Key Points New York City-based Wildcat Capital Management sold 495,606 shares of UroGen Pharma in the third quarter. The shares were worth an estimated $6.79 million. The move marked a full exit from the stock, with Wildcat reporting no shares held as of September 30. These 10 stocks could mint the next wave of millionaires › New York City-based Wildcat Capital Management sold out its entire position in UroGen Pharma Ltd. (NASDAQ:URGN), a move representing a net position change of approximately ...

UroGen Pharma FY Conference Summary Company Overview - UroGen Pharma focuses on delivering local medicine to the urothelium, addressing unmet needs in treating urothelial cancers with its innovative RT Gel technology, which transforms from liquid to gel at body temperature [6][7] Key Product: ZUSDURI - ZUSDURI is the first FDA-approved non-surgical option for intermediate-risk non-muscle-invasive bladder cancer (NMIBC) [8] - The product addresses a significant unmet need in treating low-grade, intermediate-risk NMIBC, which has a high recurrence rate [9][10] - Historical treatment involved TURBT procedures, which are invasive and not comprehensive [10][11] Commercial Launch Insights - The commercialization of ZUSDURI is complex, akin to a drug-device combination, requiring operational logistics and physician education [12][13] - The transition from patient enrollment to actual dosing can take up to 60 days, presenting a challenge in revenue recognition [15][17] - Initial sales figures indicated a slower start, but there is optimism about future growth as logistical hurdles are addressed [23][25] Reimbursement Dynamics - Revenue is recognized upon shipment, with a just-in-time inventory model [17][18] - The introduction of a permanent J-code in January is expected to enhance reimbursement confidence among physicians [19][21] - A service warranty is offered to assist physicians with reimbursement processes, although actual usage is anticipated to be low due to positive reimbursement experiences [20] Market Expectations - Approximately 70% of physicians are reportedly waiting for the J-code before using ZUSDURI [21] - Anticipated revenue growth post-J-code is expected to mirror previous experiences with similar products, with a projected 220% increase in revenue within six months [26][27] Competitive Landscape - The entry of competitors into the intermediate-risk space is viewed positively, as it can drive innovation and provide more options for patients [33][34] - UroGen's treatment offers a significant advantage with an 80% complete response rate without the need for surgery, compared to competitors that require surgical intervention [35] Future Developments - UGN-103 and UGN-104 are next-generation formulations with patent protection until 2041, aimed at replacing UGN-102 post-J-code [40][42] - The company is confident in its ability to transition from UGN-102 to UGN-103 without regulatory issues [48][50] Long-term Outlook - The company anticipates continued growth for Jelmyto, its first approved product, as awareness increases with the launch of UGN-102 [51] - 2026 is expected to be a pivotal year for UroGen, with the first two quarters crucial for demonstrating market potential [53]

UroGen Pharma FY Conference Summary Company Overview - **Company**: UroGen Pharma (NasdaqGM:URGN) - **Technology**: RTGel technology, a unique polymer combination that forms a soft gel at body temperature, facilitating drug delivery to the bladder and upper urinary tract [2][3] Core Product Insights - **Product**: Jelmyto, approved for bladder cancer treatment - **Market Opportunity**: Approximately 60,000 patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) [4] - **Unmet Medical Need**: High recurrence rates among patients, with 23% experiencing five or more recurrences and 68% having two or more [4] Market Dynamics - **Patient Population**: Focus on low-grade disease, which is highly recurrent but not life-threatening [6][7] - **Surgical Failures**: Current treatments often lead to repetitive surgeries, highlighting the need for effective non-surgical options [4][6] Launch and Sales Strategy - **Sales Force Expansion**: Increased from 40 to 82 representatives to support the launch of UGN-102, with a focus on clinical nurse educators [10][11] - **Reimbursement Challenges**: Identified as the biggest barrier to adoption; efforts are in place to address this with field reimbursement teams [10][11][19] Early Launch Metrics - **Revenue Performance**: $1.8 million in Q3 and $4.5 million in October, indicating strong early adoption [14][15] - **Patient Enrollment Forms**: Early indicators of demand are on par with Jelmyto's performance after five years, suggesting a strong market interest [15][16] Future Growth