Urogen Pharma Ltd. (URGN): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Urogen Pharma Ltd. (URGN) fica na vanguarda da assistência médica urológica transformadora, pioneira em soluções terapêuticas inovadoras que desafiam os paradigmas tradicionais de tratamento. Ao alavancar pesquisas de ponta e parcerias estratégicas, esta empresa farmacêutica dinâmica está revolucionando como as condições urológicas complexas são abordadas, oferecendo a pacientes e profissionais médicos inovadores que prometem minimamente invasivo e personalizado Metodologias de tratamento. Mergulhe na intrincada tela do modelo de negócios que revela como o urogênio está reformulando a inovação médica em urologia, promissora de esperança e estratégias de cura avançadas para pacientes que enfrentam doenças urológicas desafiadoras.

Urogen Pharma Ltd. (URGN) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A Urogen Pharma estabeleceu parcerias de pesquisa estratégica com as seguintes instituições acadêmicas e de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Clínica Mayo	Pesquisa de oncologia urológica	2020
Universidade Johns Hopkins	Desenvolvimento da terapia do trato urinário	2019
MD Anderson Cancer Center	Pesquisa de tratamento de câncer de bexiga	2021

Parceria com centros de tratamento e hospitais de urologia

As parcerias do Hospital e do Centro de Tratamento da Urogen Pharma incluem:

• NYU LANGONE SAÚDE
• Clínica de Cleveland
• Memorial Sloan Kettering Cancer Center
• Stanford Healthcare

Acordos de licenciamento com parceiros de desenvolvimento e fabricação de medicamentos

Parceiro	Tipo de contrato	Drogas/terapia	Valor do acordo
Pfizer Inc.	Licença de fabricação	RTGEL Technology Platform	US $ 12,5 milhões antecipadamente
Merck & Co.	Colaboração de desenvolvimento de medicamentos	Terapias do trato urinário	US $ 15,3 milhões em pagamentos marcantes

Redes de pesquisa colaborativa para terapias urológicas inovadoras

A Urogen Pharma participa das seguintes redes de pesquisa colaborativa:

• Sociedade de Consórcio de Pesquisa de Oncologia Urológica
• Rede Nacional de Câncer (NCCN)
• Rede de pesquisa da American Urological Association

Investimento total de parceria em 2023: US $ 37,8 milhões

Urogen Pharma Ltd. (URGN) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de novas tecnologias de tratamento urológico

Despesas de P&D para 2023: US $ 55,4 milhões

Área de foco em P&D	Valor do investimento
Oncologia urológica	US $ 22,1 milhões
Câncer urotelial do trato superior	US $ 18,3 milhões
Condições urológicas raras	US $ 15,0 milhões

Ensaios clínicos para candidatos inovadores de drogas

• Ensaios clínicos ativos em 2024: 3 Estudos em andamento da fase 2/3
• Orçamento total do ensaio clínico: US $ 37,6 milhões
• Alvo de inscrição para pacientes: 250 participantes

Processos de conformidade regulatória e aprovação de medicamentos

Interações FDA em 2023: 12 reuniões formais

Marco regulatório	Status
Novos envios de solicitação de drogas	2 pendente
Designações de medicamentos órfãos	3 ativo

Marketing e comercialização de terapias urológicas especializadas

Orçamento de marketing para 2024: US $ 28,7 milhões

• Tamanho da força de vendas: 75 representantes especializados de urologia
• Instituições de saúde -alvo: 450 centros de urologia

Desenvolvimento de produtos e inovação médica

Investimento total do pipeline de produtos: US $ 42,3 milhões

Estágio de desenvolvimento de produtos	Número de programas
Estágio pré -clínico	4 programas
Estágio clínico	3 programas
Revisão regulatória	2 programas

Urogen Pharma Ltd. (URGN) - Modelo de negócios: Recursos -chave

Equipe especializada de pesquisa e desenvolvimento farmacêutico

A partir do quarto trimestre 2023, a Urogen Pharma empregou 129 funcionários totais, com aproximadamente 68 dedicados à pesquisa e desenvolvimento.

Categoria de funcionários	Número de funcionários
Total de funcionários	129
Funcionários de P&D	68
Titulares de doutorado em P&D	24

Portfólio de propriedade intelectual

O portfólio de propriedade intelectual da Urogen Pharma inclui:

• 15 patentes concedidas
• 8 pedidos de patente pendente
• Foco primário nas tecnologias de tratamento urológico

Instalações avançadas de laboratório e pesquisa

Pesquisa Infraestrutura Investimentos A partir de 2023:

Tipo de instalação	Valor do investimento
Equipamento de pesquisa	US $ 4,2 milhões
Manutenção do laboratório	US $ 1,7 milhão

Dados de ensaios clínicos e insights de pesquisa

Estatística de ensaios clínicos para 2023:

• 3 ensaios clínicos ativos
• 2 ensaios clínicos de fase III
• Despesas totais de ensaios clínicos: US $ 12,3 milhões

Capital financeiro

Recursos Financeiros a partir do quarto trimestre 2023:

