Executive Summary / Key Takeaways

• Amgen ($AMGN) delivered robust financial results in Q3 2025, with total revenues increasing 12% year-over-year, driven by strong 14% volume growth across its diversified portfolio of innovative medicines and biosimilars.
• The company's advanced pipeline, particularly MariTide for obesity, the BiTE platform in oncology (IMDELLTRA, BLINCYTO), and UPLIZNA in rare diseases, represents significant future growth catalysts, with several key Phase III readouts and regulatory decisions anticipated in late 2025 and beyond.
• Amgen is strategically expanding market access and affordability for key products like Repatha through initiatives such as AmgenNow, while its biosimilar portfolio continues to generate substantial revenue and cash flow, annualizing at $3 billion.
• Despite industry headwinds including declining net selling prices, the Inflation Reduction Act, and increased competition for certain legacy products, Amgen maintains a strong financial position, having returned to its pre-Horizon capital structure ahead of schedule and reaffirming its 2025 revenue guidance of $35.8 billion to $36.6 billion.
• The company's deep expertise in biologics manufacturing, significant investments in R&D and U.S. infrastructure, and increasing adoption of AI across its value chain underscore its technological differentiation and commitment to long-term innovation.

A Biotech Pioneer's Enduring Strategy

Amgen Inc., incorporated in 1980, stands as a foundational pillar of the biotechnology industry, consistently focused on discovering, developing, manufacturing, and delivering innovative human therapeutics. The company's overarching strategy centers on addressing areas of high unmet medical need, leveraging its scientific expertise, and expanding its global footprint. This approach has been shaped by a history of pioneering drug development, including early successes with Epogen and Neupogen, and strategic acquisitions like Immunex, which brought Enbrel into its portfolio.

The biopharmaceutical market is intensely competitive, with Amgen vying against diversified healthcare giants such as AbbVie (ABBV), Johnson & Johnson (JNJ), Pfizer (PFE), Merck (MRK), and Eli Lilly (LLY), as well as a growing number of indirect competitors, including generic drug manufacturers and emerging biotech firms leveraging advanced technologies. Amgen differentiates itself through its specialized focus on biologics and targeted therapies, a robust pipeline, and a commitment to patient-centric solutions. The company's deep expertise in biologics manufacturing, honed over 45 years and predominantly based in the U.S., provides a foundational strength, ensuring a reliable supply of complex medicines.

Technological Edge: Precision, Durability, and AI Integration

Amgen's competitive moat is significantly reinforced by its technological differentiators, which drive both its current portfolio's efficacy and its future pipeline's potential.

At the forefront is Amgen's bispecific T cell engager (BiTE) platform. This proprietary technology creates molecules that simultaneously bind to cancer cells and T cells, redirecting the body's immune system to target and destroy malignant cells. This precision mechanism offers profound efficacy in difficult-to-treat cancers. For instance, IMDELLTRA (tarlatamab-dlle), a DLL3-targeting BiTE, demonstrated a significant 40% reduction in the risk of death and extended median overall survival by over five months compared to standard chemotherapy in Phase III trials for second-line small cell lung cancer. BLINCYTO (blinatumomab), a CD19-targeting BiTE, has achieved a 96% three-year disease-free survival rate when added to chemotherapy in pediatric B-cell acute lymphoblastic leukemia. The "so what" for investors is clear: these highly targeted therapies command premium pricing, offer durable patient benefits, and establish new standards of care, contributing to strong market positioning and sustained revenue streams.

Beyond oncology, Amgen leverages differentiated mechanisms in other therapeutic areas. TEZSPIRE (tezepelumab-ekko) targets thymic stromal lymphopoietin (TSLP), an upstream cytokine at the top of the inflammatory cascade. This broad mechanism allows TEZSPIRE to address multiple triggers of severe uncontrolled asthma and, more recently, chronic rhinosinusitis with nasal polyps (CRSwNP), where it demonstrated a near-uniform avoidance of surgical intervention in clinical trials. This broad applicability and upstream targeting provide a significant advantage in a market with substantial unmet needs.

