Core Insights - UroGen Pharma Ltd. has announced improved access to ZUSDURI (mitomycin) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) due to the implementation of a permanent J Code (J9282) effective January 1, 2026, which is expected to streamline billing and reimbursement processes [1][3][2] Company Overview - UroGen Pharma is a biotech company focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary RTGel technology for sustained drug release [6][4] - The company’s first product is approved for low-grade upper tract urothelial cancer, while ZUSDURI is specifically approved for recurrent LG-IR-NMIBC [6][4] Product Information - ZUSDURI is the first and only FDA-approved therapy for adults with recurrent LG-IR-NMIBC, providing a non-surgical chemoablative treatment option [2][4] - The drug is administered directly into the bladder using a urinary catheter in an outpatient setting, allowing for effective tumor treatment without surgery [4][6] Market Context - Approximately 82,000 individuals in the U.S. are diagnosed with NMIBC annually, with around 59,000 experiencing recurrence [5] - The median age of diagnosis for bladder cancer is 73 years, and up to 70% of NMIBC patients may face at least one recurrence, highlighting the need for effective treatment options [5]

Company Overview - Wildcat Capital Management sold all 495,606 shares of UroGen Pharma Ltd. (NASDAQ:URGN), marking a complete exit from the position valued at approximately $6.79 million [2][3][7] - UroGen Pharma's shares are currently priced at $23.52, reflecting a 113% increase over the past year, significantly outperforming the S&P 500, which rose about 15% in the same timeframe [4] - The company's market capitalization stands at $1.10 billion, with a trailing twelve months (TTM) revenue of $96.52 million and a TTM net income of -$164.64 million [5] Company Operations - UroGen Pharma specializes in developing and commercializing proprietary therapies for urothelial and specialty cancers, utilizing RTGel technology to enhance drug delivery [9][10] - The company targets healthcare providers treating patients with urothelial diseases, particularly focusing on non-muscle invasive bladder and upper tract cancers [10][11] - UroGen's product pipeline and commercial offerings position it as a differentiated player in the specialty pharmaceutical sector, addressing significant unmet medical needs in urothelial oncology [11] Investment Context - The liquidation of UroGen shares by Wildcat Capital is viewed as disciplined capital recycling rather than a lack of confidence, especially given the significant one-year price increase [12][13] - UroGen's commercial product, Jelmyto, remains a key asset, and the company continues to pursue large unmet needs in urothelial cancers [14]

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]

Group 1 - Brendan, a Pennsylvanian, completed a Ph.D. in organic synthesis at Stanford University in 2009 [1] - He worked for Merck from 2009 to 2013 and has experience in biotech startups such as Theravance and Aspira before joining Caltech [1] - Brendan is a co-founder and the first employee of 1200 Pharma, which spun out of Caltech and received significant investment in the 8 figures [1] - He remains an avid investor focused on market trends, particularly in biotechnology stocks [1]

Group 1 - The article discusses the expertise of a research firm focused on the U.S. restaurant industry, covering various segments from quick-service to fine dining [1] - The firm employs advanced financial modeling and sector-specific KPIs to identify hidden value in public equities, particularly in micro and small-cap companies [1] - The analyst has a strong academic background, holding an MBA in Controllership and Accounting Forensics, and has specialized training in valuation and financial modeling [1] Group 2 - The research has been featured on multiple platforms, indicating a broad reach and recognition in the investment community [1] - The firm also covers related sectors such as consumer discretionary, food & beverage, and casinos & gaming, showcasing a diverse analytical approach [1]

Core Insights - UroGen Pharma Ltd. will present at the Piper Sandler 37th Annual Healthcare Conference on December 2-4, 2025 [1][2] - The presentation will take place on December 2, 2025, at 1:00 PM ET in a fireside chat format [2] - UroGen is focused on developing innovative solutions for urothelial and specialty cancers, utilizing proprietary technologies [3] Company Overview - UroGen Pharma Ltd. is dedicated to treating urothelial and specialty cancers, aiming to provide better treatment options for patients [3] - The company has developed RTGel, a reverse-thermal hydrogel technology that allows for sustained release of medications, potentially enhancing therapeutic effectiveness [3] - UroGen's first product targets low-grade upper tract urothelial carcinoma (LG-UTUC), while its second product is an intravesical solution for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) [3] - The company is headquartered in Princeton, NJ, with operations in Israel [3]

Core Insights - UroGen Pharma Ltd. (NASDAQ:URGN) is recognized as a promising small-cap biotech stock by analysts [1] Financial Performance - For Q3 2025, UroGen Pharma reported a net loss of $33.3 million, an increase from $23.7 million in Q3 2024, primarily due to rising R&D expenses and delayed revenue recognition [4] - The company ended the quarter with $127.4 million in cash and marketable securities [2] Revenue Growth - Preliminary figures for October indicate that demand revenue more than doubled compared to the previous three months, reflecting increased physician adoption despite operational delays [2] - UroGen provided revenue guidance for its product JELMYTO, expecting net revenues between $94 million and $98 million for the full year [4] Market Position and Strategy - The company is expanding its sales force to 82 representatives to enhance physician outreach and patient access, achieving coverage for over 95% of insured lives [3] - With the implementation of a permanent billing code in early 2026, UroGen anticipates a smoother reimbursement process, although administrative lags of up to 60 days may still occur [3] Product Focus - UroGen Pharma specializes in developing and marketing specialty cancer treatments, offering targeted and minimally invasive therapies [5]

