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    AMGN
    Earnings call· Sep 2025(Q3 FY25)

    AMGEN INC AMGN

    Nov 4, 2025 Source

    Executive summary

    Amgen Q3 FY25 — Strong Volume Growth and Pipeline Momentum

    Amgen delivered a strong third quarter, marked by robust volume-driven revenue growth across its key therapeutic areas and biosimilar portfolio. The company is advancing a deep pipeline, particularly in obesity with MariTide and cardiovascular disease with Repatha, while also expanding access to its medicines through initiatives like AmgenNow. Management remains focused on innovation, disciplined capital allocation, and executional excellence to sustain long-term growth, despite evolving competitive dynamics for some established products.

    Highlights

    5

    • Revenues increased 12% year-over-year to $9.6 billion, driven by strong volume growth.

    • Volume growth was 14% year-over-year, with 16 products achieving double-digit growth.

    • Biosimilar revenues increased 52% year-over-year to $775 million, now annualizing at $3 billion.

    • Repatha sales grew 40% year-over-year to $794 million, annualizing at approximately $3 billion.

    • EVENITY sales increased 36% year-over-year to $541 million, driven by higher prescription volumes.

    Concerns

    3

    • Prolia sales are expected to be negatively impacted by increased biosimilar competition in future quarters.

    • The OCEAN(a) Phase III study for Olpasiran has a lower-than-initial-predictions event accrual rate, potentially delaying primary analysis.

    • FORTITUDE-102, a Phase Ib/III study of bemarituzumab in gastric cancer, was stopped due to inadequate efficacy at an ad hoc analysis.

    Guidance & targets

    8
    CategoryTargetConfidence
    Total Revenues
    $35.8 billion to $36.6 billion
    high materiality
    High
    Non-GAAP Earnings Per Share
    $20.60 to $21.40
    high materiality
    High
    Capital Expenditures
    roughly $2.2 billion to $2.3 billion
    medium materiality
    High
    Other Revenue
    approximately $1.5 billion
    low materiality
    High
    Non-GAAP R&D expenses growth
    mid-20s percentage rate year-over-year
    medium materiality
    High
    Non-GAAP OI&E
    $2.1 billion to $2.2 billion
    low materiality
    High
    Non-GAAP Tax Rate
    15.0% to 16.5%
    low materiality
    High
    Non-GAAP Operating Margin as % of Product Sales
    roughly 45%
    medium materiality
    High

    Segment performance

    14
    SegmentRevenueYoYQoQMargin
    Total Company
    Revenues increased 12% year-over-year, driven by 14% volume growth. 16 products grew at double-digit rates, and 14 are now annualizing at over $1 billion in sales.
    		$9.6 billion12%——
    General Medicine - Repatha
    Strong growth driven by increased utilization and expanded access initiatives like AmgenNow. VESALIUS-CV data shows significant benefits in preventing first heart attack or stroke.
    Annualized Sales: ~$3 billionPCSK9 Inhibitor Class Utilization: <5% of eligible patientsPatients in need of LDL-C lowering: ~100 millionU.S. Payer Coverage: >95%U.S. Out-of-Pocket Cost: <$50 per monthAmgenNow Monthly Price: $239
    		$794 million40%——
    General Medicine - EVENITY
    Growth driven by higher prescription volumes from both established and newly activated prescribers, particularly strong in the U.S. and Japan.
    U.S. Sales Growth: 44%U.S. Market Share (Bone Builder Segment): >60%U.S. Patients Treated to Date: ~270,000Japan Patients Prescribed Since Launch: ~800,000Japan Market Share (Bone Builder Category): >50%Very High-Risk Patients Not Receiving Therapy (U.S.): ~90% of 2 million
    		$541 million36%——
    General Medicine - Prolia
    Growth impacted by competitive dynamics from three biosimilars launched in the U.S., with increased competition expected to negatively impact future sales.
    		$1.1 billion9%——
    Rare Disease
    Portfolio performing well with strong performance across the board, driven by products early in their life cycle.
    Annualized Sales: >$5 billion
    		$1.4 billion13%——
    Rare Disease - UPLIZNA
    Growth driven by the launch in IgG4-related disease and increased new patient demand for NMOSD. Anticipated approval in generalized myasthenia gravis (gMG).
    Unique Prescribers (IgG4-related disease since launch): >300
    		$155 million46%——
    Rare Disease - TEPEZZA
    Growth driven by increases in inventory and price. Encouraging launch in Japan and continued engagement with prescribers in the U.S.
    Patients Treated (Japan since December): >800Patients Treated (U.S. since launch): ~25,000
    		$560 million15%——
    Rare Disease - TAVNEOS
    Strong volume growth and increasing prescriber base in the U.S.
    Patients Treated (U.S. with ANCA-associated vasculitis): >6,700Healthcare Professionals Prescribed (U.S.): >3,800Prescriber Base Increase (YTD): 31%
    		$107 million34%——
    Inflammation - TEZSPIRE
    Strong quarter with recent FDA and European Commission approvals for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps.
    Sales Year-to-Date: >$1 billion
    		$377 million40%——
    Oncology
    Growth fueled by the industry-leading bispecific T cell engager platform, including IMDELLTRA and BLINCYTO.
    		$2.3 billion9%——
    Oncology - IMDELLTRA
    Strong clinical conviction and rapid adoption, now recognized as standard of care for extensive stage small cell lung cancer.
    Sites of Care Administering (U.S.): >1,400Doses in Community Setting: >50%Overall Survival (DeLLphi-303, first-line maintenance): 25.3 monthsOverall Survival (DeLLphi-303, first-line treatment): 81% at 12 months
    		$178 million———
    Oncology - BLINCYTO
    Growth driven by broad prescribing across academic and community segments, established as standard of care in B-cell acute lymphoblastic leukemia.
    		$392 million20%——
    Biosimilar Portfolio
    Delivered another strong quarter with additional launches providing meaningful top-line growth and durable cash flow.
    Annualized Sales: $3 billionTotal Sales Since 2018: ~$13 billion
    		$775 million52%——
    Biosimilar Portfolio - PAVBLU
    Gaining momentum with positive response from retina specialists due to convenient prefilled syringe format and high-quality manufacturing.
    		$213 million———

