Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (September 2023)
24 slides from Valneva's investor presentation, September 2023
Slide 1: A Leading Specialty Vaccine Company
A LEADING SPECIALTY VACCINE COMPANY COMPANY PRESENTATION SEPTEMBER 2023 1
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 Potential CEPI/ Butantan VLA1553: Potentially eligible for PRV BLA approval (LMIC) Chikungunya 4Q 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 5
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 Q4
Potential to Deliver the World’s First Chikungunya Vaccine in Q4 VLA1553* - Live-attenuated vaccine candidate under FDA priority review Pioneering Vaccine Development in an Area of High Unmet Need – Preparing for Success • First chikungunya vaccine candidate to report positive Phase 3 data – met all
Slide 8: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2 Live-attenuated CHIKV vaccine candidate targeting rapid and long-lasting immunity with a single shot Immunogenicity Data Safety Data1 ▪ Seroresponse3 Rate (SRR) in 99% of participants after a ▪ VLA1553 was generally well tolerated among the >3,600 single vaccinat
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 Segments Targeted via Partnership Travelers from Non-Endemic Regions Endemic Region Use Travel vaccine for individuals travelling to area
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 9, 2019 Valneva - R&D Investor Day Lyme disease Vaccine Candidate – VLA15 11
Slide 12: Multivalent Recombinant Protein Vaccine Candidate for Lyme Disease
Multivalent Recombinant Protein Vaccine Candidate for Lyme Disease VLA15: the only Lyme disease program in advanced clinical development today 1 Phase 3 study ongoing, sponsored by Pfizer1 and supported by positive results for three Phase 2 clinical trials2,3,4, including first pediatric and adolesc
Slide 13: Valneva's and Pfizer's Collaboration to Co-Develop and Commercialize VLA15
Valneva’s and Pfizer’s Collaboration to Co-Develop and Commercialize Lyme Disease Vaccine VLA15 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 Pfizer’s outstan
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 N. America/EU) ▪ Primary endpoint: Rate of confirmed1 LD
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 Recovery of Travel
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 130 - 150 130 3PP 2023 guidance Travel recovery DUKORAL® 114.8 Product sales of €130 million to €150 milli
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
Key Upcoming Catalysts and News Flow Chikungunya vaccine candidate VLA1553 ▪ Adolescent study immunogenicity results November 2023 ▪ Potential BLA approval and first launch Q4 2023; Potential award of PRV ▪ Initiate EMA regulatory submission in 2023 Lyme disease vaccine candidate VLA15 ▪ Continued e
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: 6-12 months VLA15 ▪ Continued recovery of travel volumes toward pre- COVID levels and beyond Today VLA1553 VLA1553 ▪ New U.S. DoD contract for IXIARO® expected in Q4 ▪ Potent