Potential - **J Code Impact**: Anticipated positive effects on revenue post-J code implementation in January 2026, with expectations of increased physician confidence and reimbursement facilitation [18][19] - **Market Penetration**: Projected peak market penetration of over $1 billion, with a conservative estimate of 20% market share [22] Competitive Landscape - **First-Mover Advantage**: UroGen Pharma is positioned as a primary therapy for low-grade intermediate-risk bladder cancer, differentiating from competitors that require surgery [24][25] - **Future Products**: Competitors like J&J and CG are developing adjuvant therapies, which may follow surgical interventions, contrasting with UroGen's non-surgical approach [25][26] Pipeline Developments - **UGN-103**: A new formulation of mitomycin with improved production efficiency, expected to file for NDA in the second half of 2026 [30][31] - **UGN-104**: Successor product for Jelmyto, anticipated to follow UGN-103 by about a year [34] - **Oncolytic Virus (501)**: Currently in IND enabling studies, with potential applications beyond bladder cancer [35][36] Commercial Synergies - **Cross-Promotion**: Increased commercial efforts around UGN-102 are expected to drive growth for Jelmyto, as physicians become more familiar with both products [38] Conclusion UroGen Pharma is strategically positioned in the bladder cancer treatment market with innovative technology and a strong pipeline. The company is addressing significant unmet needs in patient care while navigating challenges related to reimbursement and market adoption. The anticipated impact of the J code and the first-mover advantage in the low-grade intermediate-risk segment are expected to drive future growth.

UroGen Pharma (URGN) Conference Call Summary Company Overview - **Company**: UroGen Pharma Ltd. - **Focus**: Development and commercialization of treatments for urothelial cancers, specifically bladder cancer Key Products - **Jelmyto**: Approved for low-grade upper tract urothelial carcinoma - **Market Size**: 7,000 new patients annually in the U.S., with 3,500 historically undergoing kidney removal - **Sales Projection**: Expected to reach $94 to $98 million in 2025, with a potential peak around $150 million [20][21][22] - **Zosduri (UGN-102)**: Targeting low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) - **Market Size**: 80,000 new bladder cancer patients annually, with 60,000 having recurrent low-grade, intermediate-risk disease - **Revenue Potential**: Estimated at $1 billion plus, with a target of capturing 20% of the market [41][42] Core Technology - **RTGel**: A reverse-thermal hydrogel technology that allows drugs to remain in the bladder for extended periods, enhancing treatment efficacy for urothelial cancers [10][11] Clinical Data - **Jelmyto**: High complete response rates with minimal morbidity, offering a less invasive alternative to kidney removal [12][13] - **Zosduri**: - 80% complete response rate in clinical trials, with durability data showing 72% effectiveness at two years [33][34] - Positioned as a primary therapy, distinct from other adjuvant therapies in development [33] Competitive Landscape - **Current Competitors**: Other companies are developing treatments for high-grade bladder cancer but not yet in the intermediate-risk space [35][36] - **Future Competition**: Anticipated as more products enter the market targeting similar patient populations [36] Commercialization Strategy - **J-Code Importance**: Critical for reimbursement and adoption in urology practices, expected to be established by January 1 [44][45] - **Sales Team Expansion**: Increased from 52 to 82 representatives to enhance market presence and support [62] Financial Position - **Cash Reserves**: Ended Q2 with $162 million, sufficient to reach profitability without immediate capital raising [68][69] - **Debt**: $125 million in debt with Pharmakon, indicating a manageable financial structure [69] Future Outlook - **Growth Potential**: Total addressable market for bladder cancer treatments estimated at over $5 billion, with significant opportunities for both Jelmyto and Zosduri [41][42] - **Long-term Strategy**: Plans to expand into other urothelial cancers and explore additional business development opportunities [64][66] Additional Insights - **Patient Preference**: 90% of patients preferred non-surgical Zosduri treatment over traditional TURBT procedures, indicating strong market demand [38] - **Operational Readiness**: Focus on activating sites and training staff to ensure smooth drug rollout post-J-code [52][53] This summary encapsulates the key points discussed during the UroGen Pharma conference call, highlighting the company's strategic direction, product offerings, and market potential.