    Operational metrics

    18
    Non-GAAP Operating Margin
    47%
    Q3 FY25

    Reflects significant investments across the business.

    Non-GAAP R&D Growth
    31%year-over-year
    Q3 FY25

    Includes $200 million from business development transactions. Excluding these, non-GAAP R&D grew 19% year-over-year.

    Non-GAAP Operating Expenses Growth
    14%year-over-year
    Q3 FY25

    Excluding business development transactions.

    Non-GAAP OI&E
    $568 million
    Q3 FY25

    Reported as an expense.

    Debt Retired
    $4.5 billion
    FY24

    Debt retired in 2024.

    Debt Retired
    $6.0 billion
    FY25

    Debt retired in 2025, returning to pre-Horizon capital structure ahead of plan.

    Pretax Cost Synergies (Horizon acquisition)
    >$500 million
    FY25

    Expected to be achieved in connection with the acquisition.

    Non-GAAP Tax Rate
    18.2%increased 4.8 percentage points year-over-year
    Q3 FY25

    Primarily due to change in earnings mix.

    Dividend Per Share
    $2.386% increase compared to Q3 2024
    Q3 FY25

    Returned capital to shareholders through competitive dividend payments.

    AmgenNow Repatha Price
    $239nearly 60% below current U.S. list price
    monthly

    Direct-to-patient program for Repatha, aiming to improve affordability and access.

    IgG4-related disease Prescribers (UPLIZNA)
    >300
    since launch

    Across multiple specialties, demonstrating breadth of adoption.

    Patients Treated (TEPEZZA)
    ~25,000
    since launch

    To reach more patients, Amgen continues to engage a broad prescriber base.

    Patients Treated (TAVNEOS)
    >6,700
    cumulative

    Patients with ANCA-associated vasculitis treated.

    Healthcare Professionals Prescribed (TAVNEOS)
    >3,80031% increase YTD
    cumulative

    Growing prescriber base for TAVNEOS.

    Sites of Care Administering (IMDELLTRA)
    >1,400
    cumulative

    With more than half of doses occurring in the community setting.

    Biosimilar Sales Generated
    ~$13 billion
    since 2018

    Total sales generated since the first product approvals in 2018.

    Investments in Manufacturing and R&D
    >$40 billion
    since 2017

    Invested since the passage of the Tax Cuts and Jobs Act in 2017.

    Planned Manufacturing Investments (U.S.)
    >$3 billion
    FY25

    Planned investments in manufacturing in the U.S. this year alone.

    Industry KPIs

    5
    MetricValueDetails
    Launch access metrics>95%%
    Regulatory approvals filingsDecember 14date
    Therapeutic drug market share>60%%
    Clinical trial efficacy safety dataSignificant reductions in MACE
    Cumulative patients uptake since launch~270,000patients

    Product announcements

    2
    ProductTypeDetails
    AmgenNowlaunch
    TEZSPIREexpansion

    Deals & partnerships

    1
    VariousBusiness development transactions

    Several business development transactions contributed to increased R&D expenses.

    Risks & headwinds

    4
    Biosimilar competition for ProliaFuture quarters

    Three biosimilars launched to date in the U.S.

    Mitigation: Competitive dynamics evolving in line with expectations; Amgen expects to be in good shape and competitive regardless of guidance changes.

    Lower-than-expected event rate in Olpasiran OCEAN(a) study

    Event accrual rate is lower than initial predictions.

    Mitigation: Management maintains strong conviction in the program due to genetic and epidemiological data; will update on primary analysis date as the study matures.

    Clinical trial failure (bemarituzumab)

    FORTITUDE-102 study stopped for inadequate efficacy.

    Mitigation: Amgen remains committed to creating medicines for challenging cancers but acknowledged the observed efficacy did not meet its standard for an Amgen medicine.

