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    REGN
    Earnings call· Mar 2026(Q1 FY26)

    REGENERON PHARMACEUTICALS Q1 FY26 earnings call REGN

    Apr 29, 2026 Source

    Executive summary

    Regeneron Q1 FY26 — Strong Commercial Execution and Pipeline Progress

    Regeneron delivered a strong start to the year with double-digit revenue and earnings growth, driven by robust commercial performance across key products like DUPIXENT, EYLEA HD, and Libtayo. The company continues to advance a deep pipeline with significant progress in immunology, oncology, and rare diseases, while maintaining a disciplined capital allocation strategy and addressing drug pricing concerns with the U.S. government.

    Highlights

    5

    • Total revenues increased 19% compared to Q1 2025.

    • Non-GAAP diluted net income per share increased 15% to $9.47.

    • Global DUPIXENT net sales increased 31% on a constant currency basis to $4.9 billion.

    • EYLEA HD U.S. net product sales increased 52% year-over-year to $468 million.

    • Global Libtayo product sales grew 54% to $438 million.

    Concerns

    3

    • EYLEA U.S. net sales declined 36% year-over-year to $473 million due to conversion to EYLEA HD, competitive pressures, and patient affordability issues.

    • EYLEA inventory absorption is expected to negatively impact Q2 net product sales by approximately $20 million.

    • GAAP gross margin was negatively impacted by costs from a temporary manufacturing interruption, leading to updated FY26 GAAP gross margin guidance of 77% to 78%.

    Guidance & targets

    22
    CategoryTargetConfidence
    Sanofi collaboration revenue
    Step up to reflect full share of collaboration profits
    medium materiality
    High
    EYLEA HD sequential unit demand growth
    Consistent with 10% sequential demand growth in Q1
    medium materiality
    High
    EYLEA demand decline
    Mid- to high teens
    medium materiality
    High
    GAAP gross margin
    77% to 78%
    high materiality
    High
    Sanofi development balance repayment
    Fully repaid
    medium materiality
    High
    Limerick manufacturing facility production
    Resume full production
    low materiality
    High
    Fianlimab Phase III metastatic melanoma results
    Results expected
    high materiality
    High
    Fianlimab Phase III adjuvant melanoma analysis
    Second interim analysis and if necessary, a final analysis, both expected
    medium materiality
    High
    Lynozyfic multiple myeloma results
    Results by early 2027
    high materiality
    High
    Lynozyfic multiple myeloma MRD negativity results
    Results in 2028
    medium materiality
    High
    Factor XI registrational studies commencement
    Expected to commence this year
    medium materiality
    High
    Factor XI VTE prevention study results
    Expected in the first quarter of 2027
    medium materiality
    High
    Olatorepatide global Phase III programs initiation
    Expect to initiate 2 global Phase III programs
    high materiality
    High
    Olatorepatide Praluent combination first clinical study
    Initiating shortly
    medium materiality
    High
    NASH siRNA program readings
    Expected by the end of this year
    medium materiality
    High
    Cemdisiran FDA decision
    Anticipate an FDA decision in the fourth quarter
    high materiality
    High
    EYLEA HD prefilled syringe regulatory decision
    Anticipate a regulatory decision on one or both applications during this quarter
    high materiality
    High
    PNH Phase III study results
    Results are expected late in the fourth quarter of this year
    medium materiality
    High
    Geographic Atrophy Phase III interim data
    On track to deliver interim data from the exploratory cohort of our Phase III study in the fourth quarter of this year
    medium materiality
    High
    IL-13 antibody first-in-human trial
    On track to initiate by the middle of this year
    medium materiality
    High
    Itepekimab chronic rhinosinusitis with nasal polyp Phase III results
    Results expected in 2027
    medium materiality
    High
    Garetosmab BLA PDUFA date
    PDUFA date in August of 2026
    high materiality
    High

    Operational metrics

    22
    Non-GAAP diluted net income per share
    $9.4715% growth
    Q1 FY26

    On net income of $1 billion.

    Total Sanofi collaboration revenues
    $1.6 billion
    Q1 FY26
    Regeneron's share of Sanofi collaboration profits
    $1.5 billion42% growth versus prior year
    Q1 FY26

    Driven by DUPIXENT sales growth and improving collaboration margins.

