SRPT Q3 Earnings Miss Estimates, Stock Dips on DMD Study Failure

Sarepta Therapeutics, Inc. SRPT reported third-quarter 2025 adjusted loss of 13 cents per share against the Zacks Consensus Estimate for earnings per share (EPS) of one cent. In the year-ago period, the company posted an adjusted EPS of 43 cents.

The adjusted figures exclude depreciation and amortization costs, stock-based compensation expenses, gains on strategic investments, losses on debt extinguishment and restructuring charges. Including these items, loss during the quarter was $1.80, against EPS of 34 cents in the year-ago period.

Sarepta recorded total revenues of $399.4 million, down nearly 15% year over year. This downtick was owing to lower sales of Elevidys, its one-shot gene therapy for Duchenne muscular dystrophy (DMD). Yet, the reported figure beat the Zacks Consensus Estimate of $352.6 million.

More on SRPT’s Earnings

Sarepta’s commercial portfolio includes three approved RNA-based PMO therapies — Exondys 51, Vyondys 53 and Amondys 45 — and Elevidys, all targeting DMD indications. Product revenues fell 14% year over year to $370.0 million.

The company generated $238.5 million from the product sales of its three PMO therapies, down 4% year over year. The figure beat the Zacks Consensus Estimate of $225 million and our model estimate of $220 million.

Sarepta generated $131.5 million from Elevidys sales, down 27% year over year, primarily due to its decision to suspend shipments to non-ambulatory patients in June 2025 amid safety concerns. Despite this decline, the therapy’s sales beat both the Zacks Consensus Estimate of $107 million and our model estimates of $120 million.

SRPT recorded approximately $29.3 million in collaboration and other revenues associated with the commercial Elevidys supply to Roche RHHBY. This figure fell nearly 22% year over year, reflecting lower contract manufacturing revenues due to reduced shipment volumes of Elevidys to RHHBY during the quarter.

Sarepta and Roche entered into a licensing agreement in 2019 to develop Elevidys. Per the agreement, RHHBY has exclusive rights to launch and market Elevidys in ex-U.S. markets.

Discussion on SRPT’s Operating Costs

Adjusted research and development (R&D) expenses totaled $206.5 million, up 3% year over year. This upside largely reflects an increase in up-front and milestone expenses made toward pipeline development during the quarter.

Adjusted selling, general & administrative (SG&A) expenses declined 23% to $77.1 million, primarily due to the company’s restructuring plan launched in July.

SRPT’s 2025 Guidance

Sarepta has not yet quantified the potential impact of the recent reported patient deaths on Elevidys sales, but continues to expect at least $500 million in annual revenue from Elevidys infusions in the ambulant population for the full year 2025. The company anticipates fourth-quarter infusion volumes to be flat to slightly down sequentially, reflecting ongoing market disruptions and typical seasonal dynamics.

It also expects to incur $420-$430 million in combined adjusted SG&A and R&D expenses for the full year, which includes a $200 milestone payment to Arrowhead Pharmaceuticals ARWR for the second DM1 program. The guidance for this expense for the full year is around $1.86 billion.

Sarepta expects to generate around $900 million from the sale of its three PMO therapies in 2025.

Updates on SRPT’s Pipeline & Other News

Alongside the quarterly results, Sarepta announced that it completed the phase III ESSENCE study, which evaluated the safety and efficacy of Amondys 45 and Vyondys 53, compared to placebo, in DMD patients aged 6-13 who are amenable to exon 45 or 53 skipping. While the company noted positive numerical trends favoring both therapies at 96 weeks, the study did not achieve statistical significance on its primary endpoint.

Shares of Sarepta were trading below 35% in pre-market today, as the failure of the ESSENCE study raised concerns over the regulatory path and commercial outlook for the company’s PMO therapy franchise. This study served as the confirmatory study intended to convert the FDA’s accelerated approvals for both Amondys 45 and Vyondys 53 into traditional approvals.

Year to date, the stock has plunged 80% against the industry’s 11% growth.

Sarepta attributed the lack of statistical significance in part to the impact of the COVID-19 pandemic, stating that when COVID-affected data were excluded, a meaningful treatment effect on the primary endpoint was observed. The ESSENCE study also reaffirmed a favorable safety profile for both therapies. Sarepta intends to meet with the FDA soon to discuss a potential path to traditional approval for both Amondys 45 and Vyondys 53, citing the positive risk-benefit profile and supportive multi-year real-world evidence of both drugs.

Since the beginning of 2025, the stock has been facing a lot of heat from investors after three patient deaths were linked to its gene therapy treatments and attributed to acute liver failure (ALF). While two deaths occurred in patients after receiving Elevidys, one was caused by an experimental limb-girdle muscular dystrophy (LGMD) therapy. All deaths occurred in non-ambulatory patients and were linked to the AAVrh74 gene therapy vector, used in both Elevidys and Sarepta’s experimental LGMD therapies.

The above outcomes have led the company to voluntarily suspend Elevidys dosing for non-ambulatory patients. Sarepta is closing in on discussions with the FDA to finalize the safety labelling process for Elevidys in the near-term, which includes the removal of the non-ambulatory indication, as well as a box warning for ALF and liver injury. To address the safety issue in non-ambulatory patients, Sarepta is working to create a new protocol with an enhanced immunosuppression regimen to make Elevidys administration safer for non-ambulatory DMD patients.

Due to the above recent setbacks, Sarepta has paused development of most of its LGMD pipeline and shifted focus to the siRNA programs, which were acquired earlier this year as part of a multi-billion-dollar licensing deal with Arrowhead.

Per the deal, Sarepta acquired exclusive rights to Arrowhead’s four clinical-stage programs, each being evaluated in separate phase I/II studies. These include SRP-1001 in facioscapulohumeral muscular dystrophy (FSHD), SRP-1002 in idiopathic pulmonary fibrosis (IPF), SRP-1003 in myotonic dystrophy type 1 (DM1) and SRP-1004 in spinocerebellar ataxia 2 (SCA2). Initial data on the FSHD and DM1 programs are expected in early 2026.

Sarepta Therapeutics, Inc. Price

 

Sarepta Therapeutics, Inc. price | Sarepta Therapeutics, Inc. Quote

SRPT’s Zacks Rank

Sarepta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank  #1 (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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