Slide 1: Valneva's Full Year 2023 Results and Business Update
Valneva’s Full Year 2023 Results and Business Update March 20, 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: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 3
Slide 4: Full Year 2023 Key Results and Corporate Updates
Full Year 2023 Key Results and Corporate Updates Excellent progress across R&D Pipeline ▪ Chikungunya: FDA approval and ACIP recommendation ▪ Lyme disease: Phase 3 study with Pfizer fully enrolled ▪ Zika virus: Re-entering Phase 1 with second-generation candidate Significant growth of commercial bus
Slide 5: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 5
Slide 6: 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 Capture Maximize Commercial R&D Upside integrated Growth biotech model ▪ Unlock IXCHIQ® value by building ▪ Invest in new vaccines that address ▪ B
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: 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 9: 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 10: World's leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 11: 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 12: 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 13: Second-Generation Zika Virus Vaccine Candidate VLA1601
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 14: 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 15: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 15
Slide 16: FY 2023 Financials: Product Sales of €144.6 million
FY 2023 Financials: Product Sales of €144.6 million Commercial business showing continued, significant growth €m (audited) FY FY % % 2023 2022 Change at CER* IXIARO®/JESPECT® 73.5 41.3 +78% +84% DUKORAL® 29.8 17.3 +72% +82% Third party products 35.7 26.5 +34% +37% Total product sales (excl. COVID-19
Slide 17: FY 2023 Financials: Income Statement
FY 2023 Financials: Income Statement €m (unaudited) FY 2023 FY 2022 Product sales 144.6 114.8 Other Revenues 9.1 246.5 Revenues 153.7 361.3 Cost of goods and services (100.9) (324.4) Research and development expenses (59.9) (104.9) Marketing and distribution expenses (48.8) (23.5) General and admini
Slide 18: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 18
Slide 19: Commercial Business Expected to Deliver Substantial Growth
Commercial Business* Expected to Deliver Substantial Growth 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® First and only approved and IXIARO® DUKORAL® single-shot chiku
Slide 20: 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 21: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 21
Slide 22: 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 23: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – FY 2023 Analyst Presentation 23
Slide 24: Thank you
Thank you Merci Danke Tack valneva