB issued ASU No.

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

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

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

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

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

Segment and other information

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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 and a reconciliation of segment net income to the Company’s total consolidated net income for the three and six months ended June 30, 2025 and 2024 (in millions):

The following table provides segment revenues, significant segment expenses, other segment items and reported segment net income for the Company’s one reportable segment, as well as a reconciliation of segment net income to the Company’s total consolidated net income for the three and nine months ended September 30, 2025 and 2024 (in millions):

Three months ended

June 30, Six months ended

September 30, Nine months ended

September 30,

2025 2024 2025 2024

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( 1,642 ) ( 1,661 ) ( 1,676 ) ( 696 )

Equity in loss (income) of equity method investments 18 ( 12 ) 29 ( 39 )

Equity in (income) loss of equity method investments ( 10 ) 28 19 ( 11 )

Interest income

7 unchanged sentences

Consolidated net income $ 3,216 $ 2,830 $ 6,378 $ 3,463

(1) During the three months ended June 30, 2025 and 2024, amortization of our finite-lived intangible assets was $ 1.1 billion and $ 1.2 billion, respectively.

During the six months ended June 30, 2025 and 2024, amortization of our finite-lived intangible assets was $ 2.3 billion and $ 2.4 billion, respectively.

(1) During the three months ended September 30, 2025 and 2024, amortization of our finite-lived intangible assets was $ 1.1 billion and $ 1.2 billion, respectively.

During the nine months ended September 30, 2025 and 2024, amortization of our finite-lived intangible assets was $ 3.4 billion and $ 3.6 billion, respectively.

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

In addition, during the three months ended June 30, 2025 and 2024, we recognized depreciation and right-of-use asset amortization of $ 220 million and $ 202 million, respectively.

During the six months ended June 30, 2025 and 2024, we recognized depreciation and right-of-use asset amortization of $ 429 million and $ 403 million, respectively.

(2) During the three months ended June 30, 2025 and 2024, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 339 million and $ 660 million, respectively.

During the six months ended June 30, 2025 and 2024, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 702 million and $ 1.4 billion, respectively.

In addition, during the three months ended September 30, 2025 and 2024, we recognized depreciation and right-of-use asset amortization of $ 232 million and $ 198 million, respectively.

During the nine months ended September 30, 2025 and 2024, we recognized depreciation and right-of-use asset amortization of $ 661 million and $ 601 million, respectively.

(2) During the three months ended September 30, 2025 and 2024, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 338 million and $ 661 million, respectively.

During the nine months ended September 30, 2025 and 2024, manufacturing cost of sales included amortization of step-up to fair value of inventory acquired in business combinations of $ 1.0 billion and $ 2.0 billion, respectively.

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

We operate our business in one operating segment:

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

human therapeutics.

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

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

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

Revenues were as follows (in millions):

Three months ended June 30,

Three months ended September 30,

ROW Total U.S.

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ENBREL 574 6 580 817 8 825

XGEVA 347 185 532 399 163 562

Otezla 473 112 585 460 104 564

XGEVA 357 182 539 373 168 541

EVENITY 417 124 541 289 110 399

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BLINCYTO 236 156 392 237 90 327

Nplate 333 124 457 345 111 456

KYPROLIS 225 134 359 238 140 378

Aranesp 103 254 357 105 232 337

Nplate 228 141 369 214 132 346

377 — 377 269 — 269

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Total revenues $ 9,557 $ 8,503

Six months ended June 30,

Nine months ended September 30,

ROW Total U.S.

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ENBREL 1,675 19 1,694 2,280 21 2,301

XGEVA 707 391 1,098 765 358 1,123

Otezla 1,328 312 1,640 1,185 317 1,502

XGEVA 1,064 573 1,637 1,138 526 1,664

EVENITY 1,132 369 1,501 806 326 1,132

1 unchanged sentence

BLINCYTO 779 367 1,146 555 280 835

Nplate 762 377 1,139 749 370 1,119

KYPROLIS 673 388 1,061 712 419 1,131

Aranesp 301 755 1,056 296 738 1,034

Nplate 429 253 682 404 259 663

1,004 — 1,004 676 — 676

9 unchanged sentences

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

(3) Hedging gains and losses, which are included in product sales, were not material for the three and six months ended June 30, 2025 and 2024.

The effective tax rates for the three and six months ended June 30, 2025 were 8.7 % and 10.7 %, respectively, compared with 6.0 % and 12.8 %, respectively, for the corresponding periods in the prior year.

The increase in our effective tax rate for the three months ended June 30, 2025, was primarily due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon, and current year net unfavorable items as compared to the prior period.

The decrease in our effective tax rate for the six months ended June 30, 2025, was primarily due to the change in earnings mix, including the Otezla impairment charge recorded in the first quarter of 2025, and current year net favorable items as compared to the prior period, partially offset by the net unrealized gains in the first half of 2025 compared to net unrealized losses in the prior period on equity investments.

See Note 6, Investments .

(3) Hedging gains and losses, which are included in product sales, were not material for the three and nine months ended September 30, 2025 and 2024.

The effective tax rates for the three and nine months ended September 30, 2025 were 18.0 % and 14.5 %, respectively, compared with 8.7 % and 9.5 %, respectively, for the corresponding periods in the prior year.

The increase in our effective tax rate for the three months ended September 30, 2025, was primarily due to the change in earnings mix, including lower amortization expense from the fair value step-up of inventory acquired from Horizon.

The increase in our effective tax rate for the nine months ended September 30, 2025, was primarily due to the change in earnings mix, including the net unrealized gains on equity investments in the first nine months of 2025 compared to those in the prior-year period (see Note 6, Investments) and partially offset by the year-to-date Otezla impairment charges and related tax impacts (see Note 8, Goodwill and other intangible assets) .

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

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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.

Due to the currently enacted scope of the agreement, the Company and its subsidiaries are now subject to a 15% minimum tax rate on adjusted financial statement income.

