Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (January 2023)
37 slides from Valneva's investor presentation, January 2023
Slide 1: A Leading Specialty Vaccine Company
A LEADING SPECIALTY VACCINE COMPANY COMPANY PRESENTATION JANUARY 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: Delivering on Valneva's Value Proposition
Delivering on Valneva’s Value Proposition Sharpening focus on investments that will create value for the Company Progress new Continue progressing Maximize value candidates from Valneva’s advanced from commercial Re-size pre-clinical to operations programs products clinical stage ▪ Prepare for the ▪
Slide 5: Commercial Portfolio
Delivering Value From Advanced Clinical Pipeline and Commercialized Products1 Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners VLA15532: Potentially Adolescent study - Chikungunya eligible for PRV Enrolment Completion Clinical Portfolio VLA153: Phase 3
Slide 6: 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 6
Slide 7: 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 8: VLA1553 at a Glance
VLA1553 at a Glance Live-attenuated CHIKV vaccine candidate targeting long-lasting immunity with a single shot CHIKV Vaccine Candidate VLA1553 Development Status – Completed Phase 3 • Live-attenuated, single dose, i.m., lyophilized • Pivotal Phase 3 Trial: Primary Endpoint (Seroresponse • Based on L
Slide 9: Overview of Clinical Studies
Overview of Clinical Studies Three clinical trials completed Phase 1 Phase 3 • Phase 1 study1: • Pivotal Phase 3 study: • 120 healthy adults aged 18-45 years • 4,115 participants aged ≥18 years • Three dose levels of vaccine studied • Randomized, controlled trial comparing VLA1553 • Included a re-va
Slide 10: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2 Live-Attenuated CHIKV Vaccine Candidate Targeting Long-Lasting Immunity with a Single Shot 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
Slide 11: High Seroresponse Rate Confirmed in Older Participants
High Seroresponse Rate Confirmed in Older Participants Additional Data in Adults ≥65 Years 18-64 years ≥ 65 years Subjects with VLA1553 Placebo VLA1553 Placebo Seroresponse N=269 N=94 N=107 N=33 Day 29a 251 88 104 33 n (%) 248 (98.8) 1 (1.1) 103 (99.0) 0 Day 180a 241 87 104 33 n (%) 233 (96.7) 2 (2.
Slide 12: VLA1553 Development Outlook
VLA1553 Development Outlook First and only program to meet its Phase 3 trial endpoint worldwide Completed pivotal clinical trials ▪ Met all Phase 3 immunogenicity and safety endpoints ▪ Results confirmed by final lot-to-lot consistency trial results (VLA1553-302) Additional studies initiated ▪ Antib
Slide 13: VLA1553 Regulatory Outlook
VLA1553 Regulatory Outlook First and only chikungunya program to initiate regulatory process Biologics license application (BLA) with FDA ongoing ▪ Rolling submission completed in December 2022; Eligible for priority review request ▪ Upon BLA acceptance, FDA will determine priority review eligibilit
Slide 14: The Economic Burden of CHIKV in the Americas Has Been Estimated at $185B
The Economic Burden Of CHIKV in the Americas Has Been Estimated at $185B Impact of the 2013-2015 outbreaks – A modelling study • The global burden of chikungunya is unknown, but one study estimated the health and cost impact of the 2013–2015 CHIKV epidemic in the Americas. • The study modelled the a
Slide 15: 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 16: 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 17: Lyme Disease Vaccine Candidate – VLA15
July 9, 2019 Valneva - R&D Investor Day Lyme disease Vaccine Candidate – VLA15 17
Slide 18: Lyme Disease is a Major Health Issue
Lyme Disease is a Major Health Issue Severe Tick-transmitted Infection, Increasingly Common in the U.S. and Europe Epidemiology – Seasonal (peaking in ~ July) National Surveillance by Incidence Category Incidence for three most recent available years (~475,000 annual cases) (cases/100,000 persons) (
Slide 19: Multivalent Recombinant Protein Vaccine Candidate for Lyme Disease
Multivalent Recombinant Protein Vaccine Candidate for Lyme Disease VLA15 - Only Lyme Disease Program in Advanced Clinical Development Today Phase 3 study initated1 following positive results for three Phase 2 clinical trials2,3,4, including first 1 pediatric data5 Exclusive, worldwide partnership wi
