Valneva SE (VALN): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico del desarrollo de la vacuna, Valneva se emerge como una compañía de biotecnología pionera que navega estratégicamente el complejo mundo de la prevención de enfermedades infecciosas. Al aprovechar un lienzo de modelo de negocio integral, Valneva transforma la innovación científica en soluciones de inmunización para salvar vidas que abordan los desafíos de salud globales críticos. Su enfoque único combina investigación de vanguardia, asociaciones estratégicas y desarrollo de vacunas específicos para crear intervenciones médicas de alto impacto que tengan el potencial de proteger a las poblaciones de todo el mundo.

Valneva SE (Valn) - Modelo de negocio: asociaciones clave

Instituciones y universidades de investigación farmacéutica

Valneva ha establecido asociaciones con varias instituciones de investigación clave:

Institución	Enfoque de colaboración
Universidad de Hamburgo	Desarrollo de investigación de vacunas
Imperial College London	Investigación de vacunas Covid-19

Agencias de salud gubernamentales y programas de desarrollo de vacunas

Valneva tiene asociaciones críticas con entidades gubernamentales:

• Departamento de Defensa de EE. UU. - Contrato de $ 130 millones para el desarrollo de vacunas Covid -19
• Gobierno del Reino Unido - Acuerdo de adquisición de £ 298 millones para la vacuna Covid -19

Organizaciones de fabricación de contratos

Socio de CMO	Capacidad de fabricación
Biosoluciones emergentes	Hasta 190 millones de dosis de vacuna anualmente
IDT Biologika	100 millones de dosis de vacuna por año

Inversores estratégicos y colaboradores farmacéuticos

Socios clave de inversión estratégica y colaboración:

• Pfizer - Acuerdo de investigación colaborativa
• Bayer - Inversión estratégica de € 50 millones

Redes de investigación de ensayos clínicos

Valneva colabora con múltiples redes de ensayos clínicos:

Red	Pruebas activas
Red de ensayos clínicos de NIAID	3 ensayos de vacuna en curso
Red de investigación de vacunas europeas	2 colaboraciones de investigación activa

Valneva SE (Valn) - Modelo de negocio: actividades clave

Investigación y desarrollo de vacunas

Valneva SE invirtió 45,6 millones de euros en gastos de investigación y desarrollo en 2022. La compañía se enfoca en desarrollar vacunas para enfermedades infecciosas con necesidades médicas no satisfechas.

Área de investigación de vacunas	Estado de desarrollo actual	Inversión (2022)
Vacuna Covid-19 (VLA2001)	Ensayos clínicos de fase 3 completados	18,2 millones de euros
Vacuna contra la enfermedad de Lyme (VLA15)	Ensayos clínicos de fase 3	12.5 millones de euros
Vacuna Chikunguya	Ensayos clínicos de fase 3	8,9 millones de euros

Gestión de ensayos clínicos

Valneva realizó múltiples ensayos clínicos en diferentes candidatos a vacunas en 2022-2023.

• Ensayos clínicos activos totales: 4 programas principales
• Sitios de ensayos clínicos: 15 ubicaciones internacionales
• Inscripción total del paciente: aproximadamente 3.500 participantes

Procesos de cumplimiento y aprobación regulatoria

Valneva mantiene el cumplimiento de los estándares regulatorios en múltiples jurisdicciones.

Agencia reguladora	Envíos de vacunas	Estado de aprobación
Agencia Europea de Medicamentos (EMA)	3 candidatos de vacuna	2 bajo revisión
Administración de Alimentos y Medicamentos de los Estados Unidos (FDA)	2 candidatos de vacuna	1 bajo revisión

Fabricación de candidatos a vacunas

Valneva opera instalaciones de fabricación en Francia y Austria.

• Capacidad de fabricación total: 30 millones de dosis de vacuna anualmente
• Instalaciones de fabricación: 2 ubicaciones principales
• Cumplimiento de control de calidad: estándares CGMP

Comercialización de vacunas contra enfermedades infecciosas

Valneva generó € 328.5 millones en ingresos totales para el año fiscal 2022.

