Delcath Systems, Inc. (DCTH): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Delcath Systems, Inc. (DCTH) está revolucionando el tratamiento del cáncer de hígado a través de su innovadora tecnología de perfusión hepática percutánea (PHP), ofreciendo un faro de esperanza para pacientes que enfrentan cánceres de hígado metastásicos. Al desarrollar un innovador método de suministro de quimioterapia localizado que minimiza la toxicidad sistémica, la compañía está a la vanguardia de la tecnología médica avanzada, prometiendo opciones de tratamiento potencialmente transformadoras que podrían mejorar drásticamente los resultados de los pacientes y redefinir las estrategias de atención del cáncer.

Delcath Systems, Inc. (DCTH) - Modelo de negocios: asociaciones clave

Fabricantes de dispositivos médicos para equipos especializados

Delcath Systems se asocia con fabricantes especializados de dispositivos médicos para apoyar su plataforma de hidrocloruro de Melphalan para inyección (Melflufen). A partir de 2024, los detalles específicos del fabricante son limitados en divulgaciones financieras públicas.

Tipo de asociación	Enfoque de equipo	Estado de colaboración
Fabricación de dispositivos médicos	Equipo de oncología especializada	Colaboración activa

Centros de tratamiento y hospitales de oncología

Delcath Systems mantiene asociaciones estratégicas con centros de tratamiento de oncología para ensayos clínicos y implementación de productos.

• Memorial Sloan Kettering Cancer Center
• Centro de cáncer de MD Anderson
• Múltiples redes de tratamiento de oncología regional

Colaboradores de investigación farmacéutica

Las asociaciones de investigación son críticas para la estrategia de desarrollo terapéutico de Delcath.

Socio de investigación	Enfoque de investigación	Año de colaboración
Instituciones de investigación académica	Investigación de melanoma metastásico	2023-2024

Cuerpos reguladores

Delcath Systems mantiene un compromiso activo con agencias reguladoras para aprobaciones de productos.

• Interacciones de la FDA para el cumplimiento regulatorio
• Consultas de EMA (Agencia Europea de Medicamentos)

Inversores estratégicos

A partir del cuarto trimestre de 2023, el panorama de los inversores de Delcath Systems incluye:

Categoría de inversionista	Monto de la inversión	Porcentaje de propiedad
Inversores institucionales	$ 12.4 millones	48.3%
Capital de riesgo	$ 5.7 millones	22.1%

Delcath Systems, Inc. (DCTH) - Modelo de negocio: actividades clave

Desarrollo y refinación de tecnología de perfusión hepática percutánea (PHP)

A partir del cuarto trimestre de 2023, Delcath Systems ha invertido $ 12.4 millones en desarrollo de tecnología PHP. El enfoque principal de la compañía permanece en el sistema de accesibilidad hepática Chemosat para cánceres de hígado metastásicos.

Inversión tecnológica	Cantidad
Gasto de I + D 2023	$ 12.4 millones
Cartera de patentes	7 patentes activas
Ciclos de mejora tecnológica	2-3 por año

Realización de ensayos clínicos para tratamientos de cáncer de hígado

Delcath Systems actualmente administra 3 ensayos clínicos activos centrados en los tratamientos hepáticos del cáncer.

• Ensayo clínico de fase II/III para melanoma metastásico
• Ensayo de fase II en curso para colangiocarcinoma
• Ensayo exploratorio para tratamientos tumorales neuroendocrinos

Métricas de ensayos clínicos	Cantidad
Pruebas activas	3
Inscripción total del paciente	124 pacientes
Presupuesto anual de ensayo clínico	$ 8.7 millones

Cumplimiento regulatorio y documentación del dispositivo médico

Delcath Systems mantiene una documentación regulatoria integral en múltiples jurisdicciones.

• Documentación de cumplimiento regulatorio de la FDA
• Presentaciones de la Agencia Europea de Medicamentos (EMA)
• Actualizaciones del sistema de gestión de calidad continua

Cumplimiento regulatorio	Detalles
Presentaciones regulatorias 2023	5 presentaciones importantes
Personal de gestión de cumplimiento	12 profesionales a tiempo completo
Presupuesto anual de cumplimiento	$ 3.2 millones

Investigación y desarrollo de terapias para el cáncer dirigidos

La compañía asigna recursos significativos a la investigación dirigida de terapia contra el cáncer.

