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Sep 30, 2023
UroGen Q3 2023 Earnings Report
UroGen reported strong JELMYTO® growth and progress with UGN-102 NDA submission.
Key Takeaways
UroGen Pharma reported JELMYTO® net product revenues of $20.9 million in Q3 2023, representing approximately 30% growth compared to the same period last year. The company is also preparing for a rolling NDA submission for UGN-102, planned for January 2024.
JELMYTO® net product revenues reached $20.9 million in Q3 2023, a ~30% increase year-over-year.
Agreement reached with the FDA to proceed with a rolling NDA for UGN-102, starting in January 2024.
ENVISION and ATLAS Phase 3 clinical trials met their primary endpoints in treating LG-IR-NMIBC.
Cash, cash equivalents and marketable securities totaled $153.9 million as of September 30, 2023.
Revenue by Segment
Forward Guidance
UroGen Pharma provided full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million.
Positive Outlook
- Full year 2023 net product revenues from JELMYTO to be in the range of $76 to $86 million.
- Full year 2023 operating expenses in the range of $135 to $145 million.
- Non-cash share-based compensation expense of $6.0 to $11.0 million, subject to market conditions.
- 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.
- Approximately $9.9 to $11.2 million is expected to be in cash.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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