UroGen Pharma Ltd. (URGN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Urogen Pharma Ltd. (URGN) está a la vanguardia de la atención médica urológica transformadora, pionero en soluciones terapéuticas innovadoras que desafían los paradigmas de tratamiento tradicionales. Al aprovechar la investigación de vanguardia y las asociaciones estratégicas, esta compañía farmacéutica dinámica está revolucionando cómo se abordan las condiciones urológicas complejas, ofreciendo a los pacientes y profesionales médicos tecnologías innovadoras que prometen mínimamente invasivo y personalizado Metodologías de tratamiento. Cambie en el intrincado lienzo de modelo de negocio que revela cómo urogen está reestructurando la innovación médica en urología, prometiendo esperanza y estrategias avanzadas de curación para pacientes que enfrentan enfermedades urológicas desafiantes.

Urogen Pharma Ltd. (URGN) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

Urogen Pharma ha establecido asociaciones de investigación estratégica con las siguientes instituciones académicas y de investigación:

Institución	Enfoque de colaboración	Año establecido
Clínica de mayonesa	Investigación de oncología urológica	2020
Universidad de Johns Hopkins	Desarrollo de terapia del tracto urinario	2019
Centro de cáncer de MD Anderson	Investigación del tratamiento del cáncer de vejiga	2021

Asociación con centros de tratamiento de urología y hospitales

Las asociaciones de hospital y centro de tratamiento de Urogen Pharma incluyen:

• Nyu Langone Health
• Clínica de Cleveland
• Memorial Sloan Kettering Cancer Center
• Stanford Healthcare

Acuerdos de licencia con desarrollo de medicamentos y socios de fabricación

Pareja	Tipo de acuerdo	Drogas/terapia	Valor de acuerdo
Pfizer Inc.	Licencia de fabricación	Plataforma de tecnología Rtgel	$ 12.5 millones por adelantado
Merck & Co.	Colaboración del desarrollo de drogas	Terapias del tracto urinario	$ 15.3 millones de pagos por hito

Redes de investigación colaborativa para terapias urológicas innovadoras

Urogen Pharma participa en las siguientes redes de investigación de colaboración:

• Consorcio de investigación de la Sociedad de Oncología Urológica
• Red Nacional de Cáncer Integral (NCCN)
• Red de investigación de la Asociación Americana de Urología

Inversión de asociación total en 2023: $ 37.8 millones

Urogen Pharma Ltd. (URGN) - Modelo de negocio: actividades clave

Investigación y desarrollo de nuevas tecnologías de tratamiento urológico

Gastos de I + D para 2023: $ 55.4 millones

Área de enfoque de I + D	Monto de la inversión
Oncología urológica	$ 22.1 millones
Cáncer urotelial del tracto superior	$ 18.3 millones
Condiciones urológicas raras	$ 15.0 millones

Ensayos clínicos para candidatos a drogas innovadores

• Ensayos clínicos activos en 2024: 3 estudios de fase 2/3 en curso
• Presupuesto total de ensayos clínicos: $ 37.6 millones
• Objetivo de inscripción de pacientes: 250 participantes

Cumplimiento regulatorio y procesos de aprobación de medicamentos

Interacciones de la FDA en 2023: 12 reuniones formales

Hito regulatorio	Estado
Nuevas presentaciones de solicitudes de drogas	2 pendiente
Designaciones de drogas huérfanas	3 activo

Marketing y comercialización de terapias urológicas especializadas

Presupuesto de marketing para 2024: $ 28.7 millones

• Tamaño de la fuerza de ventas: 75 Representantes de urología especializada
• Instituciones de atención médica objetivo: 450 centros de urología

Desarrollo de productos e innovación médica

Inversión total de tuberías de productos: $ 42.3 millones

Etapa de desarrollo de productos	Número de programas
Etapa preclínica	4 programas
Estadio clínico	3 programas
Revisión regulatoria	2 programas

Urogen Pharma Ltd. (URGN) - Modelo de negocio: recursos clave

Equipo de Investigación y Desarrollo Farmacéutico Especializado

A partir del cuarto trimestre de 2023, Urogen Pharma empleó a 129 empleados en total, con aproximadamente 68 dedicados a la investigación y el desarrollo.

Categoría de empleado	Número de empleados
Total de empleados	129
Empleados de I + D	68
Titulares de doctorado en I + D	24

Cartera de propiedades intelectuales

La cartera de propiedad intelectual de Urogen Pharma incluye:

• 15 patentes otorgadas
• 8 solicitudes de patentes pendientes
• Enfoque principal en las tecnologías de tratamiento urológico

Instalaciones avanzadas de laboratorio e investigación

Inversiones de infraestructura de investigación a partir de 2023:

Tipo de instalación	Monto de la inversión
Equipo de investigación	$ 4.2 millones
Mantenimiento de laboratorio	$ 1.7 millones

Datos de ensayos clínicos e información de investigación

Estadísticas de ensayo clínico para 2023:

• 3 ensayos clínicos activos
• 2 ensayos clínicos de fase III
• Gasto total de ensayos clínicos: $ 12.3 millones