Our foreign earnings are also subject to U.S.

tax at a reduced rate of 10.5%.

On July 4, 2025, the OBBBA was enacted in the United States.

The OBBBA has various provisions, including the permanent extension of certain expiring provisions of the 2017 Tax Act, and modifications to the international tax framework.

On July 4, 2025, OB3 was enacted in the United States.

OB3 has various provisions, including the permanent extension of certain expiring provisions of the 2017 Tax Act, and modifications to the international tax framework.

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

The impact of these changes on our deferred tax assets and liabilities was recorded in the third quarter of 2025 and did not have a material effect on our effective tax rate or on our condensed consolidated financial statements.

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

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taxable income for the years 2010–2012 by an amount that would result in additional federal tax of approximately $ 3.6 billion, plus interest.

Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $ 900 million of repatriation tax previously accrued on our foreign earnings.

Any additional tax that could be imposed for the years 2010–2012 would be reduced by up to approximately $ 900 million of repatriation tax previously accrued and paid on our foreign earnings.

In 2020, we received an RAR and a modified RAR from the IRS for the years 2013–2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S.

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In addition, the Notice asserts penalties of approximately $ 2.0 billion.

Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $ 2.2 billion of repatriation tax previously accrued on our foreign earnings.

Any additional tax that could be imposed for the years 2013–2015 would be reduced by up to approximately $ 2.2 billion of repatriation tax previously accrued and paid on our foreign earnings.

We firmly believe that the IRS positions set forth in the 2010–2012 and 2013–2015 Notices are without merit.

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The parties filed opening post-trial briefs on June 13, 2025, and the Court held oral argument on July 16, 2025.

The parties are scheduled to file post-trial reply briefs in October 2025.

The parties filed post-trial reply briefs on October 10, 2025.

The Company expects a decision from the U.S.

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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 expect that the IRS will begin its audit of 2019-2022 in 2025 or early 2026, and we believe that

it may seek to continue to audit similar issues related to the allocation of income between the United States and our foreign jurisdictions.

We expect that the IRS will begin its audit of 2019-2022 in 2025 or early 2026, and we believe that it may seek to continue to audit similar issues related to the allocation of income between the United States and our foreign jurisdictions.

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

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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 six months ended June 30, 2025, the gross amounts of our UTBs increased by $ 60 million and $ 100 million, respectively, as a result of tax positions taken during the current year.

Substantially all of the UTBs as of June 30, 2025, if recognized, would impact our effective tax rate.

During the three and nine months ended September 30, 2025, the gross amounts of our UTBs increased by $ 45 million and $ 145 million, respectively, as a result of tax positions taken during the current year.

Substantially all of the UTBs as of September 30, 2025, if recognized, would impact our effective tax rate.

Earnings per share

3 unchanged sentences

Three months ended

June 30, Six months ended

September 30, Nine months ended

September 30,

2025 2024 2025 2024

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Diluted earnings per share $ 5.93 $ 5.22 $ 11.77 $ 6.40

For the three and six months ended June 30, 2025 and 2024, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

For the three and nine months ended September 30, 2025 and 2024, the number of antidilutive employee stock-based awards excluded from the computation of diluted EPS was not significant.

Available-for-sale investments

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

Types of securities as of June 30, 2025 Amortized

Types of securities as of September 30, 2025 Amortized

Treasury bills $ 998 $ — $ — $ 998

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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 June 30, 2025 December 31, 2024

Condensed Consolidated Balance Sheets locations September 30, 2025 December 31, 2024

Cash and cash equivalents $ 8,708 $ 11,486

Total interest-bearing securities $ 8,708 $ 11,486

Cash and cash equivalents in the above table excludes bank account cash of $ 542 million and $ 487 million as of June 30, 2025 and December 31, 2024, respectively.

All interest-bearing securities as of June 30, 2025 and December 31, 2024, mature in one year or less.

For the three months ended June 30, 2025 and 2024, interest income on these investments was $ 86 million and $ 115 million, respectively.

For the six months ended June 30, 2025 and 2024, interest income on these investments was $ 212 million and $ 268 million, respectively.

For the three and six months ended June 30, 2025 and 2024, realized gains and losses on interest-bearing securities were not material and were recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

Cash and cash equivalents in the above table excludes bank account cash of $ 737 million and $ 487 million as of September 30, 2025 and December 31, 2024, respectively.

All interest-bearing securities as of September 30, 2025 and December 31, 2024, mature in one year or less.

For the three months ended September 30, 2025 and 2024, interest income on these investments was $ 99 million and $ 126 million, respectively.

For the nine months ended September 30, 2025 and 2024, interest income on these investments was $ 311 million and $ 394 million, respectively.

For the three and nine months ended September 30, 2025 and 2024, realized gains and losses on interest-bearing securities were not material and were recorded in Other income, net, in the Condensed Consolidated Statements of Income.

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

3 unchanged sentences

BeOne Medicines Ltd.

As of June 30, 2025 and December 31, 2024, the fair values of our investment in BeOne were $ 4.6 billion and $ 3.5 billion, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended June 30, 2025 and 2024, we recorded unrealized losses of $ 570 million and $ 260 million, respectively.

During the six months ended June 30, 2025 and 2024, we recorded an unrealized gain of $ 1.1 billion and an unrealized loss of $ 714 million, respectively.

These unrealized gains and losses were recognized in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

As of September 30, 2025 and December 31, 2024, the fair values of our investment in BeOne were $ 6.5 billion and $ 3.5 billion, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three months ended September 30, 2025 and 2024, we recorded unrealized gains of $ 1.9 billion and $ 1.6 billion, respectively.

During the nine months ended September 30, 2025 and 2024, we recorded unrealized gains of $ 3.0 billion and $ 836 million, respectively.

These unrealized gains were recognized in Other income, net, in the Condensed Consolidated Statements of Income.

