UroGen Pharma Ltd. Q2 FY2025 earnings call

• Launch Milestone: FDA approval of ZUSDURI in June 2025, a landmark for treating recurrent low-grade intermediate risk non-muscle invasive bladder cancer, transitioning UroGen to a scaled multiproduct organization.
• Commercial Expansion: Expanded sales team to 82 territories, focusing on setting up sites of care and driving clinical conviction for ZUSDURI launch.
• JELMYTO Performance: Strong Q2 with $24.2M revenue, 11% year-over-year growth, driven by underlying demand and stable gross to net rate.
• Pipeline Updates: UGN-301 in Phase I trials, UTOPIA trial for UGN-103 fully enrolled with expected top-line data by end of 2025, UGN-104 Phase III trial initiated, UGN-501 in IND-enabling studies.

JELMYTO: In the second quarter of 2025, JELMYTO had net product revenues of $24.2 million, representing an 11% increase over the same period in 2024. ZUSDURI is the primary growth driver, with FDA approval in June 2025 for adults with recurrent low-grade intermediate risk non-muscle invasive bladder cancer, entering a large market with significant potential.

• JELMYTO: Full-year 2025 net product revenues expected in the range of $94 million to $98 million, implying 8%-12% year-over-year growth.
• Operating Expenses: Full-year 2025 operating expenses expected in the range of $215 million to $225 million, including noncash share-based compensation of $11 million to $14 million.
• ZUSDURI: Guidance on 2026 and beyond to be provided later, with focus on post-J-code assignment in 2026 for broader market penetration.

• Reimbursement Challenges: Uncertainties around reimbursement for ZUSDURI, particularly before permanent J-code assignment.
• Regulatory Timelines: Dependence on regulatory approvals and timelines for pipeline products like UGN-103.
• Market Penetration: Risks associated with penetrating the large but competitive market for ZUSDURI.

Q: Aydin Huseynov asks about ZUSDURI short-term/long-term guidance and peak sales.

A: Christopher Degnan says ZUSDURI is over $1 billion opportunity, short-term guidance to be provided after initial launch phase, long-term guidance for 2026 and beyond to be considered.