Soleno Therapeutics, Inc. Q1 FY2025 earnings call

• Anish Bhatnagar highlighted the FDA approval of VYKAT XR on March 26th for hyperphagia in PWS patients aged 4 and older, and the quick launch starting in mid-April. - Meredith Manning discussed initial launch metrics: 268 start forms received in 29 days since approval, 131 unique prescribers, and the importance of payer coverage. - Jim Mackaness provided financials: $32.8M cash used in operations during Q1 2025, R&D expenses of $13.5M and SG&A expenses of $29.3M, net loss of $43.8M vs $21.4M in Q1 2024. - Mentioned global expansion efforts, including EU regulatory pathway with MAA submission planned in the first half of 2025.

There are no distinct product segments with financial performance reported. The focus is on the VYKAT XR product launch for hyperphagia in Prader-Willi syndrome (PWS) patients.

• Revenues expected to start modestly as there's a lag between start forms and revenue recognition. - Anticipate progress in EU with MAA submission in the first half of 2025. - Expect to share more launch trajectory details in the second quarter results call in August.

• Tariff impacts: Minimal impact as manufacturing is mostly US-based. - Payer coverage delays: Formal coverage policies can take 3-6 months or longer, affecting revenue. - Lag between start forms and revenue: Specialty pharmacy purchasing timeline causes a lag between receiving start forms and recording revenue.

Q: Could you quantify how soon we could start converting the starting forms into revenue?

A: Jim Mackaness mentioned there's a lag between start forms and specialty pharmacy purchasing product, so revenues are expected to start modestly.

Q: What do you project the time to fill to be at this point and how it will change over the course of 2025?

A: Meredith Manning said it's too soon to give specific details but expects it to be comparable to other rare disease launches.

Q: Can you provide color on ways of thinking about coverage decisions on a state-by-state level and how policies may differ?

A: Meredith Manning mentioned participating in MDRP program, states vary in coverage policy development.

Q: How is Soleno present at the international PWS organization conference?

A: Anish Bhatnagar said commercial, med affairs, and clinical development teams will be there with presentations.

Q: How does the ex-US opportunity for VYKAT XR shape up?

A: Anish Bhatnagar said the opportunity is significant with similar PWS incidence globally and unmet need, and enthusiasm for European market.