Soleno Therapeutics (SLNO) Q4 2025 earnings summary

Executive summary

• Achieved strong commercial launch of VYKAT XR, the first FDA-approved therapy for hyperphagia in Prader-Willi syndrome (PWS), with rapid adoption and positive patient outcomes in less than nine months of sales.

• Generated $190.4 million in net revenue for 2025 and $91.7 million in Q4 2025, marking the first full year of commercial operations.

• Ended 2025 with 1,250 patient start forms (over 12% of U.S. addressable market) and 859 active patients, reflecting robust demand and successful conversion from interest to treatment.

• Over 185 million lives covered and 630 unique prescribers engaged by December 31, 2025, with strong engagement among top physicians.

• Real-world safety and adherence rates align with clinical expectations, with a discontinuation rate of 12% due to adverse events and 15% overall.

Financial highlights

• Q4 2025 net revenue reached $91.7 million, with full-year net revenue of $190.4 million (less than nine months of sales).

• Achieved full-year profitability with net income of $20.9 million, reversing a net loss of $175.9 million in 2024.

• Generated $48.7 million in cash from operating activities in Q4; ended the year with $506.1 million in cash equivalents and marketable securities.

• Cost of goods sold was $0.9 million in Q4 and $2.7 million for the year, benefiting from zero-cost inventory; gross margin for 2025 was approximately 99.5%.

• SG&A expenses for 2025 were $132.1 million, up from $105.9 million in 2024, reflecting investments in commercialization.

Outlook and guidance

• Targeting an additional 1,000 patient start forms over the next 9–12 months, aiming to sustain launch momentum and expand market penetration.

• Long-term discontinuation rate expected to stabilize at 15–20%.

• Anticipates EU regulatory decision for DCCR by mid-2026, with commercialization options under evaluation.

• Plans to file IND and initiate clinical program for GSD I in 2026 and expand development pipeline for DCCR in additional rare diseases.

• Anticipates increased SG&A expenses as commercialization continues.