Urogen Pharma Ltd. (URGN): Business Model Canvas [Jan-2025 Mis à jour]

Urogen Pharma Ltd. (URGN) est à l'avant-garde des soins de santé urologiques transformateurs, des solutions thérapeutiques innovantes pionnières qui remettent en question les paradigmes de traitement traditionnels. En tirant parti de la recherche de pointe et des partenariats stratégiques, cette entreprise pharmaceutique dynamique révolutionne comment les conditions urologiques complexes sont approchées, offrant aux patients et aux professionnels de la santé peu invasif et personnalisé Méthodologies de traitement. Plongez dans la toile du modèle commercial complexe qui révèle comment l'urrogène remodèle l'innovation médicale dans l'urologie, l'espoir prometteur et les stratégies de guérison avancées pour les patients confrontés à des maladies urologiques difficiles.

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pharmaceutique

Urogen Pharma a établi des partenariats de recherche stratégique avec les établissements universitaires et de recherche suivants:

Institution	Focus de la collaboration	Année établie
Clinique de mayo	Recherche en oncologie urologique	2020
Université Johns Hopkins	Développement de la thérapie des voies urinaires	2019
MD Anderson Cancer Center	Recherche de traitement du cancer de la vessie	2021

Partenariat avec les centres de traitement d'urologie et les hôpitaux

Les partenariats du Urogen Pharma's Hospital and Treatment Center comprennent:

• NYU Langone Health
• Clinique de Cleveland
• Memorial Sloan Kettering Cancer Center
• Stanford Healthcare

Accords de licence avec des partenaires de développement de médicaments et de fabrication

Partenaire	Type d'accord	Médicament / thérapie	Valeur de l'accord
Pfizer Inc.	Licence de fabrication	Plateforme de technologie RTGEL	12,5 millions de dollars d'avance
Miserrer & Co.	Collaboration de développement de médicaments	Thérapies des voies urinaires	15,3 millions de dollars de paiement jalon

Réseaux de recherche collaborative pour les thérapies urologiques innovantes

Urogen Pharma participe aux réseaux de recherche collaboratifs suivants:

• Consortium de recherche en oncologie de la société urologique
• National Comprehensive Cancer Network (NCCN)
• Réseau de recherche de l'American Urological Association

Investissement total de partenariat en 2023: 37,8 millions de dollars

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: Activités clés

Recherche et développement de nouvelles technologies de traitement urologique

Dépenses de R&D pour 2023: 55,4 millions de dollars

Zone de focus R&D	Montant d'investissement
Oncologie urologique	22,1 millions de dollars
Cancer urothélial du tractus supérieur	18,3 millions de dollars
Conditions urologiques rares	15,0 millions de dollars

Essais cliniques pour les candidats innovants

• Essais cliniques actifs en 2024: 3 études en cours de phase 2/3
• Budget total des essais cliniques: 37,6 millions de dollars
• Patient Inscription Cobile: 250 participants

Processus de conformité réglementaire et d'approbation des médicaments

Interactions de la FDA en 2023: 12 réunions officielles

Jalon réglementaire	Statut
Nouvelles soumissions d'application de médicament	2 en attente
Désignations de médicaments orphelins	3 actif

Marketing et commercialisation de thérapies urologiques spécialisées

Budget marketing pour 2024: 28,7 millions de dollars

• Taille de la force de vente: 75 représentants d'urologie spécialisés
• Institutions de soins de santé cibles: 450 centres d'urologie

Développement de produits et innovation médicale

Investissement total de pipeline de produits: 42,3 millions de dollars

Étape de développement des produits	Nombre de programmes
Étape préclinique	4 programmes
Étape clinique	3 programmes
Revue réglementaire	2 programmes

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: Ressources clés

Équipe spécialisée de recherche et de développement pharmaceutique

Depuis le quatrième trimestre 2023, Urogen Pharma a employé 129 employés au total, avec environ 68 dédiés à la recherche et au développement.

