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Dynavax Technologies Corporation (DVAX): Modelo de Negocio Canvas [Actualizado en Ene-2025] |
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Dynavax Technologies Corporation (DVAX) Bundle
En el panorama dinámico de la biotecnología, Dynavax Technologies Corporation (DVAX) surge como una fuerza pionera, revolucionando el desarrollo de vacunas e inmunoterapia a través de su innovador lienzo de modelo de negocio. Al aprovechar estratégicamente la investigación de vanguardia, las asociaciones colaborativas y las capacidades científicas avanzadas, DVAX está transformando cómo se conceptualizan, desarrollan y se entregan soluciones médicas innovadoras a proveedores de atención médica y pacientes en todo el mundo. Esta exploración integral presenta el intrincado marco que posiciona a Dynavax como un jugador crítico para abordar desafíos médicos complejos a través de intervenciones inmunológicas dirigidas.
Dynavax Technologies Corporation (DVAX) - Modelo de negocios: asociaciones clave
Colaboración con compañías farmacéuticas para el desarrollo de vacunas
A partir de 2024, Dynavax ha establecido asociaciones farmacéuticas clave que incluyen:
| Pareja | Detalles de colaboración | Año iniciado |
|---|---|---|
| Gsk | Desarrollo adyuvante de vacuna Covid-19 | 2020 |
| Merck | Licencias de tecnología de vacunas de hepatitis B | 2018 |
Asociaciones de investigación estratégica con instituciones académicas
Dynavax mantiene colaboraciones de investigación con:
- Universidad de California, Berkeley
- Departamento de Inmunología de la Universidad de Stanford
- Centro de Investigación de Vacunas de la Escuela de Medicina de Harvard
Acuerdos de fabricación con organizaciones de producción de contratos
Las asociaciones actuales de fabricación de contratos incluyen:
| Fabricante de contratos | Capacidad de producción | Valor de contrato |
|---|---|---|
| Grupo lonza | Producción de adyuvantes de vacuna | $ 35.2 millones anuales |
| Biosoluciones emergentes | Apoyo para el desarrollo de vacunas | $ 22.7 millones por contrato |
Colaboraciones de la agencia de salud y de salud pública
Detalles de la asociación gubernamental:
- Subvención de investigación de vacunas de NIH: $ 4.3 millones
- Contrato de preparación de pandemia de Barda: $ 126.5 millones
- Colaboración de tecnología de inmunización de CDC
Asociaciones de licencia para tecnologías de inmunoterapia
Acuerdos de licencia actuales:
| Socio tecnológico | Tipo de licencia | Tarifa de licencia |
|---|---|---|
| Astrazeneca | Licencia de plataforma de inmunoterapia | $ 18.6 millones por adelantado |
| Johnson & Johnson | Licencia de tecnología adyuvante | $ 22.9 millones de pagos de hitos |
Dynavax Technologies Corporation (DVAX) - Modelo de negocio: actividades clave
Investigación y desarrollo de vacunas
Dynavax invirtió $ 96.8 millones en gastos de I + D en 2022. La compañía se enfoca en desarrollar vacunas e inmunoterapias innovadoras.
| Inversión de I + D | Año |
|---|---|
| $ 96.8 millones | 2022 |
Gestión de ensayos clínicos
Dynavax tiene ensayos clínicos en curso para múltiples candidatos a vacunas y productos de inmunoterapia.
- Múltiples ensayos clínicos de fase 2 y fase 3 en progreso
- Centrarse en las enfermedades infecciosas y las inmunoterapias contra el cáncer
Desarrollo de productos de inmunoterapia
El producto de inmunoterapia principal de la compañía es la vacuna contra la hepatitis B Heplisav-B, que generó $ 183.3 millones en ingresos en 2022.
| Producto | Ganancia | Año |
|---|---|---|
| Heplisav-b | $ 183.3 millones | 2022 |
Procesos de cumplimiento y aprobación regulatoria
Dynavax mantiene un cumplimiento regulatorio riguroso en múltiples mercados globales.
