Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (November 2024)
29 slides from Valneva's investor presentation, November 2024
Slide 1: A Leading Specialty Vaccine Company
Valneva A Leading Specialty Vaccine Company Company Presentation November 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 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 >129K cases 87 million 202 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 Upcoming Milestones • Multivalent, recombinant proteins • Exclusive, worldwide partnership2 • On track for initial Phase 3 trial re
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 local popul
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 (Q4)
Slide 15: IXCHIQ Builds on Key Differentiators to Drive Growth
IXCHIQ® Builds on Key Differentiators to Drive Growth The 1st and only vaccine against chikungunya providing a strong and persistent immune response with only one dose 98.9% seroresponse rate at Day 29 - Sustained seroresponse rate at 97% after two years (EU label) Only chikungunya vaccine to
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) 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 S4V
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V
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: Second-Generation Zika Virus Vaccine Candidate VLA1601
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 24: 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 25: Valneva Commercial Business
Valneva Commercial Business
Slide 26: 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 – 1704 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 27: Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook
Valneva Remains Solidly Funded with Strong Near- and Mid-term Financial Outlook Narrowed 2024 Guidance Mid-Term Outlook Product Sales: €160 - €170 million* Commercial business expected to be cash-flow positive from 2025 Total Revenues: €170 - €180 million Continued travel sales growth for IX
Slide 28: 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 29: Thank you
Thank you Merci Danke Tack valneva