What changed in this filing

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Item 2. Management’s Discussion and Analysis

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The following MD&A is intended to assist the reader in understanding Amgen’s business.

MD&A is provided as a supplement to, and should be read in conjunction with, both the condensed consolidated financial statements and accompanying notes of this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2024.

MD&A is provided as a supplement to, and should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

Our results of operations discussed in MD&A are presented in conformity with GAAP.

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Risk Factors in Part II herein and in Part I, Item 1A.

Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2024.

Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2024, and in Part II, Item 1A.

Risk Factors of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

We have based our forward-looking statements on our management’s beliefs and assumptions based on information available to our management at the time the statements are made.

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Our robust pipeline includes potential first-in-class medicines at all stages of development.

Our principal products are Prolia, Repatha, XGEVA, ENBREL, EVENITY, Otezla, TEPEZZA, BLINCYTO, Aranesp, KYPROLIS, Nplate, TEZSPIRE, Vectibix and KRYSTEXXA.

We also market a number of other products, including but not limited to MVASI, WEZLANA/WEZENLA, AMJEVITA/AMGEVITA, Neulasta, PAVBLU, RAVICTI, UPLIZNA, TAVNEOS, Aimovig, Parsabiv, LUMAKRAS/LUMYKRAS, IMDELLTRA/IMDYLLTRA and PROCYSBI.

Our principal products are Prolia, Repatha, ENBREL, XGEVA, Otezla, EVENITY, TEPEZZA, BLINCYTO, KYPROLIS, Aranesp, Nplate, TEZSPIRE, KRYSTEXXA and Vectibix.

We also market a number of other products, including but not limited to MVASI, AMJEVITA/AMGEVITA, UPLIZNA, PAVBLU, IMDELLTRA/IMDYLLTRA, Neulasta, TAVNEOS, RAVICTI, WEZLANA/WEZENLA, Parsabiv, LUMAKRAS/LUMYKRAS, Aimovig and PROCYSBI.

Tariffs and trade protection measures

The imposition of tariffs and trade protection measures by the United States and other countries, including the universal 10% tariff on goods imported into the United States, the currently-suspended country-specific tariffs, the China retaliatory tariffs on U.S.

goods, the imposition of new and/or other retaliatory tariffs, and potential sector-specific tariffs on our industry and others, may adversely affect our business and operations.

While existing tariffs have not had a material adverse effect on our results of operations for the first quarter of 2025, we are currently evaluating the potential impact of such tariffs on our business in future periods and our ability to mitigate such impacts.

For example, the tariffs that are currently in effect, or anticipated to take effect in the future, will increase our manufacturing and operating expenses in future quarters, including the cost to deliver products to markets, cost of sourcing materials for the manufacturing of our products and cost of materials used in our research and development activities.

Such tariffs may also adversely affect the cost to expand our manufacturing capacity in the United States, including increased construction costs and/or delays in construction for our Ohio and North Carolina facilities.

goods, the imposition of new and/or other retaliatory tariffs, and potential sector-specific tariffs on our industry, including the Section 232 pharmaceutical tariff, and others, may adversely affect our business and operations.

While existing tariffs have not had a material adverse effect on our results of operations for the first half of 2025, we are currently evaluating the potential impact of such tariffs on our business in future periods and our ability to mitigate such impacts.

For example, certain tariffs that are currently in effect, or anticipated to take effect in the future, have increased, and are expected to further increase, our manufacturing and operating expenses in future quarters, including the cost to deliver products to markets, cost of sourcing materials for the manufacturing of our products and cost of materials used in our R&D activities.

Such tariffs have had a limited impact in the first half of 2025, but may increasingly affect the cost to expand our manufacturing capacity in the United States, including increased construction costs and/or delays in construction for our Ohio and North Carolina facilities.

Furthermore, retaliatory tariffs imposed by other countries may adversely affect our business, operations and delivery and launches of products in such markets, including the performance of our collaborations in such markets.

However, the degree of adverse effects of any tariffs on our business and operations in future periods will depend on various factors, including the rates of such tariffs, the expansion of such tariffs to include certain goods such as pharmaceutical products, the magnitude of response by other countries to U.S.

However, the degree of adverse effects from any tariffs on our business and operations in

future periods will depend on various factors, including the rates of such tariffs, the expansion of such tariffs to include certain goods (such as pharmaceutical products), the magnitude of response by other countries to U.S.

tariffs and the length of time such tariffs are in effect.

For additional

information, see Part II, Item 1A.

Risk Factors— Global economic conditions may negatively affect us and may magnify certain risks that affect our business.

For additional discussion of these and other risks, see Part II, Item 1A.

Risk Factors, of this Quarterly Report on Form 10-Q.

Macroeconomic and other challenges

Uncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates and instability in the financial system, as well as rising healthcare costs, continue to pose challenges to our business.

Further, uncertainty around tariffs and trade protection measures in the United States and other countries, including the imposition of new or retaliatory tariffs, along with ongoing geopolitical conflicts, continue to create additional uncertainty in global macroeconomic conditions.

