Financial Performance - JELMYTO net product revenue reached $90.4 million in 2024, a 12% increase from $82.7 million in 2023, with a 15% growth in Q4 2024[6] - UroGen's net loss for 2024 was $126.9 million, or ($2.96) per share, compared to a net loss of $102.2 million, or ($3.55) per share in 2023[17] - Research and development expenses increased to $57.1 million in 2024 from $45.6 million in 2023, while selling, general and administrative expenses rose to $121.2 million from $93.3 million[13][14] - UroGen expects full-year 2025 net product revenues from JELMYTO to be in the range of $94 to $98 million, indicating an approximate 8% year-over-year growth[19] Product Development and Trials - UroGen reported an 18-month duration of response (DOR) of 80.6% from the Phase 3 ENVISION trial for UGN-102, consistent with a 12-month DOR of 82.5%[3] - Enrollment is ongoing in the Phase 3 UTOPIA trial for UGN-103, a next-generation investigational medicine for low-grade intermediate-risk non-muscle invasive bladder cancer[19] - UroGen has developed UGN-102, an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [33] - The ENVISION Phase 3 study data may support UGN-102 as an effective treatment option for recurrent LG-IR-NMIBC patients [36] Regulatory and Market Outlook - The FDA has set a PDUFA target action date of June 13, 2025, for the NDA of UGN-102[7] - The FDA accepted the New Drug Application (NDA) for UGN-102 with a Prescription Drug User Fee Act (PDUFA) goal date of June 13, 2025 [34] - UroGen plans to follow the potential FDA approval and launch of UGN-102 with UGN-103 [36] - The company faces various risks and uncertainties, including potential delays in regulatory approval and market acceptance of its products [36] Cash and Assets - The company has $241.7 million in cash, cash equivalents, and marketable securities as of December 31, 2024[18] Acquisitions and Innovations - The company acquired ICVB-1042, a next-generation investigational oncolytic virus therapy, to enhance its early-stage pipeline[3] - UroGen's proprietary RTGel® technology enables longer exposure of bladder tissue to mitomycin, potentially improving treatment efficacy [35] - UroGen's sustained release technology is designed to enhance the therapeutic profiles of existing drugs, making local therapy potentially more effective [35] Market Context - Approximately 6,000 - 7,000 new or recurrent low-grade upper tract urothelial cancer (UTUC) patients are diagnosed annually in the U.S. [32] - UroGen's first product targets LG-UTUC and aims to provide non-surgical treatment options for patients [35] - UroGen is headquartered in Princeton, NJ, with operations in Israel, focusing on innovative solutions for urothelial and specialty cancers [35]

Company Overview - UroGen is an uro-oncology focused company with an approved legacy product and a late-stage pipeline with an upcoming PDUFA [1] - The company develops a proprietary sustained release hydrogel technology called RTGel, designed to improve therapeutic benefits [1] Investment Tools and Support - The Total Pharma Tracker offers tools for DIY investors, including a software for entering any ticker to access extensive curated research material [2] - For investors needing hands-on support, in-house experts identify the best investible stocks, providing buy/sell strategies and alerts [2]

Core Viewpoint - Urogen Pharma (URGN) shows significant upside potential with a mean price target of $39.36, indicating a 209.9% increase from the current price of $12.70 [1] Price Target Analysis - The average price target consists of seven estimates ranging from $18 to $64, with a standard deviation of $15.76, suggesting variability in analyst predictions [2] - The lowest estimate indicates a potential increase of 41.7%, while the highest suggests a 403.9% upside [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement [7] Earnings Estimates and Analyst Sentiment - Analysts have shown increasing optimism about URGN's earnings prospects, as evidenced by a positive trend in earnings estimate revisions [9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 11.2%, with four estimates moving higher and no negative revisions [10] - URGN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11] Caution on Price Targets - Solely relying on price targets for investment decisions may not be wise, as they can often mislead investors [5][8] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6]

Group 1 - The article emphasizes that investing is a learning process, where failures serve as tuition and successes contribute to lessons learned [1] - The author has focused research on various stocks for approximately five years, with a primary emphasis on healthcare stocks [1] Group 2 - The author has a beneficial long position in URGN shares, indicating a personal investment interest [2] - The article expresses the author's own opinions and does not involve compensation from any company mentioned [2]

