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 our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

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.

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

Amgen operates in one business segment:

Amgen operates in one operating segment:

human therapeutics.

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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, 2023, and in Part II, Item 1A.

Risk Factors of our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

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

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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(including its subsidiaries, referred to as “Amgen,” “the Company,” “we,” “our” or “us”) discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

We focus on areas of high unmet medical need and leverage our expertise to strive for solutions that dramatically improve people’s lives, while also reducing the social and economic burden of disease.

We helped launch the biotechnology industry more than 40 years ago and have grown to be one of the world’s leading independent biotechnology companies.

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

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

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

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.

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.

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.

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.

Macroeconomic and other challenges

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

Further, ongoing geopolitical conflicts continue to create additional uncertainty in global macroeconomic conditions.

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.

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 Drug Pricing Program, have affected, and are likely to continue to affect, our business.

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

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

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

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Significant developments

Following is a summary of selected significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the period ended June 30, 2024.

For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2023, and our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024.

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

Products/pipeline

In September 2024, we announced TEPEZZA was approved for the treatment of active or high clinical activity score (CAS) thyroid eye disease (TED) in Japan.

In September 2024, we announced top-line results of the Phase 3 MINT trial of UPLIZNA, an anti-CD19 humanized monoclonal antibody.

MINT is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy and safety of UPLIZNA in patients with generalized myasthenia gravis (gMG).

The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared with placebo at week 26 of the combined patient population.

UPLIZNA demonstrated a statistically significant and clinically meaningful change from baseline compared to placebo for four out of five key secondary endpoints.

The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA.

In September 2024, we announced top-line results of the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor.

ROCKET HORIZON is a Phase 3, randomized, placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab monotherapy in adults with moderate to severe atopic dermatitis.

The study met its co-primary endpoints and reached statistically significant difference from placebo for all key secondary endpoints.

Overall safety findings in the study were comparable to those seen in the Phase 2b study.

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.

Selected financial information

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2025 2024 Change

Product sales

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Operating income $ 1,178 $ 991 19 %

Net income $ 2,830 $ 1,730 64 % $ 3,463 $ 5,950 (42) %

Diluted EPS $ 5.22 $ 3.22 62 % $ 6.40 $ 11.06 (42) %

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

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

Diluted shares 541 536 1 %

* Change in excess of 100%

In the following discussion of changes in product sales, any reference to unit demand growth or decline refers to changes in purchases of our products by healthcare providers (such as physicians or their clinics), dialysis centers, hospitals and pharmacies.

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

Total product sales increased 24% and 22% for the three and nine months ended September 30, 2024, respectively, primarily driven by volume growth of 29% and 27%, respectively, partially offset by declines in net selling price of 2% and 3%, respectively.

For the three months ended September 30, 2024, U.S.

volume grew 34% and ROW volume grew 18%.

Product sales from acquired Horizon products contributed $1.1 billion, with volume growth of 12% from our other brands, including Repatha, TEZSPIRE, EVENITY, BLINCYTO and Prolia.

For the nine months ended September 30, 2024, U.S.

volume grew 31% and ROW volume grew 17%.

Product sales from acquired Horizon products contributed $3.1 billion, with volume growth of 10% from our other brands, including Repatha, TEZSPIRE, EVENITY, Prolia and BLINCYTO.

For the remainder of 2024, we expect product sales growth from acquired Horizon products and volume growth from our other brands to be partially offset by net selling price declines on a year-over-year basis at a portfolio level.

Uncertain macroeconomic conditions, changes in the healthcare ecosystem and geopolitical conflicts 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, the 340B Drug Pricing Program and growth in numbers of Medicaid enrollees and uninsured individuals.

See Part I, Item 1A.

Risk Factors of our Annual Report on Form 10-K for the year ended December 31, 2023, and Part II, Item 1A.

Risk Factors, of our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024, June 30, 2024 and September 30, 2024.

Other revenues remained relatively unchanged for the three months ended September 30, 2024.

Other revenues increased for the nine months ended September 30, 2024, driven by higher royalty income and corporate partner revenue from licensed products.

Operating expenses increased for the three and nine months ended September 30, 2024, primarily driven by higher amortization expense from Horizon acquisition-related assets and expenses from the acquired Horizon business.

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.

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.

See Part I, Item 1.

Business—Reimbursement, and Part I, Item 1A.

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

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.

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.

