Amgen Inc.
Loading chart...
| Item 1. | BUSINESS |
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 45 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. We have a presence in approximately 100 countries worldwide.
Amgen was incorporated in California in 1980 and became a Delaware corporation in 1987. Amgen operates in one operating segment: human therapeutics.
Significant Developments
Following is a summary of significant developments affecting our business that have occurred and that we have reported since the filing of our Annual Report on Form 10-K for the year ended December 31, 2024.
Products/Pipeline
Repatha
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), removing the previous requirement that a patient have been diagnosed with cardiovascular (CV) disease.
In November 2025, we announced detailed results from the Phase 3 VESALIUS-CV clinical trial, which showed that Repatha achieved statistically significant and clinically meaningful reductions in MACEs in high-risk adults without a prior heart attack or stroke, when added to statins or other LDL-C–lowering treatments. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a cohort of patients included in a lipid sub-study, the median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm. No new safety signals were identified, and tolerability was consistent with the current prescribing information in the United States.
UPLIZNA
In April 2025, we announced the FDA approved UPLIZNA for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients. UPLIZNA is the first and only FDA approved treatment for adults living with IgG4-RD.
In December 2025, we announced the FDA approved UPLIZNA for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.
IMDELLTRA/IMDYLLTRA
In June 2025, we 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.
In November 2025, we announced that the FDA granted full approval for IMDELLTRA for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy, converting its prior accelerated approval to full approval based on results from the global Phase 3 DeLLphi-304 study.
TEZSPIRE
In October 2025, we announced that the FDA approved TEZSPIRE as an add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older.
1
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).
Maridebart cafraglutide (MariTide™)
In March 2025, we announced the initiation of two global Phase 3 studies to evaluate MariTide, a differentiated antibody-peptide conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes the glucose-dependent insulinotropic polypeptide receptor (GIPR), in chronic weight management: one study in adults living with obesity or overweight without Type 2 diabetes and another study in adults living with obesity or overweight with Type 2 diabetes.
In 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 85th Scientific Sessions and simultaneously published in The New England Journal of Medicine.
In November 2025, we announced that, in addition to the two global Phase 3 studies announced in March 2025, four global Phase 3 studies were underway, with studies in adults living with established atherosclerotic cardiovascular disease and obesity or overweight; in adults living with heart failure with preserved or mildly reduced ejection fraction and obesity; in adults living with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight; and in adults living with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight.
In January 2026, we announced that Part 2 of the Phase 2 chronic weight management study, an exploratory evaluation of MariTide treatment for an additional 52 weeks in people who lost at least 15% of their body weight in the 52-week Part 1 of the Phase 2 chronic weight management study, is complete. Key findings included the following: the large majority of participants maintained the weight loss achieved in Part 1 for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide; the second year of MariTide treatment was very well tolerated, including at quarterly doses, with a very low incidence of nausea and vomiting and no new safety signals observed; and improvements in cardiometabolic parameters were sustained with MariTide at effective maintenance doses for a full second year.
In January 2026 we also announced that a Phase 2 study of MariTide for the treatment of Type 2 diabetes in adults living with and without obesity has completed the 24-week timepoint. Key findings included the following: robust and clinically meaningful reduction in both hemoglobin A1c (HbA1c) and weight with monthly MariTide at 24 weeks, which is in line with results seen in the Type 2 diabetes population in Part 1 of the Phase 2 chronic weight management study, at 24 weeks; safety and tolerability profile consistent with the GLP-1 class, where the most common side effects were gastrointestinal-related, predominantly mild-to-moderate in nature, and occurred primarily during dose escalation; and favorable improvement in cardiometabolic parameters.
TAVNEOS
TAVNEOS was approved by the FDA in October 2021 for the adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in combination with standard therapy including glucocorticoids. TAVNEOS was developed by ChemoCentryx. Amgen acquired ChemoCentryx in October 2022, after TAVNEOS had been on the market for a year. On January 16, 2026, the FDA requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market. The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial. Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine. Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial, and after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On January 28, 2026, following FDA regulatory process, Amgen informed the FDA that it did not intend to withdraw TAVNEOS from the market. Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront.
