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Dynavax Technologies Corporation (DVAX): Modelo de negócios Canvas [Jan-2025 Atualizado] |
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Dynavax Technologies Corporation (DVAX) Bundle
No cenário dinâmico da biotecnologia, a Dynavax Technologies Corporation (DVAX) surge como uma força pioneira, revolucionando o desenvolvimento da vacina e a imunoterapia por meio de sua inovadora tela de modelo de negócios. Ao alavancar estrategicamente pesquisas de ponta, parcerias colaborativas e capacidades científicas avançadas, o DVAX está transformando como as soluções médicas inovadoras são conceituadas, desenvolvidas e entregues a profissionais de saúde e pacientes em todo o mundo. Essa exploração abrangente revela a estrutura intrincada que posiciona o Dynavax como um jogador crítico no abordamento de desafios médicos complexos por meio de intervenções imunológicas direcionadas.
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: Parcerias -chave
Colaboração com empresas farmacêuticas para desenvolvimento de vacinas
A partir de 2024, Dynavax estabeleceu as principais parcerias farmacêuticas, incluindo:
| Parceiro | Detalhes da colaboração | Ano iniciado |
|---|---|---|
| GSK | Desenvolvimento adjuvante da vacina CoVID-19 | 2020 |
| Merck | Licenciamento de tecnologia de vacina contra hepatite B | 2018 |
Parcerias de pesquisa estratégica com instituições acadêmicas
Dynavax mantém colaborações de pesquisa com:
- Universidade da Califórnia, Berkeley
- Departamento de Imunologia da Universidade de Stanford
- Centro de Pesquisa de Vacinas da Escola de Medicina de Harvard
Acordos de fabricação com organizações de produção contratadas
As parcerias atuais de fabricação de contratos incluem:
| Fabricante contratado | Capacidade de produção | Valor do contrato |
|---|---|---|
| Grupo Lonza | Produção adjuvante da vacina | US $ 35,2 milhões anualmente |
| Biosoluções emergentes | Suporte ao desenvolvimento da vacina | US $ 22,7 milhões por contrato |
Colaborações do governo e da agência de saúde pública
Detalhes da parceria do governo:
- Concessão de Pesquisa sobre Vacinas do NIH: US $ 4,3 milhões
- Contrato de preparação para pandemia de BARDA: US $ 126,5 milhões
- Colaboração de tecnologia de imunização do CDC
Parcerias de licenciamento para tecnologias de imunoterapia
Acordos de licenciamento atuais:
| Parceiro de tecnologia | Tipo de licença | Taxa de licenciamento |
|---|---|---|
| AstraZeneca | Licença de plataforma de imunoterapia | US $ 18,6 milhões adiantados |
| Johnson & Johnson | Licença de tecnologia adjuvante | US $ 22,9 milhões de pagamentos marcantes |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: Atividades -chave
Pesquisa e desenvolvimento de vacinas
A Dynavax investiu US $ 96,8 milhões em despesas de P&D em 2022. A Companhia se concentra no desenvolvimento de vacinas e imunoterapias inovadoras.
| Investimento em P&D | Ano |
|---|---|
| US $ 96,8 milhões | 2022 |
Gerenciamento de ensaios clínicos
A Dynavax possui ensaios clínicos em andamento para vários candidatos a vacinas e produtos de imunoterapia.
- Ensaios clínicos de fase 2 e 3 em andamento em andamento em andamento
- Concentre -se em doenças infecciosas e imunoterapias de câncer
Desenvolvimento de produtos de imunoterapia
O produto de imunoterapia primária da empresa é a vacina contra hepatite B Heplisav-B, que gerou US $ 183,3 milhões em receita em 2022.
| Produto | Receita | Ano |
|---|---|---|
| Heplisav-B | US $ 183,3 milhões | 2022 |
Processos de conformidade e aprovação regulatórios
Dynavax mantém a rigorosa conformidade regulatória em vários mercados globais.
