Soleno Therapeutics (SLNO) Conference Transcript

Summary of Soleno Therapeutics (SLNO) Conference Call - February 06, 2025 Company Overview - Company: Soleno Therapeutics (SLNO) - Participants: Anish Bhatnagar (CEO), Debjit Chattopadhyay (Managing Director) Key Points Regulatory Updates - The PDUFA date has been delayed from December 27 to March 27, 2025, primarily due to the volume of information provided in response to FDA inquiries [2][4] - No major new questions have been raised by the FDA, and inspections have occurred without any Form 483s issued [5][4] - The company is not expecting any earlier decisions than the March 27 PDUFA date [9][10] Market and Product Launch - Soleno is prepared to launch the drug shortly after the PDUFA date, with expectations to have the product in channels by May 2025 [10][11] - Consensus estimates for first-year sales have not fully adjusted for the PDUFA delay, indicating potential underestimation of market entry timing [11] - The target market size is estimated to be between 7,000 to 12,000 patients, with Soleno projecting around 10,000 patients likely to be on label [12][13] Patient Demographics and Targeting - Approximately 300 healthcare providers are expected to influence prescriptions for about 4,000 patients, representing 40% of the total addressable market (TAM) [15] - The company plans to utilize a combination of field sales, targeted outreach to group homes, and digital marketing to reach patients effectively [16][17] Pricing Strategy - While specific pricing details are not disclosed, the expected range is between $300,000 to $400,000, with weight-based dosing likely influencing final pricing [19][20] - The company is conducting extensive research on pricing analogs and market dynamics [19] Compliance and Patient Management - Compliance is expected to be manageable due to the nature of the patient population, particularly in group home settings where staff can assist with medication adherence [24][25] - An estimated 10% of the target patient population resides in group homes [26] European Market Strategy - Soleno plans to submit for approval in Europe in the first half of 2025, with potential for direct commercial infrastructure in the EU due to favorable market conditions [29][30] - The company is exploring partnerships for ex-US commercialization but has not made definitive decisions yet [31] Intellectual Property and Competition - The company anticipates a minimum of seven years of patent protection, with potential extensions available [36] - The competitive landscape includes Acadia's drug, which has faced regulatory challenges, suggesting limited immediate competition for Soleno [37][38] Future Directions - Soleno is evaluating additional indications for its drug DCCR, focusing on diseases associated with hyperphagia and hypoglycemia [39][40] - The current strategy remains focused on DCCR, with potential for licensing new molecules in the future [42] Additional Insights - The company is optimistic about the demand for its product, driven by advocacy from families and caregivers [17] - The CEO emphasized the importance of successfully launching DCCR before considering further licensing opportunities [42]