Amgen Inc. discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases, focusing on areas of high unmet medical need. The company helped launch the biotechnology industry more than 45 years ago and has grown to be one of the world’s leading independent biotechnology companies, with a presence in approximately 100 countries worldwide. Amgen operates in one operating segment: human therapeutics.

Amgen operates in a highly competitive environment. Primary competitors named in the filing include AbbVie Inc., Novartis AG, Regeneron Pharmaceuticals, Inc., Sanofi, Eli Lilly and Company, Johnson & Johnson Innovative Medicine, Bristol Myers Squibb Company, Pfizer Inc., AstraZeneca, GSK plc, Genentech, Inc., F. Hoffmann-La Roche Ltd, Merck & Co., Inc., and Takeda Oncology, among others. The company states that its competitive position may be based on safety, efficacy, reliability, availability, patient convenience, delivery devices, price, reimbursement, access to and timing of market entry and patent position and expiration. Amgen believes its manufacturing capabilities represent a competitive advantage, and it continues to pursue innovation efforts to strengthen its competitive position.

Amgen generates revenue primarily through product sales of human therapeutic medicines. In the United States, substantially all sales are to three pharmaceutical wholesale distributors — McKesson Corporation, Cencora, Inc. and Cardinal Health, Inc. — which is the principal means of distributing products to healthcare providers. Outside the United States, the company sells principally to healthcare providers and/or pharmaceutical wholesale distributors depending on the distribution practice in each country. The company also generates other revenues, including royalty income. On a combined basis, the three large wholesalers accounted for 77%, 77% and 79% of worldwide gross revenues for 2025, 2024 and 2023, respectively.

Amgen’s principal products include Prolia, Repatha, Otezla, ENBREL, EVENITY, XGEVA, TEPEZZA, BLINCYTO, Nplate, TEZSPIRE, KYPROLIS, Aranesp, KRYSTEXXA and Vectibix. Prolia is used for osteoporosis in postmenopausal women and men at high risk of fracture; Repatha is a PCSK9 inhibitor to reduce risk of major adverse cardiovascular events and lower LDL-C; Otezla is an oral PDE4 inhibitor for plaque psoriasis, psoriatic arthritis, and Behçet’s disease; ENBREL is a tumor necrosis factor blocker for rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis; EVENITY is for osteoporosis in postmenopausal women at high risk for fracture; XGEVA is for prevention of skeletal-related events in patients with bone metastases; TEPEZZA is for thyroid eye disease; BLINCYTO is a BiTE molecule for B-cell acute lymphoblastic leukemia; Nplate is for immune thrombocytopenia; TEZSPIRE is for severe uncontrolled asthma and chronic rhinosinusitis with nasal polyps; KYPROLIS is for relapsed or refractory multiple myeloma; Aranesp is for anemia caused by chronic kidney disease and chemotherapy; KRYSTEXXA is for chronic refractory gout; and Vectibix is for wild-type RAS metastatic colorectal cancer.

Other marketed products include MVASI, PAVBLU, UPLIZNA, IMDELLTRA/IMDYLLTRA, AMJEVITA/AMGEVITA, TAVNEOS, Neulasta, LUMAKRAS/LUMYKRAS, RAVICTI, Parsabiv, Aimovig, WEZLANA/WEZENLA and PROCYSBI. Since 2018, Amgen has launched eight biosimilars, including the 2025 U.S. launches of WEZLANA, a biosimilar to STELARA, and BKEMV, a biosimilar to SOLIRIS. The company also markets a number of other products including AVSOLA, KANJINTI, EPOGEN, RIABNI, IMLYGIC, NEUPOGEN, Corlanor, Sensipar/Mimpara, ACTIMMUNE, BUPHENYL, RAYOS, QUINSAIR, DUEXIS, VIMOVO and PENNSAID.