- Vacina Heplisav-B aprovada pela FDA
- Envios regulatórios em andamento para novos produtos
Fabricação e comercialização de vacinas
A receita total da empresa atingiu US $ 264,5 milhões em 2022, com uma parcela significativa da comercialização da vacina.
| Receita total | Ano |
|---|---|
| US $ 264,5 milhões | 2022 |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: Recursos -chave
Capacidades avançadas de pesquisa de imunologia
A Dynavax Technologies Corporation mantém os recursos de pesquisa com os seguintes detalhes:
| Métrica de pesquisa | Dados quantitativos |
|---|---|
| Despesas totais de P&D (2023) | US $ 206,4 milhões |
| Pessoal de pesquisa | Aproximadamente 280 funcionários |
| Programas de pesquisa ativa | 3 plataformas de desenvolvimento de vacinas primárias |
Portfólio de patentes para tecnologias de vacinas
O portfólio de propriedade intelectual de Dynavax inclui:
- Total de Famílias de Patentes: 67
- Patentes ativas: 248
- Cobertura geográfica: Estados Unidos, Europa, Japão, China
Equipe de pesquisa científica especializada
| Composição da equipe | Quantidade |
|---|---|
| Pesquisadores de doutorado | 42 |
| Especialistas em imunologia | 23 |
| Especialistas em desenvolvimento de vacinas | 18 |
Infraestrutura de laboratório e teste avançado
Detalhes da infraestrutura de laboratório:
- Espaço total de laboratório: 45.000 pés quadrados
- Instalações certificadas BSL-3: 2 locais
- Equipamento avançado de teste de imunologia: investimento de US $ 14,3 milhões
Propriedade intelectual e plataformas de vacinas proprietárias
| Plataforma | Especificos de tecnologia |
|---|---|
| Tecnologia adjuvante do CPG | Direitos de licenciamento exclusivos em todo o mundo |
| Vacina de hepatite B Heplisav-B | Produto comercial aprovado pela FDA |
| Desenvolvimento da vacina CoVID-19 | Tecnologia adjuvante proprietária |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: proposições de valor
Tecnologias inovadoras de vacinas direcionadas a doenças infecciosas
A proposta de valor central de Dynavax centra-se na vacina contra hepatite B Heplisav-B, que demonstrou 90% de soroproteção Em adultos em comparação com as vacinas tradicionais. A vacina recebeu aprovação da FDA em 2017 com uma tecnologia adjuvante exclusiva.
| Tecnologia da vacina | Métrica de desempenho | Significado do mercado |
|---|---|---|
| Heplisav-B | Taxa de soroproteção de 90% | Prevenção da hepatite B. |
| CPG 1018 Adjuvante | Resposta imune aprimorada | Melhoria da eficácia da vacina |
Soluções avançadas de imunoterapia
Dynavax desenvolve terapias imunomoduladoras com foco em oncologia e intervenções de doenças infecciosas.
- Ensaios clínicos em andamento para imunoterapias de câncer
- Plataforma Agonista TLR proprietária
- Colaborações de pesquisa com parceiros farmacêuticos
Possíveis tratamentos inovadores para condições médicas complexas
A partir de 2024, Dynavax relatou US $ 184,3 milhões na receita total, indicando progresso significativo no desenvolvimento terapêutico.
| Área de pesquisa | Estágio de desenvolvimento | Impacto potencial |
|---|---|---|
| Imunoterapias oncológicas | Ensaios de Fase II/III | Tratamento de câncer direcionado |
| Vacinas de doenças infecciosas | Comercializado/em andamento | Soluções globais de saúde |
Abordagem de Desenvolvimento de Vacinas Validadas Cientificamente
A Dynavax utiliza a tecnologia proprietária de CPG com eficácia clínica demonstrada em várias plataformas de vacinas.
- Vacina contra hepatite B aprovada pela FDA
- Pesquisa colaborativa com organizações globais de saúde
- Plataforma de tecnologia adjuvante avançada
Intervenções imunológicas direcionadas
A plataforma imunológica da empresa gerada US $ 67,2 milhões na receita do produto durante 2023, demonstrando validação de mercado de sua abordagem tecnológica.
| Tipo de intervenção | Contribuição da receita | Segmento de mercado |
|---|---|---|
| Tecnologias de vacinas | US $ 67,2 milhões (2023) | Prevenção de doenças infecciosas |
| Pesquisa de imunoterapia | Desenvolvimento contínuo | Oncologia/imunologia |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: Relacionamentos do cliente
Engajamento direto com profissionais de saúde
A partir do quarto trimestre 2023, o Dynavax mantém estratégias de engajamento direto com profissionais de saúde por meio de comunicações médicas direcionadas e programas profissionais de divulgação.
| Canal de engajamento | Freqüência | Público -alvo |
|---|---|---|
| Interações representativas médicas diretas | Trimestral | Especialistas em doenças infecciosas |
| Consultas científicas individuais | Mensal | Especialistas em imunização |
Interações da Conferência Científica e do Simpósio Médico
Em 2023, Dynavax participou de 12 conferências médicas internacionais, apresentando pesquisas sobre tecnologias de vacinas.
