VALNEVA SE (VALN): Analyse Pestle [Jan-2025 MISE À JOUR]

Dans le paysage dynamique du développement des vaccins, Valneva SE apparaît comme un joueur charnière naviguant dans un écosystème mondial complexe de défis et d'opportunités. This comprehensive PESTLE analysis delves into the multifaceted external factors shaping the company's strategic trajectory, revealing how political regulations, economic volatility, societal shifts, technological innovations, legal frameworks, and environmental considerations intertwine to define Valneva's potential for growth and impact in the rapidly evolving healthcare et secteurs de la biotechnologie.

Valneva SE (Valn) - Analyse du pilon: facteurs politiques

Paysage réglementaire européen

L'Agence européenne des médicaments (EMA) a approuvé le vaccin VLA2001 de Valneva Covid-19 le 24 juin 2022. Le vaccin a reçu une autorisation de marketing conditionnel dans l'Union européenne. Les processus d'approbation réglementaire en Europe nécessitent des données complètes sur les essais cliniques et des évaluations de sécurité strictes.

Corps réglementaire	Statut d'approbation	Date
Agence européenne des médicaments	Autorisation de marketing conditionnel	24 juin 2022
Agence de réglementation des médicaments et des produits de santé britannique	Autorisation temporaire	22 avril 2022

Impacts du Brexit

Le Brexit a introduit des complexités réglementaires importantes pour les opérations transfrontalières de Valneva entre les marchés du Royaume-Uni et de l'UE.

• Exigences de conformité réglementaire supplémentaires
• Documentation accrue pour la distribution des vaccins transfrontaliers
• Barrières tarifaires et commerciales potentielles

Financement et soutien du gouvernement

Valneva a reçu un financement gouvernemental important pour la recherche sur les vaccins:

Gouvernement	Montant du financement	Projet vaccinal
Gouvernement britannique	298 millions de livres sterling	Développement du vaccin Covid-19
Gouvernement français	30 millions d'euros	Support d'infrastructure de recherche

Tensions géopolitiques

Des défis internationaux de distribution des vaccins sont apparus des tensions géopolitiques mondiales, en particulier pendant la pandémie Covid-19.

• Perturbations de la chaîne d'approvisionnement sur plusieurs marchés
• Exporter des restrictions dans certaines régions
• Le nationalisme vaccinal a un impact sur la distribution mondiale

Valneva SE (Valn) - Analyse du pilon: facteurs économiques

Environnement d'investissement de biotechnologie volatile

La capitalisation boursière de Valneva SE en janvier 2024: 360,42 millions d'euros. Gamme de volatilité des cours des actions en 2023: 4,70 € - 8,50 € par action.

Métrique financière	Valeur 2022	Valeur 2023
Revenu	428,4 millions d'euros	387,2 millions d'euros
Revenu net	18,6 millions d'euros	-12,3 millions d'euros
Dépenses de R&D	115,7 millions d'euros	98,4 millions d'euros

Dépendance à l'élaboration des vaccins

Covid-19 Vaccine Partnership Revenue with Pfizer: 100,8 millions d'euros en 2023. Portefeuille total de développement des vaccins: 4 candidats au vaccin à scène clinique.

Impact de dépenses de santé

Le marché mondial des vaccins prévoyait la valeur d'ici 2027: 73,5 milliards d'euros. Part de marché de Valneva dans les vaccins contre les voyages et les maladies infectieuses: 2,3%.

Segment de marché	2023 Investissement	Croissance projetée
Vaccins de voyage	157,6 millions d'euros	5,4% CAGR
Vaccins contre les maladies infectieuses	226,3 millions d'euros	6,2% CAGR

Risques de taux de change

Distribution internationale des revenus:

• Europe: 62%
• États-Unis: 28%
• Reste du monde: 10%

Coûts de couverture des devises en 2023: 4,2 millions d'euros.

