Soleno Therapeutics reported fourth‑quarter and full‑year 2025 results that exceeded analyst expectations, with total revenue of $91.7 million and a net income of $20.9 million. The company’s earnings per share for the quarter were $0.80, a significant improvement over the $0.40 per share figure previously reported for the quarter and a clear beat to the consensus estimate of $0.725 per share.
Revenue rose 40% sequentially from $66 million in Q3 2025 to $91.7 million in Q4, driven by the rapid uptake of VYKAT XR in the U.S. market. The figure also represents a 1.5% beat over the analyst estimate of $90.42 million, underscoring strong demand for the first‑in‑class therapy for hyperphagia in Prader‑Willi syndrome.
EPS of $0.80 per share surpassed the consensus estimate of $0.725, a beat of $0.075 or roughly 10%. The strong margin performance—supported by zero‑cost inventory and a high gross margin—combined with disciplined cost management enabled the company to generate profitability in its first commercial year.
Operating expenses increased to $132.1 million from $105.9 million a year earlier, reflecting expanded commercial activities and the launch of a patient services program. Despite the higher spend, the company maintained profitability, illustrating effective scaling of its commercial operations.
Gross margin remained exceptionally high, driven by the low cost of goods sold associated with zero‑cost inventory. While the exact percentage is not consistently cited, the company’s high gross margin reflects the pricing power and cost structure of its product portfolio.
Cash and liquidity were robust at the end of the year, with $506.1 million in cash, cash equivalents and market‑able securities and a $200 million credit facility. The strong balance sheet provides ample runway for commercialization and future product launches.
Market reaction to the results was cautious; after‑hours trading saw a modest decline of 2.4%. Investors focused on a sequential slowdown in new patient start forms—207 in Q4 versus 397 in Q3—despite the revenue beat, indicating concerns about the sustainability of growth momentum.
Management highlighted a positive outlook, noting that the company expects a decision on its European Union regulatory submission in mid‑2026 and plans to evaluate the diazoxide choline extended‑release platform in other rare diseases. The company also projects approximately 1,000 new patient start forms in the next 9 to 12 months. "Our first year as a commercial organization has been an outstanding success. In just nine months, we received patient start forms representing over 12% of the U.S. VYKAT XR addressable market," said CEO Anish Bhatnagar. CFO James H. MacKaness added, "We achieved profitability with positive net income for the year of $20.9 million, became cash flow positive including generating $48.7 million of cash from operating activities in the fourth quarter, and ended the year with over $500 million of cash, cash equivalents and marketable securities."
Conclusion: Soleno’s first commercial year demonstrates strong execution and profitability, but the slowdown in new patient acquisition highlights a potential headwind that the company will need to address as it expands into the EU and explores additional indications.
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