UroGen Q1 2022 Earnings Report
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.