Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (October 2024)
31 slides from Valneva's investor presentation, Oct 10, 2024
Slide 1: A Leading Specialty Vaccine Company
Valneva A Leading Specialty Vaccine Company Company Presentation October 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 Augmented Commercial and R&D Portfolio
Valneva’s Augmented Commercial and R&D Portfolio Further extending 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 ap
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 WMvalneva
Slide 7: World's leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 8: 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 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 Upcoming Milestones • Multivalent, recombinant proteins • Exclusive, worldwide partnership2 • Completed Valneva contribution to Pha
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 Efficacy Study Key Conclusions Expected by Year End 2025
Phase 3 Efficacy Study Key Conclusions Expected by Year End 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 activities) in U.S., Ca
Slide 12: The World's First and Only Chikungunya Vaccine
The World’s First and Only Chikungunya Vaccine IXCHIQ® / VLA1553 IXCHIQ® is currently approved by the U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada for the prevention of disease caused by chikungunya virus in individuals 18 years of age and older. Continued
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 impact explosive outbreaks Nearly half (43%) of those Affecting up to 75% of the infected develop severe loca
Slide 14: 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: Brazil last
Slide 15: 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 16: 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 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) Observational effectiveness study: participants >12 years of age in Brazil (n ~5,000) Pragmatic randomized controlled
Slide 18: Driving Further IXCHIQ Growth with Global Market Launches
Driving Further IXCHIQ® Growth with Global Market Launches Expanding Access for Travelers and Low-and-Middle-Income Countries Additional Brazil LATAM/ certain LMICs8 Additional IXCHIQ® filing markets Q4 2023 Prioritization and first Europe / UK submission in 2024 Canada Target countries First potent
Slide 19: World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V
Slide 20: Opportunity to develop first-in-class vaccine for a life-threatening disease
Opportunity to develop first-in-class vaccine for a life-threatening disease Expected to provide near-term R&D upside for investors with appealing risk-benefit profile Aligned with Aligned with Aligned with Our Vision Our Mission Our Corp. Strategy Addresses significant unmet medical Differentia
Slide 21: Shigellosis: Significant Unmet Medical Need
Shigellosis: Significant Unmet Medical Need1 No approved Shigella vaccine is currently available Second-leading cause of fatal diarrheal disease worldwide Estimated to cause up to 165 million cases and 600,000 deaths each year, particularly among children in LMICs2 Caused by species of Shigell
Slide 22: S4V: Opportunity to develop first-in-class vaccine for a life-threatening disease
S4V: 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 ex
Slide 23: Strategic Partnership with LMTB on Shigella vaccine candidate S4V
Strategic Partnership with LMTB on Shigella vaccine candidate S4V Key terms VLA receives global exclusive license to develop, manufacture and commercialize “S4V” LMTB to receive upfront, is eligible for future milestone and royalty payments − €10 million upfront payment − Future development, reg
Slide 24: Second-Generation Zika Virus Vaccine Candidate VLA1601
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 25: 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 26: Valneva Commercial Business
Valneva Commercial Business
Slide 27: Product Sales: Continued Growth Anticipated, Driven by Travel Recovery
Product Sales: Continued Growth Anticipated, Driven by Travel Recovery1,2 Surpassed Pre-Pandemic Levels by 12% in 20231; continued growth in H1 20243 160 – 1804 IXCHIQ® Strong Growth 145 pre-COVID (€ million) 130 115 104 COVID-19 Impact 93 VLA2001 80 3PP 66 63 DUKORAL® IXIARO® (travel) IXIARO® (DoD)
Slide 28: Commercial Business Expected to Deliver Substantial Growth
Commercial Business Expected to Deliver Substantial Growth Driven by Portfolio of Differentiated Products1 Only Japanese encephalitis vaccine approved in U.S. and Europe; vaccine requirement for U.S. military deployed to parts of Asia €160-180m IXCHIQ® €145m VLA2001 3PP Driven by IXCHIQ® First and o
Slide 29: Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook
Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook Confirmed 2024 Guidance Mid-Term Outlook Product Sales: €160 - €180 million* Commercial business expected to be cash-flow positive (including IXCHIQ®) from 2025 Total Revenues: €170 - €190 million Continued trave
Slide 30: Valneva's Near- and Mid-Term Value Drivers
Valneva’s Near- and Mid-Term Value Drivers VLA15 Success • Potential for major value inflection with key study conclusions next year • Sustained profitability upon potential approval, driven by substantial commercial milestones and royalties Growing commercial revenues • Near term: continued growth
Slide 31: Thank you
Thank you Merci Danke Tack valneva