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AMGEN INC

For the period ended Sep 30, 2025. Filed Nov 5, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 5, 2025

AMGN$460.42+0.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-06.

0000318154-25-000056

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-05.

0000318154-25-000072

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 160 previous paragraphs and 158 current paragraphs.

83 unchanged; 59 reworded; 12 added; 17 removed; 1 previous and 4 current paragraphs rearranged.

Tables are not compared: 22 previous and 22 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (12)

Current report

In August 2025, we announced that the FDA broadened the approved use of Repatha to include adults at increased risk for major adverse cardiovascular events (MACE) due to uncontrolled low-density lipoprotein cholesterol (LDL-C). The update removes a prior requirement for a patient to have been diagnosed with cardiovascular (CV) disease.

Current report

In October 2025, we announced that the Phase 3 VESALIUS-CV trial met its dual primary endpoints demonstrating that Repatha significantly reduced the risk of MACE in individuals without a prior history of heart attack or stroke. No new safety signals were observed.

Current report

In October 2025, we announced that the FDA approved TEZSPIRE for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.

Current report

In November 2025, we announced that FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab in patients with first-line gastric cancer, was stopped.

Current report

Other revenues increased 19% and 7% for the three and nine months ended September 30, 2025, respectively, primarily driven by higher royalty income.

Current report

The increase in global Otezla sales for the three months ended September 30, 2025 was primarily driven by volume growth of 6% and favorable changes to estimated sales deductions of 5%, partially offset by lower net selling price of 5%.

Current report

Global XGEVA sales remained relatively unchanged for the three months ended September 30, 2025, as favorable changes to estimated sales deductions of 6% were offset by lower volume of 3% and lower inventory.

Current report

Global Nplate sales for the nine months ended September 30, 2025 increased 2% and included U.S. government orders of $90 million and $128 million for the nine months ended September 30, 2025 and 2024, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 6% for the nine months ended September 30, 2025, primarily driven by volume growth.

Current report

The increase in TEZSPIRE sales for the three months ended September 30, 2025 was driven by volume growth of 48%, partially offset by lower net selling price.
Removed paragraphs (17)

Previous report

In June 2025, the underlying details from Part 1 of the Phase 2 study of MariTide and complete results from the primary analysis of the Phase 1 pharmacokinetics low dose initiation (PK-LDI) study evaluating lower starting doses of MariTide were presented at the American Diabetes Association 85 th Scientific Sessions and simultaneously published in The New England Journal of Medicine. These data are consistent with the topline results from Part 1 of the Phase 2 study as previously announced and presented by the Company in November 2024. See Part I, Item 1. Business—Significant Developments, of our Annual Report on Form 10-K for the year ended December 31, 2024.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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

Previous report

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.

Previous report

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.

Previous report

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.

Previous report

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

Previous report

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

Previous report

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.
Reworded paragraphs (59)

Previous wording

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.

Current wording

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 Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 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.

Previous wording

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.

Current wording

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 Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 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.

Previous wording

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.

Current wording

Our principal products are Prolia, Repatha, ENBREL, Otezla, XGEVA, EVENITY, TEPEZZA, BLINCYTO, Nplate, KYPROLIS, Aranesp, TEZSPIRE, KRYSTEXXA and Vectibix. We also market a number of other products, including but not limited to MVASI, PAVBLU, AMJEVITA/AMGEVITA, UPLIZNA, IMDELLTRA/IMDYLLTRA, TAVNEOS, RAVICTI, Neulasta, LUMAKRAS/LUMYKRAS, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI.

Previous wording

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.