Subject to certain exceptions or otherwise agreed to by BeOne, while Amgen holds at least 5.0 % of BeOne’s outstanding common stock, (A) we may only sell our BeOne equity investment via:

2 unchanged sentences

Other equity securities

Excluding our equity investments in BeOne (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 287 million and $ 314 million as of June 30, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and six months ended June 30, 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 and six months ended June 30, 2025 and 2024, were not material.

We held investments of $ 323 million and $ 319 million in equity securities without readily determinable fair values as of June 30, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and six months ended June 30, 2025 and 2024, upward and downward adjustments on these securities were not material.

Excluding our equity investments in BeOne (discussed above) and Neumora (discussed below), we held investments in other equity securities with readily determinable fair values (publicly traded securities) of $ 300 million and $ 314 million as of September 30, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and nine months ended September 30, 2025, and 2024, net unrealized gains 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, 2025 and 2024, were not material.

We held investments of $ 339 million and $ 319 million in equity securities without readily determinable fair values as of September 30, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

During the three and nine months ended September 30, 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 six months ended June 30, 2025 and 2024, were not material.

Net realized gains and losses on sales of securities without readily determinable fair values for the three and nine months ended September 30, 2025 and 2024, were not material.

Equity method investments

Neumora Therapeutics, Inc.

As of June 30, 2025 and December 31, 2024, our ownership interest in Neumora was approximately 21.9 % and the fair values of our investment were $ 26 million and $ 375 million, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

As of September 30, 2025 and December 31, 2024, our ownership interest in Neumora was approximately 21.8 % and 21.9 %, respectively, and the fair values of our investment were $ 64 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 (expense) income, net, in the 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, net, in the Condensed Consolidated Statements of Income 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 June 30, 2025 and 2024, we recognized unrealized losses of $ 9 million and $ 138 million, respectively.

During the six months ended June 30, 2025 and 2024, we recognized unrealized losses of $ 349 million and $ 255 million, respectively.

During the three months ended September 30, 2025 and 2024, we recognized unrealized gains of $ 38 million and $ 119 million, respectively, and during the nine months ended September 30, 2025 and 2024, we recognized unrealized losses of $ 311 million and $ 136 million, respectively.

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 $ 235 million and $ 262 million as of June 30, 2025 and December 31, 2024, respectively, which were included in Other noncurrent assets in the Condensed Consolidated Balance Sheets.

We held limited partnership investments of $ 246 million and $ 262 million as of September 30, 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 June 30, 2025, we had $ 146 million of unfunded additional commitments to be made for these investments during the next several years.

For the three and six months ended June 30, 2025 and 2024, net unrealized gains and losses recognized from our limited partnership investments were not material.

As of September 30, 2025, we had $ 142 million of unfunded additional commitments to be made for these investments during the next several years.

For the three and nine months ended September 30, 2025 and 2024, net unrealized gains and losses recognized from our limited partnership investments were not material.

Inventories consisted of the following (in millions):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

Raw materials $ 955 $ 818

6 unchanged sentences

Foreign currency translation adjustments

Balance at June 30, 2025

Balance at September 30, 2025

Other intangible assets

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

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

amounts Accumulated

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and upfront payments associated with royalty obligations for marketed products.

Marketing-related rights primarily consists of rights related to the sale and distribution of marketed products.

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

Marketing-related rights primarily consists of rights related to the sale and distribution of marketed products.

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.

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This selection represented a triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment.

In the first quarter of 2025, the Company utilized a discounted cash flow analysis based on Level 3 inputs, including estimated product sales, operating expenses and a discount rate, that resulted in an intangible asset fair value of $ 4.0 billion, which was lower than the carrying value of $ 4.8 billion, and resulted in a partial impairment of both the gross and net carrying amounts of $ 800 million, which was recognized in Other operating expenses in the Condensed Consolidated Statements of Income.

In the third quarter of 2025, new facts and circumstances, primarily from the CMS price setting process, indicated a further triggering event that required the Company to evaluate the underlying developed-product-technology rights for impairment.

A subsequent discounted cash flow analysis, prepared using the same Level 3 input framework and updated assumptions, resulted in a revised intangible asset fair value of $ 3.0 billion, which was lower than the carrying value of $ 3.4 billion, and an additional impairment of $ 400 million.

The impairment charges of $ 400 million and $ 1.2 billion for three and nine months ended September 30, 2025, respectively, were recorded in Other operating expenses in the Condensed Consolidated Statements of Income.

See Note 11, Fair value measurement.

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

During the three months ended June 30, 2025 and 2024, we recognized amortization of our finite-lived intangible assets of $ 1.1 billion and $ 1.2 billion, respectively.

During the six months ended June 30, 2025 and 2024, we recognized amortization of our finite-lived intangible assets of $ 2.3 billion and $ 2.4 billion, respectively.

During the three months ended September 30, 2025 and 2024, we recognized amortization of our finite-lived intangible assets of $ 1.1 billion and $ 1.2 billion, respectively.

During the nine months ended September 30, 2025 and 2024, we recognized amortization of our finite-lived intangible assets of $ 3.4 billion and $ 3.6 billion, respectively.

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

As of June 30, 2025, the total estimated future

amortization of our finite-lived intangible assets for the remaining six months ending December 31, 2025, and the years ending December 31, 2026, 2027, 2028, 2029 and 2030, was $ 2.0 billion, $ 3.7 billion, $ 3.7 billion, $ 2.9 billion, $ 2.3 billion and $ 2.2 billion, respectively.

As of September 30, 2025, the total estimated future amortization of our finite-lived intangible assets for the remaining three months ending December 31, 2025, and the years ending December 31, 2026, 2027, 2028, 2029 and 2030, was $ 0.9 billion, $ 3.6 billion, $ 3.5 billion, $ 2.8 billion, $ 2.3 billion and $ 2.2 billion, respectively.

