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.

Kysy yhtiöstä
Liikevaihto110milj. USD
+21,4 %v/v
Liikevoitto (EBIT)−125milj. USD
−29,0 %v/v
EBIT-marginaali−113,7%
−6,7 %-yks.v/v
Nettotulos−153milj. USD
−21,0 %v/v
Vapaa kassavirta−163milj. USD
−67,7 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−150−100−50050100150milj. USD2020: 12 milj. USD2020: EBIT −127 milj. USD20202021: 48 milj. USD2021: EBIT −92 milj. USD20212022: 64 milj. USD2022: EBIT −79 milj. USD20222023: 83 milj. USD2023: EBIT −66 milj. USD20232024: 90 milj. USD2024: EBIT −97 milj. USD20242025: 110 milj. USD2025: EBIT −125 milj. USD2025110−125
LiikevaihtoLiikevoitto (EBIT)
Kysy Clarifolta: UroGen Pharma Ltd.

Liiketoiminta

Osuus liikevaihdosta
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.

Tuotteet

Raportoitu · osuus liikevaihdosta
85,6%14,4%FY2025100 %
  • Jelmyto85,6 %
  • Zusduri14,4 %

Lähde: 10-K FY2025, yhtiön tuotelinjoittain raportoima liikevaihto (SEC XBRL). Osuudet on laskettu näytetyistä riveistä ja ne summautuvat 100 %:iin.

Asiakkaat

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.

Strategia

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 productsLyhyt aikaväli

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

Advance pipeline developmentKeskipitkä aikaväli

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

Build commercialization partnerships outside the U.S.Keskipitkä aikaväli

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

Maantiede

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.

Riskit

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.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Financing risk1Commercial dependence on a limited product base2Manufacturing and supply-chain risk3Regulatory and clinical development risk4Reimbursement and physician adoption risk5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Financing riskVaikutus: KorkeaTodennäköisyys: Korkea

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

    Kohdistuu: Operations and R&D

  2. Commercial dependence on a limited product baseVaikutus: KorkeaTodennäköisyys: Kohtalainen

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

    Kohdistuu: Approved products

  3. Manufacturing and supply-chain riskVaikutus: KorkeaTodennäköisyys: Kohtalainen

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

    Kohdistuu: Jelmyto and pipeline candidates

  4. Regulatory and clinical development riskVaikutus: KorkeaTodennäköisyys: Matala

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

    Kohdistuu: UGN-501 and other candidates

  5. Reimbursement and physician adoption riskVaikutus: KeskitasoTodennäköisyys: Kohtalainen

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

    Kohdistuu: U.S. commercial market

Kysy Clarifolta: UroGen Pharma Ltd.

Kirjanpito

Harkinnanvaraiset erät
Net product revenue reserves

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

Vaikutus: Affects reported revenue and gross margin

Inventory write-offs and unit-cost changes

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

Vaikutus: Affects cost of revenue

Debt and prepaid forward obligation accounting

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

Vaikutus: Affects net loss and cash flow interpretation

Acquired asset consideration and royalties

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

Vaikutus: Affects future expense recognition and contingent obligations

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Päivitetty: 24.9.2026