Uncertainty around tariffs and trade protection measures in the United States and other countries, including the imposition of new or retaliatory tariffs, along with ongoing geopolitical conflicts and rising geopolitical tensions, continue to create additional uncertainty in global macroeconomic conditions.

Additionally, with public and private healthcare-provider focus, the industry continues to be subject to cost containment measures and significant pricing pressures, resulting in net price declines.

Moreover, provisions of the IRA, as well as the 340B Program, have affected, and are likely to continue to affect, our business.

Moreover, provisions of the IRA, as well as the 340B Program, have negatively affected, and are likely to continue to negatively affect, our business.

For example, ENBREL and Otezla have been selected by CMS for Medicare price setting beginning in 2026 and 2027, respectively.

In addition to the IRA, other recent and proposed U.S.

policy actions, including the Most-Favored-Nations Prescription Drug Pricing Executive Order (MFN EO), may negatively impact our product sales depending on their scope and implementation.

Finally, wholesale and end-user buying patterns can affect our product sales.

These buying patterns can cause fluctuations in quarterly product sales, but have generally not been significant to date when comparing full-year product performance to the prior year.

See Part II, Item 1A.

For additional discussion of these and other risks, see Part II, Item 1A.

Risk Factors, of this Quarterly Report on Form 10-Q.

Significant developments

The following is a summary of select significant developments affecting our business that occurred since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024.

For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2024.

Significant developments

The following is a summary of select significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025.

Products/pipeline

Maridebart cafraglutide (MariTide ™ )

In March 2025, we announced the initiation of two Phase 3 studies to evaluate MariTide, a differentiated peptide-antibody conjugate subcutaneously administered monthly or less frequently, in chronic weight management:

one study in adults living with obesity or overweight without Type 2 diabetes and another study in adults living with obesity or overweight with Type 2 diabetes.

In March 2025, we announced results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD).

The IGNITE study, which evaluated two dose strengths of rocatinlimab, met its co-primary endpoints and all key secondary endpoints, achieving statistical significance for both rocatinlimab dose strengths versus placebo.

The SHUTTLE study, which evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) using the same co-primary endpoints as IGNITE, met its co-primary endpoints and all key secondary endpoints.

Lastly, the VOYAGER study successfully demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.

Across ROCKET program results to date, safety findings were generally consistent with the safety profile of rocatinlimab previously observed.

The most frequent treatment-emergent adverse events (≥5%) with higher observed proportion in rocatinlimab groups were pyrexia, chills and headache.

A higher number of patients receiving rocatinlimab compared with placebo experienced gastrointestinal ulceration events, with an overall incidence of less than 1%.

In April 2025, we announced the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients.

UPLIZNA is the first and only FDA approved treatment for adults living with IgG4-RD.

In April 2025, we announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy met its primary endpoint at a planned interim analysis.

IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy.

The safety profile for IMDELLTRA was consistent with its known profile.

In June 2025, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85 th Scientific Sessions and simultaneously published in The New England Journal of Medicine .

These data are consistent with the topline results from Part 1 of the Phase 2 study as previously announced and presented by the Company in November 2024.

See Part I, Item 1.

Business—Significant Developments, of our Annual Report on Form 10-K for the year ended December 31, 2024.

In Part 1 of the Phase 2 study, among participants living with obesity without type 2 diabetes, MariTide demonstrated average weight loss up to approximately 20% compared to 2.6% in the placebo arm.

In participants living with obesity and type 2 diabetes, MariTide demonstrated average weight loss up to approximately 17% compared to 1.4% in the placebo arm, per the efficacy estimand.

Weight loss had not plateaued by 52 weeks, indicating the potential for further weight reduction.

Additionally, weight loss with MariTide was associated with improvements in cardiometabolic parameters, including reductions in hemoglobin A1c (up to 2.2 percentage points), waist circumference, blood pressure, high-sensitivity C-reactive protein and select lipid levels.

No new safety signals were identified in Part 1 of the Phase 2 study, and tolerability was consistent with the GLP-1 class.

The most frequently reported adverse events (AEs) were gastrointestinal (GI) related, and most were mild to moderate.

GI events were predominantly limited to initial dosing and less frequent when dose escalation was used without compromising efficacy.

Discontinuation rates of MariTide due to GI AEs in the dose escalation arms (up to 7.8%) were lower than non-dose escalation arms.

IMDELLTRA/IMDYLLTRA

In June 2025, Amgen announced interim results from the global Phase 3 DeLLphi-304 trial evaluating IMDELLTRA/IMDYLLTRA in patients with small cell lung cancer (SCLC) who had progressed on or after one line of platinum-based chemotherapy.

The study demonstrated that IMDELLTRA/IMDYLLTRA significantly reduced the risk of death by 40% compared to standard-of-care chemotherapy, with a median overall survival of 13.6 months compared to 8.3 months.

Additionally, IMDELLTRA/IMDYLLTRA showed a statistically significant improvement in median progression-free survival of 4.2 months compared to 3.7 months and enhanced patient-reported outcomes related to cancer-associated symptoms, including dyspnea and cough.

The safety profile of IMDELLTRA/IMDYLLTRA was consistent with prior studies.

