Soleno (SLNO) Q2 Revenue Jumps 30%

Soleno Therapeutics (SLNO -0.54%), a biotech company focused on rare disease treatments, posted its inaugural commercial revenue following the U.S. launch of VYKAT XR for Prader-Willi syndrome (PWS). In its earnings release on August 6, 2025, the company reported GAAP revenue of $32.7 million. This result was well ahead of analyst predictions, which had expected $25.14 million in GAAP revenue. Earnings per share (EPS, GAAP) improved to $(0.09), a beat of $0.36 per share (GAAP) compared to consensus. The quarter marks a major milestone as Soleno transitions from developing therapies to commercial sales, showing promising early demand but also highlighting rising costs associated with launching a first-in-class treatment.

Source: Analyst estimates for the quarter provided by FactSet.

Company Overview and Recent Focus

Soleno Therapeutics develops therapies for rare diseases, with a primary focus on Prader-Willi syndrome, a genetic disorder that causes chronic hunger and severe obesity due to hyperphagia. VYKAT XR, its lead product, is a once-daily extended-release tablet designed to manage hyperphagia in people living with PWS.

Recently, Soleno moved from the development stage to commercial operations. The company’s near-term success now depends on scaling up VYKAT XR’s distribution, securing broad insurance coverage, and driving physician and patient adoption in the U.S. For future growth, accelerating European regulatory progress, supporting ongoing manufacturing, and maintaining first-mover advantage will be critical success factors.

Quarterly Highlights and Key Developments

The second quarter (Q2 2025) marked Soleno's first period of commercial revenue, achieved after the U.S. Food and Drug Administration (FDA) approved VYKAT XR on March 26, 2025. Commercial launch began on April 14, and by June 30, 2025, 646 patient start forms had been received from 295 unique prescribers. The covered patient base exceeded 100 million U.S. lives, highlighting strong initial payer and physician interest for a new rare disease therapy.

From a financial perspective, the GAAP revenue figure beat expectations. The company reported a GAAP operating loss of $6.5 million, much improved from the $24.868 million operating loss (GAAP) in Q2 2024. Its net loss (GAAP) also narrowed substantially compared to Q2 2024, while ongoing investment in launch activities increased total operating expenses (GAAP) to $39.182 million, up 57.6% compared to Q2 2024.

The cost of goods sold, or the direct cost of making VYKAT XR, was $0.7 million (GAAP). On the regulatory front, Soleno validated its Marketing Authorization Application (MAA) in Europe with the European Medicines Agency, beginning the process of potential European Union market entry. The company spent $0.6 million on these regulatory efforts.

Selling, general, and administrative (SG&A) expense (GAAP) climbed to $28.2 million, up from $10.9 million (GAAP). The increase included non-cash stock-based compensation and significant hiring and investment for the VYKAT XR commercial launch, patient advocacy, marketing, and educational activities for clinicians. Management expects these expenses will continue to rise as launch activities progress.

Outlook and What to Watch

Soleno entered the second half of FY2025 with $293.8 million in cash, cash equivalents, and marketable securities, further strengthened by $230 million raised in gross proceeds after Q2 2025.

The company did not provide explicit financial guidance for the remainder of fiscal 2025. Investors should focus on VYKAT XR patient onboarding trends, further developments with European regulators, and ongoing SG&A cost management as Soleno’s sales ramp up.

SLNO does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.