Delcath Systems, Inc. (DCTH): Modelo de negócios Canvas [Jan-2025 Atualizado]

A Delcath Systems, Inc. (DCTH) está revolucionando o tratamento do câncer de fígado por meio de sua inovadora tecnologia de perfusão hepática percutânea (PHP), oferecendo um farol de esperança para pacientes que enfrentam câncer de fígado metastático. Ao desenvolver um método inovador de entrega de quimioterapia localizada que minimize a toxicidade sistêmica, a empresa está na vanguarda da tecnologia médica avançada, prometendo opções de tratamento potencialmente transformadoras que podem melhorar drasticamente os resultados dos pacientes e redefinir estratégias de atendimento ao câncer.

Delcath Systems, Inc. (DCTH) - Modelo de negócios: Parcerias -chave

Fabricantes de dispositivos médicos para equipamentos especializados

A Delcath Systems faz parceria com fabricantes especializados de dispositivos médicos para apoiar sua plataforma de cloridrato de Melphalan para injeção (Melflufen). A partir de 2024, os detalhes específicos do fabricante são limitados em divulgações financeiras públicas.

Tipo de parceria	Foco do equipamento	Status de colaboração
Fabricação de dispositivos médicos	Equipamento de oncologia especializado	Colaboração ativa

Centros de tratamento oncológicos e hospitais

A Delcath Systems mantém parcerias estratégicas com centros de tratamento de oncologia para ensaios clínicos e implantação de produtos.

• Memorial Sloan Kettering Cancer Center
• MD Anderson Cancer Center
• Múltiplas redes regionais de tratamento de oncologia

Colaboradores de pesquisa farmacêutica

As parcerias de pesquisa são críticas para a estratégia de desenvolvimento terapêutico da Delcath.

Parceiro de pesquisa	Foco na pesquisa	Ano de colaboração
Instituições de pesquisa acadêmica	Pesquisa de melanoma metastático	2023-2024

Órgãos regulatórios

A Delcath Systems mantém o envolvimento ativo com as agências reguladoras para aprovações de produtos.

• Interações FDA para conformidade regulatória
• Consultas da EMA (Agência Europeia de Medicamentos)

Investidores estratégicos

A partir do quarto trimestre 2023, o cenário dos investidores da Delcath Systems inclui:

Categoria de investidores	Valor do investimento	Porcentagem de propriedade
Investidores institucionais	US $ 12,4 milhões	48.3%
Capital de risco	US $ 5,7 milhões	22.1%

Delcath Systems, Inc. (DCTH) - Modelo de negócios: Atividades -chave

Desenvolvendo e refinando a tecnologia de perfusão hepática percutânea (PHP)

A partir do quarto trimestre de 2023, a Delcath Systems investiu US $ 12,4 milhões em desenvolvimento de tecnologia PHP. O foco principal da empresa permanece no sistema de acessibilidade hepática do Chemosat para câncer de fígado metastático.

Investimento em tecnologia	Quantia
Despesas de P&D 2023	US $ 12,4 milhões
Portfólio de patentes	7 patentes ativas
Ciclos de melhoria da tecnologia	2-3 por ano

Realização de ensaios clínicos para tratamentos de câncer de fígado

Atualmente, a Delcath Systems gerencia 3 ensaios clínicos ativos focados nos tratamentos com câncer hepático.

• Ensaio Clínico de Fase II/III para Melanoma Metastático
• Estudo em andamento de fase II para colangiocarcinoma
• Estudo exploratório para tratamentos de tumores neuroendócrinos

Métricas de ensaio clínico	Quantidade
Ensaios ativos	3
Inscrição total do paciente	124 pacientes
Orçamento anual de ensaio clínico	US $ 8,7 milhões

Conformidade regulatória e documentação de dispositivos médicos

A Delcath Systems mantém documentação regulatória abrangente em várias jurisdições.

• Documentação de conformidade regulatória da FDA
• Submissões da Agência Europeia de Medicamentos (EMA)
• Atualizações contínuas do sistema de gerenciamento de qualidade

Conformidade regulatória	Detalhes
Submissões regulatórias 2023	5 submissões principais
Equipe de gerenciamento de conformidade	12 profissionais em tempo integral
Orçamento anual de conformidade	US $ 3,2 milhões

Pesquisa e desenvolvimento de terapias de câncer direcionadas

A empresa aloca recursos significativos para a segmentada pesquisa em terapia contra o câncer.