Financial Data and Key Metrics Changes - The company expects revenues for the product Almighta to be between $94 million and $98 million for the year, indicating year-over-year growth [62] - The peak potential for the XaStorY opportunity is projected to exceed $1 billion, suggesting a clear path to profitability over the next five years [63] Business Line Data and Key Metrics Changes - The total addressable market (TAM) for low-grade intermediate risk non-muscle invasive bladder cancer is over $5 billion, significantly larger than the $700 million TAM for low-grade upper tract urothelial carcinoma [14] - The company reported that 80% of patients achieved a complete response without undergoing TURBT, with 72% remaining recurrence-free at 24 months [23] Market Data and Key Metrics Changes - The company has expanded its sales force to cover 8,500 physicians, targeting 85% to 90% of the market opportunity, with an initial focus on 2,000 physicians more inclined to adopt new products [36][38] - The company anticipates that 70% of utilization will eventually occur in community settings, despite initial usage being more concentrated in hospital settings [36] Company Strategy and Development Direction - The company is focused on lifecycle management, with plans to transition to UGN-one 103, which has a patent extension until December 2041, and aims to target high-grade disease [71][72] - The company is also exploring collaborations to enhance the efficacy of other drugs using its gel technology, indicating a strategy for broader market penetration [88] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming permanent J code expected in January, which is anticipated to accelerate adoption and utilization of their products [44][56] - The management team noted that logistical and reimbursement barriers, rather than clinical concerns, are the primary challenges facing adoption in the urology market [46] Other Important Information - The company is conducting a study on UGN-one 103, with expectations for similar efficacy data to the existing product, and plans to file for approval in 2026 [70][81] - The company is also developing UGN-five 01, an oncolytic virus, with plans to expand its application beyond bladder cancer in the future [89] Q&A Session Summary Question: What is the importance of the J code? - The J code is crucial for urologists as it allows for electronic reimbursement processes, reducing administrative burdens and increasing confidence in product adoption [39][42] Question: How does the company plan to reach community practices? - The company has expanded its sales force and is focusing on a subset of physicians more likely to adopt new products, with a strategy to increase community practice engagement over time [36][38] Question: What is the expectation for breaking even based on the story? - The company has not provided specific guidance on the timeline to breakeven but believes its current cash runway supports a path to profitability given the size of the XaStorY opportunity [62][63]

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $24.2 million for the second quarter of 2025, an 11% increase compared to $21.8 million in the same period in 2024, driven by underlying demand growth of 7% and price favorability [9][30] - The net loss for the second quarter of 2025 was $49.9 million, or $1.5 per basic and diluted share, compared to a net loss of $33.4 million, or $0.82 per basic and diluted share in the same period in 2024 [32][33] - Cash, cash equivalents, and marketable securities totaled $161.6 million as of June 30, 2025, providing sufficient capital for the launch of Zysturi and support for the pipeline [12][33] Business Line Data and Key Metrics Changes - Jelmyto continues to show strong growth with net product revenues of $24.2 million, reflecting continued adoption and usage among urologists [9][30] - Zysturi, the newly approved product, is expected to penetrate a total available market exceeding $5 billion annually, with an expanded sales team of 82 territories as of August 1, up from 50 previously [7][8] Market Data and Key Metrics Changes - The total available market for Zysturi is estimated to exceed $5 billion annually, indicating a significant opportunity for UroGen Pharma as it transitions from a rare disease-focused company to a multi-product organization [7][8] - Approximately 59,000 annual patients in the US face recurrence of low-grade, intermediate-risk, non-muscle invasive bladder cancer, highlighting the unmet medical need that Zysturi addresses [6] Company Strategy and Development Direction - UroGen Pharma aims to develop and commercialize a differentiated portfolio of treatments addressing unmet needs across urothelial and specialty cancers, with Zysturi being a primary growth driver [4][10] - The company is focused on a disciplined strategic launch of Zysturi, leveraging learnings from the launch of Jelmyto to ensure a successful market entry [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the launch of Zysturi, noting strong interest from healthcare providers and the potential for significant patient uptake once a permanent J code is assigned [41][42] - The company anticipates broader reimbursement and market access in 2026, which