Significant operational developments during the period include: the FDA broadened the approved use of Repatha in August 2025 to include adults at increased risk for MACE without prior CV disease; the FDA approved UPLIZNA for IgG4-RD in April 2025 and for generalized myasthenia gravis in December 2025; the FDA granted full approval for IMDELLTRA for ES-SCLC in November 2025; the FDA approved TEZSPIRE for CRSwNP in October 2025; the European Commission granted marketing authorization for TEPEZZA for TED in June 2025; Amgen initiated two global Phase 3 studies for MariTide in March 2025 and four additional global Phase 3 studies by November 2025; in January 2025, Amgen opened its Holly Springs, North Carolina drug substance facility and broke ground on a second facility at that location; and in 2025, Amgen announced expansions of its manufacturing network in New Albany, Ohio and the U.S. territory of Puerto Rico, and broke ground on a new R&D facility in Thousand Oaks, California.

Total product sales increased 10% in 2025 to $35.148 billion ¹, driven by volume growth of 13%, partially offset by declines in net selling price of 3%. Total revenues were $36.751 billion ² for 2025, compared to $33.424 billion ³ for 2024. Operating income was $9.080 billion ⁴ for 2025, compared to $7.258 billion ⁵ for 2024. Net income was $7.711 billion ⁶ for 2025, compared to $4.090 billion ⁷ for 2024. Diluted EPS was $14.23 ⁸ for 2025, compared to $7.56 ⁹ for 2024. Cash flows from operating activities in 2025 totaled $9.958 billion ¹⁰.

Management states that for 2026, they expect volume growth from certain brands to be partially offset by net selling price declines, and that the first quarter of a year historically represents the lowest product sales quarter for the year. For Repatha in 2026, management expects net selling price to decline by approximately mid-single digits. For ENBREL in 2026, management expects product sales to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters. For Otezla in 2026, management expects product sales to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters, and expects further declines in net selling price driven by Medicare price setting beginning in 2027. For TEZSPIRE in 2026, management expects product sales to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters. For KRYSTEXXA in 2026, management expects product sales to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters.

A major growth vector is MariTide, a differentiated antibody-peptide conjugate that activates the GLP-1 receptor and antagonizes the GIPR. In March 2025, Amgen announced the initiation of two global Phase 3 studies in chronic weight management: one in adults living with obesity or overweight without Type 2 diabetes and another in adults living with obesity or overweight with Type 2 diabetes. By November 2025, four additional global Phase 3 studies were underway in adults with established atherosclerotic cardiovascular disease and obesity or overweight; in adults with heart failure with preserved or mildly reduced ejection fraction and obesity; and in adults with obstructive sleep apnea on positive airway pressure therapy and living with obesity or overweight, and in adults with obstructive sleep apnea not on positive airway pressure therapy and living with obesity or overweight. In January 2026, Part 2 of the Phase 2 chronic weight management study showed that the large majority of participants maintained weight loss for an additional 52 weeks on a lower monthly dose or quarterly dose of MariTide, with very low incidence of nausea and vomiting and no new safety signals. A Phase 2 study of MariTide for Type 2 diabetes showed robust and clinically meaningful reduction in both HbA1c and weight with monthly MariTide at 24 weeks.

Another growth vector is Repatha, following the FDA’s August 2025 broadening of approved use to include adults at increased risk for MACE due to uncontrolled LDL-C, removing the previous requirement of diagnosed CV disease. In November 2025, detailed results from the Phase 3 VESALIUS-CV clinical trial showed that Repatha achieved a 25% relative reduction in the risk of a composite of CHD death, heart attack or ischemic stroke (3-P MACE), a 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE), and a 36% reduction in the risk of heart attack. The median achieved LDL-C was 45 mg/dL compared to 109 mg/dL in the placebo arm. No new safety signals were identified. Additionally, IMDELLTRA/IMDYLLTRA represents a growth vector following the June 2025 interim results from the Phase 3 DeLLphi-304 trial showing a 40% reduction in risk of death compared to standard-of-care chemotherapy, with median overall survival of 13.6 months compared to 8.3 months, and the FDA’s November 2025 conversion of accelerated approval to full approval for ES-SCLC.

