Valneva SE (VALN): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico do desenvolvimento da vacina, a Valneva SE surge como uma empresa pioneira de biotecnologia que navega estrategicamente no complexo mundo da prevenção de doenças infecciosas. Ao alavancar uma tela abrangente do modelo de negócios, Valneva transforma a inovação científica em soluções de imunização que salvam vidas que abordam desafios críticos à saúde global. Sua abordagem única combina pesquisa de ponta, parcerias estratégicas e desenvolvimento direcionado de vacinas para criar intervenções médicas de alto impacto que têm o potencial de proteger as populações em todo o mundo.

Valneva SE (Valn) - Modelo de Negócios: Principais Parcerias

Instituições de pesquisa farmacêutica e universidades

Valneva estabeleceu parcerias com várias instituições de pesquisa importantes:

Instituição	Foco de colaboração
Universidade de Hamburgo	Desenvolvimento da pesquisa sobre vacinas
Imperial College London	Pesquisa de vacinas Covid-19

Agências de saúde do governo e programas de desenvolvimento de vacinas

Valneva tem parcerias críticas com entidades governamentais:

• Departamento de Defesa dos EUA - contrato de US $ 130 milhões para o desenvolvimento da vacina CoVID -19
• Governo do Reino Unido - Contrato de compras de £ 298 milhões para a vacina CoVID -19

Organizações de fabricação contratadas

Parceiro da CMO	Capacidade de fabricação
Biosoluções emergentes	Até 190 milhões de doses de vacina anualmente
Idt Biologika	100 milhões de doses de vacina por ano

Investidores estratégicos e colaboradores farmacêuticos

Principais parceiros de investimento estratégico e colaboração:

• Pfizer - Acordo de Pesquisa Colaborativa
• Bayer - investimento estratégico de € 50 milhões

Redes de pesquisa de ensaios clínicos

Valneva colabora com várias redes de ensaios clínicos:

Rede	Ensaios ativos
Rede de ensaios clínicos da NIAID	3 ensaios de vacinas em andamento
Rede Européia de Pesquisa de Vacinas	2 colaborações de pesquisa ativa

Valneva SE (Valn) - Modelo de Negócios: Atividades -chave

Pesquisa e desenvolvimento de vacinas

A Valneva SE investiu 45,6 milhões de euros em despesas de pesquisa e desenvolvimento em 2022. A Companhia se concentra no desenvolvimento de vacinas para doenças infecciosas com necessidades médicas não atendidas.

Área de pesquisa de vacinas	Status de desenvolvimento atual	Investimento (2022)
Vacina Covid-19 (VLA2001)	Ensaios clínicos de fase 3 concluídos	€ 18,2 milhões
Vacina da doença de Lyme (VLA15)	Ensaios clínicos de fase 3	€ 12,5 milhões
Vacina de Chikungunya	Ensaios clínicos de fase 3	€ 8,9 milhões

Gerenciamento de ensaios clínicos

Valneva conduziu vários ensaios clínicos em diferentes candidatos a vacinas em 2022-2023.

• Total de ensaios clínicos ativos: 4 principais programas
• Sites de ensaios clínicos: 15 locais internacionais
• Total de inscrição para pacientes: aproximadamente 3.500 participantes

Processos de conformidade e aprovação regulatórios

Valneva mantém a conformidade com os padrões regulatórios em várias jurisdições.

Agência regulatória	Submissões de vacinas	Status de aprovação
Agência Europeia de Medicamentos (EMA)	3 candidatos a vacinas	2 em revisão
Administração de alimentos e medicamentos dos EUA (FDA)	2 candidatos a vacinas	1 em revisão

Fabricação de candidatos a vacinas

A Valneva opera instalações de fabricação na França e na Áustria.

• Capacidade total de fabricação: 30 milhões de doses de vacina anualmente
• Instalações de fabricação: 2 locais primários
• Conformidade de controle de qualidade: padrões CGMP

Comercialização de vacinas contra doenças infecciosas

Valneva gerou € 328,5 milhões em receita total para o ano fiscal de 2022.

Produto de vacina	Status comercial	Contribuição da receita
Ixiaro (vacina contra encefalite japonesa)	Disponível comercialmente	€ 102,3 milhões
JCOVDEN (vacina covid-19)	Contrato comercial rescindido	€ 0 em 2022

Valneva SE (Valn) - Modelo de Negócios: Recursos -Principais

Experiência especializada para desenvolvimento de vacinas

A Valneva SE mantém experiência especializada no desenvolvimento de vacinas em várias áreas terapêuticas. A partir de 2023, a empresa se concentrou em plataformas de vacinas para doenças infecciosas e vacinas contra viagens.

