Financial Data and Key Metrics Changes - In Q2 2025, total revenue was reported at $60 million, representing a 22% growth over the previous quarter [9] - The company reiterated its full-year 2025 revenue guidance of $250 million to $300 million, which includes sales from Ampagni in the US and Prolupine globally [10][18] - Gross margin was reported at 31%, excluding non-cash items, with expectations for improvement due to strategic restructuring [10][11] Business Line Data and Key Metrics Changes - Product revenue from US Ampagni sales was approximately $54 million in Q2 2025, reflecting a 24% quarter-over-quarter growth [15] - Prolupine revenue was approximately $6 million, showing a 2% increase quarter-over-quarter [15] - The number of patients treated with Ampagni reached 102 in Q2, up from 85 in Q1, indicating strong adoption [40][41] Market Data and Key Metrics Changes - The company is focused on expanding its market presence, with plans to onboard large community practices to enhance patient access [8] - There is potential for US peak sales of Ampagni to exceed $1 billion, with significant opportunities in international markets [10][19] Company Strategy and Development Direction - The company is committed to improving profitability through a strategic restructuring that includes a workforce reduction of approximately 19%, expected to generate over $100 million in annual cost savings [12] - The focus remains on expanding the product pipeline and achieving multiple clinical milestones in the second half of 2025 [9][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing demand for Ampagni and the potential for continued growth in the second half of the year [43] - The company is optimistic about its cash position, expecting it to fund operations into 2026, despite a projected net cash burn of less than $245 million [13] Other Important Information - The company withdrew its submission from the European Medicines Agency due to a need for additional analysis, with plans to resubmit [62] - The new Chief Financial Officer, Corleen Roche, joined the team and will cover financial results in future calls [14] Q&A Session Summary Question: Can you talk about the patient number from Q1 to Q2? - The number of infusions increased from 85 in Q1 to 102 in Q2, with a price increase to $562,000 effective April 1 [40][41] Question: What gives you confidence around Prolupin's performance? - Prolupin is expected to see continued orders from wholesalers, reflecting increased utilization alongside Ampagni [51] Question: Can you elaborate on the decision to withdraw the marketing authorization application in Europe? - The withdrawal was due to the need for additional analysis, and the company plans to resubmit without requiring additional clinical trials [62][63] Question: How do you see infusions tracking for Ampagni quarter to date? - Strong demand is noted, but specific infusion numbers cannot be disclosed [68] Question: Can you provide an update on patient drop-offs and manufacturing success rates? - Manufacturing success rates improved in Q2, with lower patient drop-off rates compared to Q1 [78]