Amgen Inc. (AMGN) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
Amgen's earnings call presents several positive indicators: increased revenue and EPS guidance, strong product development, and a robust biosimilar portfolio. The Q&A session reveals confidence in pipeline expansions and market opportunities, despite some unclear responses. The raised guidance and strong financial metrics are likely to positively influence the stock price, while the lack of market cap data suggests a moderate impact, leading to a positive sentiment prediction.
Key Financial Performance
Revenue Amgen delivered double-digit growth in revenues for 2025, driven by strong operational performance and a broad portfolio of products.
Earnings Per Share (EPS) Amgen achieved double-digit growth in EPS for 2025, supported by the strong performance of its portfolio.
Repatha Sales Repatha sales grew 36% year-over-year in 2025, surpassing $3 billion. Growth was driven by increased urgency to treat patients in both secondary and primary prevention, supported by landmark trial data.
EVENITY Sales EVENITY sales increased 34% in 2025, reaching $2.1 billion. Growth was driven by higher volumes from both established and new prescribers, with EVENITY leading the bone builder segment.
Prolia Sales Prolia delivered $4.4 billion in sales in 2025, an increase of 1% year-over-year. Growth was limited due to anticipated competition from biosimilars.
Rare Disease Portfolio Sales The rare disease portfolio grew 14% year-over-year to nearly $5.2 billion in 2025. Growth was driven by strong performance across the portfolio, including UPLIZNA and TEPEZZA.
UPLIZNA Sales UPLIZNA sales increased 73% year-over-year to $655 million in 2025, reflecting growing patient demand across all three approved indications.
TEPEZZA Sales TEPEZZA grew 3% to $1.9 billion in 2025, driven by higher net selling price and increased prescribing by endocrinologists and specialists.
TAVNEOS Sales TAVNEOS sales were $459 million in 2025, an increase of 62% year-over-year, driven by strong volume growth and increased adoption for ANCA-associated vasculitis.
TEZSPIRE Sales TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion in 2025, driven by its differentiated mechanism targeting multiple inflammatory pathways in severe uncontrolled asthma.
Otezla Sales Otezla sales increased 7% year-over-year to nearly $2.3 billion in 2025, though future sales are expected to face erosion due to pricing pressures and generic launches.
Innovative Oncology Portfolio Sales The innovative oncology portfolio grew 11% year-over-year, generating $8.7 billion in full-year sales in 2025, driven by products like BLINCYTO and IMDELLTRA.
IMDELLTRA Sales IMDELLTRA delivered $627 million in full-year sales in 2025, supported by strong clinical conviction and rapid adoption across care settings.
BLINCYTO Sales BLINCYTO grew 28% year-over-year to over $1.5 billion in full-year sales in 2025, driven by broad prescribing across both academic and community segments.
Biosimilar Portfolio Sales The biosimilar portfolio delivered $3 billion in sales in 2025, a 37% increase year-over-year, driven by products like PAVBLU, a biosimilar to EYLEA.
Non-GAAP Operating Margin Amgen delivered a non-GAAP operating margin of 46% for the full year 2025, reflecting strong revenue growth and disciplined cost management.
Non-GAAP R&D Spending Non-GAAP R&D spending increased 22% year-over-year to a record $7.2 billion in 2025, driven by investments in late-stage pipeline opportunities.
Free Cash Flow Amgen generated $8.1 billion in free cash flow for the full year 2025, reflecting operational momentum and rigorous management of working capital.
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Operating Highlights
Repatha, EVENITY, TEZSPIRE: These products grew by more than 30% year-over-year in 2025, addressing large unmet medical needs and representing multibillion-dollar global franchises.
MariTide: A differentiated treatment for obesity, type 2 diabetes, and related conditions, offering strong efficacy and favorable tolerability with infrequent dosing. Six global Phase III studies are underway.
UPLIZNA: Generated $655 million in sales, with approvals in IgG4-related disease and generalized myasthenia gravis in 2025.
IMDELLTRA: Rapidly became the standard of care for second-line small cell lung cancer, supported by unprecedented survival benefits.
Rare Disease Portfolio: Generated over $5 billion in sales in 2025, driven by new patient reach, geographic expansion, and new indications.
