Release Date: May 07, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- FDA approval of Vykat XR as the first treatment for hyperphagia in Prader-Willi syndrome (PWS) patients aged 4 and older.
- Successful and rapid commercial launch of Vykat XR, with the first patient receiving treatment ahead of schedule.
- Strong initial market response with 268 patient start forms received within 29 business days post-approval.
- Broad prescriber base with 131 unique prescribers, indicating widespread acceptance and interest.
- Sufficient cash reserves of $290 million to fund operations through cash flow breakeven, with additional $75 million available under a loan agreement.
Negative Points
- No revenue generated in the first quarter of 2025 as Vykat XR was not yet commercialized.
- Significant net loss of $43.8 million for the first quarter, compared to $21.4 million in the same period of 2024.
- High selling, general, and administrative expenses of $29.3 million, reflecting increased investment in personnel and programs.
- Potential delays in revenue recognition due to the lag between receiving start forms and specialty pharmacy orders.
- Uncertainty in payer coverage policies, which can take three to six months or longer to develop and implement.
Q & A Highlights
Q: Could you quantify how soon we could start converting the starting forms into revenue? What do you project the time to fill to be at this point, and how will it change over the course of 2025?
A: James Mackaness, CFO: There are several steps to convert start forms into commercial drug orders, and specialty pharmacies will likely be cautious with inventory. We anticipate modest revenues for Q2.
Meredith Manning, CCO: It's too early to provide specific turnaround times, but we are seeing ordinary timelines for rare disease launches and will provide more information in the next call.
Q: What percentage of the Phase III program patients are reflected in the current start forms?
A: Meredith Manning, CCO: In the randomized withdrawal period, we had 77 patients, 60 of whom are in the U.S. The majority have submitted start forms, and we are pleased with the conversion speed.
Q: Can you help us understand coverage decisions on a state-by-state level and how policies may differ?
A: Meredith Manning, CCO: Soleno is participating in the Medicaid Drug Rebate Program, allowing states to upload Vykat XR as of May 1. States vary in policy timing, with some deciding within a month and others taking longer. We are already seeing coverage in several states.
Q: Could you share more about the interest from doctors outside the initial targeted group of high prescribers?
A: Meredith Manning, CCO: We are encouraged by the broad spectrum of prescribers, including community physicians. This is due to strong prelaunch awareness efforts and partnerships with thought leaders and advocacy groups.
Q: How do you see the competitive landscape in Prader-Willi hyperphagia? Are there any noteworthy potential rivals in late-stage development?
A: Anish Bhatnagar, CEO: The late-stage competitor is Acadia with carbetocin, which is undergoing another study after receiving a CRL. Aardvark is starting a Phase III study, but their data is early and short-term.
Q: How do you see the ex-U.S. opportunity for Vykat XR shaping up?
A: James Mackaness, CFO: The opportunity is significant, with similar patient numbers in the EU as in the U.S. The unmet need is the same globally, and rare disease pricing in Europe is favorable.
Q: What are the steps for new patients to get the drug prescribed?
A: James Mackaness, CFO: Patients or caregivers typically need to see a physician who fills out a start form. The form goes to a specialty pharmacy, which starts the process of providing the drug.
Q: Regarding European development, is there a decision on whether to launch the product independently or seek a partner?
A: Anish Bhatnagar, CEO: We are assessing both options. The key next step is the MAA submission with the EMA, expected this quarter. Decisions on commercialization will follow.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