Cost of sales decreased to 32.8% of total revenues for 2025, driven by lower amortization expense from acquisition-related assets, including the fair value step-up of inventory acquired from Horizon, and lower manufacturing costs, partially offset by higher profit share expense and changes in sales mix. R&D expense increased 22% to $7.272 billion ¹¹ for 2025, driven by investments in Later-Stage Clinical Programs, including those related to MariTide, and in Research and Early Pipeline, partially offset by lower spend in Marketed Product Support. Management expects to continue to grow spend on Later-Stage Clinical Programs as the pipeline advances. SG&A expense decreased 1% to $7.050 billion ¹² for 2025, driven by lower Horizon acquisition-related expenses and lower amortization expense from acquisition-related assets, partially offset by higher general and administrative expenses. Other operating expenses for 2025 included Otezla intangible asset impairment charges of $1.2 billion ¹³.

Amgen is expanding its manufacturing capacity and incorporating state-of-the-art technologies. In January 2025, the company opened its Holly Springs, North Carolina site, a cutting-edge drug substance facility, and broke ground on a second drug substance manufacturing facility at this location. In 2025, Amgen announced expansions of its manufacturing network in New Albany, Ohio and the U.S. territory of Puerto Rico. The company also broke ground on a new state-of-the-art R&D facility in Thousand Oaks, California. Amgen’s internal manufacturing network has commercial production capabilities for bulk manufacturing, formulation, fill, finish, tableting and final device assembly, performed within the United States (including Puerto Rico, Rhode Island, Ohio and California) and internationally in Ireland, Netherlands and Singapore facilities. The company uses third-party contract manufacturers to supplement capacity or capability. Amgen operates distribution centers in Puerto Rico, Kentucky, California and the Netherlands. As of December 31, 2025, Amgen had approximately 31,500 staff members in over 50 countries, including approximately 13,000 staff members outside the United States.

R&D spending was $7.272 billion ¹⁴ for 2025. Capital expenditures were $1.9 billion ¹⁵ for 2025, and management currently estimates 2026 investments in capital projects to be approximately $2.6 billion ¹⁶. During 2025, the company did not repurchase shares under the stock repurchase program. As of December 31, 2025, $6.779 billion ¹⁷ of authorization remained available under the stock repurchase program. The Board of Directors declared quarterly cash dividends of $2.38 ¹⁸ per share of common stock paid in 2025, reflecting a year-over-year increase of 6%. In December 2025, the Board declared a cash dividend of $2.52 ¹⁹ per share for the first quarter of 2026, an increase of 6% over the same period in the prior year.

A significant headwind is the expiration of patents for RANKL antibodies, including sequences, for Prolia and XGEVA in February 2025 in the United States and in November 2025 in select countries in Europe. For 2026, management expects accelerated sales erosion driven by increased competition, as multiple biosimilars have launched in the United States and ROW. Another headwind is the impact of the Inflation Reduction Act of 2022, which includes mandatory Medicare price setting. CMS has set Medicare Part D prices for ENBREL, effective January 1, 2026, and Otezla, effective January 1, 2027, in each case at significantly lower prices that are expected to negatively impact their profitability in Medicare. The IRA’s Medicare price setting and Medicare redesign have had, and are likely to have, an adverse effect on sales, business and results of operations, and such impact is expected to increase through the end of the decade. Additionally, the expanded utilization of the 340B Program has had a negative impact on the Company’s financial performance.

Structural headwinds include pricing and reimbursement pressures from government and commercial third-party payers. In the United States, payers are increasingly using stricter utilization management criteria, such as prior authorization and step therapy, and the top six integrated health plans and PBMs controlled about 89% of all pharmacy prescriptions. The Most-Favored-Nations Prescription Drug Pricing Executive Order and the July MFN Letter delivered to pharmaceutical companies, including Amgen, represent additional policy risks. In December 2025, Amgen announced it is taking actions that satisfy the components outlined in the July MFN Letter, including the Administration’s MFN pricing requests. At the state level, eight states have enacted laws establishing Prescription Drug Affordability Boards, and four states include authority to set upper payment limits on certain drugs. The Colorado PDAB deemed ENBREL “unaffordable” and established an Upper Payment Limit substantially lower than the wholesale acquisition cost, effective no earlier than January 1, 2027. Outside the United States, governments continue to take aggressive steps to reduce spending on drugs and biologics, including mandatory price controls, international reference pricing, and health technology assessments.

