UroGen Pharma(URGN) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $25.2 million for JELMYTO in Q3 2024, a 21$20.9 million in Q3 2023, driven by strong underlying demand and a significant increase in new patient enrollments [7][20] - The net loss for Q3 2024 was $23.7 million, or$0.55 per share, compared to a net loss of $21.9 million, or$0.68 per share, in the same period in 2023 [24] - Cash and cash equivalents as of September 30, 2024, stood at $254.2 million, providing a strong balance sheet to support business objectives [24] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was partially offset by gross-to-net erosion due to the Medicare wastage provision and increased 340B utilization [20] - New patient enrollments for JELMYTO increased over 30$5 billion, significantly larger than the JELMYTO market [6] Market Data and Key Metrics Changes - The market for low-grade intermediate-risk non-muscle invasive bladder cancer is widespread, with nearly all urologists managing these cases, contrasting with the rare disease nature of JELMYTO [6] - The company anticipates low double-digit revenue growth for JELMYTO for the full year 2024 despite gross-to-net headwinds [25] Company Strategy and Development Direction - UroGen is focused on the commercialization of UGN-102, with a PDUFA target date of June 13, 2025, and is initiating pre-commercial activities to ensure a robust launch [5][14] - The company aims to expand its sales force from approximately 42 to over 80 representatives to enhance market engagement and support for UGN-102 [15] - A Notice of Allowance for a patent covering key technology for UGN-103 and UGN-104 was received, extending intellectual property protection through December 2041 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of clinical data supporting UGN-102 and its potential to transform treatment for bladder cancer [14] - The company is preparing for an advisory committee meeting (ODAC) and expects to receive notification regarding the timing early in 2025 [11][43] - Management acknowledged the challenges posed by the Miscellaneous J code for billing upon UGN-102's approval but is committed to providing robust reimbursement support [17][42] Other Important Information - The company reported an increase in R&D expenses to $11.4 million in Q3 2024, primarily due to costs associated with the Phase 3 UTOPIA trial for UGN-103 [21] - Selling, general, and administrative expenses rose to$28.9 million, driven by pre-commercialization activities for UGN-102 [22] Q&A Session Summary Question: Clarity on the FDA's decision for standard review of UGN-102 - Management indicated that the FDA did not provide specific reasons for the standard review designation and noted that they had not yet reviewed the clinical data at the time of the letter [28] Question: Commercial points regarding gross-to-net discounting for JELMYTO - Management explained that the gross-to-net headwinds are primarily due to 340B and Medicare wastage provisions, which are not expected to significantly impact UGN-102 [31][32] Question: Timeline for ODAC and impact of Miscellaneous J code on UGN-102 uptake - Management expects the ODAC to occur in April or May 2025, with preparations already underway [43][41] Question: Updates on the Teva litigation and implications for UGN-102 - Management stated that they are awaiting a trial date, expected around 2026, and indicated that outcomes could impact UGN-102 due to overlapping IP [37][38] Question: Cash runway and financial position ahead of UGN-102 launch - Management confirmed a strong cash position of $254 million, sufficient to support business objectives leading up to the anticipated launch of UGN-102 [49]