Biosimilars: Contributed $3 billion in 2025 sales, with a total of $13 billion since 2018. Positioned for growth with new launches.
TEPEZZA: Plans to launch in additional markets in 2026 to expand access globally.
R&D Investments: Increased by 22% year-over-year to $7.2 billion, focusing on late-stage pipeline opportunities like MariTide and olpasiran.
AI Integration: Leveraged AI to accelerate therapeutic discovery, optimize manufacturing, and improve customer engagement.
Manufacturing Expansion: Invested in facilities across the U.S. to support volume growth and pipeline product launches.
Cardiometabolic Leadership: Focused on expanding leadership with Repatha, olpasiran, and MariTide for chronic diseases.
Portfolio Decisions: Terminated development of rocatinlimab and bemarituzumab to prioritize other late-stage programs.
Technology Convergence: Emphasized the impact of convergent innovation in discovering, developing, and commercializing medicines.
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Risk or Challenges
Prolia sales erosion: Accelerated sales erosion expected in 2026 due to increased competition from multiple biosimilars globally.
Otezla sales erosion: Anticipated sales erosion driven by unfavorable pricing in the U.S. and generic launches, particularly in the EU.
Denosumab biosimilar competition: Anticipated declines in sales due to increased competition from biosimilars.
TAVNEOS FDA discussions: Ongoing dialogue with the FDA regarding TAVNEOS, with potential regulatory challenges.
OCEAN(a)-Outcomes study delays: Event-driven study for olpasiran progressing slower than initial predictions, potentially delaying primary analysis.
Rocatinlimab termination: Decision to terminate development and commercialization collaboration with Kyowa Kirin, reallocating resources to other programs.
Bemarituzumab regulatory decision: Decision not to pursue regulatory approval for bemarituzumab in first-line gastric cancer due to unmet efficacy expectations.
Economic pressures on pricing: Price declines for certain products and increased 340B program utilization expected to impact revenues in 2026.
Seasonal sales headwinds: Seasonal headwinds in Q1 2026 due to annual U.S. health insurance cycle, including benefit plan changes and higher patient co-pay obligations.
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Guidance & Outlook
Revenue Expectations: Amgen expects total revenues in the range of $37.0 billion to $38.4 billion for 2026, reflecting strong performance from key growth drivers and offsetting anticipated declines from increased competition and price reductions.
Earnings Per Share (EPS): Non-GAAP earnings per share for 2026 are projected to be between $21.60 and $23.
Growth Drivers: Key growth drivers for 2026 include Repatha, EVENITY, TEZSPIRE, rare disease portfolio, innovative oncology, and biosimilars portfolios.
Seasonal Revenue Trends: Amgen anticipates a seasonal headwind to sales in Q1 2026 due to annual health insurance cycle changes, including benefit plan adjustments and higher patient co-pay obligations.
R&D Investments: Non-GAAP R&D expenses are expected to grow at low single digits, with continued investments in late-stage assets like MariTide and other innovative programs.
Capital Expenditures: Capital expenditures for 2026 are projected to be approximately $2.6 billion, focusing on scaling manufacturing capacity and preparing for MariTide's launch.
Pipeline Developments: Amgen plans to execute six global Phase III clinical trials for MariTide and advance additional late-stage assets, including olpasiran and xaluritamig.
Product-Specific Guidance: Repatha sales are expected to grow due to its strong evidence base and expanded access programs. EVENITY and TEZSPIRE are also projected to continue their growth trajectories. Prolia sales are expected to face accelerated erosion due to biosimilar competition.
Biosimilars Portfolio: The biosimilars portfolio is expected to continue contributing to growth, with new launches planned.
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Shareholder Return Plan
Dividend Payments: Amgen returned capital to shareholders through competitive dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024.
Share Repurchase: Amgen expects share repurchases not to exceed $3 billion in 2026.
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Key Q&A
Q:What is Amgen's view on the obesity portfolio, particularly MariTide?
A:Amgen is focused on developing MariTide across various indications, including cardiovascular and respiratory diseases. They have another clinical stage asset, AMG 513, in Phase I clinical investigation, and preclinical programs include both incretin-based and non-incretin-based medicines. They aim to compete broadly in the obesity field.
Q:What is the status of dazodalibep for primary Sjogren's syndrome?