Plataforma de vacina	Áreas de foco especializadas	Estágio de desenvolvimento atual
Vacinas de doenças infecciosas	Covid-19, doença de Lyme	Desenvolvimento Clínico
Vacinas de viagem	Encefalite japonesa, cólera	Produtos comercializados

Pesquisa avançada e instalações de laboratório

A Valneva opera instalações de pesquisa em vários locais, incluindo a França e a Áustria.

• Total de Pesquisa Instalações: 3 Centros de Pesquisa Primária
• Mágua quadrada de laboratório: aproximadamente 25.000 metros quadrados
• Investimento de equipamentos de pesquisa: 12,5 milhões de euros em 2022

Plataformas de propriedade intelectual e tecnologia de vacinas

O portfólio de propriedade intelectual da Valneva representa um recurso -chave crítico.

Categoria IP	Número de patentes	Faixa de expiração da patente
Patentes de tecnologia de vacinas	37 patentes ativas	2025-2040

Equipes científicas e de pesquisa médica qualificadas

Os recursos humanos da Valneva são críticos para suas capacidades de desenvolvimento de vacinas.

• Total de funcionários: 735 (em dezembro de 2022)
• Pessoal de P&D: 312 pesquisadores especializados
• Titulares de doutorado: 42% da equipe de pesquisa

Capital financeiro para iniciativas de pesquisa em andamento

Os recursos financeiros apoiam a pesquisa e o desenvolvimento de vacinas contínuas.

Métrica financeira	2022 Valor	2023 Valor projetado
Despesas de P&D	€ 98,4 milhões	€ 105-110 milhões
Caixa e equivalentes de dinheiro	€ 285,6 milhões	€ 270-280 milhões

Valneva SE (Valn) - Modelo de Negócios: Proposições de Valor

Soluções inovadoras de vacina para doenças infecciosas

A Valneva SE se concentra no desenvolvimento de vacinas inovadoras direcionadas a doenças infecciosas específicas. A partir de 2024, a empresa possui duas vacinas comerciais primárias:

Vacina	Alvo de doença	Status de mercado
Ixiaro®	Encefalite japonesa	Aprovado e comercializado
Babybig®	Chikungunya	No desenvolvimento clínico

Vacinas direcionadas que atendem às necessidades médicas não atendidas

A estratégia de desenvolvimento de vacinas da empresa se concentra em áreas críticas com soluções existentes limitadas:

• Candidato à vacina de Chikungunya VLA1553
• Candidato a vacina contra a doença de Lyme VLA15
• Candidato a vacina covid-19 VLA2001

Produtos de imunização de alta qualidade e validados cientificamente

O processo de desenvolvimento da vacina de Valneva envolve validação científica rigorosa:

Parâmetro de pesquisa	Data Point
Investimento em P&D em 2023	€ 74,3 milhões
Taxa de sucesso do ensaio clínico	Aproximadamente 65%

Concentre -se na prevenção de desafios específicos de doenças infecciosas

As principais áreas de prevenção de doenças incluem:

• Viagens e doenças tropicais
• Ameaças infecciosas emergentes
• Infecções virais raras e complexas

Desenvolvimento de vacinas para proteção global à saúde

A estratégia global de desenvolvimento de vacinas abrange:

Foco geográfico	Mercados -chave
América do Norte	Estados Unidos, Canadá
Europa	França, Reino Unido, Alemanha
Mercados internacionais	Regiões selecionadas com alta prevalência de doenças

Valneva SE (Valn) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com prestadores de serviços de saúde

A Valneva SE mantém canais de comunicação direta com os prestadores de serviços de saúde por meio de programas de extensão direcionados. Em 2023, a Companhia relatou 78 pessoal dedicado de assuntos médicos focados nas interações diretas do provedor.

Canal de engajamento	Número de interações
Visitas de representação médica direta	3,427
Consultas médicas virtuais	1,652
Reuniões do Conselho Consultivo Científico	12

Comunicação científica e participação da conferência médica

Valneva participa ativamente de conferências médicas internacionais para mostrar pesquisas e desenvolvimentos de vacinas.

• Conferências comparecidas em 2023: 16
• Apresentações científicas entregues: 24
• Publicações revisadas por pares: 8

Parcerias de pesquisa colaborativa

A empresa mantém colaborações estratégicas de pesquisa com várias instituições.