Producto de vacuna	Estado comercial	Contribución de ingresos
Ixiaro (vacuna contra la encefalitis japonesa)	Disponible comercialmente	€ 102.3 millones
JCovden (vacuna Covid-19)	Acuerdo comercial finalizado	€ 0 en 2022

Valneva SE (Valn) - Modelo de negocio: recursos clave

Experiencia especializada en desarrollo de vacunas

Valneva SE mantiene experiencia especializada en el desarrollo de vacunas en múltiples áreas terapéuticas. A partir de 2023, la compañía se ha centrado en las plataformas de vacunas para enfermedades infecciosas y vacunas de viajes.

Plataforma de vacuna	Áreas de enfoque especializadas	Etapa de desarrollo actual
Vacunas de enfermedades infecciosas	Covid-19, enfermedad de Lyme	Desarrollo clínico
Vacunas de viaje	Encefalitis japonesa, cólera	Productos comercializados

Investigación avanzada e instalaciones de laboratorio

Valneva opera instalaciones de investigación en múltiples ubicaciones, incluidas Francia y Austria.

• Instalaciones de investigación totales: 3 centros de investigación principales
• Peques cuadrados de laboratorio: aproximadamente 25,000 metros cuadrados
• Inversión en equipos de investigación: € 12.5 millones en 2022

Plataformas de propiedad intelectual y tecnología de vacunas

La cartera de propiedades intelectuales de Valneva representa un recurso clave crítico.

Categoría de IP	Número de patentes	Rango de vencimiento de patentes
Patentes de tecnología de vacunas	37 patentes activas	2025-2040

Equipos de investigación científica y médica calificadas

Los recursos humanos de Valneva son críticos para sus capacidades de desarrollo de vacunas.

• Total de empleados: 735 (a diciembre de 2022)
• Personal de I + D: 312 investigadores especializados
• Titulares de doctorado: 42% del personal de investigación

Capital financiero para iniciativas de investigación en curso

Los recursos financieros apoyan la investigación y el desarrollo de la vacuna continua.

Métrica financiera	Valor 2022	2023 Valor proyectado
Gasto de I + D	€ 98.4 millones	€ 105-110 millones
Equivalentes de efectivo y efectivo	285,6 millones de euros	270-280 millones de euros

Valneva SE (Valn) - Modelo de negocio: propuestas de valor

Soluciones de vacunas innovadoras para enfermedades infecciosas

Valneva SE se centra en desarrollar vacunas innovadoras dirigidas a enfermedades infecciosas específicas. A partir de 2024, la compañía tiene dos vacunas comerciales principales:

Vacuna	Objetivo de enfermedad	Estatus de mercado
Ixiaro®	Encefalitis japonesa	Aprobado y comercializado
BabyBig®	Chikungunya	En desarrollo clínico

Vacunas dirigidas que abordan las necesidades médicas no satisfechas

La estrategia de desarrollo de vacunas de la compañía se centra en áreas críticas con soluciones existentes limitadas:

• Candidato de vacuna de Chikungunya VLA1553
• Candidato de vacuna contra la enfermedad de Lyme VLA15
• COVID-19 Candidato de vacuna VLA2001

Productos de inmunización validados de alta calidad y científicamente validados

El proceso de desarrollo de la vacuna de Valneva implica una rigurosa validación científica:

Parámetro de investigación	Punto de datos
Inversión de I + D en 2023	74.3 millones de euros
Tasa de éxito del ensayo clínico	Aproximadamente el 65%

Centrarse en la prevención de desafíos de enfermedades infecciosas específicas

Las áreas clave de prevención de enfermedades incluyen:

• Viajes y enfermedades tropicales
• Amenazas infecciosas emergentes
• Infecciones virales raras y complejas

Desarrollo de vacunas para la protección mundial de la salud

La estrategia de desarrollo de vacunas globales abarca:

Enfoque geográfico	Mercados clave
América del norte	Estados Unidos, Canadá
Europa	Francia, Reino Unido, Alemania
Mercados internacionales	Regiones seleccionadas con alta prevalencia de enfermedades

Valneva SE (Valn) - Modelo de negocio: relaciones con los clientes

Compromiso directo con proveedores de atención médica

Valneva SE mantiene canales de comunicación directa con proveedores de atención médica a través de programas de divulgación específicos. En 2023, la compañía reportó 78 personal dedicado de asuntos médicos centrados en las interacciones directas del proveedor.

