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    AMGN
    Earnings call· Jun 2025(Q2 FY25)

    AMGEN Q2 FY25 earnings call AMGN

    Aug 5, 2025 Source

    Executive summary

    Amgen Q2 FY25 — Strong Volume Growth and Pipeline Advancement

    Amgen delivered a strong second quarter, marked by robust volume-driven revenue growth across its diverse portfolio, including significant contributions from rare disease and biosimilars. The company is actively advancing a world-class pipeline, with multiple late-stage programs in obesity, cardiovascular disease, and oncology, while also navigating industry pricing pressures and investing in AI for innovation. Management remains focused on long-term growth and disciplined execution.

    Highlights

    5

    • Total revenues grew by 9% year-over-year to $9.2 billion, driven by 13% volume growth.

    • 15 products delivered at least double-digit sales growth, demonstrating portfolio breadth.

    • Rare disease portfolio grew 19% year-over-year, delivering nearly $1.4 billion in sales.

    • Biosimilar portfolio sales grew 40% year-over-year to $661 million.

    • IMDELLTRA generated $134 million in sales in its launch quarter, showing strong uptake in second-line small cell lung cancer.

    Concerns

    2

    • Prolia sales declined 4% year-over-year to $1.1 billion, driven by lower net selling price due to biosimilar entry.

    • Industry-wide focus on pricing and tariffs continues to be a discussion point with government officials.

    Guidance & targets

    9
    CategoryTargetConfidence
    Total Revenues
    $35.0 billion to $36.0 billion
    high materiality
    High
    Non-GAAP Earnings Per Share
    $20.20 and $21.30
    high materiality
    High
    Non-GAAP Operating Margin as percentage of product sales
    roughly 45%
    medium materiality
    Medium
    Non-GAAP R&D expense growth
    over 20%
    medium materiality
    Medium
    Non-GAAP OI&E
    approximately $2.2 billion
    medium materiality
    Medium
    Other Revenue
    approximately $1.4 billion
    low materiality
    High
    Non-GAAP Tax Rate
    14.5% to 16.0%
    medium materiality
    High
    Share Repurchases
    not to exceed $500 million
    medium materiality
    High
    Capital Expenditures
    $2.3 billion
    medium materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    General Medicine
    General Medicine portfolio is reaching large, underserved patient populations. Repatha continues to see strong demand and improved access, with less net price erosion expected. EVENITY is growing significantly, especially in the US, with a large unmet need remaining in high-risk fracture patients. Prolia sales declined due to lower net selling price and biosimilar entry.
    Repatha sales: $696 millionRepatha growth_yoy: 31%Repatha new-to-brand prescriptions from primary prevention: 40%EVENITY sales: $518 millionEVENITY growth_yoy: 32%EVENITY US growth_yoy: 41%EVENITY patients treated in Japan since launch: 700,000+EVENITY patients treated in US to date: 250,000Prolia sales: $1.1 billionProlia growth_yoy: -4%
    		————
    Rare Disease
    Rare disease portfolio is a key growth driver, with strong performance from TEPEZZA and UPLIZNA. TEPEZZA launched in Japan in December. UPLIZNA's growth is bolstered by FDA approval for IgG4-related disease and anticipated approval for generalized myasthenia gravis.
    Annualized sales: >$5 billionTEPEZZA sales: $505 millionTEPEZZA growth_yoy: 5%UPLIZNA sales: $176 millionUPLIZNA growth_yoy: 91%
    		$1.4 billion19%——
    Inflammation
    TEZSPIRE continues strong growth, expanding the severe asthma category and gaining market share due to its differentiated profile. Significant opportunity for continued growth remains as biologic penetration is still low.
    TEZSPIRE sales: $342 millionTEZSPIRE growth_yoy: 46%US biologic penetration in severe asthma: <25%
    		————
    Oncology
    Innovative oncology portfolio, including products from the BiTE platform, is redefining standards of care. IMDELLTRA is building momentum as a new standard of care in second-line small cell lung cancer. BLINCYTO is seeing broad prescribing and NCCN guideline updates.
    IMDELLTRA sales: $134 millionBLINCYTO sales: $384 millionBLINCYTO growth_yoy: 45%
    		$2.2 billion14%——
    Biosimilars
    Biosimilar portfolio continues to be a significant contributor to top-line growth and cash flow. PAVBLU (EYLEA biosimilar) is gaining momentum with retina specialists.
    Cumulative sales since 2018: ~$12 billionPAVBLU sales: $130 million
    		$661 million40%——

    Operational metrics

    15
    Non-GAAP Operating Expenses growth
    8%YoY
    Q2 FY25

    Led by non-GAAP R&D growth.