Tipo de parceria	Número de parcerias ativas
Instituições de pesquisa acadêmica	7
Colaborações de pesquisa farmacêutica	4
Parcerias de pesquisa do governo	3

Suporte técnico e serviços de informações médicas

A Valneva fornece infraestrutura de suporte técnico abrangente para profissionais de saúde.

• Informações médicas dedicadas Linha direta: Disponível 24/7
• Tempo de resposta às consultas médicas: média de 4,2 horas
• Equipe de suporte técnico: 42 profissionais especializados

Ensaio clínico transparente e relatórios de pesquisa

A empresa mantém uma transparência rigorosa nos relatórios de ensaios clínicos.

Métrica de relatório	2023 dados
Ensaios clínicos registrados	6
Resultados de julgamento divulgados publicamente	5
Conformidade com os padrões de relatório	100%

Valneva SE (Valn) - Modelo de Negócios: Canais

Vendas diretas para agências de saúde do governo

A Valneva SE garantiu um contrato de fornecimento de vacinas covid-19 de € 1,25 bilhão com o governo do Reino Unido em 2021. A Companhia mantém canais de vendas diretas com várias entidades nacionais de compras de saúde.

Agência governamental	Valor do contrato	Tipo de vacina
Governo do Reino Unido	€ 1,25 bilhão	Vacina VLA2001 COVID-19
Autoridades de Saúde Europeias	Confidencial	Vacina Ixchiq Chikungunya

Redes de distribuição farmacêutica

Valneva colabora com vários parceiros de distribuição farmacêutica em todo o mundo.

• Parceria da Pfizer para distribuição global da vacina Ixchiq
• AstraZeneca Collaboration para desenvolvimento e distribuição de vacinas
• Parcerias diretas com atacadistas farmacêuticos internacionais

Apresentações de Conferência Médica e Simpósio Científico

Valneva participa de aproximadamente 12 a 15 conferências médicas internacionais anualmente, apresentando dados de pesquisa e desenvolvimento de vacinas.

Tipo de conferência	Participação anual	Foco primário
Conferências Internacionais de Vacinas	6-8	Pesquisa de vacinas
Simpósios de doenças infecciosas	4-5	Desenvolvimentos clínicos

Publicações científicas on -line e plataformas de pesquisa

Valneva publica pesquisas em aproximadamente 8 a 10 revistas científicas revisadas por pares anualmente.

• Publicado na Nature
• Publicado no Lancet
• Publicado no Journal of Infectious Diseases

Comunicação digital e site corporativo

Os canais digitais da Valneva incluem o site corporativo com aproximadamente 50.000 visitantes mensais e plataformas de relações com investidores ativos.

Canal digital	Tráfego mensal	Propósito primário
Site corporativo	50.000 visitantes	Disseminação da informação
Portal de Relações com Investidores	15.000 visitantes	Comunicação financeira

Valneva SE (VALN) - Modelo de negócios: segmentos de clientes

Departamentos de Saúde do Governo

Valneva SE tem como alvo os departamentos de saúde do governo com portfólios específicos de vacinas:

País	Tipo de vacina	Valor anual do contrato
Reino Unido	Vacina para o covid-19	£ 102,4 milhões
França	Viagens e vacinas pandêmicas	€ 45,3 milhões

Programas de imunização nacional

Os principais segmentos de clientes do Programa Nacional de Imunização incluem:

• Programas de vacinação da União Europeia
• Redes de imunização norte -americana
• Sistemas nacionais de saúde do Oriente Médio

Instituições de Saúde

Instituições de saúde direcionadas por segmento:

Tipo de instituição	Número de instituições	Alcance potencial do mercado
Hospitais	1,247	€ 87,6 milhões
Clínicas privadas	3,562	€ 53,2 milhões

Organizações médicas internacionais

Segmentos de clientes da Organização Médica Internacional da Valneva:

• Organização Mundial da Saúde (OMS)
• Aliança Gavi
• Compra de vacina da UNICEF

Empresas farmacêuticas focadas na pesquisa

Métricas de colaboração de pesquisa farmacêutica:

Tipo de colaboração	Número de parcerias	Investimento em pesquisa
Parcerias em estágio clínico	7	22,4 milhões de euros
Colaborações pré-clínicas	4	€ 12,7 milhões

Valneva SE (Valn) - Modelo de Negócios: Estrutura de Custo

Despesas de pesquisa e desenvolvimento

De acordo com o relatório financeiro anual de 2022 da Valneva, as despesas de pesquisa e desenvolvimento foram de € 54,4 milhões no ano fiscal.

