Soleno Therapeutics, a biopharmaceutical company, announced select preliminary financial and operating results for Q4 and FY 2025. The Company's performance in 2025, particularly with the launch of VYKAT XR, reflects strategic advancements and financial success.
Preliminary unaudited full-year 2025 net revenue for U.S. sales of VYKAT XR expected to be between $189 million and $191 million. This revenue guidance underscores the significant market acceptance of Soleno's flagship product.
Q4 2025 net revenue anticipated to be in the range of $90 million to $92 million, demonstrating consistent revenue generation and growth momentum in the final quarter.
Revenue Estimates
Soleno anticipates full-year 2025 net revenue to range between $189 million and $191 million, with Q4 revenue projected at $90 million to $92 million, driven by the robust adoption of VYKAT XR in the U.S. market.
Patient Reach
The Company received over 1,200 new patient start forms in 2025, capturing approximately 12.5% of the U.S. VYKAT XR addressable market, indicating a strong demand for the product within the Prader-Willi syndrome (PWS) patient population.
Prescribers & Coverage
Soleno engaged 630 unique prescribers throughout the year, including 136 new prescribers in Q4, with a reach extending to over 185 million covered lives, highlighting the broad accessibility and physician acceptance of VYKAT XR.
Financial Position
Ending 2025 with cash, cash equivalents, and marketable securities totaling around $500 million post the completion of a $100 million share repurchase program, showcasing the Company's strong liquidity position and prudent capital management.
Company Achievements
Soleno achieved profitability and positive cash flow in 2025, alongside addressing queries from the European Medicines Agency, underscoring operational excellence, financial prudence, and regulatory compliance.
- Soleno's robust performance in Q4 2025 signifies a pivotal year fueled by the successful market entry of VYKAT XR, positioning the Company for sustainable growth and market leadership in the rare disease segment.
- The substantial inflow of patient start forms underscores the compelling value proposition of VYKAT XR in addressing the unmet medical needs of individuals with PWS, laying a strong foundation for continued product uptake and revenue expansion.
- With a solid financial foundation, positive cash flow, and strategic milestones achieved, Soleno is well-positioned to drive innovation, expand its market presence, and offer enhanced therapeutic solutions for rare diseases, fostering long-term value creation and sustainability.
Soleno's successful performance in 2025, particularly with the introduction of VYKAT XR, establishes a promising trajectory for sustained growth and impact in 2026 and beyond, leveraging its strong financial profile, market penetration, and operational efficiencies.