Bemarituzumab
In February 2026, we announced that, based upon data from the FORTITUDE-101 and FORTITUDE-102 Phase 3 studies, the Company does not intend to pursue regulatory approval of bemarituzumab in first-line gastric cancer.
Rocatinlimab
In January 2026, we and Kyowa Kirin agreed to terminate the rocatinlimab collaboration agreement and to transition control of the global development and commercialization program to Kyowa Kirin, subject to receipt of clearance under the
2
Hart-Scott-Rodino Antitrust Improvements Act of 1976. In February 2026, we received such regulatory clearance. In the first quarter of 2026, Kyowa Kirin will assume full responsibility for rocatinlimab worldwide, except that Amgen will continue to manufacture rocatinlimab and perform other transition activities for an agreed upon period of time.
Marketing, Distribution and Selected Marketed Products
The largest concentration of our sales and marketing forces is based in the United States and Europe. We also commercialize and market our products into other geographic territories, including Japan, China and other parts of Asia, Latin America and the Middle East by using our own affiliates, by acquiring existing third-party businesses or product rights or by collaborating with third parties. In the Asia Pacific region, we also sell our products in partnership with other companies, including Astellas Pharma Inc., BeOne, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd. and Kyowa Kirin. This international footprint allows us to deliver our medicines to more patients globally. See Business Relationships for our significant alliances. Whether we use our own sales and marketing forces or a third party’s services varies across these markets. Such use typically depends on several factors, including the nature of entry into the new market, the size of an opportunity and operational capabilities. Together with our collaborators, we market our products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals and pharmacies.
In the United States, substantially all of our sales are to pharmaceutical wholesale distributors, which is the principal means of distributing our products to healthcare providers. We market certain products through direct-to-patient channels, including print, television and online media. For further discussion, see Government Regulation—Regulation in the United States—Regulation of Product Marketing and Promotion. Outside the United States, we sell principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country.
Our product sales to three large wholesalers, McKesson Corporation, Cencora, Inc. and Cardinal Health, Inc., each individually accounted for more than 10% of total revenues for each of the years 2025, 2024 and 2023. On a combined basis, these wholesalers accounted for 77%, 77% and 79% of worldwide gross revenues for 2025, 2024 and 2023, respectively. We monitor the financial condition of our larger customers and limit our credit exposure by setting credit limits and, in certain circumstances, by requiring letters of credit or obtaining credit insurance.
3
Our products are marketed around the world, with the United States as our largest market. The following chart shows our product sales by principal product, and the table below (dollar amounts in millions) shows product sales by geography for the years 2025, 2024 and 2023.
| 2025 | 2024 | 2023 | ||||||||||||||||||||||
| Product Sales by Geography: | ||||||||||||||||||||||||
| U.S. | $ | 25,656 | 73 | % | $ | 23,301 | 73 | % | $ | 19,272 | 72 | % | ||||||||||||
| ROW | ||||||||||||||||||||||||
Loading financial statements...
Financial statements
data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .
| Line item |
|---|
| Period ending |
| Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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, the consolidated financial statements and accompanying notes of our Annual Report on Form 10-K for the year ended December 31, 2025, and the condensed consolidated financial statements and accompanying notes of this Quarterly Report on Form 10-Q and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026. 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, 2025, and in Part II, Item 1A. Risk Factors of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026. 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 45 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 Repatha, Prolia, EVENITY, TEPEZZA, ENBREL, Otezla, BLINCYTO, TEZSPIRE, Nplate, KRYSTEXXA, XGEVA, UPLIZNA, Aranesp, KYPROLIS, Vectibix and IMDELLTRA/IMDYLLTRA. We also market a number of other products, including but not limited to PAVBLU, Neulasta, AMJEVITA/AMGEVITA, MVASI, TAVNEOS, LUMAKRAS/LUMYKRAS, Parsabiv, Aimovig, PROCYSBI and WEZLANA/WEZENLA.