- Vacuna HEPLISAV-B aprobada por la FDA
- Presentaciones regulatorias continuas para nuevos productos
Fabricación y comercialización de vacunas
Los ingresos totales de la compañía alcanzaron los $ 264.5 millones en 2022, con una porción significativa de la comercialización de vacunas.
| Ingresos totales | Año |
|---|---|
| $ 264.5 millones | 2022 |
Dynavax Technologies Corporation (DVAX) - Modelo de negocio: recursos clave
Capacidades de investigación de inmunología avanzada
Dynavax Technologies Corporation mantiene capacidades de investigación con los siguientes detalles:
| Métrico de investigación | Datos cuantitativos |
|---|---|
| Gasto total de I + D (2023) | $ 206.4 millones |
| Personal de investigación | Aproximadamente 280 empleados |
| Programas de investigación activos | 3 plataformas de desarrollo de vacunas primarias |
Portafolio de patentes para tecnologías de vacuna
La cartera de propiedades intelectuales de Dynavax incluye:
- Familias de patentes totales: 67
- Patentes activas: 248
- Cobertura geográfica: Estados Unidos, Europa, Japón, China
Equipo de investigación científica especializada
| Composición del equipo | Cantidad |
|---|---|
| Investigadores de doctorado | 42 |
| Especialistas en inmunología | 23 |
| Expertos en desarrollo de vacunas | 18 |
Infraestructura avanzada de laboratorio y pruebas
Detalles de la infraestructura de laboratorio:
- Espacio de laboratorio total: 45,000 pies cuadrados
- Instalaciones certificadas BSL-3: 2 ubicaciones
- Equipo de prueba de inmunología avanzada: $ 14.3 millones de inversión
Propiedad intelectual y plataformas de vacunas patentadas
| Plataforma | Detalles tecnológicos |
|---|---|
| Tecnología adyuvante de CPG | Derechos de licencia mundiales exclusivos |
| Vacuna de hepatitis B Heplisav-B | Producto comercial aprobado por la FDA |
| Desarrollo de vacunas Covid-19 | Tecnología adyuvante patentada |
Dynavax Technologies Corporation (DVAX) - Modelo de negocio: propuestas de valor
Tecnologías innovadoras de vacunas dirigidas a enfermedades infecciosas
La propuesta de valor central de Dynavax se centra en la vacuna contra la hepatitis B Heplisav-B, que demostró 90% de seroprotección en adultos en comparación con las vacunas tradicionales. La vacuna recibió la aprobación de la FDA en 2017 con una tecnología adyuvante única.
| Tecnología de vacunas | Métrico de rendimiento | Importancia del mercado |
|---|---|---|
| Heplisav-b | Tasa de seroprotección del 90% | Prevención de la hepatitis B |
| CPG 1018 adyuvante | Respuesta inmune mejorada | Mejora de la eficacia de la vacuna |
Soluciones de inmunoterapia avanzadas
Dynavax desarrolla terapias inmunomoduladoras con enfoque en oncología e intervenciones de enfermedades infecciosas.
- Ensayos clínicos en curso para inmunoterapias contra el cáncer
- Plataforma agonista TLR patentada
- Colaboraciones de investigación con socios farmacéuticos
Posibles tratamientos innovadores para afecciones médicas complejas
A partir de 2024, Dynavax informó $ 184.3 millones en ingresos totales, lo que indica un progreso significativo en el desarrollo terapéutico.
| Área de investigación | Etapa de desarrollo | Impacto potencial |
|---|---|---|
| Inmunoterapias oncológicas | Ensayos de fase II/III | Tratamiento del cáncer dirigido |
| Vacunas de enfermedades infecciosas | Comercializado/en curso | Soluciones de salud globales |
Enfoque de desarrollo de vacunas validado científicamente
Dynavax utiliza tecnología CPG patentada con efectividad clínica demostrada en múltiples plataformas de vacunas.
- Vacuna contra la hepatitis B aprobada por la FDA
- Investigación colaborativa con organizaciones de salud globales
- Plataforma de tecnología adyuvante avanzada
Intervenciones inmunológicas dirigidas
La plataforma inmunológica de la compañía generada $ 67.2 millones En los ingresos del producto durante 2023, demostrando la validación del mercado de su enfoque tecnológico.
| Tipo de intervención | Contribución de ingresos | Segmento de mercado |
|---|---|---|
| Tecnologías de vacuna | $ 67.2 millones (2023) | Prevención de enfermedades infecciosas |
| Investigación de inmunoterapia | Desarrollo continuo | Oncología/inmunología |
Dynavax Technologies Corporation (DVAX) - Modelo de negocios: relaciones con los clientes
Compromiso directo con profesionales de la salud
A partir del cuarto trimestre de 2023, Dynavax mantiene estrategias de participación directa con profesionales de la salud a través de comunicaciones médicas específicas y programas de divulgación profesional.
| Canal de compromiso | Frecuencia | Público objetivo |
|---|---|---|
| Interacciones representativas médicas directas | Trimestral | Especialistas en enfermedades infecciosas |
| Consultas científicas individuales | Mensual | Expertos en inmunización |
Conferencia científica e interacciones de simposio médico
En 2023, Dynavax participó en 12 conferencias médicas internacionales, presentando investigaciones sobre tecnologías de vacunas.
