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    SRPT
    Earnings call· Jun 2026(Q2 FY26)

    Sarepta Therapeutics Q2 FY26 earnings call SRPT

    Aug 5, 2026 Source

    Executive summary

    Sarepta Q2 FY26 — Strong Financials & Pipeline Progress Amidst ELEVIDYS Adoption Focus

    Sarepta Therapeutics reported a financially strong second quarter, marked by operating profitability and increased cash, enabling independent advancement of its pipeline. While ELEVIDYS adoption and exon-skipping competition remain concerns, the company is focused on commercial execution and anticipates significant data readouts from its siRNA programs and Duchenne regulatory decisions. The core strategy emphasizes biology-driven innovation and disciplined capital allocation to drive future growth.

    Highlights

    5

    • Achieved GAAP operating income of $13 million and non-GAAP operating income of $86 million for the quarter.

    • Increased cash and investments by approximately $197 million during the quarter, reaching $945 million.

    • PMO franchise demonstrated stable demand and sustained patient/physician confidence, with over 1,800 patients treated worldwide and adherence rates exceeding 90%.

    • FDA accepted supplemental NDA submissions for AMONDYS 45 and VYONDYS 53 for review, with a target action date of February 28, 2027.

    • Narrowed FY26 total net product revenue guidance to $1.2 billion to $1.3 billion, with the midpoint being the appropriate reference, consistent with prior expectations.

    Concerns

    4

    • Total net product revenue decreased 34% year-over-year in Q2, primarily driven by lower ELEVIDYS demand.

    • ELEVIDYS revenue in the second half of 2026 is expected to be modestly lower than the first half, with Q3 trending lower than Q2.

    • A $39 million litigation contingency charge was included in GAAP results for the quarter.

    • Acknowledged concerns around ELEVIDYS adoption and competition on the horizon for exon skipping treatments.

    Guidance & targets

    6
    CategoryTargetConfidence
    Total net product revenue
    $1.2B to $1.3B
    high materiality
    High
    Total collaboration and other revenue
    $550M to $600M
    medium materiality
    High
    Non-GAAP OpEx
    $800M to $850M
    medium materiality
    High
    ELEVIDYS revenue
    modestly lower than in the first half
    high materiality
    Medium
    ELEVIDYS revenue
    trend lower than Q2
    high materiality
    Medium
    ELEVIDYS revenue contribution from enrollment forms
    more meaningfully to revenue in 2027
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    ELEVIDYS
    Performance was in line with expectations, with sales remaining relatively steady and quarter-over-quarter growth in enrollment forms signaling increasing demand.
    Enrollment forms: quarter-over-quarter growth
    		$98M———
    PMO franchise
    Performance continues to reflect stable demand and sustained patient and physician confidence, supported by extensive real-world experience and evidence.
    Patients treated worldwide: >1,800Adherence rates: >90%
    		$231M———
    Total Net Product Revenue
    Total net product revenue for the second quarter.
    		$329M———

    Operational metrics

    17
    Total revenues
    $401Mdecrease of 34% year-over-year
    Q2 FY26

    Driven by a decrease in net product revenues, primarily ELEVIDYS, due to lower demand.

    Total revenues
    $1.13Bdecreased 17% compared to prior years
    YTD H1 FY26

    Driven by lower ELEVIDYS product revenue, partially offset by higher collaboration and contract manufacturing revenue.

    Collaboration and other revenues
    $73M
    Q2 FY26

    Consisting primarily of contract manufacturing revenue from partnership with Roche.

    Total cost of sales
    $149Mdecrease of 2% compared to the prior year period
    Q2 FY26

    Reflective of lower cost of goods due to decrease in product sales, partially offset by higher cost of goods related to contract manufacturing revenues.

    Total cost of sales
    $248Mdecrease of 11% year-over-year
    YTD H1 FY26

    Driven by similar dynamics as Q2.

    Gross margins on net product revenues
    75%
    Q2 FY26

    Gross margin for net product revenues.

