AMGEN INC (AMGN)

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, Otezla, ENBREL, BLINCYTO, Nplate, TEZSPIRE, XGEVA, Aranesp, KRYSTEXXA, KYPROLIS, Vectibix, UPLIZNA 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, including in the Middle East, continue to pose challenges to our business. The geopolitical conflict, particularly in the Middle East, 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

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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. 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 March 31, 2026. For additional developments, see our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.

Products/pipeline

IMDELLTRA/IMDYLLTRA

In June 2026, we announced that the European Commission has granted marketing authorization for IMDYLLTRA as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. The approval was based on results from DeLLphi-304, the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in this setting.

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Selected financial information

The following is an overview of our results of operations (in millions, except percentages and per-share data):

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 9% for the three months ended June 30, 2026, driven by volume growth. Total product sales increased 7% for the six months ended June 30, 2026, driven by volume growth of 9%, partially offset by lower net selling price.

For the three months ended June 30, 2026, U.S. volume grew 9% and ROW volume grew 8%, driven by certain brands, including Repatha, EVENITY, UPLIZNA, TEZSPIRE, IMDELLTRA/IMDYLLTRA and PAVBLU.

For the six months ended June 30, 2026, U.S. volume grew 9% and ROW volume grew 10%, driven by certain brands, including Repatha, EVENITY, IMDELLTRA/IMDYLLTRA, UPLIZNA, PAVBLU and TEZSPIRE.

Other revenues increased 27% and 34% for the three and six months ended June 30, 2026, respectively, driven by higher corporate partner revenue and royalty income.

Operating expenses remained relatively unchanged for the three months ended June 30, 2026, as lower amortization expense from acquisition-related assets was offset by higher profit share expense and changes in our sales mix, as well as higher R&D, SG&A and litigation expenses. Operating expenses decreased 7% for the six months ended June 30, 2026, reflecting lower amortization expense from acquisition-related assets and the impact of the Otezla intangible asset impairment charge recorded in the first quarter of 2025, partially offset by higher spend in Later-Stage Clinical Programs and higher profit share expense. 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.

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 and June 30, 2026.

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Results of operations

Product sales

Worldwide product sales were as follows (dollar amounts in millions):

* Change in excess of 100%

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(1)

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Item 7. 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, our consolidated financial statements and accompanying notes. 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 Part I, Item 1A. Risk Factors. 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 Prolia, Repatha, Otezla, ENBREL, EVENITY, XGEVA, TEPEZZA, BLINCYTO, Nplate, TEZSPIRE, KYPROLIS, Aranesp, KRYSTEXXA and Vectibix. We also market a number of other products, including but not limited to MVASI, PAVBLU, UPLIZNA, IMDELLTRA/IMDYLLTRA, AMJEVITA/AMGEVITA, TAVNEOS, Neulasta, LUMAKRAS/LUMYKRAS, RAVICTI, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI. For additional information about our products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products.

Our strategy is the integrated set of actions we take to improve our competitive position in the industry. In 2025, we generated strong sales growth across our product portfolio and regions; advanced our innovative pipeline; and continued to expand and enhance our world-class manufacturing network. We accomplished these objectives while maintaining a strategic and disciplined approach to capital allocation, including retiring $6.0 billion of debt.

In 2025, we achieved several significant regulatory, clinical and operational milestones. We obtained multiple regulatory approvals, including new indications for UPLIZNA and TEZSPIRE; a broadened FDA approval for Repatha; and full FDA approval for IMDELLTRA for the treatment of ES-SCLC. We also advanced our innovative pipeline, including the initiation of six global Phase 3 clinical studies for MariTide and the reporting of Phase 3 data across several programs. In addition, we continued to invest in expanding and enhancing our manufacturing capacity, including facilities in Ohio, North Carolina and the U.S. territory of Puerto Rico. Furthermore, in 2025 we also broke ground on a new state-of-the-art R&D facility in Thousand Oaks, California, to further enhance collaboration and innovation across R&D and process development activities. For additional information on our pipeline and clinical development updates, see Part I, Item 1. Business—Research and Development and Selected Product Candidates, and Part I, Item 1. Business—Significant Developments. For additional information on our manufacturing operations, see Part I, Item 1. Business—Manufacturing, Distribution and Raw Materials.