- Congreso de Vacunas Americanas
- Simposio de inmunización internacional
- Conferencia global de enfermedades infecciosas
Comunicación de participantes en ensayos clínicos en curso
Dynavax mantiene protocolos de comunicación activa para participantes de ensayos clínicos en múltiples estudios en curso.
| Método de comunicación | Puntos de contacto de los participantes | Frecuencia de comunicación |
|---|---|---|
| Portales de pacientes digitales | 1.247 participantes activos | Actualizaciones bimensuales |
| Monitoreo directo del paciente | Coordinadores de investigación clínica | Seguimiento mensual |
Plataformas de información digital y recursos científicos
Dynavax mantiene plataformas digitales integrales para la difusión de información científica.
- Biblioteca de recursos científicos del sitio web
- Repositorio de publicación revisado por pares
- Documentación de investigación digital
Apoyo de consulta médica personalizada
En 2023, Dynavax brindó apoyo especializado de consulta médica a través de canales dedicados.
| Tipo de consulta | Canales de soporte | Tiempo de respuesta |
|---|---|---|
| Consultas de asesoramiento científico | Correo electrónico, teleconferencia | Garantía de respuesta de 48 horas |
| Solicitudes de información médica | Línea directa de soporte dedicada | Compromiso de respuesta las 24 horas |
Dynavax Technologies Corporation (DVAX) - Modelo de negocios: canales
Ventas directas a instituciones de atención médica
Dynavax mantiene relaciones de ventas directas con los siguientes segmentos de atención médica:
| Tipo de institución de atención médica | Alcance de ventas |
|---|---|
| Hospitales | 157 hospitales dirigidos en los Estados Unidos |
| Clínicas pediátricas | 2.346 conexiones de cuenta directa |
| Departamentos de salud pública | 48 departamentos de salud a nivel estatal |
Redes de distribución farmacéutica
Dynavax colabora con múltiples canales de distribución farmacéutica:
- AmerisourceBergen
- Salud cardinal
- McKesson Corporation
| Distribuidor | Cobertura del mercado |
|---|---|
| AmerisourceBergen | 87% de distribución farmacéutica nacional |
| Salud cardinal | Red de proveedores de atención médica del 79% |
Plataformas de información científica en línea
Los canales de participación digital incluyen:
- PubMed Central
- Clinicaltrials.gov
- Sitio web de la compañía: www.dynavax.com
| Plataforma | Tráfico científico mensual |
|---|---|
| PubMed Central | 42,500 visitantes científicos únicos |
| Sitio web de la empresa | 18,750 visitantes profesionales mensuales |
Presentaciones de conferencia médica
Detalles anuales de participación de la conferencia:
| Tipo de conferencia | Presentaciones anuales |
|---|---|
| Conferencias de enfermedades infecciosas | 7 conferencias principales |
| Simposios de inmunización | 4 simposios internacionales |
Canales de presentación regulatoria
Plataformas de compromiso regulatorias:
- Envíos electrónicos de la FDA
- Portal en línea de EMA
- Canales de comunicación de vacunas de CDC
| Cuerpo regulador | Recuento de presentación anual |
|---|---|
| FDA | 12 presentaciones regulatorias |
| EMA | 5 presentaciones regulatorias europeas |
Dynavax Technologies Corporation (DVAX) - Modelo de negocio: segmentos de clientes
Proveedores de atención médica
Dynavax se dirige a proveedores de atención médica con soluciones de vacuna específicas:
| Tipo de segmento | Penetración del mercado | Volumen de vacunación |
|---|---|---|
| Hospitales | 42 estados de EE. UU. | Más de 500,000 vacunas anuales de hepatitis B |
| Clínicas privadas | 2.300 instalaciones de atención médica | Aproximadamente 250,000 dosis Heplisav-B administradas |
Agencias de salud gubernamentales
Interacciones clave del segmento de salud del gobierno:
- Valor del contrato de Control y Prevención de Enfermedades (CDC): $ 74.5 millones
- Asociaciones del Programa Nacional de Inmunización
- Programas federales de adquisición de vacunas
Instituciones de investigación
Detalles de colaboración de investigación:
| Tipo de institución | Colaboraciones activas | Financiación de la investigación |
|---|---|---|
| Instituciones académicas | 12 asociaciones de investigación activa | $ 6.3 millones en subvenciones de investigación |
| Laboratorios afiliados a NIH | 7 proyectos de investigación en curso | $ 4.1 millones en fondos colaborativos |
Compañías farmacéuticas
Métricas de colaboración farmacéutica:
- 3 Asociaciones activas de desarrollo farmacéutico
- Acuerdos de licencia valorados en $ 45.2 millones
- Programas de desarrollo de vacunas conjuntas
Pacientes que requieren tratamientos de vacuna especializados
Desglose del segmento del paciente:
| Categoría de paciente | Población objetivo | Potencial de vacunación |
|---|---|---|
| Hepatitis B de alto riesgo | 1,2 millones de candidatos anuales | Penetración de mercado de Heplisav-B: 35% |
| Pacientes inmunocomprometidos | 650,000 destinatarios potenciales | Cobertura de vacuna especializada: 28% |
Dynavax Technologies Corporation (DVAX) - Modelo de negocio: Estructura de costos
Gastos de investigación y desarrollo
Para el año fiscal 2023, Dynavax reportó gastos totales de I + D de $ 116.9 millones, lo que representa una parte significativa de sus costos operativos.
