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UroGen Pharma Ltd (URGN) Q1 2024 Earnings Call Transcript Highlights: Key Financials and ...

GuruFocus Research
·4-min read

  • Jelmyto Revenue: $18.8 million for Q1 2024, up 10% from $17.2 million in Q1 2023.

  • Net Loss: $32.3 million in Q1 2024, compared to $30.2 million in Q1 2023.

  • Earnings Per Share (EPS): Loss of $0.97 per share in Q1 2024 versus loss of $1.30 per share in Q1 2023.

  • Cash Position: $164.5 million in cash, cash equivalents, and marketable securities as of March 31, 2024.

  • Cost of Revenue: Decreased to $1.7 million in Q1 2024 from $2.3 million in Q1 2023.

  • R&D Expenses: Increased to $15.5 million in Q1 2024 from $12.5 million in Q1 2023.

  • SG&A Expenses: $27.3 million in Q1 2024, up from $24.5 million in Q1 2023.

  • Interest Expense: Reduced to $2.4 million in Q1 2024 from $3.6 million in Q1 2023.

  • Full Year Revenue Guidance: Expected to be between $95 million and $102 million for 2024.

  • Operating Expenses Guidance: Anticipated to be between $175 million and $185 million for 2024.

Release Date: May 13, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • UGN-102 has shown compelling clinical profiles in trials, potentially advancing the standard of care for bladder cancer.

  • Strong market potential for UGN-102, estimated to be over $3 billion, significantly larger than the current market addressed by Jelmyto.

  • Positive reception from urologists and patients for UGN-102, with high intent to use reported in surveys.

  • Robust financial position with $164.5 million in cash, cash equivalents, and marketable securities, supporting ongoing operations and commercialization efforts without the need for additional capital.

  • Continued growth in Jelmyto sales, with revenues increasing by approximately 10% over the previous year to $18.8 million in the quarter.

Negative Points

  • Dependence on the successful approval and commercialization of UGN-102 to drive future growth.

  • Potential risks associated with the regulatory approval process, including the possibility of not receiving priority review for UGN-102.

  • Operational challenges in scaling up for the commercial launch of UGN-102, including sales force expansion and market access.

  • Seasonal fluctuations in sales, as seen with Jelmyto, which could affect quarterly financial results.

  • Ongoing need to manage high R&D and commercialization costs, which totaled $27.3 million for the quarter.

Q & A Highlights

Q: Could you tell us approximately how many patients are included in each of the three buckets of initial adopters for UGN-102, and which of those you think may be the most robust users? A: (Jeff Bova, Chief Commercial Officer) - About 10-15% of patients are unwilling or unfit for surgery, approximately 23% have five or more recurrences, and a similar percentage experience early recurrence within 6 to 9 months. These groups are seen as primary beneficiaries of UGN-102. Adoption is expected to be quickest in these groups, with broader adoption following as education and awareness efforts continue.

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Q: With respect to reimbursement for UGN-102, could you provide some details on the potential upside to your envisaged pricing range and what factors might influence that? A: (Elizabeth Barrett, President and CEO) - There is potential for pricing upside based on the final data to be shared in June. The clinical data efficacy profile will influence the final pricing decision. The better the data, the higher the value provided, which could justify a higher price range.

Q: Can you give us more detail on what to expect from the ENVISION study's 12-month durability data? A: (Elizabeth Barrett, President and CEO) - The upcoming ENVISION data will include 12-month durability and any updates on safety. Expectations are set around the mid-60s percentage for durability, consistent with previous trials. Better-than-expected results could significantly impact pricing and market adoption.

Q: Regarding the development pathways for next-gen products UGN-103 and UGN-104, are you contemplating just single Phase 3 studies for each? A: (Mark Schoenberg, Chief Medical Officer) - Yes, single Phase 3 studies, smaller than those required for original approvals, are anticipated for both UGN-103 and UGN-104. These studies are expected to be adequate for achieving approval.

Q: Could you discuss the potential commercial launch speed of UGM-102 compared to Jelmyto? A: (Jeff Bova, Chief Commercial Officer) - The launch of UGM-102 is expected to be more rapid than Jelmyto due to significant prescriber overlap and an expanded sales force. Unlike Jelmyto, UGM-102 targets a larger patient population, which should enhance its adoption rate.

Q: What updates can we expect regarding UGN-301, particularly in terms of safety data and combination therapy studies? A: (Mark Schoenberg, Chief Medical Officer) - Safety data and a recommended Phase 2 dose for UGN-301 are expected later this year, with updates on combination therapy studies anticipated in 2025. The program will likely target the BCG-refractory population initially.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.