Amgen Earnings Call: Broad Growth Amid Manageable Risks

Amgen Inc ((AMGN)) has held its Q4 earnings call. Read on for the main highlights of the call.

Amgen Balances Broad Growth With Manageable Risks in Latest Earnings Call

Amgen’s latest earnings call struck a notably constructive tone, underscoring broad-based commercial momentum, double‑digit revenue and earnings growth, and a deepening late‑stage pipeline. Management highlighted 2025 as a year of strong execution across cardiovascular, bone health, oncology, respiratory, rare diseases, and biosimilars, while acknowledging regulatory setbacks, clinical timing uncertainties, and upcoming biosimilar and seasonal headwinds. Overall, the message to investors was that diversified growth drivers and disciplined capital allocation more than outweigh the identifiable risks.

Broad Commercial Momentum With Expanding Blockbuster Base

Amgen emphasized the breadth and durability of its portfolio as a key pillar of the growth story. Fourteen products reached blockbuster status with over $1 billion in annual sales, and 13 products delivered double‑digit growth during 2025. In total, 18 products posted record results, driving double‑digit gains in both revenue and EPS. This diversification reduces dependence on any single therapy and helps cushion the impact of patent cliffs and competitive pressures, positioning the company as a multi‑franchise growth platform rather than a single‑product story.

Strong 2025 Financials and Clear 2026 Targets

Management reported 10% sales growth for 2025, supported by a non‑GAAP operating margin of 46%, free cash flow of $8.1 billion, and the retirement of $6 billion in debt. This combination of growth, profitability, and deleveraging underpins Amgen’s ability to invest aggressively in R&D while returning capital to shareholders. Looking ahead, the company set 2026 revenue guidance in the $37.0–$38.4 billion range and non‑GAAP EPS of $21.60–$23.00, signaling confidence that current growth drivers can offset known headwinds and that margins can remain robust in the mid‑40s.

Repatha Emerges as a Flagship Cardiovascular Growth Engine

Repatha was highlighted as one of Amgen’s most powerful growth engines, with sales up 36% year‑over‑year in 2025 to above $3 billion. The company underscored recent Phase III Vesalius CV trial data, which showed a 25% relative risk reduction in first major cardiovascular events and a 36% reduction in heart attacks. These results support Repatha’s use not just in high‑risk secondary prevention but also in primary prevention populations, expanding its addressable market. Management framed Repatha as a cornerstone asset within its cardiovascular strategy, with significant room for further penetration as outcomes data and guideline support build.

Evenity and Bone Franchise Deliver Durable Volume-Led Growth

The bone health franchise, led by Evenity, continues to post strong, volume‑driven growth. Evenity’s 2025 sales increased 34% to $2.1 billion, with U.S. revenue up 41% driven primarily by higher patient volumes rather than price. Evenity holds more than 60% market share in the bone builder segment, and new U.S. patients grew 33% year‑over‑year. This performance suggests durable demand in osteoporosis and fractures, with Amgen leveraging both physician adoption and broader awareness of bone health as the population ages.

Rare Disease Portfolio and New Indications Fuel High-Margin Growth

Rare diseases remain a key strategic and financial pillar for Amgen, with the portfolio generating nearly $5.2 billion in 2025, up roughly 14% year‑over‑year. The company spotlighted Uplisna/Aplisna, which secured approvals in IgG4‑related disease and generalized myasthenia gravis in 2025. Eplisna sales grew 73% to $655 million, underscoring the rapid uptake of innovative therapies in underserved conditions. Management positioned the rare disease segment as both a growth driver and a margin enhancer, given the premium pricing and targeted patient populations typical in this space.

Respiratory and Immunology: Tespire’s Rapid Climb in Severe Asthma

In respiratory and immunology, Tespire is emerging as a leading therapy for severe uncontrolled asthma. Full‑year 2025 sales grew about 52% to nearly $1.5 billion, reflecting rapid adoption across allergy, pulmonology, and other respiratory specialties. The strong growth trajectory suggests that Tespire is gaining share in a competitive biologics market by offering differentiated efficacy and broad patient eligibility. Management indicated that continued penetration in severe asthma and potential label expansions could sustain this high‑growth profile.

Oncology Advancements and the Rise of Amgen’s Bispecific Platform

Oncology remains a central strategic focus, with Amgen highlighting both commercial and clinical advances. IMDELTRA received full FDA approval and is now considered standard of care in second‑line small cell lung cancer, generating $627 million in 2025 sales. BLINCYTO, a key bispecific T‑cell engager, grew 28% to over $1.5 billion. The company stressed the progress of its bispecific T‑cell engager platform, with multiple late‑stage programs advancing, signaling a growing, technology‑driven oncology franchise rather than reliance on a single asset.

Biosimilars: A Growing, Diversified Revenue Stream

Amgen’s biosimilars segment delivered $3.0 billion in 2025 sales, up 37% year‑over‑year, and has generated more than $13 billion cumulatively since 2018. The company pointed to strong performance from its ophthalmology entrant PAV Blue, a biosimilar to EYLEA, which reached $700 million in full‑year sales. Management presented biosimilars as an increasingly important contributor to both top‑line growth and market access, leveraging Amgen’s manufacturing scale and payer relationships, while also acknowledging that biosimilars will pose competitive pressure in some of its legacy brands.

