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Jun 30, 2022
UroGen Q2 2022 Earnings Report
UroGen reported positive momentum and reaffirmed 2022 full-year revenue guidance.
Key Takeaways
UroGen Pharma reported a net product revenue of $16.6 million for Q2 2022, a 28% increase year-over-year. The company is on track with its clinical development programs, including the UGN-102 Phase 3 trial and UGN-301 Phase 1 clinical trial. They are focused on reaching cash flow break-even in 2025 while strategically deploying capital.
Jelmyto net product revenue reached $16.6 million, a 22% increase from the previous quarter and a 28% increase year-over-year.
The company reaffirmed its 2022 full-year revenue guidance of $70-$80 million.
Enrollment is ongoing and on track for the UGN-102 Phase 3 ENVISION pivotal trial, with completion anticipated by the end of 2022.
Progress was made in the first-in-human multi-arm Phase 1 clinical trial of UGN-301 in high-grade non-muscle invasive bladder cancer (HG-NMIBC).
UroGen
UroGen
UroGen Revenue by Segment
Revenue by Segment
JELMYTO Revenue
CapyFin.com Forward Guidance
UroGen anticipates full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million. Anticipated full year 2022 operating expenses to be in the range of $130 to $140 million. Anticipates full year 2022 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.
Positive Outlook
- Reiterated full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million.
- Enrollment of UGN-102 Phase 3 single-arm, ENVISION pivotal trial is on track to be completed before end of 2022.
- Progressed first in human multi-arm Phase 1 clinical trial of UGN-301.
- Jelmyto adoption continues to grow.
- Focus on reaching cash flow break-even in 2025.
Challenges Ahead
- Clinical trial enrollment challenges may impact the expected timing of ongoing and planned clinical trials.
- Potential safety and other complications from any approved products.
- The company may face challenges in commercialization activities, including complications resulting from the ongoing COVID-19 pandemic.
- The ability to satisfy required customary bring down conditions and deliverables for the second tranche of the term loan facility with Pharmakon is uncertain.
- Negative effects on UroGen’s business, commercialization and product development plans caused by or associated with COVID-19 or geopolitical events.