Total product sales increased 10% in 2025, driven by volume growth of 13%, partially offset by declines in net selling price of 3%.

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Cash flows from operating activities in 2025 totaled $10.0 billion, which supported investment in our business, including capital expenditures of $1.9 billion to enhance and expand our manufacturing network, and allowed us to both reduce our debt and return capital to shareholders through the payment of cash dividends. For 2025, we retired $6.0 billion of debt and increased our quarterly cash dividend by 6% to $2.38 per share of common stock. In December 2025, the Board of Directors declared a cash dividend of $2.52 per share of common stock for the first quarter of 2026, an increase of 6% over the same period in the prior year, to be paid in March 2026.

Amgen’s approach to human capital management focuses on attracting, developing and retaining a highly skilled global workforce to support the discovery, development and commercialization of innovative medicines. Our compensation, benefits and development programs are designed to promote performance, accountability, adherence to Company values and alignment with shareholder interests. We believe our culture supports innovation, collaboration and productivity as we execute on our mission to serve patients. For additional information, see Part I, Item 1. Business—Human Capital Resources.

We have a long-standing ambition to be environmentally responsible, and we regularly set targets to challenge ourselves to deliver further improvements. As part of our environmental sustainability efforts, we have established long-term targets to meet by 2027, including achieving carbon neutrality, reducing water consumption by 40% and reducing waste disposed by 75%.2,3

Our long-term success depends, to a great extent, on our ability to continue to discover, develop and commercialize innovative products and acquire or collaborate on therapies currently in development by other companies. We must grow sales from existing and new products to achieve revenue growth and to offset revenue losses caused by products’ loss of their exclusivity or launches of competing products. For example, 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. Certain of our products face increasing pressure from competition, including biosimilars and generics. For additional information, including information on the expirations of patents for various products, see Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Patents, and Part I, Item 1. Business—Marketing, Distribution and Selected Marketed Products—Competition. We devote considerable resources to R&D activities, but successful product development in the biotechnology industry is highly uncertain. We also face increasing regulatory scrutiny of safety and efficacy both before and after products launch.

Tariffs and trade protection measures

Recent and ongoing changes in U.S. trade and tariff policies, including the imposition, modification, suspension and threatened expansion of tariffs on imported goods, as well as retaliatory measures by foreign governments, have increased uncertainty in the overall business and operating environment. Numerous tariffs and trade protection measures have been proposed, and in a number of cases, implemented by the United States and other countries, including the April 2025 Tariff EO, which imposed a universal 10% tariff on goods imported into the United States, with certain exceptions including pharmaceuticals. Further, there were previous proposals for sector-specific tariffs on our industry, and in December 2025, in recognition of our capital investments in U.S. manufacturing, we received relief from Section 232 tariffs, pending final determination under such section of the Trade Expansion Act of 1962, for approximately the next three years. Tariffs and trade protection measures may adversely affect our business and results of operations. For additional discussion of these and other risks, see Part I, Item 1A. Risk Factors, of this Annual Report on Form 10-K.

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, modification, suspension and threatened expansion of tariffs on imported goods, 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 expanded utilization of the 340B Program, 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-Nations 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

2 Represents reductions against established baselines, taking into account only verified reduction projects and does not take into account changes associated with contraction or expansion of the Company.

3 Carbon neutrality goal refers to Scopes 1 and 2.

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that we are taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests. We also announced the expansion of our direct-to-patient program. While this development reflects 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. For additional discussion of these and other risks, see Part I, Item 1A. Risk Factors, of this Annual Report on Form 10-K.

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

[Excerpt truncated for page length; the complete text is on the linked full-MD&A page.]