Rhythm Pharmaceuticals (RYTM) Q4 2025 earnings summary

Executive summary

• Achieved strong global IMCIVREE sales growth in 2025, reaching $57.3M in Q4 and $194.8M for the year, driven by U.S. and international expansion, especially in Bardet-Biedl syndrome.

• Advanced clinical programs for MC4R agonists, with positive Phase 2 data for bivamelagon and setmelanotide, and pivotal progress in acquired hypothalamic obesity and BBS indications.

• Prepared for major regulatory milestones in 2026, including FDA PDUFA for acquired hypothalamic obesity in March and EMA review in Europe.

• Expanded commercial infrastructure, increasing U.S. sales force and building operations in Japan, with early-access programs and launches in new countries.

• Robust cash position at year-end 2025 ($388.9M), supporting at least 24 months of operations.

Financial highlights

• Q4 2025 IMCIVREE revenues reached $57.3M, up 12% sequentially; full-year revenue was $194.8M, a 50% increase year-over-year.

• U.S. accounted for 68% of Q4 product revenue ($39M); ex-U.S. for 32% ($18.3M), with ex-U.S. revenue up 40% sequentially due to a one-time charge adjustment in France.

• Q4 net product revenue rose $15.4M (37%) over Q4 2024; net loss for Q4 2025 was $48.8M and for FY 2025 was $201.9M, both improved year-over-year.

• Q4 GAAP net loss per share was $0.73; FY 2025 net loss per share was $3.11, both improved from prior year.

• Ended 2025 with $388.9M in cash and equivalents, up from $320.6M at end-2024.

Outlook and guidance

• 2026 non-GAAP operating expenses expected at $385M–$415M, with R&D at $197M–$213M and SG&A at $188M–$213M, reflecting increased investment in R&D, commercial launch, and Japan expansion.

• Anticipates FDA PDUFA decision for acquired hypothalamic obesity in March 2026 and EMA opinion in Q2, with EU marketing authorization expected in H2 2026.

• Plans to initiate Phase 3 HO study for bivamelagon by year-end 2026, with multiple clinical milestones and data readouts expected.

• U.S. launch of setmelanotide for acquired hypothalamic obesity expected after March 2026 FDA decision.

• Cash position expected to fund operations for at least 24 months.