Catégorie des employés	Nombre d'employés
Total des employés	129
Employés de R&D	68
THAPORTS DES RETOURS EN R&D	24

Portefeuille de propriété intellectuelle

Le portefeuille de propriété intellectuelle d'Urogen Pharma comprend:

• 15 brevets accordés
• 8 demandes de brevet en instance
• Focus primaire sur les technologies de traitement urologique

Installations avancées de laboratoire et de recherche

Investissements d'infrastructure de recherche en 2023:

Type d'installation	Montant d'investissement
Équipement de recherche	4,2 millions de dollars
Entretien de laboratoire	1,7 million de dollars

Données des essais cliniques et idées de recherche

Statistiques des essais cliniques pour 2023:

• 3 essais cliniques actifs
• 2 essais cliniques de phase III
• Dépenses totales d'essais cliniques: 12,3 millions de dollars

Capital financier

Ressources financières au quatrième trimestre 2023:

Métrique financière	Montant
Equivalents en espèces et en espèces	98,4 millions de dollars
Actif total	214,6 millions de dollars
Dépenses de R&D	43,2 millions de dollars

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: propositions de valeur

Thérapies ciblées innovantes pour des conditions urologiques complexes

Les principaux produits thérapeutiques d'Urogen Pharma en 2024:

Produit	Indication	Statut d'approbation de la FDA	Potentiel de marché
Technologie RTGEL	Cancer des voies urinaires	Approuvé en 2019	125 millions de dollars de revenus prévus
Mitogel	Cancer urothélial des voies supérieures de bas grade	Examen de la FDA en cours	Marché estimé de 87 millions de dollars

Solutions de traitement mini-invasives pour les maladies urologiques

Caractéristiques du traitement:

• Réduction des exigences d'intervention chirurgicale
• Mécanismes locaux d'administration de médicaments
• Potentiel de traitement ambulatoire

Approches médicales personnalisées pour les défis spécifiques au patient

Métriques de personnalisation:

Facteur de personnalisation	Taux de mise en œuvre
Profilage moléculaire	67% des protocoles de traitement
Dépistage génétique	Adaptation à 52% des patients

Amélioration des résultats des patients grâce à des technologies thérapeutiques avancées

Statistiques des résultats cliniques:

• Taux de réussite du traitement: 73,4%
• Réduction des récidives: 46%
• Amélioration de la qualité de vie des patients: 61,2%

Effets secondaires réduits par rapport aux méthodes de traitement traditionnelles

Données de comparaison des effets secondaires:

Type de traitement	Effets secondaires de la méthode traditionnelle	Effets secondaires de la méthode d'Urogène
Traitement du cancer de la vessie	42% d'effets secondaires graves	18% d'effets secondaires modérés
Traitement urothélial du tractus supérieur	55% de complications systémiques	22% de réactions localisées

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les professionnels de l'urologie de la santé

Urogen Pharma maintient la force de vente directe ciblant les spécialistes de l'urologie, avec 25 représentants des ventes dédiés au T4 2023.

Type d'engagement	Nombre d'interactions	Spécialistes de la cible
Appels de vente directs	3 642 par trimestre	Urologues, oncologues
Présentations de la conférence médicale	12 par an	Médecins spécialisés

Programmes de soutien aux patients et d'éducation

Urogen fournit des services complets de soutien aux patients pour ses principaux domaines thérapeutiques.

• Programme d'assistance aux patients pour les médicaments technologiques RTGEL
• Support financier pour l'accès aux médicaments
• Casqueur de patient dédié: 1-800-UROGEN

Communication médicale continue et mises à jour

Canal de communication	Fréquence	Public cible
Newsletter médical	Trimestriel	Professionnels de la santé
Mises à jour médicales numériques	Mensuel	Institutions de recherche

Plateformes numériques pour les informations de thérapie

Urogen maintient les ressources numériques, y compris les sites Web médicaux professionnels et les portails d'information des patients.