Financing arrangements

Our borrowings consisted of the following (in millions):

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

1.90 % notes due 2025 ( 1.90 % 2025 Notes)

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4.40 % notes due 2062 ( 4.40 % 2062 Notes)

June 30, 2025 December 31, 2024

September 30, 2025 December 31, 2024

5.75 % notes due 2063 ( 5.75 % 2063 Notes)

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Debt repayments

During the three months ended June 30, 2025 and 2024, debt repayments totaled $ 1.0 billion and $ 1.4 billion, respectively.

During the six months ended June 30, 2025 and 2024, debt repayments totaled $ 3.5 billion and $ 1.4 billion, respectively.

During the three months ended September 30, 2025 and 2024, debt repayments totaled $ 1.5 billion and $ 2.2 billion, respectively.

During the nine months ended September 30, 2025 and 2024, debt repayments totaled $ 5.0 billion and $ 3.6 billion, respectively.

Debt extinguishment

During the three months ended June 30, 2025, we repurchased an aggregate principal amount of our debt of $ 418 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 $ 301 million, which resulted in a $ 117 million gain on extinguishment of debt.

During the three months ended June 30, 2024, we did not have any extinguishments of debt.

During the six months ended June 30, 2025, we repurchased an aggregate principal amount of our debt of $ 832 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 $ 602 million, which resulted in a $ 228 million gain on extinguishment of debt.

During the six months ended June 30, 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 on extinguishments of debt are recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

During the three months ended September 30, 2025, we repurchased an aggregate principal amount of our debt of $ 119 million, including portions of the 2.80 % 2041 Notes, 3.375 % 2050 Notes and 3.00 % 2052 Notes, for an aggregate cost of $ 81 million, which resulted in a $ 36 million gain on extinguishment of debt .

During the three months ended September 30, 2024, we repurchased an aggregate principal amount of our debt of $ 331 million, including portions of the 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes and 3.00 % 2052 Notes, for an aggregate cost of $ 249 million, which resulted in an $ 82 million gain on extinguishment of debt.

During the nine months ended September 30, 2025, we repurchased an aggregate principal amount of our debt of $ 1.0 billion, including portions of the 2.00 % 2032 Notes, 3.15 % 2040 Notes, 2.80 % 2041 Notes, 3.375 % 2050 Notes, 3.00 % 2052 Notes, 4.20 % 2052 Notes and 4.40 % 2062 Notes, for an aggregate cost of $ 683 million, which resulted in a $ 264 million gain on extinguishment of debt.

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 a $ 215 million gain on extinguishment of debt.

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

Interest rate swap contracts

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Stock repurchase program

During the six months ended June 30, 2025 and 2024, we did not repurchase shares under our stock repurchase program.

As of June 30, 2025, $ 6.8 billion of authorization remained available under the stock repurchase program.

In March 2025 and December 2024, our Board of Directors declared quarterly cash dividends of $ 2.38 per share, which were paid in June 2025 and March 2025, respectively.

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

During the nine months ended September 30, 2025 and 2024, we did not repurchase shares under our stock repurchase program.

As of September 30, 2025, $ 6.8 billion of authorization remained available under the stock repurchase program.

In August 2025, March 2025 and December 2024, our Board of Directors declared quarterly cash dividends of $ 2.38 per share, which were paid in September 2025, June 2025 and March 2025, respectively.

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

Accumulated other comprehensive income (loss)

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hedges Other AOCI

Balance as of March 31, 2025

Balance as of June 30, 2025

$ ( 231 ) $ ( 335 ) $ 22 $ ( 544 )

Foreign currency translation adjustments 11 — — 11

Unrealized losses — ( 323 ) — ( 323 )

Unrealized gains — 73 — 73

Reclassification adjustments into earnings

— ( 184 ) — ( 184 )

Other — — 1 1

Income taxes — ( 30 ) — ( 30 )

Balance as of June 30, 2025

Balance as of September 30, 2025

$ ( 220 ) $ ( 225 ) $ 23 $ ( 422 )

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Income taxes — 140 — 140

Balance as of June 30, 2025

Balance as of September 30, 2025

$ ( 220 ) $ ( 225 ) $ 23 $ ( 422 )

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

Three months ended June 30, Condensed Consolidated

Three months ended September 30, Condensed Consolidated

Statements of Income locations

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Cash flow hedges:

Foreign currency forward contract gains $ 12 $ 55 Product sales

Cross-currency swap contract gains (losses) 172 ( 3 ) Other (expense) income, net

Foreign currency forward contract (losses) gains $ ( 28 ) $ 45 Product sales

Cross-currency swap contract (losses) gains ( 39 ) 121 Other income, net

( 67 ) 166 Income before income taxes

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$ ( 53 ) $ 130 Net income

Six months ended June 30, Condensed Consolidated

Nine months ended September 30, Condensed Consolidated

Statements of Income locations

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Foreign currency forward contract gains $ 40 $ 151 Product sales

Cross-currency swap contract gains (losses) 255 ( 34 ) Other (expense) income, net

Cross-currency swap contract gains 216 87 Other income, net

256 238 Income before income taxes

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(Level 2) Significant

Fair value measurement as of June 30, 2025, using:

Fair value measurement as of September 30, 2025, using:

Available-for-sale securities:

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Cross-currency swap contracts — 48 — 48

Interest rate swap contracts — 1 — 1

Total assets $ 14,400 $ 1,269 $ — $ 15,669

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

The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeOne and Neumora, as of June 30, 2025 and December 31, 2024, are based on quoted market prices in active markets, with no valuation adjustment.

The fair values of our money market mutual funds and equity investments in publicly traded securities, including our equity investments in BeOne and Neumora, as of September 30, 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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We estimate the fair values of our fixed-rate debt by using Level 2 inputs.

As of June 30, 2025 and December 31, 2024, the aggregate fair values of our fixed-rate debt were $ 52.1 billion and $ 54.9 billion, respectively, and the carrying values of our fixed-rate debt were $ 54.4 billion and $ 58.3 billion, respectively.