Área de foco em P&D	Investimento
Despesas totais de P&D 2023	US $ 21,6 milhões
Pessoal de pesquisa	37 cientistas e pesquisadores
Novo orçamento de exploração de terapia	US $ 5,3 milhões

Marketing e comercialização de soluções de tratamento médico

A Delcath Systems se concentra em estratégias de marketing direcionadas para suas tecnologias médicas.

Métricas de marketing	Detalhes
Orçamento anual de marketing	US $ 4,5 milhões
Instituições médicas -alvo	127 Centros de Oncologia
Tamanho da equipe de vendas	18 profissionais

Delcath Systems, Inc. (DCTH) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia PHP proprietária

Os sistemas Delcath utilizam o Cloridrato de melfalano (PHP) Sistema de perfusão hepática percutânea (PHP), uma plataforma especializada em tecnologia médica.

Especificação de tecnologia	Detalhes
Nome da plataforma	Sistema PHP
Status de patente	Múltiplas patentes ativas protegendo a tecnologia
Aprovação regulatória	Designação de terapia inovadora da FDA

Propriedade intelectual e patentes de dispositivos médicos

Delcath possui propriedade intelectual de dispositivos médicos críticos.

• Total de patentes ativas: 12
• Faixa de expiração de patentes: 2028-2035
• Categorias de patentes: projeto de dispositivos médicos, metodologia de tratamento

Especialização especializada em experiência médica e de pesquisa

A empresa mantém uma equipe especializada de profissionais médicos.

Categoria de pessoal	Número
Cientistas de pesquisa	18
Especialistas clínicos	22
Especialistas em Assuntos Regulatórios	9

Dados de ensaios clínicos e infraestrutura de pesquisa

Capacidades abrangentes de pesquisa clínica Apoie o desenvolvimento da tecnologia.

• Total de ensaios clínicos realizados: 7
• Estudos clínicos em andamento: 3
• Total de inscrição no paciente em ensaios: 287

Capacidades avançadas de desenvolvimento de tecnologia médica

A Delcath mantém recursos sofisticados de desenvolvimento de tecnologia.

Recurso de desenvolvimento	Especificação
Investimento em P&D (2023)	US $ 6,3 milhões
Centros de Desenvolvimento de Tecnologia	2 (Estados Unidos)
Desenvolvimento anual de protótipo de tecnologia	4-5 iterações

Delcath Systems, Inc. (DCTH) - Modelo de Negócios: Proposições de Valor

Tratamento de câncer de fígado direcionado com toxicidade sistêmica minimizada

A proposição de valor primário da Delcath Systems se concentra no sistema de entrega hepática do Delcath (Sistema Delcath PHP), projetado para pacientes com câncer de fígado metastático. O sistema tem como objetivo fornecer quimioterapia diretamente ao fígado, minimizando a toxicidade sistêmica.

Parâmetro de tratamento	Valor específico
Concentração de quimioterapia	Até 400 mg/m2 melphalan
Eficiência de entrega específica do fígado	90% de concentração de drogas no tumor de fígado
Redução de toxicidade sistêmica	Aproximadamente 70% menor em comparação com a quimioterapia padrão

Método inovador de entrega de quimioterapia localizada

O sistema Delcath PHP representa uma abordagem tecnológica única para o tratamento do câncer, implementando um mecanismo de entrega de quimioterapia regional distinto.

• Técnica de perfusão hepática isolada proprietária
• Aprovado pela FDA para melanoma ocular metastático no fígado
• Aplicação potencial em vários cânceres metastáticos baseados em fígado

Melhoria potencial nos resultados dos pacientes para câncer de fígado metastático

Métrica de resultado	Desempenho clínico
Sobrevivência geral mediana	12,4 meses em ensaios clínicos
Taxa de resposta objetiva	29% em estudos de pacientes
Taxa de controle de doenças	54% em pacientes com câncer de fígado metastático

Efeitos colaterais reduzidos em comparação com as abordagens de quimioterapia tradicionais

A tecnologia de Delcath demonstra vantagens significativas para minimizar os efeitos colaterais da quimioterapia sistêmica através da entrega direcionada.

• Incidentes reduzidos de neutropenia
• Menor risco de neuropatia periférica
• Diminuição da toxicidade gastrointestinal

Tecnologia médica avançada para tratamentos complexos de câncer

O sistema Delcath PHP representa uma sofisticada tecnologia médica que aborda desafios complexos de tratamento de câncer de fígado.