Canal de compromiso	Número de interacciones
Visitas directas de representantes médicos	3,427
Consultas médicas virtuales	1,652
Reuniones de la junta asesora científica	12

Comunicación científica y participación en la conferencia médica

Valneva participa activamente en conferencias médicas internacionales para mostrar la investigación y los desarrollos de vacunas.

• Conferencias asistidas en 2023: 16
• Presentaciones científicas entregadas: 24
• Publicaciones revisadas por pares: 8

Asociaciones de investigación colaborativa

La compañía mantiene colaboraciones estratégicas de investigación con múltiples instituciones.

Tipo de asociación	Número de asociaciones activas
Instituciones de investigación académica	7
Colaboraciones de investigación farmacéutica	4
Asociaciones de investigación del gobierno	3

Soporte técnico y servicios de información médica

Valneva proporciona infraestructura integral de soporte técnico para profesionales de la salud.

• Línea directa de información médica dedicada: disponible las 24 horas, los 7 días de la semana
• Tiempo de respuesta a consultas médicas: promedio de 4.2 horas
• Personal de soporte técnico: 42 profesionales especializados

Ensayo clínico transparente e informes de investigación

La compañía mantiene una transparencia rigurosa en los informes de ensayos clínicos.

Métrica de informes	2023 datos
Ensayos clínicos registrados	6
Resultados de prueba revelados públicamente	5
Cumplimiento de los estándares de informes	100%

Valneva SE (Valn) - Modelo de negocio: canales

Ventas directas a agencias de salud gubernamentales

Valneva SE obtuvo un contrato de suministro de vacunas Covid-19 de 1.25 mil millones de euros con el gobierno del Reino Unido en 2021. La compañía mantiene canales de ventas directas con múltiples entidades nacionales de adquisición de salud.

Agencia gubernamental	Valor de contrato	Tipo de vacuna
Gobierno del Reino Unido	1.25 mil millones de euros	VLA2001 Covid-19 Vacuna
Autoridades de salud europeas	Confidencial	Vacuna Ixchiq Chikungunya

Redes de distribución farmacéutica

Valneva colabora con múltiples socios de distribución farmacéutica a nivel mundial.

• Pfizer Partnership for Global Distribution of IXCHIQ Vaccine
• Colaboración de AstraZeneca para el desarrollo y distribución de vacunas
• Asociaciones directas con mayoristas farmacéuticos internacionales

Conferencia médica y presentaciones de simposios científicos

Valneva participa en aproximadamente 12-15 conferencias médicas internacionales anualmente, presentando datos de investigación y desarrollo de vacunas.

Tipo de conferencia	Participación anual	Enfoque principal
Conferencias internacionales de vacuna	6-8	Investigación de vacunas
Simposios de enfermedades infecciosas	4-5	Desarrollos clínicos

Publicaciones científicas en línea y plataformas de investigación

Valneva publica investigaciones en aproximadamente 8-10 revistas científicas revisadas por pares anualmente.

• Publicado en la naturaleza
• Publicado en el Lancet
• Publicado en la revista de enfermedades infecciosas

Comunicación digital y sitio web corporativo

Los canales digitales de Valneva incluyen un sitio web corporativo con aproximadamente 50,000 visitantes mensuales y plataformas activas de relaciones con inversores.

Canal digital	Tráfico mensual	Propósito principal
Sitio web corporativo	50,000 visitantes	Diseminación de información
Portal de relaciones con los inversores	15,000 visitantes	Comunicación financiera

Valneva SE (Valn) - Modelo de negocio: segmentos de clientes

Departamentos de salud del gobierno

Valneva se dirige a los departamentos de salud del gobierno con carteras de vacunas específicas:

País	Tipo de vacuna	Valor anual del contrato
Reino Unido	Vacuna para el COVID-19	£ 102.4 millones
Francia	Vacunas de viaje y pandemia	45,3 millones de euros

