Quarterly Revenue Growth
Global net revenues of $60.1M in Q1 2026, representing 5% sequential growth from $57M in Q4 2025. 61% of Q1 revenue was generated in the United States.
International Revenue Acceleration
Revenue outside the U.S. rose from $18.3M to $23.2M in Q1, a 27% sequential increase driven by higher sales volumes in Germany and France and named-patient markets (e.g., Saudi Arabia, Greece).
Growth in Patients on Reimbursed Therapy
Globally, patients on reimbursed therapy increased by 8% quarter-over-quarter, driven primarily by BBS and international early access programs.
Strong Early Launch for Acquired Hypothalamic Obesity (HO)
More than 150 start forms received in the first six weeks post-U.S. approval (approx. 40 from clinical trial conversions). ~110 unique prescribers (≈80% new to IMCIVREE) and ~80% of prescribers are endocrinologists. U.S. salesforce scaled from 16 to 42 reps to address an estimated ~10,000-patient HO opportunity in the U.S. and Europe.
Regulatory and Market Access Milestones
FDA approval for acquired HO (March 19, 2026), European Commission marketing authorization granted quickly following positive CHMP opinion, and PMDA in Japan has accepted the NDA with anticipated approval/launch in Japan by end of 2026 and EU country launches targeted in 2027.
Real-World Evidence and Early Access Programs
Early access programs in France and Italy provided meaningful reimbursed patient experience; French AP1 program produced real-world data from >60 HO patients (including up to 12 months on therapy) to be presented at European Congress of Endocrinology.
Solid Cash Position and Runway
Ended Q1 with approximately $341M in cash, cash equivalents and short-term investments, projected to fund planned operations for at least 24 months.
Pipeline and Milestones on Track
Near-term clinical and program milestones: anticipated sharing of Dr. Miller's 6-month PWS data at Endo (June), RM-718/718 data midyear, Part C HO results targeted for Q2 call, and CMC/bioequivalence work underway aiming for a Phase III start of bivamelagon (RM-718) in HO by end of 2026.