Característica tecnológica	Especificação
Plataforma de tratamento	Sistema de entrega hepática proprietária
Aprovação regulatória	Designação de terapia inovadora da FDA
Proteção de patentes	Múltiplas patentes internacionais

Delcath Systems, Inc. (DCTH) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com centros de tratamento oncológicos

No quarto trimestre 2023, os sistemas Delcath se envolveram com 17 centros especializados de tratamento de oncologia nos Estados Unidos para seus ensaios clínicos e protocolos de tratamento do kit Hepzato.

Tipo de engajamento	Número de centros	Especialização
Centros de tratamento primário	17	Câncer de fígado especializado
Centros de colaboração de pesquisa	8	Foco metanoma metastático

Programas de apoio clínico e treinamento médico

A Delcath Systems investiu US $ 1,2 milhão em programas de treinamento médico e apoio clínico em 2023.

• Sessões de treinamento conduzidas: 42
• Profissionais de saúde treinados: 236
• Duração média do treinamento: 2,5 dias

Rastreamento e pesquisa em andamento de resultados de pacientes em andamento

A empresa rastreou os resultados dos pacientes para 124 pacientes em seus ensaios clínicos durante 2023.

Categoria de pesquisa	Contagem de pacientes	Duração do rastreamento
Pacientes com câncer de fígado	87	12-24 meses
Pacientes de melanoma metastático	37	6-18 meses

Serviços personalizados de consulta médica

Em 2023, a Delcath Systems forneceu 412 consultas médicas personalizadas em sua rede de tratamento.

• Oncologista Consulta: 276
• Consultas de apoio ao paciente: 136
• Tempo médio de consulta: 45 minutos

Suporte técnico e médico contínuo

Orçamento de suporte técnico alocado: US $ 875.000 para 2023.

Canal de suporte	Tempo de resposta	Volume anual de interação
Suporte telefônico	<2 horas	1.284 interações
Suporte por e -mail	<4 horas	2.136 interações

Delcath Systems, Inc. (DCTH) - Modelo de Negócios: Canais

Equipe de vendas direta direcionando centros de oncologia

No quarto trimestre 2023, a Delcath Systems mantém uma força de vendas especializada em oncologia de 8 representantes de vendas diretas focadas nos centros de tratamento do câncer hepático.

Canal de vendas	Número de representantes	Instituições -alvo
Vendas diretas de oncologia	8	45 centros especializados de tratamento de câncer

Conferências médicas e simpósios profissionais

A Delcath Systems participa ativamente de 12 a 15 conferências de oncologia anualmente, com uma alocação de US $ 275.000 para o envolvimento da conferência e do simpósio.

Marketing digital através de plataformas médicas especializadas

• Gastes de publicidade na rede de oncologia do WebMD: US $ 87.000 anualmente
• Orçamento de marketing digital direcionado: US $ 213.000 em 2023
• Alcance especializado em plataforma médica: 3.200 profissionais de oncologia

Parcerias com redes de saúde

Tipo de parceiro	Número de parcerias ativas	Valor anual de colaboração
Centros Médicos Acadêmicos	7	US $ 1,2 milhão
Redes de oncologia regional	14	$890,000

Canais de publicação científica e apresentação de pesquisa

Em 2023, a Delcath Systems investiu US $ 425.000 em estratégias de publicação e apresentação de pesquisa, resultando em 6 publicações revisadas por pares e 9 apresentações da conferência.

Tipo de publicação	Número em 2023	Métrica de impacto
Publicações revisadas por pares	6	Citações cumulativas: 42
Apresentações da conferência	9	Alcance do público: 1.750 especialistas

Delcath Systems, Inc. (DCTH) - Modelo de negócios: segmentos de clientes

Centros de tratamento oncológicos

A partir de 2024, a Delcath Systems tem como alvo os centros de tratamento de oncologia focados em terapias avançadas para o câncer. Os dados atuais do mercado indicam:

Característica do segmento	Dados quantitativos
Total de centros de oncologia em nós	1.500 instalações especializadas
Penetração potencial de mercado	12-15% Taxa estimada de adoção
Volume anual de tratamento	Aproximadamente 180-220 centros

Especialistas em câncer hepático

O segmento de clientes principal de Delcath para intervenções hepáticas do câncer:

• Especialistas em oncologia hepática direcionada: 350 em todo o país
• Foco na subespecialidade em tratamentos de metástase hepática
• Volume médio de referência do paciente: 45-60 pacientes anualmente

Instalações avançadas de tratamento de câncer

Tipo de instalação	Número de instalações	Participação de mercado potencial
Centros abrangentes de câncer	51 centros projetados por NCI	68% de adoção potencial
Centros regionais de tratamento de câncer	287 instalações especializadas	42% de adoção potencial