Métrica financeira	Quantia
Caixa e equivalentes de dinheiro	US $ 98,4 milhões
Total de ativos	US $ 214,6 milhões
Despesas de P&D	US $ 43,2 milhões

Urogen Pharma Ltd. (URGN) - Modelo de negócios: proposições de valor

Terapias direcionadas inovadoras para condições urológicas complexas

Os principais produtos terapêuticos da Urogen Pharma a partir de 2024:

Produto	Indicação	Status de aprovação da FDA	Potencial de mercado
Tecnologia RTGEL	Câncer de trato urinário	Aprovado em 2019	Receita projetada de US $ 125 milhões
Mitogel	Câncer urotelial do trato superior de baixo grau	Revisão da FDA em andamento	Mercado estimado de US $ 87 milhões

Soluções de tratamento minimamente invasivas para doenças urológicas

Características do tratamento:

• Requisitos de intervenção cirúrgica reduzidos
• Mecanismos locais de entrega de medicamentos
• Potencial de tratamento ambulatorial

Abordagens médicas personalizadas para desafios específicos do paciente

Métricas de personalização:

Fator de personalização	Taxa de implementação
Perfil molecular	67% dos protocolos de tratamento
Triagem genética	52% de adaptação para pacientes

Melhores resultados dos pacientes por meio de tecnologias terapêuticas avançadas

Estatísticas de resultados clínicos:

• Taxa de sucesso do tratamento: 73,4%
• Redução de recorrência: 46%
• Melhoria da qualidade de vida do paciente: 61,2%

Efeitos colaterais reduzidos em comparação aos métodos de tratamento tradicionais

Dados de comparação de efeitos colaterais:

Tipo de tratamento	Efeitos colaterais do método tradicional	Efeitos colaterais do método de Urogen
Tratamento do câncer de bexiga	42% de efeitos colaterais graves	18% de efeitos colaterais moderados
Tratamento urotelial do trato superior	55% de complicações sistêmicas	22% reações localizadas

Urogen Pharma Ltd. (URGN) - Modelo de negócios: relacionamentos com o cliente

Engajamento direto com os profissionais de saúde de urologia

A Urogen Pharma mantém os especialistas em urologia da Força de Vendas diretas, com 25 representantes de vendas dedicados a partir do quarto trimestre 2023.

Tipo de engajamento	Número de interações	Especialistas -alvo
Chamadas de vendas diretas	3.642 por trimestre	Urologistas, oncologistas
Apresentações da conferência médica	12 por ano	Médicos especializados

Programas de apoio ao paciente e educação

O Urogen fornece serviços abrangentes de apoio ao paciente para suas principais áreas terapêuticas.

• Programa de Assistência ao Paciente para RTGEL Technology Medications
• Apoio financeiro para acesso à medicação
• Helpline de pacientes dedicados: 1-800-UROGEN

Comunicação médica contínua e atualizações

Canal de comunicação	Freqüência	Público -alvo
Newsletter médico	Trimestral	Profissionais de saúde
Atualizações médicas digitais	Mensal	Instituições de pesquisa

Plataformas digitais para informações de terapia

O Urogen mantém recursos digitais, incluindo sites médicos profissionais e portais de informações sobre pacientes.

• Site profissional com dados clínicos: www.urogenpharma.com/professionals
• Portal de recursos do paciente com informações de tratamento
• Labinos educacionais online: 6 por ano

Serviços personalizados de consulta médica

Abordagem especializada em consulta médica para intervenções terapêuticas complexas.

Tipo de consulta	Cobertura de serviço	Disponibilidade
Consultas médicas especializadas	Terapias tecnológicas rtgel	Com hora marcada
Revisão do caso do paciente	Casos de oncologia e urologia	Ciclos de revisão semanais

Urogen Pharma Ltd. (URGN) - Modelo de negócios: canais

Equipe direta da equipe de vendas, direcionando especialistas em urologia

A Urogen Pharma mantém uma força de vendas dedicada de 45 representantes especializados focados em especialistas em urologia e oncologia no quarto trimestre 2023.

Métrica da equipe de vendas	2023 dados
Total de representantes de vendas	45
Especialidades do médico -alvo	Urologia, oncologia
Interações médias do médico por mês	312

Conferências médicas e eventos profissionais de saúde

A Urogen Pharma participa de 18 conferências médicas principais anualmente, visando redes profissionais urológicas e oncológicas.

• Reunião Anual da Associação Americana de Urologia
• Congresso da Associação Europeia
• Reunião Anual da Sociedade de Oncologia Urológica

Plataformas de marketing digital

O orçamento de marketing digital para 2023 foi de US $ 2,3 milhões, com foco no engajamento profissional de saúde on -line direcionado.

Canal digital	Métricas de engajamento
Rede Profissional do LinkedIn	87.500 impressões profissionais de saúde direcionadas
Webinars médicos especializados	12 webinars realizados em 2023

Redes de distribuição farmacêutica

A Urogen utiliza três parceiros de distribuição farmacêutica primária, cobrindo 92% dos mercados de saúde dos EUA.

