UroGen Pharma Ltd., a biotechnology company, engages in the development and commercialization novel solutions for specialty cancers and urothelial diseases. It offers RTGel, a polymeric biocompatible and reverse thermal gelation hydrogel to improve therapeutic profiles of existing drugs; and Jelmyto for pyelocalyceal solution. The company's lead product candidate is UGN-102, which is in Phase III clinical trials for the treatment of several forms of non-muscle invasive urothelial cancer that include low-grade upper tract urothelial carcinoma and low-grade non-muscle invasive bladder cancer. It is also developing UGN-301 for the treatment of high-grade non-muscle invasive bladder cancer. The company has a license agreement with Allergan Pharmaceuticals International Limited for developing and commercializing pharmaceutical products that contain RTGel and clostridial toxins; Agenus Inc. to develop, make, use, sell, import, and commercialize products of Agenus for the treatment of cancers of the urinary tract via intravesical delivery; and strategic research collaboration with MD Anderson to advance investigational treatment for high-grade bladder cancer. UroGen Pharma Ltd. was incorporated in 2004 and is based in Princeton, New Jersey.
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Here are 1-3 brief analogies for UroGen Pharma (URGN):
- Vertex Pharmaceuticals for urothelial cancers.
- A highly specialized Bristol Myers Squibb, focused exclusively on specific urological cancers.
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- JELMYTO (mitomycin) for pyelocalyceal solution: The first and only non-surgical treatment approved for low-grade upper tract urothelial cancer (UTUC).
- UGN-102 (mitomycin) for intravesical solution: An investigational product currently in Phase 3 clinical trials for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
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UroGen Pharma (URGN) sells primarily to other companies, specifically to a limited number of wholesale distributors who then supply the company's products to specialty pharmacies, hospitals, and other healthcare providers.
According to its SEC filings, the company's major customers, which are wholesale distributors, are:
- McKesson Corporation (NYSE: MCK)
- AmerisourceBergen Corporation (NYSE: ABC)
- Cardinal Health, Inc. (NYSE: CAH)
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- Recipharm
- Evonik Industries AG (Symbol: EVK.DE)
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Liz Barrett, President and Chief Executive Officer
Ms. Barrett was appointed CEO of UroGen Pharma in January 2019. She is a highly regarded industry leader with extensive experience in leading business organizations and Fortune 500 pharmaceutical companies. Prior to UroGen, she served as CEO of Novartis Oncology and was a member of the Novartis Executive Committee. She also held the position of Global President of Oncology at Pfizer Inc., where her leadership roles included President of Global Innovative Pharma for Europe, President of the Specialty Care Business Unit for North America, and President of United States Oncology. Before Pfizer, Ms. Barrett worked at Cephalon Inc. as Vice President and General Manager of the Oncology Business Unit, and at Johnson & Johnson. She began her career at Kraft Food Groups, Inc. Ms. Barrett has overseen the launch of major cancer drugs, including Ibrance (palbociclib) at Pfizer and was involved in the commercialization of Kymriah (tisagenlecleucel) at Novartis.
Chris Degnan, Chief Financial Officer
Mr. Degnan was appointed Chief Financial Officer in October 2024. He brings extensive experience as a CFO for publicly traded biotech companies, having most recently served in this role at Galera Therapeutics and Verrica Pharmaceuticals. His expertise spans financial strategy, investor relations, SEC reporting, accounting, and compliance. Earlier in his career, Mr. Degnan held senior positions at Endo International plc and spent over 10 years at the global biopharmaceutical company AstraZeneca plc. He is a Certified Public Accountant.
Mark P. Schoenberg, M.D., Chief Medical Officer
Dr. Schoenberg joined UroGen Pharma in 2017. He is an internationally recognized expert in the treatment of urothelial cancer, with significant contributions to peer-reviewed literature in urologic oncology. Dr. Schoenberg held prominent academic positions, including the Bernard Schwartz Distinguished Professor of Urologic Oncology at Johns Hopkins University from 2005 to 2014. He completed his fellowship in urologic oncology at The James Buchanan Brady Urological Institute of Johns Hopkins University. He also served as a resident in surgery and urology at the Hospital of The University of Pennsylvania and earned his medical degree from The University of Texas (Houston). He is a founding member of the scientific advisory board of The Bladder Cancer Advocacy Network. In 2014, he was named Professor and University Chair of Urology at the Albert Einstein College of Medicine.
Jason Smith, General Counsel and Chief Compliance Officer
Mr. Smith joined UroGen Pharma in 2020. He is an experienced lawyer with extensive background in healthcare, pharmaceutical, and corporate law. Before his tenure at UroGen, he served as Chief Counsel, Oncology at Pfizer. Prior to Pfizer, Mr. Smith worked in the legal department at Wyeth, where he held various roles, including antitrust counsel, Global Product Counsel, and Chief Counsel, U.S. Pharmaceuticals. He began his legal career as an associate at Howrey, Simon, Arnold & White in Washington, D.C., focusing on antitrust and commercial litigation.
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UroGen Pharma (URGN) faces several key business risks, primarily centered around regulatory hurdles for its product pipeline, its challenging financial health, and the complexities of market penetration and competition.
The most significant risk stems from **regulatory hurdles and clinical trial outcomes for its product candidates, particularly UGN-102**. The FDA's Oncologic Drugs Advisory Committee (ODAC) voted against UGN-102 due to concerns over deficiencies in its clinical trial design, specifically the lack of a concurrent control arm. This resulted in substantial drops in UroGen's stock price and initiated class-action lawsuits alleging misleading statements to investors. While UGN-102 may have later received approval, its commercial viability and widespread physician adoption remain uncertain given the established surgical standards it aims to replace.