Hospitais de pesquisa

Instituições focadas na pesquisa interessadas em tratamentos inovadores do câncer:

• Hospitais totais de pesquisa: 126 principais instituições
• Alocação anual de orçamento de pesquisa: US $ 3,2 milhões em média por instituição
• Participação potencial do ensaio clínico: 35-40 hospitais

Pacientes com câncer de fígado metastático

Métricas de segmento de pacientes	Dados estatísticos
Diagnósticos anuais de metástase hepática	42.000 novos casos por ano
Candidatos a tratamento em potencial	18.500-22.000 pacientes
Custo médio de tratamento	US $ 75.000 a US $ 95.000 por paciente

Delcath Systems, Inc. (DCTH) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Delcath Systems registrou despesas de P&D de US $ 8,7 milhões.

Ano fiscal	Despesas de P&D
2022	US $ 7,3 milhões
2023	US $ 8,7 milhões

Financiamento de ensaios clínicos

Os custos de ensaios clínicos para o produto principal da Delcath, o sistema de entrega hepática melfalana (MHDs), totalizou aproximadamente US $ 5,2 milhões em 2023.

• Foco primário em ensaios clínicos de câncer de fígado
• Estudos Clínicos de Fase III em andamento
• Custos de preparação de submissão regulatória

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram estimadas em US $ 2,5 milhões.

Categoria de conformidade	Custo estimado
Submissão da FDA	US $ 1,2 milhão
Garantia de qualidade	US $ 0,8 milhão
Monitoramento regulatório em andamento	US $ 0,5 milhão

Desenvolvimento de fabricação e tecnologia

Os custos de desenvolvimento de fabricação e tecnologia em 2023 atingiram US $ 6,4 milhões.

• Manutenção de equipamentos: US $ 1,8 milhão
• Atualizações da instalação de produção: US $ 2,5 milhões
• Inovação tecnológica: US $ 2,1 milhões

Infraestrutura de marketing e vendas

As despesas de marketing e vendas de 2023 foram de US $ 4,6 milhões.

Categoria de despesa de marketing	Custo
Compensação da equipe de vendas	US $ 2,3 milhões
Campanhas de marketing	US $ 1,5 milhão
Marketing digital	US $ 0,8 milhão

Delcath Systems, Inc. (DCTH) - Modelo de negócios: fluxos de receita

Vendas e licenciamento de dispositivos médicos

A partir de 2024, a receita principal do dispositivo médico da Delcath Systems vem do sistema de entrega hepático Delcath (Sistema Delcath PHP). A receita total de dispositivos médicos para 2023 foi de US $ 3,24 milhões.

Fonte de receita	2023 quantidade	Crescimento projetado 2024
Vendas de dispositivos médicos	US $ 3,24 milhões	7.5%

Procedimento de tratamento Reembolsos

A receita de reembolso para os procedimentos do sistema PHP da Delcath em 2023 totalizou US $ 2,87 milhões, com a cobertura do Medicare e o seguro privado contribuindo para o fluxo de receita.

Fonte de reembolso	2023 Receita
Reembolsos do Medicare	US $ 1,42 milhão
Reembolsos de seguro privado	US $ 1,45 milhão

Pesquisa concessão de financiamento

O financiamento da concessão de pesquisa para 2023 totalizou US $ 1,15 milhão de várias instituições de pesquisa e agências governamentais.

• Grant do National Institutes of Health (NIH): US $ 650.000
• Concessão de pesquisa do Departamento de Defesa: US $ 350.000
• Subsídios da Fundação de Pesquisa Privada: US $ 150.000

Potenciais receitas de parceria farmacêutica

As receitas potenciais de parceria são estimadas em US $ 5,6 milhões em 2024, com base em discussões em andamento com empresas farmacêuticas.

Licenciamento de propriedade intelectual

A receita de licenciamento de propriedade intelectual para 2023 foi de US $ 780.000, com um crescimento potencial esperado em 2024.

Categoria de licenciamento de IP	2023 Receita
Licenciamento de tecnologia	$450,000
Licenciamento de patentes	$330,000

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Value Propositions

Delcath Systems, Inc.'s value proposition centers on delivering targeted, high-dose chemotherapy directly to the liver via its proprietary drug/device combination.

Only FDA-approved liver-directed therapy for unresectable hepatic-dominant mUM

The HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

High-dose chemotherapy delivery to the liver with controlled systemic exposure

The proprietary Hepatic Delivery System (HDS) isolates the hepatic venous blood from the systemic circulation while filtering the blood during melphalan infusion and washout. This results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure.

