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Mar 31, 2022
UroGen Q1 2022 Earnings Report
UroGen reported an increase in Jelmyto net product revenue and advanced clinical programs.
Key Takeaways
UroGen Pharma reported first quarter 2022 financial results, highlighted by an 81% increase in Jelmyto net product revenue compared to Q1 2021, reaching $13.6 million. The company also progressed its clinical programs with the ongoing Phase 3 ENVISION trial for UGN-102 and the initiation of a Phase 1 clinical trial for UGN-301.
Jelmyto net product revenue increased by 81% year-over-year, reaching $13.6 million in Q1 2022.
Enrollment is ongoing for the UGN-102 Phase 3 ENVISION pivotal trial, with completion expected by the end of 2022.
A novel, multi-arm Phase 1 clinical trial of UGN-301 in high-grade non-muscle invasive bladder cancer (NMIBC) was initiated.
Cash, cash equivalents, and marketable securities totaled $137.1 million as of March 31, 2022, including the first tranche of a term loan facility.
UroGen
UroGen
Forward Guidance
UroGen anticipates full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million and full year 2022 operating expenses in the range of $140 to $160 million.
Positive Outlook
- Net product revenues from Jelmyto to be in the range of $70 to $80 million.
- Ongoing Phase 3 ENVISION trial for UGN-102 with enrollment expected to be completed by the end of 2022.
- Initiation of Phase 1 clinical trial of UGN-301 in high-grade NMIBC.
- Continued clinical and operational progress.
- Strengthened financial position to support business initiatives.
Challenges Ahead
- Operating expenses in the range of $140 to $160 million, including non-cash share-based compensation expense of $10 to $16 million, subject to market conditions.
- Non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $22 to $26 million, of which approximately $9.1 to $10.4 million will be paid in cash.
- Clinical trial enrollment challenges.
- Potential safety and other complications of clinical trials.
- Complications associated with commercialization activities.