CAMBRIDGE, Mass. — Sarepta Therapeutics reported second-quarter revenue of $401.3 million and appointed Michael Severino, M.D., as chief executive officer as the rare-disease drugmaker continued to advance its commercial products and genetic medicine pipeline.
Total revenue declined 34 percent from $611.1 million in the same quarter last year. The decrease primarily reflected lower ELEVIDYS sales following an updated label limiting treatment to ambulatory patients, as well as the absence of a regulatory milestone payment recorded in the prior-year period.
Net product revenue totaled $328.7 million, including $230.6 million from the company’s phosphorodiamidate morpholino oligomer therapies and $98.1 million from ELEVIDYS.
Sarepta reported a net loss of $4.9 million, or 5 cents per share, compared with net income of $196.9 million, or $1.89 per diluted share, a year earlier.
Non-GAAP net income was $78.6 million, or 64 cents per share, compared with $215.2 million, or $2.02 per share, in the second quarter of 2025.
The company reported GAAP operating income of $13.3 million and non-GAAP operating income of $86.5 million.
“As I begin my tenure as CEO, I am excited by the strength of Sarepta’s foundation, the impact our therapies are having for patients, and the significant opportunities ahead,” said Michael Severino, MD, chief executive officer, Sarepta Therapeutics. “Our second quarter results, including $328.7 million in total net product revenue and both GAAP and non-GAAP operating profitability, reflect the strength and resilience of our business. With important data readouts expected in DM1 and FSHD, continued progress across our broader pipeline, and a talented team dedicated to transforming the lives of patients with rare diseases, we have significant opportunities ahead and remain committed to delivering sustainable long-term value. Our priorities are clear: execute our commercial strategy, advance our promising siRNA pipeline, and continue allocating capital with discipline. With a strong balance sheet, an innovative pipeline, and an experienced leadership team, I believe Sarepta is well positioned to deliver on its long-term potential.”
Severino became CEO and joined Sarepta’s board on July 28. He has more than 25 years of biopharmaceutical industry experience, including senior executive roles at AbbVie, Amgen and Merck.
Former CEO Doug Ingram retired and will remain with the company in an advisory capacity through the end of 2026.
Sarepta narrowed its full-year net product revenue guidance to between $1.2 billion and $1.3 billion, from a previous range of $1.2 billion to $1.4 billion.
The company also narrowed its forecast for combined non-GAAP research and development and selling, general and administrative expenses to between $800 million and $850 million, from $800 million to $900 million.
Research and development expenses declined to $91.3 million from $204.4 million. Sarepta attributed the decrease to lower manufacturing and clinical costs, pipeline reprioritization and reduced personnel expenses following a restructuring announced in July 2025.
Selling, general and administrative expenses fell to $107.6 million from $137.9 million, reflecting lower personnel costs and reduced professional services related to ELEVIDYS commercialization.
Sarepta recorded a $39 million litigation contingency charge related to the potential resolution of certain patent lawsuits. The company said the parties had reached an agreement in principle, although the settlement remained subject to further negotiations and final documentation.
The company ended the quarter with approximately $945 million in cash, cash equivalents, restricted cash and investments, an increase of about $197 million during the quarter.
Sarepta said data from multiple-ascending-dose cohorts in ongoing Phase 1/2 studies in myotonic dystrophy type 1 and facioscapulohumeral muscular dystrophy remain on track for the second half of 2026.
The company expects to complete enrollment in Cohort 8 of the ENDEAVOR study of ELEVIDYS by the end of 2026, with 12-week data from the full cohort expected in the first quarter of 2027.
Dosing is also underway in INSIGHTT, a first-in-human Phase 1 study of SRP-1005, an experimental small interfering RNA therapy for Huntington’s disease.
The U.S. Food and Drug Administration has accepted supplemental applications seeking to convert AMONDYS 45 and VYONDYS 53 from accelerated to traditional approval.