The estimates of the fair values of our term loans approximate their carrying values as of June 30, 2025 and December 31, 2024, as these debt instruments bear interest at floating rates.

During the six months ended June 30, 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 in the first quarter of 2025 as discussed in Note 8, Goodwill and other intangible assets, there were no material remeasurements of the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

As of September 30, 2025 and December 31, 2024, the aggregate fair values of our fixed-rate debt were $ 51.2 billion and $ 54.9 billion, respectively, and the carrying values of our fixed-rate debt were $ 52.8 billion and $ 58.3 billion, respectively.

The estimate of the fair value of our term loan approximates its carrying value as of September 30, 2025 and December 31, 2024, as this debt instrument bears interest at a floating rate.

During the nine months ended September 30, 2025 and 2024, there were no transfers of assets or liabilities between fair value measurement levels.

Except with respect to the partial impairments of the Otezla intangible asset in the first and third quarters of 2025 as discussed in Note 8, Goodwill and other intangible assets, there were no material remeasurements of the fair values of assets and liabilities that are not measured at fair value on a recurring basis.

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 June 30, 2025 and December 31, 2024, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.4 billion and $ 7.2 billion, respectively.

As of September 30, 2025 and December 31, 2024, we had outstanding foreign currency forward contracts with aggregate notional amounts of $ 7.7 billion and $ 7.2 billion, respectively.

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

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We have designated these cross-currency swap contracts as cash flow hedges.

Accordingly, the unrealized gains and losses on these contracts are recorded in AOCI in the Condensed Consolidated Balance Sheets and reclassified to Other (expense) 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 June 30, 2025, 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, 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, 2025, were as follows (notional amounts in millions):

Foreign currency U.S.

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Gains and losses on forward interest rate contracts, which are designated as cash flow hedges, are recognized in AOCI in the 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 six months ended June 30, 2025 and 2024, and amounts expected to be recognized during the next 12 months are not material.

Amounts recognized in connection with forward interest rate contracts during the nine months ended September 30, 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

June 30, Six months ended

September 30, Nine months ended

September 30,

Derivatives in cash flow hedging relationships 2025 2024 2025 2024

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Cross-currency swap contracts ( 50 ) 80 196 50

Total unrealized (losses) gains $ ( 323 ) $ 117 $ ( 469 ) $ 295

Total unrealized gains (losses) $ 73 $ ( 158 ) $ ( 396 ) $ 137

Fair value hedges

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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 June 30, 2025 and December 31, 2024, we had interest rate swap contracts with aggregate notional amounts of $ 5.7 billion and $ 6.7 billion respectively, that hedge certain portions of our long-term debt issuances.

The reduction in aggregate notional amount of these contracts during the six months ended June 30, 2025, was due to the termination of swaps that occurred in connection with the repayment of the 3.125 % 2025 Notes (see Note 9, Financing arrangements).

As of September 30, 2025 and December 31, 2024, we had interest rate swap contracts with aggregate notional amounts of $ 6.2 billion and $ 6.7 billion respectively, that hedge certain portions of our long-term debt.

During the nine months ended September 30, 2025 there was a reduction in the aggregate notional amount of these contracts due to the termination of swaps that occurred in connection with the repayment of the 3.125 % 2025 Notes (see Note 9, Financing arrangements).

In addition, we entered into $ 550 million of new interest rate swaps to hedge a portion of our 5.25 % 2033 Notes, resulting in an interest rate of SOFR plus 1.7 % on the $ 550 million hedged portion.

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.

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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 June 30, 2025 December 31, 2024 June 30, 2025 December 31, 2024

Condensed Consolidated Balance Sheets locations September 30, 2025 December 31, 2024 September 30, 2025 December 31, 2024

Current portion of long-term debt $ 1,266 $ 1,045 $ 16 $ 45

Long-term debt $ 4,670 $ 5,152 $ ( 175 ) $ ( 388 )

(1) Current portion of long-term debt includes $ 53 million and $ 56 million of carrying value with discontinued hedging relationships as of June 30, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 206 million and $ 232 million of carrying value with discontinued hedging relationships as of June 30, 2025 and December 31, 2024, respectively.

(2) Current portion of long-term debt includes $ 53 million and $ 56 million of hedging adjustments on discontinued hedging relationships as of June 30, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 106 million and $ 132 million of hedging adjustments on discontinued hedging relationships as of June 30, 2025 and December 31, 2024, respectively.

(1) Current portion of long-term debt includes $ 51 million and $ 56 million of carrying value with discontinued hedging relationships as of September 30, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 194 million and $ 232 million of carrying value with discontinued hedging relationships as of September 30, 2025 and December 31, 2024, respectively.

(2) Current portion of long-term debt includes $ 51 million and $ 56 million of hedging adjustments on discontinued hedging relationships as of September 30, 2025 and December 31, 2024, respectively.

Long-term debt includes $ 94 million and $ 132 million of hedging adjustments on discontinued hedging relationships as of September 30, 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 June 30, 2025 Six months ended June 30, 2025

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

Three months ended September 30, 2025 Nine months ended September 30, 2025

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

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

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The effects of cash flow and fair value hedging:

Gains on cash flow hedging relationships reclassified out of AOCI:

(Losses) gains on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ ( 28 ) $ — $ — $ 40 $ — $ —

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Derivatives designated as hedging instruments $ — $ — $ 40 $ — $ — $ 227

Three months ended June 30, 2024 Six months ended June 30, 2024

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

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

1 unchanged sentence

The effects of cash flow and fair value hedging:

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

Gains on cash flow hedging relationships reclassified out of AOCI:

Foreign currency forward contracts $ 45 $ — $ — $ 151 $ — $ —

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

As of June 30, 2025, $ 131 million of net losses on our foreign currency forward and cross-currency swap contracts were expected to be reclassified out of AOCI and recognized into earnings during the next 12 months.