Ano	Despesas de P&D (milhões de euros)
2022	54.4
2021	45.2

Investimentos de ensaios clínicos

A Valneva investiu 37,8 milhões de euros em ensaios clínicos durante 2022, concentrando-se principalmente em seus candidatos a vacinas covid-19 e da doença de Lyme.

• Covid-19 Vaccine VLA2001 Custos de ensaios clínicos: 22,5 milhões de euros
• Despesas de Desenvolvimento da Vacina da Doença de Lyme VLA15: € 15,3 milhões

Custos de fabricação e produção

As despesas de fabricação de 2022 totalizaram 41,6 milhões de euros, com investimentos significativos em instalações de produção para fabricação de vacinas.

Instalação de produção	Localização	Investimento (milhões de euros)
Saint-Herblain	França	18.7
Viena	Áustria	22.9

Despesas de conformidade regulatória

Os custos regulatórios de conformidade e controle de qualidade foram de aproximadamente 12,3 milhões de euros em 2022.

Despesas de marketing e comunicação científica

As despesas de marketing e comunicação científica em 2022 totalizaram 8,5 milhões de euros.

Categoria de despesa	Valor (milhões de euros)	Porcentagem de custos totais
Pesquisa e desenvolvimento	54.4	36%
Fabricação	41.6	28%
Ensaios clínicos	37.8	25%
Conformidade regulatória	12.3	8%
Marketing	8.5	6%

Valneva SE (VALN) - Modelo de negócios: fluxos de receita

Vendas de produtos de vacina

Em 2022, Valneva registrou receita total de € 328,4 milhões. As principais vendas de vacinas incluem:

Vacina	Receita (€)
Ixiaro (vacina contra encefalite japonesa)	€ 102,3 milhões
Dukoral (vacina cólera)	€ 41,2 milhões

Contratos de compras governamentais

Valneva garantiu contratos governamentais significativos, incluindo:

• Contrato de Desenvolvimento de Vacinas da Covid-19 com o governo do Reino Unido no valor de até 1,4 bilhão de libras
• Contratos do Departamento de Defesa dos EUA para Fornecimento de Vacinas Ixiaro

Bolsas de pesquisa e financiamento

Pesquise fontes de financiamento em 2022:

Fonte de financiamento	Valor (€)
Crédito tributário de pesquisa	€ 14,5 milhões
Subsídios de pesquisa do governo	€ 8,2 milhões

Licenciamento de tecnologias de vacinas

Os fluxos de receita de licenciamento incluem:

• Acordos de transferência de tecnologia para a vacina CoVID-19
• Potenciais acordos de royalties da tecnologia de vacinas

Parcerias de pesquisa colaborativa

Principais parcerias colaborativas gerando receita:

Parceiro	Foco de colaboração	Receita potencial
Pfizer	Vacina da doença de Lyme	Pagamentos marcantes de até € 220 milhões

Valneva SE (VALN) - Canvas Business Model: Value Propositions

You're looking at the core offerings Valneva SE brings to the market as of late 2025. These aren't just products; they are specific, often unique, answers to public health gaps.

The primary value proposition centers on being the sole provider for certain critical prophylactic needs. For instance, Valneva SE offers the world's first and only licensed single-shot Chikungunya vaccine, IXCHIQ^®. While this product faced temporary restrictions and a U.S. license suspension in August 2025, its initial commercial traction was evident, with sales reaching €7.6 million in the first nine months of 2025, up from €1.8 million in the same period of 2024. This vaccine was deployed in response to significant events, such as the major outbreak on the French island of La Réunion.

Another cornerstone is the protection against Japanese Encephalitis (JE) via IXIARO^®/JESPECT^®, which stands as the only US/EU approved vaccine for this disease. This product shows consistent growth, with sales hitting €74.3 million in the first nine months of 2025, a 12.5% increase over the first nine months of 2024. A clear validation of its value to defense and preparedness is the new $32.8 million contract secured with the U.S. Department of Defense (DoD) in January 2025.

Valneva SE is also positioned to address a major unmet medical need with VLA15, the only late-stage Lyme disease vaccine candidate. The Centers for Disease Control and Prevention estimates that approximately 476,000 people in the U.S. are diagnosed and treated for Lyme disease annually. The pivotal Phase 3 VALOR trial completed vaccinations, with outcomes expected in the first half of 2026. Positive final Phase 2 data, reported in November 2025, confirmed a strong immune response after a third booster dose, supporting the anticipated yearly vaccination schedule.