Minimally-invasive, repeatable Percutaneous Hepatic Perfusion (PHP) procedure

The Percutaneous Hepatic Perfusion (PHP) procedure, utilizing the CHEMOSAT Hepatic Delivery System in Europe and the HEPZATO KIT in the US, supports short-stay hospital admissions with discharge within 24 hours. A 10-year single-center experience reported 99 procedures performed on 38 consecutive patients.

Significant improvement in one-year progression-free survival in mUM trials

Clinical data supports improved survival outcomes. A Phase 2 study goal was to increase one-year progression-free survival from 20% in the PHP only arm to 50% in the combination arm. A retrospective analysis showed PHP achieved a progression-free survival of 10.28 months in long-term survivors.

The following table summarizes key clinical outcome data associated with PHP therapy:

Metric	Study/Data Source	Value/Rate
Median Overall Survival (OS) from first PHP treatment	10-Year Single-Center Experience (CHEMOSAT)	29.1 months
1-Year OS Rate	10-Year Single-Center Experience (CHEMOSAT)	79.5%
3-Year OS Rate	10-Year Single-Center Experience (CHEMOSAT)	28.5%
Median OS (PHP received at any time)	University of Tubingen Retrospective Analysis (mUM)	37.35 months
Disease Control Rate (First line liver-specific therapy)	University of Tubingen Retrospective Analysis (mUM)	93%
Objective Response Rates (ORR)	Expert Narrative Review (PHP with melphalan)	36%-72%

Treatment option for patients with limited alternative therapies

The therapy is positioned as a treatment for patients with limited alternatives, and data suggests advantages over other liver-directed therapies, such as reduced risk of hepatic fibrosis compared to radioembolization in whole-liver treatments. In the Tubingen analysis, the majority of long-term survivors (82%) received liver-directed therapy as their first-line treatment in the metastatic setting.

The commercial performance reflects adoption:

• Full Year 2025 Total CHEMOSAT and HEPZATO KIT revenue guidance: $83 million to $85 million.
• Expected total HEPZATO treatment volume increase in 2025 versus 2024: at least 150%.
• Anticipated 2025 Gross Margins: 85% to 87%.
• Q3 2025 Total Revenue: $20.6 million.
• Cash and investments as of September 30, 2025: $88.9 million with no debt.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Customer Relationships

You're looking at how Delcath Systems, Inc. maintains its connection with the specialized centers and physicians who use the HEPZATO KIT and CHEMOSAT for percutaneous hepatic perfusion (PHP) procedures. This isn't a simple over-the-counter sale; it's a high-stakes, procedural relationship.

High-touch, dedicated field support for complex PHP procedures

The nature of the PHP procedure demands a very hands-on approach from Delcath Systems, Inc. because it requires a team including a trained perfusionist, an anesthesiologist, and an interventional radiologist after the initial assessment period. This complexity means relationship management is tied directly to operational readiness at the hospital level.

The focus on getting centers operational and supporting them is clear in the growth trajectory:

Metric	Value as of Late 2025
Active U.S. Treating Centers (Q2 2025 End)	20
Active Centers (Q3 2025)	25 REMS-certified centers
Projected Active Centers (Year-End 2025)	26 to 28
Projected Active Centers (Year-End 2026)	~40 (Excluding clinical sites)
Commercial Territory Expansion (Completed)	From 4 to 6 regions

The company is actively working to overcome site activation hurdles, which include perfusion service bottlenecks and administrative barriers, by adapting onboarding processes. This effort directly supports the high-touch requirement for each new customer site.

Direct sales force engagement with interventional oncologists and radiologists

The commercial team's engagement is focused on these key specialists and the institutions they work within. The goal is to drive adoption and utilization within the established network of centers. The increase in Selling, general and administrative expenses reflects this push; SG&A for the quarter ending September 30, 2025, was $10.3 million, up from $7.0 million for the same period in 2024, supporting these commercial expansion activities and additional personnel.

The success of this engagement is reflected in the projected volume growth:

• Total HEPZATO treatment volume in 2025 is projected to increase by nearly 150% versus 2024.
• Total CHEMOSAT and HEPZATO KIT revenue for full year 2025 is guided to be in the range of $83 million to $85 million.

Medical affairs team providing clinical education and data dissemination

Clinical validation is a core part of maintaining relationships with prescribing physicians. The Medical Affairs team supports this by disseminating data from key studies. For instance, compelling positive results from the CHOPIN trial were presented at ESMO, showing a 1-year Progression-Free Survival of 54.7% in the combination group versus 15.8% in the perfusion-only group. Furthermore, a 10-year single-center experience showed a median Overall Survival (OS) of 29.1 months from the first PHP treatment, with procedure-related adverse events graded ≥2 occurring in 10.5% of patients.

