Rhythm Pharmaceuticals ((RYTM)) has held its Q3 earnings call. Read on for the main highlights of the call.
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Rhythm Pharmaceuticals’ recent earnings call conveyed an optimistic sentiment, driven by strong revenue growth and significant regulatory progress. The company highlighted its achievements with IMCIVREE, particularly in addressing hypothalamic obesity, and showcased promising data in Bardet-Biedl Syndrome (BBS). Despite facing challenges in international revenue, the successful equity offering and rising R&D costs reflect a positive outlook for the future.
Strong Revenue Growth
Rhythm Pharmaceuticals reported a robust Q3 2025 revenue of $51.3 million, marking a 6% sequential increase from Q2 2025. The U.S. market played a significant role, contributing $38.2 million, which accounts for 74% of the total revenue. Meanwhile, international sales added $13.1 million or 26% to the overall revenue, showcasing the company’s expanding global footprint.
Successful Equity Offering
In a strategic move to bolster its financial position, Rhythm Pharmaceuticals completed a $189 million equity offering in July 2025. This capital infusion has significantly strengthened the company’s balance sheet, providing a solid foundation for future growth and ensuring operational stability for at least the next 24 months.
Regulatory Progress for IMCIVREE
The company achieved a major milestone with the acceptance of IMCIVREE’s regulatory filings for acquired hypothalamic obesity by both the FDA and EMEA. A PDUFA date is set for December 20, 2025, signaling potential market entry and expansion opportunities in the near future.
Promising Data in Bardet-Biedl Syndrome
A recent German study revealed encouraging results for patients with Bardet-Biedl Syndrome (BBS) undergoing setmelanotide therapy. Remarkably, 80% of these patients experienced either improvement in steatotic liver disease or stabilization at the lowest grade after six months of treatment, underscoring the therapy’s potential efficacy.
International Revenue Decrease
Despite the overall revenue growth, Rhythm Pharmaceuticals faced a $3.4 million decline in international revenue quarter-over-quarter. This decrease was primarily due to variability in named patient sales ordering patterns and a $3.2 million charge related to pricing agreements in France.
Research and Development Costs
The company’s commitment to innovation is reflected in the 9% increase in R&D expenses, amounting to an additional $3.7 million over Q2 2025. This rise is largely attributed to ongoing CMC work aimed at enhancing the formulation of bivamelagon, highlighting Rhythm’s dedication to advancing its product pipeline.
Forward-Looking Guidance
Looking ahead, Rhythm Pharmaceuticals provided comprehensive guidance, emphasizing its strategic initiatives and growth prospects. The company is preparing for the potential U.S. launch of IMCIVREE for acquired hypothalamic obesity, with a PDUFA date set for December 20, 2025, and a European launch anticipated in the second half of 2026. Additionally, Rhythm plans to report preliminary results from its Phase II trial in Prader-Willi syndrome by year-end, targeting a 5% BMI decrease at 52 weeks in the Phase III trial.
In summary, Rhythm Pharmaceuticals’ earnings call painted a picture of optimism and strategic growth. The company’s strong revenue performance, successful equity offering, and promising regulatory progress underscore a positive outlook. Despite some challenges in international markets, Rhythm’s commitment to innovation and expansion positions it well for future success.