Sarepta Therapeutics Q2 Earnings Call Highlights

Key Points

• Q2 revenue fell 34% to $401 million, primarily due to lower ELEVIDYS sales, although Sarepta reported operating profits and increased cash and investments to $945 million. The company narrowed 2026 net product revenue guidance to $1.2 billion–$1.3 billion.
• ELEVIDYS revenue is expected to decline in Q3 and remain softer in the second half, while recent improvements in enrollment forms may support stronger revenue in 2027. The PMO franchise remains stable, with adherence above 90% and FDA decisions on AMONDYS 45 and VYONDYS 53 conversions expected by February 2027.
• Sarepta expects interim data later this year from its SRP-1001 and SRP-1003 siRNA programs for FSHD and DM1. The company also expects full enrollment in its ELEVIDYS safety study by year-end, with 12-week data due in Q1 2027.

Sarepta Therapeutics NASDAQ: SRPT reported second-quarter 2026 total revenue of $401 million, down 34% from a year earlier, as lower ELEVIDYS sales weighed on results. The company nevertheless posted GAAP operating income of $13 million and non-GAAP operating income of $86 million, while increasing cash and investments by approximately $197 million during the quarter to $945 million.

New Chief Executive Officer Michael Severino, who was hosting his first earnings call in the role, said the company’s approved Duchenne muscular dystrophy portfolio and emerging siRNA pipeline provide a foundation for future growth. Sarepta has four approved Duchenne therapies, including gene therapy ELEVIDYS and its exon-skipping PMO franchise.

Revenue Guidance Narrowed

Total net product revenue in the second quarter was $329 million, comprising $98 million from ELEVIDYS and $231 million from the PMO franchise. Sarepta also recorded $73 million in collaboration and other revenue, primarily related to contract manufacturing under its partnership with Roche.

The company narrowed its 2026 net product revenue outlook to $1.2 billion to $1.3 billion, from a prior range of $1.2 billion to $1.4 billion. Management said the midpoint of the revised range is the appropriate reference point. Sarepta reported $659 million in net product revenue during the first half of the year.

Chief Commercial Officer Patrick Moss said ELEVIDYS revenue during the first half was supported by patients who entered the treatment pipeline after the late-2024 label expansion and later progressed to infusion. Revenue in the second half is expected to reflect lower enrollment-form activity from before Sarepta completed its expanded commercial initiatives.

As a result, Sarepta expects total net product revenue in the second half of 2026 to be modestly below first-half levels. ELEVIDYS revenue in the third quarter is also expected to decline from the second quarter, though management noted that quarterly variability is inherent in a one-time gene therapy.

Management said enrollment forms for ELEVIDYS improved sequentially during the second quarter, including activity from returning treatment sites and sites outside the company’s existing network. However, Severino said the company generally assumes about six months between an enrollment form and infusion, meaning recent demand trends are expected to contribute more materially to revenue in 2027.

PMO Franchise Remains Stable

Sarepta described demand for its PMO exon-skipping therapies as stable, citing adherence rates above 90% and more than 1,800 patients treated worldwide. The company said its commercial infrastructure, reimbursement experience, home-infusion support and real-world evidence base position it to compete as other exon-skipping treatments potentially enter the market.

Severino said any competitive impact on the PMO franchise would likely take time to emerge, potentially later in 2027, because competitors would need to establish reimbursement pathways and patient-support programs. EXONDYS 51 will mark 10 years since its U.S. approval on Sept. 19.

The Food and Drug Administration accepted Sarepta’s supplemental new drug applications seeking to convert AMONDYS 45 and VYONDYS 53 from accelerated to traditional approval. The FDA assigned a Feb. 28, 2027, target action date. Management said the applications are under standard review and that the agency has not indicated plans to convene an advisory committee.

siRNA Readouts Expected This Year

Sarepta expects to report interim multiple-ascending-dose data in the second half of 2026 for SRP-1001 in facioscapulohumeral muscular dystrophy, or FSHD, and SRP-1003 in myotonic dystrophy type 1, or DM1.

President of R&D and Technical Operations Louise Rodino-Klapac said the company’s muscle-focused RNA platform uses alpha V beta six integrin targeting to improve muscle exposure and intracellular delivery. SRP-1001 is designed to reduce production of DUX4 protein in FSHD, while SRP-1003 is intended to silence DMPK messenger RNA in DM1.

The upcoming FSHD dataset is expected to include safety, pharmacokinetics, a DUX4-related gene panel, circulating biomarkers, creatine kinase and preliminary functional assessments. Sarepta said the six-month study is intended primarily to establish tissue exposure, target knockdown and biomarker effects rather than definitively demonstrate functional benefit in a slowly progressing disease.

For DM1, Sarepta plans to report safety, serum and muscle pharmacokinetics, DMPK knockdown, a CASI-22 splicing index and additional analyses. Management said the results will help determine dose selection and the path toward registrational studies. The company said it will evaluate accelerated and traditional approval options based on its data, the competitive landscape and discussions with regulators.

ELEVIDYS Safety Study and Expense Outlook

Sarepta is enrolling approximately 25 nonambulatory Duchenne patients in Cohort 8 of its ENDEAVOR study, which is evaluating prophylactic sirolimus before and after ELEVIDYS infusion. The study is intended to assess whether sirolimus can reduce acute liver injury, a known risk associated with AAV gene therapies.

The company now expects full enrollment by the end of 2026 and 12-week data from the full cohort in the first quarter of 2027. Sarepta had previously anticipated data by year-end, but Rodino-Klapac said investigators are dosing participants sequentially rather than in parallel. The company plans to meet with the FDA in early 2027 after the data are available.

Chief Financial Officer Ryan Wong said Sarepta tightened 2026 non-GAAP operating expense guidance to $800 million to $850 million, the low end of its previous range. The company increased guidance for collaboration and other revenue to $550 million to $600 million, driven mainly by higher contract manufacturing revenue, though Wong noted that associated cost of goods sold to Roche should rise by a roughly equivalent amount.

Sarepta said it believes its commercial cash flow, cash balance and operating profitability provide sufficient resources to advance its priority commercial and research programs independently.

About Sarepta Therapeutics (NASDAQ:SRPT)

Sarepta Therapeutics, Inc is a biopharmaceutical company focused on the discovery and development of precision genetic medicines for rare neuromuscular diseases. Headquartered in Cambridge, Massachusetts, Sarepta's core expertise lies in designing RNA-targeted therapies and gene therapies that address underlying genetic mutations. The company's mission is to transform the treatment paradigm for patients with Duchenne muscular dystrophy (DMD) and related disorders through innovative modalities.

Sarepta's commercial products include several exon-skipping therapies approved by the U.S.

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