Rhythm Pharmaceuticals reported a strong 2022, highlighted by the successful U.S. launch of IMCIVREE for Bardet-Biedl syndrome (BBS) following FDA approval in June and its expansion into eight international markets. The company also initiated a pivotal Phase 3 trial for setmelanotide in hypothalamic obesity and acquired Xinvento B.V. to broaden its pipeline into congenital hyperinsulinism (CHI).
IMCIVREE U.S. launch for Bardet-Biedl syndrome (BBS) reflects strong demand with more than 200 new prescriptions received since FDA approval
IMCIVREE now available in eight ex-U.S. markets; first commercial sales for BBS expected in Germany in 2Q 2023
Pivotal Phase 3 trial evaluating setmelanotide in acquired hypothalamic obesity initiated
Acquired Xinvento B.V., a rare disease company in preclinical development for congenital hyperinsulinism
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. The company expects its existing cash, cash equivalents and short-term investments as of December 31, 2022 will be sufficient to fund its operating expenses and capital expenditure requirements into 2025.