Slide 1: Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates
Valneva Reports Half Year 2024 Financial Results and Provides Corporate Updates August 13, 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 H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 2024 Analyst Presentation 3
Slide 4: First Half 2024 Key Results and Corporate Updates
First Half 2024 Key Results and Corporate Updates On track to meet full year guidance based on anticipated supply and phasing Sales Performance in Line with 2024 Guidance €68.3m in product sales; including first IXCHIQ® sales in U.S. Total revenue €70.8m Net Profit of €34.0m, reflecting PRV sa
Slide 5: Agenda
Agenda Introduction Business Update Financial Report H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 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 Maximize Commercial Capture integrated Growth R&D Upside biotech model Unlock IXCHIQ® value by building Leverage proven R&D engine Build cont
Slide 7: 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 8: 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 9: 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 10: IXCHIQ U.S. Launch Success
IXCHIQ® U.S. Launch Success Continuing to deliver with more to come Recent Achievements: Launched unbranded traveler campaign to build consumer awareness DHA-IHD1 adopted CDC2 recommendations and published chikungunya virus and vaccines guidance Growing customer base; distributors and customer
Slide 11: 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 12: 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 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 partnership2 • Completed Valneva contribution to Pha
Slide 15: Phase 3 Efficacy Study Fully Enrolled; Completed Primary Vaccination
Phase 3 Efficacy Study Fully Enrolled; Completed Primary Vaccination 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.
Slide 16: World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V
Slide 17: 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 vaccine mar
Slide 18: 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 19: Second-Generation Zika Virus Vaccine Candidate VLA1601
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: Agenda
Agenda Introduction Business Update Financial Report H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 2024 Analyst Presentation 21
Slide 22: H1 2024 Financials: Product Sales of €68.3 million
H1 2024 Financials: Product Sales of €68.3 million Commercial business on track for continued, significant growth €m (audited) H1 H1 % 2024 2023 Change IXIARO®/JESPECT® 41.9 30.3 +38% DUKORAL® 14.9 17.1 -13% IXCHIQ® 1.0 -- -- Third party products 10.5 16.5 -37% Total product sales 68.3 64.0 +7% COVI
Slide 23: H1 2024 Financials: Income Statement
H1 2024 Financials: Income Statement €m (unaudited) H1 2024 H1 2023 Product sales 68.3 69.7 Other Revenues 2.5 4.1 Revenues 70.8 73.7 Cost of goods and services (45.6) (53.8) Research and development expenses (29.7) (26.0) Marketing and distribution expenses (23.2) (20.0) General and administrative
Slide 24: Agenda
Agenda Introduction Business Update Financial Report H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 2024 Analyst Presentation 24
Slide 25: 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 26: 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 27: Agenda
Agenda Introduction Business Update Financial Report H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 2024 Analyst Presentation 27
Slide 28: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Chikungunya vaccine Upcoming potential approvals: Anvisa (Brazil), MHRA (UK) Submit for label extension for adolescents in H2 2024 36-month antibody persistence data expected in H2 2024 Initiate Phase 4 clinical program Lyme disease vaccine candidate VLA1
Slide 29: Agenda
Agenda Introduction Business Update Financial Report H1 2024 Financial Outlook Newsflow Q&A Valneva – H1 2024 Analyst Presentation 29
Slide 30: Thank you
Thank you Merci Danke Tack valneva