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    REGN
    Earnings call· Jun 2026(Q2 FY26)

    REGENERON PHARMACEUTICALS Q2 FY26 earnings call REGN

    Jul 30, 2026 Source

    Executive summary

    Regeneron Q2 FY26 — Strong Dupixent, Eylea HD, and Libtayo Growth Drive Double-Digit Revenue and EPS Increase

    Regeneron delivered a robust second quarter, driven by strong commercial execution across its key franchises, particularly Dupixent, EYLEA HD, and Libtayo. The company is actively pursuing further collaborations with Sanofi for next-generation programs and is focused on advancing its broad and diverse pipeline, including anticipated regulatory decisions for cemdisiran and garituzumab, and progressing its obesity and Factor XI programs. Management remains disciplined in capital allocation, prioritizing internal science while evaluating external opportunities.

    Highlights

    5
    • Total revenues up 17% compared to Q2 FY25.

    • Non-GAAP earnings per share up 11% compared to Q2 FY25.

    • Dupixent Global net sales (as reported by Sanofi) were $6 billion, up 38% on a constant currency basis.

    • EYLEA HD U.S. net sales were $96 million, up 52% year-over-year and 27% quarter-over-quarter, exceeding EYLEA sales for the first time.

    • Libtayo Global net product sales reached nearly $500 million, up 29% on a constant currency basis.

    Concerns

    3
    • GAAP gross margin was 78%, negatively impacted by unabsorbed manufacturing costs related to a temporary interruption at the Limerick facility.

    • EYLEA U.S. net sales declined 45% year-over-year and 13% quarter-over-quarter due to conversion to EYLEA HD and biosimilar competition.

    • Sanofi development balance repayment lowered reported Sanofi collaboration revenue by approximately $530 million in H1 FY26.

    Guidance & targets

    23
    CategoryTargetConfidence
    EYLEA HD prefilled syringe approval
    Approval before the end of the year
    medium materiality
    High
    EYLEA HD sequential demand growth
    Low to mid-teens
    medium materiality
    Medium
    EYLEA U.S. sequential quarterly demand declines
    Low to mid-teens
    medium materiality
    Medium
    Dupixent global net sales growth
    Remain strong but moderate relative to H1 FY26
    medium materiality
    Medium
    Cemdisiran (GMG) FDA decision
    Decision in November
    high materiality
    High
    Cemdisiran (GMG) EMA decision
    Anticipated in second half of 2027
    medium materiality
    Medium
    Cemdisiran/Pozelimab (PNH) registrational data readout
    Fourth quarter of this year
    high materiality
    High
    Cemdisiran (GA) 26-week data readout
    Fourth quarter of 2026
    medium materiality
    High
    Long-acting IL-13 antibody registration-enabling studies initiation
    Potentially by the end of next year or early 2028
    high materiality
    Medium
    Next-generation Dupixent (spud) clinic readiness
    Early 2027
    low materiality
    Medium
    IL-13 specific next-gen candidates first-in-human studies
    Next year
    low materiality
    Medium
    Ubamatamab (MUC16) detailed data presentation
    Medical meeting this fall
    medium materiality
    High
    Linvoseltamab (LINKER-MM3 study) results
    Next year
    medium materiality
    High
    Linvoseltamab (first-line study) MRD negativity results
    2028
    medium materiality
    High
    Linvoseltamab/carfilzomib combination study results
    2028
    medium materiality
    High
    Linvoseltamab (first-line light chain amyloidosis) Phase III study start
    Early next year
    medium materiality
    High
    Factor XI remaining Phase III studies initiation
    This year
    high materiality
    High
    Factor XI (VTE prevention) study results
    First half of 2027
    medium materiality
    High
    Factor XI (Roxy ATLAS study) results
    2027
    medium materiality
    High
    Oloreptitide (obesity/T2D) Phase III studies initiation
    Later this year
    high materiality
    High
    Garituzumab (FOP) FDA decision
    Decision in August
    high materiality
    High
    Oloreptitide (Chinese patients with obesity) Phase III data presentation
    Late breaker at EASD in October
    medium materiality
    High
    siRNAs for MASH and NPE R1 antagonist antibody for POTS clinical data presentation
    Medical meetings this fall
    low materiality
    High

