greeksoup/ stock research

Sarepta Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 2 narrowed. The quarter’s numbers.

Key takeaways

  • Net product revenue fell year on year: Products net revenue was $323.8 million in the quarter, versus $370.0 million a year earlier. Total revenues were $381.4 million, down $18.0 million, mainly from lower ELEVIDYS volume after the label narrowed to ambulatory patients. Source
  • Operating result turned to GAAP loss: GAAP operating loss was $9.0 million, against non-GAAP operating income of $22.9 million. Diluted GAAP loss per share was $0.27; non-GAAP diluted EPS was $0.13. Source
  • PMO and ELEVIDYS revenue split: Net product revenue comprised $240.3 million of PMO revenue and $83.5 million of ELEVIDYS revenue in the quarter. Second-quarter PMO revenue was $230.6 million and ELEVIDYS $98.1 million. Source
  • ELEVIDYS label limited to ambulatory patients: Management attributed lower ELEVIDYS volume to the updated label, which includes only the ambulatory patient population for treatment. Source
  • Cost of sales rose on take-or-pay charge: Cost of sales excluding in-license amortization was $188.5 million, up $37.7 million, including a $62.0 million take-or-pay charge related to Catalent manufacturing obligations for inventories not manufactured. Source
  • PMO demand described as strong: Management said the PMO franchise performance drove the raised revenue floor and expects it to remain strong. Source
  • Cash position rose modestly: Cash, cash equivalents, restricted cash and investments were $998.7 million at September 30, 2026, up from $945.0 million at June 30, 2026 and $953.8 million at December 31, 2025. Source
  • DM1 and FSHD data due by year end: Multiple ascending dose data from SRP-1003 in DM1 and SRP-1001 in FSHD are expected in Q4 2026, covering DMPK knockdown, splicing correction and DUX4 knockdown. Source
  • Preparing for Phase 3 in DM1 and FSHD: Sarepta is preparing Phase 3 development in both programs, including manufacturing of clinical supply, and is preparing for accelerated and traditional approval pathways. Source

“We have work to do, and I want us to be measured by execution, but I believe Sarepta has the commercial foundation, pipeline opportunities and financial strength to deliver meaningful long-term value.”

Michael Severino, M.D., chief executive officer, Sarepta

Guidance

AreaPeriodFigureAgainst last quarter
Total net product revenue Sourcefull year 2026$1.25 billion to $1.3 billionNarrowed, low end up from $1.2-$1.3 billion
Combined non-GAAP R&D and SG&A expenses Sourcefull year 2026$800 million to $825 millionNarrowed, top end cut from $800.0-$850.0 million

What changed from last quarter

  • Guidance raised: Low end of full-year total net product revenue guidance raised by $50.0 million, to $1.25-$1.3 billion, citing strong PMO performance. Source
  • Guidance lowered: High end of full-year combined non-GAAP R&D and SG&A expense guidance lowered by $25.0 million, to $800-$825 million. Source
  • New: Michael Severino, M.D., became chief executive officer effective July 28, 2026, and was reported as having completed his first 90 days. Source
  • New: Company now reports preclinical SRP-1003 nuclear DMPK knockdown data presented at the 2026 Oligonucleotide Therapeutics Society meeting. Source

Results and growth drivers

  • Net product revenue fell year on year: Products net revenue was $323.8 million in the quarter, versus $370.0 million a year earlier. Total revenues were $381.4 million, down $18.0 million, mainly from lower ELEVIDYS volume after the label narrowed to ambulatory patients. Source
  • Operating result turned to GAAP loss: GAAP operating loss was $9.0 million, against non-GAAP operating income of $22.9 million. Diluted GAAP loss per share was $0.27; non-GAAP diluted EPS was $0.13. Source
  • Nine-month results include Roche and Arrowhead items: Nine-month revenue was $1,513.4 million, down $241.9 million, but collaboration revenue included $365.0 million recognized for Roche's declined option. Nine-month GAAP operating income was $362.7 million. Source

Segments and regions

  • PMO and ELEVIDYS revenue split: Net product revenue comprised $240.3 million of PMO revenue and $83.5 million of ELEVIDYS revenue in the quarter. Second-quarter PMO revenue was $230.6 million and ELEVIDYS $98.1 million. Source
  • Roche contract manufacturing revenue rose: Contract manufacturing revenue increased $31.4 million on higher commercial ELEVIDYS supply delivered to Roche, offsetting part of the total revenue decline. Source

