Soleno Therapeutics (NasdaqCM:SLNO) 2025 Conference Transcript

Summary of Soleno Therapeutics Conference Call Company Overview - Company: Soleno Therapeutics (NasdaqCM:SLNO) - Conference Date: November 12, 2025 - Key Speakers: Anish Bhatnagar (CEO), Jim Mackaness (CFO) Key Points Financial Performance - Q3 revenues reached $66 million, doubling from Q2, with 397 start forms submitted [2][3] - The company is profitable and covers over 130 million lives [2] - A stock buyback was initiated, indicating management believes the market undervalues the company [2][18] Market Dynamics - Initial patient script growth was strong, but there are indications of flattening in Q4, which is considered normal [3][4] - The company aims to capture 10% of the Total Addressable Market (TAM) of 10,000 patients within the first six months post-launch, with expectations to reach 20% by next year [4][8][10] - The company anticipates continued net patient growth despite some fluctuations due to seasonal factors [5][6] Patient Discontinuation Rates - Discontinuation rates are currently between 8% to 10%, with expectations to stabilize around 15% based on clinical data [21][31] - Most discontinuations are due to non-serious adverse events, with a focus on improving patient adherence through education [21][22][32] Prescriber Engagement - There is a strong focus on physician education to improve prescribing practices, especially among less experienced doctors [26] - High-volume prescribers are not reaching capacity, indicating room for growth in patient prescriptions [29][30] Safety and Efficacy - The safety profile in the real world appears to be better than in clinical trials, with lower rates of adverse events reported [42][44] - Anecdotal evidence suggests positive efficacy outcomes, with patients experiencing significant improvements in their conditions [39][40] Market Access and Reimbursement - The company has achieved broad coverage, with over 130 million lives covered and successful reimbursement from various channels [48] - Reauthorizations are occurring, primarily based on physician and caregiver attestations [49][50] Future Outlook - The company is preparing for potential approval in the EU, with approximately 9,500 diagnosed patients in the region [62] - There is ongoing interest in potential partnerships in the EU, but the company is also equipped to launch independently [65] - The competitive landscape remains open, with limited successful alternatives in the market for PWS [68] Strategic Focus - The company is focused on both organic and inorganic growth strategies moving forward [69] - Profitability is expected to be maintained while judicious investments are made in the commercial side of the business [70] Additional Insights - The company is actively engaging with patient advocacy groups and the broader community to gather feedback and improve treatment logistics [46] - There is a recognition of the need for ongoing education for both prescribers and caregivers to enhance treatment adherence and patient outcomes [32][26]