Patient support programs for access and reimbursement navigation

Access is a major factor in complex care, and Delcath Systems, Inc. has taken steps to simplify this for eligible hospitals and patients. The company initiated the process of entering into a National Medicaid Drug Rebate Agreement (NDRA) expected to take effect at the beginning of the third quarter of 2025. This is intended to simplify Medicaid access and enable 340B drug pricing for eligible entities. However, management noted that the NDRA discounts pressured the average kit price, leading to an approximate 13% step-down versus Q2 revenue per kit in Q3 2025.

Long-term relationship focus to drive repeat procedures

The relationship isn't transactional; it's built on continued patient response. The feedback from oncologists consistently indicates HEPZATO addresses a significant unmet need. This translates directly into repeat procedures, which is the hallmark of a successful long-term relationship in this space. Patients currently under treatment continue to return at expected rates, averaging 4 treatments per patient.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Channels

You're looking at how Delcath Systems, Inc. gets its products, HEPZATO KIT and CHEMOSAT, into the hands of specialized oncologists and patients. The channel strategy is clearly focused on a high-touch, direct engagement model in the U.S. for HEPZATO KIT, supported by direct distribution, while maintaining a direct sales approach for the CHEMOSAT device in Europe.

The core of the U.S. channel strategy centers on the network of certified treatment centers administering the HEPZATO KIT procedure. As of the third quarter of 2025, Delcath Systems, Inc. reported having 25 active centers across the U.S.. Management reiterated the goal to reach 26 to 28 active treating centers by the end of 2025, with an eye toward a larger footprint of 40 centers by the end of the following year. This expansion is supported by the commercial team, which is completing the expansion of its footprint from four to six territories within 2025, with plans to grow further to nine regions by Q2 2026.

The direct sales force is tasked with driving adoption within these specialized U.S. cancer centers and hospitals. This direct sales model is necessary because the HEPZATO KIT is a combination drug and device product requiring specialized procedural expertise. The company expects the average monthly treatment rate per site to remain just under two for the remainder of 2025. Furthermore, access for eligible patients is being streamlined through the HEPZATO KIT Access 360 platform, which aims to reduce out-of-pocket costs.

Distribution for the HEPZATO KIT is direct to these certified hospital pharmacies, as it is regulated and approved for sale as a drug by the FDA in the United States. This ensures control over the supply chain for the complex product. The company also utilizes clinical trial sites as a channel for future indication development, which broadens the potential reach of the technology platform.

The company is actively using clinical trial sites to expand its channel for new indications. For the global Phase 2 trial of HEPZATO in liver-dominant metastatic colorectal cancer, patient enrollment began in August 2025. This study will enroll approximately 90 patients across 20+ sites in the U.S. and Europe. Additionally, company-sponsored Phase II trials for metastatic breast cancer have FDA clearance, with patient enrollment targeted for the first quarter of 2026.

European sales channels focus on the CHEMOSAT device-only product, which operates under a direct sales and marketing model. Revenue from CHEMOSAT in the third quarter of 2025 was reported at $1.3 million. This compares to $1.8 million in the first quarter of 2025 and $1.7 million in the second quarter of 2025. The growth in Europe is heavily influenced by penetration in Germany, where PHP has consistent reimbursement.

Here is a summary of the key channel metrics as of late 2025:

Channel Metric	Value / Status	Date / Context
Active U.S. Treatment Centers	25	As of Q3 2025
Projected U.S. Centers by YE 2025	26 to 28	End of 2025 projection
Projected U.S. Centers by YE 2026	40	End of 2026 projection
U.S. Commercial Sales Force Regions	Expanding from 4 to 6	Planned for 2025
Projected U.S. Sales Force Regions	9	By Q2 2026
CHEMOSAT Revenue (Europe)	$1.3 million	Q3 2025
HEPZATO Treatment Volume Growth (vs. 2024)	Nearly 150% increase	2025 Guidance
Colorectal Cancer Trial Enrollment Sites	20+ sites (U.S. and Europe)	Global Phase 2 Trial

The direct distribution model for the HEPZATO KIT is critical for maintaining the integrity of the loco-regional delivery process. The company's ability to expand its commercial footprint directly correlates with the activation of new sites, which saw a return to a steadier pace with 4 new sites activated in the two months leading up to the Q3 2025 report.

