Amgen Inc.

Company Overview

Business Model: Amgen Inc. discovers, develops, manufactures, and delivers innovative human therapeutics, focusing on areas of high unmet medical need. The Company leverages its expertise to provide solutions that aim to dramatically improve people's lives and reduce the social and economic burden of disease. Amgen Inc. operates in one segment: human therapeutics, encompassing the entire value chain from discovery to commercialization.

Market Position: Amgen Inc. is one of the world’s leading independent biotechnology companies, with a history spanning over 45 years in the biotechnology industry. The Company maintains a robust pipeline of potential first-in-class medicines across all stages of development. Amgen Inc. is recognized as a leader in biologics manufacturing, which provides a competitive advantage and positions it strongly in the global biosimilars market. The Company has a global presence in approximately 100 countries, with the United States being its largest market. In 2025, three major pharmaceutical wholesale distributors—McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.—collectively accounted for 77% of Amgen Inc.'s worldwide gross revenues.

Recent Strategic Developments:

• Repatha: In August 2025, 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 prior requirement of a cardiovascular disease diagnosis. Phase 3 VESALIUS-CV trial results in November 2025 showed statistically significant reductions in MACEs (25% relative reduction in 3-P MACE, 19% in 4-P MACE, 36% in heart attack risk) in high-risk adults without prior heart attack or stroke, with a median achieved LDL-C of 45 mg/dL versus 109 mg/dL in the placebo arm.
• UPLIZNA: The FDA approved UPLIZNA in April 2025 for the treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients, making it the first and only approved treatment for this condition. In December 2025, the FDA further approved UPLIZNA for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor and anti-muscle specific tyrosine kinase antibody positive.
• IMDELLTRA/IMDYLLTRA: Interim Phase 3 DeLLphi-304 trial results in June 2025 demonstrated a significant 40% reduction in the risk of death for small cell lung cancer (SCLC) patients compared to standard-of-care chemotherapy (median overall survival of 13.6 months vs. 8.3 months). This led to full FDA approval for IMDELLTRA in extensive stage SCLC in November 2025, converting its prior accelerated approval.
• TEPEZZA: In June 2025, the European Commission granted marketing authorization approval for TEPEZZA for the treatment of adults with moderate-to-severe thyroid eye disease (TED).
• Maridebart cafraglutide (MariTide): Amgen Inc. initiated two global Phase 3 studies in March 2025 for chronic weight management and expanded to four additional global Phase 3 studies by November 2025, covering cardiovascular disease, heart failure, and obstructive sleep apnea in adults with obesity or overweight. January 2026 updates from Phase 2 studies showed sustained weight loss and cardiometabolic improvements with good tolerability.
• TAVNEOS: In January 2026, the FDA requested ChemoCentryx, Inc. (an Amgen Inc. subsidiary) voluntarily withdraw TAVNEOS from the U.S. market due to concerns regarding trial data re-adjudication and hepatotoxicity. Amgen Inc. informed the FDA it would not withdraw the product, expressing confidence in its effectiveness and benefit-risk profile, and is evaluating next steps.
• Bemarituzumab: In February 2026, Amgen Inc. announced it would not pursue regulatory approval for bemarituzumab in first-line gastric cancer based on Phase 3 study data.
• Rocatinlimab: In January 2026, Amgen Inc. and Kyowa Kirin Co., Ltd. agreed to terminate their collaboration, transitioning global development and commercialization to Kyowa Kirin Co., Ltd. in Q1 2026.
• Manufacturing Expansion: In 2025, Amgen Inc. opened a cutting-edge drug substance facility in Holly Springs, North Carolina, and broke ground on a second, state-of-the-art, sustainable facility there. Expansions were also announced for manufacturing networks in New Albany, Ohio, and the U.S. territory of Puerto Rico, enhancing U.S.-based capabilities.
• R&D Facility: In 2025, Amgen Inc. broke ground on a new state-of-the-art R&D facility in Thousand Oaks, California, to foster collaboration and innovation.
• Direct-to-Patient Program: In December 2025, Amgen Inc. expanded its direct-to-patient program, AmgenNow, to include Aimovig and AMJEVITA, complementing Repatha, with expected availability through TrumpRx.