As of September 30, 2025, the amount of net losses on our foreign currency forward and cross-currency swap contracts expected to be reclassified out of AOCI and recognized into earnings during the next 12 months was 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 June 30, 2025 and December 31, 2024, the total notional amounts of these foreign currency forward contracts were $ 226 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 and six months ended June 30, 2025 and 2024.

As of September 30, 2025 and December 31, 2024, the total notional amounts of these foreign currency forward contracts were $ 245 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 and nine months ended September 30, 2025 and 2024.

Fair values of derivatives

1 unchanged sentence

Derivative assets Derivative liabilities

June 30, 2025 Condensed Consolidated

September 30, 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 June 30, 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.

Our derivative contracts that were in liability positions as of September 30, 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.

1 unchanged sentence

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 financing activities.

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

Contingencies and commitments

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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;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.

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.

1 unchanged sentence

Our legal proceedings involve various aspects of our business and a variety of claims, some of which present novel factual allegations and/or unique legal theories.

In each of the matters described in this filing;

in 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;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, 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 each of the matters described in this filing, in which we could incur a liability, our opponents seek an award of a not-yet-quantified amount of damages or an amount that is not material.

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

As a result, none of the matters described in this filing;

in 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;

and in Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, 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.

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

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

On May 15, 2025, the Regional Court of Munich, which is considering Sanofi-Aventis Deutschland GmbH and Regeneron Pharmaceutical Inc.’s (Regeneron) request for damages arising from Amgen’s provisional enforcement of an injunction against PRALUENT ® , canceled the hearing scheduled for May 21, 2025 and indicated it will reschedule the hearing for December 2025.

Patent Disputes in the International Region

Unified Patent Court (UPC) of the European Union

In Sanofi Biotechnologies SAS (Sanofi) and Regeneron’s action filed against Amgen before the Dusseldorf Local Division of the UPC, alleging infringement of European Patent No.

3,536,712 (the EP’712 Patent), on May 13, 2025, the Dusseldorf Local Division of the UPC issued a decision that the EP’712 Patent, which Sanofi Biotechnology SAS licensed from Regeneron, is valid but not infringed by Amgen.

Amgen filed a Statement of Appeal on July 11, 2025, and Sanofi and Regeneron filed a Statement of Appeal on July 14, 2025.

On June 9, 2025, Sanofi filed a motion seeking to stay its lawsuit against Amgen in the Dusseldorf Local Division of the UPC that alleges Amgen’s Repatha infringes European Patent No.

On August 6, 2025, the Dusseldorf Local Division of the UPC stayed Sanofi’s lawsuit against Amgen alleging infringement of the European Patent No.

4,252,857 until the UPC Court of Appeals reaches a decision on the appeal from Sanofi’s lawsuit against Amgen involving European Patent No.

3,536,712 (the EP’712 Patent).

On June 24, 2025, Amgen filed its Statement of Defense and Counterclaims in response to Sanofi’s allegation of infringement of the EP’857 Patent and, on June 30, 2025, opposed Sanofi’s motion to stay the case.

The Court of Appeals of the UPC rescheduled oral argument from May 22, 2025, to August 12, 2025 on Amgen’s appeal seeking to set aside the Central Division of the UPC’s decision to revoke Amgen’s European Patent No.

European Patent Office

On June 2, 2025, the European Patent Office (EPO) Board of Appeal accelerated Amgen’s appeal from the EPO’s decision that Regeneron’s EP’712 Patent is valid and scheduled oral argument to take place on March 26, 2026.

On June 23, 2025, Amgen filed a Notice of Opposition and Grounds of Opposition before the EPO against Regeneron’s EP’857 Patent.

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

On May 27, 2025, Amgen filed petition for acceptance of an appeal with the Supreme Court of Japan from the Intellectual Property High Court’s dismissal of Amgen’s appeal in Amgen’s lawsuit against Sanofi K.K.

seeking monetary compensation for past patent infringement.

On August 12, 2025, the Court of Appeals of the UPC heard oral argument on Amgen’s appeal seeking to set aside the Central Division of the UPC’s decision to revoke Amgen’s European Patent No.

On September 15, 2025, Amgen and Sanofi Biotechnologies SAS and Regeneron Pharmaceuticals, Inc.

(Regeneron) filed respective Statements of Grounds of Appeal from the Dusseldorf Local Division of the UPC’s decision that the EP’712 Patent is valid but not infringed by Amgen.

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

Accord et al.

The parties entered into a confidential settlement agreement that resolves the patent litigation related to Accord Biopharma, Inc., Accord Healthcare, Inc.

and Intas Pharmaceuticals, Ltd.’s (collectively, Accord) denosumab biosimilar products.

Samsung Bioepis Co.

The parties entered into a confidential settlement agreement that resolves the patent litigation related to Samsung Bioepis Co Ltd.’s and Samsung Biologics Co., Ltd’s (collectively, Samsung) denosumab biosimilar products in the United States.

Accordingly, the U.S.

District Court for the District of New Jersey (New Jersey District Court) entered a Consent Judgment and Injunction on July 16, 2025, that the patents-in-suit are valid, enforceable and infringed and enjoining Accord from making, using, selling or offering for sale or importing its denosumab biosimilar products into the United States until the injunction expires on October 1, 2025.

The confidential settlement allows Accord to launch its denosumab biosimilar products in the United States as early as October 1, 2025, subject to regulatory approval.

District Court for the District of New Jersey (New Jersey District Court) entered a Consent Order and Judgment on September 5, 2025, finding the claims of Amgen’s U.S.

patents asserted against Samsung are valid, enforceable and infringed by Samsung’s denosumab biosimilars in the United States.

In addition, Amgen and Samsung have reached a confidential settlement that allows Samsung to launch its biosimilar products in the United States.

Shanghai Henlius Biotech Inc.

