Time to fill expectations, revenue growth and expectations are the key contradictions discussed in
Therapeutics' latest 2025Q2 earnings call.
Commercial Launch of Vykat XR:
-
reported
$32.7 million in total net revenue for Q2 2025, with a strong initial reception and demand for Vykat XR.
- The successful launch was attributed to the urgent need for an FDA-approved therapy to treat hyperphagia in PWS patients and effective outreach to patients, physicians, and payers by the experienced commercial team.
Patient and Payer Coverage Growth:
- The company received
646 patient start forms from launch through June 30, with
295 unique prescribers, indicating strong early momentum.
- Approximately
33% of all insured lives in the U.S. are now covered for Vykat XR, reflecting rapid and broad coverage surpassing recent rare disease launches.
- These positive outcomes are due to proactive engagement with payers, enabling recognition of the value of Vykat XR in addressing PWS-related hyperphagia.
Balance Sheet Strength and Financial Performance:
- Soleno Therapeutics had
$293.8 million in cash, cash equivalents, and marketable securities at the end of Q2, following a
$230 million gross proceed raise through an underwritten offering.
- The company used
$12.6 million in cash for operating activities during the quarter.
- This financial strength supports the execution of an effective U.S. launch of Vykat XR and progress toward regulatory approvals and commercialization in other geographies.
European Market Expansion:
- The company submitted and EMA validated a marketing authorization application for Vykat XR in the EU in May.
- Gaining approval to market DCCR in the EU represents a significant expansion of the commercial market, adding to the high unmet need among PWS patients in Europe.
- This effort aligns with Soleno's strategy to make DCCR available to as many patients worldwide as possible, leveraging market research and strategic partnerships.
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