Bemarituzumab

In June 2025, Amgen announced interim results from the Phase 3 FORTITUDE-101 clinical trial evaluating first-line bemarituzumab plus chemotherapy (mFOLFOX6).

The study met its primary endpoint of overall survival (OS) at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in OS as compared to placebo plus chemotherapy in people living with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and who are non-HER2 positive.

The most common treatment-emergent adverse events (>25%) in patients treated with bemarituzumab plus chemotherapy were reduced visual acuity, punctate keratitis, anaemia, neutropenia, nausea, corneal epithelium defect and dry eye.

In June 2025, the European Commission granted marketing authorization approval of TEPEZZA for treatment of adults with moderate to severe thyroid eye disease (TED).

Selected financial information

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Product sales

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Operating income $ 2,656 $ 1,909 39 % $ 3,834 $ 2,900 32 %

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

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

Net income $ 1,432 $ 746 92 % $ 3,162 $ 633 *

Diluted EPS $ 2.65 $ 1.38 92 % $ 5.84 $ 1.17 *

Diluted shares 541 541 — % 541 541 — %

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In addition, any reference to increases or decreases in inventory refers to changes in inventory held by wholesaler customers and end users (such as pharmacies) as may be noted.

Total product sales increased 11% for the three months ended March 31, 2025, primarily driven by volume growth of 14%, partially offset by declines in net selling price of 6%.

For the three months ended March 31, 2025, U.S.

volume grew 16% and ROW volume grew 11%, driven by volume growth in certain brands, including Repatha, WEZLANA/WEZENLA, Prolia, BLINCYTO, TEZSPIRE and EVENITY.

Total product sales increased 9% and 10% for the three and six months ended June 30, 2025, respectively, driven by volume growth of 13% and 14%, respectively, partially offset by declines in net selling price of 3% and 4%, respectively.

For the three months ended June 30, 2025, U.S.

volume grew 13% and ROW volume grew 15%, driven by volume growth in certain brands, including Repatha, PAVBLU, IMDELLTRA/IMDYLLTRA, BLINCYTO, EVENITY and TEZSPIRE.

For the six months ended June 30, 2025, U.S.

volume grew 14% and ROW volume grew 13%, driven by volume growth in certain brands, including Repatha, BLINCYTO, PAVBLU, TEZSPIRE, EVENITY, IMDELLTRA/IMDYLLTRA, WEZLANA/WEZENLA and Prolia.

For the remainder of 2025, we expect volume growth from certain brands to be partially offset by net selling price declines.

Uncertain macroeconomic conditions, including uncertainty around tariffs and trade production measures and ongoing geopolitical conflicts, and changes in the healthcare ecosystem have the potential to introduce variability into product sales.

Furthermore, product sales continue to be impacted by actions from governments and other entities to curb high inflation, provisions of the IRA, inappropriate expanded utilization of the 340B Program and growth in numbers of Medicaid enrollees and uninsured individuals.

Uncertain macroeconomic conditions, including uncertainty around tariffs and trade production measures, ongoing geopolitical conflicts and rising geopolitical tensions, and changes in the healthcare ecosystem have the potential to introduce variability into product sales.

Furthermore, product sales continue to be impacted by actions from governments and other entities to address macroeconomic challenges, provisions of the IRA, inappropriate expanded utilization of the 340B Program and growth in numbers of Medicaid enrollees and uninsured individuals.

See Part I, Item 1.

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and Part II, Item 1A.

Risk Factors, of this Quarterly Report on Form 10-Q.

Other revenues decreased for the three months ended March 31, 2025, driven by lower corporate partner revenue.

Operating expenses increased for the three months ended March 31, 2025, driven by the Otezla intangible asset impairment charge, partially offset by lower amortization expense from the fair value step-up of inventory acquired from Horizon.

Risk Factors, of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.

Other revenues increased 18% for the three months ended June 30, 2025, primarily driven by higher corporate partner revenue from licensed products.

Other revenues increased 1% for the six months ended June 30, 2025.

Operating expenses increased 1% for the three months ended June 30, 2025.

Operating expenses increased 4% for the six months ended June 30, 2025, driven by the Otezla intangible asset impairment charge and higher R&D expense, partially offset by lower amortization expense from the fair value step-up of inventory acquired from Horizon.

See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements, for additional information related to the Otezla intangible asset impairment charge.

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Prolia $ 1,122 $ 1,165 (4) % $ 2,221 $ 2,164 3 %

Repatha 696 532 31 % 1,352 1,049 29 %

XGEVA 566 561 1 %

ENBREL 604 909 (34) % 1,114 1,476 (25) %

EVENITY 442 342 29 %

XGEVA 532 562 (5) % 1,098 1,123 (2) %

Otezla 618 544 14 % 1,055 938 12 %

EVENITY 518 391 32 % 960 733 31 %

TEPEZZA 505 479 5 % 886 903 (2) %

BLINCYTO 384 264 45 % 754 508 48 %

Aranesp 340 349 (3) %

KYPROLIS 378 377 0 % 702 753 (7) %

Aranesp 359 348 3 % 699 697 0 %

Nplate 369 346 7 % 682 663 3 %

Vectibix 267 247 8 %

342 234 46 % 627 407 54 %

KRYSTEXXA 349 294 19 % 585 529 11 %

Vectibix 305 270 13 % 572 517 11 %

Other products (2)

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Business—Marketing, Distribution and Selected Marketed Products;

(ii) Part I, Item 1.