Macroeconomic and other challenges
Uncertain macroeconomic conditions, including the risk of inflation, fluctuating interest rates and financial system instability, together with rising healthcare costs, evolving tariffs and trade protection measures, and geopolitical conflict continue to pose challenges to our business. The geopolitical conflict has increased volatility in the energy and transportation markets and disrupted global supply chains. 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 expanded utilization of the 340B Program from broadened application of 340B discounts, have negatively affected, and are likely to continue to negatively affect, our business. For example, CMS has selected ENBREL and Otezla 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-Nation Prescription Drug Pricing Executive Order (MFN EO) and the July MFN Letter that was delivered to a number of pharmaceutical companies, including Amgen. In December 2025, we announced that we are taking actions that satisfy the components outlined in the July MFN
31
Letter, including the Administration’s MFN pricing requests. We also announced the expansion of our direct-to-patient program. As part of the Administration’s MFN pricing initiative, CMS also announced the GENEROUS Model, under which we and other participating manufacturers will provide additional supplemental rebates for certain drugs to participating state Medicaid programs designed to align Medicaid net prices with prices paid in select other countries for drugs covered under the model. In September 2026, CMS announced that all 50 states, the District of Columbia and the U.S. territory of Puerto Rico had applied to participate in the GENEROUS Model. While these developments reflect ongoing engagement on pricing policy, the ultimate effects on our pricing, reimbursement, net sales and profitability remain uncertain in light of such evolving regulatory and policy expectations. 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.
Numerous tariffs and trade protection measures have been proposed, and in a number of cases, implemented by the United States and other countries. Further, there have been previous proposals for sector-specific tariffs on our industry. In April 2026, the Administration issued a proclamation imposing Section 232 tariffs on certain patented pharmaceuticals and associated active pharmaceutical ingredients. However, in December 2025, in recognition of our capital investments in U.S. manufacturing, we received relief from Section 232 tariffs for approximately the next three years from that date. Given the many uncertainties and variables, tariffs and trade protection measures may adversely affect our business and results of operations.
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 June 30, 2026. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026.
Products/pipeline
TEZSPIRE
In August 2026, we and our collaboration partner AstraZeneca announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing). The safety profile of TEZSPIRE was generally consistent with its approved indications. Additionally, detailed results were presented in October 2026 at international medical congresses.
Repatha
In August 2026, the European Commission approved an expanded indication for the use of Repatha in adults with established or at high risk for atherosclerotic cardiovascular disease (ASCVD) to reduce cardiovascular (CV) risk by lowering low-density lipoprotein cholesterol (LDL-C) levels, as an adjunct to correction of other risk factors, based on results from the Phase 3 VESALIUS-CV trial.
IMDELLTRA/IMDYLLTRA
In September 2026, we announced results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis, demonstrating a statistically significant and clinically meaningful improvement in overall survival with IMDELLTRA/IMDYLLTRA in combination with AstraZeneca’s IMFINZI® (durvalumab) compared to IMFINZI alone. This study tested IMDELLTRA/IMDYLLTRA as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC) whose disease had not progressed following initial treatment with IMFINZI, platinum-based chemotherapy and etoposide. The study also demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) and objective response rate (ORR) among patients treated with IMDELLTRA/IMDYLLTRA in combination with IMFINZI. Overall, the safety profile of IMDELLTRA/IMDYLLTRA in combination with IMFINZI was consistent with the known safety profiles of the individual medicines. No new or unexpected safety signals were identified in DeLLphi-305. Additionally, detailed results were presented in October 2026 at an international medical congress.
