UroGen Pharma(US:URGN)2025-05-12 15:02Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [30][32] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [32] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [13][32] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, with underlying demand growth of 12% [12][30] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity of over $5 billion, significantly larger than the Jelmyto market [11][12] Market Data and Key Metrics Changes - The company anticipates that the Medicare population will comprise about 70% of the business for UGN-102, consistent with the overall patient demographic in low-grade intermediate risk NMIBC [35] - The market for UGN-102 is expected to be more accessible, with a significant portion of patients managed by community urologists [11][12] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product team, with plans to expand the sales force from approximately 50 to over 80 representatives at the launch of UGN-102 [10][12] - The company is preparing for the potential launch of UGN-102, targeting commercial readiness by June 2025, with product availability expected in July [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [16][55] - The management team emphasized the importance of addressing the unmet medical need in the recurrent low-grade intermediate risk NMIBC patient population [46][55] Other Important Information - UroGen has a strong balance sheet with over $200 million in cash and equivalents, allowing for continued investment in innovation [13][32] - The company is actively engaged in prelaunch activities for UGN-102, including educational efforts with urologists and payer engagement strategies [24][26] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of the business for UGN-102, with a focus on driving reimbursement confidence with providers [35] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [41][46] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is progressing ahead of plan, with top-line data anticipated in 2026 [21][71] Question: Expectations regarding the gross-to-net for Jelmyto and UGN-102 - The gross-to-net profile for Jelmyto is in the mid-70s percent, with expectations for UGN-102 to be more favorable due to a higher proportion of community-based business [101]