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    REGN
    Earnings call· Dec 2025(Q4 FY25)

    REGENERON PHARMACEUTICALS Q4 FY25 earnings call REGN

    Jan 30, 2026 Source

    Executive summary

    Regeneron Q4 FY25 — Strong Commercial Execution and Robust Pipeline Advancement

    Regeneron concluded Q4 FY25 with solid commercial performance, driven by double-digit growth in DUPIXENT, EYLEA HD, and LIBTAYO, alongside significant pipeline advancements. The company is focused on maximizing its leading brands and advancing a robust pipeline with multiple pivotal readouts and regulatory milestones expected in 2026, while prudently deploying capital to enhance shareholder value.

    Highlights

    5

    • Total revenue up 3% year-over-year in Q4 FY25.

    • Global DUPIXENT net sales increased 32% year-over-year to $4.9 billion in Q4 FY25, reaching $17.8 billion for full year 2025.

    • EYLEA HD U.S. net sales grew 66% year-over-year to $506 million in Q4 FY25, totaling $1.6 billion for full year 2025.

    • Global LIBTAYO net product sales increased 13% year-over-year to $425 million in Q4 FY25, reaching $1.45 billion for full year 2025.

    • Anticipate at least 4 FDA approvals in 2026, including 3 new molecular entities and EYLEA HD prefilled syringe.

    Concerns

    4

    • EYLEA 2 milligrams U.S. net sales declined 15% sequentially to $577 million in Q4 FY25 due to competitive pressure and conversion to EYLEA HD.

    • EYLEA HD and EYLEA wholesaler inventory levels were elevated by approximately $30 million at the end of Q4 FY25, expected to negatively impact Q1 FY26 net sales.

    • EYLEA 2 milligrams expected to face intensified competitive pressure in H2 2026 from biosimilar launches.

    • Patient co-pay affordability issues continue to dampen branded anti-VEGF category growth.

    Guidance & targets

    25
    CategoryTargetConfidence
    2026 R&D spend
    $5.9 billion to $6.1 billion
    high materiality
    High
    2026 SG&A
    $2.5 billion to $2.65 billion
    medium materiality
    High
    2026 Gross margin on net product sales
    83% to 84%
    medium materiality
    High
    2026 Capital expenditures
    $1.1 billion to $1.3 billion
    medium materiality
    High
    2026 Effective tax rate
    13% to 15%
    low materiality
    High
    DUPIXENT development balance reimbursement
    Fully reimbursed
    medium materiality
    High
    EYLEA HD prefilled syringe regulatory decision
    Expected
    medium materiality
    High
    fianlimab + LIBTAYO in advanced melanoma readout
    On track to read out
    high materiality
    High
    fianlimab in adjuvant melanoma interim analysis
    Expecting an interim analysis
    medium materiality
    High
    fianlimab in advanced non-small cell lung cancer Phase II data
    Expecting Phase II data
    low materiality
    High
    cemdisiran in gMG U.S. regulatory application submission
    On track to submit
    high materiality
    High
    cemdisiran in gMG potential approval
    Anticipated
    high materiality
    High
    cemdisiran + pozelimab in PNH pivotal data
    Expected
    high materiality
    High
    DB-OTO gene therapy regulatory decision
    Awaiting a regulatory decision
    medium materiality
    High
    garetosmab regulatory decisions (U.S. and EU)
    Waiting on regulatory decisions
    medium materiality
    High
    olatorepatide monotherapy pivotal studies
    Entering pivotal monotherapy studies
    high materiality
    High
    olatorepatide + PRALUENT clinical program
    Expected to begin
    high materiality
    High
    Long-acting IL-13 antibody clinic entry
    Expected to enter the clinic
    medium materiality
    High
    Other long-acting antibodies clinic entry
    Expected to enter the clinic
    low materiality
    High
    First new I&I antibody clinical development
    Expected to enter clinical development
    medium materiality
    High
    Confirmatory Phase III study for cat allergy initiation
    Anticipate initiating
    medium materiality
    High
    Next-generation Ig-producing cell targeting agents clinical development
    Expected to enter clinical development
    medium materiality
    High
    C5 program for geographic atrophy interim data
    Expect interim data
    high materiality
    High
    Factor XI pivotal studies initiation
    Expected to initiate
    medium materiality
    High
    LYNOZYFIC pivotal studies initiation
    4 more initiating
    high materiality
    High