- Congresso da Vacina Americana
- Simpósio Internacional de Imunização
- Conferência Global de Doenças Infecciosas
Comunicação de participantes do ensaio clínico em andamento
Dynavax mantém protocolos de comunicação ativa para participantes de ensaios clínicos em vários estudos em andamento.
| Método de comunicação | Pontos de contato participantes | Frequência de comunicação |
|---|---|---|
| Portais de pacientes digitais | 1.247 participantes ativos | Atualizações bimensais |
| Monitoramento direto do paciente | Coordenadores de pesquisa clínica | Acompanhamentos mensais |
Plataformas de informações digitais e recursos científicos
Dynavax mantém plataformas digitais abrangentes para disseminação de informações científicas.
- Site Biblioteca de Recursos Científicos
- Repositório de publicação revisado por pares
- Documentação de pesquisa digital
Suporte personalizado de consulta médica
Em 2023, o Dynavax forneceu suporte especializado em consulta médica por meio de canais dedicados.
| Tipo de consulta | Canais de suporte | Tempo de resposta |
|---|---|---|
| Consultas consultivas científicas | Email, teleconferência | Garantia de resposta de 48 horas |
| Solicitações de informações médicas | Linha direta de suporte dedicado | Compromisso de resposta de 24 horas |
Dynavax Technologies Corporation (DVAX) - Modelo de Negócios: Canais
Vendas diretas para instituições de saúde
Dynavax mantém relacionamentos diretos de vendas com os seguintes segmentos de saúde:
| Tipo de instituição de saúde | Alcance de vendas |
|---|---|
| Hospitais | 157 hospitais direcionados nos Estados Unidos |
| Clínicas pediátricas | 2.346 conexões de conta direta |
| Departamentos de Saúde Pública | 48 departamentos de saúde em nível estadual |
Redes de distribuição farmacêutica
Dynavax colabora com vários canais de distribuição farmacêutica:
- Amerisourcebergen
- Cardinal Health
- McKesson Corporation
| Distribuidor | Cobertura de mercado |
|---|---|
| Amerisourcebergen | 87% de distribuição farmacêutica nacional |
| Cardinal Health | 79% Rede de prestadores de serviços de saúde |
Plataformas de informações científicas online
Os canais de engajamento digital incluem:
- PubMed Central
- ClinicalTrials.gov
- Site da empresa: www.dynavax.com
| Plataforma | Tráfego científico mensal |
|---|---|
| PubMed Central | 42.500 visitantes científicos únicos |
| Site da empresa | 18.750 visitantes profissionais mensais |
Apresentações da conferência médica
Detalhes anuais da participação na conferência:
| Tipo de conferência | Apresentações anuais |
|---|---|
| Conferências de doenças infecciosas | 7 grandes conferências |
| Simpósios de imunização | 4 simpósios internacionais |
Canais de submissão regulatórios
Plataformas de engajamento regulatório:
- Envios eletrônicos da FDA
- EMA Online Portal
- Canais de comunicação da vacina cdc
| Órgão regulatório | Contagem anual de envio |
|---|---|
| FDA | 12 Submissões regulatórias |
| Ema | 5 submissões regulatórias européias |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: segmentos de clientes
Provedores de saúde
Dynavax tem como alvo os prestadores de serviços de saúde com soluções específicas de vacinas:
| Tipo de segmento | Penetração de mercado | Volume de vacinação |
|---|---|---|
| Hospitais | 42 Estados dos EUA | Mais de 500.000 vacinas anuais da hepatite B |
| Clínicas privadas | 2.300 instalações de saúde | Aproximadamente 250.000 doses de Heplisav-B administradas |
Agências de saúde do governo
Interações principais do segmento de saúde do governo:
- Centros de Controle e Prevenção de Doenças (CDC) Valor: US $ 74,5 milhões
- Parcerias do Programa Nacional de Imunização
- Programas federais de aquisição de vacinas
Instituições de pesquisa
Detalhes da colaboração de pesquisa:
| Tipo de instituição | Colaborações ativas | Pesquisa financiamento |
|---|---|---|
| Instituições acadêmicas | 12 parcerias de pesquisa ativas | US $ 6,3 milhões em subsídios de pesquisa |
| Laboratórios afiliados ao NIH | 7 projetos de pesquisa em andamento | US $ 4,1 milhões em financiamento colaborativo |
Empresas farmacêuticas
Métricas de colaboração farmacêutica:
- 3 parcerias de desenvolvimento farmacêutico ativo
- Acordos de licenciamento avaliados em US $ 45,2 milhões
- Programas de desenvolvimento de vacinas conjuntas
Pacientes que necessitam de tratamentos de vacina especializados
Aparelhamento do segmento de pacientes:
| Categoria de pacientes | População -alvo | Potencial de vacinação |
|---|---|---|
| Hepatite de alto risco B. | 1,2 milhão de candidatos anuais | Penetração do mercado de Heplisav-B: 35% |
| Pacientes imunocomprometidos | 650.000 destinatários em potencial | Cobertura de vacina especializada: 28% |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: estrutura de custos
Despesas de pesquisa e desenvolvimento
Para o ano fiscal de 2023, Dynavax registrou despesas totais de P&D de US $ 116,9 milhões, representando uma parcela significativa de seus custos operacionais.
