Valneva SE (Valn): Análise de Pestle [Jan-2025 Atualizada]

No cenário dinâmico do desenvolvimento da vacina, o Valneva SE surge como um jogador fundamental que navega por um complexo ecossistema global de desafios e oportunidades. Essa análise abrangente de pilões investiga os fatores externos multifacetados que moldam a trajetória estratégica da Companhia, revelando como regulamentos políticos, volatilidade econômica, mudanças sociais, inovações tecnológicas, estruturas legais e considerações ambientais se entrelaçar e setores de biotecnologia.

Valneva SE (Valn) - Análise de Pestle: Fatores Políticos

Paisagem regulatória européia

A Agência Europeia de Medicamentos (EMA) aprovou a vacina CoVID-19 da Valneva VLA2001 em 24 de junho de 2022. A vacina recebeu autorização de marketing condicional na União Europeia. Os processos de aprovação regulatória na Europa requerem dados abrangentes de ensaios clínicos e avaliações rigorosas de segurança.

Órgão regulatório	Status de aprovação	Data
Agência Europeia de Medicamentos	Autorização de marketing condicional	24 de junho de 2022
Agenda Reguladora de Medicamentos e Produtos para Saúde do Reino Unido	Autorização temporária	22 de abril de 2022

Impactos do Brexit

O Brexit introduziu complexidades regulatórias significativas para as operações transfronteiriças da Valneva entre os mercados do Reino Unido e da UE.

• Requisitos adicionais de conformidade regulatória
• Maior documentação para distribuição de vacina transfronteiriça
• Potenciais barreiras tarifárias e comércio

Financiamento e apoio do governo

Valneva recebeu financiamento significativo do governo para pesquisa de vacinas:

Governo	Valor de financiamento	Projeto de vacina
Governo do Reino Unido	£ 298 milhões	Desenvolvimento da vacina CoVID-19
Governo francês	€ 30 milhões	Suporte de infraestrutura de pesquisa

Tensões geopolíticas

Desafios internacionais de distribuição de vacinas surgiram das tensões geopolíticas globais, particularmente durante a pandemia Covid-19.

• Interrupções da cadeia de suprimentos em vários mercados
• Restrições de exportação em determinadas regiões
• Nacionalismo vacina que afeta a distribuição global

Valneva SE (Valn) - Análise de Pestle: Fatores Econômicos

Ambiente volátil de investimento de biotecnologia

A capitalização de mercado da Valneva SE em janeiro de 2024: € 360,42 milhões. Volatilidade do preço das ações Faixa em 2023: € 4,70 - € 8,50 por ação.

Métrica financeira	2022 Valor	2023 valor
Receita	€ 428,4 milhões	€ 387,2 milhões
Resultado líquido	€ 18,6 milhões	-12,3 milhões
Despesas de P&D	€ 115,7 milhões	€ 98,4 milhões

Dependência do desenvolvimento da vacina

Receita de parceria da vacina CoVID-19 com a Pfizer: € 100,8 milhões em 2023. Portfólio de desenvolvimento de vacinas totais: 4 candidatos a vacinas em estágio clínico.

Impacto de gastos com saúde

O valor global do mercado de vacinas projetou em 2027: € 73,5 bilhões. A participação de mercado de Valneva nas vacinas contra viagens e doenças infecciosas: 2,3%.

Segmento de mercado	2023 Investimento	Crescimento projetado
Vacinas de viagem	€ 157,6 milhões	5,4% CAGR
Vacinas de doenças infecciosas	226,3 milhões de euros	6,2% CAGR

Riscos de taxa de câmbio

Distribuição de receita internacional:

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

Custos de hedge de moeda em 2023: € 4,2 milhões.