Business—Reimbursement;

(iii) Part I, Item 1A.

(ii) Part I, Item 1A.

Risk Factors;

and (iv) Part II, Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Results of operations—Product sales.

and (iii) Part II, Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Results of operations—Product sales, as well as in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025:

(i) Part I, Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of operations—Product sales;

and (ii) Part II, Item 1A.

Risk Factors.

Total Prolia sales by geographic region were as follows (dollar amounts in millions):

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Prolia — U.S.

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Total Prolia $ 1,122 $ 1,165 (4) % $ 2,221 $ 2,164 3 %

The increase in global Prolia sales for the three months ended March 31, 2025 was primarily driven by volume growth of 13%, partially offset by lower net selling price of 5%.

The decrease in global Prolia sales for the three months ended June 30, 2025 was driven by lower net selling price.

The increase in global Prolia sales for the six months ended June 30, 2025 was driven by volume growth of 7%, partially offset by lower net selling price.

As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, Part I, Item 1.

Business—Marketing, Distribution and Selected Marketed Products—Patents, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and will expire in November 2025 in select countries in Europe.

For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year.

For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S.

For a discussion of litigation, including associated settlements, related to Prolia, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024;

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

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

Total Repatha sales by geographic region were as follows (dollar amounts in millions):

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Repatha — U.S.

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Total Repatha $ 696 $ 532 31 % $ 1,352 $ 1,049 29 %

The increase in global Repatha sales for the three months ended March 31, 2025 was primarily driven by volume growth of 41%, partially offset by lower net selling price of 9%.

The increase in global Repatha sales for the three months ended June 30, 2025 was driven by volume growth of 36%, partially offset by unfavorable changes to estimated sales deductions.

The increase in global Repatha sales for the six months ended June 30, 2025 was primarily driven by volume growth of 38%, partially offset by lower net selling price of 3% and unfavorable changes to estimated sales deductions.

For a discussion of ongoing litigation related to Repatha, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024;

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

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

Total ENBREL sales by geographic region were as follows (dollar amounts in millions):

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ENBREL — U.S.

$ 597 $ 902 (34) % $ 1,101 $ 1,463 (25) %

ENBREL — Canada 7 7 — % 13 13 — %

Total ENBREL $ 604 $ 909 (34) % $ 1,114 $ 1,476 (25) %

The decrease in ENBREL sales for the three months ended June 30, 2025 was driven by unfavorable changes to estimated sales deductions of 20% and lower net selling price of 19% resulting from increased 340B Program mix and the impact of the U.S.

Medicare Part D redesign, partially offset by volume growth of 3%.

The decrease in ENBREL sales for the six months ended June 30, 2025 was driven by lower net selling price of 27% resulting from increased 340B Program mix, higher commercial discounts and the impact of the U.S.

Medicare Part D redesign, and by unfavorable changes to estimated sales deductions of 8%, partially offset by higher inventory of 6% and volume growth of 4%.

Total XGEVA sales by geographic region were as follows (dollar amounts in millions):

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$ 347 $ 399 (13) % $ 707 $ 765 (8) %

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Total XGEVA $ 532 $ 562 (5) % $ 1,098 $ 1,123 (2) %

Global XGEVA sales for the three months ended March 31, 2025 increased 1%.

The decrease in global XGEVA sales for the three months ended June 30, 2025 was driven by unfavorable changes to estimated sales deductions of 2% and lower volume.

The decrease in global XGEVA sales for the six months ended June 30, 2025 was driven by lower volume.

As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, Part I, Item 1.

For 2025, we expect sales erosion driven by biosimilar competition, particularly in the second half of the year.

For 2025, we expect sales erosion driven by biosimilar competition in the second half of the year, as biosimilars have now launched in the U.S.

For a discussion of litigation, including associated settlements, related to XGEVA, see Part IV—Note 20, Contingencies and commitments, to the consolidated financial statements in our Annual Report on Form 10-K for the year ended December 31, 2024;

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

Total ENBREL sales by geographic region were as follows (dollar amounts in millions):

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

Total Otezla sales by geographic region were as follows (dollar amounts in millions):

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ENBREL — U.S.

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Otezla — U.S.

$ 512 $ 432 19 % $ 855 $ 725 18 %

ENBREL — Canada 6 6 — %

Total ENBREL $ 510 $ 567 (10) %

The decrease in ENBREL sales for the three months ended March 31, 2025 was driven by lower net selling price of 47% resulting from increased 340B Program mix and higher commercial discounts, partially offset by favorable changes to estimated sales deductions of 19%, higher inventory and volume growth.

The year-over-year impact on net selling price is expected to be less pronounced in future quarters.

