Soleno Therapeutics, Inc. (SLNO) Earnings

Management highlights

- Launched BICAT XR in Q2 last year, with strong growth in Q4 2025 and full year 2025. Received 1250 patient start forms since launch through Dec 31, 2025, representing ~12.5% of U.S. addressable market, with 859 people on active treatment. - Positive net income for the year, became cash flow positive, ended the year with over $500 million in cash, etc. - Update on EU approval for DCCR: Submission and EMA validation in May, received day 120 questions, responses submitted by end of year, next step day 180 questions around end of Feb 2026, anticipate decision mid-2026. - Meredith covered commercial update: 1250 new patient start forms from launch to year end, 859 actively treated, added 136 new prescribers in Q4, total unique prescribers 630, real-world safety profile mirrors expectations, high adherence, community outreach with webinars, etc. - Jim covered financials, mentioned retirement and incoming CFO Jennifer Volk. - Aneesh outlined next steps including pursuing additional metabolic rare disease indications, first for glycogen storage disease type 1 (GSD1), plan to file IND in first half 2026 and initiate clinical program later in 2026.

Guidance

- Expect to capture an additional approximately 1,000 start forms over the next 9 to 12 months. - Anticipate a decision in mid-year 2026 timeframe for EU approval of DCCR. - Plan to file IND for GSD1 in first half of 2026 and initiate clinical program later in 2026. - Mentioned seasonality impact on revenue in Q1 but will provide better color once Q1 is through.

Segment performance

Total net revenue for the fourth quarter was 91.7 million, with full year 2025 net revenue (less than nine months of sales) at 190.4 million. Cost of goods sold was $0.9 million for Q4 and $2.7 million for the full year. Research and development expense for Q4 was $9.6 million, with full year 2025 at $40.6 million. SG&A expense for Q4 2025 was $14.9 million, full year 2025 at $132.1 million. Net income for Q4 was approximately 43.4 million or 82 cents per basic and 80 per diluted share, full year 2025 net income was $20.9 million or $0.40 per basic and $0.39 per diluted share. Revenue contribution from BICAT XR is the main segment with strong growth since launch in Q2 last year.

Risks & headwinds

- Risks that may cause actual results to differ from forward-looking statements, as referred to in filings. - Uncertainty around EU approval decision and potential commercial launch. - Seasonality impact on revenue in Q1, such as co-pay resets and changes in patient plan coverage. - Uncertainty around discontinuation rates and how they might fluctuate and impact active patient growth. - Uncertainty regarding pricing flexibility in different launch scenarios (self-launch vs. with partners) in Europe and other geographies.

Analyst Q&A

• Q: Regarding the 1,000 patient start forms over next 9-12 months, cadence?

  A: Hard to think of bolus, over the year, doubling down on broadening with KOLs, community, caregiver populations.

• Q: What percent of market accessible in U.S. for PWS at peak?

  A: No other treatments exist, expect higher penetration than 40-50% in larger rare diseases.

• Q: Dosing in GSD1, similar or lower?

  A: First trial will look at dosing, expect in range of current, more room to dose as patients less obese, etc.

• Q: Refill rates with larger proportion of patients on drug for several months?

  A: High adherence, patients settling into optimal dose, pleased with refill rates.

• Q: Average weight of new patients changing over time?

  A: Predominant patients 4-26, likely heavier than clinical trial population, average weight expected to go up.

• Q: Longer term discontinuation rate 15-20%, how efficacy plays in?

  A: Discontinuations for lack of efficacy few, if stay on drug, likely see benefits, anecdotes relate to hyperphagia, downstream effects.

• Q: Cadence of start forms and seasonality?

  A: Can't comment on Q1, but seasonality impacts revenue with co-pay resets, etc.

• Q: Physicians' uptake of VicodXR today?

  A: Strong uptake among top 300, majority with more than one patient, influencing treatment patterns, peer-to-peer programs, expert on demand.

• Q: Exclusivity of Viacat based on patent prosecution?

  A: 2035 patent, related patents can be extended, filed additional IP.

• Q: EU approval, comfort with imperfect data, timing of 180-day questions?

  A: Rare disease data sets imperfect, day 120 questions responded to, 180-day questions imminently, attempt to prevail like in US.

• Q: Potential launch trajectory in Europe vs U.S., key learnings?

  A: More centers of excellence in Europe, strong education of treaters key in US.

• Q: Next wave of patients, more difficult?

  A: Spectrum across patient population, 4-26, younger adults up to 45, broad spectrum expected.

• Q: Next-gen product follow DCCR?

  A: Have internal lifecycle management programs, not discussing today.

• Q: Mechanism of action for GSD1?

  A: Target channels in beta cells to suppress insulin secretion, elevate glucose levels, different side effect profile expected.

• Q: Seasonality impact on patient visits and scripts in Q1?

  A: Launching first hyperphagia drug, learning as go, visits happen, cadence to be determined.

• Q: Active patient number gap, drivers?

  A: Lag due to benefits assessment time, no significant reimbursement issues.

• Q: Discontinuation rate fluctuating and impact on active patient growth?

  A: Difficult to predict, but 15-20% range acceptable, likely to fluctuate but no major changes expected during year.