Rhythm Pharmaceuticals Q1 2024 Financial Results and Business Update

Rhythm Pharmaceuticals, Inc., a biopharmaceutical firm at the commercial stage, has released its financial results for Q1 of 2024, ending March 31, 2024, and provided insights into its business operations. The company focuses on treating patients with rare neuroendocrine diseases through its lead drug, IMCIVREE® (setmelanotide).

In the first quarter of 2024, Rhythm Pharmaceuticals reported global sales of IMCIVREE® amounting to $26.0 million. The company is planning to submit a supplementary New Drug Application (sNDA) to the FDA in the second quarter of 2024, aiming to treat pediatric patients aged 2 to below 6 years in approved indications. Furthermore, a Phase 3 trial of setmelanotide in hypothalamic obesity is on track, with data expected in the first half of 2025. Initial patient dosing in Japan is anticipated in the second quarter of 2024.

Additionally, Rhythm secured $150 million in convertible preferred stock financing, extending its operational funding into 2026. The company is also advancing its broader melanocortin-4 receptor (MC4R) portfolio, including the RM-718 and LB54640 programs.

Rhythm announced that in the first quarter of 2024, approximately 100 new prescriptions for IMCIVREE for Bardet-Biedl syndrome (BBS) were issued by U.S. prescribers, and payor approval for reimbursement was received for around 70 prescriptions. The company also participated in The Pediatric Endocrine Society’s Annual Meeting, highlighting data that showed setmelanotide achieved significant weight reduction in pediatric patients with hypothalamic obesity, BBS, or POMC and LEPR deficiency obesities.

On April 29, 2024, results from a Phase 2 study of setmelanotide for hypothalamic obesity were published in The Lancet Diabetes & Endocrinology. This study revealed a mean percent reduction in BMI of 15% at 16 weeks and a 26% reduction at one year in a long-term extension study.

In terms of financing, on April 1, 2024, Rhythm announced an investment agreement with current shareholders for the sale of its series A convertible preferred stock for gross proceeds of $150 million. This transaction closed on April 15, 2024. Furthermore, the company initiated a Phase 1 clinical trial of RM-718, an investigational MC4R agonist, in March 2024.

Rhythm anticipates achieving several upcoming milestones, including the completion of the sNDA submission to the FDA in the second quarter of 2024 and EMA approval potentially in the fourth quarter. The company also plans to start dosing patients in the Japanese cohort of the Phase 3 trial for hypothalamic obesity in the second quarter of 2024 and initiate patient dosing in the Phase 2 SIGNAL trial evaluating LB54640 in the third quarter of 2024.

Financially, as of March 31, 2024, Rhythm reported cash, cash equivalents, and short-term investments of approximately $201 million, down from $275.8 million as of December 31, 2023. This decrease included a $40 million upfront payment to LG Chem for global rights to LB-54640.

Net product revenues from IMCIVREE sales were $26.0 million for Q1 2024, compared to $11.5 million for the same period in 2023. Research and development expenses were $128.7 million, up from $37.9 million in Q1 2023, primarily due to in-process R&D costs related to the acquisition of LB54640. Selling, general, and administrative expenses stood at $34.4 million, compared to $24.6 million in Q1 2023.

The company's net loss for Q1 2024 was $(141.4) million, or $(2.35) per share, compared to a net loss of $(52.2) million, or $(0.92) per share, in the same period in 2023.

For the full year 2024, Rhythm anticipates Non-GAAP Operating Expenses of approximately $250 million to $270 million. The company expects that its existing cash and the proceeds from the sale of preferred stock will fund its operations into 2026.

Rhythm Pharmaceuticals continues to advance its mission of transforming the lives of patients with rare neuroendocrine diseases through its innovative treatments and ongoing research and development efforts.