UroGen Pharma Ltd. Q1 FY2025 earnings call

• The NDA for UGN-102 is in the final stages of FDA review with a PDUFA target date of June 13th, and an ODAC meeting is scheduled for May 21st. - The ENVISION trial showed 80.6% of patients who achieved a CR at three months remained in response at 18 months. - The commercial team is preparing for UGN-102 launch, expanding the sales force to over 80 reps. - Acquired UGN-501, a next-generation investigational oncolytic virus. - Clinical updates: Enrollment ongoing in Phase 3 UTOPIA trial for UGN-103, and plan to commence Phase 3 study for UGN-104 by mid-2025. - Phase 1 study of UGN-301, an anti-CTLA4 antibody, shows favorable safety profile.

JELMYTO had first quarter net product revenues of $20.3 million, an 8% year-over-year growth compared to the first quarter of 2024, driven by underlying demand growth of 12% but partially offset by higher 340B chargebacks. R&D expenses for the first quarter of 2025 were $19.9 million, up from $15.5 million in the same period in 2024, primarily due to the acquisition of UGN-501, higher manufacturing costs, and costs for the Phase 3 UTOPIA trial. Selling, general and administrative expenses were $35 million in Q1 2025, up from $27.3 million in Q1 2024, mainly due to UGN-102 commercial preparation activities.

• Full year 2025 net product revenues from JELMYTO are expected to be in the range of $94 million to $98 million, implying a year-over-year growth of approximately 8% to 12%. - Full year 2025 operating expenses are expected to be in the range of $215 million to $225 million, including non-cash share-based compensation expense of $11 million to $14 million.

• Potential impact of 340B chargebacks on JELMYTO revenue growth. - Uncertainty around ODAC panel reactions due to the lack of specific precedent for products in low-grade intermediate-risk NMIBC. - Risks associated with maintaining the same FDA team during the review process.

Q: Can you provide breakdown of Medicare and Medicaid exposure for UGN-102 and current for JELMYTO, and pricing dynamics?

A: Liz and David note Medicare is anticipated to comprise about 70% of UGN-102 business, consistent with patient demographics, and focus on driving reimbursement confidence.

Q: How are you preparing for the ODAC and expected pushback?

A: Liz and Mark state they've conducted mock ODAC panels, prepared extensively with medical oncologists and statisticians, and will highlight the unmet medical need and robust clinical data.

Q: Update on UGN-103 clinical development program and next material update?

A: Liz says UGN-103 is almost fully enrolled, with data expected in 2026.

Q: Thoughts on market for UGN-102, 340B utilization, and go/no-go for UGN-301?

A: Liz and Mark discuss 340B being less impactful for UGN-102, and UGN-301's go/no-go decision will be based on durability and safety data from Phase 1 study later this year.

Q: FDA representatives, 18-month data in ODAC, and direct-to-consumer?

A: Liz confirms FDA team is still in place, 18-month data is part of discussions, and direct-to-consumer not broad-based but patient engagement will occur.

Q: What happens to patients who progress on UGN-102?

A: Liz and Mark state physicians are likely to retreat with UGN-102, and data will be generated on retreatment and partial responders.