Par de moeda	2023 Volatilidade	Impacto na receita
EUR/USD	±5.6%	€ 12,7 milhões
EUR/GBP	±3.2%	6,4 milhões de euros

Valneva SE (Valn) - Análise de pilão: Fatores sociais

Aumentar a conscientização e a demanda do público por tecnologias de vacinação

O tamanho do mercado global de vacinas atingiu US $ 62,1 bilhões em 2022, com crescimento projetado para US $ 85,7 bilhões até 2030, representando um CAGR de 4,3%.

Métricas de conscientização sobre vacinação	2022 dados	2023 Projeção
Taxa de conscientização da vacinação global	68.5%	72.3%
Confiança pública em vacinas	65.7%	69.2%
Conformidade de vacinação para adultos	52.4%	56.1%

Mudança de prioridades de saúde pós-Covid-19 Pandemia

Os gastos globais em saúde aumentaram para US $ 9,4 trilhões em 2023, com alocação de pesquisa de vacinas em US $ 42,5 bilhões.

Mudanças de prioridade de saúde	Pré-pandemia	Pós-pandêmica
Orçamento de preparação para pandemia	US $ 12,3 bilhões	US $ 37,6 bilhões
Investimento em tecnologia da vacina	US $ 18,7 bilhões	US $ 42,5 bilhões
Pesquisa de doenças infecciosas	US $ 22,1 bilhões	US $ 51,3 bilhões

Foco crescente em cuidados de saúde preventivos e remédios de viagem

O mercado de vacinas para viagens deve atingir US $ 7,2 bilhões até 2027, com CAGR de 6,8% a partir de 2022.

Métricas preventivas de saúde	2022 Valor	2027 Projeção
Mercado de vacinas contra viagens	US $ 5,3 bilhões	US $ 7,2 bilhões
Gastos preventivos para a saúde	US $ 1,2 trilhão	US $ 1,6 trilhão
Consultas de medicina de viagem	42,6 milhões	58,3 milhões

Mudanças demográficas que influenciam a dinâmica do mercado de vacinas

A população global com mais de 65 anos atinge 1,5 bilhão até 2050, impulsionando a demanda de vacinas.

Impacto demográfico da vacina	2022 dados	2030 Projeção
População acima de 65 anos	771 milhões	1,1 bilhão
Taxa de vacinação idosa	57.3%	65.7%
Prevalência de doenças crônicas	42.5%	48.2%

Valneva SE (VALN) - Análise de pilão: Fatores tecnológicos

Plataformas avançadas de desenvolvimento de vacinas e tecnologia de mRNA

A Valneva SE se concentra no desenvolvimento de tecnologias inovadoras de vacinas com investimentos específicos de plataforma:

Plataforma de vacina	Investimento (€)	Status de desenvolvimento
VALA15 VACINA DO HYME DOENHE	25,4 milhões	Ensaios clínicos de fase 3
Vacina covid-19 inativada	19,2 milhões	Descontinuado em 2022
Vacina de Chikungunya	12,7 milhões	Desenvolvimento Clínico de Fase 3

Investimento contínuo em pesquisa e inovação

As despesas de P&D da Valneva demonstram compromisso com o avanço tecnológico:

Ano	Despesas de P&D (milhão de €)	Porcentagem de receita
2022	84.3	42.6%
2021	71.6	38.9%

Tecnologias de saúde digital Melhorando a distribuição e rastreamento da vacina

Principais investimentos em tecnologia da saúde digital:

• Sistemas de monitoramento da cadeia de frio: € 3,2 milhões de investimentos
• Plataformas de rastreamento de vacinas em tempo real
• Integração do Registro de Imunização Digital

Métodos computacionais emergentes para design e teste de vacinas

Investimentos de tecnologia computacional no desenvolvimento da vacina:

Tecnologia	Investimento (€)	Propósito
Seleção de antígeno acionada por IA	5,6 milhões	Acelerar a identificação do candidato à vacina
Triagem de aprendizado de máquina	4,3 milhões	Otimize os parâmetros de design da vacina
Mapeamento do epítopo computacional	3,9 milhões	Melhorar a previsão da imunogenicidade

