Urogen Pharma (URGN) shares ended the last trading session 14.1% higher at $11.26. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 11.9% loss over the past four weeks.The stock rallied after the company presented multiple data at the annual meeting of the American Urological Association 2025 on its pipeline candidates that are being studied for different cancer indications.This company is expected to post quarterly ...

UroGen Pharma Ltd. URGN on Sunday highlighted a duration of response of nearly four years from a long-term follow-up study with Jelmyto (mitomycin) for pyelocalyceal solution.The U.S. Food And Drug Administration approved Jelmyto in 2020 for low-grade upper tract urothelial cancer (LG-UTUC) in adults.Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with Jelmyto (n = 41), the median duration of response was 47.8 months, regardless of whether their cancer was ...

Core Insights - The article reflects on the author's investment journey, emphasizing the learning process from both successes and failures in the investment landscape, particularly in healthcare stocks [1]. Company Analysis - UroGen Pharma (NASDAQ: URGN) is highlighted as a focus of the author's investment research, indicating a long-term beneficial position in the company's shares [2]. - The author has been conducting focused research on various stocks for approximately five years, with a primary emphasis on healthcare stocks, suggesting a deep understanding of the sector [1]. Market Perspective - The article serves as a platform for sharing experiences and insights related to investing, particularly in the context of UroGen Pharma, which may indicate potential investment opportunities in the healthcare sector [1].

UroGen Pharma (URGN) Q4 2024 Earnings Call March 10, 2025 06:16 PM ET Company Participants Vincent Perrone - Senior Director of Investor RelationsLiz Barrett - President & CEOMark Schoenberg - Chief Medical OfficerDavid Lin - Chief Commercial OfficerChris Degnan - CFORaghuram Selvaraju - Managing Director, Healthcare Equity Research Conference Call Participants None - AnalystMichael Schmidt - Senior Managing Director & Equity Research Analyst - BiotechnologyLeland Gershell - MD & Senior Biotechnology Analys ...

Market Potential and Product Development - UGN-102, if approved, could address a treatable population of approximately 82,000 low-grade intermediate risk NMIBC patients in the U.S., with a total addressable market exceeding $5.0 billion [506]. - The company has initiated the Phase 3 ENVISION trial to evaluate UGN-102 as primary chemoablative therapy for low-grade intermediate risk NMIBC [524]. - The FDA accepted the NDA for UGN-102, with a PDUFA goal date of June 13, 2025, potentially making it the first FDA-approved treatment for low-grade intermediate-risk NMIBC [530]. - The company entered into a licensing agreement with medac for UGN-103 and UGN-104, aiming for an NDA submission for UGN-103 in 2026 and a commercial launch in 2027 [531]. Clinical Trial Results - The complete response rate for Jelmyto in the OLYMPUS trial was 58%, with a durability of response estimated at 81.8% at 12 months [513]. - In the OPTIMA II trial, 65% of patients achieved a complete response three months after treatment with UGN-102, with a 72.5% probability of durable response at nine months [522]. - In the Phase 3 ATLAS trial, UGN-102 reduced the risk of recurrence, progression, or death by 55% compared to TURBT alone, with a 64.8% complete response (CR) rate at three months for UGN-102 patients [525]. - The ENVISION trial demonstrated a 79.6% CR rate at three months for patients treated with UGN-102, with 60.8% of all enrolled patients in CR at 12 months [526][527]. - Updated 18-month duration of response (DOR) data from the ENVISION trial showed an 80.6% DOR for patients who achieved CR at three months [528]. - The company completed a Phase 3b study indicating that UGN-102 can be administered at home, with 75% of patients achieving CR three months after treatment [529]. Financial Performance - Revenue from Jelmyto sales increased to $90.4 million in 2024 from $82.7 million in 2023 [539]. - The consolidated net revenue for the year ended December 31, 2024, was $90.4 million, an increase from $82.7 million in 2023, representing a growth of approximately 9.3% [628]. - Gross profit for 2024 was $81.5 million, up from $73.4 million in 2023, reflecting an increase of $8.2 million [562]. - The net loss for the year ended December 31, 2024, was $126.9 million, compared to a net loss of $102.2 million in 2023, an increase of $24.6 million [562]. - Selling, general and administrative expenses rose significantly to $121.2 million in 2024, up from $93.3 million in 2023, marking an increase of about 30% [636]. Research and Development Expenses - Research and development expenses increased from $45.6 million in 2023 to $57.1 million in 2024, primarily due to clinical development costs [543]. - Research and development expenses rose to $57.1 million in 2024 from $45.6 million in 2023, an increase of $11.5 million primarily due to higher manufacturing costs and regulatory expenses [565]. - Research and development expenses are expensed as incurred, primarily consisting of salaries, share-based compensation, and costs related to clinical trials and professional services [685]. Cash Flow and Financing - The company expects to finance cash needs through equity or debt financings and collaboration arrangements until substantial product revenue is generated [585]. - As of December 31, 2024, the company had $241.7 million in cash and cash equivalents and marketable securities [572]. - Net cash used in operating activities increased to $96.8 million in 2024 from $76.4 million in 2023, primarily due to higher operating expenses related to UGN-102 [588]. - Net cash provided by financing activities increased to $194.6 million in 2024 from $116.9 million in 2023, driven by proceeds from the issuance of ordinary shares and debt related to the Pharmakon loan [590]. Inventory and Asset Management - As of December 31, 2024, total inventories increased to $9,446,000 from $7,341,000 as of December 31, 2023, representing a year-over-year growth of approximately 28.6% [699]. - The Company commenced capitalization of inventory costs for Jelmyto upon receipt of FDA approval, with inventory valued at the lower of cost or net realizable value [671]. - The company’s inventory assessment includes a review for recoverability each reporting period to determine any necessary write-downs due to excess or obsolete inventories [672]. Regulatory and Compliance - The company has adopted new accounting standards updates, including ASU 2023-07 for segment reporting disclosures, effective for fiscal years beginning after December 15, 2023 [693]. - The Company is party to a loan agreement with Pharmakon Advisors, recognizing interest expense in current earnings and capitalizing financing expenses as a direct offset to long-term debt [676]. Shareholder Information - The company reported a weighted average number of shares outstanding of 42,876,737 for the year ended December 31, 2024, compared to 28,834,303 in 2023, an increase of approximately 48.7% [636]. - The net loss attributable to equity holders of the Company for the year ended December 31, 2024, was $126.874 million, compared to a net loss of $102.244 million for 2023, resulting in a loss per ordinary share of $(2.96) for 2024 and $(3.55) for 2023 [692].

Urogen Pharma (URGN) came out with a quarterly loss of $0.80 per share versus the Zacks Consensus Estimate of a loss of $0.74. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -8.11%. A quarter ago, it was expected that this company would post a loss of $0.84 per share when it actually produced a loss of $0.55, delivering a surprise of 34.52%.Over the last four quarters, the company has surpassed ...

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]