Valneva SE (VALN): Análisis PESTLE [Actualizado en enero de 2025]

En el panorama dinámico del desarrollo de la vacuna, Valneva SE emerge como un jugador fundamental que navega por un complejo ecosistema global de desafíos y oportunidades. Este análisis integral de mano de mortero profundiza en los factores externos multifacéticos que dan forma a la trayectoria estratégica de la Compañía, revelando cómo las regulaciones políticas, la volatilidad económica, los cambios sociales, las innovaciones tecnológicas, los marcos legales y las consideraciones ambientales se entrelazan para definir el potencial de crecimiento y el impacto de Valneva en el rápido desarrollo de la salud que evolucionan rápidamente. y sectores de biotecnología.

Valneva SE (Valn) - Análisis de mortero: factores políticos

Paisaje regulatorio europeo

La Agencia Europea de Medicamentos (EMA) aprobó la vacuna Covid-19 VLA2001 de Valneva el 24 de junio de 2022. La vacuna recibió autorización de marketing condicional en la Unión Europea. Los procesos de aprobación regulatoria en Europa requieren datos integrales de ensayos clínicos y evaluaciones de seguridad estrictas.

Cuerpo regulador	Estado de aprobación	Fecha
Agencia Europea de Medicamentos	Autorización de marketing condicional	24 de junio de 2022
Agencia Reguladora de Productos de Medicamentos y Salud del Reino Unido	Autorización temporal	22 de abril de 2022

Impactos del Brexit

Brexit introdujo complejidades regulatorias significativas para las operaciones transfronterizas de Valneva entre los mercados del Reino Unido y la UE.

• Requisitos adicionales de cumplimiento regulatorio
• Aumento de la documentación para la distribución de la vacuna transfronteriza
• Posibles barreras de aranceles y comerciales

Financiación y apoyo del gobierno

Valneva recibió importantes fondos gubernamentales para la investigación de vacunas:

Gobierno	Monto de financiación	Proyecto de vacuna
Gobierno del Reino Unido	£ 298 millones	Desarrollo de vacunas Covid-19
Gobierno francés	30 millones de euros	Soporte de infraestructura de investigación

Tensiones geopolíticas

Los desafíos de distribución de vacunas internacionales surgieron de las tensiones geopolíticas globales, particularmente durante la pandemia Covid-19.

• Interrupciones de la cadena de suministro en múltiples mercados
• Restricciones de exportación en ciertas regiones
• Nacionalismo de vacuna que impacta la distribución global

Valneva SE (Valn) - Análisis de mortero: factores económicos

Entorno de inversión de biotecnología volátil

Capitalización de mercado de Valneva SE a partir de enero de 2024: € 360.42 millones. Rango de volatilidad del precio de las acciones en 2023: € 4.70 - € 8.50 por acción.

Métrica financiera	Valor 2022	Valor 2023
Ganancia	€ 428.4 millones	387.2 millones de euros
Lngresos netos	18,6 millones de euros	€ -12.3 millones
Gastos de I + D	115.7 millones de euros	€ 98.4 millones

Dependencia del desarrollo de la vacuna

Ingresos de la Asociación de Vacunas de CoVID-19 con Pfizer: € 100.8 millones en 2023. Portafolio total de desarrollo de vacunas: 4 candidatos a la vacuna clínica en etapa.

Impacto en el gasto de atención médica

Mercado global de vacunas Valor proyectado para 2027: € 73.5 mil millones. La cuota de mercado de Valneva en viajes y vacunas contra enfermedades infecciosas: 2.3%.

Segmento de mercado	2023 inversión	Crecimiento proyectado
Vacunas de viaje	€ 157.6 millones	5.4% CAGR
Vacunas de enfermedades infecciosas	226,3 millones de euros	6.2% CAGR

Riesgos de tipo de cambio de divisas

Distribución de ingresos internacionales:

• Europa: 62%
• Estados Unidos: 28%
• Resto del mundo: 10%

Costos de cobertura de divisas en 2023: € 4.2 millones.