Geographic Footprint: Amgen Inc. has a global presence, with sales and marketing forces concentrated in the United States and Europe, and commercialization efforts extending to Japan, China, other parts of Asia, Latin America, and the Middle East. In 2025, the U.S. market accounted for 73% ($25.656 billion) of total product sales, with the rest of the world (ROW) contributing 27% ($9.492 billion). Major R&D centers are located in Thousand Oaks, California; San Francisco, California; Iceland; and the United Kingdom. Manufacturing facilities are in the U.S. (including the U.S. territory of Puerto Rico, Rhode Island, Ohio, and California) and internationally (Ireland, Netherlands, and Singapore). Distribution centers are located in the U.S. territory of Puerto Rico, Kentucky, California, and the Netherlands.

Financial Performance

Revenue Analysis

Profitability Metrics (2025):

• Gross Margin: 67.25%
• Operating Margin: 24.71%
• Net Margin: 20.98%

Investment in Growth (2025):

• R&D Expenditure: $7.272 billion (19.8% of total revenue)
• Capital Expenditures: $1.858 billion
• Strategic Investments: Significant investments in Later-Stage Clinical Programs (e.g., MariTide) and Research and Early Pipeline. Capital expenditures primarily supported the construction of new plants and expansion of manufacturing capacity in Ohio, North Carolina, and the U.S. territory of Puerto Rico, as well as a new R&D facility in Thousand Oaks, California.

Business Segment Analysis

Amgen Inc. operates in one operating segment: human therapeutics.

Human Therapeutics

Financial Performance (2025):

• Total Product Sales: $35.148 billion (+10% Year-over-Year)
• U.S. Product Sales: $25.656 billion (+10% Year-over-Year)
• ROW Product Sales: $9.492 billion (+9% Year-over-Year)
• Key Growth Drivers: Global volume growth of 13%, partially offset by a 3% decline in net selling price. Volume growth was particularly strong for Repatha, PAVBLU, EVENITY, IMDELLTRA/IMDYLLTRA, and TEZSPIRE. Favorable changes to estimated sales deductions also contributed to Prolia and Otezla sales.

Product Portfolio:

• Principal Products: Prolia, Repatha, Otezla, ENBREL, EVENITY, XGEVA, TEPEZZA, BLINCYTO, Nplate, TEZSPIRE, KYPROLIS, Aranesp, KRYSTEXXA, and Vectibix.
• New Product Launches/Major Updates (2025):
  • WEZLANA (biosimilar to STELARA) and BKEMV (biosimilar to SOLIRIS) launched in the U.S.
  • UPLIZNA received FDA approvals for IgG4-RD and generalized myasthenia gravis.
  • IMDELLTRA received full FDA approval for extensive stage SCLC.
  • TEPEZZA received European Commission marketing authorization for TED.
  • Repatha received broadened FDA approval for cardiovascular risk reduction.

Market Dynamics:

• Competitive Landscape: Amgen Inc. faces increasing competition from biosimilars and generics. Patents for Prolia and XGEVA expired in February 2025 (U.S.) and November 2025 (Europe), leading to expected accelerated sales erosion.
• Pricing Pressures: ENBREL and Otezla were selected by CMS for Medicare price setting, effective January 1, 2026, and January 1, 2027, respectively, which is expected to negatively impact their profitability in Medicare. The high concentration and negotiating leverage of major health insurers and pharmacy benefit managers (PBMs) continue to exert pressure on pricing, leading to increased discounts and rebates.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: No shares were repurchased under the stock repurchase program during 2025. The Company purchased 1,700 shares from staff members for $284.67 per share to satisfy federal law compliance obligations. As of December 31, 2025, $6.8 billion of authorization remained available under the stock repurchase program.
• Dividend Payments: Amgen Inc. paid $5.124 billion in dividends during 2025, with quarterly cash dividends of $2.38 per share, representing a 6% increase year-over-year. The Board of Directors declared a cash dividend of $2.52 per share for the first quarter of 2026, a further 6% increase.