Current wording

Numerous tariffs and trade protection measures have been proposed, and in a number of cases, implemented by the United States and other countries. These tariffs and trade protection measures include the universal 10% tariff on goods imported into the United States, the July Tariff EOs imposing additional country-specific tariffs for more than 60 countries, the trade framework with the EU effective September 2025 that imposes a baseline 15% tariff on most goods from the EU, bilateral trade deals with certain other countries such as Vietnam, Japan and the United Kingdom for special tariff rates, China’s country-specific tariff that is expected to become effective on November 10, 2025, and retaliatory tariffs on U.S. goods. These tariffs and trade protection measures may adversely affect our business and results of operations. Further, there are a number of proposed and potential sector-specific tariffs on our industry that are in development. See Part II, Item 1A. Risk Factors—Global economic conditions may negatively affect us and may magnify certain risks that affect our business, of this Quarterly Report on Form 10-Q for further discussion. While existing tariffs have not had a material adverse effect on our results of operations for the nine months ended September 30, 2025, certain tariffs that are currently in effect, or anticipated to take effect in the future, 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. Furthermore, such tariffs may increasingly affect the cost to expand our manufacturing capacity in the United

Previous wording

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.

Current wording

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, retaliatory or sector-specific 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.

Previous wording

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.

Current wording

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 focus on drug pricing, including the Most-Favored-Nations Prescription Drug Pricing Executive Order (MFN EO) that is aimed at using price benchmarks from other developed countries to set U.S. pricing targets, and the July MFN Letter that was delivered to many pharmaceutical companies, including Amgen, and called for drug manufacturers to: 1) extend MFN pricing to Medicaid; 2) guarantee MFN pricing to Medicaid, Medicare and commercial payers on all newly launched drugs; 3) use future increased revenues from outside the United States to reduce U.S. drug prices; and 4) participate in direct-to-consumer models to provide MFN pricing for certain drugs. The details of these drug pricing actions and how they might be operationalized are unclear, but if put into place they could reasonably be expected to adversely affect our business. See Part II, Item 1A. Risk Factors—Changing U.S. federal coverage and reimbursement policies and practices have affected, and are likely to continue to affect, access to, pricing of, and sales of our products, of this Quarterly Report on Form 10-Q for further discussion.

Previous wording

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.

Current wording

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 June 30, 2025. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025.

Previous wording

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.

Current wording

Total product sales increased 12% and 11% for the three and nine months ended September 30, 2025, respectively, driven by volume growth of 14% for both periods, partially offset by declines in net selling price of 4% and 3%, respectively.

Previous wording

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.

Current wording

For the three months ended September 30, 2025, U.S. volume grew 13% and ROW volume grew 16%, driven by volume growth in certain brands, including PAVBLU, Repatha, EVENITY, IMDELLTRA/IMDYLLTRA, TEZSPIRE and BLINCYTO.

Previous wording

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.

Current wording

For the nine months ended September 30, 2025, U.S. and ROW volumes grew 14% each, driven by volume growth in certain brands, including Repatha, PAVBLU, EVENITY, TEZSPIRE, IMDELLTRA/IMDYLLTRA and BLINCYTO.

Previous wording

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.

Current wording

Operating expenses increased 9% and 6% for the three and nine months ended September 30, 2025, respectively, driven by investments in Later-Stage Clinical Programs and Otezla intangible asset impairment charges, 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 charges.

Previous wording

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.

Current wording

Uncertain macroeconomic conditions, including uncertainty around tariffs and trade protection measures, ongoing geopolitical conflicts and rising geopolitical tensions, changes in the healthcare ecosystem, and potential government policy actions, including MFN pricing or similar drug pricing reforms, 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, June 30, 2025 and September 30, 2025.

Previous wording

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.

Current wording

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 Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 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.

Previous wording

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.

Current wording

The increase in global Prolia sales for the three months ended September 30, 2025 was primarily driven by favorable changes to estimated sales deductions of 14%, partially offset by lower net selling price.

Previous wording

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.

Current wording

The increase in global Prolia sales for the nine months ended September 30, 2025 was driven by volume growth.

Previous wording

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.

Current wording

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.

Previous wording

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.

Current wording

The increases in global Repatha sales for the three and nine months ended September 30, 2025 were primarily driven by volume growth.

Previous wording

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%.

Current wording

The decrease in ENBREL sales for the three months ended September 30, 2025 was primarily driven by lower net selling price of 38% resulting from the impact of the U.S. Medicare Part D redesign and increased 340B Program mix, partially offset by favorable changes to estimated sales deductions and volume growth.