Products and customers

  • ELEVIDYS label limited to ambulatory patients: Management attributed lower ELEVIDYS volume to the updated label, which includes only the ambulatory patient population for treatment. Source
  • Ages 8-12 data presented at congress: At the World Muscle Society congress, ELEVIDYS data in ambulatory patients aged 8 to 12 showed durable benefit over two years versus an external control group, and dystrophin expression data was shown for patients treated at ages 2 and 3. Source
  • Liver safety data from Phase 4 study: Initial real-world results from the Phase 4 ENDURE study were presented on approaches to liver safety risk mitigation. Source

Costs, margins and pricing

  • Cost of sales rose on take-or-pay charge: Cost of sales excluding in-license amortization was $188.5 million, up $37.7 million, including a $62.0 million take-or-pay charge related to Catalent manufacturing obligations for inventories not manufactured. Source
  • R&D expense fell after 2025 Arrowhead milestone: R&D expense was $82.5 million versus $218.9 million, reflecting no repeat of the $100.0 million Arrowhead milestone and lower manufacturing and clinical spend after the July 2025 reprioritization. Non-GAAP R&D was $71.6 million. Source
  • SG&A rose year on year: SG&A was $118.6 million, up $26.7 million, reflecting a prior-year reversal of incentive and stock compensation. Non-GAAP SG&A was $97.6 million, up $20.5 million. Source
  • Other expense rose on interest: Other expense, net was $16.7 million, reflecting the 2025 sale of the Arrowhead investment and higher interest on the 2030 Notes. Source
  • Quality write-offs on Roche batches: Cost of sales included write-offs of certain Roche-collaboration batches that did not meet quality specifications. Source

Demand and the order book

  • PMO demand described as strong: Management said the PMO franchise performance drove the raised revenue floor and expects it to remain strong. Source

Capital, cash and returns to shareholders

  • Cash position rose modestly: Cash, cash equivalents, restricted cash and investments were $998.7 million at September 30, 2026, up from $945.0 million at June 30, 2026 and $953.8 million at December 31, 2025. Source
  • Debt partly exchanged for notes and shares: The 2027 Notes were partly exchanged for $602.0 million of 2030 Notes, with $127.3 million in cash and 5.9 million shares of common stock. The current portion of long-term debt is $158.0 million. Source
  • Cash flow described as positive: Management described the quarter as having positive cash flow and non-GAAP operating profit. Source
  • Funding for late-stage programs: Management said balance-sheet strength and commercial cash flows are expected to fund DM1 and FSHD programs through late-stage development. Source

Strategy and investment

  • DM1 and FSHD data due by year end: Multiple ascending dose data from SRP-1003 in DM1 and SRP-1001 in FSHD are expected in Q4 2026, covering DMPK knockdown, splicing correction and DUX4 knockdown. Source
  • Preparing for Phase 3 in DM1 and FSHD: Sarepta is preparing Phase 3 development in both programs, including manufacturing of clinical supply, and is preparing for accelerated and traditional approval pathways. Source
  • Nuclear DMPK knockdown shown preclinically: Preclinical data showed SRP-1003 reduced DMPK mRNA in nucleus and cytoplasm dose-dependently, with comparable knockdown in each compartment and MBNL-dependent splicing correction. Source

Leadership and people

  • New CEO's first 90 days: Michael Severino, M.D., CEO, said after his first 90 days he believes the company's core strengths remain intact. Source
  • Restructuring charge absent this year: No restructuring charge was recorded in the quarter, against $40.5 million a year earlier from the July 2025 restructuring plan. Source

Coming up, as management said on 5 November 2026

  • DM1 and FSHD MAD data: Multiple ascending dose data from SRP-1003 (DM1) and SRP-1001 (FSHD) expected in the fourth quarter of 2026. Source
  • Phase 3 preparation and regulatory discussions: Regulatory strategy for both programs to be informed by the data and discussions with FDA. Source

Risks management discussed

  • Operational: Manufacturing obligations with Catalent produced a take-or-pay charge for inventories not manufactured, and some Roche batches failed quality specifications. Source
  • Demand: ELEVIDYS volume has fallen since the label was limited to ambulatory patients, and its fourth-quarter revenue is subject to variability. Source
  • Regulatory: Final regulatory strategy for DM1 and FSHD depends on data and FDA discussions. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.