Loading...
Rhythm Pharmaceuticals Q1 2025 Earnings Report
Rhythm Pharmaceuticals reported its first quarter 2025 financial results, highlighting strong revenue growth from IMCIVREE, progress in clinical trials for setmelanotide and bivamelagon, and a solid cash position.
Key Takeaways
Rhythm Pharmaceuticals reported strong first quarter 2025 results with net product revenue from global sales of IMCIVREE reaching $37.7 million. The company achieved significant progress in its clinical trials, with the pivotal Phase 3 TRANSCEND trial for setmelanotide in acquired hypothalamic obesity meeting its primary endpoint, and regulatory submissions on track for Q3 2025. Additionally, the company's cash on-hand is expected to support operations into 2027.
First quarter 2025 net product revenue from global sales of IMCIVREE was $37.7 million.
The pivotal Phase 3 TRANSCEND trial for setmelanotide in acquired hypothalamic obesity met its primary endpoint with a -19.8% placebo-adjusted BMI reduction.
U.S. and EU regulatory submissions for setmelanotide in acquired hypothalamic obesity are on track to be completed in the third quarter of 2025.
Cash on-hand is expected to support planned operations into 2027.
Revenue by Segment
Revenue by Geographic Location
Forward Guidance
Rhythm Pharmaceuticals anticipates Non-GAAP Operating Expenses for the year ending December 31, 2025, to be approximately $285 million to $315 million, with cash on-hand expected to support planned operations into 2027.
Positive Outlook
- Submit supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide for the treatment of acquired HO in the third quarter of 2025.
- Announce topline data from the bivamelagon Phase 2 trial in acquired HO in the third quarter of 2025.
- Complete enrollment in the setmelanotide Phase 2 trial in Prader-Willi syndrome (PWS) in the second half of 2025.
- Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with acquired hypothalamic obesity in the second half of 2025.
- Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital hypothalamic obesity in the second half of 2025.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...