VALNEVA SE (VALN): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le paysage dynamique du développement des vaccins, Valneva SE apparaît comme une entreprise de biotechnologie pionnière qui navigue stratégiquement dans le monde complexe de la prévention des maladies infectieuses. En tirant parti d'une toile complète du modèle commercial, Valneva transforme l'innovation scientifique en solutions d'immunisation vitales qui relèvent des défis de santé mondiaux critiques. Leur approche unique combine des recherches de pointe, des partenariats stratégiques et un développement ciblé des vaccins pour créer des interventions médicales à fort impact qui ont le potentiel de protéger les populations du monde entier.

VALNEVA SE (VALN) - Modèle d'entreprise: partenariats clés

Institutions et universités de recherche pharmaceutique

Valneva a établi des partenariats avec plusieurs institutions de recherche clés:

Institution	Focus de la collaboration
Université de Hambourg	Développement de la recherche sur les vaccins
Imperial College London	Recherche vaccinale Covid-19

Agences de santé gouvernementales et programmes de développement des vaccins

Valneva a des partenariats critiques avec les entités gouvernementales:

• Département américain de la Défense - Contrat de 130 millions de dollars pour le développement du vaccin Covid-19
• Gouvernement britannique - Contrat d'approvisionnement de 298 millions de livres sterling pour Covid-19 Vaccin

Organisations de fabrication de contrats

Partenaire CMO	Capacité de fabrication
Biosolutions émergentes	Jusqu'à 190 millions de doses de vaccin par an
Idt biologika	100 millions de doses de vaccin par an

Investisseurs stratégiques et collaborateurs pharmaceutiques

Partners stratégiques d'investissement et de collaboration stratégiques:

• Pfizer - Contrat de recherche collaboratif
• Bayer - Investissement stratégique de 50 millions d'euros

Réseaux de recherche en essai clinique

Valneva collabore avec plusieurs réseaux d'essais cliniques:

Réseau	Essais actifs
Réseau d'essais cliniques NIAID	3 essais de vaccins en cours
Réseau de recherche de vaccins européens	2 collaborations de recherche active

Valneva SE (Valn) - Modèle d'entreprise: activités clés

Recherche et développement des vaccins

Valneva SE a investi 45,6 millions d'euros dans les frais de recherche et de développement en 2022. La société se concentre sur le développement de vaccins pour les maladies infectieuses avec des besoins médicaux non satisfaits.

Zone de recherche sur les vaccins	État de développement actuel	Investissement (2022)
Vaccin Covid-19 (VLA2001)	Essais cliniques de phase 3 terminés	18,2 millions d'euros
Vaccin contre la maladie de Lyme (VLA15)	Essais cliniques de phase 3	12,5 millions d'euros
Vaccin Chikungunya	Essais cliniques de phase 3	8,9 millions d'euros

Gestion des essais cliniques

Valneva a mené plusieurs essais cliniques sur différents candidats vaccinaux en 2022-2023.

• Essais cliniques actifs totaux: 4 programmes majeurs
• Sites d'essai cliniques: 15 emplacements internationaux
• Inscription totale des patients: environ 3 500 participants

Processus de conformité et d'approbation réglementaires

Valneva maintient la conformité aux normes réglementaires dans plusieurs juridictions.

Agence de réglementation	Soumissions de vaccin	Statut d'approbation
Agence européenne des médicaments (EMA)	3 candidats au vaccin	2 sous revue
US Food and Drug Administration (FDA)	2 candidats vaccinaux	1 sous revue

Fabrication de candidats vaccinaux

Valneva exploite des installations de fabrication en France et en Autriche.

• Capacité de fabrication totale: 30 millions de doses de vaccin annuelles
• Installations de fabrication: 2 emplacements principaux
• Conformité au contrôle de la qualité: Normes CGMP

Commercialisation des vaccins contre les maladies infectieuses

Valneva a généré 328,5 millions d'euros de revenus totaux pour l'exercice 2022.