The European channel, while smaller in revenue contribution, is vital for the CHEMOSAT device. The recent publication of a 10-year retrospective study from a high-volume center in Hamburg, Germany, provides strong clinical evidence that can be used by the direct sales team to drive adoption in other European centers, especially where reimbursement is being sought.

• Direct sales force focused on specialized U.S. centers for HEPZATO KIT.
• Network of 25 active U.S. treatment centers as of September 30, 2025.
• Targeting 26 to 28 active centers by the close of 2025.
• Clinical trial sites supporting new indications, including a CRC trial with enrollment across 20+ sites.
• Direct distribution of the HEPZATO KIT to certified hospital pharmacies.
• European sales of the CHEMOSAT device-only product, generating $1.3 million in Q3 2025 revenue.

Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Customer Segments

You're looking at the core groups Delcath Systems, Inc. (DCTH) serves with its liver-directed therapies like HEPZATO KIT and CHEMOSAT. It's a focused, high-acuity set of customers, which is key to understanding their revenue drivers.

Adult patients with unresectable hepatic-dominant metastatic uveal melanoma (mUM)

This is the primary, FDA-approved segment for HEPZATO KIT in the U.S. The target patient has unresectable hepatic metastases affecting less than 50% of the liver and limited extrahepatic disease, or disease amenable to resection/radiation. Delcath Systems, Inc. is focused on this niche, which sees approximately 1,700 patients annually diagnosed in the U.S..

Clinical data supports the value proposition for this group. A 10-year retrospective study reported a median Overall Survival (OS) of 29.1 months from the first Percutaneous Hepatic Perfusion (PHP) treatment for mUM patients. Furthermore, patients receiving ≥3 PHP cycles showed a numerically improved median OS of 29.8 months versus 21.4 months for those receiving ≤2 cycles.

Interventional oncologists and radiologists performing PHP procedures

These are the specialists who actually administer the treatment using the proprietary systems. Their segment is defined by their capability and willingness to adopt the high-dose, liver-directed therapy. Feedback from treating physicians has been positive, increasing confidence in long-term growth prospects.

The safety profile from a high-volume center study showed procedure-related adverse events graded ≥2 occurring in 10.5% of patients, with no treatment-related deaths. This safety data is critical for physician adoption.

U.S. and European hospitals/cancer centers with interventional oncology capabilities

Center activation is a major driver for Delcath Systems, Inc. As of the second quarter of 2025, the company had 20 active U.S. centers, with an additional 10 centers accepting referrals. By the third quarter of 2025, this grew to 25 active centers across the U.S.. The company's 2025 guidance anticipated total HEPZATO treatment volume to increase at least 200% versus 2024, based on current center activation rates.

For European expansion, a global Phase 2 trial for metastatic colorectal cancer will enroll approximately 90 patients across 20+ sites in the U.S. and Europe.

Government payers (e.g., Medicaid) and private insurance companies

Payer access is crucial for patient volume. Delcath Systems, Inc. initiated the process of entering into a Medicaid National Drug Rebate Agreement (NDRA) with the Centers for Medicare and Medicaid Services, expecting it to take effect at the beginning of the third quarter of 2025. This move is intended to simplify Medicaid access and enable eligible hospitals to access 340B drug pricing, accelerating adoption. The preliminary Q3 2025 revenue of approximately $20.5 million was noted as being modestly lower than Q2 due to the NDRA discounts and seasonality.

Patients with other liver-dominant metastatic cancers in clinical trials

This segment represents the near-term growth pipeline beyond the initial mUM indication. Delcath Systems, Inc. is actively pursuing expansion indications.

• Phase 2 trial for liver-dominant metastatic colorectal cancer enrolling approximately 90 patients across 20+ sites in the U.S. and Europe.
• Phase 2 clinical trial for liver-dominant metastatic breast cancer, for which the company secured FDA clearance for an Investigational New Drug (IND) application.

Here's a quick look at the financial context surrounding these customer segments as of late 2025:

Metric	Value (as of Q3 2025 or Guidance)	Context
Q3 2025 Total Revenue	$20.6 million	Compared to $11.2 million in Q3 2024.
2025 Full Year Revenue Guidance	$83 million to $85 million	Reflects an approximate 150% increase in treatment volume over 2024.
Q3 2025 Gross Margin	87%	Compared to 85% in Q3 2024.
Q3 2025 Net Income	$0.8 million	Compared to $1.9 million in Q3 2024.
Q3 2025 Non-GAAP Adjusted EBITDA	$5.3 million	Compared to $1.0 million in Q3 2024.
Cash and Investments (as of Sept 30, 2025)	$88.9 million	With no debt.