| Año | Gastos de I + D | Porcentaje de gastos totales |
|---|---|---|
| 2022 | $ 104.3 millones | 42.5% |
| 2023 | $ 116.9 millones | 45.2% |
Costos de gestión de ensayos clínicos
Los gastos de ensayo clínico para Dynavax en 2023 ascendieron a $ 45.2 millones, cubriendo múltiples programas de investigación de vacunas e inmunoterapia.
- Ensayos clínicos de vacuna Covid-19: $ 18.7 millones
- Desarrollo de la vacuna contra la hepatitis B: $ 15.5 millones
- Investigación de inmuno-oncología: $ 11 millones
Inversiones de cumplimiento regulatorio
Dynavax invirtió $ 22.4 millones en procesos de cumplimiento regulatorio y documentación en 2023.
| Área de cumplimiento | Inversión |
|---|---|
| Preparación de sumisión de la FDA | $ 9.6 millones |
| Sistemas de gestión de calidad | $ 7.8 millones |
| Aprobaciones regulatorias internacionales | $ 5 millones |
Infraestructura de fabricación
Los costos de fabricación para Dynavax en 2023 totalizaron $ 37.6 millones, cubriendo instalaciones de producción y mantenimiento de equipos.
- Costos operativos de la instalación de producción: $ 22.3 millones
- Mantenimiento y actualizaciones del equipo: $ 9.5 millones
- Gestión de la cadena de suministro: $ 5.8 millones
Mantenimiento de la propiedad intelectual
Dynavax gastó $ 8.7 millones en protección de propiedad intelectual y mantenimiento de patentes en 2023.
| Categoría de IP | Gastos |
|---|---|
| Presentación de patentes | $ 4.2 millones |
| Renovación de patente | $ 2.9 millones |
| Protección legal de IP | $ 1.6 millones |
Dynavax Technologies Corporation (DVAX) - Modelo de negocios: flujos de ingresos
Venta de productos de vacuna
Para el año fiscal 2023, Dynavax reportó ingresos totales del producto de $ 345.4 millones, principalmente impulsados por las ventas de vacunas de hepatitis B Heplisav-B.
| Producto | Ingresos (2023) | Volumen de ventas |
|---|---|---|
| Heplisav-b | $ 345.4 millones | Aproximadamente 1.1 millones de dosis |
Acuerdos de tecnología de licencia
Dynavax genera ingresos a través de acuerdos de licencia estratégica para su tecnología adyuvante CPG patentada.
- Asociaciones activas de licencias activas con compañías farmacéuticas
- Las tarifas de licencia de tecnología oscilan entre $ 500,000 y $ 2 millones anuales
Subvenciones de investigación
Dynavax recibe subvenciones de investigación de organizaciones gubernamentales y privadas.
| Fuente de subvenciones | Cantidad (2023) |
|---|---|
| Institutos Nacionales de Salud (NIH) | $ 3.2 millones |
| Ministerio de defensa | $ 1.8 millones |
Financiación de la investigación colaborativa
Las asociaciones de investigación colaborativa contribuyen a las fuentes de ingresos de Dynavax.
- Acuerdos de colaboración farmacéutica
- Financiación total de investigación colaborativa en 2023: $ 6.5 millones
Pagos potenciales de hitos
Los pagos de hitos de los acuerdos de asociación proporcionan un potencial de ingresos adicional.
| Asociación | Valor de hito potencial |
|---|---|
| Desarrollo de vacunas Covid-19 | Hasta $ 50 millones |
| Inmunoterapia oncológica | Hasta $ 35 millones |
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Value Propositions
You're looking at the core value Dynavax Technologies Corporation (DVAX) offers to its customers and partners right now, late in 2025. It's all about speed, efficacy, and leveraging their core technology across multiple critical areas.
