Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (May 2024)
26 slides from Valneva's investor presentation, May 2024
Slide 1: A Leading Specialty Vaccine Company
Valneva A Leading Specialty Vaccine Company Company Presentation May 2024
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 Further extending a unique, best-in class 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 (ETEC*) vaccine approved in >
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 ▪ Invest in new vaccines that address ▪ B
Slide 6: R&D
R&D WMvalneva
Slide 7: The World's First and Only Chikungunya Vaccine
The World’s First and Only Chikungunya Vaccine IXCHIQ® / VLA1553 *IXCHIQ® is approved by the U.S. Food & Drug Administration (FDA) and is indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIK
Slide 8: 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 impact explosive outbreaks Nearly half (43%) of those Affecting up to 75% of the infected develop severe loca
Slide 9: IXCHIQ: The World's First and Only Licensed Chikungunya Vaccine
IXCHIQ®: The World’s First and Only Licensed Chikungunya Vaccine FDA-approved in adults, with potential additional regulatory approvals in 2024 Vaccine Highlights Market Opportunity Upcoming Milestones • Live-attenuated: offers strong and long- • Travelers • Potential upcoming approvals: EMA, lastin
Slide 10: IXCHIQ Key Features and Differentiators
IXCHIQ® Key Features and Differentiators ▪ We expect to benefit by being first to market with a potentially best-in-class vaccine ▪ We believe we have a differentiated and competitive product characterized by a strong and durable immunological response from a single injection Indicated for the preve
Slide 11: Only CHIKV vaccine to achieve target immunogenicity with a single shot
Only CHIKV vaccine to achieve target immunogenicity with a single shot Differentiated vaccine shows rapid, long-lasting immunity across all age groups tested1,2,5 Immunogenicity Data Safety Data ▪ 99% Seroresponse3 Rate (SRR) after ▪ Generally well tolerated by >3,600 single vaccination → maintained
Slide 12: IXCHIQ is FDA approved for adults under the accelerated pathway
IXCHIQ® is FDA approved for adults under the accelerated pathway1 Robust clinical program to support continued approval, label expansion, product profile Post-Marketing Effectiveness2 (Phase 4) ▪ Observational effectiveness study: participants >12 years of age in Brazil (n ~5,000) ▪ Pragmatic random
Slide 13: Preparing for Global Market Launches
Preparing for Global Market Launches Planned additional and future regulatory processes1 Additional LATAM/ Brazil certain LMICs9 Additional IXCHIQ® filing Europe / UK markets Q4 2023 Prioritization and first Canada Filed with EMA4 Target countries First potential submission in 2024 United States Oct
Slide 14: World's leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 15: Lyme Disease is a Major Health Issue
Lyme Disease is a Major Health Issue Severe Tick-transmitted Infection, Increasingly Common in the U.S. and Europe Epidemiology – Seasonal (peaking in ~ July) National Surveillance by Incidence Category Incidence for three most recent available years (~475,000 annual cases) (cases/100,000 persons) (
Slide 16: 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 Upcoming Milestones • Multivalent, recombinant proteins • Exclusive, worldwide partnership1 • Complete Valneva contribution to Phas
Slide 17: 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 18: Phase 3 Efficacy Study Fully Enrolled
Phase 3 Efficacy Study Fully Enrolled Pfizer aims to submit regulatory applications in U.S. and Europe in 20261 ▪ Population: 9,437 evaluable participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activities) in U.S., Canada and Europe (randomizati
Slide 19: Second-Generation Zika Virus Vaccine Candidate
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 20: VLA1601: Optimized Second-Generation Vaccine Candidate Against Zika Virus
VLA1601: Optimized Second-Generation Vaccine Candidate Against Zika Virus Entering Phase 1, further program evaluation planned Vaccine Highlights Market Opportunity Upcoming Milestones • Second-generation adjuvanted • Flaviviral disease transmitted by Aedes • Execute Phase 1 clinical trial with enha
Slide 21: Valneva Commercial Business
Valneva Commercial Business
Slide 22: Product Sales: Continued Growth Anticipated, Driven by Travel Recovery
Product Sales: Continued Growth Anticipated, Driven by Travel Recovery1,2 Revenues Surpassed Pre-Pandemic Levels by 12% in 20231 160 - 180 IXCHIQ® 145 Strong Growth 130 pre-COVID (€ million) 115 104 COVID-19 Impact 93 VLA2001 80 3PP 66 63 DUKORAL® IXIARO® (travel) IXIARO® (DoD) 2016 2017 2018 2019 2
Slide 23: Commercial Business Expected to Deliver Substantial Growth over Mid-Term
Commercial Business Expected to Deliver Substantial Growth over Mid-Term Driven by Portfolio of Differentiated Products* Only Japanese encephalitis vaccine approved in U.S. and Europe; vaccine requirement for U.S. military deployed to parts of Asia 160-180 IXCHIQ® 145 VLA2001 3PP Driven by IXCHIQ® a
Slide 24: Valneva is Solidly Funded with Strong Near- and Mid-term Financial Outlook
Valneva is Solidly Funded with Strong Near- and Mid-term Financial Outlook Improved 2024 Guidance Mid-Term Outlook ▪ Product Sales: €160 - €180 million* ▪ Commercial business expected to cash-flow positive (including IXCHIQ®) from 2025 ▪ Total Revenues: €170 - €190 million ▪ Continued travel sales g
Slide 25: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Chikungunya vaccine ▪ Initiate Phase 3 immunocompromised individuals study in H1 2024 ▪ Upcoming potential approvals: EMA, Health Canada, Anvisa (Brazil) ▪ File for potential label extension ▪ Initiate Phase 4 clinical program Lyme disease vaccine candidate VLA15
Slide 26: Thank you
Thank you Merci Danke Tack valneva