Amgen(US:AMGN)2026-02-13 21:07Financial Performance - Amgen's total product sales for 2025 reached $35.148 billion, a 9.5% increase from $32.026 billion in 2024[45]. - In the U.S., product sales accounted for $25.656 billion, representing 73% of total sales, consistent with the previous years[45]. - Amgen's three largest wholesalers accounted for 77% of total revenues in 2025, highlighting significant reliance on major distributors[40]. Product Approvals and Developments - UPLIZNA became the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD) in adults, expanding its market presence[25]. - TEZSPIRE was approved as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps in patients aged 12 and older[28]. - IMDELLTRA/IMDYLLTRA demonstrated a 40% reduction in the risk of death in small cell lung cancer patients compared to standard chemotherapy[26]. - Repatha achieved a 25% relative reduction in the risk of major adverse cardiovascular events (MACE) in high-risk adults, with a 36% reduction in heart attack risk[24]. - TEZSPIRE is approved for severe uncontrolled asthma and chronic rhinosinusitis with nasal polyps in over 70 countries, highlighting its broad market reach[56]. - TEPEZZA, acquired in October 2023, is the first and only approved medicine for the treatment of Thyroid Eye Disease (TED) and is marketed in multiple countries[53]. - BLINCYTO, launched in 2014, has shown efficacy in treating CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) and is marketed globally[54]. - Nplate, launched in 2008, is indicated for treating thrombocytopenia in patients with immune thrombocytopenia (ITP) who have had insufficient response to other treatments[55]. - KYPROLIS, launched in 2012, is indicated for relapsed or refractory multiple myeloma and is marketed primarily in the U.S. and Europe[57]. - Vectibix, launched in 2006, is indicated for wild-type RAS metastatic colorectal cancer and is marketed in multiple countries[60]. - KRYSTEXXA, acquired in October 2023, is the first FDA-approved treatment for chronic refractory gout, expanding the company's product portfolio[59]. - The company initiated two global Phase 3 studies for MariTide, targeting chronic weight management in adults with and without Type 2 diabetes[30]. - MariTide has a patent expiration estimate of 2038 in both the U.S. and Europe[141]. - Otezla was approved in Japan for palmoplantar pustulosis[139]. - UPLIZNA received FDA and EC approval for IgG4-RD and generalized myasthenia gravis[139]. - TEZSPIRE was approved by the FDA and the EC for chronic rhinosinusitis with nasal polyps[139]. - AMJEVITA received FDA approval for its interchangeability study[139]. Competition and Market Challenges - The company faces increasing competition from biosimilars and generics, particularly as patents for key products like XGEVA are set to expire in February 2025 in the U.S.[68]. - The company anticipates substantial competition from biosimilars and generics, which may impact pricing and market share[70]. - The company faces ongoing pricing and reimbursement pressures from government and commercial payers, which have impacted profitability and are expected to continue doing so[199]. - The company is subject to risks related to competition, particularly from biosimilars and generics, which are anticipated to increase in the future[199]. - The company is required to provide rebates and discounts under various government programs, including the 340B Program, which has negatively impacted financial performance[74]. - The company faces increasing scrutiny from payers regarding drug pricing and clinical evidence requirements, impacting product access and utilization[73]. - The company relies on third-party suppliers for raw materials and components, and disruptions in manufacturing could significantly impair product supply[203]. - Legislative and regulatory changes at both federal and state levels continue to evolve, creating uncertainty regarding future pricing and reimbursement policies[210]. - Significant consolidation in the health insurance industry has increased pressure on pricing and negotiations, leading to greater discount and rebate requirements, which may adversely affect product sales and operations[213]. - International actions to reduce drug expenditures and intellectual property protections are expected to continue, impacting access to and sales of products[214]. - Health technology assessment organizations may recommend narrower indications for reimbursement than regulatory approvals, impacting product sales[216]. Research and Development - The company invests billions annually in R&D to drive innovation and maintain competitive advantage[81]. - R&D expenses for the years ended December 31, 2025, 2024, and 2023 were $7.3 billion, $6.0 billion, and $4.8 billion, respectively, indicating a significant increase in investment in research and development[129]. - The company has 23 Phase 3 programs being studied in investigational indications as of February 