• Amerisourcebergen
• Cardinal Health
• McKesson Corporation

Portais de informações médicas online

O investimento em plataformas de informações médicas on -line atingiu US $ 1,1 milhão em 2023, direcionando a educação médica e a conscientização do produto.

Portal online	Visitantes únicos mensais
Medscape	42,300
Mdedge	29,750

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

Urologistas e médicos especializados

Tamanho do segmento alvo: aproximadamente 15.872 urologistas nos Estados Unidos a partir de 2023.

Foco especial	Número de praticantes	Penetração de mercado
Oncologia urológica	3,245	20.5%
Reconstrução urológica	2,187	13.8%

Pacientes com condições urológicas complexas

População total de pacientes endereçáveis: 287.000 pacientes anualmente.

• Pacientes com carcinoma urotelial do trato superior (UTUC): 68.500
• Pacientes com câncer de bexiga invasiva não muscular: 142.000
• Condições complexas do trato urinário: 76.500

Centros de tratamento hospitalar e médico

Tipo de instalação de saúde	Total de instalações	Potenciais centros de tratamento de urogênio
Centros abrangentes de câncer	71	52
Centros Médicos Acadêmicos	155	118
Centros de Oncologia Comunitária	1,200	675

Instituições de pesquisa de oncologia e urologia

Cobertura da instituição de pesquisa: 89 centros de pesquisa especializados nos Estados Unidos.

• Instituto Nacional do Câncer (NCI) Centros designados: 71
• Centros de pesquisa focados em urologia: 18

Provedores de seguros de saúde

Categoria de provedor de seguros	Total de provedores	Potencial de cobertura
Seguradoras nacionais de saúde	15	92%
Seguradoras de saúde regionais	87	68%

Urogen Pharma Ltd. (URGN) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2022, a Urogen Pharma registrou despesas de P&D de US $ 84,1 milhões. A pesquisa em andamento da empresa se concentra no desenvolvimento de novas terapêuticas para condições urológicas.

Ano	Despesas de P&D	Porcentagem de receita
2022	US $ 84,1 milhões	87.3%
2021	US $ 78,5 milhões	85.6%

Investimento de ensaios clínicos e gestão

Os custos de ensaios clínicos da Urogen Pharma em 2022 foram de aproximadamente US $ 52,3 milhões, cobrindo vários programas de desenvolvimento de pipeline.

• Ensaios clínicos de fase 2 e fase 3 para tecnologia RTGEL
• Estudos em andamento para câncer de bexiga e tratamentos do trato urinário
• Despesas de aplicação de novos medicamentos para investigação (IND)

Custos de conformidade e aprovação regulatórios

As despesas regulatórias de 2022 totalizaram US $ 12,7 milhões, incluindo atividades de envio e conformidade da FDA.

Atividade regulatória	Custo estimado
Custos de envio da FDA	US $ 6,2 milhões
Monitoramento de conformidade	US $ 4,5 milhões
Documentação regulatória	US $ 2,0 milhões

Infraestrutura de fabricação e produção

Os custos de fabricação para 2022 foram de US $ 23,6 milhões, cobrindo a produção de produtos existentes e de oleodutos.

• Instalações de produção especializadas
• Infraestrutura de controle de qualidade
• Gestão da cadeia de abastecimento

Despesas operacionais de marketing e vendas

As despesas de marketing e vendas em 2022 atingiram US $ 41,2 milhões, apoiando o lançamento e promoção de produtos comerciais.

Categoria de despesa	Quantia
Força de vendas	US $ 22,5 milhões
Campanhas de marketing	US $ 12,7 milhões
Suporte comercial	US $ 6,0 milhões

Urogen Pharma Ltd. (URGN) - Modelo de negócios: fluxos de receita

Vendas de produtos de terapias urológicas especializadas

O fluxo de receita primário da Urogen Pharma a partir de 2024 é derivado das vendas de suas terapias urológicas especializadas:

Produto	Receita anual (2023)
Jelmyto (solução de mitomicina)	US $ 22,4 milhões
UGN-102 (terapia investigacional)	Ainda não disponível comercialmente

Taxas de licenciamento de parcerias de desenvolvimento de medicamentos

Detalhes da receita de licenciamento:

• Renda total de licenciamento em 2023: US $ 3,5 milhões
• Parcerias estratégicas com organizações de pesquisa farmacêutica

Potenciais pagamentos marcantes

Colaboração de pesquisa	Pagamento em potencial
Colaborações ativas atuais	Até US $ 15 milhões em potencial pagamentos marcos

Royalties de produtos farmacêuticos

Repartição da receita da realeza:

• Taxa de royalties: 5-8% das vendas líquidas
• Renda total de royalties em 2023: US $ 1,2 milhão

Monetização da propriedade intelectual

Fontes de receita relacionadas a IP:

• Valor da portfólio de patentes: estimado $ 75-90 milhões
• Potencial de licenciamento de patentes: negociações em andamento

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.