Record R&D Spend and a Deepening Late-Stage Pipeline

Non‑GAAP R&D spending rose 22% to a record $7.2 billion in 2025, reflecting Amgen’s commitment to investing behind its pipeline. The company outlined multiple late‑stage efforts, including six global Phase III trials for Meritide, the ongoing OCEAN‑A outcome study for olpasiran, positive Phase II data for the autoimmune candidate daxdilimab, and several planned pivotal trial initiations. Management framed this elevated R&D spend as a deliberate strategy to secure the next generation of growth assets across cardiovascular, metabolic, oncology, immunology, and rare disease indications.

Capital Allocation: Dividends, Capex, and Deleveraging

On capital deployment, Amgen balanced shareholder returns with strategic investment. The company raised its Q4 dividend to $2.38 per share, a 6% increase versus 2024, signaling confidence in cash‑flow durability. It invested $2.2 billion in capex during 2025 and plans about $2.6 billion in 2026, primarily to expand manufacturing capacity and prepare for a potential Meritide launch. At the same time, Amgen retired $6 billion of debt, reinforcing balance sheet strength while maintaining a disciplined stance on share repurchases.

Regulatory Overhang: Tavneos Withdrawal Request

A key regulatory setback emerged with the FDA’s request for a voluntary withdrawal of Tavneos, a therapy for ANCA‑associated vasculitis, tied to concerns over readjudication of endpoints for nine patients. Amgen is currently in discussions with the agency, and the outcome remains unresolved. While the commercial impact is limited relative to the company’s broader portfolio, the issue introduces some headline risk and highlights the inherent regulatory uncertainties in complex, rare disease indications.

Clinical Timing Risk for Olpasiran’s OCEAN-A Study

The company flagged timing risk around olpasiran, a key cardiovascular pipeline asset aimed at lowering lipoprotein(a). The fully enrolled OCEAN‑A outcomes trial is event‑driven, but aggregate endpoint accrual is running slower than initially expected. This delays the primary analysis date and injects uncertainty into the timeline for potential regulatory filings and commercialization. Management nonetheless maintained that the asset’s scientific rationale and market opportunity remain attractive, even if investors may need to wait longer for pivotal data.

Portfolio Pruning and Program Terminations

Amgen also updated investors on portfolio prioritization, underscoring a willingness to redeploy capital away from underperforming assets. The collaboration on rocotinlimab was terminated and returned to its partner, and the company decided not to pursue regulatory approval for bimirtuzumab after the FORTITUDE trial failed to meet expectations. These moves signal disciplined portfolio management, focusing resources on programs with clearer paths to differentiation and commercial scale.

Rising Competitive Pressures From Biosimilars and Generics

Management was candid about mounting competitive pressures in parts of the portfolio. Prolia is expected to face accelerated sales erosion in 2026 as biosimilar competition intensifies, and Otezla is anticipated to come under pricing pressure and generic competition, particularly in Europe. Additional denosumab biosimilar competition is expected in early 2026. While these headwinds will weigh on certain franchises, Amgen argued that growth from newer assets and biosimilar launches should ultimately more than offset these declines.

Seasonal and Inventory Headwinds Cloud Near-Term Results

Near‑term growth will also be tempered by seasonal and inventory dynamics. Amgen cited typical Q1 headwinds tied to U.S. insurance cycles, including benefit changes, reverifications, and higher patient copays, all of which tend to depress early‑year demand. The company also disclosed roughly $250 million of inventory build in 2025, which is expected to reverse and negatively impact Q1 2026 sales. As a result, management guided to lower mid‑single‑digit year‑over‑year revenue growth for the first quarter and noted that Q1 operating margin will likely be the lowest of the year.

Pipeline Timelines and Design Still in Flux

Despite its robust late‑stage pipeline, Amgen acknowledged that several program timelines and trial designs remain to be finalized. This includes details such as the control arm for a planned type 2 diabetes cardiovascular outcomes trial and the exact sequencing of Meritide’s cardiovascular and diabetes studies. These open questions create some uncertainty around the timing of future readouts and potential launches, but management framed this as normal course for a complex, multi‑indication development strategy rather than a sign of underlying weakness.

Guidance and Outlook: Growth Drivers Poised to Offset Headwinds

For 2026, Amgen guided total revenues of $37.0–$38.4 billion and non‑GAAP EPS of $21.60–$23.00, with a non‑GAAP operating margin of roughly 45%–46% of product sales. Other revenue is expected at $1.6–$1.8 billion, non‑GAAP other income/(expense) around $2.3–$2.4 billion, and a non‑GAAP tax rate of 16%–17.5%. Capex is pegged at approximately $2.6 billion, and share repurchases are not expected to exceed $3 billion as the company prioritizes investment and balance sheet strength. Non‑GAAP R&D expense is projected to grow at a low single‑digit rate, excluding about $300 million of 2025 business‑development‑related spend. Management expects a lower mid‑single‑digit revenue decline in Q1 due to seasonality and inventory normalization, but reiterated that growth from six priority drivers—Repatha, Evenity, Tespire, rare disease, innovative oncology, and biosimilars—should more than offset the drag from biosimilar competition, pricing pressure, and higher 340B utilization over the full year.

In closing, Amgen’s earnings call painted the picture of a company in transition from a mature, legacy‑heavy profile to a diversified growth platform anchored by cardiovascular, bone health, oncology, respiratory, rare disease, and biosimilar franchises. While regulatory issues around Tavneos, timing risks for olpasiran, and imminent biosimilar and seasonal headwinds pose challenges, the breadth of blockbuster products, strong 2025 financial execution, and clear 2026 guidance suggest that the growth story remains intact. For investors, the key takeaway is that Amgen’s multi‑asset pipeline and expanding portfolio appear well‑positioned to sustain long‑term value creation, even as it navigates near‑term volatility.