Valneva Se · EURONEXT:VLA
Valneva — Q1 2025 Earnings Presentation
26 slides from Valneva's earnings presentation, May 7, 2025
Slide 1: Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates
Valneva Reports First Quarter 2025 Financial Results and Provides Corporate Updates May 7, 2025
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 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 3
Slide 4: First Quarter 2025 Key Highlights
First Quarter 2025 Key Highlights Total Revenues Solid Cash Position €49.2m €153m 50% YoY growth Excludes $14.2m gross proceeds (April ATM transaction) Q1 2025 Strong Regulatory 71% Reduction in Execution Operating Cash Burn* IXCHIQ® adolescent label extension; Targeting 50% reduction First endemic-
Slide 5: First Quarter 2025 Highlights
First Quarter 2025 Highlights Fulfilling Unmet Medical Needs ▪ New $32.8 million IXIARO® U.S. Department of Defense contract ▪ Responding to French government’s call for IXCHIQ® to combat chikungunya outbreaks in La Réunion and Mayotte ▪ Responding to cholera outbreak in Mayotte by supplying doses o
Slide 6: Agenda
Agenda Introduction Business Update Financial Report Q1 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 6
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: Phase 3: First Data Expected at the End of 2025
Phase 3: First Data Expected at the End of 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., Canada and Europe (
Slide 10: A Highly Differentiated single-shot Chikungunya Vaccine IXCHIQ / VLA1553
A Highly Differentiated single-shot Chikungunya Vaccine IXCHIQ® / VLA1553 IXCHIQ® is approved by the European Medicines Agency (EMA) in individuals 12 years of age and older. It is approved by the U.S. Food & Drug Administration (FDA), the UK’s Medicines and Healthcare products Regulatory Agency (MH
Slide 11: IXCHIQ Builds on Key Differentiators to Drive Growth
IXCHIQ® Builds on Key Differentiators to Drive Growth Provides a strong and persistent immune response with a single dose ▪ 98.9% seroresponse rate at Day 29 - Sustained seroresponse rate at 96% after three years1 ▪ Strong and persistent immune response in adults 18-64 yrs and 65+2, as well as adol
Slide 12: Recent Changes to IXCHIQ Recommendations
Recent Changes to IXCHIQ® Recommendations Responses to reports of serious adverse events (SAEs) in frail elderly individuals ▪ ACIP recommended a precaution for use in 65+ with comorbidities ▪ EMA cautioned against use in frail older adults, especially those with comorbidities potentially affecting
Slide 13: 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 14: World's Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
World’s Most Clinically Advanced Tetravalent Shigella Vaccine Candidate S4V2
Slide 15: 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 16: Novel Zika Virus Vaccine Candidate VLA1601
Novel Zika Virus Vaccine Candidate VLA1601
Slide 17: VLA1601: Optimized Vaccine Candidate Against Zika Virus
VLA1601: Optimized Vaccine Candidate Against Zika Virus Phase 1 results expected this year Vaccine Highlights Market Opportunity Upcoming Milestones • Novel adjuvanted inactivated whole- • Flaviviral disease transmitted by • Execute Phase 1 clinical trial with virus vaccine Aedes mosquitoes2 enhance
Slide 18: Agenda
Agenda Introduction Business Update Financial Report Q1 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 18
Slide 19: Q1 2025 Financials: Product Sales of €48.6 million
Q1 2025 Financials: Product Sales of €48.6 million Reflects IXCHIQ® launch, recovery from Q1 2024 supply shortages €m (audited) Q1 Q1 % 2025 2024 Change IXIARO®/JESPECT® 27.5 16.6 65.5% DUKORAL®* 12.3 11.3 9.4% IXCHIQ®** 3.0 0.2 1665% Third party products 5.8 4.1 41.1% Total product sales 48.6 32.1
Slide 20: Q1 2025 Financials: Income Statement
Q1 2025 Financials: Income Statement €m (unaudited) Q1 2025 Q1 2024 Product sales 48.6 32.1 Other Revenues 0.6 0.6 Revenues 49.2 32.8 Cost of goods and services (23.0) (22.2) Research and development expenses (15.0) (13.1) Marketing and distribution expenses (10.4) (11.3) General and administrative
Slide 21: Agenda
Agenda Introduction Business Update Financial Report Q1 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 21
Slide 22: Valneva Remains Solidly Funded with Strong Financial Outlook
Valneva Remains Solidly Funded with Strong Financial Outlook 2025 Guidance Financial Outlook ▪ Product Sales: €170 - €180 million1; Commercial ▪ Continued revenue growth and cash flows from business expected to be cash-flow positive commercialized vaccines ▪ Total Revenues: €180 - €190 million ▪ Foc
Slide 23: Agenda
Agenda Introduction Business Update Financial Report Q1 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 23
Slide 24: Valneva Outlook: Growth Drivers for 2025 and Beyond
Valneva Outlook: Growth Drivers for 2025 and Beyond VLA15 success case • Potential for sustained profitability upon potential approval and commercialization*, driven by substantial milestones and royalties starting in 2027 Growing commercial revenues • Near term: continued growth trajectory of IXIAR
Slide 25: Agenda
Agenda Introduction Business Update Financial Report Q1 2025 Financial Outlook Growth Drivers Q&A Valneva – Q1 2025 Analyst Presentation 25
Slide 26: Thank you
Thank you Merci Danke Tack valneva