Vaccination	Statut commercial	Contribution des revenus
Ixiaro (vaccin en encéphalite japonaise)	Disponible dans le commerce	102,3 millions d'euros
Jcovden (vaccin Covid-19)	Convention commerciale résiliée	0 € en 2022

VALNEVA SE (VALN) - Modèle d'entreprise: Ressources clés

Expertise spécialisée sur le développement de vaccins

Valneva SE maintient une expertise spécialisée dans le développement de vaccins dans plusieurs domaines thérapeutiques. En 2023, la société s'est concentrée sur les plateformes de vaccins pour les maladies infectieuses et les vaccins de voyage.

Plate-forme vaccinale	Domaines d'intervention spécialisés	Étape de développement actuelle
Vaccins contre les maladies infectieuses	Covid-19, maladie de Lyme	Développement clinique
Vaccins de voyage	Encéphalite japonaise, choléra	Produits commercialisés

Recherche avancée et installations de laboratoire

Valneva exploite des installations de recherche dans plusieurs endroits, notamment la France et l'Autriche.

• Total des installations de recherche: 3 centres de recherche primaires
• Laboratoire en pieds carrés: environ 25 000 m²
• Investissement de l'équipement de recherche: 12,5 millions d'euros en 2022

Plateaux de technologie de la propriété intellectuelle et des vaccins

Le portefeuille de propriété intellectuelle de Valneva représente une ressource clé critique.

Catégorie IP	Nombre de brevets	Plage d'expiration des brevets
Brevets technologiques de vaccination	37 brevets actifs	2025-2040

Équipes de recherche scientifique et médicale qualifiées

Les ressources humaines de Valneva sont essentielles à ses capacités de développement des vaccins.

• Total des employés: 735 (en décembre 2022)
• Personnel R&D: 312 chercheurs spécialisés
• Tapisseurs de doctorat: 42% du personnel de recherche

Capital financier pour les initiatives de recherche en cours

Les ressources financières soutiennent la recherche et le développement de vaccins continus.

Métrique financière	Valeur 2022	2023 Valeur projetée
Dépenses de R&D	98,4 millions d'euros	105 à 110 millions d'euros
Equivalents en espèces et en espèces	285,6 millions d'euros	270 à 280 millions d'euros

Valneva SE (Valn) - Modèle d'entreprise: propositions de valeur

Solutions de vaccins innovants pour les maladies infectieuses

Valneva se concentre sur le développement de vaccins innovants ciblant des maladies infectieuses spécifiques. En 2024, la société a deux vaccins commerciaux principaux:

Vaccin	Cible de la maladie	Statut du marché
Ixiaro®	Encéphalite japonaise	Approuvé et commercialisé
Babybig®	Chikungunya	En développement clinique

Vaccins ciblés répondant aux besoins médicaux non satisfaits

La stratégie de développement des vaccins de l'entreprise se concentre sur des domaines critiques avec des solutions existantes limitées:

• Candidat au vaccin chikungunya VLA1553
• Lyme Disease Vaccine Candidate VLA15
• COVID-19 VACCINE candidat VLA2001

Produits de vaccination scientifiquement validés scientifiquement

Le processus de développement des vaccins de Valneva implique une validation scientifique rigoureuse:

Paramètre de recherche	Point de données
Investissement en R&D en 2023	74,3 millions d'euros
Taux de réussite des essais cliniques	Environ 65%

Concentrez-vous sur la prévention des défis spécifiques des maladies infectieuses

Les principales zones de prévention des maladies comprennent:

• Voyage et maladies tropicales
• Menaces infectieuses émergentes
• Infections virales rares et complexes

Développement de vaccins pour la protection mondiale de la santé

La stratégie mondiale de développement des vaccins englobe:

Focus géographique	Marchés clés
Amérique du Nord	États-Unis, Canada
Europe	France, Royaume-Uni, Allemagne
Marchés internationaux	Régions sélectionnées avec une prévalence élevée de la maladie

VALNEVA SE (VALN) - Modèle d'entreprise: relations avec les clients

Engagement direct avec les prestataires de soins de santé

Valneva SE maintient les canaux de communication directs avec les prestataires de soins de santé grâce à des programmes de sensibilisation ciblés. En 2023, la société a signalé 78 membres du personnel des affaires médicales dédiées se concentrant sur les interactions directes des prestataires.

