Financial Data and Key Metrics Changes - Total net revenue for Q3 2025 was $66 million, more than doubling from $32.7 million in Q2 2025 [3][16] - The company achieved profitability with a net income of $26 million for the quarter, compared to a net loss of $76.6 million in the same period of 2024 [20] - Cash generated from operating activities was $43.5 million, and the company had $556.1 million in cash, cash equivalents, and marketable securities at the end of Q3 [16][20] Business Line Data and Key Metrics Changes - ViCAD XR, the company's leading product, had 764 active patients at the end of Q3, with 1,043 cumulative patient start forms since launch [12][16] - The number of unique prescribers increased to 494, with 199 new prescribers added in Q3 [12][16] - Over 50% of the top 300 providers submitted start forms, indicating strong adoption [13] Market Data and Key Metrics Changes - Coverage policies for ViCAD XR reached approximately 132 million lives by the end of Q3, with significant access across commercial, Medicaid, and Medicare channels [14] - The company is actively pursuing regulatory approval for DCCR in Europe, with a potential market of 9,500 individuals living with PWS in key European countries [10] Company Strategy and Development Direction - The company aims to establish ViCAD XR as the standard of care for hyperphagia in individuals with PWS, focusing on education and engagement with the PWS community [9][10] - Continued investment in stakeholder awareness, education, and access resources is planned to support the treatment journey for patients [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a disruption in launch momentum due to a short seller report but noted efforts to re-engage patients and educate stakeholders [7][32] - The company remains optimistic about the long-term growth potential, with a focus on expanding prescriber education and patient access [9][10] Other Important Information - The discontinuation rate for ViCAD XR related to adverse events was approximately 8%, with total discontinuation at about 10% [7] - The company is preparing responses to EMA's day 120 questions regarding DCCR's marketing authorization application in Europe [10] Q&A Session Summary Question: Can you comment on the restart rate regarding discontinuations? - Management indicated that it is early to provide meaningful numbers on restarts, but some patients have already started again [22][23] Question: What is the lag time between start forms and insurance coverage? - The fill rate for prescriptions is approximately 30 days, with a backlog of about one month for start forms [28] Question: How did the short report impact discontinuations and patient start forms? - Management noted a decrease in start forms and an increase in discontinuations during August and September, attributing it to the short report and summer factors [32][60] Question: What is the average dose across all patients currently on the drug? - The average dosing is still evolving, with most patients coming in between four and 26 years of age [39][40] Question: What is the profile of adverse events leading to discontinuations? - Most reported adverse events are non-serious and on-label, such as low levels of peripheral edema and hyperglycemia [44][56] Question: Is there a need for additional efforts to find new patients? - The company has identified approximately 12,000 claims for individuals with PWS and is confident in targeting these patients effectively [76]