Otezla — ROW 106 112 (5) % 200 213 (6) %

Total Otezla $ 618 $ 544 14 % $ 1,055 $ 938 12 %

The increases in global Otezla sales for the three and six months ended June 30, 2025 were driven by favorable changes to estimated sales deductions of 12% and 7%, respectively, and volume growth of 4% for both periods.

In January 2025, Otezla was selected by CMS for Medicare price setting that will be applicable beginning in 2027.

See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements, for additional information related to the Otezla intangible asset impairment charge of $800 million recorded in the first quarter of 2025.

Total EVENITY sales by geographic region were as follows (dollar amounts in millions):

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EVENITY — U.S.

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Total EVENITY $ 518 $ 391 32 % $ 960 $ 733 31 %

The increase in global EVENITY sales for the three months ended March 31, 2025 was driven by volume growth.

Total Otezla sales by geographic region were as follows (dollar amounts in millions):

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Otezla — U.S.

$ 343 $ 293 17 %

Otezla — ROW 94 101 (7) %

Total Otezla $ 437 $ 394 11 %

The increase in global Otezla sales for the three months ended March 31, 2025 was driven by favorable changes to estimated sales deductions of 12%, as volume growth of 4% was offset by lower net selling price of 5%.

In January 2025, Otezla was selected by CMS for Medicare price setting that will be applicable beginning in 2027.

The increases in global EVENITY sales for the three and six months ended June 30, 2025 were primarily driven by volume growth.

Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):

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TEPEZZA — U.S.

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* Change in excess of 100%

The decrease in global TEPEZZA sales for the three months ended March 31, 2025 was primarily driven by lower volume of 9% and lower inventory of 8%, partially offset by higher net selling price.

The increase in global TEPEZZA sales for the three months ended June 30, 2025 was primarily driven by higher inventory.

The decrease in global TEPEZZA sales for the six months ended June 30, 2025 was driven by lower volume of 5%, partially offset by higher net selling price.

Total BLINCYTO sales by geographic region were as follows (dollar amounts in millions):

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BLINCYTO — U.S.

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Total BLINCYTO $ 384 $ 264 45 % $ 754 $ 508 48 %

The increase in global BLINCYTO sales for the three months ended March 31, 2025 was primarily driven by volume growth.

Total Aranesp sales by geographic region were as follows (dollar amounts in millions):

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Aranesp — U.S.

$ 91 $ 100 (9) %

Aranesp — ROW 249 249 — %

Total Aranesp $ 340 $ 349 (3) %

The decrease in global Aranesp sales for the three months ended March 31, 2025 was driven by unfavorable changes to foreign currency exchange rates of 4% and unfavorable changes to estimated sales deductions of 3%, partially offset by volume growth outside the United States.

The increases in global BLINCYTO sales for the three and six months ended June 30, 2025 were driven by volume growth.

Total KYPROLIS sales by geographic region were as follows (dollar amounts in millions):

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KYPROLIS — U.S.

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Total KYPROLIS $ 378 $ 377 0 % $ 702 $ 753 (7) %

The decrease in global KYPROLIS sales for the three months ended March 31, 2025 was driven by lower volume due to increased competition.

Global KYPROLIS sales remained relatively unchanged for the three months ended June 30, 2025.

The decrease in global KYPROLIS sales for the six months ended June 30, 2025 was driven by lower volume due to increased competition.

Total Aranesp sales by geographic region were as follows (dollar amounts in millions):

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Aranesp — U.S.

$ 107 $ 91 18 % $ 198 $ 191 4 %

Aranesp — ROW 252 257 (2) % 501 506 (1) %

Total Aranesp $ 359 $ 348 3 % $ 699 $ 697 0 %

The increase in global Aranesp sales for the three months ended June 30, 2025 was driven by favorable changes to estimated sales deductions of 7%, partially offset by lower net selling price.

Global Aranesp sales remained relatively unchanged for the six months ended June 30, 2025.

Total Nplate sales by geographic region were as follows (dollar amounts in millions):

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Nplate — U.S.

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Total Nplate $ 369 $ 346 7 % $ 682 $ 663 3 %

Global Nplate sales for the three months ended March 31, 2025 decreased 1% as volume growth was more than offset by unfavorable changes to both estimated sales deductions and foreign currency exchange rates.

The increase in global Nplate sales for the three months ended June 30, 2025 was driven by volume growth.

The increase in global Nplate sales for the six months ended June 30, 2025 was primarily driven by volume growth of 9%, partially offset by unfavorable changes to estimated sales deductions of 3% and unfavorable changes to foreign currency exchange rates.

Total TEZSPIRE sales by geographic region were as follows (dollar amounts in millions):

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2025 2024 Change 2025 2024 Change

TEZSPIRE — U.S.

$ 342 $ 234 46 % $ 627 $ 407 54 %

The increase in TEZSPIRE sales for the three months ended March 31, 2025 was driven by volume growth.

The increases in TEZSPIRE sales for the three and six months ended June 30, 2025 were driven by volume growth.

Total KRYSTEXXA sales by geographic region were as follows (dollar amounts in millions):

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KRYSTEXXA — U.S.