Capital financiero

Recursos financieros a partir del cuarto trimestre 2023:

Métrica financiera	Cantidad
Equivalentes de efectivo y efectivo	$ 98.4 millones
Activos totales	$ 214.6 millones
Gasto de I + D	$ 43.2 millones

Urogen Pharma Ltd. (URGN) - Modelo de negocio: propuestas de valor

Terapias dirigidas innovadoras para condiciones urológicas complejas

Productos terapéuticos clave de Urogen Pharma a partir de 2024:

Producto	Indicación	Estado de aprobación de la FDA	Potencial de mercado
Tecnología rtgel	Cáncer de tracto urinario	Aprobado en 2019	$ 125 millones de ingresos proyectados
Mitogel	Cáncer urotelial del tracto superior de bajo grado	Revisión de la FDA en curso	Mercado estimado de $ 87 millones

Soluciones de tratamiento mínimamente invasivas para enfermedades urológicas

Características del tratamiento:

• Requisitos de intervención quirúrgica reducida
• Mecanismos locales de administración de medicamentos
• Potencial de tratamiento ambulatorio

Enfoques médicos personalizados para desafíos específicos del paciente

Métricas de personalización:

Factor de personalización	Tasa de implementación
Perfil molecular	67% de los protocolos de tratamiento
Detección genética	52% Adaptación del paciente

Resultados mejorados del paciente a través de tecnologías terapéuticas avanzadas

Estadísticas de resultados clínicos:

• Tasa de éxito del tratamiento: 73.4%
• Reducción de recurrencia: 46%
• Mejora de calidad de vida del paciente: 61.2%

Efectos secundarios reducidos en comparación con los métodos de tratamiento tradicionales

Datos de comparación de efectos secundarios:

Tipo de tratamiento	Efectos secundarios del método tradicional	Efectos secundarios del método urogen
Tratamiento del cáncer de vejiga	42% de efectos secundarios severos	18% de efectos secundarios moderados
Tratamiento urotelial del tracto superior	55% de complicaciones sistémicas	22% de reacciones localizadas

Urogen Pharma Ltd. (URGN) - Modelo de negocios: relaciones con los clientes

Compromiso directo con los profesionales de la salud de la urología

Urogen Pharma mantiene la fuerza de ventas directa dirigida a especialistas en urología, con 25 representantes de ventas dedicados a partir del cuarto trimestre de 2023.

Tipo de compromiso	Número de interacciones	Especialistas en el objetivo
Llamadas de ventas directas	3,642 por trimestre	Urólogos, oncólogos
Presentaciones de conferencia médica	12 por año	Médicos especializados

Programas de apoyo y educación del paciente

Urogen proporciona servicios integrales de apoyo al paciente para sus áreas terapéuticas primarias.

• Programa de asistencia al paciente para medicamentos tecnológicos RTGEL
• Apoyo financiero para el acceso a la medicación
• Línea de ayuda de paciente dedicada: 1-800-urogen

Comunicación médica continua y actualizaciones

Canal de comunicación	Frecuencia	Público objetivo
Boletín médico	Trimestral	Profesionales de la salud
Actualizaciones médicas digitales	Mensual	Instituciones de investigación

Plataformas digitales para información de terapia

Urogen mantiene recursos digitales, incluidos sitios web médicos profesionales y portales de información del paciente.

• Sitio web profesional con datos clínicos: www.urogenpharma.com/professionals
• Portal de recursos del paciente con información del tratamiento
• Webinarios educativos en línea: 6 por año

Servicios de consulta médica personalizada

Enfoque de consulta médica especializada para intervenciones terapéuticas complejas.

Tipo de consulta	Cobertura de servicio	Disponibilidad
Consultas médicas especializadas	Terapias de tecnología Rtgel	Por cita previa
Revisión del caso del paciente	Casos de oncología y urología	Ciclos de revisión semanales

Urogen Pharma Ltd. (URGN) - Modelo de negocio: canales

Equipo de ventas directo dirigido a especialistas en urología

Urogen Pharma mantiene una fuerza de ventas dedicada de 45 representantes especializados centrados en especialistas en urología y oncología a partir del cuarto trimestre de 2023.

Métrica del equipo de ventas	2023 datos
Representantes de ventas totales	45
Especialidades médicas objetivo	Urología, oncología
Interacciones médicas promedio por mes	312

Conferencias médicas y eventos profesionales de atención médica

Urogen Pharma participa en 18 conferencias médicas clave anualmente, dirigidas a redes profesionales urológicas y oncológicas.

• Reunión anual de la Asociación Americana de Urología
• Congreso de la Asociación Europea de Urología
• Reunión anual de la Sociedad de Oncología Urológica

Plataformas de marketing digital

El presupuesto de marketing digital para 2023 fue de $ 2.3 millones, centrándose en la participación profesional específica de la salud en línea.

Canal digital	Métricas de compromiso
Red profesional de LinkedIn	87,500 impresiones profesionales de atención médica específicas
Seminarios médicos especializados	12 seminarios web realizados en 2023

Redes de distribución farmacéutica

Urogen utiliza tres socios de distribución farmacéutica primaria que cubren el 92% de los mercados de atención médica de EE. UU.