    Total Bayer collaboration revenue
    $287 million
    Q1 FY26
    Regeneron's share of Bayer collaboration net profits (ex-U.S.)
    $240 million
    Q1 FY26
    Other revenue
    $171 million109% growth
    Q1 FY26

    Includes $101 million related to share of profits from ARCALYST and royalty income from Ilaris.

    SG&A
    $560 million
    Q1 FY26

    Reflecting investments to support Libtayo launch in adjuvant CSCC and EYLEA HD growth.

    Matching contribution to Good Days
    de minimis
    Q1 FY26

    Company committed to matching up to $200 million in 2026.

    Non-GAAP gross margin on net product sales
    86%
    Q1 FY26
    GAAP gross margin
    76%
    Q1 FY26

    Negatively impacted by costs due to a temporary interruption in bulk manufacturing at Limerick, Ireland site.

    Cash and marketable securities less debt
    $15.8 billion
    End of Q1 FY26
    Share repurchases executed
    $800 million
    Q1 FY26
    New share repurchase program authorization
    $3 billion
    Authorized

    Reflecting confidence in business and financial position.

    Total available for share repurchases
    $3.4 billion
    As of call date

    Includes new $3 billion authorization.

    EYLEA HD sequential demand growth
    10%Sequentially
    Q1 FY26

    Despite typical first quarter seasonality.

    EYLEA inventory reduction
    modest
    Q1 FY26

    Continued inventory absorption expected to negatively impact Q2 net product sales by approximately $20 million.

    EYLEA HD contribution to retina franchise net sales
    half
    Q1 FY26

    EYLEA HD now contributes half of net sales for our retina franchise.

    DUPIXENT patients worldwide
    more than 1.4 million
    Current

    With type 2 inflammatory diseases currently on treatment.

    DUPIXENT annualized global net sales
    nearly $20 billion
    Annualized

    With significant room for further market penetration across indications.

    Evkeeza net sales
    $46 million48% growth year-over-year
    Q1 FY26

    For homozygous familial hypercholesterolemia.

    Evkeeza U.S. patient penetration
    more than half
    Current

    Of all diagnosed U.S. patients with homozygous familial hypercholesterolemia are on Evkeeza or starting it.

    Olatorepatide mean body weight loss
    up to 19%
    Week 48

    In Chinese patients with obesity from Phase II results.

    Industry KPIs

    6
    MetricValueDetails
    Capital deployment$15.8 billionUSD
    Regulatory approvals filings—
    Therapeutic drug market share#1
    Clinical trial efficacy safety data—
    Collaboration milestone royalty revenue$101 millionUSD
    Cumulative patients uptake since launchmore than 100 millioninjections

    Product announcements

    1
    ProductTypeDetails
    Otarmenilaunch

    Deals & partnerships

    3
    TelixStrategic collaboration

    To codevelop and commercialize next-generation radiopharmaceutical therapies, combining Regeneron's antibody discovery and oncology capabilities with Telix' radiopharmaceutical development and manufacturing expertise.

    TriNetXCollaboration

    To access de-identified electronic health record data from a global network representing 300 million patients, accelerating drug discovery, translation, development, and addressing digital health issues.

    United States governmentMost Favored Nation pricing agreement

    Aims to ensure timely and affordable access to groundbreaking medical advancements for Medicare patients, maintain U.S. leadership in biotechnology innovation, and address the imbalance in the distribution of cost for medical innovation.

    Risks & headwinds

    5
    Competitive pressures and patient affordability issues for EYLEAOngoing

    EYLEA U.S. net sales declined 36% year-over-year to $473 million in Q1 FY26.

    Mitigation: Conversion to EYLEA HD, focus on EYLEA HD's clinical profile and dosing flexibility.

    Continued EYLEA inventory absorptionQ2 FY26

    Expected to negatively impact Q2 net product sales by approximately $20 million.

    Mitigation: Wholesaler inventory levels for EYLEA HD reduced to normal range in Q1.

    Potential launch of additional EYLEA biosimilarsSecond half of FY26

    Anticipated to contribute to EYLEA demand decline in the mid- to high teens in Q2 FY26.

    Mitigation: Focus on EYLEA HD uptake and differentiated profile.

    Temporary manufacturing interruption at Limerick, Ireland siteQ1 FY26 and Q2 FY26

    Negatively impacted GAAP gross margin to 76% in Q1 FY26; expected to continue negatively impacting GAAP gross margin in Q2 FY26.