Results of operations

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Prolia $ 1,099 $ 999 10 %

ENBREL 825 1,035 (20) % 2,301 2,682 (14) %

XGEVA 541 519 4 % 1,664 1,585 5 %

Repatha 656 517 27 %

Otezla 564 567 (1) % 1,502 1,559 (4) %

488 — N/A 1,391 — N/A

XGEVA 566 561 1 %

ENBREL 510 567 (10) %

EVENITY 442 342 29 %

Otezla 437 394 11 %

TEPEZZA 381 424 (10) %

BLINCYTO 370 244 52 %

Aranesp 340 349 (3) %

KYPROLIS 324 376 (14) %

Nplate 313 317 (1) %

Aranesp 337 323 4 % 1,034 1,043 (1) %

KRYSTEXXA (1)

310 — N/A 839 — N/A

BLINCYTO 327 220 49 % 835 620 35 %

Vectibix 267 247 8 %

269 161 67 % 676 390 73 %

KRYSTEXXA 236 235 0 %

Other products (2)

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Total product sales $ 7,873 $ 7,118 11 %

N/A = not applicable

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

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

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Business—Marketing, Distribution and Selected Marketed Products;

(ii) Part I, Item 1A.

Risk Factors;

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 Reports on Form 10-Q for the periods ended March 31, 2024 and June 30, 2024:

(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.

(ii) Part I, Item 1.

Business—Reimbursement;

(iii) Part I, Item 1A.

Risk Factors;

and (iv) Part II, Item 7.

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

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 $ 1,099 $ 999 10 %

The increase in global Prolia sales for the three months ended September 30, 2024 was driven by volume growth of 9%,

partially offset by lower inventory.

The increase in global Prolia sales for the nine months ended September 30, 2024 was driven by volume growth.

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%.

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 U.S.

patent for RANKL antibodies (including sequences) for Prolia and XGEVA expires in February 2025.

For information about our settlement with Sandoz Inc., see Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the period ended March 31, 2024.

For a discussion of litigation 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, 2023;

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

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

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 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.

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

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ENBREL — U.S.

2025 2024 Change

Repatha — U.S.

$ 343 $ 273 26 %

ENBREL — Canada 8 9 (11) % 21 37 (43) %

Total ENBREL $ 825 $ 1,035 (20) % $ 2,301 $ 2,682 (14) %

The decrease in ENBREL sales for the three months ended September 30, 2024 was primarily driven by unfavorable changes to estimated sales deductions of 13% and lower net selling price of 12%.

The decrease in ENBREL sales for the nine months ended September 30, 2024 was driven by lower net selling price.

Going forward, we expect relatively flat volumes with continued declines in net selling price, including the impact from the IRA Medicare Part D price set by CMS beginning in 2026.

Repatha — ROW 313 244 28 %

Total Repatha $ 656 $ 517 27 %

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%.

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

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$ 360 $ 366 (2) %

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Total XGEVA $ 566 $ 561 1 %

The increase in global XGEVA sales for the three and nine months ended September 30, 2024 was driven by higher net selling price.

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

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 U.S.

patent for RANKL antibodies (including sequences) for Prolia and XGEVA expires in February 2025.

For a discussion of litigation 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, 2023;

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

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

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):

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Repatha — U.S.

2025 2024 Change

ENBREL — U.S.

$ 504 $ 561 (10) %

Repatha — ROW 286 223 28 % 792 626 27 %

Total Repatha $ 567 $ 406 40 % $ 1,616 $ 1,218 33 %

The increase in global Repatha sales for the three months ended September 30, 2024 was driven by volume growth of 41% and favorable changes to estimated sales deductions of 8%, partially offset by lower net selling price of 10%.

The increase in global Repatha sales for the nine months ended September 30, 2024 was driven by volume growth of 44%, partially offset by lower net selling price of 13%.

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, 2023, and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the periods ended March 31, 2024, June 30, 2024 and September 30, 2024.

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.

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

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EVENITY — U.S.

$ 320 $ 236 36 %

EVENITY — ROW 122 106 15 %

Total EVENITY $ 442 $ 342 29 %

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.

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Total Otezla $ 437 $ 394 11 %

The decrease in global Otezla sales for the three months ended September 30, 2024 was primarily driven by lower net selling price of 7%, partially offset by volume growth of 5%.

The decrease in global Otezla sales for the nine months ended September 30, 2024 was driven by lower net selling price of 8%, partially offset by higher inventory of 3% and volume growth of 2%.

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.

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.

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

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TEPEZZA — U.S.

$ 482 $ — N/A $ 1,379 $ — N/A

TEPEZZA — ROW 6 — N/A 12 — N/A

Total TEPEZZA $ 488 $ — N/A $ 1,391 $ — N/A

N/A = not applicable

TEPEZZA was acquired on October 6, 2023 from our Horizon acquisition and generated $488 million and $1.4 billion in product sales for the three and nine months ended September 30, 2024, respectively.

As TEPEZZA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.

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

$ 365 $ 419 (13) %

TEPEZZA — ROW 16 5 *

Total TEPEZZA $ 381 $ 424 (10) %

* 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.

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

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EVENITY — U.S.

2025 2024 Change

BLINCYTO — U.S.

$ 273 $ 153 78 %

EVENITY — ROW 110 93 18 % 326 272 20 %

Total EVENITY $ 399 $ 307 30 % $ 1,132 $ 842 34 %

The increase in global EVENITY sales for the three and nine months ended September 30, 2024 was driven by volume growth.

BLINCYTO — ROW 97 91 7 %

Total BLINCYTO $ 370 $ 244 52 %

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.

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 $ 324 $ 376 (14) %

The increase in global KYPROLIS sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth outside the United States.

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

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 $ 313 $ 317 (1) %

Global Nplate sales for the three months ended September 30, 2024 increased 9% and included U.S.

government orders of $128 million and $142 million for the three months ended September 30, 2024 and 2023, respectively.

Excluding the U.S.

government orders from this comparison, global Nplate sales increased 18% for the three months ended September 30, 2024, driven by volume growth of 14% and higher net selling price.

Global Nplate sales for the nine months ended September 30, 2024 increased 3% and included U.S.

government orders of $128 million and $224 million for the nine months ended September 30, 2024 and 2023, respectively.

Excluding the U.S.

government orders from this comparison, global Nplate sales increased 14% for the nine months ended September 30, 2024, driven by volume growth of 9% and higher net selling price.

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

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Aranesp — U.S.

$ 105 $ 107 (2) % $ 296 $ 345 (14) %

Aranesp — ROW 232 216 7 % 738 698 6 %

Total Aranesp $ 337 $ 323 4 % $ 1,034 $ 1,043 (1) %

The increase in global Aranesp sales for the three months ended September 30, 2024 was driven by volume growth outside the United States.

The decrease in global Aranesp sales for the nine months ended September 30, 2024 was driven by unfavorable changes to estimated sales deductions and unfavorable changes to foreign currency exchange rates, partially offset by volume growth outside the United States.

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

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KRYSTEXXA — U.S.

$ 310 $ — N/A $ 839 $ — N/A

KRYSTEXXA — ROW

— — N/A — — N/A

Total KRYSTEXXA

$ 310 $ — N/A $ 839 $ — N/A

N/A = not applicable

KRYSTEXXA was acquired on October 6, 2023 from our Horizon acquisition and generated $310 million and $839 million in product sales for the three and nine months ended September 30, 2024, respectively.

As KRYSTEXXA was acquired on October 6, 2023, there were no recorded product sales for the comparative prior periods.

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

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.

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

Three months ended

September 30, Nine months ended

September 30,

2024 2023 Change 2024 2023 Change

BLINCYTO — U.S.

2025 2024 Change

TEZSPIRE — U.S.

$ 285 $ 173 65 %

BLINCYTO — ROW 90 73 23 % 280 202 39 %

Total BLINCYTO $ 327 $ 220 49 % $ 835 $ 620 35 %

The increase in global BLINCYTO sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.

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

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

Three months ended

September 30, Nine months ended

September 30,

2024 2023 Change 2024 2023 Change

2025 2024 Change

Vectibix — U.S.

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Total Vectibix $ 267 $ 247 8 %

The increase in global Vectibix sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.

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

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

September 30, Nine months ended

September 30,

2024 2023 Change 2024 2023 Change

TEZSPIRE — U.S.

2025 2024 Change

KRYSTEXXA — U.S.

$ 236 $ 235 0 %

The increase in TEZSPIRE sales for the three and nine months ended September 30, 2024 was primarily driven by volume growth.

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%.

Other products

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Three months ended

September 30, Nine months ended

September 30,

2024 2023 Change 2024 2023 Change

$ 136 $ 140 (3) % $ 341 $ 384 (11) %

2025 2024 Change

$ 138 $ 105 31 %

WEZLANA — U.S.

WEZENLA — ROW 27 1 *

AMJEVITA — U.S.

28 23 22 % 49 93 (47) %

AMGEVITA — ROW

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Neulasta — U.S.

84 92 (9) % 246 502 (51) %

Neulasta — ROW 20 31 (35) %

PAVBLU — U.S.

RAVICTI — U.S.

98 — N/A 286 — N/A

RAVICTI — ROW 3 2 50 %

9 — N/A 12 — N/A

Parsabiv — U.S.

32 59 (46) % 164 171 (4) %

Parsabiv — ROW 38 36 6 % 117 102 15 %

UPLIZNA — U.S.

74 — N/A 221 — N/A

UPLIZNA — ROW 9 10 (10) %

32 — N/A 57 — N/A

LUMAKRAS — U.S.

53 48 10 % 161 146 10 %

LUMYKRAS — ROW

45 4 * 104 57 82 %

Aimovig — U.S.

77 88 (13) % 222 230 (3) %

Aimovig — ROW 5 6 (17) % 15 15 — %

TAVNEOS — U.S.

74 32 * 180 84 *

TAVNEOS — ROW 13 6 *

Aimovig — U.S.

Aimovig — ROW 5 5 — %

Parsabiv — U.S.

Parsabiv — ROW 38 40 (5) %

LUMAKRAS — U.S.

LUMYKRAS — ROW

IMDELLTRA — U.S.

IMDYLLTRA — ROW

PROCYSBI — U.S.

57 — N/A 160 — N/A

PROCYSBI — ROW 2 1 100 %

1 — N/A 6 — N/A

EPOGEN — U.S.

221 302 (27) %

IMDELLTRA — U.S.

36 — N/A 48 — N/A

176 143 23 % 674 490 38 %

Other — ROW (1)

46 44 5 % 153 161 (5) %

Total other products $ 1,647 $ 1,373 20 %

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* Change in excess of 100%

(1) RAVICTI, UPLIZNA and PROCYSBI were acquired from our Horizon acquisition on October 6, 2023, and include product sales in the periods after the acquisition date.

(2) Consists of product sales from (i) KANJINTI, RIABNI, Corlanor, AVSOLA, NEUPOGEN, IMLYGIC, BEKEMV, WEZLANA/WEZENLA and Sensipar/Mimpara;

and (ii) ACTIMMUNE, RAYOS, BUPHENYL, QUINSAIR, PENNSAID and DUEXIS in the periods after our Horizon acquisition on October 6, 2023.

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

Operating expenses

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Three months ended

September 30, Nine months ended

September 30,

2024 2023 Change 2024 2023 Change

2025 2024 Change

Operating expenses:

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Total operating expenses $ 6,971 $ 6,456 8 %

* Change in excess of 100%

Cost of sales

Cost of sales increased to 38.9% and 40.0% of total revenues for the three and nine months ended September 30, 2024, respectively, driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher royalty and profit share expense.

The increase for the nine months ended September 30, 2024 was partially offset by the prior year impact of the 2022 Puerto Rico tax law change, which replaced an excise tax with an income tax beginning in 2023.

See Note 4, Income taxes, to the condensed consolidated financial statements.

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.

Research and development

The increase in R&D expense for the three and nine months ended September 30, 2024, was driven by higher spend in later-stage clinical programs, marketed product support and research and early pipeline, including Horizon-acquired programs.

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.

We expect to continue to grow our spend on later-stage clinical programs as we advance our pipeline.

Selling, general and administrative

The increase in SG&A expense for the three months ended September 30, 2024, was primarily driven by commercial expenses related to Horizon-acquired products.

The increase in SG&A expense for the nine months ended September 30, 2024, was driven by expenses from the acquired Horizon business and other commercial expenses.

Other operating expenses for the three and nine months ended September 30, 2024, consisted primarily of impairment charges associated with IPR&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc.

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.

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 and nine months ended September 30, 2023, consisted of a net impairment charge resulting from the termination of AMG 340 and expenses related to our restructuring plan initiated in the first quarter of 2023.

Nonoperating expense/income and income taxes

Nonoperating expense/income and income taxes were as follows (dollar amounts in millions):

Nonoperating expenses/income and income taxes

Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions):

Three months ended

September 30, Nine months ended

September 30,

2024 2023 2024 2023

Interest expense, net $ (723) $ (824)

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

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

Provision for income taxes $ 243 $ 45

1 unchanged sentence

Interest expense, net

Interest expense, net, remained relatively unchanged for the three months ended September 30, 2024.

The increase in Interest expense, net, for the nine months ended September 30, 2024, was primarily due to higher average debt outstanding and higher weighted-average fixed and floating interest rates on the debt.