    Gross margins on net product revenues
    78%
    H1 FY26

    Gross margin for net product revenues for the first half of the year.

    Non-GAAP R&D and SG&A expenses
    $165Mdecreased 44% compared to the prior year period
    Q2 FY26

    Reflecting the benefit of cost restructuring initiatives and prioritization of promising siRNA programs.

    Non-GAAP R&D and SG&A expenses
    $388Mdown 66% compared to the same period prior year
    YTD H1 FY26

    Driven by restructuring, pipeline reprioritization, and the Arrowhead collaboration upfront expense recognized in the prior year.

    GAAP operating income
    $13M
    Q2 FY26

    Operating income on a GAAP basis.

    Non-GAAP operating income
    $86M
    Q2 FY26

    Operating income on a non-GAAP basis.

    GAAP operating income
    $372M
    YTD H1 FY26

    Operating income on a GAAP basis for the first half of the year.

    Non-GAAP operating income
    $484M
    YTD H1 FY26

    Operating income on a non-GAAP basis for the first half of the year.

    Litigation contingency charge
    $39M
    Q2 FY26

    Charge to potentially resolve certain outstanding patent claims.

    Cash and investments balance
    $945Mgrowing a $197M increase from the prior quarter
    end of Q2 FY26

    Robust cash increase due to strong operating performance and receipt of Roche commercial sale milestone.

    Cash generated from base business
    >$240M
    H1 FY26

    Excluding $250 million of collaboration payments made to Arrowhead in the first quarter.

    Cash generated from base business
    ~$400M
    LTM

    Looking back at the last 12 months, the base business generated this amount.

    Industry KPIs

    2
    MetricValueDetails
    Collaboration milestone royalty revenue$40MUSD
    Cumulative patients uptake since launch>1,800patients

    Deals & partnerships

    1
    RocheCollaboration and contract manufacturing revenue$40M

    Receipt of $40 million from the Roche commercial sale milestone earned in Q1.

    Risks & headwinds

    4
    ELEVIDYS adoption concernsH2 FY26

    ELEVIDYS revenue in H2 FY26 expected to be modestly lower than H1; Q3 FY26 expected to trend lower than Q2.

    Mitigation: Expanded commercial footprint, improved patient identification, expanded education for patients and families, strengthening healthcare providers' confidence, record number of HCP interactions.

    Competition for exon skipping treatmentsLikely later in 2027

    Not explicitly quantified, but acknowledged as a concern.

    Mitigation: Confidence in the durability of the PMO franchise due to long track record, extensive real-world evidence, favorable safety profile, high adherence rates (>90%), and established infrastructure for patient support and reimbursement.

    Acute liver injury (ALI) associated with AAV gene therapyAcute post-infusion

    Known risk associated with AAV gene therapy as a class effect.

    Mitigation: Cohort 8 of the ENDEAVOR study is assessing prophylactic sirolimus treatment to reduce ALI. Interim safety data from the Phase 4 ENDURE study showed zero incidence of ALI in patients treated prophylactically with sirolimus.

    Litigation contingency chargeQ2 FY26

    $39M

    Mitigation: Charge to potentially resolve certain outstanding patent claims.

    What to watch in Q3 FY26

    5

    ELEVIDYS 12-week Cohort 8 data

    Q1 2027
    CurrentEnrollment underway, expected completion end of 2026.
    Target12-week data from full cohort, including incidence of ALI and dystrophin expression.

    Why it matters

    Will determine if prophylactic sirolimus can reduce acute liver injury, potentially expanding ELEVIDYS' label to non-ambulatory patients and impacting its commercial opportunity.

    We expect to fully enroll the ENDEAVOR Cohort 8 study by the end of 2026. Based on observations that our study investigators are dosing participants sequentially, we now expect 12-week data from the full cohort in the first quarter of 2027.

    Q&A highlights

    8

    What aspects of the pipeline are most exciting, specifically Cohort 8 data for ELEVIDYS and the Arrowhead/siRNA programs?