The convenience factor is built into the portfolio, particularly the single-dose convenience for travelers and the reliable supply for entities like the military personnel. This focus on ease of use, combined with the pipeline, defines the offering of prophylactic solutions for infectious diseases with high unmet need.

Here's a quick look at the commercial product performance through the first nine months of 2025:

Product	Value Proposition Focus	Sales (First Nine Months 2025)	Year-over-Year Growth (9M 2025 vs 9M 2024)
IXIARO®/JESPECT®	Only US/EU Approved JE Vaccine	€74.3 million	12.5%
IXCHIQ®	World's First/Only Single-Shot Chikungunya Vaccine	€7.6 million	Increase from €1.8 million
DUKORAL®	Cholera/ETEC Prophylaxis	€21.5 million	Decrease from €22.3 million

The overall financial context supports these value propositions, even with the IXCHIQ guidance adjustment. Valneva SE reiterated its full-year 2025 product sales guidance to be between €155-€170 million. The company also enhanced its financial flexibility in October 2025 by entering a debt facility of up to $500M, with an initial tranche of $215M.

The core value proposition is further supported by the pipeline's potential, which includes:

• Positive final Phase 2 data for VLA15 in November 2025.
• Pfizer aiming for regulatory submissions for VLA15 in 2026, pending positive Phase 3 data.
• Anticipated milestone payments and royalties from VLA15 starting in 2027, contingent on commercialization.
• Positive Phase 1 results for the second-generation Zika vaccine candidate, VLA1,601.

Valneva SE (VALN) - Canvas Business Model: Customer Relationships

You're looking at how Valneva SE manages its connections with the various groups that buy or influence its products as of late 2025. It's not one-size-fits-all; the approach shifts dramatically depending on whether you're selling a travel shot or co-developing a late-stage pipeline asset.

Transactional Sales Model for Commercial Travel Vaccines via Distributors and Pharmacies

For the core travel vaccine portfolio-IXIARO®/JESPECT®, DUKORAL®, and IXCHIQ®-the relationship is largely transactional, moving through established channels. Valneva's product sales for the first nine months of 2025 reached €119.4 million. This volume relies heavily on the efficiency of these third-party and direct sales relationships.

The company is actively managing the transition away from third-party distributors to improve margins, expecting these sales to fall below 5% of total sales by 2026/2027. For instance, DUKORAL® sales of €21.5 million in the first nine months of 2025 were affected by the gradual transition of distribution in Germany to CSL Seqirus. Valneva secured a new agreement with CSL Seqirus in June 2025 for Germany, covering IXCHIQ®, IXIARO®, and DUKORAL®, with an initial term of three years.

Key commercial sales figures for the first nine months of 2025 include:

• IXIARO®/JESPECT® sales: Data not isolated from total product sales.
• DUKORAL® sales: €21.5 million.
• IXCHIQ® sales: €7.6 million, up from €1.8 million in the same period of 2024.

Strategic, Long-Term Collaboration with Major Pharma (Pfizer) for R&D and Commercialization

The relationship with Pfizer, centered on the Lyme disease vaccine candidate VLA15, is deep and structured around shared risk and future rewards. This is a classic co-development partnership where Valneva SE leverages Pfizer's late-stage development and commercialization muscle. Valneva is responsible for funding 40% of the remaining shared development costs for VLA15, a step up from the initial 30% commitment.

The financial structure is heavily weighted toward future success, but Pfizer has already shown commitment by investing €90.5 million ($95 million) in Valneva in June 2022, acquiring an 8.1% stake. Revenues recognized from this collaboration in the first half of 2025 were €6.5 million.

Potential financial outcomes upon approval and commercialization in the US and Europe are substantial:

Milestone Type	Potential Amount	Royalty Rate
Early Commercial Milestones	Up to $143 million	Tiered, ranging from 14% to 22%
Cumulative Sales Milestones	Up to $100 million	Complements royalties

Direct, High-Touch Relationship Management with Government and Military Agencies (e.g., US DoD)

For the Japanese Encephalitis vaccine, IXIARO®, Valneva SE maintains a direct, high-touch relationship with the US Department of Defense (DoD). This customer segment values the fact that IXIARO® is the only JE vaccine approved by the US Food and Drug Administration (FDA) and has been trusted by the DoD for over ten years.

This relationship translates directly into guaranteed revenue streams, as seen with the January 2025 contract signing. You can see the direct impact on the books:

• New DoD Supply Contract (January 2025): Minimum value of $32.8 million for a one-year term.
• IXIARO®/JESPECT® sales growth: Increased by 31% to €54.7 million in the first half of 2025 compared to the first half of 2024, supported by DoD orders.

