Soleno Therapeutics, Inc. Q3 FY2025 earnings call

• Strong third quarter performance with net revenue doubling from Q2, achieving profitability. - VYKAT XR is the first FDA-approved treatment for hyperphagia in PWS, addressing a significant unmet need. - Educational initiatives include PACE team educating families/caregivers, live community events, and HCP education programs. - Progress in EU regulatory pathway with submission and EMA validation of marketing authorization application, receiving day 120 questions. - Field teams dedicated to providing educational support on therapeutic expectations, dosing, and monitoring for VYKAT XR.

The company's total net revenue for the third quarter of 2025 was $66 million, more than doubling from the second quarter's $32.7 million. The company achieved profitability with a positive net income of $26 million for the quarter. The leading product, VYKAT XR, which is the first and only FDA-approved treatment for hyperphagia in PWS patients 4 years and older, contributed to this performance. Revenue from VYKAT XR was the key driver, with cumulative patient start forms from launch through September 30th totaling 1,043, 397 of which were in the third quarter, unique prescribers at 494, and lives covered at approximately 132 million.

• Continue to work tirelessly to make VYKAT XR available to as many PWS-related hyperphagia patients as possible. - Look forward to continuing the successful launch seen to date. - No specific numerical forward-looking guidance provided beyond general commitment to growth and availability.

• Discontinuations up due to nonserious adverse events following a short seller report, primarily involving on-label AEs like peripheral edema or hyperglycemia. - Concerns about physicians not specialized in PWS struggling to manage side effects of VYKAT XR. - Variability in reimbursement turnaround time, with a target of 30 days but potential fluctuations in the first year of launch.

Q: Can you comment on the restart rate with regard to discontinuations and the lag time between start forms and patients getting coverage?

A: Restarts are early with a handful of people starting, but no meaningful numbers available yet. Lag time in coverage is still evolving with claims being reimbursed for the 764 active patients, but not reaching steady state.

Q: Elaborate on the impact of the short report on discontinuations and early launch momentum into Q4?

A: August and September saw a decrease in start forms due to the short report and summer complexity, with October looking similar to September. Efforts are being made to reach out to patients who discontinued, including webinars with patients sharing experiences.

Q: Elaborate on the EU regulatory progress and if questions received improve confidence in approval?

A: Submission and EMA validation of marketing authorization application, received day 120 questions similar to FDA discussions. Can't provide specific details on questions but discussions feel similar to FDA process, but exact confidence level not specified.

Q: Proportion of patients on on-label dose versus those undergoing dose reduction, and time on therapy before discontinuation?

A: Very small minority undergo dose reductions. Discontinuations happen earlier in treatment, with about 2/3 of active patients beyond the 3-month time frame.