HEPLISAV-B: Two-dose, one-month hepatitis B vaccine series completion
The primary value proposition here is convenience and speed for the adult hepatitis B market. HEPLISAV-B is the first and only adult hepatitis B vaccine approved in the U.S., the European Union, and the United Kingdom that enables series completion with only two doses in one month. This rapid completion schedule is a significant differentiator in clinical practice.
The commercial success reflects this value proposition:
| Metric | Value (as of Q3 2025) | Context/Guidance |
| Q3 2025 Net Product Revenue | $90.0 million | 13% Year-over-Year increase |
| Q2 2025 Net Product Revenue | $91.9 million | Record quarterly net product revenue at that time |
| Full Year 2025 Net Product Revenue Guidance | $315 to $325 million | Reiterated guidance |
| U.S. Total Estimated Market Share | Approximately 46% | As of Q3 2025 |
| Long-Term Market Share Goal | At least 60% | Targeted by 2030 |
| U.S. Adult Hepatitis B Market Peak Projection | Over $900 million in annual sales | Expected by 2030 |
The focus on specific segments is also key. Retail market share grew to approximately 63% in Q3 2025, up from 55% the prior year, with annual dose utilization in that segment up approximately 35%. The cost of sales - product for HEPLISAV-B in Q3 2025 was $14.4 million.
High-efficacy vaccine adjuvant (CpG 1018) for partners' pipeline
Dynavax Technologies Corporation offers its proprietary adjuvant, CpG 1018, which has demonstrated the ability to enhance immune response with a favorable tolerability profile. This technology is a value driver for collaborations.
- CpG 1018 has been used in 5 approved COVID vaccines globally.
- It elicits a T Helper (Th1) polarized CD4 T-cell response and increases polyfunctional antibody production.
- The adjuvant is central to the Plague Vaccine Program with the U.S. Department of Defense (DoD).
- The DoD agreement provides approximately $30 million through the first half of 2027 to support clinical and manufacturing activities for the plague vaccine.
- The company is evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine as a proof-of-concept for pandemic preparedness.
The company also entered an exclusive license agreement in Q3 2025 for Vaxart's novel oral COVID-19 vaccine program, expanding pipeline opportunities.
Pipeline of differentiated vaccine candidates (e.g., shingles)
The pipeline offers potential disruption in major vaccine markets by leveraging the CpG 1018 adjuvant. The shingles vaccine candidate, Z-1018, is a major focus.
Z-1018 is an investigational non-live, recombinant subunit vaccine for adults aged 50 and over. Shingles affects approximately 1 in 3 people in their lifetime.
Key clinical data points for Z-1018 as of late 2025:
| Trial Part | Population/Goal | Key Finding/Status |
| Part 1 (Phase 1/2) | Adults 50-69 years; compared to Shingrix® | Showed comparable immunogenicity to Shingrix® and a favorable tolerability profile. |
| Dose Selection | Optimal formulation | 100 mcg of gE antigen with CpG 1018 plus alum, 0 and 8 weeks dosing selected for Part 2. |
| Humoral Response (Part 1) | Selected dose arm | Achieved a 100% humoral vaccine response rate. |
| Part 2 (Phase 1/2) | Adults 70 years and older; head-to-head vs. Shingrix® | Initiated; topline data expected in the second half of 2026. |
Other pipeline assets include:
- HEPLISAV-B for adults on hemodialysis: developing a four-dose regimen.
- Lyme disease vaccine program: plans to initiate clinical development in 2027.
Addressing unmet public health needs in infectious diseases
The value extends to providing solutions where current standards are insufficient or inconvenient. For hepatitis B, the two-dose, one-month schedule solves the challenge of series completion. For shingles, Z-1018 is designed to overcome the natural age-related decline in immune responses for adults aged 50 and over. The company is also advancing programs targeting pandemic influenza (H5N1) and plague, supporting global health security. Research and development expenses for Q3 2025 were $19.1 million.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Customer Relationships
You're looking at how Dynavax Technologies Corporation manages its key relationships as of late 2025, which is heavily tied to commercial success and capital stewardship.
Dedicated commercial sales force for direct engagement with healthcare providers
The relationship with healthcare providers is driven by the commercial success of HEPLISAV-B. The company is focused on growing its share in the U.S. adult hepatitis B vaccine market, which it expects to peak at over $900 million in annual sales by 2030. As of the second quarter of 2025, HEPLISAV-B held an estimated U.S. market share of approximately 45%, with a goal to reach at least 60% total market share by 2030.
- HEPLISAV-B Q3 2025 net product revenue: $90 million.
- HEPLISAV-B Q2 2025 net product revenue: $91.9 million.