32
Dazodalibep
In September 2026, we announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjögren’s disease and moderate-to-severe systemic disease activity. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at week 48, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI). Improvements in ESSDAI were observed as early as week 4 with treatment with dazodalibep, which were sustained through week 48 of the study. The most common adverse events (>/= 5% incidence, reported at a higher rate in dazodalibep compared with placebo) were nasopharyngitis, urinary tract infection, hypertension and infusion-related reactions, and were generally mild to moderate in nature. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups. No imbalance in the incidence of thromboembolic events or opportunistic infections was observed across treatment arms. Additionally, in October 2026 we released further detail of these results.
ABP 206
In September 2026, we announced submission of our Biologics License Application and its acceptance for review by the FDA for ABP 206, our biosimilar candidate to OPDIVO® (nivolumab).
ABP 234
In September 2026, we announced completion of the primary analysis of a pharmacokinetic/comparative clinical study of ABP 234, our biosimilar candidate to KEYTRUDA® (pembrolizumab), which met both primary and secondary endpoints.
Selected financial information
The following is an overview of our results of operations (in millions, except percentages and per-share data):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| Product sales | ||||||||||||||||||||||||||||||||
| U.S. | $ | 7,259 | $ | 6,751 | 8 | % | $ | 20,022 | $ | 18,737 | 7 | % | ||||||||||||||||||||
| ROW | 2,624 | 2,386 | 10 | % | 7,616 | 7,044 | 8 | % | ||||||||||||||||||||||||
| Total product sales | 9,883 | 9,137 | 8 | % | 27,638 | 25,781 | 7 | % | ||||||||||||||||||||||||
| Other revenues | 482 | 420 | 15 | % | 1,399 | 1,104 | 27 | % | ||||||||||||||||||||||||
| Total revenues | $ | 10,365 | $ | 9,557 | 8 | % | $ | 29,037 | $ | 26,885 | 8 | % | ||||||||||||||||||||
| Operating expenses | $ | 6,655 | $ | 7,031 | (5) | % | $ | 19,147 | $ | 20,525 | (7) | % | ||||||||||||||||||||
| Operating income | $ | 3,710 | $ | 2,526 | 47 | % | $ | 9,890 | $ | 6,360 | 56 | % | ||||||||||||||||||||
| Net income | $ | 3,864 | $ | 3,216 | 20 | % | $ | 8,058 | $ | 6,378 | 26 | % | ||||||||||||||||||||
| Diluted EPS | $ | 7.08 | $ | 5.93 | 19 | % | $ | 14.79 | $ | 11.77 | 26 | % | ||||||||||||||||||||
| Diluted shares | 546 | 542 | 1 | % | 545 | 542 | 1 | % | ||||||||||||||||||||||||
In the following discussion of changes in product sales, any reference to volume 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, in certain circumstances, end users (such as pharmacies) as may be noted.
Total product sales increased 8% for the three months ended September 30, 2026, driven by volume growth. Total product sales increased 7% for the nine months ended September 30, 2026, driven by volume growth of 10%, partially offset by lower net selling price.
For the three months ended September 30, 2026, U.S. volume grew 8% and ROW volume grew 16%, driven by certain brands, including Repatha, UPLIZNA, EVENITY, IMDELLTRA/IMDYLLTRA, TEZSPIRE and PAVBLU.
For the nine months ended September 30, 2026, U.S. volume grew 8% and ROW volume grew 12%, driven by certain brands, including Repatha, UPLIZNA, EVENITY, IMDELLTRA/IMDYLLTRA, PAVBLU and TEZSPIRE.
Other revenues increased 15% and 27% for the three and nine months ended September 30, 2026, respectively, driven by higher royalty income and corporate partner revenue.
33
Operating expenses decreased 5% and 7% for the three and nine months ended September 30, 2026, respectively, reflecting lower amortization expense from acquisition-related assets and the impact of the Otezla intangible asset impairment charges recorded in 2025, partially offset by higher spend in Research and Early Pipeline, higher profit share expense and changes in our sales mix. 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 recorded in 2025.
For the remainder of 2026, we expect volume growth from certain brands to be partially offset by net selling price declines.