Balance Sheet Position (as of December 31, 2025):

• Cash and Equivalents: $9.129 billion
• Total Debt: $54.604 billion (carrying value)
• Net Cash Position: -$45.475 billion
• Credit Rating: Amgen Inc. maintains investment-grade credit ratings from S&P (BBB+), Moody’s (Baa1), and Fitch (BBB+).
• Debt Maturity Profile (Aggregate contractual maturities as of December 31, 2025):
  • 2026: $4.599 billion
  • 2027: $2.724 billion
  • 2028: $4.984 billion
  • 2029: $2.943 billion
  • 2030: $4.000 billion
  • Thereafter: $36.822 billion

Cash Flow Generation (2025):

• Operating Cash Flow: $9.958 billion
• Free Cash Flow: $8.100 billion (Operating Cash Flow of $9.958 billion minus Capital Expenditures of $1.858 billion).
• Cash Conversion Metrics: Cash provided by operating activities decreased in 2025 compared to 2024, primarily due to the timing of working capital items, partially offset by higher net income after noncash adjustments and lower interest payments.

Operational Excellence

Production & Service Model: Amgen Inc. is a vertically integrated enterprise focused on the discovery, development, manufacturing, and delivery of innovative human therapeutics. The Company's manufacturing capabilities, particularly in biologics, are a key competitive advantage. It produces both complex biologics (in living cells) and small molecule drugs. The internal manufacturing network handles bulk manufacturing, formulation, fill, finish, tableting, and final device assembly across facilities in the U.S. (including Puerto Rico, Rhode Island, Ohio, and California) and internationally (Ireland, Netherlands, and Singapore). Third-party contract manufacturers are utilized to supplement capacity for both commercial and clinical production.

Supply Chain Architecture: Key Suppliers & Partners:

• Pharmaceutical Wholesale Distributors: McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc. are critical for U.S. distribution, accounting for 77% of worldwide gross revenues in 2025.
• Raw Materials, Medical Devices & Components: Amgen Inc. relies on unaffiliated third-party suppliers for certain proprietary raw materials, medical devices (e.g., SureClick autoinjectors for Repatha and ENBREL), and components, some of which are sole sources. Raw materials are sourced globally, including from biological sources.
• Contract Manufacturing Organizations (CMOs): The acquisition of Horizon Therapeutics plc added over 30 CMOs, many of which are single-source suppliers for critical products like TEPEZZA and KRYSTEXXA.
• Collaboration Partners: Strategic alliances include AstraZeneca (TEZSPIRE, AMG 104), UCB (EVENITY), and BeOne Medicines Ltd. (oncology portfolio in China).

Facility Network:

• Manufacturing: Key production sites include Juncos, Puerto Rico (substantial majority of commercial manufacturing), Thousand Oaks, California (substantial majority of clinical manufacturing), West Greenwich, Rhode Island, New Albany, Ohio (FDA-approved for commercial production in January 2024), Ireland, Netherlands, and Singapore. New state-of-the-art drug substance facilities are under development in Holly Springs, North Carolina.
• Research & Development: Major R&D centers are located in Thousand Oaks, California; San Francisco, California; Iceland; and the United Kingdom. A new R&D facility is under construction in Thousand Oaks, California.
• Distribution: Primary distribution centers are in the U.S. territory of Puerto Rico, Kentucky, California, and the Netherlands (which also handles labeling and packaging for Europe and much of the rest of the world).

Operational Metrics: Amgen Inc. is expanding its manufacturing capacity and integrating state-of-the-art technologies to optimize its network, enhance flexibility, and mitigate risks. New facilities are designed for lower cost, faster construction, and improved environmental sustainability, including reduced water and energy consumption and lower carbon emissions. The Company has established long-term environmental targets for 2027, including achieving carbon neutrality (Scopes 1 and 2), reducing water consumption by 40%, and reducing waste disposed by 75%.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Amgen Inc. maintains its own sales and marketing forces in key regions, including the United States, Europe, Japan, China, other parts of Asia, Latin America, and the Middle East.
• Channel Partners: The Company collaborates with partners such as Astellas Pharma Inc., BeOne Medicines Ltd., Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceutical Co., Ltd., and Kyowa Kirin Co., Ltd. in the Asia Pacific region.
• Pharmaceutical Wholesale Distributors: In the United States, sales are primarily made to pharmaceutical wholesale distributors (McKesson Corporation, Cencora, Inc., and Cardinal Health, Inc.), which then distribute products to healthcare providers. Outside the U.S., sales are to healthcare providers and/or pharmaceutical wholesale distributors.
• Digital Platforms: Amgen Inc. utilizes direct-to-patient channels, including print, television, and online media. The AmgenNow program has been expanded to include Aimovig and AMJEVITA, supplementing Repatha, and is expected to be available through TrumpRx.