    CEO Michael Severino expressed excitement for Cohort 8's potential to improve ELEVIDYS' benefit-risk in non-ambulatory patients and the tremendous potential of the siRNA programs (FSHD, DM1, Huntington's) due to predictive preclinical models, high knockdown, and effective delivery technology.

    “But when I look at the earlier pipeline in the siRNA programs that we're advancing, I believe they have tremendous potential. First of all, what I would say is in this space, pre-clinical models and early clinical data have a very high degree of predictive power.”

    asked by Anupam Rama · answered by Michael Severino

    2 min read7 chapters

    Detailed Narrative

    01

    CEO Transition and Strategic Vision

    Michael Severino, in his first earnings call as CEO, expressed confidence in Sarepta's position as a leader in Duchenne and rare disease innovation. He highlighted the company's scientific achievements, including exon skipping and ELEVIDYS, and the potential of its siRNA platform. Severino emphasized the financial strength to independently advance pipeline programs and the importance of upcoming milestones, including Cohort 8 data and siRNA program readouts, to clarify the company's growth trajectory.

    02

    Commercial Performance and ELEVIDYS Momentum

    Total net product revenue for Q2 FY26 was $329 million, with ELEVIDYS contributing $98 million and the PMO franchise $231 million. ELEVIDYS performance was in line with expectations, showing improving quarter-over-quarter enrollment forms, signaling increasing demand. The company expanded its commercial footprint and deployed sales teams, resulting in a record number of healthcare provider interactions and broader site activity, reinforcing confidence in ELEVIDYS' benefit-risk profile.

    03

    Pipeline Progress in siRNA Programs

    Sarepta remains on track to announce interim results from its Multi-Ascending Study (MAD) for SRP-1001 (FSHD) and SRP-1003 (DM1) in the second half of 2026. The siRNA platform is differentiated by biology-driven tissue targeting, efficient intracellular delivery, and catalytic siRNA potency. The company aims to achieve deep DUX4 knockdown in FSHD and DMPK knockdown in DM1, with preclinical models showing high muscle concentration and strong safety profiles, positioning these programs as potential best-in-class therapies.

    04

    Duchenne Regulatory Updates and ELEVIDYS Safety

    The FDA accepted supplemental NDA submissions for AMONDYS 45 and VYONDYS 53, seeking conversion to traditional approvals with a target action date of February 28, 2027. Enrollment and dosing continue in Cohort 8 of the ENDEAVOR study for ELEVIDYS, assessing prophylactic sirolimus to reduce acute liver injury (ALI) in non-ambulant Duchenne patients. Interim safety data from the Phase 4 ENDURE study showed zero incidence of ALI in patients treated prophylactically with sirolimus.

    05

    Financial Strength and Capital Allocation

    Sarepta delivered strong financial performance in Q2, with GAAP and non-GAAP operating profitability. Cash and investments increased by $197 million to $945 million. The company's disciplined cost management led to a 44% decrease in non-GAAP R&D and SG&A expenses year-over-year. Management reiterated its strong financial position, with the base business generating approximately $400 million in cash over the last 12 months, enabling independent funding of its promising pipeline.

    06

    EXONDYS 51 10-Year Anniversary

    Sarepta celebrated the 10-year anniversary of EXONDYS 51's U.S. approval on September 19th. This milestone underscores Sarepta's leadership in Duchenne, establishing exon skipping as a foundational treatment approach. The company has built a substantial body of real-world evidence demonstrating benefits across ambulation, pulmonary and cardiac function, and survival, with over 1,800 patients treated worldwide with exon skipping therapies.

    07

    Huntington's Disease Program Progress

    The CNS Huntington's program is ongoing, with the first patients dosed earlier this year. This program utilizes a transferrin receptor-based approach for blood-brain barrier delivery. Early proof of biology data is expected early next year, focusing on safety and knockdown of Huntington in the CSF, which would validate the platform's potential for CNS indications.

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