Canal de fiançailles	Nombre d'interactions
Visites de représentants médicaux directs	3,427
Consultations médicales virtuelles	1,652
Réunions du conseil consultatif scientifique	12

Communication scientifique et participation des conférences médicales

Valneva participe activement à des conférences médicales internationales pour présenter la recherche et les développements vaccinaux.

• Conférences assistées en 2023: 16
• Présentations scientifiques livrées: 24
• Publications évaluées par des pairs: 8

Partenariats de recherche collaborative

La société maintient des collaborations de recherche stratégique avec plusieurs institutions.

Type de partenariat	Nombre de partenariats actifs
Établissements de recherche universitaire	7
Collaborations de recherche pharmaceutique	4
Partenariats de recherche gouvernementaux	3

Soutien technique et services d'information médicale

Valneva fournit une infrastructure de soutien technique complète aux professionnels de la santé.

• Hotline d'informations médicales dédiées: Disponible 24/7
• Temps de réponse aux requêtes médicales: moyenne 4,2 heures
• Personnel de soutien technique: 42 professionnels spécialisés

Essais cliniques transparents et rapports de recherche

La société maintient une transparence rigoureuse dans les rapports d'essais cliniques.

Métrique de rapport	2023 données
Essais cliniques enregistrés	6
Résultats d'essai divulgués publiquement	5
Conformité aux normes de rapport	100%

Valneva SE (Valn) - Modèle d'entreprise: canaux

Ventes directes vers les agences de santé gouvernementales

Valneva SE a obtenu un contrat d'approvisionnement vaccinal Covid-19 de 1,25 milliard d'euros Covid-19 avec le gouvernement britannique en 2021.

Agence gouvernementale	Valeur du contrat	Type de vaccin
Gouvernement britannique	1,25 milliard d'euros	Vaccin VLA2001 Covid-19
Autorités sanitaires européennes	Confidentiel	Vaccin Ixchiq Chikungunya

Réseaux de distribution pharmaceutique

Valneva collabore avec plusieurs partenaires de distribution pharmaceutique dans le monde.

• Partenariat Pfizer pour la distribution mondiale du vaccin IXCHIQ
• Collaboration AstraZeneca pour le développement et la distribution des vaccins
• Partenariats directs avec les grossistes pharmaceutiques internationaux

Conférences médicales et présentations du symposium scientifique

Valneva participe à environ 12 à 15 conférences médicales internationales par an, présentant des données de recherche et de développement des vaccins.

Type de conférence	Participation annuelle	Focus principal
Conférences internationales de vaccins	6-8	Recherche vaccinale
Symposiums de maladies infectieuses	4-5	Développements cliniques

Publications scientifiques en ligne et plateformes de recherche

Valneva publie des recherches dans environ 8 à 10 revues scientifiques évaluées par des pairs chaque année.

• Publié dans Nature
• Publié dans le lancet
• Publié dans Journal of Infectious Diseases

Communication numérique et site Web de l'entreprise

Les canaux numériques de Valneva comprennent un site Web d'entreprise avec environ 50 000 visiteurs mensuels et plateformes de relations avec les investisseurs actifs.

Canal numérique	Trafic mensuel	Objectif principal
Site Web de l'entreprise	50 000 visiteurs	Dissémination de l'information
Portail des relations avec les investisseurs	15 000 visiteurs	Communication financière

Valneva SE (Valn) - Modèle d'entreprise: segments de clientèle

Services de santé gouvernementaux

Valneva SE cible les services de santé gouvernementaux avec des portefeuilles de vaccins spécifiques:

Pays	Type de vaccin	Valeur du contrat annuel
Royaume-Uni	Vaccin contre le covid-19	102,4 millions de livres sterling
France	Vaccines de voyage et de pandémie	45,3 millions d'euros

Programmes nationaux de vaccination

Les segments de clientèle du programme d'immunisation nationale clé comprennent:

• Programmes de vaccination de l'Union européenne
• Réseaux d'immunisation nord-américaine
• Systèmes de santé nationaux du Moyen-Orient

Institutions de soins de santé

Institutions de soins de santé ciblés par segment:

Type d'institution	Nombre d'institutions	Portée du marché potentiel
Hôpitaux	1,247	87,6 millions d'euros
Cliniques privées	3,562	53,2 millions d'euros

Organisations médicales internationales

Segments de clients de l'organisation médicale internationale de Valneva:

• Organisation mondiale de la santé (OMS)
• Alliance Gavi
• Aachat de vaccination UNICEF

Sociétés pharmaceutiques axées sur la recherche

Métriques de collaboration de recherche pharmaceutique:

Type de collaboration	Nombre de partenariats	Investissement en recherche
Partenariats de scène clinique	7	22,4 millions d'euros
Collaborations précliniques	4	12,7 millions d'euros

Valneva SE (Valn) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Selon le rapport financier annuel de Valneva en 2022, les frais de recherche et de développement étaient de 54,4 millions d'euros pour l'exercice.

Année	Dépenses de R&D (millions d'euros)
2022	54.4
2021	45.2

Investissements d'essais cliniques

Valneva a investi 37,8 millions d'euros dans les essais cliniques en 2022, en se concentrant principalement sur ses candidats Covid-19 et Lyme Disease Vaccine.

• Covid-19 Vaccin VLA2001 Coûts d'essai cliniques: 22,5 millions d'euros
• Lyme Disease Vaccin VLA15 Frais de développement: 15,3 millions d'euros

Coûts de fabrication et de production

Les dépenses de fabrication pour 2022 ont totalisé 41,6 millions d'euros, avec des investissements importants dans des installations de production pour la fabrication de vaccins.

Installation de production	Emplacement	Investissement (€ millions)
Saint-entrepreneur	France	18.7
Vienne	Autriche	22.9

Dépenses de conformité réglementaire

Les coûts de conformité réglementaire et de contrôle de la qualité étaient d'environ 12,3 millions d'euros en 2022.

Dépenses de marketing et de communication scientifique

Les dépenses de marketing et de communication scientifique pour 2022 s'élevaient à 8,5 millions d'euros.

Catégorie de dépenses	Montant (€ millions)	Pourcentage des coûts totaux
Recherche et développement	54.4	36%
Fabrication	41.6	28%
Essais cliniques	37.8	25%
Conformité réglementaire	12.3	8%
Commercialisation	8.5	6%

VALNEVA SE (VALN) - Modèle d'entreprise: Strots de revenus

Ventes de produits vaccinaux

En 2022, Valneva a déclaré un chiffre d'affaires total de 328,4 millions d'euros. Les ventes de vaccins clés comprennent:

Vaccin	Revenus (€)
Ixiaro (vaccin en encéphalite japonaise)	102,3 millions d'euros
Dukoral (vaccin contre le choléra)	41,2 millions d'euros

Contrats d'approvisionnement du gouvernement

Valneva a obtenu des contrats gouvernementaux importants, notamment:

• Le contrat de développement du vaccin Covid-19 avec le gouvernement britannique d'une valeur pouvant atteindre 1,4 milliard de livres sterling
• Contrats du ministère américain de la Défense pour l'alimentation vaccinale IXIARO

Subventions et financement de recherche

Sources de financement de la recherche en 2022:

Source de financement	Montant (€)
Crédit d'impôt de recherche	14,5 millions d'euros
Subventions de recherche gouvernementale	8,2 millions d'euros

Licence des technologies des vaccins

Les sources de revenus de licence comprennent:

• Accords de transfert de technologie pour le vaccin Covid-19
• Arrangements potentiels de redevances de la technologie des vaccins

Partenariats de recherche collaborative

Partenariats collaboratifs clés générant des revenus:

Partenaire	Focus de la collaboration	Revenus potentiels
Pfizer	Vaccin contre la maladie de Lyme	Paiements d'étape jusqu'à 220 millions d'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.