Financial Data and Key Metrics Changes - Net revenue for Q2 2025 reached $25.9 million, reflecting a 26% increase from Q1 2025, which had revenue of $17.1 million [6][30] - Adjusted net loss for Q2 2025 was $3.2 million, compared to a GAAP net loss of $19.9 million in Q2 2024 [30] - Net income for the quarter was $74.7 million, or $1.24 per basic share and $1.21 per diluted share, largely due to a one-time sale of a PRV asset [30] Business Line Data and Key Metrics Changes - Myclypha generated $21.5 million in revenue for Q2 2025, with a 26% quarter-over-quarter growth [18][30] - Alprova contributed $0.3 million in revenue during the same period, indicating slow uptake [30] - The company recognized a non-cash impairment charge of $58.7 million related to Alprova due to market dynamics [28] Market Data and Key Metrics Changes - Coverage for Myclypha reached 52% of all covered lives in the U.S. as of Q2 2025 [19] - In Europe, the company ended Q2 2025 with 89 patients enrolled in its expanded access program, showing growth from previous quarters [41] Company Strategy and Development Direction - The company aims to build a leading life sciences company focused on rare diseases, driven by four strategic pillars: commercial excellence, pipeline and innovation, talent and culture, and corporate foundation [5] - The submission of the marketing authorization application for Aramchol in Europe marks a significant step in geographic expansion efforts [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early stages of Myclypha's launch and its potential to drive long-term success [30] - The company is focused on increasing awareness and shortening the time to diagnosis for NPC, which is critical for patient treatment [11][70] Other Important Information - The company has a solid balance sheet with total cash and investments of $217.7 million as of June 30, 2025, compared to $68.7 million at the end of the prior quarter [30] - Total debt was approximately $60.7 million, indicating a strong financial position to support strategic priorities [31] Q&A Session Summary Question: Trends in new patient enrollment for Myclypha in the U.S. - Management noted a strong performance with 129 total enrollments by the end of Q2, representing about one-third of diagnosed patients [36][66] Question: Conversion of EAP patients in Europe - Management indicated that the growth in the EAP program in Europe bodes well for future patient conversions post-approval [42] Question: Patients diagnosed but not receiving treatment - Management explained that these patients are typically those diagnosed before therapies were available and are now returning for treatment [46] Question: Average time from enrollment to getting a patient on reimbursed drug - Management stated that the time frame is improving, with some patients getting covered within 72 hours [61] Question: Investment in commercializing Alprova - Management highlighted that the commercial infrastructure for Alprova is synergistic with Myclypha, making it difficult to separate the costs [62] Question: Growth in patient enrollment forms going forward - Management expressed optimism about continued growth in patient enrollments, leveraging awareness and clinical differentiation strategies [68]