Financial Data and Key Metrics Changes - Q2 net revenue was $96 million, marking a return to growth and bringing total net Visovac revenue since launch to over $525 million [6][27] - Net income for the quarter was $38.3 million, representing $1.33 per basic and $1.29 per diluted share, compared to $15.6 million in the prior year's second quarter [29] - Gross margin remained consistent at 93% in Q2 2025, with cost of goods sold at $7.2 million compared to $6 million in the prior year [28] Business Line Data and Key Metrics Changes - The return to growth in Q2 was attributed to patients resuming treatment and the ongoing expansion of the sales team [6] - Reimbursement approvals increased, with over 575 approvals secured by the end of Q2 [6] - Compliance while on drug was reported at 82%, although a decline is expected as the patient mix shifts [7] Market Data and Key Metrics Changes - The company is preparing for launches in Europe and Japan, with the European launch expected to begin this quarter [12][14] - Japan's Ministry of Health approved VYZUVAC, allowing for a broad label that includes all DEP patients from birth [11] - The identified patient pool in Germany and France exceeds 500 patients each, supported by expert centers [13] Company Strategy and Development Direction - The company aims for steady, multiyear growth in Europe and Japan, leveraging broad labels and flexible dosing options [16] - The focus remains on expanding the sales force and enhancing patient support to drive long-term sustainable growth [10] - The company is pursuing opportunities in other global markets through distributors and partners [17] Management's Comments on Operating Environment and Future Outlook - Management expects Q3 revenues to be below Q2 due to seasonal trends but anticipates a return to growth in Q4 [9] - The company is confident in the long-term growth trajectory, driven by a rich pipeline of clinical-stage programs [31] - Management highlighted the unpredictability of patient restarts and the need for ongoing monitoring of treatment patterns [8] Other Important Information - The company reported a strong balance sheet with over $820 million in cash and investments, positioning it well for upcoming launches and R&D objectives [30] - The R&D team is progressing with multiple clinical trials, including those in oncology and aesthetics [18][23] Q&A Session Summary Question: Was the revenue growth in Q2 impacted by the Salesforce expansion? - Management clarified that part of the increase was due to patients resuming treatment, and the full impact of new hires will be felt in the coming quarters [36] Question: Can you provide quantitative commentary on the slower start to Q3? - Management noted that it is early in the quarter and summer vacations typically lead to more treatment pauses, making it difficult to quantify [40] Question: How do drug holidays factor into the guidance for U.S. patients initiating VYJUVEC? - Management indicated they are on track but may be a quarter or two behind the original goal of reaching 720 patients [46] Question: What is the compliance rate among patients using different vial counts? - Management explained that compliance is defined based on the duration of drug use, with a range of 76-84% being consistent across calculations [102] Question: What are the timelines for capturing the remaining patient market in the U.S.? - Management emphasized that the goal is to target the entire 1,200 patient base, with a focus on achieving 60% market share within two years [92]