Management’s message emphasizes that in 2025, the company generated strong sales growth across its product portfolio and regions, advanced its innovative pipeline, and continued to expand and enhance its world-class manufacturing network, while maintaining a strategic and disciplined approach to capital allocation, including retiring $6.0 billion ²⁴ of debt. Key themes include the achievement of multiple regulatory approvals, including new indications for UPLIZNA and TEZSPIRE, a broadened FDA approval for Repatha, and full FDA approval for IMDELLTRA for ES-SCLC. Management highlights the advancement of the pipeline, including the initiation of six global Phase 3 clinical studies for MariTide and the reporting of Phase 3 data across several programs. The company also increased its quarterly cash dividend by 6% to $2.38 ²⁵ per share and declared a first quarter 2026 dividend of $2.52 ²⁶ per share, another 6% increase. Management states that total product sales increased 10% in 2025, driven by volume growth of 13%, partially offset by declines in net selling price of 3%. Cash flows from operating activities in 2025 totaled $9.958 billion ²⁷, which supported capital expenditures of $1.9 billion ²⁸ and allowed the company to reduce debt and return capital to shareholders. Management’s strategic priorities for the period ahead include continuing to invest in expanding and enhancing manufacturing capacity, advancing the innovative pipeline, and maintaining a strategic and disciplined approach to capital allocation.

Total revenues were $36.751 billion ²⁹ for 2025, compared to $33.424 billion ³⁰ for 2024. Net income was $7.711 billion ³¹ for 2025, compared to $4.090 billion ³² for 2024. Diluted EPS was $14.23 ³³ for 2025, compared to $7.56 ³⁴ for 2024. Operating income was $9.080 billion ³⁵ for 2025, compared to $7.258 billion ³⁶ for 2024. Cost of sales as a percentage of total revenues was 32.8% ³⁷ for 2025, compared to 38.5% ³⁸ for 2024. The effective tax rate was 14.1% ³⁹ for 2025, compared to 11.3% ⁴⁰ for 2024. Cash and cash equivalents were $9.129 billion ⁴¹ as of December 31, 2025, compared to $11.973 billion ⁴² as of December 31, 2024. Long-term debt was $50.005 billion ⁴³ as of December 31, 2025, compared to $56.549 billion ⁴⁴ as of December 31, 2024. Other operating expenses for 2025 included Otezla intangible asset impairment charges of $1.2 billion ⁴⁵, which reduced reported net income. Interest expense, net was $2.755 billion ⁴⁶ for 2025, compared to $3.155 billion ⁴⁷ for 2024. Other income, net was $2.651 billion ⁴⁸ for 2025, compared to $506 million ⁴⁹ for 2024, with the increase primarily due to current year net unrealized gains on equity investments, primarily BeOne, compared to net unrealized losses in the prior year. For segment performance, total U.S. product sales were $25.656 billion ⁵⁰ for 2025, compared to $23.301 billion ⁵¹ for 2024, and total ROW product sales were $9.492 billion ⁵² for 2025, compared to $8.725 billion ⁵³ for 2024.

The most material risks include the expiration of patents for RANKL antibodies for Prolia and XGEVA in February 2025 in the United States and November 2025 in select countries in Europe, with management expecting accelerated sales erosion from multiple biosimilar launches. The Inflation Reduction Act’s Medicare price setting has set significantly lower prices for ENBREL effective January 1, 2026, and Otezla effective January 1, 2027, and CMS has issued guidance allowing for re-setting of prices. The IRS is seeking additional federal tax of approximately $3.6 billion ²⁰ plus interest for 2010-2012 and approximately $5.1 billion ²¹ plus interest and approximately $2.0 billion ²² in penalties for 2013-2015, related to the allocation of profits between U.S. entities and Puerto Rico, with a trial concluded and a decision expected no earlier than the second half of 2026. The company faces significant competition from biosimilars and generics, with multiple biosimilar versions of Prolia and XGEVA already approved in the United States and EU. Concentration of sales at three wholesalers (McKesson, Cencora, Cardinal Health) accounted for 77% ²³ of worldwide gross revenues in 2025, and the top six integrated health plans and PBMs control about 89% of all pharmacy prescriptions, giving them substantial negotiating leverage.