Slide 1: Valneva's Q1 2024 Financial Results and Business Update
Valneva’s Q1 2024 Financial Results and Business Update May 7, 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 Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 Analyst Presentation 3
Slide 4: First Quarter 2024 Key Results and Corporate Updates
First Quarter 2024 Key Results and Corporate Updates Q1 Pipeline Progress ▪ Chikungunya: ACIP recommendation and first commercial revenues ▪ Lyme disease: Participants expected to complete primary vaccinations in Q2 ▪ Zika virus: Advanced second-generation candidate to Phase 1 Q1 Financial Highlight
Slide 5: Agenda
Agenda Introduction Business Update Financial Report Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 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 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 ▪ No difference in immu
Slide 9: Next Steps: IXCHIQ Launch Success
IXCHIQ® Launch Success Continued Progress on Plan Execution Coming Soon Build HCP Gain ACIP Ensure Customer Activate Awareness & Approval & Stocking & Build Consumers & Stock Distributor CDC Acceptance Payor Coverage Engage Military Channel Next Steps: ▪ Support customers who are already actively pr
Slide 10: Driving Value by Executing Global Launch Plan
Driving Value by Executing Global Launch Plan Multiple ex-U.S. regulatory processes currently ongoing1 Additional Additional Markets LATAM/ Brazil Target countries Certain LMICs9 with established Europe / UK travelers' or IXCHIQ® filing Prioritization and first Canada Q4 2023 endemic markets Filed w
Slide 11: 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 12: IXCHIQ Global Market Opportunity
IXCHIQ® Global Market Opportunity Prioritizing Traveler Segment Traveler Access Strategy: • Ensure quick and broad access • Accelerate reimbursement • Focus on consumer journey 77.6% Endemic Access Strategy: • Raise awareness of chik/Ixchiq 21.2% • Latin America and certain LMICs • Expand to new cus
Slide 13: World's leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 14: 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 15: 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 16: Second-Generation Zika Virus Vaccine Candidate VLA1601
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 17: 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 18: Agenda
Agenda Introduction Business Update Financial Report Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 Analyst Presentation 18
Slide 19: Q1 2024 Financials: Product Sales of €32.1 million
Q1 2024 Financials: Product Sales of €32.1 million Commercial business on track for continued, significant growth €m (audited) Q1 Q1 % 2024 2023 Change IXIARO®/JESPECT® 16.6 17.4 -4% DUKORAL® 11.3 10.2 10% IXCHIQ® 0.2 -- -- Third party products 4.1 4.5 -9% Total product sales 32.1 32.1 0.1% Valneva
Slide 20: Q1 2024 Financials: Income Statement
Q1 2024 Financials: Income Statement €m (unaudited) Q1 2024 Q1 2023 Product sales 32.1 32.1 Other Revenues 0.6 1.4 Revenues 32.8 33.5 Cost of goods and services (22.2) (20.5) Research and development expenses (13.1) (14.1) Marketing and distribution expenses (11.3) (9.0) General and administrative e
Slide 21: Agenda
Agenda Introduction Business Update Financial Report Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 Analyst Presentation 21
Slide 22: 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 23: Reiterating Strong Mid-Term Outlook
Reiterating Strong Mid-Term Outlook Valneva is Solidly Funded with a Clear Pathway Toward Sustained Profitability1 2024 Guidance Mid-Term Outlook ▪ Product Sales: €160 - €180 million2 ▪ Commercial business expected to cash-flow positive (including IXCHIQ®) from 2025 ▪ Total Revenues: €170 - €190 mil
Slide 24: Agenda
Agenda Introduction Business Update Financial Report Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 Analyst Presentation 24
Slide 25: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Chikungunya vaccine ▪ Upcoming potential approvals: EMA, Health Canada, Anvisa (Brazil) ▪ Initiate Phase 3 immunocompromised individuals study in H1 2024 ▪ Report 6-month follow up results and file for initial label extension (adolescents) ▪ Initiate Phase 4 clin
Slide 26: Agenda
Agenda Introduction Business Update Financial Report Q1 2024 Financial Outlook Newsflow Q&A Valneva – Q1 2024 Analyst Presentation 26
Slide 27: Thank you
Thank you Merci Danke Tack valneva