    Mitigation: Resumed initial production, expect to resume full production by end of Q2 FY26; no impact on product availability.

    FDA did not act by the April 2026 PDUFA date for EYLEA HD prefilled syringe from a second contract manufacturerOngoing

    Application remains pending.

    Mitigation: Working closely with FDA to resolve outstanding issues; anticipate regulatory decision on one or both applications during Q2 FY26.

    Q&A highlights

    7

    Discuss willingness to collaborate with Sanofi on next-gen DUPIXENT assets given its success and the upcoming patent cliff, or if Regeneron will pursue these independently.

    Len thanked Paul Hudson and welcomed Belen Garijo. He stated Regeneron is open-minded to transactions leveraging its development and commercial capabilities, but can also pursue opportunities independently. He looks forward to discussions with Sanofi's new leadership.

    “We are always open-minded to transactions certainly leveraging what we've built in terms of both development capabilities as well as commercial capabilities has merit to it. We can do these things ourselves. We've had interest for many different places to sort of take on some of the next opportunities with us.”

    asked by Tyler Van Buren · answered by Leonard Schleifer

    2 min read6 chapters

    Detailed Narrative

    01

    Strategic Capital Allocation and Share Repurchase Program

    Regeneron maintains a balanced approach to capital allocation, prioritizing internal investment for long-term growth while also returning capital to shareholders. The Board authorized a new $3 billion share repurchase program, reflecting confidence in the company's financial position and business outlook. This program adds to the approximately $400 million remaining from previous authorizations, bringing the total available for share repurchases to $3.4 billion.

    02

    Commitment to Patient Access and Innovation

    Regeneron recently entered into a Most Favored Nation pricing agreement with the U.S. government, aiming to ensure timely and affordable access to medical advancements for Medicare patients. This agreement also seeks to maintain U.S. leadership in biotechnology innovation and address the disproportionate burden of medical innovation costs on American patients. The company also made the unconventional decision to offer its newly approved gene therapy, Otarmeni, for genetic hearing loss for free in the U.S., highlighting its mission to benefit humanity.

    03

    Complement-Mediated Disease Strategy

    Regeneron employs a differentiated strategy for complement-mediated diseases, utilizing customized approaches with siRNAs, antibodies, or combinations based on the required level and durability of complement inhibition. For generalized myasthenia gravis (GMG), the C5 siRNA cemdisiran provides optimal efficacy, safety, and convenience with quarterly subcutaneous dosing. In contrast, for PNH, a combination of cemdisiran and the C5 antibody pozelimab is required for complete and sustained disease control, with results from the registrational Phase III study expected in late Q4 2026.

    04

    Next-Generation Immunology and Inflammation Programs

    Beyond DUPIXENT, Regeneron is advancing next-generation approaches to strengthen its leadership in immunology. This includes developing innovative VelocImmune-derived fully human, long-acting antibodies and bispecifics targeting the IL-4 receptor, IL-13, and IL-4 cytokines. A first-in-human trial for an IL-13 antibody is on track to initiate by mid-2026, with plans for an expedited path to regulatory approvals. The company is also exploring genetically validated targets for diseases like lupus and Sjogren's.

    05

    Obesity and Cardiovascular Risk Management

    Regeneron is rapidly advancing its GLP/GIP receptor agonist, olatorepatide, for obesity, with positive Phase II results in China showing up to 19% mean body weight loss at week 48. Building on this, two global Phase III programs are expected to initiate later in 2026 for obesity and obesity with type 2 diabetes. The company is also developing a combination of olatorepatide with Praluent, aiming to offer a best-in-class GLP that also significantly lowers bad cholesterol and reduces cardiovascular risk, addressing a critical comorbidity in the obese population.

    06

    EYLEA HD and EYLEA Market Dynamics

    EYLEA HD continues to see strong physician adoption, with U.S. net sales growing 52% year-over-year to $468 million, and sequential demand increasing 10% in Q1. Its broad label and dosing flexibility are key drivers. Conversely, EYLEA U.S. net sales declined 36% to $473 million due to conversion to EYLEA HD, competitive pressures, and affordability issues. Further demand decline for EYLEA is anticipated in Q2 ahead of potential biosimilar launches in the second half of the year.

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