Rhythm Pharmaceuticals, Inc. reported a significant increase in its financial performance for the first quarter of 2025, with net product revenue reaching $37.7 million, a 45% increase from $25.97 million in the same period last year. The company attributed this growth primarily to the continued demand for its lead product, IMCIVREE® (setmelanotide), which is designed to treat obesity caused by rare genetic disorders. However, the company also recognized a reduction of $5.0 million in license revenue due to the termination of its exclusive license agreement with RareStone Group Ltd. As a result, total net revenue for the quarter was $32.7 million, compared to $25.97 million in the prior year.

In terms of profitability, Rhythm Pharmaceuticals reported a net loss of $49.5 million for the first quarter of 2025, a substantial improvement from the $141.4 million loss recorded in the same quarter of 2024. This reduction in losses was largely due to a significant decrease in research and development expenses, which fell by 71% to $37.0 million, primarily because of the absence of one-time costs associated with the acquisition of in-process research and development assets from LG Chem in the previous year. Selling, general, and administrative expenses also increased by 14% to $39.1 million, reflecting the company's efforts to expand its commercial operations.

Operationally, the company reported a 14% increase in the number of patients on reimbursed therapy for IMCIVREE compared to the previous quarter, indicating a growing customer base. The U.S. market accounted for approximately 65% of total product revenue, while international sales contributed 35%. The company has achieved market access for IMCIVREE in over 15 countries outside the U.S. and continues to pursue additional approvals in various regions. As of March 31, 2025, Rhythm Pharmaceuticals had cash and cash equivalents totaling approximately $314.5 million, which management believes will be sufficient to fund operations into 2027.

Looking ahead, Rhythm Pharmaceuticals is preparing to submit a supplemental New Drug Application to the FDA and a Type II variation request to the European Medicines Agency for setmelanotide as a treatment for acquired hypothalamic obesity, following positive results from its pivotal Phase 3 TRANSCEND trial. The company anticipates that these submissions will occur in the third quarter of 2025. Additionally, it plans to announce topline data from the Phase 2 trial of bivamelagon in the same timeframe. Despite the positive outlook, the company acknowledges the ongoing risks associated with product development, regulatory approvals, and market acceptance, which could impact its future financial performance.

About RHYTHM PHARMACEUTICALS, INC.

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