    Segment performance

    5
    SegmentRevenueYoYQoQMargin
    DUPIXENT (Global)
    Full year 2025 global net sales were $17.8 billion.
    		$4.9 billion32% (constant currency)——
    LIBTAYO (Global)
    Full year 2025 global net product sales were $1.45 billion. U.S. net sales grew 14% year-over-year to $285 million.
    		$425 million13% (constant currency)——
    EYLEA HD (U.S.)
    Full year 2025 U.S. net sales were $1.6 billion, up 36%. Performance driven by 10% increase in physician demand compared to Q3.
    		$506 million66%18% sequential growth—
    EYLEA 2 milligrams (U.S.)
    Declined due to competitive pressure and ongoing conversion to EYLEA HD.
    		$577 million—-15% sequentially—
    EYLEA and EYLEA 8 milligrams (outside U.S. - Bayer)
    Includes $312 million of EYLEA 8 milligram sales.
    		$817 million———

    Operational metrics

    24
    Non-GAAP Diluted Net Income Per Share
    $11.44
    Q4 FY25

    On net income of $1.2 billion.

    Sanofi collaboration revenues
    $1.6 billion
    Q4 FY25

    Driven by strong global DUPIXENT sales growth and improving collaboration margins.

    Regeneron's share of Sanofi collaboration profits growth
    42%vs prior year
    Q4 FY25

    Primarily driven by DUPIXENT.

    Sanofi development balance
    Just below $600 millionReduced by $300 million since Q3 FY25, over $1 billion in full year 2025
    End of 2025

    Expected to be fully reimbursed by mid-2026.

    Bayer collaboration revenue
    $319 million
    Q4 FY25

    Related to Regeneron's share of net profits outside the United States.

    Other revenue
    $239 million33% growth
    Q4 FY25

    Includes profit share and royalties associated with license agreements as well as amounts earned for contract manufacturing.

    Ilaris royalty tier
    15%
    2025

    Achieved for the first time as net sales exceeded $1.5 billion.

    Non-GAAP R&D expense
    $1.3 billion
    Q4 FY25

    Reflecting continued investments to support Regeneron's innovative pipeline.

    Non-GAAP SG&A
    $691 million
    Q4 FY25

    Inclusive of a matching contribution to the Good Days' Vascular and Neovascular Retinal Disease Fund.

    Effective tax rate (non-GAAP)
    17%Increased from prior year
    Q4 FY25

    Primarily reflects a lower tax benefit from stock-based compensation.

    Cash and marketable securities less debt
    $16.2 billion
    End of Q4 FY25

    Balance at the end of the quarter.

    Capital returned to shareholders
    $3.8 billion
    FY25

    Primarily through share repurchases.

    Share repurchases
    $3.4 billion
    FY25

    Executed in 2025.

    Remaining share repurchase authorization
    $1.5 billion
    As of December 31st

    Remaining authorized for repurchases.

    Cash dividends paid
    Nearly $400 million
    2025

    Paid in 2025.

    Quarterly dividend
    $0.94 per share
    Q1 FY26

    Authorized by Board of Directors, payable in March.

    Anti-VEGF category growth (full year)
    Approximately 5%vs 2024
    FY25

    The innovative branded segment, which excludes Avastin and biosimilars, declined.

    EYLEA HD physician demand growth
    10%sequential growth vs Q3
    Q4 FY25

    Despite a 7% sequential decline in the overall anti-VEGF category.

    EYLEA HD treatment duration extension
    Almost 4 weeks
    Real-world data

    For patients with ongoing anti-VEGF therapy who switched to EYLEA HD.

    EYLEA HD / EYLEA wholesaler inventory elevation
    Approximately $30 million
    End of Q4 FY25

    Expected to negatively impact Q1 FY26 net sales as the inventory is absorbed.

    EYLEA HD sequential demand growth (anticipated)
    High single-digit
    Q1 FY26

    Anticipated for the first quarter.

    EYLEA demand decline (anticipated)
    Double-digitsequential
    Q1 FY26

    Due to competition and ongoing conversion to EYLEA HD.

    Good Days' Retinal Vascular and Neovascular Disease Fund donation
    $60 million
    Q4 FY25

    Matched donation.

    Good Days' Retinal Vascular and Neovascular Disease Fund matching program extension
    Up to $200 million
    Through end of 2026

    Reiterated commitment to helping patients afford their medicines.

    Industry KPIs

    4
    MetricValueDetails
    Launch access metricsCategory 1 preferred immunotherapy
    Patent cliff loe bridgeEYLEA 2 milligrams
    Collaboration milestone royalty revenue$179 millionUSD
    Cumulative patients uptake since launchMore than 1.4 millionpatients

    Risks & headwinds

    5
    Patient co-pay affordability issuesOngoing

    Dampened branded anti-VEGF category growth.

    Mitigation: Matched a $60 million donation to Good Days' Fund in Q4 FY25; extended matching program through end of 2026 up to $200 million.

    Competitive pressure on EYLEA 2 milligramsExpected to intensify in H2 2026

    U.S. net sales declined 15% sequentially to $577 million in Q4 FY25.

