UroGen Pharma reported JELMYTO net product revenues of $21.8 million for Q2 2024 and ended the quarter with $241.3 million in cash, cash equivalents, and marketable securities. The company is focused on completing the NDA submission for UGN-102 and preparing for its potential approval and launch.
UGN-102 NDA submission is ahead of schedule with potential FDA decision in Q1 2025, assuming priority review.
UGN-102 Phase 3 ENVISION trial demonstrated 82.3% Duration of Response at 12 Months in LG-IR-NMIBC patients who achieved complete response at three months.
The company concluded Q2 2024 with $241.3 million in cash, cash equivalents, and marketable securities.
JELMYTO generated $21.8 million in net product revenues during Q2 2024.
UroGen anticipates JELMYTO revenue to be towards the lower end of the previously provided full-year 2024 guidance range and operating expenses to be towards the higher end of the guidance range. The company expects non-cash share-based compensation expense of $9 to $13 million and non-cash financing expense related to the prepaid obligation to RTW Investments to be in the range of $21 to $26 million for 2024. The cash component of the RTW obligation will be 13% of global net product sales of JELMYTO in 2024.