On June 25, 2025, Amgen Inc.

and Amgen Manufacturing Limited LLC filed a lawsuit in the New Jersey District Court against Shanghai Henlius Biotech Inc., Shanghai Henlius Biologics Co., Ltd, Organon LLC and Organon & Co.

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

The complaint asserts infringement of the following patents:

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

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

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

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

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

A trial date has not yet been set.

On September 5, 2025, Shanghai Henlius Biotech Inc., Shanghai Henlius Biologics Co., Ltd., Organon LLC and Organon & Co.

responded to Amgen’s complaint, asserting counterclaims and affirmative defenses.

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

Hikma Pharmaceuticals USA Inc.

On June 25, 2025, Amgen Inc.

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

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

The complaint asserts infringement of the following patents:

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

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

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

On June 25, 2025, this litigation

became a member of In Re:

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

A trial date has not yet been set.

On September 5, 2025, Hikma Pharmaceuticals USA Inc., Gedeon Richter Plc., and Gedeon Richter USA, Inc.

responded to Amgen’s complaint, asserting counterclaims and affirmative defenses on September 5, 2025.

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

Biocon Biologics, Inc.

On June 30, 2025, Amgen Inc.

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

District Court for the Eastern District of Massachusetts (Massachusetts District Court) against Biocon Biologics, Inc., Biocon Biologics UK Limited, and Biocon Biologics Limited (collectively Biocon) based on the submission to the FDA of a BLA seeking approval to market and sell a biosimilar version of Amgen’s Prolia and XGEVA products.

The complaint asserts infringement of the following patents:

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

Amgen seeks a judgment from the Massachusetts District Court that Biocon has infringed or will infringe one or more claims of each of the Asserted Patents against Biocon 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 Biocon’s proposed denosumab biosimilar before expiration of each of the patents found infringed.

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

On July 3, 2025, the Judicial Panel on Multidistrict Litigation issued a Conditional Order transferring the case from the Massachusetts District Court to the New Jersey District Court pursuant to 28 U.S.C.

§ 1407 for coordinated and consolidated pretrial proceedings with the other cases involving Prolia/XGEVA biosimilars pending in the district.

On July 17, 2025, this case became a member of In Re:

Denosumab Patent Litigation multi-district litigation.

A trial date has not yet been set.

On September 5, 2025, Biocon Biologics, Inc., Biocon Biologics UK Limited, and Biocon Biologics Limited (collectively, Biocon) responded to Amgen’s complaint, asserting counterclaims and affirmative defenses.

Pursuant to a consent order providing leave to amend, Amgen filed an Amended Complaint on September 23, 2025, adding Biosimilars Newco Limited (BNCL) as a defendant to the litigation.

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

Accordingly, the New Jersey District Court entered a Consent Judgment and Injunction on September 30, 2025, finding the claims of Amgen’s U.S.

patents asserted against Biocon valid, enforceable and infringed by Biocon's denosumab biosimilars in the United States.

In addition, Amgen and Biocon have reached a confidential settlement that allowed Biocon to launch its biosimilar products in the United States as early as October 1, 2025.

Denosumab Patent Litigation (Multidistrict Litigations)

The claim construction hearing previously set by the New Jersey District Court was cancelled and on September 8, 2025, a new case schedule was issued for all matters pending in the multidistrict litigation.

Neither a claim construction hearing nor a trial date have been set.

PAVBLU ™ (aflibercept-ayyh) Patent Litigation

On June 17, 2025, Regeneron filed a lawsuit in the U.S.

District Court for the Central District of California (California Central District Court) against Amgen alleging infringement of U.S.

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

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

On July 17, 2025, the Judicial Panel on Multidistrict Litigation issued a Conditional Order transferring the case from the California Central District Court to the U.S.

District Court for the Northern District of West Virginia (West Virginia District Court) pursuant to 28 U.S.C.

§ 1407 for coordinated and consolidated pretrial proceedings with the other cases involving EYLEA ® biosimilars pending in the district, and on July 31, 2025, the case was opened in the West Virginia District Court.

Antitrust Class Action

Regeneron Pharmaceuticals, Inc.

Antitrust Action

A jury trial was held in the U.S.

District Court for the District of Delaware (Delaware District Court) from May 5, 2025 to May 14, 2025.

On May 15, 2025, the jury returned a verdict finding for Regeneron on its federal and state antitrust law and tortious interference claims but finding for Amgen on its below-cost pricing claim under California’s Unfair Practices Act.

The jury awarded Regeneron $ 135.6 million in compensatory damages on its antitrust claims (which are subject to trebling under applicable law), or in the alternative, in compensatory damages plus $ 271.2 million in punitive damages on its tortious interference claim, with such damages under either alternative claim totaling $ 406.8 million.

As Regeneron must elect between recovery under the antitrust or tortious interference claims, any potential damages award would be limited to one of these claims.

Although we cannot predict with certainty the ultimate outcome of this litigation, Amgen believes that the jury’s decision and amounts awarded are inconsistent with the law and evidence at trial.

Both parties have filed post-trial motions.

On June 12, 2025, Amgen filed a renewed motion for judgment as a matter of law or, in the alternative, for a new trial.

Also on June 12, 2025, Regeneron filed a motion for permanent injunctive relief, a constructive trust, and prejudgment interest.

Both motions have since been fully briefed.

A hearing on the post-trial motions has been set for August 27, 2025.

In assessing whether we should accrue a liability for this litigation in our condensed consolidated financial statements, we considered various factors, including the legal and factual circumstances of the case, the jury’s award, the court’s post-trial proceedings, applicable law, and the likelihood that the jury’s award will be upheld after post-trial briefing and potentially on appeal.

As a result of this review, we have determined, in accordance with applicable accounting standards, that it is not probable that we will incur a loss as a result of this litigation, and we have therefore not recorded a liability for this matter.

