Soleno Therapeutics (SLNO) FY 2025 Conference September 04, 2025 01:30 PM ET Company ParticipantsAnish Bhatnagar - CEO & ChairmanJim Mackaness - CFOConference Call ParticipantsDerek Archila - MD, Co-Head - Therapeutics Research & Senior Biotechnology AnalystDerek ArchilaAll right, everyone, I think we'll get started here with our next fireside discussion. My name is Derek Archila. I'm the Senior Biotech Analyst here at Wells Fargo. Looking forward to our next discussion here with Soleno Therapeutics from th ...

Financial Data and Key Metrics Changes - Soleno Therapeutics received FDA approval for its first drug, VYKAT XR, for Prader-Willi syndrome at the end of March 2025, with a successful launch shortly thereafter [4] - In Q2, the company reported 646 start forms and 295 prescribers, exceeding expectations [4][10] - The discontinuation rate for adverse events was about 5.2%, which is consistent with the clinical trial population [18] Business Line Data and Key Metrics Changes - The launch of VYKAT XR has been successful, with a significant number of prescribers and start forms indicating strong initial uptake [4][10] - The patient population primarily consists of younger individuals aged 4 to 26, who are heavier than those in clinical trials, leading to potential challenges in monitoring [14][15] Market Data and Key Metrics Changes - The total addressable market (TAM) for Prader-Willi syndrome in the U.S. is estimated at 10,000 patients, with 12,500 patients identified based on claims analysis [36] - In Europe, the prevalence of Prader-Willi syndrome is similar to that in the U.S., with an estimated 9,000 patients across the EU4 plus the UK [40] Company Strategy and Development Direction - The company aims to maintain a strong commercial focus on the launch of VYKAT XR while exploring potential partnerships for European commercialization [43][55] - Soleno Therapeutics is open to exploring additional assets or mechanisms of action (MOAs) related to Prader-Willi syndrome in the future [54] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the drug's safety profile and the ongoing education of healthcare providers regarding monitoring and titration [16][17] - The company anticipates a slow and steady increase in patient uptake over time, rather than exponential growth [27][28] Other Important Information - The company has a robust intellectual property (IP) strategy, with multiple patent families and potential extensions into the late 2030s [52] - Management highlighted the importance of long-term safety data, which provides a competitive advantage over new entrants in the market [48][49] Q&A Session Summary Question: What is the launch trajectory for VYKAT XR? - Management indicated that while initial uptake has been strong, it is not sustainable at the same rate, and a moderate growth trajectory is expected [27][28] Question: How is the physician community responding to VYKAT XR? - The embrace of the drug is significant, with many prescribers being previously unknown to the company, indicating a broad acceptance [12] Question: What are the expectations for payer coverage and reauthorizations? - Currently, there have been no reauthorizations, and the focus will be on whether the drug is effective for patients [22][23] Question: What is the competitive landscape for Prader-Willi syndrome treatments? - Management believes there is room for multiple treatments in the market, as no single drug will work for everyone [44][45] Question: What is the company's strategy regarding commercialization in Europe? - The company is considering both self-commercialization and potential partnerships, with ongoing discussions in this area [43] Question: How does the company plan to manage its cash and commercial footprint? - The company is well-capitalized with over $500 million in cash, allowing for continued investment in the launch and potential expansion [56][57]