Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (August 2025)
30 slides from Valneva's investor presentation, August 2025
Slide 1: Valneva: A Leading Specialty Vaccine Company
Valneva A Leading Specialty Vaccine Company August 2025
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an Certain information and statements included in this presentation are not historical offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any facts but are forward-looking sta
Slide 3: A Leading Specialty Vaccine Company
A Leading Specialty Vaccine Company Focused on vaccines that make a difference We develop, manufacture, & commercialize prophylactic vaccines for infectious diseases addressing unmet medical needs ▪ Proven Expertise: Three in-house vaccine approvals; three proprietary commercialized travel vaccines
Slide 4: Valneva's Commercial and R&D Portfolio
Valneva’s Commercial and R&D Portfolio A unique, differentiated portfolio Program Vaccine Design Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial IXIARO® Only U.S./ EU approved vaccine against Japanese encephalitis Commercial DUKORAL® Established Cholera (ETEC1) vaccine approved in >30 countries Prod
Slide 5: Our Strategy to Become a Globally Recognized Vaccine Company
Our Strategy to Become a Globally Recognized Vaccine Company Contribute to a world where no one dies or suffers from a vaccine preventable disease Drive Maximize Commercial Capture integrated Growth R&D Upside biotech model ▪ Unlock IXCHIQ® value by building ▪ Leverage proven R&D engine ▪ Build cont
Slide 6: R&D
R&D Wvalneva
Slide 7: World's Leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 8: Lyme Disease Represents A Major Medical Need And Market Opportunity
Lyme Disease Represents A Major Medical Need And Market Opportunity No vaccine is currently available to prevent Lyme disease in humans Annual Burden of Disease Commercial opportunity for Valneva U.S.1 Europe2 U.S. Europe ~476K cases >132K cases 87 million 223 million Severe Manifestations3 Populati
Slide 9: World's Leading Vaccine Candidate Against Lyme Disease
World’s Leading Vaccine Candidate Against Lyme Disease VLA15: the only Lyme disease program in advanced clinical development today Vaccine Highlights Market Opportunity Key Milestones • Exclusive, worldwide partnership2 • On track for first Phase 3 data readout (end • Multivalent, recombinant protei
Slide 10: VLA15 Demonstrated Strong Immunogenicity Across 1,030 Adults and Children
VLA15 Demonstrated Strong Immunogenicity Across 1,030 Adults and Children Three Phase 2 studies optimized dose and schedule across age groups 2020: First positive immunogenicity data1 ▪ Immunogenic (all serotypes & dose groups) ▪ Higher doses elicited higher antibody responses ▪ Encouraging profile
Slide 11: Phase 3: Vaccination Completed; First Data Readout Expected at the End of 2025
Phase 3: Vaccination Completed; First Data Readout Expected at the End of 2025 Pfizer aims to submit regulatory applications in U.S. and Europe in 20261 ▪ Population: ~9,400 evaluable participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activitie
Slide 12: A Highly Differentiated single-shot Chikungunya Vaccine
A Highly Differentiated single-shot Chikungunya Vaccine IXCHIQ® / VLA1553 IXCHIQ® is approved by the European Medicines Agency (EMA) in individuals 12 years of age and older. It is approved by the U.S. Food & Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MH
Slide 13: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-transmitted outbreak disease with potentially debilitating consequences Substantial quality-of-life and Often causes large, health-economic impact2 explosive outbreaks Nearly half (43%) of those Affecting up to 75% of the infected develop local popu
Slide 14: IXCHIQ: A Highly Differentiated single-shot Chikungunya Vaccine
IXCHIQ®: A Highly Differentiated single-shot Chikungunya Vaccine Approved in adults in U.S., EU, UK, Canada - additional approvals expected in 2025 Vaccine Highlights Market Opportunity Key Milestones • Live-attenuated: offers strong and long-lasting • Travelers • Potential upcoming approval of VLA1
Slide 15: Only CHIKV Vaccine to Achieve Long-Lasting Immunogenicity with a Single Shot
Only CHIKV Vaccine to Achieve Long-Lasting Immunogenicity with a Single Shot Differentiated vaccine shows rapid, persistent immunity across all age groups tested1,2,5 Immunogenicity Data Safety Data ▪ 99% Seroresponse3 Rate (SRR) after single ▪ Generally well tolerated by >3,600 adults and vaccinati