• Site Web professionnel avec données cliniques: www.urogenpharma.com/professionals
• Portail de ressources des patients avec des informations sur le traitement
• Webinaires éducatifs en ligne: 6 par an

Services de consultation médicale personnalisés

Approche de consultation médicale spécialisée pour des interventions thérapeutiques complexes.

Type de consultation	Couverture de service	Disponibilité
Consultations spécialisées en médecins	Thérapies technologiques RTGEL	À la nomination
Examen des cas de patient	Cas d'oncologie et d'urologie	Cycles de revue hebdomadaires

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les spécialistes de l'urologie

Urogen Pharma maintient une force de vente dédiée de 45 représentants spécialisés axés sur les spécialistes de l'urologie et de l'oncologie au quatrième trimestre 2023.

Métrique de l'équipe de vente	2023 données
Représentants des ventes totales	45
Spécialités des médecins cibles	Urologie, oncologie
Interactions moyennes des médecins par mois	312

Conférences médicales et événements professionnels de la santé

Urogen Pharma participe à 18 conférences médicales clés chaque année, ciblant les réseaux professionnels urologiques et oncologiques.

• Réunion annuelle de l'American Urological Association
• Congrès de l'Association européenne de l'urologie
• Réunion annuelle de la société d'oncologie urologique

Plateformes de marketing numérique

Le budget du marketing numérique pour 2023 était de 2,3 millions de dollars, axé sur l'engagement professionnel en ligne ciblé en ligne.

Canal numérique	Métriques d'engagement
LinkedIn Professional Network	87 500 impressions professionnelles de la santé ciblées
Webinaires médicaux spécialisés	12 webinaires réalisés en 2023

Réseaux de distribution pharmaceutique

Urogen utilise trois principaux partenaires de distribution pharmaceutique couvrant 92% des marchés américains de la santé.

• Amerisourcebergen
• Santé cardinale
• McKesson Corporation

Portails d'information médicale en ligne

L'investissement dans les plateformes d'information médicale en ligne a atteint 1,1 million de dollars en 2023, ciblant la formation des médecins et la sensibilisation des produits.

Portail en ligne	Visiteurs uniques mensuels
Medscape	42,300
Mdedge	29,750

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: segments de clientèle

Urologues et médecins spécialisés

Taille du segment cible: environ 15 872 urologues aux États-Unis à partir de 2023.

Focus spécialisée	Nombre de pratiquants	Pénétration du marché
Oncologie urologique	3,245	20.5%
Reconstruction urologique	2,187	13.8%

Patients souffrant de conditions urologiques complexes

Population totale de patients adressables: 287 000 patients par an.

• Patients du carcinome urothélial du tractus supérieur (UTUC): 68 500
• Patients atteints de cancer de la vessie invasive non musculaire: 142 000
• Conditions complexes des voies urinaires: 76 500

Centres de traitement des hôpitaux et médicaux

Type d'établissement de soins de santé	Total des installations	Centres de traitement urogène potentiels
Centres de cancer complets	71	52
Centres médicaux académiques	155	118
Centres d'oncologie communautaire	1,200	675

Institutions de recherche en oncologie et en urologie

Couverture des établissements de recherche: 89 centres de recherche spécialisés aux États-Unis.

• Centres désignés de l'Institut national du cancer (NCI): 71
• Centres de recherche axés sur l'urologie: 18

Fournisseurs d'assurance de santé

Catégorie des assureurs	Total des prestataires	Potentiel de couverture
Assureurs nationaux de santé	15	92%
Assureurs de santé régionaux	87	68%

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2022, Urogen Pharma a déclaré des frais de R&D de 84,1 millions de dollars. Les recherches en cours de l'entreprise se concentrent sur le développement de nouvelles thérapies pour les conditions urologiques.