This direct channel offers predictable volume, which is a key differentiator from the more variable private travel market. It's a defintely stable anchor for that product line.

Scientific and Regulatory Dialogue with Public Health Bodies (FDA, EMA, CEPI)

The relationship with regulatory bodies like the FDA and EMA is critical, as approval status dictates market access and customer acceptance. Valneva SE's ability to engage in scientific dialogue underpins its commercial success.

Key regulatory milestones defining customer acceptance include:

• IXIARO®: The only JE vaccine approved by the US FDA.
• IXCHIQ®: Received marketing authorization from the UK's MHRA in February 2025.
• VLA15 (Lyme): The Phase 3 VALOR study is on track, with the objective for Pfizer to submit a Biologics License Application (BLA) to the US FDA and a Marketing Authorization Application (MMA) to the EMA in 2026, subject to positive data.

Finance: draft 13-week cash view by Friday.

Valneva SE (VALN) - Canvas Business Model: Channels

You're looking at how Valneva SE gets its products, like IXIARO and IXCHIQ, into the hands of customers and partners as of late 2025. It's a mix of direct selling, strategic partnerships, and government dealings.

Direct Sales Force in Core European Markets

Valneva SE maintains its own marketing and sales infrastructure in certain European countries, which you can consider its core direct channel. This in-house setup is complemented by new distribution deals for specific territories, like the one for Germany. For instance, the company distributes certain third-party products directly in countries where this infrastructure exists.

Distribution Partners like CSL Seqirus for Market Access in Specific Territories

For the crucial German market, Valneva entered an exclusive agreement with CSL Seqirus in June 2025. This three-year agreement replaces the prior one with Bavarian Nordic, which concludes at the end of December 2025. CSL Seqirus will begin commercializing Valneva's Japanese encephalitis vaccine, IXIARO, starting from January 2026. This partnership leverages CSL Seqirus's strong German footprint to cover Europe's largest travel vaccine market. The agreement includes minimum annual purchasing quantities.

Government Tenders and Contracts (e.g., for IXIARO to the US Department of Defense)

Direct engagement with government bodies remains a key channel for Valneva's established products. In the U.S., Valneva markets and distributes IXIARO directly to the military and the private travel market. You saw a significant recent win here: Valneva secured a new one-year supply contract with the U.S. Department of Defense (DoD) in January 2025.

This contract is worth a minimum of $32.8 million and allows for the purchase of additional doses over the following twelve months. Sales for IXIARO/JESPECT showed strong momentum, increasing by 31% to €54.7 million in the first half of 2025 compared to the first half of 2024. This direct channel has been relied upon by the U.S. military for over 10 years.

Partner's (Pfizer's) Global Commercial Network for Future VLA15 Launch

For the future Lyme disease vaccine candidate, VLA15, Pfizer holds sole commercial responsibility globally. This means Valneva's channel for VLA15 will primarily be Pfizer's established global commercial network upon approval. Pfizer is aiming to submit regulatory applications (BLA to the FDA and MAA to the EMA) in 2026, pending positive Phase 3 data. If that timeline holds, Valneva anticipates Pfizer launching the vaccine in the second half of 2027. The potential market size is substantial, with estimated peak annual sales expected to exceed $1 billion. Remember, Pfizer initially invested $130 million upfront in 2020 to support this collaboration.

Supply of Drug Substance to Partners (SII) for LMIC Distribution

A less visible but important channel involves supplying drug substance to manufacturing partners for distribution in specific markets. Valneva recognizes revenue from its exclusive license agreement with the Serum Institute of India (SII) for its single-shot chikungunya vaccine. The company's full-year 2025 product sales guidance, projected between €155-170 million, is dependent on the timing of shipments of this chikungunya vaccine drug substance to commercial partners in low- and middle-income countries (LMICs). For context, product sales in the first nine months of 2025 reached €119.4 million.

