UroGen Pharma(URGN) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $21.8 million for JELMYTO in Q2 2024, reflecting a 16$33.4 million, or $0.91 per share, compared to a net loss of$24.1 million, or $1.03 per share, in the same period of 2023 [27] - Cash, cash equivalents, and marketable securities as of June 30, 2024, were approximately$241.3 million, with expectations to end the year with about $220 million on the balance sheet [27][11] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was impacted by headwinds from 340B and wastage provisions, as well as a contraction in past conversions [10] - Patient enrollment forms for JELMYTO grew by 14$5 billion, with approximately 82,000 patients treated annually in the U.S. for low-grade intermediate risk non-muscle invasive bladder cancer [7][12] - UGN-102 is expected to transform the treatment paradigm for this patient population, significantly larger than the JELMYTO market [7] Company Strategy and Development Direction - The immediate priority for UroGen is to complete the NDA submission for UGN-102, with expectations for approval as early as Q1 2025 [6] - UroGen plans to transition from a focus on rare diseases to a specialty product with broader potential, scaling commercial capabilities and increasing the sales force [21][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth of JELMYTO despite recent revenue results being below expectations, citing a strong clinical conviction among physicians [10][55] - The company is confident in obtaining priority review for UGN-102 based on compelling data and the absence of approved alternatives for the target patient population [54] Other Important Information - UroGen completed a public offering in June 2024, raising approximately $116.2 million to support the launch of UGN-102 and evaluate business development opportunities [11][28] - The company is also developing UGN-301, an immuno-oncology candidate, with plans to report safety and tolerability data in late 2024 [18] Q&A Session Summary Question: Expectations for JELMYTO revenue by quarter - Management refrained from providing quarterly guidance due to variability in conversion rates and gross-to-net increases, but sees a path to the lower end of revenue guidance for the year [31] Question: High-touch support for JELMYTO - The company is focusing on increasing support for physicians to ensure patient conversion and treatment adherence, emphasizing the importance of being present during patient identification [32][33] Question: Commercial introduction of UGN-102 - Plans for UGN-102 include educating physicians on the unmet need and ensuring seamless integration into their workflows, with a modest increase in the sales force anticipated [35][39] Question: Impact of UGN-102 on JELMYTO sales - Management believes that the introduction of UGN-102 could create a "reverse halo" effect, potentially boosting JELMYTO sales as physicians become more engaged with a larger patient population [43] Question: Development timelines for UGN-103 and UGN-104 - The company is accelerating the development of UGN-103 and UGN-104, with expectations for timely patient dosing and potential interim data updates in 2025 or 2026 [44][45]