Pareja	2023 volatilidad	Impacto en los ingresos
EUR/USD	±5.6%	12.7 millones de euros
EUR/GBP	±3.2%	6.4 millones de euros

Valneva SE (Valn) - Análisis de mortero: factores sociales

Aumento de la conciencia pública y la demanda de tecnologías de vacunación

El tamaño del mercado de la vacuna global alcanzó los $ 62.1 mil millones en 2022, con un crecimiento proyectado a $ 85.7 mil millones para 2030, que representa una tasa compuesta anual del 4.3%.

Métricas de conciencia de vacunación	Datos 2022	2023 proyección
Tasa de conciencia de vacunación global	68.5%	72.3%
Confianza pública en vacunas	65.7%	69.2%
Cumplimiento de la vacunación para adultos	52.4%	56.1%

Presiones de atención médica cambiantes Post-Covid-19 Pandemic

El gasto en salud global aumentó a $ 9.4 billones en 2023, con una asignación de investigación de vacunas a $ 42.5 mil millones.

Cambios de prioridad de atención médica	Pre-pandemia	Postpandemia
Presupuesto de preparación pandemia	$ 12.3 mil millones	$ 37.6 mil millones
Inversión en tecnología de vacunas	$ 18.7 mil millones	$ 42.5 mil millones
Investigación de enfermedades infecciosas	$ 22.1 mil millones	$ 51.3 mil millones

Creciente enfoque en la salud preventiva y la medicina de viaje

Se espera que el mercado de la vacuna de viajes alcance los $ 7.2 mil millones para 2027, con un 6,8% de CAGR de 2022.

Métricas de atención médica preventiva	Valor 2022	Proyección 2027
Mercado de vacunas de viajes	$ 5.3 mil millones	$ 7.2 mil millones
Gastos de atención médica preventiva	$ 1.2 billones	$ 1.6 billones
Consultas de medicina de viaje	42.6 millones	58.3 millones

Cambios demográficos que influyen en la dinámica del mercado de vacunas

Se espera que la población mundial de más de 65 llegue a 1,5 mil millones para 2050, impulsando la demanda de vacunas.

Impacto de la vacuna demográfica	Datos 2022	2030 proyección
Población de más de 65	771 millones	1.100 millones
Tasa de vacunación de ancianos	57.3%	65.7%
Prevalencia de enfermedades crónicas	42.5%	48.2%

Valneva SE (Valn) - Análisis de mortero: factores tecnológicos

Plataformas de desarrollo de vacunas avanzadas y tecnología de ARNm

Valneva SE se centra en desarrollar tecnologías de vacunas innovadoras con inversiones de plataformas específicas:

Plataforma de vacuna	Inversión (€)	Estado de desarrollo
Vacuna contra la enfermedad de Lyme VLA15	25.4 millones	Ensayos clínicos de fase 3
Vacuna inactivada de Covid-19	19.2 millones	Descontinuado en 2022
Vacuna Chikunguya	12.7 millones	Desarrollo clínico de fase 3

Inversión continua en investigación e innovación

Los gastos de I + D de Valneva demuestran un compromiso con el avance tecnológico:

Año	Gastos de I + D (millones de euros)	Porcentaje de ingresos
2022	84.3	42.6%
2021	71.6	38.9%

Tecnologías de salud digital que mejoran la distribución y seguimiento de las vacunas

Inversiones clave de tecnología de salud digital:

• Sistemas de monitoreo de la cadena de frío: inversión de € 3.2 millones
• Plataformas de seguimiento de vacunas en tiempo real
• Integración del registro de inmunización digital

Métodos computacionales emergentes para el diseño y las pruebas de las vacunas

Inversiones de tecnología computacional en desarrollo de vacunas:

Tecnología	Inversión (€)	Objetivo
Selección de antígeno impulsado por IA	5.6 millones	Acelerar la identificación del candidato de vacuna
Detección de aprendizaje automático	4.3 millones	Optimizar los parámetros de diseño de vacunas
Mapeo de epítopos computacionales	3.9 millones	Mejorar la predicción de inmunogenicidad

Valneva SE (Valn) - Análisis de mortero: factores legales

Cumplimiento regulatorio estricto en sectores farmacéuticos y de vacunas

Valneva SE opera bajo estrictos marcos regulatorios en múltiples jurisdicciones. A partir de 2024, la compañía debe cumplir con:

Cuerpo regulador	Requisitos clave de cumplimiento	Costo de cumplimiento anual
Agencia Europea de Medicamentos (EMA)	GMP, regulaciones de ensayos clínicos	3.2 millones de euros
FDA (Estados Unidos)	Aplicaciones de IN, estándares de fabricación	$ 4.5 millones
MHRA (Reino Unido)	Protocolos de desarrollo de vacunas	£ 2.7 millones

Protección de propiedad intelectual para tecnologías de vacuna

Desglose de la cartera de patentes:

Categoría de patente	Número de patentes activas	Valor estimado
Tecnología de vacunas	37	78.5 millones de euros
Procesos de fabricación	22	45,3 millones de euros
Innovaciones terapéuticas	15	32,1 millones de euros

Acuerdos complejos de licencias internacionales y distribución

Valneva SE mantiene múltiples acuerdos de licencia internacional:

Pareja	Tipo de acuerdo	Ingresos anuales	Duración del contrato
Pfizer	Distribución de vacunas	€ 22.6 millones	5 años
Gsk	Colaboración de investigación	€ 15.4 millones	3 años
Merck	Licencias de tecnología	18,9 millones de euros	4 años

Posibles problemas de responsabilidad relacionados con el desarrollo y distribución de la vacuna

Cobertura de seguro de responsabilidad civil:

Categoría de responsabilidad	Cantidad de cobertura	Prima anual
Responsabilidad del producto	250 millones de euros	€ 4.7 millones
Riesgo de ensayo clínico	150 millones de euros	3.2 millones de euros
Cumplimiento regulatorio	€ 100 millones	€ 2.5 millones

Valneva SE (Valn) - Análisis de mortero: factores ambientales

Prácticas de fabricación sostenible en la producción de vacunas

Valneva SE implementa la certificación ISO 14001: 2015 de gestión ambiental en sus instalaciones de fabricación en Escocia y Austria. El sitio de Viena de la compañía consume 4.250 MWh de energía renovable anualmente, lo que representa el 62% del consumo total de energía de las instalaciones.

Ubicación	Consumo anual de energía	Porcentaje de energía renovable
Instalación de Viena	4.250 MWH	62%
Instalación de Escocia	3.780 MWh	45%

Reducción de la huella de carbono en los procesos de investigación y desarrollo

Valneva se redujo las emisiones directas de CO2 en 18.4 toneladas métricas en 2022, implementando equipos de laboratorio de eficiencia energética y optimización de flujos de trabajo de investigación.

Año	Reducción de emisiones de CO2	Inversiones de eficiencia energética
2022	18.4 toneladas métricas	€475,000

Abastecimiento ético de materias primas para el desarrollo de vacunas

Valneva SE mantiene un estricto código de conducta de proveedores, con el 97% de los proveedores de materias primas certificadas para estándares ambientales y éticos.

Categoría de proveedor	Tarifa de certificación	Frecuencia de auditoría
Proveedores de materia prima	97%	Anual

El cambio climático impacta en los patrones de enfermedades infecciosas y la investigación de vacunas

Valneva SE asignó € 2,3 millones en 2022 para investigaciones que exploran las adaptaciones de enfermedad infecciosa relacionadas con el cambio climático, centrándose en el desarrollo de la vacuna contra la enfermedad transmitida por vectores.

