Slide 1: Valneva Reports First Nine Months 2024 Financial Results and Provides Corporate Updates
Valneva Reports First Nine Months 2024 Financial Results and Provides Corporate Updates November 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 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 3
Slide 4: First Nine Months 2024 Key Results
First Nine Months 2024 Key Results Performance in Line with 2024 Guidance Product Sales Cash Position €112.5m €156.3m** Guidance €160-170m* Well financed 9M 2024 Strong R&D execution Scientific Positioning Lyme, Chik adolescents/peds & Partnering and persistence IXCHIQ®: Lancet, CEPI Long-term R&D s
Slide 5: Valneva Strategy for Growth
Valneva Strategy for Growth Mid-Term Vision: A Major Turning Point in Valneva’s Evolution Targeting sustained profitability from 2027; driven by success of the Lyme disease vaccine program* − On track in pivotal Phase 3 trial − Regulatory filings (2026), first approvals and sales (2027)* − $143m i
Slide 6: Agenda
Agenda Introduction Business Update Financial Report 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 6
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: World's leading Lyme Disease Vaccine Candidate VLA15
World’s leading Lyme Disease Vaccine Candidate VLA15
Slide 9: 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 10: 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 Phase 3 trial conclusion
Slide 11: 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 12: The World's First and Only Chikungunya Vaccine IXCHIQ / VLA1553
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: 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 14: Key Achievements Focused on Expanding Access to IXCHIQ
Key Achievements Focused on Expanding Access to IXCHIQ® Milestones Achieved • Phase 3 adolescent trial showed strong safety and immunogenicity profile (up to six months) • Enrollment in Phase 2 pediatric trial to support Phase 3 and enable further label extension • Published long-term antibody persi
Slide 15: Upcoming and Future Opportunities to Capture Greater Penetration
Upcoming and Future Opportunities to Capture Greater Penetration Upcoming and Future Opportunities MMWR1 publication expected to drive further retail growth in U.S. Launches in Europe; Channel expansion in Canada Additional ACIP2 and European recommendations Travel software protocol updates
Slide 16: World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
Slide 17: 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 18: 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 19: 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 20: Second-Generation Zika Virus Vaccine Candidate VLA1601
Second-Generation Zika Virus Vaccine Candidate VLA1601
Slide 21: 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 22: Agenda
Agenda Introduction Business Update Financial Report 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 22
Slide 23: 9M 2024 Financials: Product Sales of €112.5 million
9M 2024 Financials: Product Sales of €112.5 million Commercial business on track for continued growth €m (audited) 9M 9M % 2024 2023 Change IXIARO®/JESPECT® 66.0 50.3 +31% DUKORAL® 22.3 21.1 +6% IXCHIQ® 1.8 -- -- Third party products 22.5 29.1 -23% Total product sales 112.5 100.4 +12% COVID-19 -- 5.
Slide 24: 9M 2024 Financials: Income Statement
9M 2024 Financials: Income Statement €m (unaudited) 9M 2024 9M 2023 Product sales 112.5 106.1 Other Revenues 4.2 5.7 Revenues 116.6 111.8 Cost of goods and services (71.3) (74.8) Research and development expenses (48.6) (42.2) Marketing and distribution expenses (35.7) (33.9) General and administrat
Slide 25: Agenda
Agenda Introduction Business Update Financial Report 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 25
Slide 26: Traveler from U.S. and EU: History and Forecast
Traveler from U.S. and EU: History and Forecast Recovering from pre-COVID-19; strong growth anticipated 2030 vs 2024: + 22% (Chik) + 29.5 % (JE) 2024 vs 2019: + 5.5% (Chik) - 5.2% (JE) Data source: IATA data – last update August 2024 Valneva – 9M 2024 Analyst Presentation 26
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: Agenda
Agenda Introduction Business Update Financial Report 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 28
Slide 29: Key Upcoming Catalysts and News Flow
Key Upcoming Catalysts and News Flow Chikungunya vaccine Upcoming potential approvals: Anvisa (Brazil), MHRA (UK) 36-month antibody persistence data expected in Q4 2024 Initiate Phase 4 clinical program Lyme disease vaccine candidate VLA15 Complete final booster dosing for by mid-2025 Moni
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: Agenda
Agenda Introduction Business Update Financial Report 9M 2024 Financial Outlook Newsflow Q&A Valneva – 9M 2024 Analyst Presentation 31
Slide 32: Thank you
Thank you Merci Danke Tack valneva