Rhythm Pharmaceuticals reported financial results for the first quarter ended March 31, 2023. The company saw strong commercial progress with IMCIVREE in the U.S. and launched it in Germany. They also dosed the first patients in their pivotal Phase 3 trial for hypothalamic obesity and expect to complete enrollment in Q1 2024.
IMCIVREE saw commercial progress with over 300 new U.S. prescriptions for Bardet-Biedl syndrome (BBS) since FDA approval.
IMCIVREE was launched for BBS in Germany with federal reimbursement.
The first patients were dosed in the pivotal Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity, with enrollment completion expected in Q1 2024.
Rhythm is executing on six clinical trials with three data readouts expected in the second half of 2023.
Rhythm anticipates approximately $200 million to $220 million in Non-GAAP Operating Expenses for the year ending December 31, 2023, comprised of $120 million to $130 million from R&D expenses and $80 million to $90 million from S,G&A expenses. Based on its current operating plans, Rhythm expects that its existing cash, cash equivalents and short-term investments as of March 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into 2025.