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $25.2 million for JELMYTO in Q3 2024, a 21% increase from $20.9 million in Q3 2023, driven by strong underlying demand and a significant increase in new patient enrollments [7][20] - The net loss for Q3 2024 was $23.7 million, or $0.55 per share, compared to a net loss of $21.9 million, or $0.68 per share, in the same period in 2023 [24] - Cash and cash equivalents as of September 30, 2024, stood at $254.2 million, providing a strong balance sheet to support business objectives [24] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was partially offset by gross-to-net erosion due to the Medicare wastage provision and increased 340B utilization [20] - New patient enrollments for JELMYTO increased over 30% year-over-year, marking an all-time high since its launch [7] - UGN-102 is expected to address a market of over 80,000 patients annually in the US, representing a total addressable market of over $5 billion, significantly larger than the JELMYTO market [6] Market Data and Key Metrics Changes - The market for low-grade intermediate-risk non-muscle invasive bladder cancer is widespread, with nearly all urologists managing these cases, contrasting with the rare disease nature of JELMYTO [6] - The company anticipates low double-digit revenue growth for JELMYTO for the full year 2024 despite gross-to-net headwinds [25] Company Strategy and Development Direction - UroGen is focused on the commercialization of UGN-102, with a PDUFA target date of June 13, 2025, and is initiating pre-commercial activities to ensure a robust launch [5][14] - The company aims to expand its sales force from approximately 42 to over 80 representatives to enhance market engagement and support for UGN-102 [15] - A Notice of Allowance for a patent covering key technology for UGN-103 and UGN-104 was received, extending intellectual property protection through December 2041 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of clinical data supporting UGN-102 and its potential to transform treatment for bladder cancer [14] - The company is preparing for an advisory committee meeting (ODAC) and expects to receive notification regarding the timing early in 2025 [11][43] - Management acknowledged the challenges posed by the Miscellaneous J code for billing upon UGN-102's approval but is committed to providing robust reimbursement support [17][42] Other Important Information - The company reported an increase in R&D expenses to $11.4 million in Q3 2024, primarily due to costs associated with the Phase 3 UTOPIA trial for UGN-103 [21] - Selling, general, and administrative expenses rose to $28.9 million, driven by pre-commercialization activities for UGN-102 [22] Q&A Session Summary Question: Clarity on the FDA's decision for standard review of UGN-102 - Management indicated that the FDA did not provide specific reasons for the standard review designation and noted that they had not yet reviewed the clinical data at the time of the letter [28] Question: Commercial points regarding gross-to-net discounting for JELMYTO - Management explained that the gross-to-net headwinds are primarily due to 340B and Medicare wastage provisions, which are not expected to significantly impact UGN-102 [31][32] Question: Timeline for ODAC and impact of Miscellaneous J code on UGN-102 uptake - Management expects the ODAC to occur in April or May 2025, with preparations already underway [43][41] Question: Updates on the Teva litigation and implications for UGN-102 - Management stated that they are awaiting a trial date, expected around 2026, and indicated that outcomes could impact UGN-102 due to overlapping IP [37][38] Question: Cash runway and financial position ahead of UGN-102 launch - Management confirmed a strong cash position of $254 million, sufficient to support business objectives leading up to the anticipated launch of UGN-102 [49]

Company Performance - Urogen Pharma reported a quarterly loss of $0.55 per share, better than the Zacks Consensus Estimate of a loss of $0.84, and an improvement from a loss of $0.68 per share a year ago, representing an earnings surprise of 34.52% [1] - The company posted revenues of $25.2 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 4.06%, compared to year-ago revenues of $20.85 million [2] - Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Stock Performance - Urogen Pharma shares have declined approximately 18.6% since the beginning of the year, contrasting with the S&P 500's gain of 21.2% [3] - The current estimate revisions trend for Urogen Pharma is unfavorable, resulting in a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is -$0.83 on revenues of $27.27 million, and for the current fiscal year, it is -$3.49 on revenues of $92.1 million [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the top 38% of Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]

Investment Rating - The report maintains a Neutral rating on UroGen Pharma (URGN) with a 12-month price target of $22, indicating a potential upside of 51.6% from the current price of $14.51 [42][43]. Core Insights - UroGen Pharma's Jelmyto sales remained flat year-over-year at $21.8 million, slightly below estimates, with challenges related to Medicaid/Medicare discounting impacting revenue guidance for FY24 [2][42]. - The company is focused on completing the rolling NDA submission for UGN-102, with expectations for priority review and potential commercialization in early 2025 [2][42]. - Management expressed confidence in the company's capitalization to reach profitability as it launches UGN-102 and advances its pipeline, despite caution regarding UGN-102's ability to replace TURBT surgery in the near term [2][42]. Financial Summary - UroGen Pharma reported total operating expenses of $184.9 million for 2Q24, slightly above expectations, driven by pre-commercial manufacturing costs for UGN-102 and increased R&D expenses for UGN-103 [2][42]. - The gross margin improved to 90.1%, while R&D expenses increased by 7.1% year-over-year [15][42]. - The company anticipates revenue growth, with projections of $95 million to $102 million for FY24, contingent on the uptake of Jelmyto and the successful launch of UGN-102 [2][42]. Model Adjustments - The report updates its model to reflect actuals from 2Q24 and adjusts near-term operating expense assumptions based on recent trends [2][42].

