Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (July 2023)
25 slides from Valneva's investor presentation, July 2023
Slide 1: A Leading Specialty Vaccine Company
A LEADING SPECIALTY VACCINE COMPANY COMPANY PRESENTATION JULY 2023
Slide 2: Disclaimer
Disclaimer This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to any person in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Valneva is a European company. Information d
Slide 3: Valneva Summary and Core Strengths
Valneva Summary and Core Strengths Fully integrated specialty vaccine company focused on development, manufacturing and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need ◼ Highly specialized and targeted approach to development of unique prophylac
Slide 4: Clinical Portfolio
Advanced, Focused and Differentiated Clinical Pipeline and Promising Early- Stage Targets Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners Potentially Potential CEPI/ Butantan VLA1553: eligible for PRV BLA approval (LMIC) Chikungunya 3Q 202
Slide 5: Chikungunya Vaccine Candidate – VLA1553
Chikungunya Vaccine Candidate – VLA1553* *VLA1553 is an investigational chikungunya vaccine candidate and is not approved for use in the United States or any other jurisdiction
Slide 6: Chikungunya: A Major Public Health Threat
Chikungunya: A Major Public Health Threat Mosquito-transmitted disease with potentially debilitating consequences ▪ Chikungunya virus (CHIKV) is transmitted by Aedes mosquitoes1 ▪ Acute chikungunya, seen in up to 97% of those infected, typically presents with sudden onset of high fever and joint pai
Slide 7: Potential to Deliver the World's First Chikungunya Vaccine in Q3
Potential to Deliver the World’s First Chikungunya Vaccine in Q3 VLA1553* - Live-attenuated vaccine candidate under FDA priority review Pioneering Vaccine Development in an Area of High Unmet Need – Preparing for Success • First and only chikungunya vaccine candidate to report positive Phase 3 data
Slide 8: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2 Key data Immunogenicity Data Safety Data1 ▪ Seroresponse3 Rate (SRR) in 99% 98.9% ofof ▪ VLA1553 was generally well tolerated among participants after a single vaccination the 3,082 subjects evaluated for safety ▪ Immunogenicity profile maintained over time: ▪ Ap
Slide 9: Chikungunya Global Market Segments
Chikungunya Global Market Segments Global market for chikungunya vaccines estimated to exceed $500 million per year by 20321 Segments Targeted Directly by Valneva Endemic Region Use Travelers from Non-Endemic Regions Vaccine in endemic / LMIC markets, Targeted via CEPI / Instituto Butantan Partnersh
Slide 10: VLA1553 Fits Perfectly Within our Existing Commercial Infrastructure
VLA1553 Fits Perfectly Within our Existing Commercial Infrastructure High-caliber team with significant experience in the vaccine space Commercial Footprint Highly experienced teams with deep expertise in vaccine commercialization Commercial infrastructure present in most key travel markets; footpri
Slide 11: Lyme Disease Vaccine Candidate – VLA15
July 2023Company Presentation Valneva Lyme disease Vaccine Candidate – VLA15
Slide 12: Only Lyme Disease Vaccine in Advanced Clinical Development Today
Only Lyme Disease Vaccine in Advanced Clinical Development Today VLA15: multivalent recombinant protein vaccine candidate 1 Phase 3 study ongoing1 and supported by positive results for three Phase 2 clinical trials2,3,4, including first pediatric data5 Exclusive, worldwide partnership with Pfizer; t
Slide 13: Valneva's and Pfizer's Collaboration on Lyme Disease Vaccine VLA15
Valneva’s and Pfizer’s Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine VLA15 Key features Established April 2020 Updated June 2022; Equity Investment of $95 Million by Pfizer; Phase 3 cost split 40/60% (Valneva/Pfizer)* Rationale Maximize Lyme disease opportunity by leveraging Pfi
Slide 14: VLA15 Demonstrated Strong Immunogenicity Across 1,030 Participants
VLA15 Demonstrated Strong Immunogenicity Across 1,030 Adult and Pediatric Participants VLA15-221: First positive pediatric data (April 20221) ▪ Strong immunogenicity profile in adult 2 (ages 18-65) and pediatric participants (ages 5-17) ▪ More immunogenic in pediatric participants than in adults, wi
Slide 15: Phase 3 Efficacy Study
Phase 3 Efficacy Study ▪ Population: ~9000 total participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activities) in U.S., Canada and Europe (randomization approx. 1:1 VLA15/Placebo and 2:1 U.S./EU) ▪ Primary endpoint: Rate of confirmed1 LD cases
Slide 16: Valneva Commercial Products
Valneva Commercial Products
Slide 17: Current Commercial Portfolio
Current Commercial Portfolio Brand Indication* Partner / Year Valneva commercial rights & key markets Active immunization against Valneva direct markets : US, CA, UK, FR, Nordics, BE, Global Proprietary Japanese encephalitis from 2 NL, AT months of age Rights Key markets addressed by Partners: DE, A
Slide 18: Product Sales: Strong Growth Anticipated, Driven by Travel Recovery
Product Sales: Strong Growth Anticipated, Driven by Recovery of Travel Segment Revenues Expected to Recover to Pre-Pandemic Levels in 20231; and on volume basis by 20242 Global product sales €m DRIVERS + Pent-up travel demand 130 - 150 + Re-establishment of Travel Medicine clinics/ 130 ramping up of
Slide 19: Commercial Portfolio: Strong Sales Performance of €114.8 Million in 2022
Commercial Portfolio: Strong Sales Performance of €114.8 Million in 2022 2023 guidance 2022 product sales grew by 82.3% vs. prior period Significant recovery in travel markets ▪ Product sales of the Japanese encephalitis vaccine in the travel Product sales of €130 million to market increased to €28.
Slide 20: Executing Our Commercial Strategy
Executing Our Commercial Strategy Three key levers to accelerate commercial performance Travel health recovery Expand vaccine portfolio VLA1553 launch preparedness Customer engagement Evaluation of new in- Evolution of commercial through Valneva Travel licensing and product infrastructure Health acq
Slide 21: Financial Overview
Financial Overview
Slide 22: Company is Well Capitalized to at Least 2024
Company is Well Capitalized to at Least 2024 Balance sheet strengthened by successful capital raises May 2021: U.S. Initial Public Offering with gross proceeds of $107.6 million 2021-2022: Follow on offerings and debt financing ▪ Most recent upsized Global Offering brought in €102.9 million in gross
Slide 23: Key Upcoming Catalysts and News Flow in 2023
Key Upcoming Catalysts and News Flow in 2023 Chikungunya vaccine candidate VLA1553 ▪ First adolescent study results mid-2023 ▪ Potential BLA approval and first launch; Potential PRV sale in H2 2023 ▪ Initiate additional ex-U.S. regulatory submissions in 2023 Lyme disease vaccine candidate VLA15 ▪ Ad
Slide 24: Valneva is Poised for Substantial Growth
Valneva is Poised for Substantial Growth Led by potential new product launches 3-4 years Additional potential growth drivers: 1-2 years VLA15 ▪ Continued recovery of travel volumes toward pre- COVID levels and beyond Today VLA1553 VLA1553 ▪ New U.S. DoD contract for IXIARO® expected in the coming mo
Slide 25: Thank you
Thank you Merci Danke Tack WVAvalneva