$ 349 $ 294 19 % $ 585 $ 529 11 %

The increase in KRYSTEXXA sales was 19% for the three months ended June 30, 2025, of which 12% was derived from higher inventory and 6% from volume growth.

The increase in KRYSTEXXA sales for the six months ended June 30, 2025 was driven by volume growth of 8% and higher inventory of 2%.

Total Vectibix sales by geographic region were as follows (dollar amounts in millions):

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Vectibix — U.S.

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Total Vectibix $ 305 $ 270 13 % $ 572 $ 517 11 %

The increase in global Vectibix sales for the three months ended March 31, 2025 was driven by volume growth.

Total KRYSTEXXA sales by geographic region were as follows (dollar amounts in millions):

Three months ended

2025 2024 Change

KRYSTEXXA — U.S.

$ 236 $ 235 0 %

KRYSTEXXA sales for the three months ended March 31, 2025 remained relatively unchanged as volume growth of 11% was offset by lower inventory of 10%.

The increases in global Vectibix sales for the three and six months ended June 30, 2025 were driven by volume growth.

Other products

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$ 142 $ 100 42 % $ 280 $ 205 37 %

WEZLANA — U.S.

WEZENLA — ROW 27 1 *

49 57 (14) % 90 154 (42) %

AMJEVITA — U.S.

— (9) (100) % 4 21 (81) %

AMGEVITA — ROW

133 142 (6) % 265 280 (5) %

Neulasta — U.S.

Neulasta — ROW 20 31 (35) %

PAVBLU — U.S.

RAVICTI — U.S.

RAVICTI — ROW 3 2 50 %

UPLIZNA — U.S.

132 77 71 % 214 147 46 %

UPLIZNA — ROW 44 15 * 53 25 *

PAVBLU — U.S.

126 — N/A 225 — N/A

PAVBLU — ROW 4 — N/A 4 — N/A

IMDELLTRA — U.S.

107 12 * 186 12 *

IMDYLLTRA — ROW

27 — N/A 29 — N/A

Neulasta — U.S.

63 75 (16) % 172 162 6 %

Neulasta — ROW 19 30 (37) % 39 61 (36) %

TAVNEOS — U.S.

103 61 69 % 180 106 70 %

TAVNEOS — ROW 7 10 (30) % 20 16 25 %

Aimovig — U.S.

Aimovig — ROW 5 5 — %

RAVICTI — U.S.

99 96 3 % 190 188 1 %

RAVICTI — ROW 6 1 * 9 3 *

WEZLANA — U.S.

— — N/A 123 — N/A

WEZENLA — ROW 35 — N/A 62 1 *

Parsabiv — U.S.

51 67 (24) % 101 132 (23) %

Parsabiv — ROW 41 39 5 % 79 79 — %

LUMAKRAS — U.S.

52 55 (5) % 107 108 (1) %

LUMYKRAS — ROW

IMDELLTRA — U.S.

IMDYLLTRA — ROW

38 30 27 % 68 59 15 %

Aimovig — U.S.

64 80 (20) % 149 145 3 %

Aimovig — ROW 6 5 20 % 11 10 10 %

PROCYSBI — U.S.

55 54 2 % 112 103 9 %

PROCYSBI — ROW 2 4 (50) % 4 5 (20) %

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Other — ROW (2)

50 56 (11) % 105 106 (1) %

Total other products $ 1,690 $ 1,326 27 % $ 3,337 $ 2,699 24 %

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Total other products $ 1,690 $ 1,326 27 % $ 3,337 $ 2,699 24 %

N/A = not applicable

* Change in excess of 100%

(1) Consists of product sales from AVSOLA, KANJINTI, RIABNI, EPOGEN, BEKEMV, ACTIMMUNE, NEUPOGEN, IMLYGIC, Corlanor, RAYOS, BUPHENYL, Sensipar/Mimpara, QUINSAIR, DUEXIS and PENNSAID.

N/A = not applicable

AMJEVITA product sales for the three and six months ended June 30, 2024, included unfavorable changes to estimated sales deductions.

(2) Consists of product sales from AVSOLA, KANJINTI, EPOGEN, RIABNI, BKEMV/BEKEMV, ACTIMMUNE, NEUPOGEN, IMLYGIC, Corlanor, RAYOS, BUPHENYL, QUINSAIR, DUEXIS, Sensipar/Mimpara and PENNSAID.

Operating expenses

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Operating expenses:

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Cost of sales

Cost of sales decreased to 36.4% of total revenues for the three months ended March 31, 2025, driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by changes in our sales mix.

Cost of sales decreased to 32.8% and 34.5% of total revenues for the three and six months ended June 30, 2025, respectively, driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon and lower manufacturing costs, partially offset by higher profit share expense and changes in our sales mix.

Research and development

The increase in R&D expense for the three months ended March 31, 2025, was driven by higher spend in later-stage clinical programs, partially offset by lower spend in marketed product support and research and early pipeline.

The increase in R&D expense for the three months ended June 30, 2025, was driven by investments in Later-Stage Clinical Programs, including those related to MariTide.

