UroGen Q1 2024 Earnings Report
Key Takeaways
UroGen Pharma reported Q1 2024 financial results, highlighted by JELMYTO net product revenues of $18.8 million, a 10% increase compared to Q1 2023. The company is advancing its pipeline, with UGN-102 nearing NDA completion and UGN-103's IND accepted by the FDA.
JELMYTO net product revenues reached $18.8 million in Q1 2024, a 10% increase year-over-year.
UroGen is preparing for the announcement of 12-month duration of response results from the ENVISION study of UGN-102.
The company expects ENVISION data to support completion of the UGN-102 NDA in Q3 2024.
FDA accepted the IND for UGN-103, a next-generation mitomycin-based formulation for LG-IR-NMIBC.
UroGen
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UroGen Revenue by Segment
Forward Guidance
UroGen Pharma Ltd. reiterated its full year 2024 net product revenues guidance from JELMYTO in the range of $95 to $102 million and expects full year 2024 operating expenses in the range of $175 to $185 million.
Positive Outlook
- Full year 2024 net product revenues guidance from JELMYTO in the range of $95 to $102 million.
- Ongoing clinical trials and potential FDA approval for UGN-102.
- Potential advantages related to production, cost, supply, and product convenience for UGN-103.
- The company's RTGel technology has the potential to improve the therapeutic profiles of existing drugs.
- The sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications.
Challenges Ahead
- Increased discounts related to Medicare refunds for discarded drugs and 340B purchases will further impact net revenues in 2024.
- Full year 2024 operating expenses are expected to be in the range of $175 to $185 million.
- Full year 2024 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21 to $26 million.
- Unforeseen delays may impact the timing of progressing clinical trials and reporting data
- The company's financial condition and need for additional capital in the future.