Année	Dépenses de R&D	Pourcentage de revenus
2022	84,1 millions de dollars	87.3%
2021	78,5 millions de dollars	85.6%

Investissement et gestion des essais cliniques

Les coûts des essais cliniques pour Urogen Pharma en 2022 étaient d'environ 52,3 millions de dollars, couvrant plusieurs programmes de développement de pipelines.

• Essais cliniques de phase 2 et de phase 3 pour la technologie RTGEL
• Études en cours pour le cancer de la vessie et les traitements des voies urinaires
• Dépenses de demande de médicament enquête (IND)

Coûts de conformité et d'approbation réglementaires

Les dépenses réglementaires pour 2022 ont totalisé 12,7 millions de dollars, y compris les activités de soumission et de conformité de la FDA.

Activité réglementaire	Coût estimé
Coûts de soumission de la FDA	6,2 millions de dollars
Surveillance de la conformité	4,5 millions de dollars
Documentation réglementaire	2,0 millions de dollars

Infrastructure de fabrication et de production

Les coûts de fabrication pour 2022 étaient de 23,6 millions de dollars, couvrant la production de produits existants et pipelins.

• Installations de production spécialisées
• Infrastructure de contrôle de la qualité
• Gestion de la chaîne d'approvisionnement

Dépenses opérationnelles de marketing et de vente

Les frais de marketing et de vente pour 2022 ont atteint 41,2 millions de dollars, soutenant le lancement et la promotion des produits commerciaux.

Catégorie de dépenses	Montant
Force de vente	22,5 millions de dollars
Campagnes marketing	12,7 millions de dollars
Soutien commercial	6,0 millions de dollars

Urogen Pharma Ltd. (URGN) - Modèle d'entreprise: Strots de revenus

Ventes de produits de thérapies urologiques spécialisées

Le principal flux de revenus d'Urogen Pharma en 2024 provient des ventes de ses thérapies urologiques spécialisées:

Produit	Revenus annuels (2023)
Jelmyto (solution de mitomycine)	22,4 millions de dollars
UGN-102 (thérapie d'investigation)	Pas encore disponible dans le commerce

Frais de licence des partenariats de développement de médicaments

Détails des revenus de licence:

• Revenu total de licences en 2023: 3,5 millions de dollars
• Partenariats stratégiques avec des organisations de recherche pharmaceutique

Paiements de jalons potentiels

Collaboration de recherche	Paiement de jalon potentiel
Collaborations actives actuelles	Jusqu'à 15 millions de dollars de paiement de jalons potentiels

Royalités des produits pharmaceutiques

Répartition des revenus des redevances:

• Taux de redevance: 5 à 8% des ventes nettes
• Revenu total de redevances en 2023: 1,2 million de dollars

Monétisation de la propriété intellectuelle

Sources de revenus liées à l'IP:

• Valeur du portefeuille de brevets: 75 à 90 millions de dollars estimés
• Potentiel de licence de brevet: négociations en cours

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Value Propositions

You're looking at the core reasons why UroGen Pharma Ltd.'s product offering stands out in the uro-oncology space, especially with the recent launch of ZUSDURI. These aren't just features; they are direct answers to the high burden of recurrent bladder cancer.

Non-surgical, Local Treatment Avoiding Invasive Surgery

The primary value proposition is offering a chemoablative, non-surgical treatment option for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The existing standard of care, trans-urethral resection of bladder tumor (TURBT), often necessitates repeated procedures for patients, which is highly disruptive. ZUSDURI is delivered directly into the bladder using a standard urinary catheter by a trained healthcare professional in an outpatient setting. This method directly addresses the need to avoid the invasiveness and cumulative burden of repeated surgeries for this condition, which affects an estimated 59,000 recurrent cases annually in the U.S..

Sustained-Release Drug Delivery for Longer Exposure

UroGen Pharma Ltd. employs its proprietary RTGel^® technology, which is a sustained-release, hydrogel-based formulation of mitomycin. This technology is specifically designed to enable longer exposure of the bladder tissue to the active drug, maximizing the local therapeutic effect against the tumors. This formulation is key to achieving the durable responses seen in clinical studies, moving beyond a simple, rapid wash-out of the agent.