Enfoque de investigación	Inversión	Duración de la investigación
Investigación de enfermedades climáticas infecciosas	€ 2.3 millones	2022-2024

Valneva SE (VALN) - PESTLE Analysis: Social factors

Core focus on vaccines for infectious diseases with significant unmet medical needs (e.g., Lyme, Chikungunya).

Valneva's primary social contribution is its focus on infectious diseases where patient need is high and existing solutions are scarce. You see this clearest in the pipeline: the Lyme disease vaccine candidate, VLA15, is the only one in advanced clinical development globally, and it targets the six most prevalent Borrelia serotypes, covering over 97% of cases in the U.S. and Europe.

For Chikungunya, the single-shot vaccine IXCHIQ® already has approvals in major markets for adults, and the company reported a robust, sustained 98.3% sero-response rate one year after a single dose in adolescents in January 2025. This focus means they are tackling serious, growing public health threats, which is a huge social tailwind. The downside is that regulatory setbacks, like the U.S. license suspension for IXCHIQ® in August 2025 over safety concerns, can immediately impact public trust and sales, which hit €7.6 million in the first nine months of 2025.

Commitment to global vaccine equity, ensuring access in Low- and Middle-Income Countries (LMICs).

This is a critical social factor for a vaccine company, and Valneva has a clear strategy to address it. They recognize that the people who need a vaccine like IXCHIQ® most are often in endemic, low-income regions. To be fair, this isn't just altruism; it's a dual-market strategy.

The company has established key partnerships to ensure broad access, including an agreement with the Serum Institute of India (SII) for Asia and with Instituto Butantan for the Americas. Plus, they secured a significant $41.3 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to support wider access to the Chikungunya vaccine.

Here's the quick math on their 2025 guidance: their full-year product sales forecast of €155-170 million is explicitly dependent on the timing of shipments of chikungunya vaccine drug substance to these commercial partners in LMICs.

Demand for proprietary travel vaccines (IXIARO, DUKORAL) is sensitive to global travel trends.

The performance of their commercial portfolio-Japanese Encephalitis vaccine IXIARO®/JESPECT® and Cholera/ETEC-diarrhea vaccine DUKORAL®-is a direct reflection of global travel confidence and endemic outbreaks. Travel vaccines are a highly discretionary purchase, so sales are sensitive to geopolitical stability or pandemic-related restrictions.

In the first nine months of 2025, IXIARO®/JESPECT® sales showed a strong increase of 12.5%, reaching €74.3 million, which suggests a healthy rebound in global travel and continued demand from the U.S. Department of Defense (DoD). DUKORAL® sales were €21.5 million in the first nine months of 2025, a slight drop from the prior year, but its social value was underscored by a €1.1 million supply of doses in Q1 2025 to combat an outbreak on the French island of Mayotte. That's a concrete example of social need driving revenue.

Proprietary Travel Vaccine	Sales (9M 2025)	YoY Change (9M 2025 vs. 9M 2024)	Key Social/Market Driver
IXIARO®/JESPECT®	€74.3 million	+12.5%	Global travel recovery, DoD contracts
DUKORAL®	€21.5 million	Slight decrease (due to FX/distribution changes)	Outbreak response (e.g., €1.1M for Mayotte in Q1 2025)
IXCHIQ®	€7.6 million	N/A (recent launch)	U.S. license suspension is a major headwind

Strong ESG focus on employee satisfaction and high ethical standards across the organization.

A strong social license to operate requires high ethical standards and a committed workforce. Valneva addresses this through a robust Corporate Compliance and Ethics framework, including policies on Anti-Bribery, Anti-Corruption, and Human Rights. They defintely take internal culture seriously.

Their workforce composition and commitment to fairness are measurable:

• Workforce Gender Balance: 58% of all employees are women.
• Gender Equality Index (France): Scored 94/100 for 2024, demonstrating strong parity.
• Labor Relations: 100% of employees within the European Union are covered by collective agreements.

