Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (February 2024)
28 slides from Valneva's investor presentation, February 2024
Slide 1: A Leading Specialty Vaccine Company
A LEADING SPECIALTY VACCINE COMPANY COMPANY PRESENTATION FEBRUARY 2024
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: Valneva's R&D Pipeline Overview
Valneva’s R&D Pipeline Overview Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners IXCHIQ®/VLA1553: IXCHIQ®: FDA Approved Expect to launch CEPI/ Butantan PRV received early 2024 (LMIC) Chikungunya Phase 3 fully enrolled; VLA153: primary/boost
Slide 5: The World's First Chikungunya Vaccine IXCHIQ / VLA1553
The World’s First Chikungunya Vaccine IXCHIQ® / VLA1553 *IXCHIQ® is approved by the U.S. Food & Drug Administration (FDA) and is indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV. Contin
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: IXCHIQ: The World's First Approved Chikungunya Vaccine
IXCHIQ®: The World’s First Approved Chikungunya Vaccine FDA-approved, live-attenuated vaccine with potential additional regulatory approvals in 2024 Pioneering Vaccine Development in an Area of High Unmet Need – Preparing for Success • First chikungunya vaccine to be approved by the FDA – PRV awarde
Slide 8: VLA1553: Clinical Data Highlights
VLA1553: Clinical Data Highlights1,2,5 Live-attenuated CHIKV vaccine demonstrates rapid and long-lasting immunity with a single shot Immunogenicity Data Safety Data ▪ 99% Seroresponse3 Rate (SRR) after a single ▪ VLA1553 was generally well tolerated among the >3,600 vaccination adults and 754 adoles
Slide 9: VLA1553 Induces Early and Sustained Response Regardless Of Age
VLA1553 Induces Early and Sustained Response Regardless Of Age High seroresponse rates across studies Seroresponse sustained at highest levels up to Month 12 Comparable titers in younger and older adults Geometric Mean Titer (GMT) - CHIKV Neutralizing Antibodies ** * 10000 100 3 507 90 1 056 1 031 8
Slide 10: VLA1553: Fast and Robust Induction of Neutralizing CHIKV Antibodies
VLA1553: Fast and Robust Induction of Neutralizing CHIKV Antibodies High neutralizing antibody titers at Day 15 in Phase 1; by Day 29 for pivotal trial endpoint 10000 Geometric Mean Titer (GMT) 1000 Adults Phase 3 Pivotal Study1, N = 266 Adults Phase 1 Study2, Low Dose, 100 Seroresponse Threshold *
Slide 11: IXCHIQ is approved under the accelerated licensure pathway
IXCHIQ® is approved under the accelerated licensure pathway1 Phase 4 aims to verify the clinical benefit in two2 key post-marketing effectiveness studies VLA1553-402 VLA1553-404 Observational effectiveness study in population > 12 years Pragmatic randomized controlled effectiveness and safety of age
Slide 12: 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 13: IXCHIQ Fits Perfectly Within our Existing Commercial Infrastructure
IXCHIQ® 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 market segments Commercial infrastructure in most key markets; footprint extended throu
Slide 14: Preparing for Global Market Launches
Preparing for Global Market Launches Planned additional and future regulatory processes1 IXCHIQ®: Valneva Instituto Butantan Additional Additional Markets LATAM/other Europe/UK Brazil LMICs9 Countries with Canada established travelers' Prioritization in 2024: First submission in 2024 Filed with EMA4
Slide 15: Lyme Disease Vaccine Candidate – VLA15
July 9, 2019 Valneva - R&D Investor Day Lyme Disease Vaccine Candidate – VLA15
Slide 16: 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 Phase 3 study ongoing, sponsored by Pfizer1 and supported by positive results for three 1 Phase 2 clinical trials2,3,4, incl. first pediatric/adolescent data
Slide 17: 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 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 18: 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 19: Phase 3 Efficacy Study Fully Enrolled
Phase 3 Efficacy Study Fully Enrolled ▪ Population: 9,437 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 (randomization approx. 1:1 VLA15/Placebo and 2:1 N. America/EU) ▪ Primary endpoint: Ra
Slide 20: Zika Virus Vaccine Candidate – VLA1601
July 9, 2019 Valneva - R&D Investor Day Zika Virus Vaccine Candidate – VLA1601
Slide 21: VLA1601: Potential to be a Differentiated Zika Virus Vaccine
VLA1601: Potential to be a Differentiated Zika Virus Vaccine Adjuvanted, inactivated whole virus vaccine candidate Zika viral disease Valneva’s vaccine candidate ▪ Flaviviral disease transmitted by Aedes mosquitoes1 ▪ Highly purified ▪ Common flu-like symptoms, lasting between 2 -7 days ▪ Adjuvanted
Slide 22: Valneva Commercial Products
Valneva Commercial Products
Slide 23: 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 24: 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 sales3 €m 130 - 150 130 2023 guidance4 3PP Travel recovery DUKORAL® 114.8 Product sales of €130 million to €150 mil
Slide 25: Financial Overview
Financial Overview
Slide 26: 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 2021-2023: Follow on offerings and debt financing ▪ Most recent upsized Global Offering brought in €102.9 million in gross
Slide 27: Key Upcoming 2024 Catalysts and News flow
Key Upcoming 2024 Catalysts and News flow Chikungunya vaccine ▪ ACIP recommendation expected Q1 2024 ▪ Initiation Phase 3 immunocompromised individuals studies expected in H1 2024 ▪ Four potential approvals: EMA, Health Canada, Anvisa (Brazil) and UK expected in 2024 ▪ Initiation of Phase 4 clinical
Slide 28: Thank you
Thank you Merci Danke Tack WwWavalneva