Soleno Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Update on U.S. Launch of VYKAT™ XR

Core Insights - Soleno Therapeutics reported strong financial results for Q4 and full-year 2025, achieving profitability with a net income of $20.9 million, a significant turnaround from a net loss of $175.9 million in 2024 [4][12] - The U.S. launch of VYKAT™ XR has been successful, capturing over 12% of the addressable market within nine months, with 1,250 patient start forms received [3][4] - The company plans to pursue regulatory approval for VYKAT XR in the EU and expand its development pipeline to include additional rare diseases [3] Financial Performance - Product revenue for Q4 2025 was $91.7 million, and for the full year, it reached $190.4 million, marking the first revenue generation since the product's launch [4][7] - Research and development expenses decreased to $9.6 million in Q4 2025 from $21.5 million in Q4 2024, and for the full year, they dropped to $40.6 million from $78.6 million in 2024 [5][6] - Selling, general and administrative expenses increased to $40.9 million in Q4 2025 from $37.3 million in Q4 2024, with a total of $132.1 million for the year compared to $105.9 million in 2024 [7][9] Operational Highlights - As of December 31, 2025, there were 859 active patients on VYKAT XR, with 630 unique prescribers, including 136 new prescribers in Q4 [7] - The company achieved a cash flow from operating activities of $48.7 million in Q4 2025 and ended the year with $506.1 million in cash, cash equivalents, and marketable securities [7] - Soleno has committed to cash payments of up to $21.2 million to former Essentialis stockholders based on commercial milestones related to DCCR sales [10] Market and Product Information - VYKAT XR is indicated for the treatment of hyperphagia in patients with Prader-Willi syndrome, a rare genetic disorder affecting approximately 1 in 15,000 live births [14][15] - The product addresses significant health risks associated with hyperphagia, including obesity and diabetes, which can severely impact quality of life [14]