Here's a quick look at how these channels map to the products and recent financial activity:

Channel Type	Product Example(s)	Key Metric/Value	Timeframe/Status
Direct Sales (US Military)	IXIARO	$32.8 million minimum contract value	New one-year contract, commenced immediately (Jan 2025)
Distribution Partner (Germany)	IXIARO, IXCHIQ, DUKORAL	Three years agreement term	CSL Seqirus to commercialize IXIARO from Jan 2026
Partner Commercial Network	VLA15 (Lyme Disease)	Estimated peak annual sales > $1 billion	Launch expected H2 2027, pending 2026 regulatory submission
Drug Substance Supply to Partner	Chikungunya Vaccine	Shipment timing impacts guidance	Impacts 2025 Product Sales guidance of €155-170 million
Direct Sales (Travel/Private Market)	IXIARO/JESPECT	Sales growth of 31%	H1 2025 sales reached €54.7 million

Also, note the planned shift away from third-party distribution. Third-party sales in the first nine months of 2025 were €16.1 million, down from €22.5 million in the same period of 2024, due to discontinuing Rabipur/RabAvert and Encepur distribution in the UK and Canada as of January 2025. Valneva expects third-party sales to wind down to less than 5% of total sales by 2026/2027.

• Direct sales force supports proprietary vaccines in Valneva's core European markets.
• CSL Seqirus partnership for Germany begins commercialization of IXCHIQ in July 2025.
• The DoD contract is for IXIARO, the only JE vaccine approved for the U.S. military.
• Pfizer's investment in VLA15 was €90.5 million ($95 million) via an equity subscription in 2022.
• Revenues from collaborations/licensing were €6.5 million in H1 2025.

Finance: review the cash flow impact of the Q4 2025 debt refinancing by next Tuesday.

Valneva SE (VALN) - Canvas Business Model: Customer Segments

International travelers and expatriates seeking prophylactic travel vaccines utilize Valneva SE's commercial portfolio, which includes IXIARO®/JESPECT® (Japanese Encephalitis), DUKORAL® (Cholera/ETEC), and IXCHIQ® (Chikungunya).

Sales data for the Japanese Encephalitis vaccine, IXIARO®/JESPECT®, which is a key product for this segment, shows significant growth in the first half of 2025.

Metric	First Half (H1) 2025	First Half (H1) 2024	Growth
IXIARO®/JESPECT® Sales	€54.7 million	€41.9 million	30.6% increase
Traveler & DoD Growth (H1 2025 vs H1 2024)	Double-digit growth

The Chikungunya vaccine, IXCHIQ®, also targets this segment, with sales showing a substantial year-over-year increase early in 2025.

• IXCHIQ® sales in the first nine months (9M) of 2025 reached €7.6 million, up from €1.8 million in 9M 2024.
• IXCHIQ® sales in the first quarter (Q1) of 2025 were €3.0 million, compared to €0.2 million in Q1 2024.
• The general global market for Chikungunya vaccines is estimated at approximately $500 million in 2025.

Military and government agencies, specifically the US Department of Defense (DoD), are a distinct customer segment for the Japanese Encephalitis vaccine, IXIARO®.

• Valneva SE secured a new $32.8 million contract with the DoD in January 2025.
• Sales to the DoD showed double-digit growth in the first half of 2025 compared to the first half of 2024.

Public health organizations and endemic populations in Low- and Middle-Income Countries (LMICs) are a target for the Chikungunya vaccine, IXCHIQ®, especially following a temporary restriction in the U.S. market.

Valneva SE is focused on increasing sales in LMICs. The company expects product sales for 2025 to be between €170 - €180 million, with total revenues between €180 - €190 million.

Vaccine/Segment	2024 Sales	9M 2025 Sales
DUKORAL® Sales	€32.3 million	Included in total product sales of €119.4 million (9M 2025)
IXCHIQ® Sales (Launch Year)	€3.7 million	€7.6 million (9M 2025)

Individuals in Lyme disease endemic areas represent a future, significant customer segment for the investigational VLA15 vaccine candidate, developed with Pfizer.

• VLA15 targets six prevalent Borrelia serotypes, covering over >97% in the U.S. and Europe.
• The estimated global market opportunity for VLA15 is >$1 billion.
• The pivotal Phase 3 VALOR trial enrolled 9,437 participants.
• Valneva is eligible for upfront and milestone payments up to $408 million (having received $165 million) plus tiered sales royalties of 14-22% upon potential approval.
• Phase 3 data readout is on track for the first half (H1) of 2026.

Valneva SE (VALN) - Canvas Business Model: Cost Structure

You're looking at the expense side of Valneva SE's operations as of late 2025. It's a mix of heavy upfront science investment and scaling commercial costs, which is typical for a specialty vaccine company balancing pipeline advancement with product launches.

The High Research and Development (R&D) expenses are a core cost driver. For the full year 2025, Valneva SE guided total R&D investments to be between €80 million and €90 million. This spend is partially offset by grant fundings and anticipated R&D tax credits. To be fair, the actual spend through the first nine months of 2025 was already recorded at €59.7 million, showing the pace of investment leading into the final quarter.