- HEPLISAV-B Q1 2025 net product revenue: $65 million.
- Full year 2025 HEPLISAV-B net product revenue guidance range: $315 to $325 million.
Investor relations and capital allocation communication (e.g., $100 million share repurchase program)
Dynavax Technologies Corporation communicates its financial discipline and commitment to stockholders through capital allocation actions. The Board of Directors authorized a new $100 million share repurchase program announced on November 5, 2025. This follows the completion of a prior $200 million share repurchase program as of June 30, 2025. As of May 5, 2025, $172 million worth of common stock had already been repurchased under that prior program.
| Capital Allocation Action | Amount | Date Announced/Status |
| New Share Repurchase Program Authorization | $100 million | November 5, 2025 |
| Prior Share Repurchase Program Completion | $200 million | As of June 30, 2025 |
| Prior Repurchases Completed Under $200M Program | $172 million | As of May 5, 2025 |
Strategic collaboration management with pharmaceutical partners
A key relationship involves leveraging Dynavax Technologies Corporation's adjuvant technology and commercial experience through partnerships. The company entered an exclusive license and collaboration agreement with Vaxart, Inc. for a COVID-19 vaccine candidate. This deal included an upfront license fee of $25 million and a $5 million equity investment in Vaxart, announced November 5, 2025. Furthermore, the relationship with the U.S. Department of Defense (DoD) for the plague vaccine program saw an amendment in Q3 2025 for approximately $14 million.
- Vaxart Upfront License Fee: $25 million.
- Vaxart Equity Investment: $5 million.
- DoD Amendment (Q3 2025): Approximately $14 million.
- DoD Initial Agreement (through H1 2027): Approximately $30 million.
High-touch support for integrated delivery networks (IDNs)
Engagement with IDNs is part of the broader commercial strategy to drive adoption of HEPLISAV-B across large healthcare systems. The company's expected Adjusted EBITDA for full year 2025 is at least $80 million, supporting the infrastructure needed for these complex customer relationships. Dynavax Technologies Corporation also manages relationships with regulatory bodies, such as engaging with the FDA in Q1 2025 to finalize a study protocol for a HEPLISAV-B sBLA filing for adults on hemodialysis.
- Expected Full Year 2025 Adjusted EBITDA: At least $80 million.
- FDA engagement for hemodialysis sBLA: Q1 2025.
Finance: draft 13-week cash view by Friday.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Channels
You're looking at how Dynavax Technologies Corporation gets its value proposition-primarily the HEPLISAV-B vaccine-into the hands of customers. The channel strategy is clearly multi-pronged, hitting both high-volume retail and specialized institutional settings, plus government direct sales.
The U.S. retail pharmacy network is a major engine for HEPLISAV-B adoption. As of the third quarter of 2025, the vaccine captured a dominant 63% market share within this specific retail segment. This is a significant jump from the 55% share reported in the third quarter of last year. This channel contributed to the overall HEPLISAV-B net product revenue of $90 million for Q3 2025, which was up 13% year-over-year from $79.3 million in Q3 2024. The total U.S. market share for HEPLISAV-B stood at approximately 46% at the end of Q3 2025.
Here's a quick look at HEPLISAV-B's penetration across key U.S. institutional and retail channels as of late 2025:
| Channel Segment | HEPLISAV-B Market Share (Late 2025) |
| U.S. Retail Pharmacy Networks | 63% |
| Dialysis Centers | 64% |
| Integrated Delivery Networks (IDNs) | 50% |
Beyond retail, the vaccine is making inroads into other key healthcare settings. The data shows strong positions in the institutional space, too. Specifically, HEPLISAV-B holds a 64% position in dialysis centers and a 50% position within integrated delivery networks (IDNs). The company maintains a long-term goal of achieving at least 60% total U.S. market share by 2030.
Direct sales and development activities with government agencies are centered on the CpG 1018 adjuvant technology, not the commercial HEPLISAV-B product. Dynavax Technologies Corporation is developing a plague (rF1V) vaccine candidate fully funded by the U.S. Department of Defense (DoD). The funding structure includes several tranches:
- An earlier agreement provided approximately $22 million in funding.
- In the fourth quarter of 2024, a new agreement for approximately $30 million was executed, supporting activities through the first half of 2027.
- An amendment in the third quarter of 2025 added approximately $14 million from the DoD to support non-human primate studies.
