Short answer
SOLENO THERAPEUTICS INC (SLNO) filed its fiscal 2025 10-K annual report with the SEC on Feb 25, 2026. It reported revenue of $190M and net income of $21M.
- Top risk flagged: Regulatory risk: FDA approval of VYKAT XR in March 2025 triggered contingent payments of $7.0 million due Q1 2026
FY2025 key financial metrics · XBRL
- Revenue
- $190M
- Net income
- $21M
- +111.9% YoY
- Operating margin
- 4.9%
- EPS (diluted)
- $0.39
- +108.9% YoY
- ROE
- 4.6%
- +76.4 pp YoY
- Operating cash flow
- $47M
- +167.7% YoY
Source: XBRL data from the SOLENO THERAPEUTICS INC (SLNO) FY2025 10-K on SEC EDGAR. USD.
SOLENO THERAPEUTICS INC FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: Biopharmaceutical company developing and commercializing novel therapeutics for rare diseases, with initial focus on Prader-Willi syndrome (PWS)
- New product: FDA approval and first commercial sales of VYKAT XR (diazoxide choline extended-release tablets) for hyperphagia in PWS patients aged 4 and older in March 2025
- Strategic shift: Transition from clinical development to commercialization phase with a 65-person U.S. field force targeting PWS specialists and multidisciplinary care teams
- Quantitative metric: Identified PWS patient population approx. 10,000 in U.S. with growing diagnosis rates; product priced at $6.0976 per mg with global patent protection expiring 2026-2035
- Noteworthy fact: In February 2026, new U.S. legislation codified FDA’s interpretation allowing multiple orphan drug approvals for different subpopulations within the same rare disease, impacting market exclusivity and competition strategy
Management Discussion & Analysis
- No profitability or operating margin data provided
- No cash flow, buybacks, dividends, or capex amounts stated
- Forward-looking statements highlight risks including maintaining profitability, capital needs, intellectual property, regulatory approvals, and market competition
Risk Factors
- Regulatory risk: FDA approval of VYKAT XR in March 2025 triggered contingent payments of $7.0 million due Q1 2026
- Macroeconomic exposure: $50 million outstanding loan with Oxford at 1-month SOFR + 5.50% interest, with $100 million more contingent on mutual consent
- Operational risk: Manufacturing and supply chain costs included in $40.6 million R&D spend, reduced by $7.5 million from prior year NDA support
- Competitive risk: Commercial launch costs increased by $23.4 million for marketing and commercial programs supporting VYKAT XR sales
- Financial risk: Contingent liability for milestone payments up to $21.2 million linked to VYKAT XR sales milestones of $100 million and $200 million
Generated from the filing text; verify against the original. How to read a 10-K
Ask about this 10-K
Compare years, dig into a risk factor or check the numbers against insider trades and fund holders.