What this estimate hides is the need for continuous improvement: the company has a new People & Organization action plan for 2025-2027, which includes implementing an annual employee satisfaction survey by 2027 to systematically identify areas for improvement in engagement.

Valneva SE (VALN) - PESTLE Analysis: Technological factors

Total R&D investment is expected to be between €80 million and €90 million for 2025.

Valneva's commitment to innovation is clear in its projected research and development (R&D) spend for the 2025 fiscal year. The company is guiding for a total R&D investment between €80 million and €90 million. This significant allocation underscores their strategy to push multiple late-stage clinical programs forward, a critical factor for a specialized vaccine company.

This level of investment is defintely a high-stakes bet, but it's necessary to move candidates like the Lyme disease vaccine through the final, most expensive trial phases. Here's the quick math: committing up to €90 million in R&D is a direct signal to the market that they are prioritizing pipeline execution over short-term profitability, which is typical for a growth-focused biotech.

Lyme disease vaccine (VLA15) Phase 3 VALOR study data readout is expected by the end of 2025.

The single biggest near-term technological catalyst for Valneva is the Phase 3 VALOR study for VLA15, their Lyme disease vaccine candidate. The market is keenly awaiting the data readout, which is expected by the end of 2025. This vaccine, if successful, represents a potential first-in-class solution for a significant unmet medical need in the US and Europe.

The VALOR study's results will either validate years of technological development or force a major strategic pivot. Honestly, the success of VLA15 is the primary factor driving the company's valuation right now. If the data is positive, it unlocks a massive market opportunity; if not, the technological risk profile rises sharply.

Advancing a second-generation Zika vaccine candidate (VLA1601) with positive Phase 1 results.

Beyond the headline VLA15 program, Valneva is also advancing VLA1601, a second-generation vaccine candidate targeting the Zika virus. The technology has already proven its initial promise, having delivered positive Phase 1 results. This candidate is built on their proprietary inactivated vaccine platform, a technology they know well and have successfully commercialized before.

The positive Phase 1 results demonstrated good tolerability and immunogenicity, which is a key technical hurdle cleared. This program shows their ability to rapidly apply their core technological strengths to emerging global health threats. Plus, a second-generation approach means they are learning from and improving upon earlier vaccine designs, aiming for a more robust or easier-to-manufacture product.

Leveraging proprietary technology platforms to develop first- or only-in-class vaccine solutions.

Valneva's long-term competitive edge rests on its proprietary technology platforms. These are not just buzzwords; they are the engine for developing first- or only-in-class vaccine solutions, which is the most valuable segment of the vaccine market. Their two main technological pillars are the inactivated whole-virus vaccine platform and their VLA15-specific technology.

The inactivated whole-virus platform, used for their commercialized Japanese Encephalitis vaccine (IXIARO) and the Zika candidate (VLA1601), is a proven technology for inducing a broad immune response. This technological capability allows them to tackle complex viruses where subunit vaccines have struggled.

Here is a breakdown of the key technological programs and their near-term milestones:

Technological Program	Platform/Technology	2025 Key Milestone	Strategic Value
VLA15 (Lyme Disease)	Proprietary OspA-based Lipidated Recombinant Protein	Phase 3 VALOR Study Data Readout (End of 2025)	Potential First-in-Class Vaccine for a Major Unmet Need
VLA1601 (Zika)	Inactivated Whole-Virus Vaccine Platform	Advancing to Next Clinical Phase Post-Positive Phase 1	Leveraging Proven Technology for an Emerging Threat
R&D Investment	Overall Pipeline Funding	€80M to €90M Total Spend	Sustaining High-Value Late-Stage Clinical Trials

The ability to consistently generate novel, complex vaccine candidates from these platforms is what differentiates Valneva. It's not just about one drug; it's about a repeatable, high-value process. Finance: track the R&D spend against the €80M to €90M guidance quarterly to ensure capital is efficiently deployed against these technical goals.

