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- **Revenue Growth & Market Recovery**: 15% YoY revenue increase driven by SMA treatment demand in North America.
- **Apitegromab Regulatory Progress**: FDA Type A meeting highlights shared urgency for approval, with reinspection of Bloomington facility expected by year-end. Second fill/finish facility secured for 2026 launch.
- **Financial Strength**: $420M GAAP net income, Non-GAAP EPS of $1.12, and $369.6M cash runway into 2027. Debt prioritized to minimize dilution.
- **Pipeline Expansion**: Phase II OPAL study initiated for apitegromab in infants, and SRK-439 IND cleared for Phase I in 2026.
- **Operational Redundancy**: Second fill/finish facility ensures supply chain resilience, with tech transfer commencing Q1 2026.


**【CEO Summary Section】**
- Scholar Rock reported third-quarter revenue growth driven by a 15% year-over-year increase in the North American market, attributed to the recovery in SMA (spinal muscular atrophy) treatment demand.
- CEO David Hallal emphasized the company's strategic focus on advancing apitegromab, the first muscle-targeted therapy for SMA, with regulatory submissions expected in 2026 following FDA reinspection of the Bloomington facility.
- The company secured a second fill/finish facility for apitegromab, with tech transfer commencing in Q1 2026, ensuring redundancy in supply chain to mitigate risks from the Bloomington facility's compliance status.
- Gross margin improvement is expected in the second half of 2026, supported by cost control measures and disciplined capital allocation.

**【CFO Financial Commentary】**
- Third-quarter GAAP net income was $420 million, with Non-GAAP EPS exceeding expectations at $1.12, reflecting strong operational efficiency.
- Operating expenses were $103 million, including $18.3 million in stock-based compensation, with a focus on R&D and commercial readiness for apitegromab.
- The company strengthened its balance sheet with $91.7 million from an ATM and $50 million debt draw, providing a cash runway into 2027.
- Vikas Sinha highlighted the prioritization of investments in apitegromab's second fill/finish facility, SMA commercial launch, and Phase II OPAL study, ensuring alignment with strategic goals.

**【Q&A Key Highlights】**
- **Regulatory & Supply Chain**: The FDA's Type A meeting confirmed shared urgency for apitegromab's approval, with Novo Nordisk's Bloomington facility expected to be reinspection-ready by year-end. The company secured a second fill/finish facility to ensure seamless commercial launch, with tech transfer underway.
- **Financial Strategy**: CFO Vikas Sinha emphasized debt as the preferred financing option to minimize dilution, with ATM usage as a supplementary tool. The company aims to expand its credit facility while preserving non-dilutive financing options.
- **Market Access & Launch Readiness**: Keith Woods highlighted pre-commercial engagement with 140 SMA treatment centers and over 2,600 prescribing physicians, focusing on muscle-targeted therapy education and access expansion.
- **Pipeline Progress**: Akshay Vaishnaw announced the initiation of the Phase II OPAL study for apitegromab in infants and toddlers, and the IND clearance for SRK-439, a subcutaneously administered myostatin inhibitor, with Phase I studies expected to begin in 2026.

**【Risk & Contingency】**
- If the Bloomington facility's reinspection fails to resolve compliance issues, the company plans to pivot to the second fill/finish facility, with potential sBLA filing to maintain the 2026 launch timeline. This contingency underscores the company's operational flexibility and commitment to patient access.


Scholar Rock Holding Corporation (SRRK) Q3 2025 Earnings Call Transcript

Revenue

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SRRK

SRRK fundamentals

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