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]