Strong Q4 and Full-Year Revenue Growth
Q4 2025 product revenue of $57.3M, up 12% sequentially; full-year 2025 revenue of $194.8M, approximately +50% year-over-year. Q4 net product revenues were +37% versus Q4 2024.
Improving Patient Base
Sequential quarterly growth driven by ~10% increase in number of patients on reimbursed therapy globally in Q4 2025; U.S. represented 68% ($39M) and ex-U.S. 32% ($18.3M) of Q4 revenue; ex-U.S. revenue increased ~$5.2M or ~40% vs Q3 2025.
Bivamelagon Phase 2 Durable Efficacy at 40 Weeks
40-week open-label data show mean BMI decreases of 10.8% for the 400 mg cohort and 14.3% for the 600 mg cohort (including non-compliant patients); 11 of 14 patients in higher-dose cohorts decreased BMI by ≥10%.
Regulatory Progress for Bivamelagon and HO
End-of-Phase-2 FDA meeting concluded bivamelagon is ready to move to Phase 3; company intends to run a 12-month randomized controlled trial consistent with FDA feedback and integrate full 142-patient dataset into labeling plans.
Multiple Near-Term Catalysts
Key upcoming milestones include PDUFA for Acquired Hypothalamic Obesity (Mar 20, 2026), top-line data from Japanese HO cohort and M&A readout in March, CHMP opinion anticipated in Q2 and potential EU marketing authorization H2 2026.
International Expansion and KOL Activity
IMCIVREE available in >25 countries ex-U.S.; international organization grew to >100 employees across 13 countries; eight new countries added in 2025; 64 abstracts accepted at 12 scientific congresses in 2025.
Commercial Preparedness for AHO Launch
U.S. sales force expanded from 16 to 42 ahead of potential AHO launch; field teams engaged HCPs caring for >2,000 patients diagnosed or suspected with acquired HO; identified ~40 priority medical centers concentrating AHO care.
Solid Balance Sheet and Runway
Ended 2025 with ~$389M in cash equivalents and short-term investments; cash used in operations $116M for the year; company expects cash to fund planned operations for at least 24 months.
Clinical Development Momentum Across Portfolio
RM-718 weekly formulation is enrolling with initial 3-month data expected by mid-year; PWS trial remains on track with 17 of 18 patients continuing on treatment and 6-month data expected mid-year; formulation and phase 3 supply plans on track for next-gen compounds.