    Segment performance

    9
    SegmentRevenueYoYQoQMargin
    Dupixent
    Global product sales as reported by Sanofi. Demand trends robust across all approved indications. U.S. sales grew 42% year-over-year to $4.6 billion, boosted by favorable gross to net adjustment.
    #1 biologic prescribed by dermatologists, pulmonologists, allergists, ENTs1.5 million patients actively treated worldwide
    $6 billion38% (constant currency)
    EYLEA HD (U.S.)
    Exceeded EYLEA net sales for the first time. Strong uptake following FDA label expansions for retinal vein occlusion and additional dosing options. Only innovative brand with quarter-over-quarter share growth.
    Physician unit demand: 24% sequential increaseComprises approximately 60% of U.S. franchise net sales (vs 34% in Q2 FY25)57% share in innovative branded category (combined with EYLEA)
    $96 million52%27%
    EYLEA (U.S.)
    Primarily driven by ongoing conversion to EYLEA HD and competitive dynamics.
    $412 million-45%-13%
    EYLEA HD & EYLEA (U.S. Combined)
    Combined U.S. net sales.
    More than 100 million doses administered since EYLEA's launch in 2011
    Just over $1 billion7%
    Libtayo
    Growth driven by strong adoption in non-melanoma skin cancers and penetration in non-small cell lung cancer. Recent launch in adjuvant cutaneous squamous cell carcinoma.
    U.S. sales: $343 million, up 38% year-over-year20% share of new-to-brand prescriptions in U.S. non-small cell lung cancer (doubled since early 2025)
    $489 million29% (constant currency)
    Evkeeza
    For homozygous familial hypercholesterolemia.
    $53 million29%
    Sanofi Collaboration
    Reached an all-time high. Driven by Dupixent growth and improving collaboration margins. Sanofi development balance fully repaid.
    Share of collaboration profits: $2 billion, up 59% vs prior year
    $2.2 billion
    Bayer Collaboration
    Total Bayer collaboration revenue.
    Share of net profits outside U.S.: $227 millionNet sales of EYLEA HD 8 mg and EYLEA outside U.S.: $667 million (inclusive of $366 million of EYLEA 8 mg sales)
    $276 million
    Other Revenue
    Includes royalty income and share of profits.
    Royalty income from Alnylam combined with share of profits from Arcellx: $157 million, up 44% vs prior year
    $193 million5%

    Operational metrics

    12
    Non-GAAP Earnings Per Share
    $14.29up 11% YoY
    Q2 FY26

    Diluted net income per share. Included a negative impact from acquired in-process research and development expense, reflecting upfront and opt-in payments associated with collaboration and licensing agreements.

    Total Revenue
    $4.3 billionup 17% YoY
    Q2 FY26

    Driven by higher Sanofi collaboration revenue and strong growth for EYLEA HD in the U.S. and Libtayo globally.

    Sanofi Development Balance Repayment
    $3.1 billionfully repaid
    Prior to Q3 FY26

    The balance was approximately $3.1 billion when the Sanofi antibody collaboration agreement was amended. Full repayment means Sanofi collaboration revenue is expected to step up from Q3 FY26 as Regeneron records its full share of collaboration profits.

    R&D Expense
    $1.5 billion
    Q2 FY26

    Reflecting continued investment to support Regeneron's innovative pipeline of approximately 50 product candidates.

    SG&A Expense
    $574 million
    Q2 FY26

    Reflecting investments to support the commercial portfolio, including EYLEA HD and Libtayo growth, and ongoing launch activities.

    Non-GAAP Gross Margin on Net Product Sales
    87%
    Q2 FY26

    Reported for the quarter.

    GAAP Gross Margin
    78%
    Q2 FY26

    Similar to Q1 FY26, negatively impacted by unabsorbed manufacturing costs. Production at Limerick facility resumed to normal levels by end of Q2 FY26.

    Cash and Marketable Securities (Net of Debt)
    $15.1 billion
    As of June 30, FY26

    Ended the second quarter with this balance.

    Capital Deployment
    $2.5 billion
    H1 FY26

    Deployed approximately $2.5 billion through the first half of 2026.

    Share Repurchases
    $1.2 billiontotal $2 billion for H1 FY26
    Q2 FY26

    Repurchased $1.2 billion in Q2 FY26, bringing total to $2 billion for H1 FY26, resulting in a net reduction of 2.4 million shares outstanding.

    Share Repurchase Authorization Remaining
    $2.5 billion
    As of June 30, FY26

    Remaining authorization as of June 30.

    Libtayo New-to-Brand Prescriptions Share
    20%doubled since early 2025
    Q2 FY26

    Libtayo is now firmly established as a second most prescribed immunotherapy treatment in the U.S.

    Industry KPIs

    6
    MetricValueDetails
    Pipeline read out calendarApproximately 50programs
    Regulatory approvals filings2decisions
    Therapeutic drug market share57%%
    Clinical trial efficacy safety dataNormalization of free light chain by day 15
    Collaboration milestone royalty revenue$157 millionUSD
    Cumulative patients uptake since launchMore than 1.5 millionpatients

    Product announcements

    1
    ProductTypeDetails
    Taminilaunch

    Deals & partnerships

    2
    SanofiDiscussions for further collaboration on Dupixent follow-on programs.

    Productive early discussions to identify potential opportunities for further collaboration, including for several of Regeneron's Dupixent follow-on programs. Aim to leverage joint learned capabilities and experience in developing and commercializing Dupixent.

    HansaIn-license of Oloreptitide (dual GLP-1/GIP receptor agonist).

    Oloreptitide, our dual GLP gift receptor agonist in license for HANSO continues to advance.

    Risks & headwinds

    4
    EYLEA U.S. sales decline due to conversion and competitionOngoing, expected to continue in H2 FY26

    45% year-over-year decline and 13% quarter-over-quarter decline in Q2 FY26

    Mitigation: Conversion to EYLEA HD, which is gaining momentum; continued work on EYLEA HD prefilled syringe to drive further adoption.