In rare diseases, UPLIZNA (inebilizumab-cdon) exemplifies Amgen's precision approach by targeting CD19-positive B cells, which are core drivers of certain autoimmune conditions. This mechanism has shown remarkable efficacy, including an 87% reduction in disease flares in IgG4-related disease and durable, sustained symptom relief with convenient twice-yearly dosing (after an initial loading dose) in generalized myasthenia gravis, offering a differentiated profile compared to existing treatments.

Amgen is also aggressively integrating artificial intelligence (AI) across its value chain. This includes leveraging AI to inform molecule design and discovery research, accelerate trial enrollment, streamline regulatory filings and clinical development, and enhance responsiveness in commercial operations. These initiatives are aimed at driving productivity, speeding up innovation cycles, and ultimately improving financial efficiency and market responsiveness.

Strong Performance and Strategic Financial Management

Amgen's financial performance in the third quarter of 2025 reflects the strength of its diversified portfolio and disciplined execution. Total revenues reached $9,557 million, marking a 12% increase year-over-year. Product sales, the primary revenue driver, also grew 12% to $9,137 million, fueled by a robust 14% volume growth across both U.S. and international markets. This volume expansion was critical in offsetting a 4% decline in net selling prices, a trend observed across the industry. For the first nine months of 2025, total revenues increased 10% to $26,885 million, with product sales up 11% to $25,781 million.

Profitability remains a core focus, with a non-GAAP operating margin of 47% in Q3 2025. While operating expenses increased 9% year-over-year, this was largely due to strategic investments in Later-Stage Clinical Programs, including MariTide, and approximately $200 million from business development transactions. Non-GAAP R&D expenses saw a significant 31% year-over-year increase, underscoring the company's commitment to its innovative pipeline. Cost of sales decreased to 32.20% of total revenues, benefiting from lower amortization expense related to the Horizon acquisition and reduced manufacturing costs.

Key product highlights from Q3 2025 include:

• Repatha: Sales surged 40% to $794 million, now annualizing at approximately $3 billion, driven by strong volume growth.
• EVENITY: Sales grew 36% to $541 million, with U.S. sales up 44% from increased prescription volumes.
• Rare Disease Portfolio: This segment expanded 13% to $1.4 billion, annualizing at over $5 billion, with UPLIZNA sales up 46% to $155 million.
• TEZSPIRE: Sales increased 40% to $377 million, surpassing $1 billion year-to-date.
• Innovative Oncology: The portfolio generated $2.3 billion in sales, growing 9%, with IMDELLTRA contributing $178 million and BLINCYTO growing 20% to $392 million.
• Biosimilars: This portfolio delivered a 52% increase in sales to $775 million, annualizing at $3 billion, with PAVBLU reaching $213 million.

Amgen maintains a strong liquidity position, with $9.40 billion in cash and cash equivalents as of September 30, 2025. The company has actively managed its debt, retiring $4.5 billion in 2024 and an additional $6.0 billion in 2025, successfully returning to its pre-Horizon capital structure ahead of schedule.

Cash flow from operations remains robust, providing $4.2 billion in free cash flow in Q3 2025. Capital allocation priorities include continued investment in the business, debt reduction, and returning capital to shareholders through dividends, with a quarterly cash dividend of $2.38 per share declared in October 2025.

Competitive Dynamics and Strategic Responses

Amgen's competitive strategy is multifaceted, adapting to market shifts and leveraging its strengths. In the cardiovascular market, Repatha faces competition from other PCSK9 inhibitors like Regeneron 's Praluent. An antitrust lawsuit verdict in May 2025 found Amgen liable for using bundled rebates to disadvantage Praluent, resulting in significant damages awarded to Regeneron (REGN). Despite this, Amgen is expanding Repatha's market opportunity, particularly after the October 2025 VESALIUS-CV trial demonstrated significant MACE reduction in primary prevention patients. The launch of AmgenNow, offering Repatha at a substantially reduced cash price, is a direct response to affordability concerns and aims to broaden patient access, positioning Repatha competitively against existing and emerging therapies.

In bone health, EVENITY leads the bone-builder segment with over 60% market share, but a significant portion of high-risk patients remain untreated, indicating substantial growth runway. For Prolia and XGEVA, Amgen anticipates sales erosion from biosimilar competition following patent expirations in 2025.