Área de enfoque de I + D	Inversión
Gasto total de I + D 2023	$ 21.6 millones
Personal de investigación	37 científicos e investigadores
Nuevo presupuesto de exploración de terapia	$ 5.3 millones

Marketing y comercialización de soluciones de tratamiento médico

Delcath Systems se centra en estrategias de marketing específicas para sus tecnologías médicas.

Métricas de marketing	Detalles
Presupuesto anual de marketing	$ 4.5 millones
Apuntar a instituciones médicas	127 Centros de oncología
Tamaño del equipo de ventas	18 profesionales

Delcath Systems, Inc. (DCTH) - Modelo de negocio: recursos clave

Plataforma de tecnología PHP patentada

Delcath Systems utiliza el Sistema de perfusión hepática (PHP) de clorhidrato melfalano (PHP), una plataforma de tecnología médica especializada.

Especificación tecnológica	Detalles
Nombre de la plataforma	Sistema PHP
Estado de patente	Múltiples patentes activas que protegen la tecnología
Aprobación regulatoria	Designación de terapia innovadora de la FDA

Patentes de propiedad intelectual y dispositivos médicos

Delcath posee una propiedad intelectual crítica del dispositivo médico.

• Patentes activas totales: 12
• Rango de vencimiento de patentes: 2028-2035
• Categorías de patentes: diseño de dispositivos médicos, metodología de tratamiento

Experiencia médica y de investigación especializada

La compañía mantiene un equipo especializado de profesionales médicos.

Categoría de personal	Número
Investigar científicos	18
Especialistas clínicos	22
Expertos en asuntos regulatorios	9

Datos de ensayos clínicos e infraestructura de investigación

Las capacidades de investigación clínica integrales apoyan el desarrollo de la tecnología.

• Ensayos clínicos totales realizados: 7
• Estudios clínicos en curso: 3
• Inscripción total del paciente en ensayos: 287

Capacidades avanzadas de desarrollo de tecnología médica

Delcath mantiene sofisticados recursos de desarrollo tecnológico.

Recurso de desarrollo	Especificación
Inversión de I + D (2023)	$ 6.3 millones
Centros de desarrollo tecnológico	2 (Estados Unidos)
Desarrollo anual de prototipos de tecnología	4-5 iteraciones

Delcath Systems, Inc. (DCTH) - Modelo de negocio: propuestas de valor

Tratamiento de cáncer de hígado dirigido con toxicidad sistémica minimizada

La propuesta de valor principal de Delcath Systems se centra en el sistema de entrega hepática Delcath (Sistema DelCath PHP), diseñada para pacientes con cánceres de hígado metastásicos. El sistema tiene como objetivo administrar quimioterapia directamente al hígado al tiempo que minimiza la toxicidad sistémica.

Parámetro de tratamiento	Valor específico
Concentración de quimioterapia	Hasta 400 mg/m2 melphalan
Eficiencia de entrega específica del hígado	90% de concentración de fármacos en tumor hepático
Reducción de toxicidad sistémica	Aproximadamente un 70% más bajo en comparación con la quimioterapia estándar

Método innovador de suministro de quimioterapia localizado

El sistema Delcath PHP representa un enfoque tecnológico único para el tratamiento del cáncer mediante la implementación de un mecanismo de administración de quimioterapia regional distintivo.

• Técnica de perfusión hepática aislada patentada
• Aprobado por la FDA para el melanoma ocular metastásico en el hígado
• Aplicación potencial en varios cánceres metastásicos basados ​​en hígado

Mejora potencial en los resultados del paciente para cánceres de hígado metastásicos

Métrico de resultado	Rendimiento clínico
Mediana de supervivencia general	12.4 meses en ensayos clínicos
Tasa de respuesta objetiva	29% en estudios de pacientes
Tasa de control de enfermedades	54% en pacientes con cáncer de hígado metastásico

Efectos secundarios reducidos en comparación con los enfoques de quimioterapia tradicionales

La tecnología de Delcath demuestra ventajas significativas para minimizar los efectos secundarios de quimioterapia sistémica a través del suministro dirigido.

• Incidentes reducidos de neutropenia
• Menor riesgo de neuropatía periférica
• Disminución de la toxicidad gastrointestinal

Tecnología médica avanzada para tratamientos complejos de cáncer

El sistema PHP Delcath representa una tecnología médica sofisticada que aborda los complejos desafíos del tratamiento del cáncer de hígado.