The increase in R&D expense for the six months ended June 30, 2025, was driven by investments in Later-Stage Clinical Programs, including those related to MariTide, partially offset by lower spend in Research and Early Pipeline and Marketed Product Support.

We expect to continue to grow our spend on Later-Stage Clinical Programs as we advance our pipeline.

Selling, general and administrative

The decrease in SG&A expense for the three months ended March 31, 2025, was driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses.

Other operating expenses for the three months ended March 31, 2025, consisted primarily of the Otezla intangible asset impairment charge of $800 million following its selection for price setting under the IRA.

The decrease in SG&A expense for the three months ended June 30, 2025, was driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses.

The decrease in SG&A expense for the six months ended June 30, 2025, was primarily driven by lower commercial product-related expenses and lower Horizon acquisition-related expenses, partially offset by higher general and administrative expenses.

Other operating expenses for the three months ended June 30, 2025, included litigation expenses.

Other operating expenses for the six months ended June 30, 2025, included the Otezla intangible asset impairment charge of $800 million following its selection for price setting under the IRA.

See Note 8, Goodwill and other intangible assets, to the condensed consolidated financial statements.

Other operating expenses for the three months ended March 31, 2024, consisted primarily of a net impairment charge associated with an IPR&D intangible asset and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc.

acquisition from 2021.

Other operating expenses for the three months ended June 30, 2024, included changes in the fair values of contingent consideration liabilities related to our Teneobio, Inc.

(Teneobio) acquisition from 2021.

Other operating expenses for the six months ended June 30, 2024, included a net impairment charge associated with an IPR&D asset and changes in the fair values of contingent consideration liabilities, both related to our Teneobio acquisition.

Nonoperating expenses/income and income taxes

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Three months ended

June 30, Six months ended

2025 2024 2025 2024

Interest expense, net $ (694) $ (808) $ (1,417) $ (1,632)

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

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

Provision for income taxes $ 136 $ 48 $ 379 $ 93

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Interest expense, net

Interest expense, net, decreased for the three months ended March 31, 2025 primarily due to lower average debt outstanding.

Other income (expense), net

The change in Other income (expense), net, for the three months ended March 31, 2025, was primarily due to net unrealized gains on equity investments, primarily BeiGene, compared to net unrealized losses on equity investments, primarily BeiGene, in 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., to the condensed consolidated financial statements.

Interest expense, net, decreased for the three and six months ended June 30, 2025 primarily due to lower average debt outstanding.

Other (expense) income, net

The change in Other (expense) income, net, for the three months ended June 30, 2025, was primarily due to higher net unrealized losses on equity investments, primarily BeOne, partially offset by a gain on extinguishment of debt in the second quarter of 2025.

The change in Other (expense) income, net, for the six months ended June 30, 2025, was primarily due to net unrealized gains on our equity investments, primarily BeOne, in the first half of 2025 compared with net unrealized losses, primarily BeOne, in the first half of 2024.

See Note 6, Investments, to the condensed consolidated financial statements.

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 , to the condensed consolidated financial statements.

As previously reported, the OECD reached an agreement to align countries on a minimum corporate tax rate and an expansion of the taxing rights of market countries.

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

Other countries, including the United States and the U.S.

territory of Puerto Rico, have not yet enacted the OECD agreement, and implementation remains highly uncertain.

The continued enactment of the agreement, either by all OECD participants or unilaterally by individual countries, could result in tax increases or double taxation in the United States or foreign jurisdictions.

In June 2025, the United States and the other six countries that make up the G7 nations jointly announced that U.S.

companies would be exempted from certain minimum taxes related to the OECD agreement.

However, significant details regarding the G7 announcement remain uncertain and individual countries that have enacted the OECD agreement, including countries not within the G7, must amend their local legislation for the G7 announcement to become effective.

The continued response of other countries, including the U.S.

territory of Puerto Rico to the OECD agreement and the G7 announcement remains highly uncertain.

The continued enactment of the OECD agreement, either by all OECD participants or unilaterally by individual countries, could result in tax increases or double taxation in the United States or foreign jurisdictions.

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.

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 will be recorded in the third quarter of 2025.

In 2017, we received an RAR and a modified RAR from the IRS for the years 2010–2012, proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S.

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

territory of Puerto Rico for years beyond 2018.

We expect that the IRS will begin its audit of 2019–2022 in 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.

See our Annual Report on Form 10-K for the year ended December 31, 2024, Part I, Item 1A, Risk Factors— We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation, and we anticipate additional tax liabilities from certain provisions of the 2017 Tax Act that will go into effect in 2026;

See Part II, Item 1A.

Risk Factors— We could be subject to additional tax liabilities, including from an adverse outcome in our ongoing tax dispute with the IRS and other tax examinations, enactment of the OECD minimum corporate tax rate agreement and the adoption and interpretation of new tax legislation including the OBBBA.

Such tax liabilities could adversely affect our profitability and results of operations, and Note 4, Income taxes, to the condensed consolidated financial statements of this Quarterly Report on Form 10-Q for further discussion.

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Selected financial data were as follows (in millions):

March 31, 2025 December 31, 2024

June 30, 2025 December 31, 2024

Cash and cash equivalents $ 8,028 $ 11,973

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Cash and cash equivalents

Our balance of cash and cash equivalents was $8.8 billion as of March 31, 2025.