Paire de devises	2023 Volatilité	Impact sur les revenus
EUR / USD	±5.6%	12,7 millions d'euros
EUR / GBP	±3.2%	6,4 millions d'euros

Valneva SE (Valn) - Analyse du pilon: facteurs sociaux

Augmentation de la sensibilisation du public et de la demande de technologies de vaccination

La taille du marché mondial des vaccins a atteint 62,1 milliards de dollars en 2022, avec une croissance projetée à 85,7 milliards de dollars d'ici 2030, représentant un TCAC de 4,3%.

Métriques de sensibilisation à la vaccination	2022 données	2023 projection
Taux de sensibilisation à la vaccination mondiale	68.5%	72.3%
Confiance du public dans les vaccins	65.7%	69.2%
Compliance de la vaccination des adultes	52.4%	56.1%

Priorités de santé changeantes de la pandémie post-19 après 19

Les dépenses mondiales de santé ont augmenté à 9,4 billions de dollars en 2023, avec une allocation de recherche sur les vaccins à 42,5 milliards de dollars.

Chart de priorité des soins de santé	Pré-pandémique	Post-pandémique
Budget de préparation pandémique	12,3 milliards de dollars	37,6 milliards de dollars
Investissement technologique des vaccins	18,7 milliards de dollars	42,5 milliards de dollars
Recherche de maladies infectieuses	22,1 milliards de dollars	51,3 milliards de dollars

Accent croissant sur les soins de santé préventifs et la médecine des voyages

Le marché du vaccin des voyages devrait atteindre 7,2 milliards de dollars d'ici 2027, avec 6,8% du TCAC à partir de 2022.

Métriques de santé préventives	Valeur 2022	2027 projection
Marché des vaccins de voyage	5,3 milliards de dollars	7,2 milliards de dollars
Dépenses de santé préventives	1,2 billion de dollars	1,6 billion de dollars
Consultations en médecine du voyage	42,6 millions	58,3 millions

Changements démographiques influençant la dynamique du marché des vaccins

La population mondiale de plus de 65 ans devrait atteindre 1,5 milliard d'ici 2050, ce qui stimule la demande des vaccins.

Impact du vaccin démographique	2022 données	2030 projection
Population de plus de 65 ans	771 millions	1,1 milliard
Taux de vaccination âgé	57.3%	65.7%
Prévalence des maladies chroniques	42.5%	48.2%

Valneva SE (Valn) - Analyse du pilon: facteurs technologiques

Plates-formes avancées de développement des vaccins et technologie de l'ARNm

Valneva SE se concentre sur le développement de technologies innovantes de vaccins avec des investissements de plate-forme spécifiques:

Plate-forme vaccinale	Investissement (€)	Statut de développement
Vaccin contre la maladie de Lyme VLA15	25,4 millions	Essais cliniques de phase 3
Vaccin à covide-19 inactivé	19,2 millions	Abandonné en 2022
Vaccin Chikungunya	12,7 millions	Phase 3 Développement clinique

Investissement continu dans la recherche et l'innovation

Les dépenses de R&D de Valneva démontrent un engagement dans la progression technologique:

Année	Dépenses de R&D (€ millions)	Pourcentage de revenus
2022	84.3	42.6%
2021	71.6	38.9%

Technologies de santé numérique améliorant la distribution et le suivi des vaccins

Investissements clés de la technologie de la santé numérique:

• Systèmes de surveillance de la chaîne du froid: 3,2 millions d'euros Investissement
• Plates-formes de suivi des vaccins en temps réel
• Intégration du registre de l'immunisation numérique

Méthodes de calcul émergentes pour la conception et les tests des vaccins

Investissements en technologie informatique dans le développement de vaccins:

Technologie	Investissement (€)	But
Sélection d'antigènes dirigée par l'IA	5,6 millions	Accélérer l'identification des candidats vaccinaux
Dépistage de l'apprentissage automatique	4,3 millions	Optimiser les paramètres de conception des vaccins
Cartographie des épitopes informatiques	3,9 millions	Améliorer la prédiction de l'immunogénicité

