URGNNasdaqPharmaceutical PreparationsUS GAAP · USD

UroGen Pharma Ltd.

UroGen Pharma Ltd. is a biopharmaceutical company focused on urothelial and specialty cancers, built around its proprietary RTGel reverse-thermal hydrogel platform. The company develops and commercializes local therapies for urinary tract cancers, including approved products Jelmyto and Zusduri, and maintains a pipeline of investigational oncology candidates.

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Revenue110m USD
+21.4 %y/y
Operating profit (EBIT)-125m USD
−29.0 %y/y
EBIT margin-113.7%
−6.7 ppy/y
Net income-153m USD
−21.0 %y/y
Free cash flow-163m USD
−67.7 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-150-100-50050100150m USD2020: 12 m USD2020: EBIT -127 m USD20202021: 48 m USD2021: EBIT -92 m USD20212022: 64 m USD2022: EBIT -79 m USD20222023: 83 m USD2023: EBIT -66 m USD20232024: 90 m USD2024: EBIT -97 m USD20242025: 110 m USD2025: EBIT -125 m USD2025110-125
RevenueOperating profit (EBIT)
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Business

Share of revenue
Commercial oncology products100 %

Approved therapies sold for non-muscle invasive urothelial cancers.

Drug-delivery platform technology0 %

RTGel is used to extend local exposure of drugs in the urinary tract.

Clinical-stage pipeline0 %

Investigational programs for additional urothelial and specialty cancers.

Products

Reported · share of revenue
85.6%14.4%FY2025100 %
  • Jelmyto85.6 %
  • Zusduri14.4 %

Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.

Customers

UroGen sells primarily to physicians and healthcare providers treating urothelial cancer, especially urologists and oncology-focused practices. Access and reimbursement teams also interact with payers, pharmacies, and key accounts because adoption depends on formulary coverage, administration workflows, and patient eligibility.

Urologists

Prescribe Jelmyto and Zusduri for eligible urothelial cancer patients and drive account adoption.

Oncology practices and cancer centers

Use the products in specialty cancer care settings and support broader physician uptake.

Payers and reimbursement stakeholders

Influence patient access through coverage, prior authorization, and reimbursement policies.

Pharmacies and treatment sites

Prepare, dispense, and administer the product admixture and support clinical workflow.

Strategy

UroGen’s strategy centers on expanding commercialization of Jelmyto and launching Zusduri while advancing its pipeline in urothelial and specialty cancers. The company also uses partnerships and licensing selectively to extend its technology and reach outside the United States where appropriate.

Commercialize approved productsShort term

Revenue and market presence depend on physician adoption and access for Jelmyto and Zusduri.

Advance pipeline developmentMedium term

Future growth depends on expanding the product portfolio beyond current approved therapies.

Build commercialization partnerships outside the U.S.Medium term

International markets may require local partners with established sales and distribution networks.

Geography

UroGen is organized under Israeli law, with principal executive offices in Princeton, New Jersey, and employees in both the United States and Israel. Commercial activity is centered in the United States, where Jelmyto is marketed and where the company’s customer-facing organization is based.

Risks

UroGen depends heavily on successful commercialization of a small number of products, so adoption, reimbursement, and physician acceptance are central risks. The business also faces typical biotech exposures around clinical development, manufacturing quality, single-source suppliers, intellectual property, and the need for additional financing.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Financing risk1Commercial dependence on a limited product base2Manufacturing and supply-chain risk3Regulatory and clinical development risk4Reimbursement and physician adoption risk5
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Financing riskImpact: HighLikelihood: High

    The company has a history of losses and may need external capital to support operations.

    Exposure: Operations and R&D

  2. Commercial dependence on a limited product baseImpact: HighLikelihood: Medium

    Most current revenue and strategic value depend on Jelmyto and Zusduri adoption.

    Exposure: Approved products

  3. Manufacturing and supply-chain riskImpact: HighLikelihood: Medium

    Pharmaceutical products rely on contract manufacturers and single-source suppliers.

    Exposure: Jelmyto and pipeline candidates

  4. Regulatory and clinical development riskImpact: HighLikelihood: Low

    Pipeline programs may fail to demonstrate safety, efficacy, or manufacturability.

    Exposure: UGN-501 and other candidates

  5. Reimbursement and physician adoption riskImpact: MediumLikelihood: Medium

    Specialty oncology products require coverage, formulary access, and workflow integration.

    Exposure: U.S. commercial market

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Accounting

Judgemental items
Net product revenue reserves

Jelmyto sales are reduced by chargebacks and other government-sponsored program adjustments.

Impact: Affects reported revenue and gross margin

Inventory write-offs and unit-cost changes

Commercial product manufacturing and preparation costs can create inventory valuation risk.

Impact: Affects cost of revenue

Debt and prepaid forward obligation accounting

Interest expense and financing costs affect the income statement and liquidity analysis.

Impact: Affects net loss and cash flow interpretation

Acquired asset consideration and royalties

Milestone payments and royalties tied to acquired programs require ongoing estimation.

Impact: Affects future expense recognition and contingent obligations

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Last updated: 24/09/2026