UroGen Pharma Ltd. Q3 FY2024 earnings call

• UGN-102: Submitted NDA in August, FDA accepted it in October with a PDUFA target date of June 13, 2025. Phase 3 ENVISION trial showed a 79.6% complete response rate at 3 months and 82.3% 12-month duration of response. Pre-commercial activities are underway.
• JELMYTO: Net product revenue of $25.2 million in Q3 2024, with new patient enrollments and prescribers up over 30% year-over-year. Focus on increasing reach and frequency with key accounts.
• Pipeline and Trials: Phase 3 UTOPIA trial for UGN-103 commenced in October. UGN-301 Phase 1 clinical study ongoing. Received Notice of Allowance for a patent covering key technology for UGN-103 and UGN-104.
• Leadership: Chris Degnan appointed CFO in October; David Lin appointed Chief Commercial Officer in June.

JELMYTO generated $25.2 million in net product revenue in the third quarter of 2024, representing a 21% year-over-year increase. This revenue was driven by strong underlying patient demand, including $2.6 million from CREATES Act sales in Q3 2024 compared to $1.1 million in the same period in 2023. UGN-102 is a key upcoming therapy with a large market opportunity, including over 80,000 addressable patients annually in the US and an estimated total addressable market of over $5 billion if approved.

• Full-year JELMYTO revenues are expected to be below previous guidance but will still show low double-digit revenue growth.
• 2024 full-year operating expenses are expected near the midpoint of the $175 million to $185 million range, including non-cash share-based compensation expense of $9 million to $13 million.
• Anticipated full-year 2024 non-cash financing expense related to the prepaid obligation to RTW investments remains in the range of $21 million to $26 million.

Potential risks include those detailed in the earnings press release and SEC disclosure documents, such as uncertainties around regulatory approvals, market adoption of UGN-102, and competitive factors affecting JELMYTO.

Q: Clarity on 72-day letter regarding UGN-102 NDA standard review A: Liz Barrett stated the FDA didn't mention priority review in the letter, raising questions on efficacy data, AE profile; standard review doesn't change prelaunch education efforts.

Q: Gross-to-net discounting for JELMYTO vs UGN-102 A: Chris Degnan explained 340B and Medicare wastage affect JELMYTO; UGN-102 not expected to have Medicare wastage and 340B impact mitigated by increased community utilization.

Q: Timing of ODAC for UGN-102 A: Liz Barrett mentioned expecting ODAC 2-3 months prior to PDUFA (April/May), with a mid-cycle review in Jan/Feb to get update on ODAC timing.

Q: Cash runway and UGN-102 launch A: Chris Degnan noted the company has a fortified balance sheet with $254.2 million in cash and cash equivalents, sufficient for business to profitability by June PDUFA.

Q: Commercial plan for UGN-102 A: David Lin said they leverage learnings from JELMYTO, focusing on operational and reimbursement support, and the ease of use of UGN-102 for urologists