Valneva SE (VALN) - PESTLE Analysis: Legal factors

US FDA temporary license suspension for IXCHIQ created immediate regulatory risk.

The most immediate and significant legal challenge in 2025 was the US Food and Drug Administration (FDA) suspension of the license for Valneva's chikungunya vaccine, IXCHIQ. This suspension, effective August 25, 2025, was a sudden reversal, requiring the Company to immediately halt all shipping and selling of the vaccine in the United States. The FDA cited four new reports of serious adverse events (SAEs) consistent with chikungunya-like illness, which they concluded altered the vaccine's benefit-risk profile.

This regulatory setback creates a substantial revenue risk. For context, IXCHIQ sales contributed €7.5 million to the Company's total product sales of €91.0 million in the first half of 2025. Honestly, losing the US market, even temporarily, puts immediate pressure on the commercial business. Valneva is evaluating the financial impact but has, as of November 2025, reiterated its full-year product sales guidance of €155-170 million, which depends heavily on sales in other licensed territories and shipments to Low- and Middle-Income Countries (LMICs).

Compliance with stringent global regulatory frameworks like the EU's CSRD and US SEC/Nasdaq rules.

As a dual-listed company on Euronext Paris and Nasdaq, Valneva navigates a complex web of compliance rules. The European Union's Corporate Sustainability Reporting Directive (CSRD) has imposed significant new reporting obligations for the Company, demanding extensive, audited disclosure on environmental, social, and governance (ESG) metrics starting soon. This is a massive administrative lift.

Plus, the Nasdaq listing exposes Valneva to the US system, including a higher risk of shareholder litigation following adverse regulatory news. For example, a legal investigation was launched in March 2025 by a US law firm following the CDC's notice about adverse events linked to IXCHIQ. This kind of scrutiny diverts time and resources, and it's a defintely critical legal overhead. Compliance isn't just about filing paperwork; it's about protecting the stock price.

Here's a quick look at key compliance metrics:

Compliance Area	2025 Legal/Regulatory Impact	Key Metric/Status (2024/2025)
US FDA IXCHIQ Status	License Suspension (Aug 2025)	Immediate halt of US sales.
EU CSRD	Significant new reporting obligations	Requires extensive ESG data collection and audit.
US Shareholder Litigation Risk	Active investigation initiated in March 2025	Follows adverse event reports for IXCHIQ.
French Gender Equality Index	Legal obligation for French entities	Score of 94/100 (for 2024 reporting).

Need to secure additional label extensions for IXCHIQ in key markets like Brazil and for adolescents.

Expanding the approved use (label extension) for IXCHIQ is a key legal and commercial opportunity, but it requires navigating multiple national regulatory bodies. The good news is that the Brazilian Health Regulatory Agency (ANVISA) granted marketing authorization in April 2025 for individuals 18 years and older, marking the first approval in a chikungunya-endemic country. This is a major win for market access.

For the adolescent population (ages 12 to 17), the path is moving forward in Europe, with the European Medicines Agency (EMA) recently granting a positive opinion for the label extension. Applications are also under review by the US FDA, Health Canada, and the UK MHRA. The clinical data supports this, showing a sustained 98.3% sero-response rate one-year after a single vaccination in adolescents. Still, the US FDA's recent adult license suspension will likely complicate and slow down their review of the adolescent application.

Intellectual property (IP) protection is a defintely critical risk factor for the vaccine pipeline.

Protecting the intellectual property (IP) for novel vaccine candidates is a core legal risk for a specialty vaccine company like Valneva. The entire future value of the pipeline, especially the Lyme disease vaccine candidate VLA15 and the Shigella vaccine candidate S4V2, hinges on obtaining and maintaining robust patent protection globally.