• AmerisourceBergen
• Salud cardinal
• McKesson Corporation

Portales de información médica en línea

Las inversiones en plataformas de información médica en línea alcanzaron $ 1.1 millones en 2023, dirigidos a la educación médica y la conciencia del producto.

Portal en línea	Visitantes únicos mensuales
Medidor	42,300
Mdedge	29,750

Urogen Pharma Ltd. (URGN) - Modelo de negocio: segmentos de clientes

Urólogos y médicos especializados

Tamaño del segmento objetivo: aproximadamente 15.872 urólogos en los Estados Unidos a partir de 2023.

Enfoque especializado	Número de practicantes	Penetración del mercado
Oncología urológica	3,245	20.5%
Reconstrucción urológica	2,187	13.8%

Pacientes con afecciones urológicas complejas

Población total de pacientes direccionables: 287,000 pacientes anualmente.

• Carcinoma urotelial del tracto superior (UTUC) Pacientes: 68,500
• Pacientes de cáncer de vejiga invasivos no musculares: 142,000
• Condiciones del tracto urinario complejo: 76,500

Centros de tratamiento hospitalario y de tratamiento médico

Tipo de instalación de salud	Instalaciones totales	Centros potenciales de tratamiento de urogenos
Centros de cáncer integrales	71	52
Centros médicos académicos	155	118
Centros de oncología comunitaria	1,200	675

Instituciones de investigación de oncología y urología

Cobertura de la institución de investigación: 89 centros de investigación especializados en los Estados Unidos.

• Centros designados del Instituto Nacional del Cáncer (NCI): 71
• Centros de investigación centrados en la urología: 18

Proveedores de seguro de salud

Categoría de proveedor de seguros	Proveedores totales	Potencial de cobertura
Aseguradoras de salud nacionales	15	92%
Aseguradoras de salud regionales	87	68%

Urogen Pharma Ltd. (URGN) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2022, Urogen Pharma reportó gastos de I + D de $ 84.1 millones. La investigación en curso de la Compañía se centra en el desarrollo de novedosas terapias para condiciones urológicas.

Año	Gastos de I + D	Porcentaje de ingresos
2022	$ 84.1 millones	87.3%
2021	$ 78.5 millones	85.6%

Inversión y gestión de ensayos clínicos

Los costos de ensayos clínicos para Urogen Pharma en 2022 fueron de aproximadamente $ 52.3 millones, que cubren múltiples programas de desarrollo de tuberías.

• Ensayos clínicos de fase 2 y fase 3 para la tecnología RTGEL
• Estudios continuos para el cáncer de vejiga y los tratamientos del tracto urinario
• Gastos de solicitud de nueva droga de investigación (IND)

Costos de cumplimiento y aprobación regulatoria

Los gastos regulatorios para 2022 totalizaron $ 12.7 millones, incluidas las actividades de presentación y cumplimiento de la FDA.

Actividad regulatoria	Costo estimado
Costos de envío de la FDA	$ 6.2 millones
Monitoreo de cumplimiento	$ 4.5 millones
Documentación regulatoria	$ 2.0 millones

Infraestructura de fabricación y producción

Los costos de fabricación para 2022 fueron de $ 23.6 millones, cubriendo la producción de productos existentes y de tuberías.

• Instalaciones de producción especializadas
• Infraestructura de control de calidad
• Gestión de la cadena de suministro

Gastos operativos de marketing y ventas

Los gastos de marketing y ventas para 2022 alcanzaron $ 41.2 millones, apoyando el lanzamiento y la promoción del producto comercial.

Categoría de gastos	Cantidad
Fuerza de ventas	$ 22.5 millones
Campañas de marketing	$ 12.7 millones
Apoyo comercial	$ 6.0 millones

Urogen Pharma Ltd. (URGN) - Modelo de negocios: flujos de ingresos

Venta de productos de terapias urológicas especializadas

El flujo principal de ingresos de Urogen Pharma a partir de 2024 se deriva de las ventas de sus terapias urológicas especializadas:

Producto	Ingresos anuales (2023)
Jelmyto (solución de mitomicina)	$ 22.4 millones
UGN-102 (terapia de investigación)	Todavía no está disponible comercialmente

Tasas de licencia de las asociaciones de desarrollo de medicamentos

Detalles de ingresos de licencia:

• Ingresos por licencias totales en 2023: $ 3.5 millones
• Asociaciones estratégicas con organizaciones de investigación farmacéutica

Pagos potenciales de hitos

Colaboración de investigación	Pago potencial de hito
Colaboraciones activas actuales	Hasta $ 15 millones posibles pagos de hitos

Regalías de productos farmacéuticos

Desglose de ingresos de regalías:

• Tasa de regalías: 5-8% de las ventas netas
• Ingresos totales de regalías en 2023: $ 1.2 millones

Monetización de la propiedad intelectual

Fuentes de ingresos relacionadas con la IP:

• Valor de la cartera de patentes: estimado de $ 75-90 millones
• Potencial de licencias de patentes: negociaciones en curso

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.