UroGen Pharma Ltd. Q4 FY2024 earnings call

• Clinical Update: ENVISION Phase 3 trial for UGN-102 showed an 80.6% duration of response at 18 months. Submitted NDA for UGN-102 ahead of schedule with PDUFA date June 13. Engaged with FDA in mid-cycle review, NDA referred to ODAC. - Pipeline: Acquired ICVB-1042, Phase 3 Utopia trial ongoing for UGN-103, plan to start Phase 3 study for UGN-104 in H1 2025. - Commercial: Expanding sales force to 83 reps from 52, focusing on pre-launch strategy for UGN-102, JELMYTO had 12% growth in underlying demand in 2024.

JELMYTO net product revenues for the fourth quarter of 2024 were $24.6 million compared to $23.5 million in the same period of 2023. Underlying demand revenue increased by 15%. For the full year ended December 31, 2024, JELMYTO net product revenues were $90.4 million compared with $82.7 million in 2023. Research and development expenses for the fourth quarter of 2024 were $14.9 million vs $11.3 million in 2023, and full-year R&D expenses were $57.1 million vs $45.6 million. SG&A expenses for Q4 2024 were $34.9 million vs $24.6 million in 2023, and full-year SG&A was $121.2 million vs $93.3 million. Net loss in Q4 2024 was $37.5 million vs $26 million in 2023, and full-year net loss was $126.9 million vs $102.2 million.

• 2025 JELMYTO revenues expected in range of $94 million to $98 million (8%-12% growth from 2024 demand-driven revenues). - Full-year 2025 operating expenses expected in range of $215 million to $225 million including non-cash share-based compensation expense of $11 million to $14 million.

Forward-looking statements are subject to change based on current information, assumptions, and expectations. Potential risks detailed in earnings press release and latest SEC disclosure documents.

Q: On UGN-102 approval in recurrent setting and off-label use in frontline.

A: Liz Barrett stated off-label use would require physician-payer-patient coordination, and revenue projections remain unchanged.

Q: UGN-102 launch trajectory and pricing.

A: David Lin said launch trajectory is akin to JELMYTO, and pricing is anticipated to be $18,000 to $19,000 per dose.

Q: Reimbursement for UGN-102 and UGN-103 enrollment.

A: David Lin discussed reimbursement timeline with miscellaneous J-code initially and unique J-code by Jan 2026; UGN-103 enrollment expected to complete this year with data in 2026.

Q: Pipeline and ICVB-1042 updates.

A: Liz Barrett and Mark Schoenberg mentioned ICVB-1042 to have IND enabling studies this year, and UGN-301 to have combination trial data reported later in 2025.

Q: Pricing stress test and 103 vs 102 positioning.

A: Liz Barrett said pricing is being revisited due to durability data, and UGN-103 would phase out UGN-102 post-approval with patent protection until 2041.

Q: Commercial preparedness with increased reps.

A: David Lin explained commercial footprint sizing based on patient epidemiology, aiming to cover 85% of the market with 83 reps.