Soleno Therapeutics (SLNO) investor relations material

Key product and launch updates

• VYKAT XR, the first approved therapy for hyperphagia in Prader-Willi syndrome, generated $190 million in revenue over the last three quarters and has over 600 prescribers engaged.

• Expansion plans include pursuing glycogen storage disease (GSD1) as the next indication, with trial initiation expected later this year pending FDA discussions.

• Start forms reached about 200+ in Q4, with a target of 1,000 over nine to twelve months, though quarterly numbers may fluctuate.

• Average turnaround from start form to drug delivery is 30–45 days, with most patients titrating to optimal dose in about six weeks.

• Discontinuation rates are 12–15%, expected to stabilize at 15–20% long-term, mainly due to early adverse events.

Market access and reimbursement

• Over 180 million lives are covered, with strong Medicare and Medicaid support and all major PBMs removing new-to-market blocks.

• Most patients are on paid drug, with short-term free drug programs available; conversion to paid status is generally successful.

• Prior authorization and reauthorization processes have been smooth, with most policies requiring 6–12 months for reauthorization.

• Gross-to-net is expected to be 15–20% long-term, but may be higher in Q1 due to policy changes and copay resets.

Commercial strategy and market opportunity

• Educational efforts target both high-volume and less familiar prescribers, with hybrid teams and medical affairs driving awareness.

• Patient and caregiver events have led to increased prescription requests and engagement.

• U.S. market opportunity is significant, with 12,500 confirmed cases and meaningful revenue potential even at modest penetration.