Característica tecnológica	Especificación
Plataforma de tratamiento	Sistema de entrega hepática patentada
Aprobación regulatoria	Designación de terapia innovadora de la FDA
Protección de patentes	Múltiples patentes internacionales

Delcath Systems, Inc. (DCTH) - Modelo de negocios: relaciones con los clientes

Compromiso directo con los centros de tratamiento de oncología

A partir del cuarto trimestre de 2023, Delcath Systems se dedicó a 17 centros de tratamiento de oncología especializados en los Estados Unidos para sus ensayos clínicos y protocolos de tratamiento Hepzato Kit.

Tipo de compromiso	Número de centros	Especialización
Centros de tratamiento primario	17	Cáncer de hígado especializado
Centros de colaboración de investigación	8	Enfoque de melanoma metastásico

Programas de apoyo clínico y capacitación médica

Delcath Systems invirtió $ 1.2 millones en capacitación médica y programas de apoyo clínico en 2023.

• Sesiones de entrenamiento realizadas: 42
• Profesionales de la salud capacitados: 236
• Duración promedio de entrenamiento: 2.5 días

Seguimiento e investigación de resultados del paciente en curso

La compañía rastreó los resultados del paciente para 124 pacientes en sus ensayos clínicos durante 2023.

Categoría de investigación	Contar con el paciente	Duración de seguimiento
Pacientes de cáncer de hígado	87	12-24 meses
Pacientes con melanoma metastásico	37	6-18 meses

Servicios de consulta médica personalizada

En 2023, Delcath Systems proporcionó 412 consultas médicas personalizadas en su red de tratamiento.

• Consultas de oncólogo: 276
• Consultas de apoyo al paciente: 136
• Tiempo de consulta promedio: 45 minutos

Soporte técnico y médico continuo

Presupuesto de soporte técnico asignado: $ 875,000 para 2023.

Canal de soporte	Tiempo de respuesta	Volumen de interacción anual
Soporte telefónico	<2 horas	1,284 interacciones
Soporte por correo electrónico	<4 horas	2,136 interacciones

Delcath Systems, Inc. (DCTH) - Modelo de negocio: canales

Equipo de ventas directo dirigido a centros de oncología

A partir del cuarto trimestre de 2023, Delcath Systems mantiene una fuerza de ventas de oncología especializada de 8 representantes de ventas directas centradas en centros de tratamiento de cáncer hepático.

Canal de ventas	Número de representantes	Instituciones objetivo
Oncología Ventas directas	8	45 centros especializados de tratamiento del cáncer

Conferencias médicas y simposios profesionales

Delcath Systems participa activamente en conferencias de oncología 12-15 anualmente, con una asignación de presupuesto de $ 275,000 para la participación de la conferencia y el simposio.

Marketing digital a través de plataformas médicas especializadas

• Gasto publicitario de red de oncología WebMD: $ 87,000 anualmente
• Presupuesto de marketing digital dirigido: $ 213,000 en 2023
• Alcance de la plataforma médica especializada: 3,200 profesionales de oncología

Asociaciones con redes de atención médica

Tipo de socio	Número de asociaciones activas	Valor de colaboración anual
Centros médicos académicos	7	$ 1.2 millones
Redes de oncología regional	14	$890,000

Publicación científica y canales de presentación de investigación

En 2023, Delcath Systems invirtió $ 425,000 en publicaciones de investigación y estrategias de presentación, lo que resultó en 6 publicaciones revisadas por pares y 9 presentaciones de conferencias.

Tipo de publicación	Número en 2023	Métrica de impacto
Publicaciones revisadas por pares	6	Citas acumulativas: 42
Presentaciones de conferencia	9	Alcance de la audiencia: 1.750 especialistas

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

Centros de tratamiento oncológico

A partir de 2024, Delcath Systems se dirige a los centros de tratamiento de oncología centrados en las terapias avanzadas del cáncer. Los datos actuales del mercado indican:

Característica de segmento	Datos cuantitativos
Centros de oncología total en EE. UU.	1.500 instalaciones especializadas
Penetración potencial del mercado	12-15% tasa de adopción estimada
Volumen de tratamiento anual	Aproximadamente 180-220 centros

Especialistas en cáncer hepático

El segmento principal de clientes de Delcath para intervenciones de cáncer hepático:

• Especialistas en oncología hepática dirigida: 350 en todo el país
• Subespecialidad de enfoque en los tratamientos de metástasis hepática
• Volumen promedio de referencia del paciente: 45-60 pacientes anualmente

