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Mar 31, 2023
UroGen Q1 2023 Earnings Report
UroGen's Q1 2023 earnings were released, showing revenue growth driven by JELMYTO sales.
Key Takeaways
UroGen Pharma reported a net product revenue of $17.2 million for JELMYTO in Q1 2023, representing a ~27% increase compared to Q1 2022. The company is preparing for topline results from the ENVISION and ATLAS clinical trials and anticipates submitting an NDA for UGN-102 in 2024.
JELMYTO net product revenues reached $17.2 million in Q1 2023, a ~27% increase year-over-year.
Topline data readout from the ENVISION pivotal trial and ATLAS trial are expected in summer 2023.
The company plans to submit a New Drug Application for UGN-102 in 2024.
A study showed UGN-102 was suitable to administer at home by a visiting nurse under the supervision of a treating physician and resulted in 75% (n=8) of patients achieving a complete response.
UroGen
UroGen
UroGen Revenue by Segment
Revenue by Segment
JELMYTO Revenue
CapyFin.com Forward Guidance
UroGen Pharma provides financial guidance for the full year 2023.
Positive Outlook
- Net product revenues from JELMYTO are anticipated to be in the range of $76 to $86 million.
- The company anticipates submitting an NDA for UGN-102 in 2024, based on positive findings from ongoing trials.
- Guidance includes anticipated full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million.
- Operating expenses are expected to range from $135 to $145 million.
- The company anticipates full year 2023 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21.0 to $26.0 million.
Challenges Ahead
- Operating expenses are projected to be between $135 to $145 million for the full year.
- Non-cash financing expense related to the prepaid obligation to RTW Investments is expected to be in the range of $21.0 to $26.0 million.
- Approximately $9.9 to $11.2 million of the RTW Investments expense is expected to be in cash.
- Unforeseen delays may impact the timing of progressing clinical trials and reporting data.
- UroGen's financial condition and need for additional capital in the future may pose risks.