Financial Data and Key Metrics Changes - Total net revenue for Q2 2025 was $32.7 million, reflecting strong demand for VICAT XR, compared to no revenue in Q2 2024 [20][21] - The company used $12.6 million in cash for operating activities during the quarter and had cash, cash equivalents, and marketable securities of approximately $293.8 million at the end of the quarter [20][21] - The net loss for Q2 2025 was approximately $4.7 million, or $0.09 per share, compared to a net loss of $21.9 million, or $0.57 per share, in Q2 2024 [22] Business Line Data and Key Metrics Changes - VICAT XR was launched in March 2025, becoming the first FDA-approved treatment for hyperphagia in patients with Prader-Willi syndrome (PWS) [7][8] - The company received 646 patient start forms from launch through June 30, 2025, with a majority of patients aged between 4 and 26 years [14][15] - The number of unique prescribers reached 295, with over a third of the top 300 prescribers actively writing prescriptions [15][18] Market Data and Key Metrics Changes - Approximately 33% of all insured lives in the U.S. are now covered for VICAT XR, representing over 100 million lives [18] - The company is actively engaging with payers to establish broad reimbursement coverage, which is a high priority moving forward [9][18] Company Strategy and Development Direction - The company aims to establish VICAT XR as the standard of care for PWS-related hyperphagia and is focused on expanding its market presence in Europe [24][10] - Plans for potential approval of DCCR in Europe are underway, with a marketing authorization application submitted to the EMA [10][12] - The company is considering both standalone and partnership approaches for commercialization in Europe, leveraging its strong cash position of over $500 million [20][63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for VICAT XR and its potential to become a long-term therapy for PWS patients [27][28] - The company is optimistic about the trajectory of patient starts and prescriber engagement, indicating a strong launch momentum [24][44] - Management acknowledged the need for ongoing monitoring of safety data in the post-marketing setting, with no new safety signals reported so far [41][42] Other Important Information - The cost of goods sold for Q2 2025 was $700,000, with research and development expenses at $9.1 million, reflecting a decrease from the previous year [21][22] - Selling, general, and administrative expenses for the quarter were $28.2 million, indicating increased investment in personnel and programs to support the VICAT XR launch [22] Q&A Session Summary Question: How do you see monthly scripts in July compared to earlier months? - Management refrained from discussing data post-quarter end but expressed confidence in VICAT XR becoming the standard of care for PWS [27] Question: Are there any emerging pain points during the patient start form process? - Management noted a strong start with 646 patient starts and indicated that the next couple of quarters will be educational regarding potential pain points [33] Question: What are the early compliance trends tracking? - Early data suggests discontinuation rates are lower than those seen in clinical trials, indicating strong compliance [36] Question: Can you comment on safety based on real-world evidence? - No new safety signals have been observed in the post-marketing setting, and discontinuation rates remain low [41][42] Question: What is the breakdown of revenue trends for the rest of the year? - Management indicated that while the start was strong, normalization may occur in the coming quarters [44] Question: Are there any patterns in patient severity for those receiving VICAT XR? - Management does not actively collect severity data but suspects a mix of motivated families and physician referrals are driving early prescriptions [61] Question: What are the plans for expanding the portfolio beyond VICAT XR? - The company is currently focused on the launch of VICAT XR but may consider diversification in the long term [81]