Soleno Therapeutics, Inc. Q2 FY2025 earnings call

• Commercial launch of Vykat XR on April 14, ahead of plan, with initial positive reception and demand from the PWS community.
• Received 646 patient start forms from launch through June 30, with majority aged 4-26.
• 295 unique prescribers from launch through June 30, including many unexpected early prescribers.
• ~33% of insured lives covered by payers for Vykat XR, including commercial, Medicaid, and Medicare.
• Submission and EMA validation of marketing authorization application for DCCR in EU.

Total net revenue for the second quarter ended June 30, 2025, was $32.7 million. Cost of goods sold was $0.7 million. Research and development expense was $9.1 million. Selling, general and administrative expense was $28.2 million. Net loss was approximately $4.7 million. The revenue is primarily from the commercial launch of Vykat XR, the first FDA-approved medicine for hyperphagia in PWS patients.

• Confidence in Vykat XR being the standard of care for PWS hyperphagia.
• Expectation of steady state in payer policies and prescription turnaround time, aiming for ~30 days in the long term.
• Anticipation of moderation in patient start form growth going forward.

• Uncertainty in payer policies and their impact on time to fill and coverage.
• Seasonality and holiday effects on patient start forms.
• Lack of data on patient severity and early compliance trends.

Q: How do you see monthly scripts in July compared to earlier months and future months?

A: Not addressing data after quarter end, but confident Vykat XR is on track to be standard of care.

Q: What is the current time to fill and how will it change?

A: Time to fill depends on payer policies; 33% coverage now, expecting policies to grow and turnaround time to potentially slow, aiming for ~30 days in steady state.

Q: Any emerging pain points in patient start form process?

A: Hard to predict pain points early, but next quarters will be educational.

Q: How are early compliance trends tracking?

A: Discontinuation rates lower than clinical trials, but too early to tell from data.

Q: Initial patient bolus stocking and patient weight?

A: Distribution partner PANTHERx orders weekly, no anomalies; patients seen are older, likely heavier than trial average.

Q: Patient visit cadence and rate limiter?

A: Patients seen both proactively and through clinic setup; rate limiter depends on clinic logistics and physician familiarity.

Q: Patient severity pattern and Europe launch efficiency?

A: No active collection of severity data; Europe launch efficiency manageable with $500 million balance sheet for optionality.

Q: Cash flow from operations and OpEx?

A: Cash OpEx expected ~$120-130 million in 2025, potentially increasing slightly, managed with revenue from launch.

Q: Revenue breakdown by titration vs maintenance and payer split?

A: Most patients in titration phase; too early to tell payer split as not at steady state.

Q: Reluctance with prescribers in diabetes patients?

A: Prescribers may be hesitant with uncontrolled diabetes, but not with controlled diabetes.

Q: Portfolio expansion beyond Vykat XR?

A: Laser-focused on Vykat XR launch now, but may diversify long term with adjacent opportunities.