Loading...
•
Dec 30, 2024
PTC Therapeutics Q1 2025 Earnings Report
PTC Therapeutics reported strong revenue performance and positive regulatory opinions in Q1 2025.
Key Takeaways
PTC Therapeutics reported a total net product and royalty revenue of $190 million for the first quarter of 2025. The company also announced a positive CHMP opinion for Sephience and progress in its global launch activities, maintaining a strong cash position of over $2.0 billion.
First quarter 2025 total net product and royalty revenue reached $190 million.
Positive CHMP opinion for Sephience MAA was received, with NDA review on track for July 29, 2025 PDUFA date.
The company maintained a strong cash position of over $2.0 billion as of March 31, 2025.
PTC narrowed its full-year 2025 revenue guidance to between $650 million and $800 million.
PTC Therapeutics
PTC Therapeutics
PTC Therapeutics Revenue by Segment
Revenue by Segment
Translarna Revenue
CapyFin.comEmflaza Revenue
CapyFin.comDMD Franchise Revenue
CapyFin.comEvrysdi Royalty Revenue
CapyFin.comCollaboration and License Revenue
CapyFin.com Forward Guidance
PTC Therapeutics updated its full-year 2025 financial guidance, narrowing its revenue forecast and providing estimates for GAAP and non-GAAP R&D and SG&A expenses.
Positive Outlook
- Full-year 2025 revenue anticipated between $650 million and $800 million, including in-line products, potential new product launches, and royalty revenue from Evrysdi.
- Positive CHMP opinion for Sephience received, with global launch activities progressing.
- NDA for Sephience remains on track for July 29, 2025 PDUFA date.
- NDA for vatiquinone accepted and granted Priority Review by the FDA, with a target regulatory action date of August 19, 2025.
- PTC518 Phase 2 PIVOT-HD study met primary endpoint of dose-dependent blood HTT lowering at Week 12.
Challenges Ahead
- GAAP R&D and SG&A expense anticipated between $805 million and $835 million.
- Non-GAAP R&D and SG&A expense anticipated between $730 million and $760 million, excluding estimated non-cash, stock-based compensation expense of $75 million.
- Translarna NDA currently under review by the FDA.
- Japan regulatory submission for Sephience under review with a decision expected in Q4 2025.
- The company will complete additional analyses and discuss next development and regulatory steps for PTC518, including potential for accelerated approval.