The biosimilar market is a strategic growth area for Amgen, which has generated nearly $13 billion in cumulative sales since 2018. The company's "first wave" strategy, coupled with its high-quality manufacturing, has made products like PAVBLU (biosimilar to EYLEA) successful, with retina specialists appreciating its convenient prefilled syringe. Amgen views the U.S. biosimilar market as flourishing and advocates for policies that support its growth, contrasting with concerns about the generic drug industry.

In the rapidly evolving obesity market, Amgen's MariTide is positioned as a differentiated asset, offering monthly or less frequent dosing and demonstrating significant cardiometabolic improvements beyond weight loss. This contrasts with weekly injectable peptides, which often see high discontinuation rates. Amgen is also exploring oral and non-incretin targets in its early pipeline to address the massive, underpenetrated obesity market.

Regulatory and political changes, such as the Inflation Reduction Act (IRA) and the 340B Program, pose significant challenges. Otezla and ENBREL have been selected for Medicare price setting, with Otezla's price expected to decline significantly starting in 2027, leading to intangible asset impairment charges. Amgen is also contending with various tariffs and trade protection measures, which are expected to increase manufacturing and operating expenses. The ongoing IRS tax dispute for the 2010-2015 periods, with a decision expected no earlier than the second half of 2026, represents a substantial financial contingency.

Outlook and Growth Catalysts

Amgen's outlook for 2025 remains strong, with the company raising its total revenue guidance to a range of $35.8 billion to $36.6 billion and non-GAAP earnings per share to between $20.60 and $21.40. This guidance incorporates the impact of implemented tariffs but excludes future pricing actions not yet in effect. The company projects non-GAAP R&D expenses to grow at a mid-20s percentage rate, reflecting continued strategic investments in its late-stage pipeline. Non-GAAP operating margin as a percentage of product sales is expected to be roughly 45%. Capital expenditures are estimated at $2.2 billion to $2.3 billion for 2025, supporting manufacturing capacity expansion.

Several key pipeline catalysts are anticipated in late 2025 and beyond:

• MariTide: Full Phase II data for chronic weight management will be presented, and Part 2 data from the Phase II chronic weight management study (evaluating maintenance) and the Phase II type 2 diabetes study are expected in the second half of 2025. Phase III studies for cardiovascular outcomes, heart failure, and obstructive sleep apnea are underway.
• Repatha: Detailed results from the landmark Phase III VESALIUS-CV trial, demonstrating MACE reduction in primary prevention, will be presented at the American Heart Association Scientific Sessions in November 2025.
• UPLIZNA: A PDUFA date of December 14, 2025, is set for generalized myasthenia gravis, following strong Phase III MINT study data.
• IMDELLTRA: The U.S. regulatory submission has a PDUFA date of December 18, 2025, for second-line small cell lung cancer, with regulatory reviews also underway in other geographies.
• TEZSPIRE: FDA approval for chronic rhinosinusitis with nasal polyps was granted in October 2025, and Phase III studies in COPD are enrolling.
• Olpasiran: The event-driven OCEAN(a) Phase III cardiovascular outcomes study continues to progress, with an additional Phase III primary prevention study planned for late 2025 or early 2026.
• Biosimilars: The next wave of biosimilar candidates, including those for OPDIVO, KEYTRUDA, and OCREVUS, are advancing in Phase III clinical development.

Conclusion

Amgen stands as a resilient and innovative force in the biopharmaceutical industry, demonstrating consistent growth and strategic adaptability in a dynamic market. The company's strong Q3 2025 performance, driven by volume growth across its diverse portfolio, underscores the effectiveness of its focus on high-unmet-need therapeutic areas. Amgen's technological leadership, particularly with its BiTE platform and differentiated mechanisms in inflammation and rare diseases, provides a robust competitive advantage and a foundation for future breakthroughs.

Despite facing significant headwinds from pricing pressures, regulatory changes like the IRA, and increasing biosimilar competition for some established products, Amgen's proactive strategies—such as the AmgenNow platform for Repatha and aggressive pipeline advancement—position it for sustained long-term value creation. The company's disciplined financial management, marked by debt reduction and strategic capital investments in manufacturing and R&D, further strengthens its outlook. Investors should recognize Amgen's commitment to innovation and market execution as key drivers for continued growth and shareholder returns, supported by a rich pipeline poised to deliver transformative medicines in the years ahead.