The partnership with Pfizer for VLA15 helps mitigate some of the IP risk and cost, as Pfizer is aiming to submit regulatory applications in 2026. What this estimate hides, though, is the ever-present threat of patent challenges and the need to defend market exclusivity against competitors. In this industry, if your IP is weak, your business model is weak. The legal team's job is to build a patent thicket around the novel six-valent outer surface protein A (OspA) technology for VLA15 and the tetravalent structure of S4V2 to ensure a monopoly position post-approval.

• Defend core patents for IXCHIQ against any global challenges.
• Secure new IP filings around VLA15 (Lyme) and S4V2 (Shigella).
• Monitor competitor vaccine candidates for potential infringement.
• Maintain market exclusivity in niche vaccines for high-margin sales.

Valneva SE (VALN) - PESTLE Analysis: Environmental factors

The Environmental factors for Valneva SE are a clear opportunity, driven by a strong commitment to sustainable operations and a core product pipeline that directly addresses the public health consequences of climate change.

You can see Valneva is not just talking about being green; they are putting up real numbers. For instance, the company has achieved 100% renewable electricity at its R&D and manufacturing sites, which immediately cuts a huge chunk of their Scope 2 carbon footprint (emissions from purchased energy). This shift has already helped reduce their CO₂ emissions by 48% since 2019, representing a reduction of 1,630 tonnes of CO₂ from gas and electricity consumed.

Commitment to Green Operations and Waste Reduction

In the complex world of vaccine manufacturing, reducing hazardous substances is a major challenge. That's why the launch of their Green Chemistry project in 2025 is a critical step. Green Chemistry is essentially the design of chemical products and processes that reduce or eliminate the generation of hazardous substances, which is foundational to a pharmaceutical company's environmental impact.

The project, which is currently focused on identifying and evaluating opportunities in their laboratories and manufacturing sites, shows they are looking past easy wins toward more fundamental process changes. Plus, their waste management metrics are solid, demonstrating a clear focus on circularity. In 2024, the company recycled 65% of the waste generated across its operations.

Here's a quick look at their operational sustainability metrics:

Metric	2024 Performance/2025 Target	Strategic Impact
Renewable Electricity Use (R&D/Manufacturing)	100%	Eliminates Scope 2 emissions from contracted electricity.
Waste Recycled	65% of waste generated in 2024	Demonstrates strong waste management and circular economy focus.
CO₂ Emissions Reduction (Scopes 1 & 2)	Reduced by 48% since 2019	Significant progress toward low-carbon operations.
Green Chemistry Project	Implementation started in 2025	Future reduction of hazardous substance generation in R&D and manufacturing.
Sustainable Procurement Policy	Targeted for definition by 2026	Extends environmental criteria to the upstream supply chain.

Vaccines as a Climate Change Defense Strategy

This is where Valneva's business model and the Environmental macro-factor intersect perfectly. Climate change is fueling the spread of vector-borne diseases (VBDs)-diseases carried by vectors like mosquitoes and ticks-as rising global temperatures expand their habitats into new regions, including Southern Europe and the United States.

Valneva is defintely capitalizing on this trend by positioning its pipeline as a proactive public health defense against climate change impacts. The market for their vaccines is literally expanding because of global warming.

The current and pipeline products that benefit from this climate-driven expansion include:

• IXCHIQ (Chikungunya vaccine): Chikungunya is a mosquito-borne disease, and its vector, the Aedes mosquito, is spreading geographically.
• Lyme Disease Vaccine Candidate (VLA15): Lyme disease is tick-borne, and longer summers/milder winters are increasing the risk in Europe and North America.
• Zika Virus Vaccine Candidate: Zika is another mosquito-borne disease seeing resurgence, which re-energizes development efforts.

This strategic alignment means that environmental risks for the rest of the world translate into a core business opportunity for Valneva. The company's total revenues for 2025 are now expected to reach between €165 million and €180 million, with product sales between €155 million and €170 million, a forecast that is directly tied to the successful commercialization of these vaccines.

The next step is for Finance and Regulatory to model the exact financial impact of the IXCHIQ US suspension on the 2026 forecast, assuming a six-month delay in resolution.