For international distribution, Dynavax Technologies Corporation wholly owns, manufactures, and holds worldwide commercial rights to HEPLISAV-B, which is also approved by the European Commission (EC). The company has a specific distribution agreement for one European market. Bavarian Nordic markets and distributes HEPLISAV-B in Germany, with an expected launch date originally set for the fourth quarter of 2021. Furthermore, the CpG 1018 adjuvant technology has seen global application, having been used in 5 approved COVID vaccines around the world.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Customer Segments
You're looking at the specific groups Dynavax Technologies Corporation targets with its commercial products and its proprietary adjuvant technology, as of late 2025. This is where the revenue actually comes from, so the details matter.
U.S. adults aged 18+ requiring hepatitis B vaccination
This is the core patient population for the flagship product, HEPLISAV-B. The recommendations from the Advisory Committee on Immunization Practices (ACIP) define this segment, which includes all adults aged 19-59 years, and adults aged 60 and older who have risk factors for hepatitis B, though the latter group may still face cost-sharing depending on insurance. Dynavax Technologies Corporation projects the total U.S. adult hepatitis B vaccine market will expand to a peak of over $900 million in annual sales by 2030. To put that in perspective, the entire U.S. hepatitis B vaccine market was valued at $2.60 billion in 2023.
Dynavax Technologies Corporation is aggressively capturing this market, with its HEPLISAV-B vaccine achieving an estimated total U.S. market share of approximately 46% as of the third quarter of 2025. The company is focused on maintaining a disciplined approach to capture a long-term goal of at least 60% total market share by 2030.
Healthcare providers (HCPs) and institutional purchasers (hospitals, clinics)
This segment consists of the entities that actually purchase and administer the vaccine, such as hospitals, clinics, and pharmacies. Their purchasing decisions directly drive Dynavax Technologies Corporation's top-line performance. For the third quarter of 2025, HEPLISAV-B generated net product revenue of $90 million, contributing to a full-year 2025 revenue guidance range of $315 to $325 million for the product.
Dynavax Technologies Corporation has successfully segmented its sales efforts across different healthcare settings, showing strong penetration:
- Retail pharmacy segment market share: approximately 63% as of Q3 2025.
- Dialysis centers market share: approximately 64%.
- Integrated Delivery Networks (IDNs) market share: approximately 50%.
The gross margin for HEPLISAV-B was reported at 84% for the quarter ending September 30, 2025.
Global pharmaceutical and biotech companies needing vaccine adjuvants
This segment represents partners interested in leveraging Dynavax Technologies Corporation's proprietary CpG 1018 adjuvant technology for their own vaccine candidates. The CpG 1018 adjuvant is already used in HEPLISAV-B and was noted as being used in multiple adjuvanted COVID-19 vaccines globally.
A key recent example of this customer segment engagement is the exclusive license agreement executed in Q3 2025 with Vaxart, Inc. for an oral COVID-19 vaccine candidate. The financial commitment for this partnership included:
- Upfront license fee: $25 million.
- Equity investment in Vaxart: $5 million.
- Potential future payment upon Phase 2b results: an additional $50 million.
Previously, Dynavax Technologies Corporation had a commercial supply agreement with Valneva, where Valneva had an option to purchase up to an additional 90 million doses of CpG 1018 through 2025. Dynavax Technologies Corporation is actively making the adjuvant available to select research institutions and partners globally.
Government and public health organizations (e.g., pandemic preparedness)
This segment involves direct contracts with government bodies, often focused on national security or public health threats, leveraging the company's vaccine and adjuvant platforms. The U.S. Department of Defense (DoD) is a significant customer here for the plague vaccine candidate, which is adjuvanted with CpG 1018.
Financial commitments from this segment include:
- An agreement executed in Q4 2024 for approximately $30 million through the first half of 2027 to support clinical and manufacturing activities for the plague vaccine.
- An amendment executed in Q3 2025 for approximately $14 million from the DoD to support additional non-human primate studies.
Furthermore, Dynavax Technologies Corporation is engaging with public health needs by evaluating CpG 1018 in an adjuvanted H5N1 influenza vaccine to support potential commercial supply for global pandemic preparedness efforts.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Cost Structure
You're looking at the major outlays keeping the lights on and the pipeline moving at Dynavax Technologies Corporation. For a commercial-stage vaccine company, the costs are heavily weighted toward manufacturing the successful product and funding the next generation of assets. Honestly, these numbers tell a clear story about where the capital is flowing right now.
The Cost of Goods Sold (COGS) for HEPLISAV-B production is a primary driver. For the third quarter of 2025, the cost of sales-product for HEPLISAV-B-came in at $14.4 million. That's the direct cost associated with getting that two-dose hepatitis B vaccine ready for market, and it scales with sales volume, so you'd expect it to rise as market share grows.