Uncertain macroeconomic conditions, including geopolitical conflict and rising geopolitical tensions, changes in the healthcare ecosystem, and potential government policy actions, including MFN pricing or similar drug pricing reforms and tariffs or trade protection measures, 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; expanded utilization of the 340B Program from broadened application of 340B discounts; reductions in federal Medicaid spending; and an increase in the number of people without health insurance. 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, 2025; and Part II, Item 1A. Risk Factors, of our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
Results of operations
Product sales
Worldwide product sales were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| Repatha | $ | 1,085 | $ | 794 | 37 | % | $ | 2,914 | $ | 2,146 | 36 | % | ||||||||||||||||||||
| Prolia | 632 | 1,139 | (45) | % | 2,118 | 3,360 | (37) | % | ||||||||||||||||||||||||
| EVENITY | 751 | 541 | 39 | % | 2,027 | 1,501 | 35 | % | ||||||||||||||||||||||||
| TEPEZZA | 526 | 560 | (6) | % | 1,592 | 1,446 | 10 | % | ||||||||||||||||||||||||
| ENBREL | 611 | 580 | 5 | % | 1,511 | 1,694 | (11) | % | ||||||||||||||||||||||||
| Otezla | 481 | 585 | (18) | % | 1,403 | 1,640 | (14) | % | ||||||||||||||||||||||||
| BLINCYTO | 496 | 392 | 27 | % | 1,383 | 1,146 | 21 | % | ||||||||||||||||||||||||
TEZSPIRE(1) | 538 | 377 | 43 | % | 1,367 | 1,004 | 36 | % | ||||||||||||||||||||||||
| Nplate | 472 | 457 | 3 | % | 1,314 | 1,139 | 15 | % | ||||||||||||||||||||||||
| KRYSTEXXA | 419 | 320 | 31 | % | 1,074 | 905 | 19 | % | ||||||||||||||||||||||||
| XGEVA | 288 | 539 | (47) | % | 1,051 | 1,637 | (36) | % | ||||||||||||||||||||||||
| UPLIZNA | 451 | 155 | * | 1,048 | 422 | * | ||||||||||||||||||||||||||
| Aranesp | 329 | 357 | (8) | % | 992 | 1,056 | (6) | % | ||||||||||||||||||||||||
| KYPROLIS | 330 | 359 | (8) | % | 974 | 1,061 | (8) | % | ||||||||||||||||||||||||
| Vectibix | 335 | 284 | 18 | % | 960 | 856 | 12 | % | ||||||||||||||||||||||||
| IMDELLTRA/IMDYLLTRA | 406 | 178 | * | 952 | 393 | * | ||||||||||||||||||||||||||
Other products(2) | 1,733 | 1,520 | 14 | % | 4,958 | 4,375 | 13 | % | ||||||||||||||||||||||||
| Total product sales | $ | 9,883 | $ | 9,137 | 8 | % | $ | 27,638 | $ | 25,781 | 7 | % | ||||||||||||||||||||
* Change in excess of 100%
____________
(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, 2025: (i) Part I, Item 1. Business—Marketing, Distribution and Selected Marketed
34
Products; (ii) Part I, Item 1. Business—Reimbursement; (iii) Part I, Item 1A. Risk Factors; and (iv) Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Overview, and Results of operations—Product sales, as well as in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026: (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.
Repatha
Total Repatha sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| Repatha — U.S. | $ | 666 | $ | 442 | 51 | % | $ | 1,641 | $ | 1,146 | 43 | % | ||||||||||||||||||||
| Repatha — ROW | 419 | 352 | 19 | % | 1,273 | 1,000 | 27 | % | ||||||||||||||||||||||||
| Total Repatha | $ | 1,085 | $ | 794 | 37 | % | $ | 2,914 | $ | 2,146 | 36 | % | ||||||||||||||||||||
The increases in global Repatha sales for the three and nine months ended September 30, 2026 were primarily driven by volume growth.
For a discussion of litigation, including associated settlements, 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, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.
