Loading...
•
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.
UroGen
UroGen
UroGen Revenue by Segment
Revenue by Segment
JELMYTO Revenue
CapyFin.com 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.
- Non-cash financing expense related to the prepaid obligation to RTW Investments is expected to be in the range of $21 to $26 million.
- Clinical trials may face unforeseen delays.
- Regulatory approval may not be obtained within the expected timeframe.