Next up, you have the Research and Development (R&D) spend, which is significant because that's the engine for future revenue. For the third quarter of 2025, R&D expenses totaled $19.1 million. This covers everything from preclinical work to running those expensive human trials, like the Phase 1/2 trial for the shingles vaccine candidate, Z-1018, which is key to disrupting that multi-billion-dollar market.
Then there are the Selling, General, and Administrative (SG&A) costs tied to keeping the commercial engine running. For Q3 2025, SG&A was $40.1 million. This covers the sales force, marketing efforts to drive HEPLISAV-B adoption (which hit about 46% total U.S. market share by the end of the quarter), and the general overhead of running the corporate structure. It's prudent management of this line that helps boost profitability, like the $35.5 million in Adjusted EBITDA reported for the same quarter.
Here's a quick look at those major Q3 2025 operating expenses:
| Cost Category | Q3 2025 Amount (in millions USD) |
| Selling, General, and Administrative (SG&A) | $40.1 |
| Research and Development (R&D) | $19.1 |
| Cost of Sales - Product (COGS for HEPLISAV-B) | $14.4 |
The overall cost profile is shaped by these key areas, which you need to monitor closely as the company matures. The clinical trial and regulatory compliance expenses are embedded within the R&D line, but they represent a critical, non-negotiable outlay for any vaccine developer.
- High COGS driven by HEPLISAV-B manufacturing, reported at $14.4 million in Q3 2025.
- Substantial R&D spend of $19.1 million in Q3 2025 funding pipeline advancement.
- Commercial infrastructure costs reflected in SG&A, which was $40.1 million for Q3 2025.
- Clinical trial costs are a major component of R&D, supporting programs like the shingles vaccine.
If onboarding takes 14+ days for new commercial partners, compliance risk rises, though the data doesn't specify the exact regulatory spend outside of the total R&D figure. Finance: draft 13-week cash view by Friday.
Dynavax Technologies Corporation (DVAX) - Canvas Business Model: Revenue Streams
You're looking at how Dynavax Technologies Corporation brings in the money, which is heavily weighted toward its lead product and strategic collaborations as of late 2025. The revenue streams are quite focused right now, but pipeline progress is opening up new avenues.
The primary driver remains the commercial success of its hepatitis B vaccine. Management reiterated the full-year 2025 guidance for this stream, showing confidence in continued market penetration. For context, the third quarter of 2025 saw net product revenue from this vaccine hit $90.0 million.
Here's a breakdown of the key expected and realized revenue components for the fiscal year 2025:
| Revenue Stream Component | Latest Financial Data/Guidance (2025) | Notes |
| Net Product Revenue (HEPLISAV-B) | Guidance: $315 million to $325 million | Q3 2025 actual was $90.0 million |
| Government Contract Revenue (Plague Vaccine) | New DoD Agreement: approx. $30 million (through H1 2027) | Received approx. $14 million additional DoD funding in Q3 2025 |
| Licensing Fees (Vaxart Deal) | Upfront Payment: $25 million plus $5 million in equity | Exclusive license for oral COVID-19 vaccine program |
| Adjuvant Product Revenue (CpG 1018) | Not explicitly itemized separately from product sales | CpG 1018 is the adjuvant in HEPLISAV-B and the plague vaccine candidate |
Adjuvant product revenue from CpG 1018 supply agreements isn't broken out separately in the latest reports, as its primary current revenue contribution is embedded within the net product revenue of HEPLISAV-B. However, the technology is key to other development efforts.
Strategic partnerships are generating upfront, non-recurring revenue. The exclusive license agreement for Vaxart's novel oral COVID-19 vaccine program is a clear example of this stream. This deal included an upfront payment of $25 million, supplemented by an additional $5 million in equity.
Government contract revenue is tied directly to non-commercial development programs. The plague vaccine candidate, which uses the CpG 1018 adjuvant, is being developed in collaboration with and is fully funded by the U.S. Department of Defense (DoD). Dynavax and the DoD executed a new agreement in late 2024 for approximately $30 million, covering activities through the first half of 2027. You also saw about $14 million in additional DoD funding for this program in the third quarter of 2025 alone.
The overall revenue picture for 2025 is anchored by the HEPLISAV-B guidance, supplemented by significant non-dilutive funding and upfront payments from business development activities. These streams help support pipeline advancement.
- HEPLISAV-B 2025 net product revenue guidance: $315 million to $325 million.
- U.S. adult hepatitis B market share for HEPLISAV-B reached approx. 46% as of Q3 2025.
- Vaxart upfront payment: $25 million cash plus $5 million equity.
- Plague vaccine DoD funding: New agreement worth approx. $30 million through H1 2027.
Finance: draft 13-week cash view by Friday.
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