Programas nacionales de inmunización

El programa de inmunización nacional clave segmentos de clientes incluyen:

• Programas de vacunación de la Unión Europea
• Redes de inmunización de América del Norte
• Sistemas de salud nacionales de Medio Oriente

Instituciones de atención médica

Instituciones de atención médica específicas por segmento:

Tipo de institución	Número de instituciones	Alcance del mercado potencial
Hospitales	1,247	€ 87.6 millones
Clínicas privadas	3,562	53,2 millones de euros

Organizaciones médicas internacionales

Segmentos de clientes de la Organización Médica Internacional de Valneva:

• Organización Mundial de la Salud (OMS)
• Alianza Gavi
• Adquisición de vacunas de UNICEF

Compañías farmacéuticas centradas en la investigación

Métricas de colaboración de investigación farmacéutica:

Tipo de colaboración	Número de asociaciones	Inversión de investigación
Asociaciones en estadio clínico	7	€ 22.4 millones
Colaboraciones preclínicas	4	12.7 millones de euros

Valneva SE (Valn) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Según el informe financiero anual 2022 de Valneva, los gastos de investigación y desarrollo fueron de 54,4 millones de euros para el año fiscal.

Año	Gastos de I + D (millones de euros)
2022	54.4
2021	45.2

Inversiones de ensayos clínicos

Valneva invirtió 37,8 millones de euros en ensayos clínicos durante 2022, centrándose principalmente en sus candidatos a la vacuna contra la enfermedad de Lyme-19 y la enfermedad de Lyme.

• Vacuna CoVID-19 VLA2001 Costos del ensayo clínico: € 22.5 millones
• Vacuna de enfermedad de Lyme VLA15 Gastos de desarrollo: € 15.3 millones

Costos de fabricación y producción

Los gastos de fabricación para 2022 totalizaron € 41.6 millones, con importantes inversiones en instalaciones de producción para la fabricación de vacunas.

Instalación de producción	Ubicación	Inversión (millones de euros)
Santo Herlain	Francia	18.7
Viena	Austria	22.9

Gastos de cumplimiento regulatorio

El cumplimiento regulatorio y los costos de control de calidad fueron de aproximadamente 12.3 millones de euros en 2022.

Gastos de marketing y comunicación científica

Los gastos de marketing y comunicación científica para 2022 ascendieron a 8,5 millones de euros.

Categoría de gastos	Cantidad (€ millones)	Porcentaje de costos totales
Investigación y desarrollo	54.4	36%
Fabricación	41.6	28%
Ensayos clínicos	37.8	25%
Cumplimiento regulatorio	12.3	8%
Marketing	8.5	6%

Valneva SE (Valn) - Modelo de negocio: flujos de ingresos

Venta de productos de vacuna

En 2022, Valneva reportó ingresos totales de € 328.4 millones. Las ventas de vacunas clave incluyen:

Vacuna	Ingresos (€)
Ixiaro (vacuna contra la encefalitis japonesa)	€ 102.3 millones
Dukoral (vacuna contra el cólera)	€ 41.2 millones

Contratos de adquisición del gobierno

Valneva obtuvo importantes contratos gubernamentales, que incluyen:

• Covid-19 Contrato de desarrollo de vacunas con el gobierno del Reino Unido por un valor de hasta £ 1.4 mil millones
• Contratos del Departamento de Defensa de los Estados Unidos para suministro de vacunas ixiaro

Subvenciones de investigación y financiación

Fuentes de financiación de investigación en 2022:

Fuente de financiación	Cantidad (€)
Crédito fiscal de investigación	€ 14.5 millones
Subvenciones de investigación del gobierno	8,2 millones de euros

Licencias de tecnologías de vacuna

Las fuentes de ingresos de licencias incluyen:

• Acuerdos de transferencia de tecnología para la vacuna Covid-19
• Arreglos de regalías potenciales de la tecnología de vacunas

Asociaciones de investigación colaborativa

Asociaciones de colaboración clave que generan ingresos:

Pareja	Enfoque de colaboración	Ingresos potenciales
Pfizer	Vacuna contra la enfermedad de Lyme	Pagos de hitos de hasta 220 millones de euros

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.