Customer Portfolio: Enterprise Customers:

• Healthcare Providers: Amgen Inc. markets its products to physicians, their clinics, dialysis centers, hospitals, and pharmacies.
• Strategic Partnerships: Collaborations with companies like AstraZeneca, UCB, and BeOne Medicines Ltd. are integral to development and commercialization efforts.
• Customer Concentration: Three major pharmaceutical wholesale distributors accounted for 77% of worldwide gross revenues in 2025. As of December 31, 2025, amounts due from these three customers represented 75% of net trade receivables.

Geographic Revenue Distribution (2025):

• U.S.: 73% of total product revenue ($25.656 billion)
• ROW: 27% of total product revenue ($9.492 billion)
• Growth Markets: Amgen Inc. continues to pursue expansion efforts in emerging markets globally.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The biotechnology and pharmaceutical industry is highly competitive, with numerous companies engaged in R&D for existing and new disease areas. Competition impacts product pricing and market share, intensified by the proliferation of biosimilars and generics. Product development cycles are lengthy (typically 10-15 years), and the standard of medical care, particularly in areas like oncology, evolves rapidly. Significant consolidation among health insurers and PBMs has increased their negotiating leverage, leading to greater pressure on drug pricing and access. Governments and international bodies are increasingly focused on cost containment and may adopt policies that weaken patent protection or facilitate market entry for biosimilars.

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors: Amgen Inc. faces competition from major pharmaceutical and biotechnology companies such as Novartis AG, Regeneron Pharmaceuticals, Inc., Sanofi, AbbVie Inc., Eli Lilly and Company, Johnson & Johnson Innovative Medicine, Pfizer Inc., Bristol Myers Squibb Company, GSK plc., Genentech, Inc., F. Hoffmann-La Roche Ltd., Merck KGaA, Merck & Co., Inc., Takeda Oncology, and Asahi Kasei Pharma. These competitors offer branded products that overlap with Amgen Inc.'s portfolio (e.g., LEQVIO vs. Repatha, Skyrizi vs. Otezla, HUMIRA vs. ENBREL).

Emerging Competitive Threats: The Company faces increasing threats from biosimilar and generic manufacturers, particularly following patent expirations for products like Prolia and XGEVA. New market entrants and disruptive technologies also pose challenges. Regulatory and policy initiatives, such as the Inflation Reduction Act of 2022 (IRA), the Most-Favored-Nations Prescription Drug Pricing Executive Order (MFN EO), and state-level Prescription Drug Affordability Boards (PDABs), aim to lower drug costs and increase payer leverage, potentially impacting Amgen Inc.'s pricing and profitability. Proposed EU pharmaceutical legislation could also reduce intellectual property protection.

