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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.
Revenue by Segment
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.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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