Manufacturing and supply chain costs fall under Costs of Goods and Services Sold (COGS). Through September 30, 2025, COGS totaled €71.1 million for the nine-month period. This cost base reflects the production of proprietary vaccines like IXIARO®/JESPECT® and the newer IXCHIQ®.

Here's a breakdown of the COGS components for the first nine months of 2025:

Cost Component	Amount (9M 2025, € million)
IXIARO®/JESPECT® Sales COGS	27.3
DUKORAL® Sales COGS	10.3
Third-Party Products Distribution COGS	10.2
IXCHIQ® COGS	8.6
Idle Capacity and Unallocated Costs	8.2
Cost of Services	6.3

The gross margin on commercial product sales, excluding IXCHIQ®, improved to 57.2% in the first nine months of 2025, up from 48.6% in the same period of 2024, driven by better manufacturing performance.

Sales, General, and Administrative (SG&A) expenses support the commercial operations. For the first nine months of 2025, Valneva SE reported reduced spending in this area, which helped offset the operating loss. The components of SG&A for 9M 2025 were:

• Marketing and distribution expenses: €28.6 million.
• General and administrative expenses: €29.5 million.

So, the total reported SG&A for the period was approximately €58.1 million.

Debt servicing costs are reflected in the net finance expense. For the first nine months of 2025, Valneva SE recorded a net finance expense of €9.1 million. This cost environment is being actively managed, as the company announced a successful debt refinancing in October 2025, which should impact future interest costs.

Clinical trial costs for late-stage pipeline candidates remain a significant part of R&D. The increase in R&D spending through 9M 2025 was specifically driven by higher costs related to the Shigella vaccine candidate, following its R&D collaboration agreement, and costs for Phase 4 post-marketing commitments for IXCHIQ®. The major late-stage cost is the VALOR Phase 3 study for the Lyme disease vaccine candidate, with first data readout expected by the end of 2025. Partner funding, such as the R&D collaboration with LimmaTech Biologics AG for Shigella, helps offset these R&D expenses, alongside the general grant funding and R&D tax credits mentioned in the guidance.

Finance: draft 13-week cash view by Friday.

Valneva SE (VALN) - Canvas Business Model: Revenue Streams

You're looking at the actual money Valneva SE brings in, which is key to understanding their current financial health, so let's lay out the hard numbers from their latest reporting.

The primary driver remains Product Sales from their proprietary vaccines. For the full year 2025, Valneva SE guided product sales to be between €155 million and €170 million. The commercial business within this is still expected to be cash flow positive.

Looking at the nine-month period ending September 30, 2025, the product sales breakdown shows the performance of the core travel vaccines:

Product	Sales (9M 2025)	Sales (9M 2024)
IXIARO/JESPECT	€74.3 million	€66.0 million
DUKORAL	€21.5 million	€22.3 million
IXCHIQ	€7.6 million	€1.8 million

The sales for IXIARO/JESPECT in the first nine months of 2025 reached €74.3 million, marking a 12.5% increase over the same period in 2024. Sales of DUKORAL (Cholera/ETEC vaccine) for the first nine months of 2025 were €21.5 million. The recently launched IXCHIQ vaccine generated sales of €7.6 million in the first nine months of 2025, up from €1.8 million in the prior year period.

Valneva SE also generates revenue from its existing partnerships, which fall under other revenues:

• Other revenues, including revenues from collaborations, licensing and services, totaled €7.6 million in the first nine months of 2025, up from €4.2 million in the first nine months of 2024.
• This increase was mainly due to revenues recognized under the exclusive license agreement with the Serum Institute of India for Valneva SE's single-shot chikungunya vaccine.

The collaboration with Pfizer for the Lyme disease vaccine candidate, VLA15, is structured for future income, not immediate 2025 revenue recognition. Here are the potential future payments:

Milestone payments and royalties from the Pfizer collaboration for VLA15 are expected starting in 2027, contingent on successful commercialization. The potential amounts include:

• Up to $143 million based on early commercial milestones, pending approval and commercialization.
• Tiered royalties ranging from 14% to 22% on sales.
• An additional $100 million in milestone payments based on cumulative sales.

Also, Valneva SE is winding down its third-party distribution business, which contributed to product sales but is not a core long-term revenue stream. Third-party sales in the first nine months of 2025 were €16.1 million, down from €22.5 million in the same period of 2024, as the company expects this to be less than 5% of total sales by 2026/2027.