Competitive Response Strategy: Amgen Inc. aims to strengthen its competitive position through continuous innovation, including expanding product indications and developing new, more efficient delivery and manufacturing methods. The Company leverages its global experience to differentiate its products against both branded and biosimilar competitors. Strategic initiatives include developing high-quality biosimilars, partnering with payers to share risk, providing patient support programs, expanding patient access (including direct-to-patient channels), and investing in U.S. manufacturing to ensure reliable supply. Amgen Inc. also actively engages with policymakers and stakeholders to advocate for a sustainable healthcare system that supports innovation and patient access.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics: Amgen Inc.'s sales are highly dependent on coverage and reimbursement from government and commercial third-party payers, which are increasingly focused on cost containment, leading to lower reimbursement rates and stricter utilization management. The Company faces substantial competition from existing and new drugs, biosimilars, and generics, with patent expirations (e.g., Prolia, XGEVA in 2025) accelerating sales erosion. The evolving standard of medical care and technological disruption (including AI risks) can reduce product utility. Customer concentration among a few large wholesalers and consolidated PBMs/insurers grants them significant purchasing leverage, impacting pricing and sales. Guidelines from various organizations, including value assessments, can also reduce product use. Technology Disruption: The adoption and exploration of AI in business operations introduce risks such as inaccurate or flawed outputs, operational disruptions, and potential data breaches if guardrails and training are not effectively implemented. Evolving global regulations on AI (e.g., EU Artificial Intelligence Act) could lead to significant penalties for non-compliance. Customer Concentration: A substantial majority of U.S. product sales are made to three pharmaceutical wholesale distributors (77% of worldwide gross revenues in 2025), creating dependency and potential vulnerability to their financial difficulties or purchasing decisions.

Operational & Execution Risks

Supply Chain Vulnerabilities: Amgen Inc. relies on unaffiliated third-party suppliers for certain raw materials, medical devices, and components, some of which are sole sources. Disruptions due to regulatory actions, supplier financial issues, unexpected demand, quality failures, cyberattacks, natural disasters, labor disputes, or trade barriers could limit supply and impact sales. Geographic Concentration: A substantial majority of commercial manufacturing occurs in the U.S. territory of Puerto Rico, which is vulnerable to natural disasters and infrastructure instability. Clinical manufacturing is largely concentrated in Thousand Oaks, California. Significant disruptions at these facilities could severely impair product supply and clinical trials. Capacity Constraints: Manufacturing biologics is complex and highly regulated. Expansion efforts are capital-intensive and subject to risks like construction delays, regulatory approvals, labor availability, and supply chain disruptions. Failure to meet demand or delays in clinical trials can result from these constraints. Production & Service Model: Manufacturing difficulties, including contamination, equipment failure, and non-compliance with regulatory requirements, can lead to delayed shipments, supply constraints, and product recalls. IT Systems & Cybersecurity: Amgen Inc. relies on sophisticated IT systems, including third-party services, making it vulnerable to breakdowns, cyberattacks (e.g., phishing, ransomware), and data breaches. Such incidents could compromise sensitive data, interrupt business operations, and harm reputation. Compliance with evolving global cybersecurity and data privacy laws (e.g., GDPR, CCPA, China's PIPL) is critical to avoid significant penalties.

Financial & Regulatory Risks

Market & Financial Risks: Uncertain global economic conditions, including inflation and interest rate fluctuations, can negatively affect demand and increase operational costs. The Company's significant investment portfolio is exposed to market volatility, potentially leading to impairments or losses. Tax Liabilities: Amgen Inc. faces substantial tax liabilities, including an ongoing dispute with the IRS for the 2010-2012 and 2013-2015 periods regarding profit allocation, with potential additional federal tax liabilities of $3.6 billion and $5.1 billion, respectively, plus penalties. The Company is contesting these positions. New tax legislation (e.g., OECD minimum corporate tax rate, OB3) could further impact profitability. Regulatory & Compliance Risks: Extensive regulation by U.S. (FDA) and foreign authorities (EMA) means non-compliance can lead to severe sanctions. Evolving regulatory requirements for clinical trials, post-marketing surveillance, and product approvals (including accelerated approvals) can cause delays or market withdrawals. The Company is also subject to healthcare fraud and abuse laws (e.g., antikickback, false claims), anticorruption laws (FCPA), and data privacy regulations, with potential for significant penalties for violations. Legal Proceedings: Amgen Inc. is involved in various complex legal proceedings, including patent litigation (Repatha, Prolia/XGEVA biosimilars, PAVBLU, KYPROLIS, TAVNEOS), antitrust class actions (Regeneron Pharmaceuticals, Inc., CareFirst of Maryland, Inc., Sandoz Inc.), securities class actions, and shareholder derivative actions. Outcomes are inherently uncertain and could result in costly verdicts, fines, or injunctive relief.