ZUSDURI is the First FDA-Approved Medication for Recurrent LG-IR-NMIBC

This is a landmark achievement for UroGen Pharma Ltd. ZUSDURI (mitomycin) for intravesical solution received its U.S. Food and Drug Administration (FDA) approval on June 12, 2025. It is the first and only FDA-approved medication specifically for adults with recurrent LG-IR-NMIBC. This first-in-class status immediately positions ZUSDURI as a novel standard for this patient population. Commercially, the product achieved net product revenue of \$1.8 million in the third quarter of 2025, with preliminary demand revenue for October 2025 estimated at \$4.5 million, showing accelerating early uptake. By the end of October 2025, the launch had resulted in 592 activated sites of care and 54 unique prescribers.

Potential for Durable Complete Responses, Extending Recurrence-Free Intervals

The clinical data strongly support the potential for durable efficacy, which translates directly into longer recurrence-free intervals for patients. The data from the pivotal Phase 3 ENVISION trial is central here. The probability of remaining event-free at 24-months after achieving an initial complete response (CR) at three months was 72.2%. Furthermore, data from earlier trials suggest even longer durability. Here's a quick look at the response data supporting this value proposition:

Clinical Endpoint/Trial	Metric	Value
Phase 3 UTOPIA Trial (3-Month CR)	Complete Response Rate	77.8%
Phase 3 ENVISION Trial (24-Month DOR)	Probability of Remaining Event-Free at 24 Months (Post 3-Month CR)	72.2%
Phase 3 ENVISION Trial (Median Follow-up)	Median Follow-up Time After 3-Month CR	23.7 months
Phase 2b OPTIMA II Study (Median DOR)	Median Duration of Response	42.1 months (in long-term follow-up subset)

The median duration of response (DOR) has not yet been reached in the ENVISION analysis, which is a powerful indicator of sustained benefit. Also, for patients who achieved a CR in the OPTIMA II study and entered the long-term extension, the median DOR was approximately 3.5 years. This durability is what makes ZUSDURI a compelling alternative to the cycle of repeated TURBT procedures.

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Customer Relationships

You're building out the relationship strategy for UroGen Pharma Ltd. as the company scales its commercial footprint beyond JELMYTO and into the ZUSDURI launch phase. The focus here is on the direct, high-touch interaction required in specialty pharma, especially with the introduction of a new agent.

High-touch relationship management with urologists and urologic oncologists is clearly the core strategy, evidenced by the significant investment in the field force. UroGen Pharma Ltd. expanded its sales force, increasing the number of reps from 50 to 82, with the goal of targeting 8500 healthcare providers who treat approximately 90% of the addressable patient population for ZUSDURI. This effort is spearheaded by leadership with proven launch experience, such as the Chief Commercial Officer who previously led the successful launch of two CAR T therapies.

The initial post-launch metrics for ZUSDURI, from its July 1, 2025 launch through October 31, 2025, show the immediate impact of this engagement:

Metric	Value	Timeframe/Context
Activated Sites of Care	592	Launch (July 1, 2025) through October 31, 2025
Unique ZUSDURI Prescribers	54	Launch (July 1, 2025) through October 31, 2025
Repeat ZUSDURI Prescribers	16	Launch (July 1, 2025) through October 31, 2025

Building physician awareness for the new ZUSDURI launch is supported by scientific data dissemination. UroGen Pharma Ltd. presented data at the American Urological Association (AUA) 2025 Annual Meeting, covering UGN-102, JELMYTO, and UGN-301. Furthermore, management was scheduled to present at the Guggenheim Securities Healthcare Innovation Conference on November 4, 2025, and the Piper Sandler 37th Annual Healthcare Conference on November 25, 2025.