    Mitigation: Continued growth in EYLEA HD and ongoing conversion to EYLEA HD.

    Biosimilar products launched in the United States for EYLEA 2 milligramsSecond half of 2026

    Multiple biosimilar products

    Mitigation: Focus on EYLEA HD growth and differentiation.

    Elevated wholesaler inventory levels for EYLEA HD and EYLEAEnd of Q4 FY25, expected to negatively impact Q1 FY26 net sales

    Approximately $30 million

    Mitigation: Inventory is expected to be absorbed.

    Catalent, Indiana FDA findingsOngoing

    Working with the FDA to resolve findings from a previous inspection.

    Mitigation: FDA submission for EYLEA HD prefilled syringe using a new manufacturer has been accepted for review as a backup.

    Q&A highlights

    7

    Seeking more specific timing for metastatic and adjuvant melanoma data for LIBTAYO plus fianlimab beyond the first half of 2026, and if the adjuvant interim update will coincide with the metastatic readout.

    Management reiterated that the first half of 2026 is the best estimate for both metastatic and adjuvant melanoma readouts, noting they may or may not coincide, and data will be released shortly after it's available.

    “We don't really have any additional clarity right now on the timing for the advanced melanoma readout. First half is the best estimate at this time. In terms of the adjuvant timing, that's also in the first half. They may coincide, they may not.”

    asked by Alexandria Hammond · answered by Ryan Crowe

    2 min read7 chapters

    Detailed Narrative

    01

    Commercial Performance Highlights

    DUPIXENT, EYLEA HD, and LIBTAYO demonstrated strong commercial execution in Q4 FY25, driving overall revenue growth. DUPIXENT achieved $4.9 billion in global net sales, up 32% year-over-year, and is now used by over 1.4 million patients globally across 8 indications. EYLEA HD U.S. net sales grew 66% to $506 million, benefiting from recent FDA approvals for monthly dosing and RVO, while LIBTAYO global sales rose 13% to $425 million, establishing itself as a market leader in non-melanoma skin cancers and gaining share in NSCLC.

    02

    Pipeline Expansion and Strategic Focus

    Regeneron is poised for a significant clinical development year in 2026, planning to initiate 18 additional Phase III studies with approximately 35,000 patients, laying the groundwork for future blockbuster products. The company also intends to advance at least 3 first-in-class antibodies, including two from the Regeneron Genetics Center, and a long-acting IL-13 antibody for atopic dermatitis, emphasizing a strategy of developing new drugs for new indications guided by human genetics.

    03

    Ophthalmology Advancements

    EYLEA HD's profile was strengthened by recent FDA approvals for monthly dosing and RVO treatment, with a prefilled syringe approval anticipated in late April 2026. In the pipeline, interim data for the C5 program in geographic atrophy is expected in H2 2026, exploring both systemic and intravitreal approaches. New long-acting antibodies for glaucoma and thyroid eye disease are also slated for clinical development this year.

    04

    Immunology and Inflammation Innovation

    Beyond DUPIXENT, Regeneron is developing next-generation long-acting antibodies targeting IL-4R alpha, IL-13, IL-4, and bispecifics for extended dosing, with an IL-13 antibody entering the clinic soon. The Regeneron Genetics Center has identified new I&I targets, with the first antibody expected to enter clinical development in H1 2026 for genetically linked diseases like lupus and Sjogren's.

    05

    Oncology and Hematology Progress

    The pivotal study for fianlimab in combination with LIBTAYO for first-line metastatic melanoma is on track for a H1 2026 readout, with early data suggesting a differentiated profile. LYNOZYFIC, for multiple myeloma, is demonstrating strong efficacy in late-line disease and is being advanced into earlier lines, with 4 more pivotal studies initiating by mid-2026, aiming to transform the treatment paradigm.

    06

    Metabolic and Rare Disease Programs

    Regeneron is pursuing a differentiated obesity strategy with olatorepatide, a GLP/GIP agonist, entering pivotal monotherapy studies in 2026. A co-formulation of olatorepatide with PRALUENT (PCSK9 inhibitor) is also planned for clinical development in 2026, targeting obese patients with hyperlipidemia. In rare diseases, the DB-OTO gene therapy for profound genetic deafness and garetosmab for FOP are awaiting regulatory decisions in 2026, showing transformative outcomes.

    07

    Capital Allocation and Shareholder Value

    The company generated $4.1 billion in free cash flow in 2025 and returned $3.8 billion to shareholders, primarily through $3.4 billion in share repurchases. Regeneron initiated a quarterly dividend of $0.94 per share, aiming to broaden its investor base while maintaining share repurchases as the primary means of capital return.

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