Our balance of cash and cash equivalents was $8.0 billion as of June 30, 2025.

The primary objective of our investment portfolio is to maintain safety of principal, prudent levels of liquidity and acceptable levels of risk.

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The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.

In December 2024, our Board of Directors declared a quarterly cash dividend of $2.38 per share of common stock for the first quarter of 2025, an increase of 6% over the same period in the prior year, which was paid in March 2025.

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

During the three months ended March 31, 2025, 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.

As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of March 31, 2025 and December 31, 2024.

In March 2025 and December 2024, our Board of Directors declared quarterly cash dividends of $2.38 per share of common stock, which were paid in June 2025 and March 2025, respectively, an increase of 6% over the quarterly cash dividends paid each quarter in 2024.

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

During the six months ended June 30, 2025, 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.

As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of June 30, 2025 and December 31, 2024.

Our accumulated deficit is not anticipated to affect our future ability to operate, repurchase stock, pay dividends or repay our debt given our expected continued profitability and strong financial position.

During the 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.

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

In addition, we opportunistically repurchase our debt when market conditions are favorable.

During the three months ended March 31, 2025 and 2024, we repurchased aggregate principal amounts of our debt of $414 million and $544 million, respectively, for aggregate costs of $301 million and $410 million, respectively, which resulted in the recognition of gains on extinguishment of debt of $111 million and $133 million respectively, recorded in Other income (expense), net, in the Condensed Consolidated Statements of Income (Loss).

During the six months ended June 30, 2025 and 2024, we repurchased aggregate principal amounts of our debt of $832 million and $544 million, respectively, for aggregate costs of $602 million and $410 million, respectively, which resulted in the recognition of gains on extinguishment of debt of $228 million and $133 million, respectively, recorded in Other (expense) income, net, in the Condensed Consolidated Statements of Income.

We believe that existing funds, cash generated from operations and existing sources of and access to financing are adequate to satisfy our needs for working capital, capital expenditure and debt service requirements, as well as our plans to reduce debt, pay dividends and repurchase stock, and other business initiatives we plan to strategically pursue, including acquisitions and licensing activities.

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In addition, our revolving credit agreement and term loan credit agreement include a financial covenant that requires us to maintain a specified minimum interest coverage ratio of (i) the sum of consolidated net income, interest expense, provision for income taxes, depreciation expense, amortization expense, unusual or nonrecurring charges and other noncash items (consolidated earnings before interest, taxes, depreciation and amortization) to (ii) Consolidated Interest Expense, each as defined and described in the respective agreements.

We were in compliance with all applicable covenants under these arrangements as of March 31, 2025.

We were in compliance with all applicable covenants under these arrangements as of June 30, 2025.

Our summarized cash flow activity was as follows (in millions):

Three months ended

Six months ended

Net cash provided by operating activities $ 3,671 $ 3,148

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Cash provided by operating activities has been and is expected to continue to be our primary recurring source of funds.

Cash provided by operating activities during the three months ended March 31, 2025, increased as compared to the same period in the prior year primarily due to an $800 million tax deposit made in the first quarter of 2024 and higher net income in the first quarter of 2025 after adjustments for noncash items, partially offset by the timing of working capital items.

Cash used in investing activities during the three months ended March 31, 2025 and 2024, was primarily due to capital expenditures of $411 million and $230 million, respectively, including construction costs for new plants in Ohio and North Carolina to expand our manufacturing capacity.

Cash provided by operating activities during the six months ended June 30, 2025, increased as compared to the same period in the prior year primarily due to higher net income in the first half of 2025 after adjustments for noncash items and the timing of tax payments, including an $800 million tax deposit made in the first quarter of 2024, partially offset by the timing of working capital items.

Cash used in investing activities during the six months ended June 30, 2025 and 2024, was primarily due to capital expenditures of $780 million and $468 million, respectively, including construction costs for new plants and expansion of manufacturing capacity.

We currently estimate full year 2025 investments in capital projects to be approximately $2.3 billion.

Cash used in financing activities during the three months ended March 31, 2025, was primarily due to the repayment and extinguishment of debt of $2.5 billion and $301 million, respectively, and the payment of dividends of $1.3 billion.

Cash used in financing activities during the three months ended March 31, 2024, was primarily due to the payment of dividends of $1.2 billion and the extinguishment of debt of $410 million.

Cash used in financing activities during the six months ended June 30, 2025, was primarily due to the repayment and extinguishment of debt of $3.5 billion and $602 million, respectively, and the payment of dividends of $2.6 billion.

Cash used in financing activities during the six months ended June 30, 2024, was primarily due to the payment of dividends of $2.4 billion and the repayment and extinguishment of debt of $1.4 billion and $410 million, respectively.

See Note 9, Financing arrangements, and Note 10, Stockholders’ equity, to the condensed consolidated financial statements for further discussion.

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Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our Annual Report on Form 10-K for the year ended December 31, 2024.

There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2025.

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2025.

Recently issued accounting standards

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis