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MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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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, 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. Amgen operates in one operating segment: human therapeutics. Therefore, our results of operations are discussed on a consolidated basis.
Forward-looking statements
This report and other documents we file with the SEC contain forward-looking statements that are based on current expectations, estimates, forecasts and projections about us, our future performance, our business, our beliefs and our management's assumptions. In addition, we, or others on our behalf, may make forward-looking statements in press releases, written statements or our communications and discussions with investors and analysts in the normal course of business through meetings, webcasts, phone calls and conference calls. Such words as "expect," "anticipate," "outlook," "could," "target," "project," "intend," "plan," "believe," "seek," "estimate," "should," "may," "assume" and "continue" as well as variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are not guarantees of future performance, and they involve certain risks, uncertainties and assumptions that are difficult to predict. We describe our respective risks, uncertainties and assumptions that could affect the outcome or results of operations in Item 1A. 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, 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. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. Reference is made in particular to forward-looking statements regarding product sales, regulatory activities, clinical trial results, reimbursement, expenses, EPS, liquidity and capital resources, trends, planned dividends, stock repurchases, and collaborations. Except as required under the federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update publicly any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise.
Overview
Amgen Inc. (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. 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, 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 recently announced preliminary tariff agreements, 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, 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 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 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. 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 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. 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 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 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 85thScientific 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.
TEPEZZA
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
The following is an overview of our results of operations (in millions, except percentages and per-share data):
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Three months ended
June 30,
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Six months ended
June 30,
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2025
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2024
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Change
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2025
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2024
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Change
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Product sales
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U.S.
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$
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6,324
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$
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5,840
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8
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%
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$
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11,986
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$
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10,813
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11
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%
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ROW
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2,447
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2,201
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11
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%
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4,658
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4,346
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7
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%
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Total product sales
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8,771
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8,041
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9
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%
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16,644
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15,159
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10
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%
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Other revenues
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408
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347
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18
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%
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684
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676
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1
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%
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Total revenues
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$
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9,179
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$
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8,388
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9
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%
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$
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17,328
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$
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15,835
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9
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%
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Operating expenses
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$
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6,523
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$
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6,479
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1
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%
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$
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13,494
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$
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12,935
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4
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%
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Operating income
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$
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2,656
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$
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1,909
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39
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%
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$
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3,834
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$
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2,900
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32
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%
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Net income
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$
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1,432
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$
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746
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92
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%
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$
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3,162
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$
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633
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*
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Diluted EPS
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$
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2.65
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$
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1.38
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92
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%
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$
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5.84
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$
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1.17
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*
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Diluted shares
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541
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541
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-
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%
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541
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541
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-
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%
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* 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 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, 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. 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 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.
Results of operations
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
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Three months ended
June 30,
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Six months ended
June 30,
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2025
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2024
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Change
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2025
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2024
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Change
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Prolia
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$
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1,122
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$
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1,165
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(4)
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%
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$
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2,221
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|
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$
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2,164
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3
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%
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Repatha
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696
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532
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31
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%
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1,352
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1,049
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29
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%
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ENBREL
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604
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909
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(34)
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%
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1,114
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1,476
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(25)
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%
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XGEVA
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532
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562
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(5)
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%
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1,098
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1,123
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(2)
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%
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Otezla
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618
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544
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14
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%
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1,055
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938
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12
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%
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EVENITY
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518
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391
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32
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%
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960
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733
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31
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%
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TEPEZZA
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505
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479
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5
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%
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886
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903
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(2)
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%
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BLINCYTO
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384
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264
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45
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%
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754
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508
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48
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%
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KYPROLIS
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378
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377
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0
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%
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702
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753
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(7)
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%
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Aranesp
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359
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348
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3
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%
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|
699
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|
697
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0
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%
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Nplate
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369
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|
346
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7
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%
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|
682
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|
663
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3
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%
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TEZSPIRE(1)
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342
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|
234
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46
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%
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|
627
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|
|
407
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54
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%
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KRYSTEXXA
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349
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|
|
294
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|
19
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%
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|
585
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|
|
529
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|
|
11
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%
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Vectibix
|
305
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|
|
270
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13
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%
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|
572
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|
|
517
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11
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%
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Other products(2)
|
1,690
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|
|
1,326
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|
27
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%
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3,337
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|
|
2,699
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24
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%
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Total product sales
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$
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8,771
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|
|
$
|
8,041
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9
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%
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$
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16,644
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|
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$
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15,159
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10
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%
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____________
(1) TEZSPIRE is marketed by our collaborator AstraZeneca outside the United States.
(2) Consists of product sales of our non-principal products.
Future sales of our products will depend in part on the factors discussed below and in the following sections of this report: (i) Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations-Overview, and Selected financial information; and (ii) Part II, Item 1A. Risk Factors, and in the following sections of our Annual Report on Form 10-K for the year ended December 31, 2024: (i) Part I, Item 1. 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 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.
Prolia
Total Prolia sales by geographic region were as follows (dollar amounts in millions):
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Three months ended
June 30,
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Six months ended
June 30,
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2025
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2024
|
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Change
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2025
|
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2024
|
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Change
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Prolia - U.S.
|
$
|
745
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|
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$
|
770
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(3)
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%
|
|
$
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1,465
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|
|
$
|
1,427
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|
|
3
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%
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|
Prolia - ROW
|
377
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|
|
395
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(5)
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%
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|
756
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|
|
737
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|
|
3
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%
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Total Prolia
|
$
|
1,122
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|
|
$
|
1,165
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(4)
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%
|
|
$
|
2,221
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|
|
$
|
2,164
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|
|
3
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%
|
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 in the second half of the year, as biosimilars have now launched in the U.S. market.
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 our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.
Repatha
Total Repatha sales by geographic region were as follows (dollar amounts in millions):
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Three months ended
June 30,
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Six months ended
June 30,
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2025
|
|
2024
|
|
Change
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|
2025
|
|
2024
|
|
Change
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Repatha - U.S.
|
$
|
361
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|
|
$
|
270
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|
|
34
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%
|
|
$
|
704
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|
|
$
|
543
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|
|
30
|
%
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Repatha - ROW
|
335
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|
|
262
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|
|
28
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%
|
|
648
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|
|
506
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|
|
28
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%
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|
Total Repatha
|
$
|
696
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|
|
$
|
532
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|
31
|
%
|
|
$
|
1,352
|
|
|
$
|
1,049
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|
|
29
|
%
|
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 our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.
ENBREL
Total ENBREL sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
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%.
XGEVA
Total XGEVA sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
XGEVA - U.S.
|
$
|
347
|
|
|
$
|
399
|
|
|
(13)
|
%
|
|
$
|
707
|
|
|
$
|
765
|
|
|
(8)
|
%
|
|
XGEVA - ROW
|
185
|
|
|
163
|
|
|
13
|
%
|
|
391
|
|
|
358
|
|
|
9
|
%
|
|
Total XGEVA
|
$
|
532
|
|
|
$
|
562
|
|
|
(5)
|
%
|
|
$
|
1,098
|
|
|
$
|
1,123
|
|
|
(2)
|
%
|
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. 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 in the second half of the year, as biosimilars have now launched in the U.S. market.
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 our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.
Otezla
Total Otezla sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
Otezla - U.S.
|
$
|
512
|
|
|
$
|
432
|
|
|
19
|
%
|
|
$
|
855
|
|
|
$
|
725
|
|
|
18
|
%
|
|
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.
EVENITY
Total EVENITY sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
EVENITY - U.S.
|
$
|
395
|
|
|
$
|
281
|
|
|
41
|
%
|
|
$
|
715
|
|
|
$
|
517
|
|
|
38
|
%
|
|
EVENITY - ROW
|
123
|
|
|
110
|
|
|
12
|
%
|
|
245
|
|
|
216
|
|
|
13
|
%
|
|
Total EVENITY
|
$
|
518
|
|
|
$
|
391
|
|
|
32
|
%
|
|
$
|
960
|
|
|
$
|
733
|
|
|
31
|
%
|
The increases in global EVENITY sales for the three and six months ended June 30, 2025 were primarily driven by volume growth.
TEPEZZA
Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
TEPEZZA - U.S.
|
$
|
466
|
|
|
$
|
478
|
|
|
(3)
|
%
|
|
$
|
831
|
|
|
$
|
897
|
|
|
(7)
|
%
|
|
TEPEZZA - ROW
|
39
|
|
|
1
|
|
|
*
|
|
55
|
|
|
6
|
|
|
*
|
|
Total TEPEZZA
|
$
|
505
|
|
|
$
|
479
|
|
|
5
|
%
|
|
$
|
886
|
|
|
$
|
903
|
|
|
(2)
|
%
|
* Change in excess of 100%
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.
BLINCYTO
Total BLINCYTO sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
BLINCYTO - U.S.
|
$
|
270
|
|
|
$
|
165
|
|
|
64
|
%
|
|
$
|
543
|
|
|
$
|
318
|
|
|
71
|
%
|
|
BLINCYTO - ROW
|
114
|
|
|
99
|
|
|
15
|
%
|
|
211
|
|
|
190
|
|
|
11
|
%
|
|
Total BLINCYTO
|
$
|
384
|
|
|
$
|
264
|
|
|
45
|
%
|
|
$
|
754
|
|
|
$
|
508
|
|
|
48
|
%
|
The increases in global BLINCYTO sales for the three and six months ended June 30, 2025 were driven by volume growth.
KYPROLIS
Total KYPROLIS sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
KYPROLIS - U.S.
|
$
|
232
|
|
|
$
|
240
|
|
|
(3)
|
%
|
|
$
|
448
|
|
|
$
|
474
|
|
|
(5)
|
%
|
|
KYPROLIS - ROW
|
146
|
|
|
137
|
|
|
7
|
%
|
|
254
|
|
|
279
|
|
|
(9)
|
%
|
|
Total KYPROLIS
|
$
|
378
|
|
|
$
|
377
|
|
|
0
|
%
|
|
$
|
702
|
|
|
$
|
753
|
|
|
(7)
|
%
|
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.
Aranesp
Total Aranesp sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
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.
Nplate
Total Nplate sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
Nplate - U.S.
|
$
|
228
|
|
|
$
|
214
|
|
|
7
|
%
|
|
$
|
429
|
|
|
$
|
404
|
|
|
6
|
%
|
|
Nplate - ROW
|
141
|
|
|
132
|
|
|
7
|
%
|
|
253
|
|
|
259
|
|
|
(2)
|
%
|
|
Total Nplate
|
$
|
369
|
|
|
$
|
346
|
|
|
7
|
%
|
|
$
|
682
|
|
|
$
|
663
|
|
|
3
|
%
|
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.
TEZSPIRE
Total TEZSPIRE sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
TEZSPIRE - U.S.
|
$
|
342
|
|
|
$
|
234
|
|
|
46
|
%
|
|
$
|
627
|
|
|
$
|
407
|
|
|
54
|
%
|
The increases in TEZSPIRE sales for the three and six months ended June 30, 2025 were driven by volume growth.
KRYSTEXXA
Total KRYSTEXXA sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
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%.
Vectibix
Total Vectibix sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
Vectibix - U.S.
|
$
|
144
|
|
|
$
|
133
|
|
|
8
|
%
|
|
$
|
279
|
|
|
$
|
253
|
|
|
10
|
%
|
|
Vectibix - ROW
|
161
|
|
|
137
|
|
|
18
|
%
|
|
293
|
|
|
264
|
|
|
11
|
%
|
|
Total Vectibix
|
$
|
305
|
|
|
$
|
270
|
|
|
13
|
%
|
|
$
|
572
|
|
|
$
|
517
|
|
|
11
|
%
|
The increases in global Vectibix sales for the three and six months ended June 30, 2025 were driven by volume growth.
Other products
Other product sales by geographic region were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
MVASI - U.S.
|
$
|
142
|
|
|
$
|
100
|
|
|
42
|
%
|
|
$
|
280
|
|
|
$
|
205
|
|
|
37
|
%
|
|
MVASI - ROW
|
49
|
|
|
57
|
|
|
(14)
|
%
|
|
90
|
|
|
154
|
|
|
(42)
|
%
|
|
AMJEVITA - U.S.(1)
|
-
|
|
|
(9)
|
|
|
(100)
|
%
|
|
4
|
|
|
21
|
|
|
(81)
|
%
|
|
AMGEVITA - ROW
|
133
|
|
|
142
|
|
|
(6)
|
%
|
|
265
|
|
|
280
|
|
|
(5)
|
%
|
|
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
|
%
|
|
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
|
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)
|
%
|
|
Other - U.S.(2)
|
235
|
|
|
269
|
|
|
(13)
|
%
|
|
456
|
|
|
571
|
|
|
(20)
|
%
|
|
Other - ROW(2)
|
50
|
|
|
56
|
|
|
(11)
|
%
|
|
105
|
|
|
106
|
|
|
(1)
|
%
|
|
Total other products
|
$
|
1,690
|
|
|
$
|
1,326
|
|
|
27
|
%
|
|
$
|
3,337
|
|
|
$
|
2,699
|
|
|
24
|
%
|
|
Total U.S. - other products
|
$
|
1,229
|
|
|
$
|
937
|
|
|
31
|
%
|
|
$
|
2,499
|
|
|
$
|
1,900
|
|
|
32
|
%
|
|
Total ROW - other products
|
461
|
|
|
389
|
|
|
19
|
%
|
|
838
|
|
|
799
|
|
|
5
|
%
|
|
Total other products
|
$
|
1,690
|
|
|
$
|
1,326
|
|
|
27
|
%
|
|
$
|
3,337
|
|
|
$
|
2,699
|
|
|
24
|
%
|
* Change in excess of 100%
N/A = not applicable
____________
(1) U.S. 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
Operating expenses were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
|
Six months ended
June 30,
|
|
|
|
|
2025
|
|
2024
|
|
Change
|
|
2025
|
|
2024
|
|
Change
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales
|
$
|
3,011
|
|
|
$
|
3,236
|
|
|
(7)
|
%
|
|
$
|
5,979
|
|
|
$
|
6,436
|
|
|
(7)
|
%
|
|
% of product sales
|
34.3
|
%
|
|
40.2
|
%
|
|
|
|
35.9
|
%
|
|
42.5
|
%
|
|
|
|
% of total revenues
|
32.8
|
%
|
|
38.6
|
%
|
|
|
|
34.5
|
%
|
|
40.6
|
%
|
|
|
|
Research and development
|
$
|
1,744
|
|
|
$
|
1,447
|
|
|
21
|
%
|
|
$
|
3,230
|
|
|
$
|
2,790
|
|
|
16
|
%
|
|
% of product sales
|
19.9
|
%
|
|
18.0
|
%
|
|
|
|
19.4
|
%
|
|
18.4
|
%
|
|
|
|
% of total revenues
|
19.0
|
%
|
|
17.3
|
%
|
|
|
|
18.6
|
%
|
|
17.6
|
%
|
|
|
|
Selling, general and administrative
|
$
|
1,691
|
|
|
$
|
1,785
|
|
|
(5)
|
%
|
|
$
|
3,378
|
|
|
$
|
3,593
|
|
|
(6)
|
%
|
|
% of product sales
|
19.3
|
%
|
|
22.2
|
%
|
|
|
|
20.3
|
%
|
|
23.7
|
%
|
|
|
|
% of total revenues
|
18.4
|
%
|
|
21.3
|
%
|
|
|
|
19.5
|
%
|
|
22.7
|
%
|
|
|
|
Other
|
$
|
77
|
|
|
$
|
11
|
|
|
*
|
|
$
|
907
|
|
|
$
|
116
|
|
|
*
|
|
Total operating expenses
|
$
|
6,523
|
|
|
$
|
6,479
|
|
|
1
|
%
|
|
$
|
13,494
|
|
|
$
|
12,935
|
|
|
4
|
%
|
* Change in excess of 100%
Cost of sales
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 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 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
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 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
Nonoperating expenses/income and income taxes were as follows (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
Six months ended
June 30,
|
|
|
2025
|
|
2024
|
|
2025
|
|
2024
|
|
Interest expense, net
|
$
|
(694)
|
|
|
$
|
(808)
|
|
|
$
|
(1,417)
|
|
|
$
|
(1,632)
|
|
|
Other (expense) income, net
|
$
|
(394)
|
|
|
$
|
(307)
|
|
|
$
|
1,124
|
|
|
$
|
(542)
|
|
|
Provision for income taxes
|
$
|
136
|
|
|
$
|
48
|
|
|
$
|
379
|
|
|
$
|
93
|
|
|
Effective tax rate
|
8.7
|
%
|
|
6.0
|
%
|
|
10.7
|
%
|
|
12.8
|
%
|
Interest expense, net
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.
Income taxes
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. 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. 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. territory of Puerto Rico. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2021, we filed a petition in the U.S. Tax Court to contest two duplicate Statutory Notices of Deficiency (Notices) for the years 2010-2012 that we received in May and July 2021, which seek to increase our U.S. taxable income for the years 2010-2012 by an amount that would result in additional federal tax of approximately $3.6 billion, plus interest. Any additional tax that could be imposed for the years 2010-2012 would be reduced by up to approximately $900 million of repatriation tax previously accrued on our foreign earnings.
In 2020, we received an RAR and a modified RAR from the IRS for the years 2013-2015, also proposing significant adjustments that primarily relate to the allocation of profits between certain of our entities in the United States and the U.S. territory of Puerto Rico similar to those proposed for the years 2010-2012. We disagreed with the proposed adjustments and calculations and pursued resolution with the IRS appeals office but were unable to reach resolution. In July 2022, we filed a petition in the U.S. Tax Court to contest a Notice for the years 2013-2015 that we previously reported receiving in April 2022 that seeks to increase our U.S. taxable income for the years 2013-2015 by an amount that would result in additional federal tax of approximately $5.1 billion, plus interest. In addition, the Notice asserts penalties of approximately $2.0 billion. Any additional tax that could be imposed for the years 2013-2015 would be reduced by up to approximately $2.2 billion of repatriation tax previously accrued on our foreign earnings.
We firmly believe that the IRS positions set forth in the 2010-2012 and 2013-2015 Notices are without merit. We are contesting the 2010-2012 and 2013-2015 Notices through the judicial process. The two cases were consolidated in the U.S. Tax Court on December 19, 2022. The trial began on November 4, 2024 and concluded on January 17, 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. 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 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.
Final resolution of these complex matters is not likely within the next 12 months. We continue to believe our accrual for income tax liabilities is appropriate based on past experience, interpretations of tax law, application of the tax law to our facts and judgments about potential actions by tax authorities; 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 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.
Financial condition, liquidity and capital resources
Selected financial data were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2025
|
|
December 31, 2024
|
|
Cash and cash equivalents
|
$
|
8,028
|
|
|
$
|
11,973
|
|
|
Total assets
|
$
|
87,897
|
|
|
$
|
91,839
|
|
|
Current portion of long-term debt
|
$
|
2,444
|
|
|
$
|
3,550
|
|
|
Long-term debt
|
$
|
53,760
|
|
|
$
|
56,549
|
|
|
Stockholders' equity
|
$
|
7,428
|
|
|
$
|
5,877
|
|
Cash and cash equivalents
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. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer.
Capital allocation
Consistent with the objective to optimize our capital structure, we deploy our accumulated cash balances in a strategic manner and consider a number of alternatives, including investments in innovation both internally and externally (including investments that expand our portfolio of products in areas of therapeutic interest), capital expenditures, repayment of debt, payment of dividends and stock repurchases.
We intend to continue investing in our business while reducing our debt and returning capital to stockholders through the payment of cash dividends and stock repurchases. This reflects our desire to optimize our cost of capital and our confidence in the future cash flows of our business. The timing and amount of future dividends and stock repurchases will vary based on a number of factors, including future capital requirements for strategic transactions, debt levels and debt service requirements, our credit rating, availability of financing on acceptable terms, changes to applicable tax laws or corporate laws, changes to our business model and periodic determination by our Board of Directors that cash dividends and/or stock repurchases are in the best interests of stockholders and are in compliance with applicable laws and the Company's agreements. In addition, the timing and amount of stock repurchases may also be affected by our overall level of cash, stock price and blackout periods, during which we are restricted from repurchasing stock. The manner of stock repurchases may include block purchases, tender offers, accelerated share repurchases and market transactions.
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 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 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. 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. Risk Factors-Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
Certain of our financing arrangements contain nonfinancial covenants. 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 June 30, 2025.
Cash flows
Our summarized cash flow activity was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended
June 30,
|
|
|
2025
|
|
2024
|
|
Net cash provided by operating activities
|
$
|
3,671
|
|
|
$
|
3,148
|
|
|
Net cash used in investing activities
|
$
|
(836)
|
|
|
$
|
(434)
|
|
|
Net cash used in financing activities
|
$
|
(6,780)
|
|
|
$
|
(4,357)
|
|
Operating
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 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.
Investing
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.
Financing
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.
Critical accounting policies and estimates
The preparation of our condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes to the financial statements. Some of those judgments can be subjective and complex, and therefore, actual results could differ materially from those estimates under different assumptions or conditions. A summary of our critical accounting policies and estimates is presented in Part II, Item 7. 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 six months ended June 30, 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.