UroGen Pharma(URGN) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for the fourth quarter of 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in the same period in 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% at three months and an 82.3% duration of response at 12 months for UGN-102, with updated data showing an 80.6% duration of response at 18 months [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - The anticipated launch of UGN-102 is expected to transform UroGen's market position, moving from a rare disease-focused company to a multiproduct specialty-driven team [34] Company Strategy and Development Direction - UroGen aims to enhance its commercial infrastructure by expanding its sales force from 52 to approximately 83 representatives to support the launch of UGN-102 [37][100] - The company is focused on raising awareness of unmet needs in low-grade intermediate risk non-muscle invasive bladder cancer through educational programs and scientific exchanges [35][36] - UroGen has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the bladder cancer treatment landscape [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][109] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Can UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - The launch trajectory is expected to be similar to JELMYTO, with a larger patient population leading to higher absolute numbers [61][72] Question: What are the expected differences in reimbursement levels with the J-code transition? - Initially, a miscellaneous J-code will be used, which may result in longer reimbursement times, but this will improve with a unique permanent J-code expected in January 2026 [66][68] Question: How will UGN-102 be positioned relative to UGN-103? - UGN-102 is expected to be phased out after UGN-103 is approved, with a focus on ensuring no automatic substitution occurs [94][95] Question: What is the rationale behind increasing the sales force size? - The increase is based on patient epidemiology, ensuring coverage of approximately 85% of the market for low-grade intermediate risk NMIBC [102][104]