    Unabsorbed manufacturing costs impacting GAAP gross marginQ1 and Q2 FY26

    GAAP gross margin of 78% in Q2 FY26, negatively impacted

    Mitigation: Production at Limerick facility resumed to normal levels as of the end of Q2 FY26.

    Moderation of Dupixent global net sales growthSecond half of 2026

    Expected to remain strong but moderate relative to H1 FY26

    Mitigation: Annualizing recent indication launches and facing stronger prior year comparisons.

    Challenges in oncology drug developmentOngoing

    Samimab setbacks, incremental advances in the field

    Mitigation: Broad and diverse oncology pipeline, continued investment, taking more shots with unique and first-in-class agents in monotherapies and combinations.

    What to watch in Q3 FY26

    5

    EYLEA HD Prefilled Syringe Approval

    by year-end
    CurrentUnder FDA review, discussions ongoing with multiple CMOs
    TargetApproval by year-end

    Why it matters

    Expected to drive further adoption and enhance the product's attractiveness.

    We expect launch of this enhancement to drive even further adoption of EYLEA HD, and we are continuing to work closely with the FDA and multiple contract manufacturers with a goal of approval before the end of the year.

    Q&A highlights

    8

    Given significant cash on hand and the Sanofi obligation rolling off, how does Regeneron balance robust internal investment with M&A, especially considering past 'aversion' to overpaying?

    Len clarified that he is not averse to M&A but is disciplined about valuation. He stated that Regeneron's R&D spend (internal and external) is in line with peers, but they prioritize internal R&D. They are open to small or large external opportunities if they make financial sense for shareholders.

    I don't think I expressed the conversion to M&A. I think I expressed the inversion to overpaying in M&A settings.

    asked by Chris Raymond · answered by Leonard Schleifer

    3 min read8 chapters

    Detailed Narrative

    01

    Board Acknowledgment

    The call began with a tribute to Arthur Art Ryan, a long-serving board member and financial industry luminary who recently passed away. His contributions to Regeneron's board for over two decades and his legacy of civic engagement were highlighted. Management expressed gratitude for his wisdom and unparalleled support of the company's mission.

    02

    Sanofi Collaboration Evolution

    Regeneron and Sanofi have engaged in productive early discussions to explore further collaboration opportunities, particularly for Dupixent follow-on programs. This comes after nearly two decades of successful partnership, which has established a highly productive development and commercialization engine. The aim is to adjust the relationship to reflect the current standing and complementary strengths of both companies.

    03

    EYLEA HD Enhancements and Market Position

    Management emphasized the continued strong performance of EYLEA HD, driven by recent FDA label expansions for retinal vein occlusion and additional dosing options. The company is also working towards approval of a prefilled syringe formulation, which is expected to further boost adoption. EYLEA HD now accounts for approximately 60% of the U.S. retinal franchise net sales, up from 34% in Q2 FY25, and was the only innovative brand to achieve quarter-over-quarter share growth.

    04

    Pipeline Breadth and Productivity

    Regeneron highlighted its broad and diversified pipeline, with approximately 50 active clinical programs and numerous preclinical candidates. This extensive R&D portfolio is seen as a core strength, reducing reliance on any single program and positioning the company for long-term value creation. The company expressed confidence in its ability to create substantial value for patients and shareholders through this diverse portfolio.

    05

    Obesity Program Strategy

    In the evolving obesity landscape, Regeneron aims for differentiation beyond incremental weight loss. Their strategy focuses on combination therapies, such as oloreptitide with Praluent, to address comorbidities like hypercholesterolemia, and co-treatments to mitigate side effects like muscle loss, particularly in older patients with sarcopenic obesity. They believe this approach provides a fundamentally different and enhanced patient profile.

    06

    Cemdisiran Differentiated Profile

    Cemdisiran, an siRNA targeting C5, is expected to offer a differentiated treatment option for generalized myasthenia gravis (GMG) with its efficacy, safety, and convenient quarterly subcutaneous dosing. Management believes it can compete across all segments of the GMG market, including patients who lose efficacy on FcRN approaches, by offering continuous effect and infrequent administration, which is seen as a significant advantage over current cycling treatments.

    07

    Oncology Portfolio and Challenges

    Regeneron acknowledged the inherent challenges in oncology drug development, referencing the historical 'war on cancer' and the incremental nature of advances. Despite setbacks like samimab, the company affirmed its continued excitement and investment in its broad oncology pipeline, including bispecifics like linvoseltamab. They are committed to taking 'more shots in many different ways' with unique and first-in-class agents to deliver successes against devastating diseases.

    08

    Ophthalmology Beyond VEGF

    The company expressed a strong belief in expanding its ophthalmology portfolio beyond VEGF, aiming to replicate the success of EYLEA in other areas like glaucoma, thyroid eye disease, and geographic atrophy. The focus is on developing safer, longer-acting agents that can address comorbid retinal diseases, such as patients with GA who also have wet AMD, and to avoid ocular safety issues seen with current complement treatments.

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