Financial Data and Key Metrics Changes - The company reported global revenue of $48.5 million for Q2 2025, representing a 29% increase quarter over quarter [38] - U.S. revenue accounted for 66% of total revenue, amounting to $32 million, while international revenue was $16.5 million, making up 34% [38] - Year-over-year, net product revenues increased by $19.4 million or 67% compared to Q2 2024 [41] - The company ended Q2 2025 with $291 million in cash, following an oversubscribed equity offering that raised $189.2 million [35][37] Business Line Data and Key Metrics Changes - The company experienced solid growth in VVS sales, with a focus on BBS and acquired hypothalamic obesity [8][10] - The cumulative number of BBS prescribers grew by 38% from Q2 2024 to Q2 2025, with a 9% increase in cumulative prescribers from Q1 2025 [22] - The number of reimbursed patients on therapy in the U.S. grew at mid-single-digit percentage rates [38] Market Data and Key Metrics Changes - The international market saw a steady increase in patients on therapy, particularly in France and Italy, driven by early access programs for hypothalamic obesity [29][40] - The company is expanding its presence in new countries, including Poland and the Czech Republic, with ongoing efforts in Japan [30] Company Strategy and Development Direction - The company aims to leverage its learnings from the BBS launch to prepare for the launch of Encepria in hypothalamic obesity, pending FDA approval [25][27] - The company is focused on long-term growth, with confidence in the sustainability of its revenue streams from rare diseases [9][100] - The company plans to continue expanding its market presence globally, with a focus on both existing and new markets [98][100] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the importance of the recent quarter in laying the foundation for significant growth [7][10] - The company is confident in the projected epidemiology for acquired hypothalamic obesity, estimating a patient population of 5,000 to 10,000 in the U.S. [11][26] - Management noted that the company is well-capitalized and has a cash runway of at least 24 months, indicating strong financial health [37] Other Important Information - The company is on track for U.S. and European regulatory filings in Q3 for semolantide in hypothalamic obesity [18] - The company has a robust pipeline with multiple upcoming milestones, including data releases and trial enrollments planned for 2026 [18][19] Q&A Session Summary Question: Upcoming pipeline catalyst regarding Prader Willi data - Management characterized the Prader Willi study as exploratory, with a focus on higher dosing and longer duration compared to previous trials [49][50] Question: Expected follow-up for Prader Willi study - Management indicated that patients will continue treatment beyond the initial six months if they show benefits, emphasizing the importance of long-term data [58] Question: Confidence in higher prevalence estimates for hypothalamic obesity - Management noted ongoing fieldwork and claims data analysis to support confidence in the higher end of the prevalence range [75] Question: Growth expectations for international markets - Management highlighted that while recent growth has been strong, Q3 may see a quieter period due to seasonal factors [78] Question: Off-label usage in the U.S. for hypothalamic obesity - Management confirmed minimal off-label usage currently, with a focus on adhering to approved indications [86]
Rhythm(RYTM) - 2025 Q2 - Earnings Call Transcript