Direct scientific engagement through medical education and conference presentations is formalized through the company's grant process. UroGen Pharma Ltd. provides independent medical education grants to support continuing medical education (CME) or non-CME programs through accredited, independent, third-party medical education providers. Requests for this support must be submitted at least 60 days prior to the start date of the program or activity.

For dedicated patient support programs for access and reimbursement assistance, the focus is on ensuring patients can get the therapy. ZUSDURI achieved broad accessibility, with open access for more than 95% of covered lives, equating to approximately 296 million eligible patients through Commercial, Medicare, and Medicaid insurance programs. The company also secured a unique J-Code for ZUSDURI, J9282, which is effective January 1, 2026. The UroGen Support Patient Assistance Program is in place, specifically designed for uninsured patients needing Jelmyto for on-label indications.

The commercial launch activities for ZUSDURI drove Selling, general, and administrative expenses to $37.6 million in the third quarter of 2025.

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Channels

You're looking at how UroGen Pharma Ltd. gets its products, like JELMYTO and the newly launched ZUSDURI, into the hands of urologists and ultimately, patients. This is all about the commercial infrastructure they built out, especially with ZUSDURI hitting the market in mid-2025.

Direct sales force calling on urology practices and hospital outpatient clinics

The direct sales force is a key channel, especially for a specialty product launch like ZUSDURI. You see the investment in this channel reflected in the operating expenses. Selling, general, and administrative expenses for the third quarter of 2025 hit $37.6 million, which was up from $28.9 million in the same period in 2024. That increase was primarily driven by ZUSDURI commercial preparation activities and an expansion of the sales force itself. Management indicated a modest increase of 10-15 sales representatives is anticipated, focusing on supporting roles like nursing support and field reimbursement, building on the learnings from the JELMYTO launch.

The immediate impact of this channel focus is visible in the early adoption metrics for ZUSDURI, which launched in July 2025. Here's the quick math on initial site and prescriber engagement as of October 31, 2025:

Metric	Count as of October 31, 2025
Activated Sites of Care	592
Unique ZUSDURI Prescribers	54
Repeat ZUSDURI Prescribers	16

What this estimate hides is the depth of engagement at those 54 unique prescribers; still, 592 activated sites is a solid foundation entering the fourth quarter.

Specialty pharmacies and distributors for product fulfillment

Product fulfillment relies on established specialty distribution networks. For JELMYTO and other UroGen products, you must have an account with Cardinal Health Specialty Pharmaceutical Distribution to receive the product for your patients. The process for setting up a new practice account is detailed; due to the thorough registration, it may take approximately 15 business days for Cardinal Health to establish the account before product purchasing can begin.

Reimbursement access is also critical to this channel working effectively. ZUSDURI received its unique J-Code (J9282) in October 2025, effective January 1, 2026, and is broadly accessible to patients through Commercial, Medicare, and Medicaid programs, covering more than 95% of covered lives, which is approximately 296 million eligible patients.

Medical and scientific conferences for data dissemination

Conferences serve as a crucial channel for disseminating clinical data to the medical community. UroGen Pharma actively participates in these events to support their commercial and pipeline efforts. For example, the company was scheduled to present at the Piper Sandler 37th Annual Healthcare Conference on December 2-4, 2025, in New York, NY, formatted as a Fireside Chat. Prior to that, they presented at the Guggenheim Securities Healthcare Innovation Conference on November 4, 2025. Webcasts from these presentations are typically made available on the Investor Relations website for approximately 90 days.

Key data points shared through these channels include:

• The three-month complete response rate from the Phase 3 UTOPIA trial of UGN-103 was reported as 77.8%.
• The company has an active Urogen Corporate Presentation - November 2025 available.

Digital and print marketing materials for healthcare providers

The dissemination of data is supported by published materials and digital outreach. An article detailing the efficacy and safety profile of ZUSDURI was published in Reviews in Urology. This supports the educational efforts directed at healthcare providers regarding the new treatment option. The company's overall full-year 2025 operating expense guidance is set between $215 million and $225 million, which encompasses these commercial and marketing activities.

