Rhythm Pharmaceuticals (RYTM) Q3 2025 earnings summary

Executive summary

• Q3 2025 net product revenue was $51.3 million, up 54% year-over-year, driven by IMCIVREE sales growth, especially in the U.S., and a 10% increase in patients on reimbursed therapy, despite a $3.2 million French reimbursement adjustment.

• FDA accepted the sNDA for setmelanotide in acquired hypothalamic obesity (HO) with Priority Review; PDUFA goal date is December 20, 2025, and EMA validated the Type II variation submission.

• Cash, cash equivalents, and short-term investments totaled $416.1 million at quarter end, providing at least 24 months of operational runway.

• Preparations for HO launch include expanded commercial teams, targeted physician outreach, payer engagement, and international expansion, with IMCIVREE available in over 25 countries.

• Robust clinical data for setmelanotide in HO and positive phase II results for oral MC4R agonist bivamelagon were presented; preliminary Prader-Willi syndrome phase II data expected by year-end.

Financial highlights

• Q3 2025 product revenue was $51.3 million, up from $33.3 million in Q3 2024 and up 6% sequentially from Q2.

• U.S. revenue was $38.2 million (74% of total), with international revenue at $13.1 million (26%), and a $3.2 million charge related to French reimbursement.

• Net loss for Q3 2025 was $54.3 million, or $0.82 per share; cash used in operations was $27 million.

• Cost of goods sold was $5.5 million (10.7% of product revenue); R&D expenses were $46 million, and SG&A expenses were $52.4 million.

• Gross margin for Q3 2025 was approximately 89%.

Outlook and guidance

• Cash is expected to fund operations for at least 24 months from September 30, 2025.

• Anticipates FDA approval for acquired HO by December 20, 2025, with European approval expected in the second half of 2026.

• Full-year 2025 non-GAAP operating expense guidance is $295M–$315M, with R&D at $150M–$165M and SG&A at $145M–$150M.

• Preliminary data from the Prader-Willi syndrome phase II trial expected by year-end; phase III studies for bivamelagon and HO to initiate in 2026.

• Multiple clinical and regulatory milestones expected through H1 2026, including launches in the U.S., EU, and Japan.