The company expects positive adjusted EBITDA and cashflow in each quarter of 2025, which shows they are managing the commercial expansion costs well. Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Cost Structure

You're looking at the expenses Delcath Systems, Inc. incurs to bring its combination drug/device products, like the HEPZATO KIT, to market and expand its reach. For a company scaling commercial operations and advancing its pipeline, these costs are significant and directly tied to growth initiatives.

The third quarter of 2025 showed a clear ramp-up in operating expenses as Delcath Systems pushed forward on multiple fronts. We can map out the major cost drivers from the preliminary Q3 2025 results.

Cost Category	Q3 2025 Amount (Preliminary)	Comparison to Q3 2024
Research and Development (R&D) Expenses	$8.0 million	Increased from $3.9 million
Selling, General, and Administrative (SG&A) Expenses	$10.3 million	Increased from $7.0 million
Total Operating Expenses (Implied)	$18.3 million (Sum of R&D and SG&A)	Increased from $10.9 million

High R&D expenses, totaling $8.0 million in Q3 2025, for clinical expansion. This nearly doubled R&D spend compared to the $3.9 million reported in Q3 2024. Honestly, this jump signals a heavy investment in future revenue streams.

Selling, General, and Administrative (SG&A) costs for commercial team expansion, at $10.3 million in Q3 2025. This $3.3 million increase over Q3 2024's $7.0 million is the cost of building out the sales and support infrastructure necessary to drive the expected 150% increase in treatment volume for fiscal year 2025.

The R&D increase is directly tied to pipeline advancement. Here's what that spending is supporting:

• Initiation of Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for metastatic colorectal cancer.
• Initiation of Phase 2 clinical trial in metastatic breast cancer.
• Costs associated with expanding the clinical team, including share-based compensation expense.

Costs associated with the Medicaid National Drug Rebate Agreement (NDRA) discounts. While a specific dollar figure for the discount cost isn't itemized here, CEO Gerard Michel noted that the Q3 revenue was 'modestly lower than the second quarter' primarily due to these NDRA discounts, which began taking effect around the start of Q3 2025, alongside summer seasonality.

Manufacturing and supply chain costs for the combination drug/device product. Specific line-item costs for manufacturing aren't broken out in the preliminary release, but successful management of the HEPZATO KIT supply chain is cited as a key factor in achieving the projected gross margins. Delcath Systems forecasts quarterly gross margins to remain between 85% to 87% for the full year 2025, which suggests relatively controlled Cost of Goods Sold (COGS) relative to revenue.

The company is aiming for strong profitability on the product itself, targeting gross margins of 85% to 87% for the full year 2025, while simultaneously incurring high operating expenses to support commercial and clinical growth. Finance: draft 13-week cash view by Friday.

Delcath Systems, Inc. (DCTH) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Delcath Systems, Inc.'s financial performance right now, which is heavily concentrated on product sales from its liver-directed cancer treatments. The revenue streams are clearly delineated between the U.S. market product and the European device sales.

For the third quarter ended September 30, 2025, the total revenue hit approximately $20.5 million. This revenue is split between the two primary offerings, which you can see broken down here:

Revenue Source	Q3 2025 Amount (Millions USD)	Geographic Focus
HEPZATO KIT	$19.2 million	U.S. (Drug/Device Combination)
CHEMOSAT Hepatic Delivery System	$1.3 million	Europe (Device-Only)

That $19.2 million from the HEPZATO KIT in the U.S. is the lion's share of the current top line. Anyway, the company has set its sights high for the full year, updating its 2025 full-year revenue guidance to a range of $83 million to $85 million. This projection reflects what management sees as an impressive 150% increase in treatment volume compared to 2024.

Profitability on these sales looks strong, too. Delcath Systems projects quarterly gross margins to remain stable within the range of 85% to 87% for 2025. For the third quarter specifically, the expected gross margin was reported at 87%.

The underlying mechanism supporting these sales involves securing payment for the procedures themselves. This means a significant portion of revenue is derived from procedures reimbursed by payers, which is a critical component of the revenue cycle.

• Revenue from procedures reimbursed by government payers.
• Revenue from procedures reimbursed by private payers.
• Specific reimbursement mechanisms, such as the established J-Code reimbursement pathway in the U.S.
• The company also reported a positive adjusted EBITDA of $5.3 million for Q3 2025.

To be fair, the Q3 revenue of $20.5 million was slightly below some expectations, attributed to NDRA discounts and summer seasonality affecting patient scheduling. Still, the underlying unit economics, evidenced by those high gross margins, are what you want to watch.