A:Both Phase III studies for dazodalibep are fully enrolled, with completion expected in the second half of the year. The studies target moderate-to-severe symptomatic activity and high symptom burden populations. The Phase II results showed improvement in the ESSDAI score, providing confidence for Phase III.
Q:What is the market opportunity for UPLIZNA in IgG4-related disease and gMG?
A:The diagnosed population for IgG4-related disease is estimated at 35,000, with potential growth due to increased awareness. UPLIZNA is performing well in uptake across specialties. In gMG, initial uptake is promising, with half of the patients being bio-naive and the other half switching from other therapies. The product addresses limitations in current treatments.
Q:What is the rationale for moving UPLIZNA into Phase III for CIDP?
A:UPLIZNA targets the CD19 pathologic B cell, which is evident in autoimmune conditions like CIDP. The prevalent pool in the U.S. is about 35,000 patients, with 7,000-10,000 new cases annually. The drug's mechanism and efficacy in related conditions make it a strong candidate for CIDP.
Q:How is Amgen adapting its strategy for Repatha in light of Merck's oral PCSK9 launch?
A:Amgen is focusing on promoting Repatha's primary and secondary prevention data, particularly the VESALIUS trial results. Repatha has broad access and is preferred on national formularies. Amgen believes there is room for other therapies but emphasizes Repatha's established data package and profile.
Q:What is the status of TEPEZZA and AMG 732 for thyroid eye disease (TED)?
A:TEPEZZA is a leading treatment for TED, with ongoing Phase III studies for subcutaneous administration. AMG 732, an IGF-1R targeting monoclonal antibody, is in Phase II for moderate-to-severe active TED. TEPEZZA is expanding its prescribing base and launching internationally.
Q:What is the update on MariTide's Phase III program for type 2 diabetes?
A:Amgen is excited about MariTide's potential to shift the diabetes management paradigm. The Phase II study has shown robust findings, and Phase III design details, including control arms, will be shared in the future.
Q:What is Amgen's perspective on less frequent dosing for MariTide?
A:Amgen is exploring less frequent dosing options, such as quarterly dosing, for weight maintenance. They believe less frequent dosing may not necessarily trade off efficacy and could be individualized for patients.
Q:Why did the FDA request the withdrawal of TAVNEOS?
A:The FDA requested a voluntary withdrawal due to concerns about the re-adjudication process for primary endpoint results in 9 out of 331 patients in the ADVOCATE Phase III study. Discussions with the FDA are ongoing.
Q:How does Amgen plan to maintain leadership with PAVBLU amidst new biosimilar launches?
A:Amgen has established strong relationships with national retina specialist networks and offers a competitive product with a great device. They plan to leverage their biosimilar experience to compete effectively.
Q:What is the role of MariTide in weight loss and maintenance?
A:MariTide is positioned as a paradigm-changing therapy for weight loss and maintenance. It offers monthly, 8-week, or quarterly dosing options and could attract patients switching from other therapies.
Q:Review of Unclear Management Responses
A:Management avoided directly addressing the specific design details of the MariTide Phase III program for type 2 diabetes, including the control arm. They also did not provide clarity on the rationale behind the FDA's request for TAVNEOS withdrawal, only stating that discussions are ongoing.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
ANCA vasculitis
CV trial
Executive
Kyowa Kirin
Lpa risk
Otezla
TAVNEOS medicine
VESALIUS CV
approval Phase
biosimilar competition
brand patient
cell depletion
completion
confidence MariTide
daxdilimab
decision resource
denosumab biosimilar
development transaction
diabetes obesity
enthusiasm
evidence
expenditure capital
heart attack
income expense
insurance
liver
medicine therapy
obesity type
olpasiran
option
participant
phase
portfolio decision
position
sale product
spending
xaluritamig
AMGN Transcript
Amgen Inc. (AMGN) Q4 2025 Earnings Call Transcript
Positive2-3
Amgen's earnings call presents several positive indicators: increased revenue and EPS guidance, strong product development, and a robust biosimilar portfolio. The Q&A session reveals confidence in pipeline expansions and market opportunities, despite some unclear responses. The raised guidance and strong financial metrics are likely to positively influence the stock price, while the lack of market cap data suggests a moderate impact, leading to a positive sentiment prediction.
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