Geopolitical & External Risks

Geopolitical Exposure: International operations, especially in emerging markets, are subject to political, legal, regulatory, and financial instability. Trade policies (e.g., U.S. tariffs, BIOSECURE Act) can increase costs, disrupt supply chains, and restrict collaborations. Ongoing geopolitical conflicts (e.g., Ukraine, Middle East) can cause regional economic disruptions. Global Climate Change: Many facilities are in locations prone to natural disasters, which are amplified by climate change. Such events can damage operations, disrupt supply chains, and incur significant recovery costs.

Innovation & Technology Leadership

Research & Development Focus: Amgen Inc. focuses its R&D on novel human therapeutics for serious illnesses, leveraging its strengths in human genetics, novel biology, and protein engineering. The Company aims to choose optimal modalities for drug targets and diseases, utilizing cutting-edge science and technology. A key strategic focus is on human genetics to enhance the likelihood of R&D success and guide investment decisions. Amgen Inc. is increasingly applying artificial intelligence (AI) to its R&D activities, including human data efforts and its generative biology platform for drug discovery and design. R&D expenses totaled $7.272 billion in 2025, and the Company expects continued growth in spending on Later-Stage Clinical Programs.

Core Technology Areas:

• Human Genetics: Central to R&D strategy, enhancing success rates.
• Novel Biology & Protein Engineering: Core competencies for therapeutic development.
• Bispecific T-cell Engager (BiTE) Technology: Utilized in products like BLINCYTO and IMDELLTRA/IMDYLLTRA.
• Antibody-Peptide Conjugates: Exemplified by MariTide, which activates GLP-1 receptor and antagonizes GIPR.
• Small Interfering RNA (siRNA): Employed in Olpasiran to lower lipoprotein(a).
• Artificial Intelligence (AI): Accelerating its use across the organization, with a dedicated AI Governance Council overseeing safe adoption and staff training.

Innovation Pipeline (Selected Phase 3 Programs as of February 3, 2026):

• BLINCYTO (Ph-negative B-ALL)
• Dazodalibep (Sjögren’s disease)
• IMDELLTRA/IMDYLLTRA (Small cell lung cancer)
• LUMAKRAS/LUMYKRAS (Metastatic colorectal cancer, Non-small cell lung cancer)
• MariTide (Chronic weight management, Cardiovascular disease, Heart failure, Obstructive sleep apnea)
• Nplate (Chemotherapy-induced thrombocytopenia)
• Olpasiran (Cardiovascular disease)
• Pegloticase (Subcutaneous administration for uncontrolled gout)
• Repatha (Cardiovascular disease)
• Rocatinlimab (Moderate-to-severe atopic dermatitis, Prurigo nodularis) - Collaboration with Kyowa Kirin Co., Ltd. terminated in January 2026.
• TEPEZZA (Subcutaneous administration for TED, Chronic/low clinical activity score TED in Japan)
• TEZSPIRE (Chronic obstructive pulmonary disease, Eosinophilic esophagitis)
• Xaluritamig (Metastatic castrate resistant prostate cancer)
• Biosimilar candidates: ABP 206 (to OPDIVO), ABP 234 (to KEYTRUDA), ABP 692 (to OCREVUS).

Intellectual Property Portfolio: Amgen Inc.'s success is partly dependent on its ability to obtain and defend patent rights. While patents for RANKL antibodies (Prolia, XGEVA) expired in February 2025 (U.S.) and November 2025 (Europe), the Company holds material patents for other key products with various expiration dates (e.g., Repatha U.S. antibodies 2029, methods 2032; Otezla U.S. compositions 2028, oral dosage 2042; ENBREL U.S. fusion protein 2028, DNA 2029, formulations 2037, methods 2038). TEPEZZA benefits from biologic exclusivity in the U.S. (expires 2032) and regulatory exclusivity in Europe (expires 2035). Orphan drug exclusivity applies to BLINCYTO and UPLIZNA for specific indications in the U.S. The Company is actively involved in patent litigation to defend its intellectual property, including disputes related to Repatha, Prolia/XGEVA biosimilars, PAVBLU, KYPROLIS, and TAVNEOS.

