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Soleno Therapeutics Q1 2025 Earnings Report
Soleno Therapeutics reported its first quarter 2025 financial results and provided an update on the U.S. launch of VYKAT™ XR.
Key Takeaways
Soleno Therapeutics reported a net loss of $43.8 million for the first quarter of 2025, compared to a net loss of $21.4 million in the same period of 2024. The company did not generate any revenue as commercialization of VYKAT XR had not commenced during this period. Operating expenses increased significantly, primarily due to increased selling, general and administrative costs in preparation for commercial launch.
FDA approval of VYKAT XR for hyperphagia in adults and children four years of age and older with Prader-Willi syndrome (PWS) was announced.
Patient treatments for VYKAT XR commenced on April 14, 2025, with 268 patient start forms received and 131 unique prescribers by May 6, 2025.
Research and development expense was $13.5 million, including $4.3 million of non-cash stock-based compensation.
Selling, general and administrative expense was $29.3 million, including $10.4 million of non-cash stock-based compensation, reflecting increased business activities for commercial launch.
Soleno Therapeutics
Soleno Therapeutics
Forward Guidance
The company is focused on executing a robust commercial launch of VYKAT XR and plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the second quarter of 2025.
Positive Outlook
- Strong balance sheet and world-class team position the company to sustain current momentum.
- High level of interest in VYKAT XR reflects the significant unmet need it can address.
- MAA submission to EMA for marketing approval of DCCR (VYKAT XR) in the E.U. is on track for Q2 2025.
- Continued engagement with leading payers to establish broad access for patients.
- Delivering VYKAT XR to patients in need while creating significant long-term value for the company.
Challenges Ahead
- The cadence of research and development expenditures will fluctuate based on clinical programs, manufacturing, and regulatory requirements.
- Contingent liability for Essentialis purchase price increased by $3.0 million due to FDA approval of VYKAT XR.
- No revenue generated in Q1 2025 as commercialization had not commenced.
- Net loss increased significantly compared to the prior year.
- Interest expense associated with long-term debt partially offset by increased interest income.