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Dec 31, 2023
UroGen Q4 2023 Earnings Report
UroGen reported Q4 2023 earnings, highlighted by JELMYTO net product revenues of $23.5 million and the initiation of a rolling NDA submission for UGN-102.
Key Takeaways
UroGen Pharma reported JELMYTO net product revenues of $23.5 million for Q4 2023, compared to $18.1 million for the same period in 2022. The company also initiated the submission of a rolling NDA to the FDA for UGN-102.
UroGen initiated submission of a rolling NDA to the FDA for UGN-102.
The company announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs.
JELMYTO achieved net product revenues of $82.7 million in 2023, an increase of ~28% compared with 2022.
UroGen signed a restructured agreement with Pharmakon Advisors providing up to an additional $100 million credit facility.
Revenue by Segment
Forward Guidance
UroGen anticipates full year 2024 net product revenues from JELMYTO to be in the range of $95 to $102 million. The Company also expects full year 2024 operating expenses in the range of $175 to $185 million, including non-cash share-based compensation expense of $6 to $11 million, subject to market conditions. The Company also reiterates anticipated full year 2024 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $21 to $26 million.
Positive Outlook
- Full year 2024 net product revenues from JELMYTO to be in the range of $95 to $102 million.
- UGN-102 NDA submission is on track.
- Potential FDA decision as early as the first quarter of 2025 for UGN-102.
- New mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs are being developed.
- Restructured agreement with Pharmakon Advisors provides up to an additional $100 million credit facility.
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.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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