Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- UroGen Pharma Ltd (URGN, Financial) successfully submitted the new drug application for UGN 102 ahead of schedule, with FDA acceptance and a PDUFA target date of June 13, 2025.
- UGN 102, if approved, will be the first FDA-approved treatment for low-grade intermediate-risk non-muscle invasive bladder cancer, addressing a significant unmet need.
- The market opportunity for UGN 102 is substantial, with over 80,000 addressable patients annually in the US, representing a total addressable market of over $5 billion.
- UroGen Pharma Ltd (URGN) reported a 21% year-over-year increase in net product revenue for the third quarter, driven by strong patient demand and strategic focus on key accounts.
- The company has a robust pipeline and life cycle management strategy, including the commencement of the phase three Utopia trial for UGN 103 and plans for UGN 104.
Negative Points
- UroGen Pharma Ltd (URGN) expects full-year gel Mito revenues to fall below the low end of previous guidance due to gross-to-net headwinds.
- The company faces challenges with gross-to-net discounting, particularly with 340B utilization and Medicare waste provisions affecting gel Mito.
- There is uncertainty regarding the timing and outcome of the ODAC meeting, which could impact the approval process for UGN 102.
- The initial uptake of UGN 102 may be impacted by the use of a miscellaneous J code for billing until a permanent code is secured in 2026.
- The company is involved in ongoing litigation related to intellectual property, which could have implications for UGN 102 and other products.
Q & A Highlights
Q: Can you provide more clarity on why the decision was made for a standard review for the NDA?
A: Liz Barrett, President and CEO, explained that the FDA did not mention priority review in their letter. The review questions were typical, focusing on data sufficiency and safety profile. The FDA had not reviewed the clinical portion of the data at the time of the initial meeting. The decision for standard review might be due to timing constraints and the possibility of reverting to surgery as an argument against priority review.
Q: Could you elaborate on the gross to net discounting with respect to Jelmyto and why it might not be a factor for UGN 102?
A: Chris Degnan, CFO, stated that the two main headwinds for Jelmyto are the 340B pricing and the Medicare wastage provision. For UGN 102, the wastage provision is not expected to apply due to differences in administration. Additionally, increased utilization in the community setting should mitigate some of the 340B exposure.
Q: How has the timeline shifted with the receipt of standard review for the UGN 102 NDA, and when do you expect to start specific pre-launch activities?
A: David Lin, Chief Commercial Officer, noted that the standard review does not significantly alter pre-launch activities. The focus remains on educating about the unmet need and preparing infrastructure and distribution networks. The sales force will be expanded by the time of launch.
Q: What are the implications of the litigation outcome for Jelmyto on UGN 102, given overlapping IP?
A: Liz Barrett confirmed that a favorable outcome in the Jelmyto litigation would likely extend to UGN 102, preventing generic competition. Additional pending patents for UGN 102 are expected to strengthen its position further.
Q: When do you expect to hear from the FDA about ODAC timing, and how might the miscellaneous J code impact UGN 102 uptake initially?
A: Liz Barrett expects the ODAC to occur 2-3 months before the PDUFA date, likely in April or May, with notification expected 2-3 months prior. David Lin added that while some customers might be cautious with a miscellaneous J code, the company plans to provide support to manage billing during this period.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
