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- **ESSENCE Trial Update**: 30% disease progression reduction in COVID-free patients, with real-world data showing 3-year delay in loss of ambulation.
- **FDA Confidence**: Likely acceptance of 0.09 p-value, with totality of evidence supporting continued PMO authorization.
- **Financial Resilience**: Q3 revenue $399M, $865M cash, and $500M ELEVIDYS floor for ambulatory patients.
- **Pipeline Momentum**: siRNA trials advancing, with DM1 and FSHD data expected Q1 2026.

**【CEO Summary Section】**
- Completed the ESSENCE trial for VYONDYS and AMONDYS, missing statistical significance but showing a 30% reduction in disease progression in COVID-free patients.
- Highlighted real-world evidence showing a 3-year delay in loss of ambulation and 70% reduction in mortality for PMOs.
- Plans to submit totality of evidence to FDA for traditional approval and schedule a meeting by end of 2025.
- ELEVIDYS net product revenue $131M, with 90% patient adherence and no new safety signals.
- Launched sirolimus prophylaxis study for non-ambulatory patients, aiming to resume dosing in 2026.

**【CFO Financial Commentary】**
- Q3 2025 total revenue $399M (GAAP), including $370M in product revenue and $29M in collaboration income.
- Incurred $41M restructuring charge, reducing R&D and SG&A expenses by $300M midpoint vs. prior guidance.
- Cash and investments increased to $865M, with positive cash flow and deferred manufacturing commitments.
- Advanced siRNA pipeline with DM1 and FSHD trials enrolling, targeting Q1 2026 data release.

**【Q&A Highlights】**
- FDA likely to accept 0.09 p-value for ESSENCE due to rare disease challenges, with real-world evidence supporting continued authorization.
- ELEVIDYS demand resilient despite Q3 disruptions, with $500M annual floor for ambulatory patients.
- Sirolimus study design finalized, with enrollment expected to begin soon and data in H2 2026.
- PMO franchise remains stable, with EXONDYS MISSION dose-ranging study set to read out in 2026.

Sarepta Therapeutics, Inc. (SRPT) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

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Cost of Financing Services

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Operating Expenses

Selling, General and Administrative Expenses

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SRPT

SRPT fundamentals

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