In This Article:
Release Date: March 10, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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UroGen Pharma Ltd (NASDAQ:URGN) submitted a new drug application for UGN 102 ahead of schedule, with FDA review underway and a target date set for June 13th.
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The Envision phase 3 trial for UGN 102 demonstrated a compelling complete response rate of 79.6% at 3 months and an 82.3% duration of response at 12 months.
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UroGen Pharma Ltd (NASDAQ:URGN) reported a strong balance sheet with $241.7 million in cash equivalents and marketable securities, positioning them well for future growth.
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The company achieved a 12% year-over-year increase in sales for their commercial product, Jelmyto, indicating strong market demand.
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UroGen Pharma Ltd (NASDAQ:URGN) is expanding its sales force from 52 to 83 representatives in anticipation of the UGN 102 launch, demonstrating a commitment to commercial preparedness.
Negative Points
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UroGen Pharma Ltd (NASDAQ:URGN) reported a net loss of $126.9 million for the full year 2024, an increase from the $102.2 million loss in 2023.
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Research and development expenses increased significantly to $57.1 million in 2024 from $45.6 million in 2023, driven by manufacturing and regulatory expenses.
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SG&A expenses rose to $121.2 million in 2024 from $93.3 million in 2023, primarily due to commercial preparation activities for UGN 102.
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The company anticipates using a miscellaneous J code for UGN 102 initially, which may complicate reimbursement processes for providers.
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UroGen Pharma Ltd (NASDAQ:URGN) faces potential challenges in market access and reimbursement during the initial launch period of UGN 102 due to the generic J code.
Q & A Highlights
Q: You noted on the call that you anticipate approval in the recurrent setting. Do you anticipate that UGN 102 could still be used in the about 10% of patients or so that are ineligible for surgery, which would be the frontline setting, and would this then require it to be used off label? A: Liz Barrett, CEO: Yes, that would be considered off-label, so we wouldn't be able to promote there. It would be up to the physician to work with their insurance company to ensure payment. This doesn't change our revenue projections, as we still believe UGN 102 will generate over a billion dollars in revenue. Physicians have expressed a desire to make this choice, and we are considering whether to conduct clinical work in this space.
Q: On UGN 102, as you think about the potential FDA approval later this summer, how should investors think about the initial launch trajectory, perhaps relative to Gelido or other potential benchmarks? A: David Lynn, Chief Commercial Officer: We intend to continue educating our physician provider universe and maintaining support. The overall shape of the launch curve is modeled similarly to Gelido, although the absolute numbers will be larger due to the patient population. We are considering pricing in the $18,000 to $19,000 per dose range.