Technology Partnerships:

• AstraZeneca: Collaboration for the development and commercialization of TEZSPIRE, with shared global costs, profits, and losses. Amgen Inc. manufactures and supplies TEZSPIRE worldwide. Also collaborating on AMG 104.
• UCB: Collaboration for the development and commercialization of EVENITY, with equally shared global development costs and commercialization profits/losses. Amgen Inc. manufactures and supplies EVENITY worldwide.
• BeOne Medicines Ltd.: Strategic collaboration to expand Amgen Inc.'s oncology presence in China, including an equity stake. BeOne Medicines Ltd. commercializes XGEVA, BLINCYTO, and KYPROLIS in China, with shared profits and losses. Also jointly developing a portion of the oncology portfolio.

Leadership & Governance

Executive Leadership Team (as of February 13, 2026)

Leadership Continuity: Amgen Inc. emphasizes leadership continuity through succession planning and leadership development initiatives. An executive-level council, including the CEO, regularly addresses workplace culture.

Board Composition: The Board of Directors oversees enterprise-wide risk management, with specific committees having primary risk oversight responsibilities. The Corporate Responsibility and Compliance Committee (CRCC) is responsible for information systems and cybersecurity, while the Audit Committee oversees internal controls and financial risks.

Human Capital Strategy

Workforce Composition: As of December 31, 2025, Amgen Inc. had approximately 31,500 staff members globally, with about 13,000 located outside the United States. The Company maintains overall low turnover rates.

Talent Management: Acquisition & Retention: Amgen Inc.'s approach to talent management is designed to attract, motivate, and retain a highly skilled global workforce. Compensation, benefits, and development programs are competitive within the biotechnology and pharmaceutical industries, aligning employee interests with shareholder value. The Company offers a flexible workspace initiative and launched an Apprenticeship Program in 2023 (expanded in January 2025) to attract and upskill non-four-year degreed talent. Diversity & Development: Amgen Inc. provides various development programs, including leadership development, classroom and virtual courses, self-paced learning, mentoring, networking, and coaching. The Apprenticeship Program is a skills-based approach to broaden access to talent.

Diversity & Development: Amgen Inc. provides various development programs, including leadership development, classroom and virtual courses, self-paced learning, mentoring, networking, and coaching. The Apprenticeship Program is a skills-based approach to broaden access to talent. Culture & Engagement: The Company's culture is designed to foster innovation, collaboration, and productivity, supported by regular staff engagement surveys that consistently show scores above general market benchmarks.

Environmental & Social Impact

Environmental Commitments: Climate Strategy: Amgen Inc. has established long-term environmental targets to be met by 2027, including achieving carbon neutrality for Scopes 1 and 2 emissions, reducing water consumption by 40%, and reducing waste disposed by 75%. New state-of-the-art manufacturing facilities, such as those in North Carolina and Ohio, incorporate environmental sustainability features like on-site photovoltaic renewable energy generation, aiming for reduced carbon footprint, water usage, and waste.

Social Impact Initiatives: Amgen Inc.'s mission to serve patients by transforming science into life-saving therapies underscores its social impact. The Company is committed to working with the healthcare community to ensure continued innovation and patient access to needed medicines, including through patient support and education programs.

Business Cyclicality & Seasonality

Demand Patterns: Amgen Inc. experiences seasonal trends in product sales, with the first quarter historically representing the lowest sales period. This is partly due to U.S. patient deductibles, plan changes, and insurance reverifications, particularly affecting products like ENBREL, Otezla, KRYSTEXXA, TEZSPIRE, and Repatha. Economic Sensitivity: The Company's operations and performance are affected by uncertain global economic conditions, including inflation, fluctuating interest rates, and financial system instability. These conditions can lead to reduced demand for products due to job losses, increased co-pay obligations, or loss of healthcare insurance coverage.

Planning & Forecasting: Amgen Inc. monitors wholesaler inventory levels, typically maintained at two to three weeks, to manage supply. While wholesale and end-user buying patterns can cause quarterly fluctuations, they have generally not significantly impacted full-year product performance.