Valneva SE (Valn) - Analyse du pilon: facteurs juridiques

Conformité réglementaire stricte dans les secteurs pharmaceutique et vaccinal

Valneva SE fonctionne dans des cadres réglementaires stricts dans plusieurs juridictions. Depuis 2024, la société doit se conformer:

Corps réglementaire	Exigences de conformité clés	Coût annuel de conformité
Agence européenne des médicaments (EMA)	GMP, réglementation des essais cliniques	3,2 millions d'euros
FDA (États-Unis)	Applications IND, normes de fabrication	4,5 millions de dollars
MHRA (Royaume-Uni)	Protocoles de développement des vaccins	2,7 millions de livres sterling

Protection de la propriété intellectuelle pour les technologies des vaccins

Répartition du portefeuille de brevets:

Catégorie de brevet	Nombre de brevets actifs	Valeur estimée
Technologie de vaccination	37	78,5 millions d'euros
Processus de fabrication	22	45,3 millions d'euros
Innovations thérapeutiques	15	32,1 millions d'euros

Contrats complexes de licence et de distribution internationaux

Valneva SE maintient plusieurs accords de licence internationale:

Partenaire	Type d'accord	Revenus annuels	Durée du contrat
Pfizer	Distribution des vaccins	22,6 millions d'euros	5 ans
GSK	Collaboration de recherche	15,4 millions d'euros	3 ans
Miserrer	Licence de technologie	18,9 millions d'euros	4 ans

Problèmes de responsabilité potentielle liés au développement et à la distribution des vaccins

Couverture d'assurance responsabilité civile:

Catégorie de responsabilité	Montant de la couverture	Prime annuelle
Responsabilité du produit	250 millions d'euros	4,7 millions d'euros
Risque d'essai clinique	150 millions d'euros	3,2 millions d'euros
Conformité réglementaire	100 millions d'euros	2,5 millions d'euros

Valneva SE (Valn) - Analyse du pilon: facteurs environnementaux

Pratiques de fabrication durables dans la production de vaccins

Valneva SE implémente ISO 14001: Certification de gestion de l'environnement 2015 dans ses installations de fabrication en Écosse et en Autriche. Le site de Vienne de la société consomme 4 250 MWh d'énergie renouvelable par an, ce qui représente 62% de la consommation totale d'énergie des installations.

Emplacement	Consommation d'énergie annuelle	Pourcentage d'énergie renouvelable
Installation de Vienne	4 250 MWH	62%
Installation écossaise	3 780 MWh	45%

Réduire l'empreinte carbone dans les processus de recherche et de développement

Valneva SE a réduit les émissions directes de CO2 de 18,4 tonnes métriques en 2022, mettant en œuvre un équipement de laboratoire économe en énergie et optimisant les flux de travail de recherche.

Année	Réduction des émissions de CO2	Investissements d'efficacité énergétique
2022	18,4 tonnes métriques	€475,000

Approvisionnement éthique des matières premières pour le développement des vaccins

Valneva SE maintient un code de conduite strict des fournisseurs, avec 97% des fournisseurs de matières premières certifiés pour les normes environnementales et éthiques.

Catégorie des fournisseurs	Taux de certification	Fréquence d'audit
Fournisseurs de matières premières	97%	Annuel

Les effets du changement climatique sur les modèles de maladies infectieuses et la recherche sur les vaccins

Valneva SE a alloué 2,3 millions d'euros en 2022 pour la recherche explorant les adaptations des maladies infectieuses liées au changement climatique, en se concentrant sur le développement du vaccin contre les maladies à transmission vectorielle.

Focus de recherche	Investissement	Durée de recherche
Recherche de maladies infectieuses du climat	2,3 millions d'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.