is expected to significantly enhance adoption rates [28][34] Other Important Information - The phase three Utopia trial for UGN-103 is fully enrolled, with initial complete response data expected by the end of 2025, which will be shared with the FDA to inform the regulatory path forward [11][21] - UroGen's long-term goal includes expanding its product portfolio while driving commercial success and profitability [12][33] Q&A Session Summary Question: Metrics for July regarding Zysturi launch - Management indicated that it is still early to provide specific metrics but noted positive receptivity from healthcare providers and a strong interest in the new treatment option [36][39] Question: Reimbursement process for Zysturi - The reimbursement process is currently manual due to the miscellaneous J code, and while it is too early to report paid claims, practices are being educated on the claims process [49][54] Question: Comparison of Zysturi launch to Jelmyto - Management noted that while there are similarities in the launch process, the demographic for Zysturi is much larger, allowing for potentially quicker adoption compared to Jelmyto [57][58] Question: Utopia trial and FDA discussions - Management has not yet interacted with the FDA regarding the Utopia trial but expects to do so once sufficient data is available [60][62] Question: Expansion of prescribers post-J code assignment - Management indicated that they will expand outreach beyond the initial 2,000 identified prescribers once the permanent J code is assigned, targeting a broader segment of the urology market [74][78] Question: Impact of Zysturi on Jelmyto sales - It is too early to determine if Zysturi's launch will have a positive impact on Jelmyto sales, but management believes that increased market presence will support steady growth for Jelmyto [78][79]

UroGen Pharma (URGN) Update Summary Company Overview - **Company**: UroGen Pharma - **Product**: Zostura (UGN-102) - **Event**: FDA approval announcement and investor call Key Points Industry and Product Approval - UroGen Pharma announced the FDA approval of Zostura, a treatment for non-muscle invasive bladder cancer, which is considered a significant milestone for both the company and patients in need of pharmacotherapy options [1][2][3][4][5][6][7][8][9][10] Core Insights and Arguments - **Market Launch**: The company plans to launch Zostura on July 1, 2025, with product availability expected shortly after the call [10][11] - **Pricing Strategy**: The list price per vial is set at $21,500, reflecting the unmet need and the strong clinical data supporting the therapy [11][12] - **Sales Force Expansion**: UroGen is expanding its sales force by over 30 representatives to enhance market penetration and support the launch [10][12][49] - **Market Demographics**: Approximately 65-70% of the target patient population is expected to be Medicare beneficiaries, aligning with the demographic profile of patients with non-muscle invasive bladder cancer [27][28] - **Patient Population**: The addressable market consists of about 59,000 recurring patients annually in the U.S., with initial efforts focusing on identifying early and frequent recurrences [28][30] Financial Considerations - **Cash Position**: As of March 31, the company reported $200 million in cash, which is deemed sufficient to support the commercial launch and provide a runway to profitability [13] - **Royalty Structure**: A tiered royalty rate for Zostura is established, starting at 2.5% for annual sales up to $200 million, decreasing to 1% for sales between $200 million and $300 million, and 0.5% for sales exceeding $300 million [64] Clinical and Regulatory Insights - **Clinical Data**: The company emphasized the strong clinical data from the phase three trial, which demonstrated a high complete response rate and durability of treatment [54][56][70] - **Regulatory Interactions**: Discussions with the FDA post-ODAC highlighted the importance of clinical data and the challenges of randomized control trials, which were not deemed feasible for this product [72][74][75] Launch Strategy and Market Penetration - **Initial Focus**: The launch strategy will prioritize urologists who are early adopters of new therapies, particularly those already familiar with UroGen's previous product, Jelmyto [20][62] - **Long-term Growth**: UroGen is committed to sustainable long-term growth and will continue to evaluate opportunities for expansion and capital needs [13][14] Additional Considerations - **Durability of Treatment**: The company plans to provide ongoing updates on treatment durability, which is crucial for physician confidence and payer acceptance [87] - **Market Education**: UroGen aims to educate prescribers on the benefits of Zostura, particularly in avoiding unnecessary TURBT procedures, which are common in the treatment of bladder cancer [53][56] Conclusion UroGen Pharma's recent FDA approval of Zostura marks a pivotal moment for the company and the treatment landscape for non-muscle invasive bladder cancer. The strategic focus on market launch, pricing, and sales force expansion, combined with a robust clinical data foundation, positions UroGen for potential success in addressing a significant unmet medical need.