Slide 16: Recent Regulatory Updates for IXCHIQ
Recent Regulatory Updates for IXCHIQ® FDA and EMA have now lifted the temporary restrictions against use in elderly Reports of serious adverse events (SAEs) in frail elderly individuals ▪ Primarily among elderly individuals with multiple underlying health conditions, following a mass vaccination cam
Slide 17: IXCHIQ: Focused on Expanding Access, Label Extension, Product Profile
IXCHIQ®: Focused on Expanding Access, Label Extension, Product Profile Robust clinical program supported by new $43.1 million CEPI grant1 Post-Marketing Effectiveness2 (Phase 4) To confirm effectiveness following licensure based on an immunological surrogate of protection and to optimize description
Slide 18: World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
Slide 19: S4V2: Opportunity to Develop First-in-Class Vaccine for a Life-Threatening Disease
S4V2: Opportunity to Develop First-in-Class Vaccine for a Life-Threatening Disease Tetravalent bioconjugate vaccine with potential to cover up to ~85% of shigellosis infections1 Vaccine Highlights Market Opportunity Upcoming Milestones • World’s most clinically advanced tetravalent • Global market e
Slide 20: Valneva Gains Exclusive Worldwide Rights to Tetravalent Shigella Vaccine
Valneva Gains Exclusive Worldwide Rights to Tetravalent Shigella Vaccine Strategic partnership with LimmaTech Biologics (“LMTB”) Vaccine candidate “S4V2” Key Aspects of Partnership ▪ World’s most clinically advanced tetravalent ▪ €10 million upfront payment to LMTB Shigellosis vaccine candidate ▪ Up
Slide 21: Historical and Planned Clinical Studies
Historical and Planned Clinical Studies Multiple catalysts and decision points for envisaged development strategy Monovalent vaccine (S. flex 2a) Multivalent vaccine (S. flex 2a, 3a, 6, sonnei) Phase 2 First Approval Phase 1 CHIM, S.sonnei ~2030/1 Phase 2b Phase 2 CHIM, S.Flex 2a CHIM, S.Flex ADULTS
Slide 22: Commercial Assessment of Shigella vaccine
Commercial Assessment of Shigella vaccine Shigella vaccine market estimated to peak at ~€500 million1 Children in endemic Traveler (~23%) Military (<1%) countries (~76%) 20-50% 30-100% 70-90% Recommendation (Med-high risk destinations) (OOP-reimb.) (Med-high risk destinations) 30% 15-60% (OOP) Accep
Slide 23: Novel Zika Virus Vaccine Candidate VLA1601
Novel Zika Virus Vaccine Candidate VLA1601
Slide 24: VLA1601: Optimized Vaccine Candidate Against Zika Virus
VLA1601: Optimized Vaccine Candidate Against Zika Virus Phase 1 results expected this year Vaccine Highlights Market Opportunity Upcoming Milestones • Novel adjuvanted inactivated whole- • Flaviviral disease transmitted by • Execute Phase 1 clinical trial with virus vaccine Aedes mosquitoes2 enhance
Slide 25: Valneva Commercial Business
Valneva Commercial Business
Slide 26: Continued Product Sales Growth Fuels Investments into R&D
Continued Product Sales Growth Fuels Investments into R&D +13% in 2024; Commercial business expected to be cash-flow positive in 2025 170-1801 163 IXCHIQ® 145 Strong Growth 130 pre-COVID (€ million) 115 COVID-19 104 Impact 93 VLA2001 80 3PP 66 63 DUKORAL® IXIARO® (travel) 49 Q1 IXIARO® (DoD) 2016 20
Slide 27: Valneva Remains Solidly Funded with Strong Financial Outlook
Valneva Remains Solidly Funded with Strong Financial Outlook 2025 Guidance Financial Outlook ▪ Product Sales: €170 - €180 million1; Commercial ▪ Continued revenue growth and cash flows from business expected to be cash-flow positive commercialized vaccines ▪ Total Revenues: €180 - €190 million ▪ Foc
Slide 28: Valneva Outlook: Growth Drivers for 2025 and Beyond
Valneva Outlook: Growth Drivers for 2025 and Beyond VLA15 success case • Potential for sustained profitability upon potential approval and commercialization*, driven by substantial milestones and royalties starting in 2027 Growing commercial revenues • Near term: continued growth trajectory of IXIAR
Slide 29: Reaching Further, Where Most Needed
Reaching Further, Where Most Needed Our Vision: a world in which no one dies or suffers from a vaccine-preventable disease ESG Agenda Commercial vaccines with access routes for 100% Protecting Lives people in LMICs1 We develop vaccines for unmet medical needs – focusing on universal access 4 Clinica
Slide 30: Thank you
Thank you Merci Danke Tack valneva