URGN Earnings Prediction
The chart below shows how URGN performed 10 days before and after its earnings report, based on data from the past quarters. Typically, URGN sees a +6.74% change in stock price 10 days leading up to the earnings, and a -5.79% change 10 days following the report. On the earnings day itself, the stock moves by -2.25%. This data can give you a slight idea of what to expect for the next quarter's release.
URGN Key Earning Data
2024/Q4
Year Over Year
Quarter Over Quarter
Total Revenue
25.20M
20.87%
15.36%
Gross Margin
90.27%
1.83%
0.52%
Operating Margin
-69.61%
7.52%
-41.14%
Net Margin
-93.93%
-10.48%
-38.56%
EPS
-0.55
-19.12%
-39.56%
No Data Available
URGN Earnings Analysis
UroGen Pharma Ltd. Ordinary Shares Corporation (URGN.O) Earnings Conference Call
Positive
UGN-102 FDA NDA Acceptance: 1. NDA Acceptance for UGN-102: The FDA accepted the New Drug Application for UGN-102, with a PDUFA target date of June 13, 2025, marking a significant milestone in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer.
Strong Revenue Growth: 2. Strong Revenue Growth for JELMYTO: JELMYTO generated $25.2 million in net product revenue for Q3 2024, reflecting a 21% year-over-year increase, driven by strong underlying patient demand and a 30% increase in new patient enrollments compared to the previous year.
Market Potential for UGN-102: 3. Significant Market Opportunity for UGN-102: UGN-102 targets a market of over 80,000 addressable patients annually in the US, representing an estimated total addressable market of over $5 billion, which is approximately ten times larger than the current market for JELMYTO.
Clinical Trial Success Rates: 4. High Complete Response Rate in Clinical Trials: The Phase 3 ENVISION trial for UGN-102 demonstrated a 79.6% complete response rate at three months, with a remarkable 82.3% duration of response at 12 months, the highest reported in this patient population.
Sales Force Expansion: 5. Expansion of Sales Force: UroGen plans to expand its sales force from approximately 42 representatives to over 80 by the launch of UGN-102, enhancing its commercial capabilities and engagement with healthcare providers.
Negative
Net Loss Comparison: 1. Net Loss Increase: UroGen reported a net loss of $23.7 million for Q3 2024, compared to a net loss of $21.9 million in Q3 2023, indicating a worsening financial position year-over-year.
Operating Expense Increase: 2. Operating Expense Growth: Selling, general and administrative expenses rose to $28.9 million in Q3 2024 from $21.8 million in Q3 2023, primarily due to UGN-102 pre-commercialization activities, reflecting increased operational costs.
R&D Expense Increase: 3. Research and Development Expense Rise: R&D expenses increased to $11.4 million in Q3 2024 from $10.2 million in Q3 2023, driven by higher costs associated with the initiation of the Phase 3 UTOPIA trial for UGN-103.
Revenue Guidance Adjustment: 4. Lowered Revenue Guidance: UroGen expects full-year JELMYTO revenues to fall below the low end of previous guidance, despite anticipating low double-digit revenue growth for the full year, indicating potential revenue shortfalls.
Non-Cash Financing Expense Increase: 5. High Non-Cash Financing Expense: The company reported a non-cash financing expense of $5.9 million in Q3 2024, up from $5.5 million in Q3 2023, reflecting ongoing financial burdens related to obligations to RTW investments.
URGN FAQs
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URGN Earning Call Sentiment
UroGen Pharma Ltd. (URGN) Q3 2024 Earnings Call Transcript
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URGN.O
-1.58%Positive
The earnings call summary presents a mixed picture: a 21% increase in JELMYTO revenues is positive, but the anticipated revenue fall due to gross-to-net headwinds and increased net loss are concerning. The Q&A section reveals uncertainties, such as FDA review issues and unclear patent timelines, adding to the negative sentiment. Despite a strong cash position, operational risks and high expenses weigh heavily, leading to a negative outlook.