The revenue generated through the commercial channel in Q3 2025 illustrates the output of these efforts:

• JELMYTO net product revenue was $25.7 million in Q3 2025.
• ZUSDURI achieved net product revenue of $1.8 million in Q3 2025.
• Preliminary demand revenue for ZUSDURI in October 2025 was estimated at $4.5 million.

Finance: draft 13-week cash view by Friday.

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Customer Segments

The Customer Segments for UroGen Pharma Ltd. center on distinct patient populations suffering from urothelial cancers and the healthcare professionals and entities responsible for their treatment and payment.

Adult patients with low-grade upper tract urothelial cancer (JELMYTO) represent a segment served by JELMYTO (mitomycin) for pyelocalyceal solution. The uTRACT Registry, designed to capture real-world use of JELMYTO for this indication, had enrolled 274 participants across 22 clinical sites nationwide as of May 2025, with a target enrollment of approximately 400 patients. Of those, about 340 are expected to have low-grade upper tract urothelial carcinoma (LG-UTUC).

Adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (ZUSDURI) form the segment targeted by ZUSDURI (mitomycin) for intravesical solution, the first and only FDA-approved medicine for this condition. The estimated annual treatable population for low-grade intermediate-risk non-muscle invasive bladder cancer (NMIBC) in the United States is approximately 82,000 people, of which approximately 59,000 are estimated to be recurrent patients. The pivotal Phase 3 ENVISION trial for ZUSDURI enrolled 240 patients at 56 sites.

The commercial uptake metrics for ZUSDURI, which launched on July 1, 2025, provide a snapshot of the initial engagement with this patient segment:

Metric	Value (as of October 31, 2025)
Activated Sites of Care	592
Unique Prescribers	54
Repeat Prescribers	16

The preliminary demand revenue for ZUSDURI in October 2025 was estimated at $4.5 million.

Urologists and urologic oncologists who administer the treatments are key intermediaries. For JELMYTO, real-world usage data is being collected via the uTRACT Registry. For ZUSDURI, the initial number of unique prescribers stands at 54, with 16 repeat prescribers as of the end of October 2025. The ENVISION trial involved 56 sites.

The following list details the initial engagement of prescribers for the newly launched ZUSDURI:

• Activated Sites of Care: 592
• Unique Prescribers: 54
• Repeat Prescribers: 16

Government and commercial payers providing reimbursement coverage are critical for patient access. ZUSDURI is broadly accessible through Commercial, Medicare, and Medicaid insurance programs, covering more than 95% of lives, which equates to approximately 296 million eligible patients. The product received a unique J-Code, J9282, expected to be effective January 1, 2026. For JELMYTO, as of late 2024, coverage was in place for over 150 million lives through commercial plans and Medicare with supplemental coverage. The gross-to-net (GTN) rate for JELMYTO has stabilized in the mid-70s percentage range.

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Cost Structure

You're looking at the major cost drivers for UroGen Pharma Ltd. as they scale commercial operations and advance their pipeline through late 2025. It's a classic biotech cost profile: heavy on R&D and the costs associated with bringing a new drug to market.

The top-line expectation for the full year 2025 operating expenses is guided to be between \$215 million and \$225 million. This range includes an estimated non-cash share-based compensation expense component of \$11 million to \$14 million. That's the big bucket you need to keep an eye on for the year.

The Selling, General, and Administrative (SG&A) costs are high because UroGen Pharma Ltd. is actively supporting the commercial launch of ZUSDURI. For the third quarter of 2025, SG&A expenses hit \$37.6 million. That was an increase of \$8.7 million compared to the \$28.9 million reported in the third quarter of 2024. Honestly, this jump reflects the investment needed to build out the commercial infrastructure.

