Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) has reported its fourth quarter 2023 financial results and provided a business update, revealing a net revenue of $24.2 million from global sales of Imcivree (setmelanotide) during the fourth quarter.
David Meeker, M.D., Chair, President, and CEO of Rhythm Pharmaceuticals, expressed satisfaction with the company's performance in 2023 and highlighted their focus on developing setmelanotide to treat patients with hypothalamic obesity, a condition for which there are currently no approved therapies. Meeker also mentioned the acquisition of the global rights to lb54640 and the company's readiness to enter the clinic with rm-718, further strengthening their pipeline.
Rhythm Pharmaceuticals announced multiple important developments, including the completion of enrollment in a pivotal 120-patient cohort for the Phase 3 setmelanotide trial in hypothalamic obesity. The company is on track to obtain top-line study results in the first half of 2025.
The company also provided corporate and commercial updates, including reimbursement approvals for Imcivree to treat patients with Bardet-Biedl Syndrome (BBS) in Spain and Italy. Additionally, rhythm announced its clinical development plan of setmelanotide for hypothalamic obesity in Japan.
From a financial perspective, Rhythm Pharmaceuticals reported cash, cash equivalents, and short-term investments of approximately $275.8 million as of December 31, 2023, with net product revenues of $24.2 million in the fourth quarter of 2023 and $77.4 million for the full year. The company's net loss was $41.6 million for the fourth quarter of 2023 and $184.7 million for the year ended December 31, 2023.
Looking ahead, Rhythm Pharmaceuticals expects to complete the submission of a supplementary new drug application (SNDA) to the FDA seeking a label expansion, initiate a phase 1 trial of rm-718, and announce Daybreak stage 2 data, among other anticipated milestones.
The full 8-K submission by Rhythm Pharmaceuticals to the Securities and Exchange Commission is available here.