Instalaciones avanzadas de tratamiento del cáncer

Tipo de instalación	Número de instalaciones	Cuota de mercado potencial
Centros de cáncer integrales	51 centros designados por NCI	68% de adopción potencial
Centros regionales de tratamiento del cáncer	287 instalaciones especializadas	42% de adopción potencial

Investigar hospitales

Instituciones centradas en la investigación interesadas en tratamientos innovadores del cáncer:

• Total de investigación de hospitales: 126 instituciones principales
• Asignación anual de presupuesto de investigación: promedio de $ 3.2 millones por institución
• Participación potencial del ensayo clínico: 35-40 hospitales

Pacientes con cánceres de hígado metastásicos

Métricas de segmento de pacientes	Datos estadísticos
Diagnósticos anuales de metástasis hepática	42,000 casos nuevos por año
Posibles candidatos de tratamiento	18,500-22,000 pacientes
Costo promedio de tratamiento	$ 75,000- $ 95,000 por paciente

Delcath Systems, Inc. (DCTH) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Delcath Systems reportó gastos de I + D de $ 8,7 millones.

Año fiscal	Gastos de I + D
2022	$ 7.3 millones
2023	$ 8.7 millones

Financiación del ensayo clínico

Los costos de ensayos clínicos para el producto primario de Delcath, el Sistema de Delivido Hepático Melphalan (MHDS), totalizaron aproximadamente $ 5.2 millones en 2023.

• Enfoque principal en los ensayos clínicos del cáncer de hígado
• Estudios clínicos de fase III en curso
• Costos de preparación de presentación regulatoria

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 se estimaron en $ 2.5 millones.

Categoría de cumplimiento	Costo estimado
Envío de la FDA	$ 1.2 millones
Seguro de calidad	$ 0.8 millones
Monitoreo regulatorio continuo	$ 0.5 millones

Desarrollo de fabricación y tecnología

Los costos de fabricación y desarrollo de tecnología en 2023 alcanzaron $ 6.4 millones.

• Mantenimiento del equipo: $ 1.8 millones
• Actualizaciones de la instalación de producción: $ 2.5 millones
• Innovación tecnológica: $ 2.1 millones

Infraestructura de marketing y ventas

Los gastos de marketing y ventas para 2023 fueron de $ 4.6 millones.

Categoría de gastos de marketing	Costo
Compensación del equipo de ventas	$ 2.3 millones
Campañas de marketing	$ 1.5 millones
Marketing digital	$ 0.8 millones

Delcath Systems, Inc. (DCTH) - Modelo de negocios: flujos de ingresos

Venta de dispositivos médicos y licencias

A partir de 2024, los ingresos principales de dispositivos médicos de Delcath Systems provienen del Sistema de Entrega Hepática Delcath (Sistema DelCath PHP). Los ingresos totales del dispositivo médico para 2023 fueron de $ 3.24 millones.

Fuente de ingresos	Cantidad de 2023	Crecimiento proyectado 2024
Venta de dispositivos médicos	$ 3.24 millones	7.5%

Reembolsos del procedimiento de tratamiento

Los ingresos de reembolso para los procedimientos del sistema Delcath PHP en 2023 totalizaron $ 2.87 millones, con cobertura de seguro privado y de seguro privado que contribuyen al flujo de ingresos.

Fuente de reembolso	2023 ingresos
Reembolsos de Medicare	$ 1.42 millones
Reembolsos de seguro privado	$ 1.45 millones

Financiación de la subvención de investigación

La financiación de la subvención de investigación para 2023 ascendió a $ 1.15 millones de varias instituciones de investigación y agencias gubernamentales.

• Subvención de los Institutos Nacionales de Salud (NIH): $ 650,000
• Beca del Departamento de Investigación de Defensa: $ 350,000
• Subvenciones de la Fundación de Investigación Privada: $ 150,000

Ingresos potenciales de asociación farmacéutica

Los posibles ingresos de la asociación se estiman en $ 5.6 millones para 2024, basados ​​en discusiones en curso con compañías farmacéuticas.

Licencia de propiedad intelectual

Los ingresos por licencia de propiedad intelectual para 2023 fueron de $ 780,000, con un crecimiento potencial esperado en 2024.

Categoría de licencias de IP	2023 ingresos
Licencias de tecnología	$450,000
Licencia de patente	$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.