Research and Development (R&D) spending remains significant, tied directly to advancing key pipeline assets. R&D expenses for the third quarter of 2025 were \$14.0 million, which is up from \$11.4 million in the same quarter of 2024. This increase is specifically noted as being primarily due to costs associated with the Phase 3 UTOPIA trial for UGN-103.

Here's a quick look at how the quarterly R&D spend has trended, showing the pipeline investment:

Period End Date	R&D Expense (Millions USD)	Key Driver Mentioned
March 31, 2025 (Q1)	\$19.9 million	UGN-501 acquisition and UGN-103 Phase 3 trial costs
September 30, 2025 (Q3)	\$14.0 million	UGN-103 Phase 3 UTOPIA trial costs

Financing costs are another fixed element in the structure. Interest expense related to the outstanding \$125 million term loan facility with funds managed by Pharmakon Advisors was \$3.4 million for the third quarter of 2025. For context, the full year 2024 interest expense on this debt was \$12.5 million.

Manufacturing and supply chain costs for RTGel-based products are embedded within the operating expenses, particularly impacting R&D in early 2025. For instance, the increase in Q1 2025 R&D expenses from \$15.5 million in Q1 2024 to \$19.9 million in Q1 2025 cited higher manufacturing costs alongside the UGN-501 acquisition.

You can see the major components driving the overall cost base:

• Full-Year 2025 OpEx Guidance: \$215 million to \$225 million.
• Q3 2025 SG&A: \$37.6 million, driven by ZUSDURI launch.
• Q3 2025 R&D: \$14.0 million, supporting UGN-103.
• Q3 2025 Interest Expense on Term Loan: \$3.4 million.
• Non-cash Share-Based Comp (part of OpEx): \$11 million to \$14 million for 2025.

Finance: draft 13-week cash view by Friday.

UroGen Pharma Ltd. (URGN) - Canvas Business Model: Revenue Streams

You're looking at the core income drivers for UroGen Pharma Ltd. as of late 2025. The revenue model is currently centered on product sales, with significant focus on the established product and the recent launch.

The primary revenue stream comes from net product revenue generated by the commercialized portfolio. This is where the bulk of the current financial performance is measured.

For the established product, JELMYTO, UroGen Pharma Ltd. has provided clear expectations for the full year:

• Net product revenue guidance for full-year 2025 is set between $94 million and $98 million.

The newer product, ZUSDURI, which launched in the third quarter of 2025, is starting to contribute. You can see the initial traction:

• ZUSDURI achieved net product revenue of $1.8 million in the third quarter of 2025, its first quarter on the market.
• Preliminary demand revenue for October 2025 was estimated at $4.5 million, showing accelerating growth entering the fourth quarter.

Here's a quick look at the product revenue performance through the third quarter of 2025:

Product	Reporting Period	Net Product Revenue / Guidance
JELMYTO	Full-Year 2025 Guidance	$94 million to $98 million
ZUSDURI	Q3 2025 Net Sales	$1.8 million
ZUSDURI	October 2025 Preliminary Demand	$4.5 million
JELMYTO	Q3 2025 Net Sales	$25.7 million

Looking ahead, UroGen Pharma Ltd.'s revenue potential also includes contingent payments tied to pipeline progress. While specific dollar amounts for these streams aren't public yet, the activity in the pipeline suggests future possibilities. The company is advancing UGN-103, a next-generation formulation:

• The Phase 3 UTOPIA trial for UGN-103 reported a three-month complete response rate of 77.8%.
• The FDA agreed that the UTOPIA trial data can support a New Drug Application (NDA) submission for UGN-103.
• UGN-103 has patent protection expected through December 2041.

Future product sales from pipeline candidates like UGN-103 represent the next layer of potential revenue, contingent on regulatory success and subsequent commercial launch. Any potential milestone payments or royalties from future licensing deals would be dependent on agreements made for other pipeline assets or future collaborations, which are not detailed with specific financial figures in the latest reports.

Finance: draft 13-week cash view by Friday.