    Non-GAAP R&D growth
    18%YoY
    Q2 FY25

    Reflecting continued investment in late-stage pipeline.

    Non-GAAP R&D spend
    $1.7 billion
    Q2 FY25

    An increase of 18% year-over-year.

    Non-GAAP OI&E favorability
    $213 millionYoY
    Q2 FY25

    Driven by gains from early retirement of debt and lower interest expense.

    Non-GAAP Tax Rate
    14.2%down 0.7 percentage points YoY
    Q2 FY25

    Primarily due to the change in earnings mix.

    Capital Expenditures
    $2.3 billion
    FY25

    Expected for expanding network capacity for products and innovative pipeline, including MariTide.

    Dividend per share
    $2.386% increase compared to Q2 2024
    Q2 FY25

    Capital returned to shareholders.

    Debt retired
    $4.3 billion
    H1 2025

    Follows $4.5 billion retired in 2024, contributing to a stronger capital structure.

    Total Revenue volume growth
    13%
    Q2 FY25

    Driving overall revenue increase.

    Products with double-digit sales growth
    15
    Q2 FY25

    Demonstrates breadth and depth of portfolio.

    Biosimilar regulatory success rate
    100%
    since 2018

    Success rate in regulatory and development milestones for biosimilar portfolio.

    IMDELLTRA administration in community setting
    Over half
    Q2 FY25

    Indicates growing comfort with the new cancer therapy.

    Repatha new-to-brand prescriptions from primary prevention
    40%
    current

    Patients who have yet to suffer a first vascular event.

    Unmet need in high-risk fracture patients (US)
    90%
    current

    Approximately 90% of the roughly 2 million very high-risk patients still not receiving appropriate therapy for fracture risk.

    Obesity patients addressed by current medicines
    2%
    current

    Reflects massive unmet need in the obesity market.

    Industry KPIs

    7
    MetricValueDetails
    Launch access metrics100 millionpeople
    Pipeline read out calendarMultiple Phase III readouts
    Regulatory approvals filingsFDA approval for IgG4-related disease
    Therapeutic drug market share40%%
    Prescription volume new starts40%%
    Clinical trial efficacy safety data40%%
    Cumulative patients uptake since launch700,000+patients

    Deals & partnerships

    1
    Business development transactionsSeveral business development transactions

    These transactions are included in the updated outlook for non-GAAP R&D expense growth.

    Risks & headwinds

    4
    Lower net selling prices for medicinesQ2 FY25

    Prolia sales declined 4% year-over-year to $1.1 billion due to lower net selling price.

    Mitigation: Focus on volume growth (13% increase in Q2 FY25) and portfolio breadth (15 products with double-digit growth).

    Biosimilar competitionOngoing

    3 biosimilars have launched for Prolia in the U.S.

    Mitigation: Initial market dynamics for Prolia biosimilars are unfolding in line with expectations; Amgen's biosimilar portfolio itself is a significant growth driver.

    Industry pricing and tariffsOngoing

    Focus on pricing and tariffs in the industry.

    Mitigation: Actively engaged in discussions with government officials to find ways to improve patient access and affordability while preserving the innovative ecosystem.

    Compounding of GLP-1sOngoing

    Persistent unlawful compounding in the obesity space.

    Mitigation: MariTide, as an antibody, cannot be compounded in the same way as peptides/small molecules. Amgen views compounding as not good for the industry or patients and emphasizes the importance of a quality framework.