Previous wording

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%.

Current wording

The decrease in ENBREL sales for the nine months ended September 30, 2025 was driven by lower net selling price of 30% resulting from increased 340B Program mix, the impact of the U.S. Medicare Part D redesign and higher commercial discounts, partially offset by volume growth.

Previous wording

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.

Current wording

The increase in global Otezla sales for the nine months ended September 30, 2025 was driven by volume growth of 5%, favorable changes to estimated sales deductions of 3% and higher net selling price of 2%.

Previous wording

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.

Current wording

In January 2025, Otezla was selected by CMS for Medicare price setting that will be applicable beginning in 2027. As a result, we expect further declines in net selling price driven by Medicare price setting 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 charges.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

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.

Previous wording

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

Current wording

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

Previous wording

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

Current wording

The increase in global TEPEZZA sales for the three months ended September 30, 2025 was driven by higher inventory and higher net selling price.

Previous wording

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.

Current wording

The increase in global TEPEZZA sales for the nine months ended September 30, 2025 was driven by higher net selling price of 5% and higher inventory of 2%, partially offset by lower volume.

Previous wording

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

Current wording

The increase in global BLINCYTO sales for the nine months ended September 30, 2025 was primarily driven by volume growth.

Previous wording

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

Current wording

Global Nplate sales for the three months ended September 30, 2025 remained relatively unchanged and included U.S. government orders of $90 million and $128 million for the three months ended September 30, 2025 and 2024, respectively. Excluding the U.S. government orders from this comparison, global Nplate sales increased 12% for the three months ended September 30, 2025, driven by volume growth.

Previous wording

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

Current wording

The decreases in global KYPROLIS sales for the three and nine months ended September 30, 2025 were driven by lower volume due to increased competition.

Previous wording

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.

Current wording

The increases in global Aranesp sales for the three and nine months ended September 30, 2025 were driven by volume growth of 10% and 5%, respectively, partially offset by unfavorable changes to foreign currency exchange rates of 2% for each period and lower net selling price.

Previous wording

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

Current wording

The increase in TEZSPIRE sales for the nine months ended September 30, 2025 was primarily driven by volume growth.

Previous wording

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.

Current wording

The increase in KRYSTEXXA sales for the three months ended September 30, 2025 was driven by volume growth of 9% and higher net selling price of 3%, partially offset by lower inventory of 10%.

Previous wording

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%.

Current wording

The increase in KRYSTEXXA sales for the nine months ended September 30, 2025 was driven by volume growth.

Previous wording

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

Current wording

Global Vectibix sales remained relatively unchanged for the three months ended September 30, 2025.

Previous wording

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

Current wording

The increase in global Vectibix sales for the nine months ended September 30, 2025 was driven by volume growth.

Previous wording

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

Current wording

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

Previous wording

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.

Current wording

Cost of sales decreased to 32.2% and 33.7% of total revenues for the three and nine months ended September 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.

Previous wording

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.

Current wording

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

Previous wording

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.

Current wording

The increase in SG&A expense for the three months ended September 30, 2025, was driven by higher general and administrative expenses, partially offset by lower Horizon acquisition-related expenses.

Previous wording

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.

Current wording

The decrease in SG&A expense for the nine months ended September 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.

Showing the first 40 of 59 pairs. Open the source sections for the rest.

Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

States, including increased construction costs and/or delays in construction for our Ohio and North Carolina facilities. Additionally, 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 application and rates of such tariffs, as well as 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.

Current report — wording carried from elsewhere

For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market.

Current report — wording carried from elsewhere

For the remainder of 2025, we expect sales erosion driven by biosimilar competition, as biosimilars have launched in the U.S. market.

Current report — wording carried from elsewhere

The increase in global BLINCYTO sales for the three months ended September 30, 2025 was driven by volume growth of 31%, partially offset by lower inventory.
Rearranged previous paragraphs (1)

Previous report — wording carried elsewhere

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