3, 2026, down from 25 programs in 2025, with changes including six programs initiating Phase 3 studies and five receiving regulatory approval[138]. - The company is focusing on human genetics and novel biology in its R&D efforts to enhance the likelihood of success in developing new therapeutics[126]. - A new state-of-the-art R&D facility was opened in Thousand Oaks, California, in 2025 to enhance collaboration and innovation across R&D activities[127]. - The company is continuously monitoring the impacts of health-related events and geopolitical conflicts on clinical trial enrollment and is actively opening new clinical sites[128]. - The company is focused on reducing drug development cycle times, which typically take 10 to 15 years from discovery to market[103]. Manufacturing and Operations - The company is expanding its manufacturing capacity with new state-of-the-art biomanufacturing facilities in North Carolina and Ohio, which are expected to reduce carbon emissions and resource consumption compared to traditional facilities[84]. - The North Carolina facility is designed for flexibility, allowing simultaneous production of different medicines, and is expected to have a substantially lower carbon footprint and water usage than traditional manufacturing sites[84]. - The company has commercial production capabilities across multiple U.S. states and internationally, including Puerto Rico, Rhode Island, Ohio, California, Ireland, Netherlands, and Singapore[85]. - In January 2025, the company opened a cutting-edge drug substance facility in Holly Springs, North Carolina, which will increase biologics manufacturing capacity upon FDA approval[92]. - The company is also expanding its manufacturing network in New Albany, Ohio, and Puerto Rico, enhancing U.S.-based manufacturing capabilities[93]. - The company employs a risk mitigation strategy for raw materials, including maintaining backup inventory and evaluating alternative sources to minimize supply chain disruptions[99]. Strategic Initiatives - The company is actively pursuing acquisitions and licensing of product and R&D technology rights to strengthen its strategic position within the industry[131]. - Amgen acquired an equity stake in BeOne Medicines Ltd. for approximately $2.8 billion to expand its oncology presence in China[163]. - Amgen collaborates with AstraZeneca for the development and commercialization of TEZSPIRE, sharing global costs and profits equally[161]. - The company launched an Apprenticeship Program in 2023 aimed at attracting and upskilling non-four-year degreed talent, with a new cohort starting in January 2025 at the North Carolina site[179]. - The company is focused on integrating technology and artificial intelligence across its operations, appointing a Chief Technology Officer in 2023 to accelerate these efforts[190]. Regulatory and Compliance - The FDA regulates the company's manufacturing and marketing processes, requiring compliance with safety and effectiveness standards[101]. - The company is subject to various global laws regarding privacy and data protection, including the EU's GDPR and California's CCPA, which are evolving and may result in significant penalties for non-compliance[124]. - The company is subject to income tax examinations in multiple jurisdictions, leading to potential disputes over deductions and tax credits[219]. - Tax liabilities from ongoing disputes with the IRS and new tax legislation could adversely affect profitability and results of operations[217]. Pricing and Market Access - In 2022, the Inflation Reduction Act (IRA) was enacted, mandating price setting for certain drugs under Medicare starting in 2026, which is expected to negatively affect profitability[78]. - Medicare Part D prices for ENBREL and Otezla will be set significantly lower, impacting their profitability starting January 1, 2026, and January 1, 2027, respectively[78]. - The MFN EO directs HHS to align U.S. drug prices with those in comparably developed countries, which may affect pricing and reimbursement strategies[204]. - The Congressional Budget Office projects that OB3 will lead to significant reductions in federal Medicaid spending over the next decade, potentially increasing the number of uninsured individuals[204]. - Eight states have enacted laws establishing PDABs to identify drugs with affordability challenges, with Colorado's PDAB deeming ENBREL "unaffordable" and setting an Upper Payment Limit effective no earlier than January 1, 2027[208]. - States are pursuing laws related to price controls and have proposed applying Medicare price caps to state drug prices, adding complexity to pricing strategies[208]. - U.S. commercial payers are increasingly shifting drug costs to patients through limited benefit designs and higher co-pay obligations, affecting access to products[211]. - Payers are seeking price discounts or rebates for formulary placement and imposing restrictions on access to products, which may limit sales[212].