    What to watch in Q3 FY25

    5

    MariTide Phase II data readout

    Q4 2025
    CurrentPhase II data expected Q4 2025
    TargetGranularity on maintenance dosing (Q8/Q12 weeks) and overall results for type 2 diabetes and chronic weight management studies.

    Why it matters

    This data will provide crucial insights into MariTide's long-term efficacy and dosing flexibility, informing its competitive positioning in the rapidly evolving obesity market.

    the data readout from the Phase II type 2 diabetes study and Part 2, the chronic weight management studies are expected in Q4 of 2025, and we'll have more to share about these data in due course⏳.

    Q&A highlights

    8

    How much granularity will be available from the Phase II data readout in Q4 2025 regarding patients on maintenance, specifically for Q8 and Q12 week dosing?

    The Phase II data readout for MariTide's type 2 diabetes study and chronic weight management studies is expected in Q4 2025, and more details will be shared in due course.

    “the data readout from the Phase II type 2 diabetes study and Part 2, the chronic weight management studies are expected in Q4 of 2025, and we'll have more to share about these data in due course.”

    asked by Yaron Werber · answered by James Bradner

    2 min read6 chapters

    Detailed Narrative

    01

    Volume-Driven Growth Across Diverse Portfolio

    Amgen reported strong Q2 FY25 results with total revenues growing 9% year-over-year, primarily driven by an impressive 13% increase in volume. This growth was broad-based, with 15 products achieving double-digit sales increases. Key drivers included Repatha, EVENITY, TEZSPIRE, and the innovative oncology, rare disease, and biosimilar portfolios, demonstrating the company's ability to differentiate through volume in an industry facing declining net selling prices.

    02

    Advancing a World-Class Pipeline

    The company is making significant progress in its R&D pipeline, with multiple late-stage programs advancing. MariTide, the investigational obesity therapy, has four Phase III studies underway, including for cardiovascular outcomes and heart failure, with strong enrollment momentum. Other key pipeline assets like olpasiran, IMDELLTRA, and xaluritamig are also progressing, reflecting continued heavy investment in innovation and leveraging AI across the value chain.

    03

    MariTide's Differentiated Profile and Phase III Strategy

    MariTide is highlighted for its convenient monthly or less frequent dosing, strong efficacy with up to approximately 20% weight loss at 52 weeks, and improved GI tolerability through a refined 3-step dose escalation approach in Phase III. The Phase III program is designed to optimize tolerability and provide a graded understanding of dose and response, with a 21-milligram starting dose having a very low risk of serious GI events. The company aims to guide optimal long-term maintenance therapy for chronic weight management.

    04

    Oncology Portfolio Momentum and BiTE Platform Success

    Amgen's innovative oncology portfolio grew 14% year-over-year, generating $2.2 billion in sales. This growth is underpinned by the industry-leading bispecific T cell engager (BiTE) platform, which led to IMDELLTRA and BLINCYTO. IMDELLTRA, for small cell lung cancer, showed a 40% reduced risk of death and extended median overall survival by over 5 months in the DeLLphi-304 trial, with regulatory filings underway. BLINCYTO also demonstrated strong remission rates with a subcutaneous formulation in development.

    05

    Biosimilars Continue to Drive Growth and Access

    The biosimilar portfolio delivered significant growth, up 40% year-over-year to $661 million, contributing nearly $12 billion in cumulative sales since 2018. Recent launches like PAVBLU (EYLEA biosimilar) are gaining momentum, reaching $130 million in Q2. Management views the biosimilar market as developing well, providing safe and reliable supply, and sees potential for future IV biosimilars to compete effectively, even against hyaluronidase subcutaneous versions, due to their expertise in oncology biosimilars.

    06

    Capital Structure and M&A Appetite

    Amgen has made significant progress in shoring up its balance sheet, having retired $4.3 billion in debt in the first half of 2025, following $4.5 billion in 2024. The company remains interested in rare disease for both organic and inorganic growth opportunities, but emphasizes the need to execute flawlessly on its current late-stage pipeline. While open to M&A, particularly in rare disease, the focus is on strategic fit and maintaining strong execution across existing programs.

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