Slide 20: 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 Pf
Slide 21: 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 22: VLA15-221: Six-month Antibody Persistence Results in Children and Adults
VLA15-221: Six-month Antibody Persistence Results in Children and Adults Data further validate ongoing Phase 3 study design Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule ▪ First antibody persistence da
Slide 23: VLA15 is Currently in Phase 3 Clinical Development
VLA 15 is currently in Phase 3 clinical development Overview Development Plan Valneva Co-development Valneva/ Pfizer 2017 2018 2019 2020 2021 2022 2023 2024 2025 Phase 1 First-in-Human study ✓ VLA15 generally safe and immunogenic Population: 18-39 yrs Adjuvanted groups more immunogenic than 12 µg, 4
Slide 24: Phase 3 Efficacy Study Currently Enrolling
Phase 3 Efficacy Study Currently Enrolling Randomized, Placebo-Controlled Phase 3 VALOR Study Design ▪ Population: 6,000 participants ≥5 years of age at high risk of Lyme disease (LD) (by residence and occupational/recreational activities) conducted in US and Europe (randomization approx. 2:1 US/EU)
Slide 25: Valneva Commercial Products
Valneva Commercial Products
Slide 26: 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 27: Non-COVID Product Sales: Strong Growth Anticipated
Non-COVID Product Sales: Strong Growth Anticipated, Driven by Recovery of Travel Segment and Performance of 3rd Party Products Travel Expected to Recover to Pre-COVID-19 Level by 20241 Global product sales €m DRIVERS + Pent-up travel demand + Re-establishment of Travel Medicine 130 clinics/ramping u
Slide 28: Commercial Portfolio: Strong Sales Performance in First Nine Months of 2022
Commercial Portfolio: Strong Sales Performance of €74.4 Million in the First Nine Months of 2022 Nine-Month 2022 product sales outside of COVID-19 COVID-19 vaccine sales grew by 11.2% vs. prior period Significant recovery in travel markets ▪ Product sales of the Japanese encephalitis vaccine in the
Slide 29: 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 30: Valneva's Commitment and Leadership in Travel Health
Valneva’s Commitment and Leadership in Travel Health Customer engagement through Valneva Travel Health Recently launched above-brand identity demonstrates our dedication and commitment to supporting HCPs and travelers through: ▪ Our unique range of travel vaccines ▪ A strong R&D focus resulting in a
Slide 31: The Evolution of the COVID-19 Program and Focus on the Future
The Evolution of the COVID-19 Program and Focus on the Future ▪ Manufacturing was suspended in the third quarter of 2022 ▪ As the program winds down, Valneva aims to deploy approximately eight to ten million doses of remaining inventory into international markets ▪ The Company is continuing discussi
Slide 32: Financial Overview
Financial Overview
Slide 33: 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 34: Resource Optimization to Ensure Continued Growth
Resource Optimization to Ensure Continued Growth Strategic re-sizing of operations in conjunction with COVID-19 wind-down is currently underway ▪ Expected to result in a reduction of ~20-25% of existing workforce for annualized financial savings of approximately €12 million Focused on the future ▪ P
Slide 35: Valneva is Poised for Substantial Growth
Valneva is Poised for Substantial Growth Led by potential new product launches 2025 – 2026 2023 – 2024 Additional growth drivers: VLA15 ▪ Continued recovery of travel market to “pre-COVID” Today VLA1553 VLA1553 levels and beyond ▪ New U.S. DoD contract for IXIARO®; expected 2023 IXIARO® IXIARO® IXIA
Slide 36: Valneva 2022 Financial Guidance
Valneva 2022 Financial Guidance Expected total revenues of €340 to €360 million, including: • €30 to €40 million of COVID-19 vaccine sales; ongoing efforts to sell existing inventories will run into 2023 • €70 to €80 million of other vaccine sales • Approximately €240 million of other revenues, prim
Slide 37: Significant Catalysts and Expected News Flow
Significant Catalysts and Expected News Flow Overview 2022 2023 2024 2025 Program Milestones Q4 H1 H2 H1 H2 VLA15 Antibody persistance data Phase 3 enrollment completion Lyme Primary efficacy readout, two tick seasons disease BLA and MAA filings Antibody persistence data BLA Submission completion Ad