Regulatory Environment & Compliance

Regulatory Framework: Amgen Inc. operates under extensive regulation by government authorities in the United States (FDA) and internationally (e.g., EMA). Compliance with these standards is complex, and non-compliance can result in significant sanctions, including refusal of approvals, delays in clinical trials, product recalls, or fines. Regulatory requirements are continuously evolving, impacting product development, marketing, and post-approval activities. The EU Artificial Intelligence Act, with provisions effective in 2025 and fully in 2026, introduces a risk-based framework for AI systems, adding to compliance requirements.

Trade & Export Controls: The BIOSECURE Act, enacted in December 2025, prohibits federal contracting with certain "biotechnology companies of concern," potentially restricting future collaborations. U.S. trade and tariff policies, including the April 2025 Tariff EO and a Section 301 investigation of China, can increase costs and disrupt supply chains. Cross-border data transfer regulations in China and the U.S. also impose additional compliance burdens.

Legal Proceedings: Amgen Inc. is involved in various legal proceedings, including:

• Patent Litigation: Ongoing disputes related to Repatha in Germany and Japan, and actions in the Unified Patent Court (UPC). Biosimilar patent litigation for Prolia/XGEVA, PAVBLU, KYPROLIS, and TAVNEOS.
• Antitrust Class Actions: Lawsuits alleging anticompetitive practices related to sales contracting for Repatha, ENBREL, and Otezla. A jury verdict in May 2025 found against Amgen Inc. in the Regeneron Pharmaceuticals, Inc. antitrust action, awarding $135.6 million in compensatory damages (subject to trebling) or $406.8 million in punitive damages. Amgen Inc. is contesting this verdict and has not accrued a liability. Other similar antitrust actions are pending.
• Securities Class Action and Shareholder Derivative Actions: Multiple lawsuits alleging false/misleading statements regarding tax liabilities and internal controls. These cases are currently stayed pending the outcome of the Roofers Securities Class Action.

Tax Strategy & Considerations

Tax Profile: Amgen Inc.'s effective tax rate in 2025 was 14.1%, influenced by the jurisdictional mix of income and expenses. Significant tax benefits arise from operations in Singapore, Ireland, and the U.S. territory of Puerto Rico, which are subject to tax incentive grants (Puerto Rico through 2050, Singapore through 2036). Foreign earnings are also subject to a reduced U.S. tax rate of 10.5%. Tax Reform Impact: The global minimum tax agreement (Pillar Two) enacted in several countries (effective 2024/2025) subjects Amgen Inc. and its subsidiaries to a 15% minimum tax rate on adjusted financial statement income. The U.S. OB3 legislation, enacted in July 2025, includes provisions affecting the international tax framework, with certain changes effective in 2026 and beyond. Tax Litigation: Amgen Inc. is engaged in an ongoing tax dispute with the IRS for the 2010-2012 and 2013-2015 periods, primarily concerning the allocation of profits between U.S. and Puerto Rico entities. The IRS proposes additional federal tax liabilities of approximately $3.6 billion (2010-2012) and $5.1 billion (2013-2015), plus penalties. The trial concluded in January 2025, with a decision expected no earlier than the second half of 2026. Amgen Inc. firmly believes the IRS positions are without merit and has not accrued a liability for these specific amounts. The Company is also under examination by the IRS for 2016-2018 and expects audits for 2019-2022. As of December 31, 2025, total gross unrecognized tax benefits (UTBs) were $4.371 billion, with associated accrued interest and penalties of $1.9 billion.

Insurance & Risk Transfer

Risk Management Framework: Amgen Inc. employs a multi-layered approach to risk management, including insurance coverage and various risk transfer mechanisms.

• Insurance Coverage: The Company maintains cyber-liability insurance, though it acknowledges that such coverage may not be sufficient to cover all potential losses from service interruptions, breaches, or data loss.
• Risk Transfer Mechanisms: Amgen Inc. utilizes foreign currency forward and cross-currency swap contracts to hedge exposure to foreign currency exchange rate fluctuations. Interest rate swap contracts are used to manage the mix of fixed-rate and floating-rate debt. To mitigate counterparty credit risk, derivative transactions are limited to institutions with minimum investment-grade credit ratings, and exposure limits are placed on individual counterparties. The investment policy also restricts interest-bearing security investments to investment-grade institutions.