The ultimate result of this litigation, however, is uncertain because it is reasonably possible that by settlement or final court judgment that none, some, or all of the jury’s verdict and other relief sought might ultimately be awarded but the size of an award, if any, is not estimable at this time.

On September 12, 2025, Amgen responded to Regeneron’s complaint asserting infringement of U.S.

12,331,099 (the ’099 Patent), denying infringement and asserting counterclaims seeking a declaratory judgment that the ’099 Patent is not infringed, invalid, and/or unenforceable, and counterclaims for Sherman Act (15 U.S.C.

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

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

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

On September 29, 2025, the U.S.

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

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

Onyx Therapeutics, Inc.

Somerset Therapeutics, LLC

On October 3, 2025, based on a joint request by Onyx Therapeutics, Inc.

(Onyx Therapeutics, a wholly-owned subsidiary of Amgen) and Somerset Therapeutics, LLC (Somerset), the U.S.

District Court for the District of Delaware (Delaware District Court) entered a Stipulation and Order that the filing of Somerset’s ANDA infringed, and the making, using, offering to sell, selling or importing of its proposed ANDA product will infringe, U.S.

7,737,112 (the ’112 Patent), which Somerset admits is valid and enforceable.

The Stipulation and Order enjoins Somerset and its affiliates from engaging in infringing conduct during the term of the ’112 Patent, subject to the terms of a confidential settlement agreement.

Onyx Therapeutics, Inc.

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

On September 4, 2025, Onyx Therapeutics filed a lawsuit in the Delaware District Court against Amneal Pharmaceuticals of New York, LLC and Amneal EU, Limited (collectively, Amneal), asserting infringement of the ’112 Patent based on Amneal’s submission of an application pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking FDA approval to market a generic version of KYPROLIS.

Onyx Therapeutics seeks an order from the Delaware District Court making any FDA approval of the defendant’s application effective no earlier than the expiration of the ’112 Patent.

Antitrust Actions

CareFirst of Maryland Antitrust Class Action

On September 30, 2025, the U.S.

District Court for the Eastern District of Virginia issued an order granting in part and denying in part Amgen’s motion to dismiss.

The court dismissed the plaintiffs’ antitrust claim under Puerto Rico law, and their unjust enrichment claims under the laws of seven states and Puerto Rico, but otherwise permitted the plaintiffs’ claims to proceed.

Antitrust Action

On June 20, 2025, Amgen filed a motion to dismiss the complaint.

Sandoz filed its opposition to the motion to dismiss on July 21, 2025, and Amgen’s reply is due August 21, 2025.

On August 21, 2025, Amgen filed its reply to Sandoz Inc.’s opposition to Amgen’s motion to dismiss.

Other Similar Antitrust Actions

In August and September 2025, the Company received service of process of seven cases that were filed in the California Superior Court for the County of Ventura that raise allegations substantially similar to those in the CareFirst of Maryland antitrust class action.

The cases were filed by:

Centene Corporation on July 29, 2025;

on July 29, 2025;

Molina Healthcare, Inc.

on July 29, 2025;

Blue Cross and Blue Shield of Florida, Inc.

(BCBSFL) on July 29, 2025;

Blue Cross and Blue Shield of Kansas City (BCBSKC) on July 29, 2025;

Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc.

(BCBSMA) on August 8, 2025;

and Health Care Services Corp.

(HCSC) on August 21, 2025.

Amgen subsequently removed the cases filed by BCBSFL, BCBSKC, BCBSMA, and HCSC to the U.S.

District Court for the Central District of California.

On September 29, 2025, HCSC voluntarily dismissed its case without prejudice.

BCBSFL, BCBSKC, and BCBSMA voluntarily dismissed their cases without prejudice on October 1, 2025.

Tax Litigation and Related Matters

4 unchanged sentences

149 Pension Fund)

On July 10, 2025, the U.S.

District Court for the Southern District of New York (Southern District Court of New York) rescheduled the deadline to file summary judgment motions to October 19, 2026.

Shareholder Derivative Actions

On April 9, 2025, the Delaware Court of Chancery consolidated the derivative actions filed by each of David Hamilton, Charles Blackburn and Robert Bryla purportedly on behalf of Amgen against nominal defendant Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members.

On April 21, 2025, the Southern District Court of New York consolidated the derivative action filed by DM Cohen, Inc.

with the consolidated action that was filed by Leon Martin and Cheri Clearwater purportedly on behalf of Amgen against Amgen, Robert Bradway, Peter Griffith and Amgen’s independent Board members.

On June 9, 2025, the Delaware District Court stayed the shareholder derivative action filed by Carolyn Sieveking and James P.

Tierney until a final judgment is entered in the federal securities class action.

On September 11, 2025, the U.S.

District Court for the Southern District of New York issued an order that extended deadlines.

Pursuant to the order, the class certification briefing will be completed by April 24, 2026.

The last day to file summary judgment motions is December 21, 2026, but no briefing schedule has been set.

ChemoCentryx, Inc.

Securities Matters

On May 8, 2025, the lead plaintiff filed a motion for partial summary judgment.

On May 29, 2025, defendants, including ChemoCentryx, filed an opposition to the plaintiff’s motion and a motion for summary judgment in whole or in part.

A hearing is set for August 7, 2025.

District Court for the Northern District of California (Northern District Court of California) rescheduled the trial to begin February 23, 2026.

In the case filed by RA Capital Healthcare Fund, LP in the Northern District Court of California, defendants, including ChemoCentryx, moved to dismiss the complaint, and on June 13, 2025, the court issued an order staying the federal case pending resolution of the class action.

The court did not reach the merits of defendants’ motion to dismiss.

On August 15, 2025, the U.S.

District Court for the Northern District of California granted defendants’, including ChemoCentryx’s, motion for summary judgment in its entirety and denied lead plaintiff’s motion for partial summary judgment.

On September 12, 2025, the lead plaintiff filed a notice of appeal to the Ninth Circuit Court of Appeals;

its opening brief is due December 5, 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