Valneva SE (Valn) - Análise de Pestle: Fatores Legais

Conformidade regulatória rigorosa em setores farmacêuticos e de vacinas

A Valneva SE opera sob estruturas regulatórias estritas em várias jurisdições. A partir de 2024, a empresa deve cumprir:

Órgão regulatório	Principais requisitos de conformidade	Custo anual de conformidade
Agência Europeia de Medicamentos (EMA)	GMP, regulamentos de ensaios clínicos	€ 3,2 milhões
FDA (Estados Unidos)	Aplicações IND, padrões de fabricação	US $ 4,5 milhões
MHRA (Reino Unido)	Protocolos de desenvolvimento de vacinas	£ 2,7 milhões

Proteção de propriedade intelectual para tecnologias de vacinas

Patente portfólio Redução:

Categoria de patentes	Número de patentes ativas	Valor estimado
Tecnologia da vacina	37	€ 78,5 milhões
Processos de fabricação	22	€ 45,3 milhões
Inovações terapêuticas	15	€ 32,1 milhões

Acordos complexos de licenciamento e distribuição internacionais

Valneva SE mantém vários acordos internacionais de licenciamento:

Parceiro	Tipo de contrato	Receita anual	Duração do contrato
Pfizer	Distribuição da vacina	€ 22,6 milhões	5 anos
GSK	Colaboração de pesquisa	€ 15,4 milhões	3 anos
Merck	Licenciamento de tecnologia	€ 18,9 milhões	4 anos

Questões potenciais de responsabilidade relacionadas ao desenvolvimento e distribuição da vacina

Cobertura de seguro de responsabilidade:

Categoria de responsabilidade	Quantidade de cobertura	Premium anual
Responsabilidade do produto	€ 250 milhões	4,7 milhões de euros
Risco de ensaio clínico	€ 150 milhões	€ 3,2 milhões
Conformidade regulatória	€ 100 milhões	2,5 milhões de euros

Valneva SE (Valn) - Análise de Pestle: Fatores Ambientais

Práticas de fabricação sustentáveis ​​na produção de vacinas

A Valneva SE implementa a certificação ISO 14001: 2015 Ambiental Management em suas instalações de fabricação na Escócia e na Áustria. O site de Viena da empresa consome 4.250 MWh de energia renovável anualmente, representando 62% do consumo total de energia da instalação.

Localização	Consumo anual de energia	Porcentagem de energia renovável
Instalação de Viena	4.250 mwh	62%
Instalação da Escócia	3.780 MWh	45%

Reduzindo a pegada de carbono em processos de pesquisa e desenvolvimento

A Valneva SE reduziu as emissões diretas de CO2 em 18,4 toneladas métricas em 2022, implementando equipamentos de laboratório com eficiência energética e otimizando os fluxos de trabalho de pesquisa.

Ano	Redução de emissões de CO2	Investimentos de eficiência energética
2022	18.4 Toneladas métricas	€475,000

Fornecimento ético de matérias -primas para desenvolvimento de vacinas

A Valneva SE mantém um rigoroso código de conduta do fornecedor, com 97% dos fornecedores de matéria -prima certificados para padrões ambientais e éticos.

Categoria de fornecedores	Taxa de certificação	Frequência de auditoria
Fornecedores de matéria -prima	97%	Anual

As mudanças climáticas impactam os padrões de doenças infecciosas e a pesquisa de vacinas

A Valneva SE alocou 2,3 ​​milhões de euros em 2022 para pesquisas que exploram adaptações de doenças infecciosas relacionadas à mudança climática, concentrando-se no desenvolvimento da vacina contra a doença transmitida por vetores.

Foco na pesquisa	Investimento	Duração da pesquisa
Pesquisa de doenças infecciosas sobre clima	2,3 milhões de euros	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.