Other income, net

The increase in Other income, net, for the three months ended September 30, 2024, was primarily due to higher unrealized gains on our strategic equity investments, primarily BeiGene, partially offset by reduced interest income as a result of lower average cash balances.

The decrease in Other income, net, for the nine months ended September 30, 2024, was primarily due to lower current year net unrealized gains on our strategic equity investments, primarily BeiGene, and reduced interest income as a result of lower average cash balances.

Prior period net gains on our strategic equity investments were principally composed of amounts recognized on our BeiGene investment in the first quarter of 2023 as a result of a change from the equity method of accounting to recording this investment at fair value with changes in fair value recognized in earnings.

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

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

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.

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

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.

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

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

Additional countries, including Singapore, enacted the minimum tax agreement, effective January 1, 2025.

Singapore’s enactment of the agreement applies irrespective of the Company’s incentive grant.

Our legal entities in 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.

2 unchanged sentences

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.

As of January 1, 2023, we are no longer subject to a 4% excise tax in the U.S.

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

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

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

Treasury final foreign tax credit regulations.

See Note 4, Income taxes, to the condensed consolidated financial statements.

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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Tax Court on December 19, 2022.

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

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

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

The Company expects a decision from the U.S.

Tax Court no earlier than the second half of 2026.

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

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

territory of Puerto Rico for years beyond 2018.

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

3 unchanged sentences

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;

such tax liabilities could adversely affect our profitability and results of operations, and Note 4, Income taxes, to the condensed consolidated financial statements in this filing for further discussion.

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.

Financial condition, liquidity and capital resources

Selected financial data were as follows (in millions):

September 30, 2024 December 31, 2023

March 31, 2025 December 31, 2024

Cash and cash equivalents $ 8,810 $ 11,973

4 unchanged sentences

Cash and cash equivalents

Our balance of cash and cash equivalents was $9.0 billion as of September 30, 2024.

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

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

7 unchanged sentences

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

In August 2024, March 2024 and December 2023, our Board of Directors declared quarterly cash dividends of $2.25 per share of common stock, which were paid in September 2024, June 2024 and March 2024, respectively, and was an increase of 6% over the quarterly cash dividends paid each quarter in 2023.

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

During the nine months ended September 30, 2024, we did not repurchase any of our common stock under our stock repurchase program.

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

As a result of stock repurchases and quarterly dividend payments, we have an accumulated deficit as of September 30, 2024 and December 31, 2023.

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

During the nine months ended September 30, 2024 and 2023, debt repayments totaled $3.6 billion and $1.5 billion, respectively.

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.

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.

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

During the nine months ended September 30, 2024 and 2023, we paid $659 million and $550 million, respectively, to extinguish principal amounts of debt of $875 million and $739 million, respectively.

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).

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.

We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, sales of marketable securities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets.

We anticipate that our liquidity needs can be met through a variety of sources, including cash provided by operating activities, borrowings through commercial paper and/or syndicated credit facilities and access to other domestic and foreign debt markets and equity markets.

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

2 unchanged sentences

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

We were in compliance with all applicable covenants under these arrangements as of September 30, 2024.

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

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

Nine months ended

September 30,

Three months ended

Net cash provided by operating activities $ 1,391 $ 689

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

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

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

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

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

Cash provided by operating activities during the nine months ended September 30, 2024, decreased compared with the prior year period due to the timing of repatriation and income tax payments to the IRS, partially offset by higher net income after adjustments for noncash items and timing of working capital.

Cash used in investing activities during the nine months ended September 30, 2024, was primarily due to capital expenditures of $725 million, including construction costs of new plants in North Carolina and Ohio.

Cash provided by investing activities during the nine months ended September 30, 2023, was primarily due to net cash inflows from sales and maturities of marketable securities of $1.7 billion, partially offset by capital expenditures of $863 million, including construction costs of new plants in North Carolina and Ohio.

We currently estimate full year 2024 spending on capital projects to be approximately $1.3 billion.

Cash used in financing activities during the nine months ended September 30, 2024, was primarily due to the payment of dividends of $3.6 billion and the repayment and extinguishment of debt of $3.6 billion and $659 million, respectively.

Cash provided by financing activities during the nine months ended September 30, 2023, was primarily due to proceeds from the issuance of debt of $23.8 billion, partially offset by the payment of dividends of $3.4 billion, as well as the repayment and extinguishment of debt of $1.5 billion and $550 million, respectively.

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.

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.

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

4 unchanged sentences

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.

Recently issued accounting standards

For a discussion of recently issued accounting standards, see Note 1, Significant accounting policies, to the condensed consolidated financial statements.

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