Prolia
Total Prolia sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| Prolia — U.S. | $ | 409 | $ | 806 | (49) | % | $ | 1,348 | $ | 2,271 | (41) | % | ||||||||||||||||||||
| Prolia — ROW | 223 | 333 | (33) | % | 770 | 1,089 | (29) | % | ||||||||||||||||||||||||
| Total Prolia | $ | 632 | $ | 1,139 | (45) | % | $ | 2,118 | $ | 3,360 | (37) | % | ||||||||||||||||||||
Global Prolia sales for the three and nine months ended September 30, 2026 decreased 45% and 37%, respectively, as multiple biosimilars have launched in the United States and ROW.
The decrease in global Prolia sales for the three months ended September 30, 2026 was driven by lower volume of 23%, with the remainder driven equally by lower net selling price and changes to estimated sales deductions.
The decrease in global Prolia sales for the nine months ended September 30, 2026 was primarily driven by lower volume of 20% and lower net selling price of 13%.
For the remainder of 2026, we expect continued sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW.
As disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products, our patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select countries in Europe.
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, 2025; and Note 13, Contingencies and commitments, to the condensed consolidated financial statements in our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2026, June 30, 2026 and September 30, 2026.
35
EVENITY
Total EVENITY sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| EVENITY — U.S. | $ | 557 | $ | 417 | 34 | % | $ | 1,538 | $ | 1,132 | 36 | % | ||||||||||||||||||||
| EVENITY — ROW | 194 | 124 | 56 | % | 489 | 369 | 33 | % | ||||||||||||||||||||||||
| Total EVENITY | $ | 751 | $ | 541 | 39 | % | $ | 2,027 | $ | 1,501 | 35 | % | ||||||||||||||||||||
The increases in global EVENITY sales for the three and nine months ended September 30, 2026 were driven by volume growth.
TEPEZZA
Total TEPEZZA sales by geographic region were as follows (dollar amounts in millions):
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | Change | 2026 | 2025 | Change | |||||||||||||||||||||||||||
| TEPEZZA — U.S. | $ | 441 | $ | 518 | (15) | % | $ | 1,385 | $ | 1,349 | 3 | % | ||||||||||||||||||||
| TEPEZZA — ROW | 85 | 42 | * | 207 | 97 | * | ||||||||||||||||||||||||||
| Total TEPEZZA | $ | 526 | $ | 560 | (6) | % | $ | 1,592 | $ | 1,446 | 10 | % | ||||||||||||||||||||
* Change in excess of 100%
The decrease in global TEPEZZA sales for the three months ended September 30, 2026 was driven by lower inventory.
Next expected filings
- ~2027-02-12 10-K expected by 2027-03-01 (in 89 days)
- ~2027-04-30 10-Q expected by 2027-05-06 (in 166 days)
- ~2027-08-04 10-Q expected by 2027-08-10 (in 262 days)
- ~2027-11-03 10-Q expected by 2027-11-09 (in 353 days)
Predicted from historical filing cadence; not an SEC commitment.
Recent SEC filings
- 2026-11-04 10-Q Quarterly Report
- 2026-11-03 8-K Earnings Release; Financial Statements and Exhibits
- 2026-10-27 8-K Officer/Director Change
- 2026-08-05 10-Q Quarterly Report
- 2026-08-04 8-K Earnings Release; Financial Statements and Exhibits
- 2026-07-31 8-K Cybersecurity Incident
- 2026-05-19 8-K Officer/Director Change
- 2026-05-01 10-Q Quarterly Report
- 2026-04-30 8-K Earnings Release; Financial Statements and Exhibits
- 2026-04-22 8-K Officer/Director Change; Financial Statements and Exhibits
- 2026-04-07 DEF 14A Proxy Statement
- 2026-02-19 8-K Material Agreement Entered; Financial Statements and Exhibits
- 2026-02-13 10-K Annual Report
- 2026-02-03 8-K Earnings Release; Financial Statements and Exhibits
- 2026-01-30 8-K Material Agreement Terminated; Financial Statements and Exhibits