Soleno Therapeutics posted a striking Q3 2025 earnings beat, turning a $76.6 million loss into a $26.0 million profit. The company reported net product revenue of $66.0 million for the quarter ended September 30, 2025, a 102% sequential increase from $32.7 million in Q2. Net income rose to $26.0 million, or $0.47 per diluted share, compared with a net loss of $76.6 million, or $1.83 per diluted share, in the same quarter of 2024. The jump in profitability reflects both the scale of sales and disciplined cost management, as operating expenses grew at a slower pace than revenue.
Revenue growth was driven almost entirely by the commercial launch of VYKAT XR, the first FDA‑approved treatment for hyperphagia in Prader‑Willi syndrome. The drug entered the market in April 2025 and quickly captured a large share of the niche patient population, with prescriber adoption and patient access programs accelerating uptake. The 102% sequential rise in product revenue underscores the strong demand for a first‑in‑class therapy in a rare‑disease market, and it signals that the company’s go‑to‑market strategy is resonating with clinicians and payers.
Cash and liquidity remained robust, with cash, cash equivalents and marketable securities totaling $556.1 million as of September 30. This figure includes $230 million in gross proceeds from a July equity offering, which helped fund ongoing commercialization and pipeline development. Operating cash flow of $43.5 million further demonstrates the company’s ability to generate cash from its core business, providing a cushion for future investments and potential regulatory milestones.
The surge in product revenue was driven almost entirely by the rapid uptake of VYKAT XR, the first FDA‑approved treatment for hyperphagia in Prader‑Willi syndrome. The drug’s extended‑release formulation and favorable safety profile have encouraged prescribers to prescribe it as a first‑line therapy, while patient assistance programs have reduced out‑of‑pocket costs. The strong uptake has translated into a high gross margin, as the cost of goods sold for the quarter was only $1.1 million, a negligible expense relative to revenue. This low cost base, combined with the high pricing power of a unique therapy, has enabled the company to achieve a net margin of approximately 39% for the quarter.
Operating expenses grew to $43.8 million, comprising $8.4 million in research and development and $33.8 million in selling, general and administrative costs. While R&D spending increased modestly to support ongoing pipeline assets, SG&A costs were largely driven by marketing and sales initiatives aimed at expanding VYKAT XR’s market penetration. The company’s ability to keep operating expenses in line with revenue growth reflects disciplined cost control and a focus on scalable commercial operations.
Despite the strong financials, investors reacted negatively, citing concerns over VYKAT XR discontinuation rates. Market participants expressed unease about the potential for patients to discontinue therapy, which could erode long‑term revenue streams. The concern over discontinuation rates has tempered enthusiasm for the earnings beat, highlighting that while the company is executing well commercially, sustainability of patient adherence remains a critical risk factor for the business.
The Q3 2025 results position Soleno Therapeutics as a profitable commercial entity, marking a decisive shift from its previous loss‑bearing clinical stage. The company’s rapid revenue growth, strong cash position, and disciplined cost structure provide a solid foundation for continued expansion of VYKAT XR and future pipeline assets. However, the market’s focus on discontinuation rates underscores the importance of ongoing patient support programs and real‑world evidence to sustain long‑term adoption and revenue growth.
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