Core Viewpoint - Small-cap biotech stocks are experiencing a resurgence, driven by market rotation and improving technical indicators, with healthcare emerging as a constructive sector [2][4] Industry Overview - The Health Care Select Sector SPDR Fund (XLV) has increased by 11.09% in 2025, while the iShares Biotechnology ETF has gained approximately 25% year-to-date [2][3] - Analysts suggest that capital is flowing out of high-flying AI stocks into more attractive healthcare and biotech opportunities [3][4] M&A Activity - Increased mergers and acquisitions (M&A) activity in the biotech sector has been noted, with significant deals including Pfizer's $10 billion acquisition of Metsera and Roche's $3.5 billion acquisition of 89bio [4][5] - This M&A activity is expected to bolster potential upside for both large-cap and small-to-mid-cap biotech companies [4] Methodology for Stock Selection - The list of the best small-cap biotech stocks was curated based on companies with market capitalizations between $300 million and $2 billion, focusing on those with the highest upside potential as of November 10, 2025 [8] Company Highlights - **Viridian Therapeutics, Inc. (NASDAQ:VRDN)**: - Upside potential of 36.71% with a cash position of $888 million and key patient enrollments in late-stage clinical studies [10][11][12] - **UroGen Pharma Ltd. (NASDAQ:URGN)**: - Upside potential of 49.17%, reporting a significant increase in demand revenue and a cash position of $127.4 million [14][15][16] - **Liquidia Corporation (NASDAQ:LQDA)**: - Upside potential of 55.49%, with YUTREPIA achieving profitability earlier than expected and a cash position of $157.5 million [19][20][22]

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.

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $27.5 million, consisting of $25.7 million from Gemyto and $1.8 million from Zesturi, with Gemyto sales showing a 13% year-over-year growth when excluding CreateX sales from the previous year [22][24] - Net loss for Q3 2025 was $33.3 million, or $0.69 per share, compared to a net loss of $23.7 million, or $0.51 per share in Q3 2024 [24] - Cash, cash equivalents, and marketable securities totaled $127.4 million as of September 30, 2025 [24] Business Line Data and Key Metrics Changes - Gemyto generated net product revenue of $25.7 million, reflecting a 13% increase in underlying demand revenue over the same period in 2024 [6][22] - Zesturi sales were $1.8 million in Q3 2025, with a preliminary demand revenue estimate of $4.5 million for October, indicating strong early momentum [15][22] Market Data and Key Metrics Changes - Zesturi addresses an estimated $5 billion annual market, with expectations to become a standard of care and deliver over $1 billion in peak revenue [5][6] - The company has secured broad coverage across major payers, with Zesturi now accessible to over 95% of covered lives, approximately 296 million eligible patients [16] Company Strategy and Development Direction - The company is focused on the ongoing commercialization of Zesturi and Gemyto, with Zesturi being the primary growth driver [3][4] - A permanent product-specific J code for Zesturi is expected to take effect on January 1, 2026, which is anticipated to accelerate adoption [19][20] - The company plans to submit a New Drug Application (NDA) for UGN-103 in the second half of 2026, with potential approval anticipated in 2027 [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term potential for Zesturi, citing positive physician feedback and increasing patient enrollment forms [4][5] - The company acknowledged logistical and operational challenges affecting the conversion of patient enrollment forms to actual patient dosing but expects improvements as practices gain experience [18][32] - Management emphasized the importance of the upcoming permanent J code in simplifying reimbursement and reducing barriers to adoption [19][20] Other Important Information - R&D expenses for Q3 2025 were $14 million, primarily driven by costs associated with the phase 3 Utopia trial for UGN-103 [22] - Selling, general, and administrative expenses increased to $37.6 million, driven by Zesturi commercial preparation activities and expansion of the sales force [23] Q&A Session Summary Question: Can you explain the timing for revenue recording and remittance? - Management indicated that the average lag time between patient enrollment form submission and patient dosing is currently 45-60 days, with expectations for gradual improvement as practices gain experience [31][33] Question: What visibility is there into physicians waiting for the permanent J code? - Management noted that many physicians are interested in prescribing Zesturi but are waiting for the permanent J code to take effect [36][40] Question: How are patient enrollment forms tracking month over month? - Management reported steady growth in patient enrollment forms, with some weeks showing equal or greater numbers compared to Gemyto [45][48] Question: What is the expected impact of the J code on lag time for patient dosing? - Management anticipates that the lag time will gradually decrease, potentially reaching below 30 days as practices become more familiar with the process [58][61] Question: Will additional capital be needed in 2026? - Management expressed confidence in their current cash position and operational plans, believing they can reach profitability without needing additional capital [70]