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [30][32] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [32] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [13][32] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, with underlying demand growth of 12% [12][30] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity of over $5 billion, significantly larger than the Jelmyto market [11][12] Market Data and Key Metrics Changes - The company anticipates that the Medicare population will comprise about 70% of the business for UGN-102, consistent with the overall patient demographic in low-grade intermediate risk NMIBC [35] - The market for UGN-102 is expected to be more accessible, with a significant portion of patients managed by community urologists [11][12] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product team, with plans to expand the sales force from approximately 50 to over 80 representatives at the launch of UGN-102 [10][12] - The company is preparing for the potential launch of UGN-102, targeting commercial readiness by June 2025, with product availability expected in July [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [16][55] - The management team emphasized the importance of addressing the unmet medical need in the recurrent low-grade intermediate risk NMIBC patient population [46][55] Other Important Information - UroGen has a strong balance sheet with over $200 million in cash and equivalents, allowing for continued investment in innovation [13][32] - The company is actively engaged in prelaunch activities for UGN-102, including educational efforts with urologists and payer engagement strategies [24][26] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of the business for UGN-102, with a focus on driving reimbursement confidence with providers [35] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [41][46] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is progressing ahead of plan, with top-line data anticipated in 2026 [21][71] Question: Expectations regarding the gross-to-net for Jelmyto and UGN-102 - The gross-to-net profile for Jelmyto is in the mid-70s percent, with expectations for UGN-102 to be more favorable due to a higher proportion of community-based business [101]

Financial Data and Key Metrics Changes - UroGen reported net product revenues of $20.3 million for Q1 2025, an 8% year-over-year increase from $18.8 million in Q1 2024, driven by a 12% underlying demand growth [28][30] - The net loss for Q1 2025 was $43.8 million, or $0.92 per share, compared to a net loss of $32.3 million, or $0.87 per share, in the same period in 2024 [30] - Cash, cash equivalents, and marketable securities totaled $200.4 million as of March 31, 2025 [12][30] Business Line Data and Key Metrics Changes - Jelmyto sales for Q1 2025 were $20.3 million, reflecting an 8% year-over-year growth, supported by a 12% increase in underlying demand [11][28] - UGN-102 is expected to target an addressable population of approximately 60,000 patients annually, translating to a market opportunity exceeding $5 billion, significantly larger than the Jelmyto market [10][11] Market Data and Key Metrics Changes - The company anticipates that approximately 70% of UGN-102's business will come from the Medicare population, consistent with the demographics of low-grade intermediate-risk NMIBC patients [34] - The market for UGN-102 is expected to be more accessible than the fragmented UTUC setting, as NMIBC patients are primarily managed by community urologists [10][11] Company Strategy and Development Direction - UroGen aims to transition from a rare disease-focused company to a multi-product organization, with UGN-102 as a primary growth driver alongside Jelmyto [5][9] - The company is expanding its sales force from approximately 50 to over 80 representatives in preparation for the potential launch of UGN-102 [9][24] - UroGen is committed to advancing its pipeline, including next-generation programs and immuno-oncology initiatives, while maintaining a strong balance sheet [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming ODAC meeting and the PDUFA target date, highlighting the strength of clinical data supporting UGN-102 [6][14] - The company is focused on ensuring timely access for patients and driving reimbursement confidence among providers [22][24] - Management emphasized the importance of UGN-102 as a transformative therapy for patients with recurrent low-grade intermediate-risk NMIBC [22][24] Other Important Information - The FDA has scheduled an ODAC meeting for UGN-102 on May 21, 2025, which is seen as a critical opportunity to present clinical data [6][10] - UroGen has engaged in extensive market research with physicians, indicating strong interest and demand for UGN-102 [55] Q&A Session Summary Question: Breakdown of Medicare and Medicaid exposure for UGN-102 and Jelmyto - Management anticipates that the Medicare population will comprise about 70% of UGN-102's business, aligning with the patient demographic for NMIBC [34] Question: Preparation for the ODAC meeting and expected pushback - Management has conducted mock ODAC panels and feels confident about presenting the clinical data, particularly addressing the single-arm study design of ENVISION [38][40] Question: Current status of the UGN-103 clinical development program - Enrollment for the UGN-103 trial is ongoing, with completion expected by mid-2025 and top-line data anticipated in 2026 [20][69] Question: Expectations regarding the gross-to-net for UGN-102 - Management expects the gross-to-net profile for UGN-102 to be more favorable than Jelmyto, primarily due to a higher proportion of community-based business [100]