Secondly, **UroGen Pharma's financial health presents a notable risk due to ongoing profitability challenges and significant debt**. The company has reported negative operating and net margins, as well as negative free cash flow, indicating difficulties in achieving overall profitability despite revenue growth. Its financial strength is rated as poor, with considerable debt levels contributing to a distress zone Z-Score. There are concerns about a limited financial runway and the potential need for future capital raises or non-dilutive financing.
Finally, **market penetration, intense competition, and ensuring product acceptance are significant challenges**. UroGen's business heavily relies on the successful commercialization of its approved products, like Jelmyto, and its product candidates. The company faces hurdles in achieving broad physician adoption and market acceptance, and the actual market opportunities for its therapies may be smaller than anticipated due to competition from existing treatments and new market entrants. Additionally, the high rates of adverse reactions and the necessity for repeat procedures associated with some of its treatments could hinder patient uptake and overall market performance.
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The emerging threat to UroGen Pharma (URGN) is the advanced development and potential commercialization of TAR-200 by Johnson & Johnson (Janssen) / TARIS Biomedical. TAR-200 is an intravesical drug delivery system designed for sustained release of therapeutic agents, currently undergoing evaluation in multiple clinical trials for bladder cancer. While some studies focus on high-risk non-muscle invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer, TAR-200 is also being investigated in intermediate-risk NMIBC with gemcitabine (e.g., in the SunRISe-1 study).
This directly threatens UroGen's lead pipeline asset, UGN-102 (mitomycin in RTGel™), which is targeting low-grade intermediate-risk NMIBC. Both products aim to provide sustained local delivery of chemotherapy to the bladder, offering a non-surgical or minimally invasive treatment option for NMIBC. Given Johnson & Johnson's vast resources and experience in drug development and commercialization, a successful TAR-200 could capture significant market share in a patient population that UroGen is heavily banking on for future growth with UGN-102. This represents a direct competitive platform technology from a formidable industry player, analogous to how a new disruptive technology from a major competitor can challenge an existing or emerging market leader.
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UroGen Pharma's main products and pipeline candidates address the following markets:
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UGN-102 (ZUSDURI) for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC): The estimated market opportunity for UGN-102 is over $5 billion in the U.S.. This condition affects an estimated 82,000 patients annually in the U.S.. Another estimate indicates approximately 22,000 newly diagnosed patients annually in the U.S., with 60,000 recurrences each year.
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JELMYTO (UGN-101/UGN-104) for low-grade upper tract urothelial carcinoma (LG-UTUC): The annual treatable patient population for LG-UTUC in the United States is approximately 6,000 to 7,000 individuals.
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UroGen Pharma (URGN) is poised for future revenue growth over the next 2-3 years, driven by the expansion of its commercialized products and the progression of its pipeline. Key drivers include:
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Accelerated Adoption and Market Penetration of ZUSDURI (UGN-102): Following its FDA approval in June 2025 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC), ZUSDURI is expected to be a significant revenue driver. The implementation of a permanent J-code in January 2026 is anticipated to accelerate its adoption, particularly in community settings, by streamlining reimbursement processes and facilitating wider usage. UroGen Pharma projects ZUSDURI to achieve over $1 billion in peak annual revenue, addressing an estimated $5 billion annual market opportunity.
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Continued Growth of JELMYTO: JELMYTO (mitomycin) for pyelocalyceal solution, approved for low-grade upper tract urothelial cancer (LG-UTUC), continues to demonstrate strong underlying patient demand. The company anticipates JELMYTO net product revenues to be in the range of $94 million to $98 million for 2025, representing an expected 8%-12% year-over-year growth over 2024 demand-driven revenues.
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Launch of Next-Generation Pipeline Products (UGN-103 and UGN-104): UroGen Pharma is advancing its pipeline with next-generation therapies. An New Drug Application (NDA) for UGN-103, a next-generation product for recurrent LG-IR-NMIBC, is planned for submission in the second half of 2026, with potential approval anticipated in 2027. UGN-104, designed as a next-generation therapy for JELMYTO, is expected to follow approximately a year later.
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Expanded Commercial Infrastructure and Sales Force: To maximize the market reach and adoption of its products, particularly with the launch of ZUSDURI, UroGen Pharma has significantly expanded its commercial infrastructure. This includes increasing its sales force from 40 to 82 representatives and expanding to 130 customer-facing roles. These efforts are aimed at increasing prescriber awareness and securing broad reimbursement coverage.
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Share Issuance
- In July 2023, UroGen Pharma announced a private placement of ordinary shares, expecting to receive gross proceeds of approximately $120 million. This involved the issuance of 12,579,156 ordinary shares at a purchase price of $9.54 per share.
- In June 2024, the company raised approximately $116.2 million in net proceeds from a public offering to support the UGN-102 launch and for business development opportunities.
- The number of ordinary shares outstanding significantly increased from 22.14 million at the end of 2020 to 47.73 million as of November 2025.
Inbound Investments
- A private placement in July 2023, led by RA Capital Management L.P. and Great Point Partners LLC, secured approximately $120 million from selected institutional and accredited investors.
- The company has a $125 million term loan facility with funds managed by Pharmakon Advisors, with interest expense related to this debt reported in 2024 and 2025.
Outbound Investments
- In February 2025, UroGen expanded its nonclinical oncology portfolio through the purchase of product candidate UGN-501 from IconOVir Bio, Inc.
Capital Expenditures
- Capital expenditures for UroGen Pharma were $1.22 million in 2020, $0.75 million in 2021, $0.25 million in 2022, $0.19 million in 2023, and $0.30 million in 2024.