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $21.8 million for JELMYTO in Q2 2024, reflecting a 16% sequential growth and a 3% year-over-year growth [10][23] - The net loss for Q2 2024 was $33.4 million, or $0.91 per share, compared to a net loss of $24.1 million, or $1.03 per share, in the same period of 2023 [27] - Cash, cash equivalents, and marketable securities as of June 30, 2024, were approximately $241.3 million, with expectations to end the year with about $220 million on the balance sheet [27][11] Business Line Data and Key Metrics Changes - JELMYTO's revenue growth was impacted by headwinds from 340B and wastage provisions, as well as a contraction in past conversions [10] - Patient enrollment forms for JELMYTO grew by 14% in the first half of 2024 compared to the same period in 2023, indicating potential future demand despite lower conversion rates [10] Market Data and Key Metrics Changes - The estimated market opportunity for UGN-102 is over $5 billion, with approximately 82,000 patients treated annually in the U.S. for low-grade intermediate risk non-muscle invasive bladder cancer [7][12] - UGN-102 is expected to transform the treatment paradigm for this patient population, significantly larger than the JELMYTO market [7] Company Strategy and Development Direction - The immediate priority for UroGen is to complete the NDA submission for UGN-102, with expectations for approval as early as Q1 2025 [6] - UroGen plans to transition from a focus on rare diseases to a specialty product with broader potential, scaling commercial capabilities and increasing the sales force [21][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued growth of JELMYTO despite recent revenue results being below expectations, citing a strong clinical conviction among physicians [10][55] - The company is confident in obtaining priority review for UGN-102 based on compelling data and the absence of approved alternatives for the target patient population [54] Other Important Information - UroGen completed a public offering in June 2024, raising approximately $116.2 million to support the launch of UGN-102 and evaluate business development opportunities [11][28] - The company is also developing UGN-301, an immuno-oncology candidate, with plans to report safety and tolerability data in late 2024 [18] Q&A Session Summary Question: Expectations for JELMYTO revenue by quarter - Management refrained from providing quarterly guidance due to variability in conversion rates and gross-to-net increases, but sees a path to the lower end of revenue guidance for the year [31] Question: High-touch support for JELMYTO - The company is focusing on increasing support for physicians to ensure patient conversion and treatment adherence, emphasizing the importance of being present during patient identification [32][33] Question: Commercial introduction of UGN-102 - Plans for UGN-102 include educating physicians on the unmet need and ensuring seamless integration into their workflows, with a modest increase in the sales force anticipated [35][39] Question: Impact of UGN-102 on JELMYTO sales - Management believes that the introduction of UGN-102 could create a "reverse halo" effect, potentially boosting JELMYTO sales as physicians become more engaged with a larger patient population [43] Question: Development timelines for UGN-103 and UGN-104 - The company is accelerating the development of UGN-103 and UGN-104, with expectations for timely patient dosing and potential interim data updates in 2025 or 2026 [44][45]

Core Viewpoint - Urogen Pharma reported a quarterly loss of $0.91 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.82, marking an earnings surprise of -10.98% [1] Financial Performance - The company posted revenues of $21.85 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 7.76%, but showing an increase from $21.14 million in the same quarter last year [2] - Over the last four quarters, Urogen Pharma has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2] Stock Performance - Urogen Pharma shares have declined approximately 3.3% since the beginning of the year, contrasting with the S&P 500's gain of 12.1% [3] Future Outlook - The company's earnings outlook is crucial for investors, with current consensus EPS estimates at -$0.82 for the upcoming quarter and -$3.41 for the current fiscal year, alongside expected revenues of $24.47 million and $95.78 million respectively [7] - The estimate revisions trend for Urogen Pharma is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Urogen Pharma belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

TD Cowen and Guggenheim Securities are acting as joint book-running managers for the proposed offering. Oppenheimer & Co. is acting as lead manager for the proposed offering. Ladenburg Thalmann is acting as comanager for the proposed offering. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to re ...