    Policy changes in the biosimilar market

    Undercurrent of question in some quarters about biosimilar market success.

    Mitigation: Amgen believes the market is performing well and advocates for policies that support its flourishing, watching carefully to prevent policies that might move it towards the generic drug industry model.

    What to watch in Q4 FY25

    4

    Repatha VESALIUS-CV full data

    November 8
    CurrentDual primary MACE endpoints met in Phase III
    TargetDetailed data presentation at AHA Scientific Sessions

    Why it matters

    This landmark study could significantly expand Repatha's market opportunity by demonstrating efficacy in primary prevention of cardiovascular events.

    We are very excited to share the full results from this trial at the American Heart Association Scientific Sessions on November 8 and would encourage all to review the detailed data when presented.

    Q&A highlights

    8

    What is Amgen's confidence in Olpasiran given the lower-than-expected event rate in OCEAN(a), and how does returning to pre-Horizon debt levels impact BD strategy for 2026?

    Management maintains strong conviction in Olpasiran due to clear genetic and epidemiological data, best-in-class properties, and good study conduct, but will not guide on the readout date. For BD, returning to pre-Horizon debt levels does not significantly change the strategy; Amgen is actively looking for earlier-stage opportunities in its therapeutic areas of interest.

    “Our conviction remains very strong. The genetic association for Lp(a) in cardiovascular disease is crystal clear from human genetics, from epidemiological data.”

    asked by Salveen Richter · answered by James Bradner

    3 min read6 chapters

    Detailed Narrative

    01

    Repatha's Expanded Cardiovascular Impact

    Amgen highlighted the significant potential of Repatha following positive results from the VESALIUS-CV outcome study, which met its dual major adverse cardiovascular events (MACE) endpoints in high-risk patients without prior heart attack or stroke. This landmark study, enrolling over 12,000 patients, demonstrated additive benefits beyond statins, reinforcing Repatha's role in primary prevention. The full data will be presented at the American Heart Association Scientific Sessions on November 8, with management emphasizing its importance for primary care physicians and patient access.

    02

    MariTide's Rapid Advancement in Obesity Pipeline

    MariTide, Amgen's differentiated obesity candidate, has seen rapid progress with both Phase III chronic weight management studies fully enrolled, attracting approximately 5,000 adults in six months. Additional Phase III studies for atherosclerotic cardiovascular disease (MARITIME-CV) and heart failure (MARITIME-HF) are underway, alongside two new Phase III studies in obstructive sleep apnea. This broad development program aims to build a robust evidence base for MariTide, which has shown statistically significant reductions in cardiovascular risk factors beyond weight loss in Phase II.

    03

    UPLIZNA's Growth and Upcoming gMG Approval

    UPLIZNA sales increased 46% year-over-year to $155 million, driven by strong uptake in IgG4-related disease, a recently defined condition where UPLIZNA is the only FDA-approved treatment. Over 300 unique prescribers have adopted it across multiple specialties. The company is also preparing for the anticipated approval of UPLIZNA in generalized myasthenia gravis (gMG) with a PDUFA date of December 14, expecting strong market presence due to its differentiated profile, durable efficacy, and convenient twice-yearly dosing after the initial loading dose.

    04

    Oncology Bispecific T-cell Engager Platform Momentum

    Amgen's bispecific T-cell engager platform continues to drive growth in oncology, with IMDELLTRA and BLINCYTO redefining standards of care. IMDELLTRA generated $178 million in sales, rapidly adopted as standard of care for extensive stage small cell lung cancer, with over 1,400 sites now administering it. Promising overall survival data from the DeLLphi-303 study in first-line maintenance and induction settings suggest potential for earlier lines of therapy. BLINCYTO grew 20% to $392 million, firmly established in B-cell acute lymphoblastic leukemia.

    05

    Biosimilar Portfolio's Strategic Importance and Performance

    The biosimilar portfolio delivered strong results, with sales increasing 52% year-over-year to $775 million and now annualizing at $3 billion. Since 2018, biosimilars have generated nearly $13 billion in sales, providing meaningful top-line growth and durable cash flow. PAVBLU, a biosimilar to EYLEA, is gaining momentum with $213 million in sales, benefiting from its prefilled syringe format and Amgen's manufacturing quality. Management views the biosimilar market as functioning well in the U.S. and advocates for policies that support its continued growth.

    06

    Capital Allocation and Investment Strategy

    Amgen has returned to its pre-Horizon capital structure ahead of plan, retiring $4.5 billion of debt in 2024 and $6.0 billion in 2025. The company expects to achieve over $500 million in pretax cost synergies in 2025 from the Horizon acquisition. Capital expenditures for 2025 are projected at $2.2 billion to $2.3 billion, focused on expanding network capacity and supporting the innovative pipeline, particularly MariTide. Investments in R&D, including late-stage programs and AI, are a priority for long-term growth.

    AI-generated summary of the company’s earnings call. Not investment advice.