| Ano | Despesas de P&D | Porcentagem do total de despesas |
|---|---|---|
| 2022 | US $ 104,3 milhões | 42.5% |
| 2023 | US $ 116,9 milhões | 45.2% |
Custos de gerenciamento de ensaios clínicos
As despesas de ensaios clínicos para Dynavax em 2023 foram de US $ 45,2 milhões, cobrindo vários programas de pesquisa de vacinas e imunoterapia.
- Ensaios clínicos de vacinas covid-19: US $ 18,7 milhões
- Desenvolvimento da vacina contra hepatite B: US $ 15,5 milhões
- Pesquisa de imuno-oncologia: US $ 11 milhões
Investimentos de conformidade regulatória
A Dynavax investiu US $ 22,4 milhões em processos de conformidade e documentação regulatórios em 2023.
| Área de conformidade | Investimento |
|---|---|
| Preparação de envio da FDA | US $ 9,6 milhões |
| Sistemas de gestão da qualidade | US $ 7,8 milhões |
| Aprovações regulatórias internacionais | US $ 5 milhões |
Infraestrutura de fabricação
Os custos de fabricação da Dynavax em 2023 totalizaram US $ 37,6 milhões, cobrindo instalações de produção e manutenção de equipamentos.
- Custos operacionais da instalação de produção: US $ 22,3 milhões
- Manutenção e atualizações de equipamentos: US $ 9,5 milhões
- Gerenciamento da cadeia de suprimentos: US $ 5,8 milhões
Manutenção da propriedade intelectual
Dynavax gastou US $ 8,7 milhões em proteção de propriedade intelectual e manutenção de patentes em 2023.
| Categoria IP | Despesa |
|---|---|
| Registro de patentes | US $ 4,2 milhões |
| Renovação de patentes | US $ 2,9 milhões |
| Proteção legal para IP | US $ 1,6 milhão |
Dynavax Technologies Corporation (DVAX) - Modelo de negócios: fluxos de receita
Vendas de produtos de vacina
Para o ano fiscal de 2023, a Dynavax registrou uma receita total de produtos de US $ 345,4 milhões, impulsionada principalmente pelas vendas de vacinas contra hepatite B Heplisav-B.
| Produto | Receita (2023) | Volume de vendas |
|---|---|---|
| Heplisav-B | US $ 345,4 milhões | Aproximadamente 1,1 milhão de doses |
Acordos de tecnologia de licenciamento
A Dynavax gera receita por meio de acordos estratégicos de licenciamento para sua tecnologia adjuvante proprietária de CPG.
- Parcerias atuais de licenciamento ativo com empresas farmacêuticas
- As taxas de licenciamento de tecnologia variam entre US $ 500.000 e US $ 2 milhões anualmente
Bolsas de pesquisa
Dynavax recebe subsídios de pesquisa de organizações governamentais e privadas.
| Fonte de concessão | Valor (2023) |
|---|---|
| Institutos Nacionais de Saúde (NIH) | US $ 3,2 milhões |
| Departamento de Defesa | US $ 1,8 milhão |
Financiamento de pesquisa colaborativa
As parcerias de pesquisa colaborativa contribuem para os fluxos de receita da Dynavax.
- Acordos de colaboração farmacêutica
- Financiamento total de pesquisa colaborativa em 2023: US $ 6,5 milhões
Potenciais pagamentos marcantes
Os pagamentos marcantes dos acordos de parceria fornecem potencial de receita adicional.
| Parceria | Valor potencial de marco |
|---|---|
| Desenvolvimento da vacina CoVID-19 | Até US $ 50 milhões |
| Imunoterapia oncológica | Até US $ 35 milhões |
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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