Q3 2024 Urogen Pharma Ltd Earnings Call Transcript
Key Points
- UroGen Pharma Ltd (URGN) 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.
- 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.
Good morning. Ladies and gentlemen. Thank you for standing by and welcome to the Urogen Pharma Ltd third quarter, 2024 earnings call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Vincent Perrone, head of investor relations. You may now begin.
Thank you, operator. Good morning, everyone and welcome to Urogen Pharma Ltd third quarter, 2024 financial results and business update conference call.
Earlier this morning, we issued a press release providing an overview of our recent corporate highlights and financial results for the quarter ended. September 30, 2024.
The press release can be accessed on the investors portion of our website at investors.Urogen.com.
Joining me on the call today are Liz Barrett, President and Chief Executive Officer, Mark P. Schoenberg, M.D., Chief Medical Officer David Lin, Chief Commercial Officer and Chris Degnan, Chief Financial Officer.
During today's
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