Valneva Se · EURONEXT:VLA
Valneva — H1 2023 Earnings Presentation
25 slides from Valneva's earnings presentation, Sep 21, 2023
Slide 1: Half Year 2023 Results & Corporate Update Analyst Presentation
A LEADING SPECIALTY VACCINE COMPANY HALF YEAR 2023 RESULTS & CORPORATE UPDATE ANALYST PRESENTATION SEPTEMBER 21, 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: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – HY 2023 Analyst Presentation September 21, 2023 3
Slide 4: Valneva Reports Half Year 2023 Results and Provides Corporate Updates
Valneva Reports Half Year 2023 Results and Provides Corporate Updates R&D Highlights ▪ Progress towards potential FDA approval of the world’s first chikungunya vaccine ▪ Lyme disease: Phase 3 VALOR study continues; Cohort 1 completing first tick season; Cohort 2 currently enrolling ▪ Re-initiation o
Slide 5: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – HY 2023 Analyst Presentation September 21, 2023 5
Slide 6: 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 7: Fast and Robust Induction of Neutralizing CHIKV Antibodies
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 1000 Geometric Mean Titer (GMT) 100 Seroresponse Phase 3 Pivotal Study1, Threshold * N = 266 Phase 1 Study2, Low Dose, N = 31 10 Phase 1 Study
Slide 8: VLA1553 Induces Early and Sustained Response Regardless Of Age
VLA1553 Induces Early and Sustained Response Regardless Of Age High seroresponse rates across different 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 0
Slide 9: Positive Initial Safety Results in Adolescent and Pre-Exposed Participants
Positive Initial Safety Results in Adolescent and Pre-Exposed Participants1 Conducted in partnership with Instituto Butantan, funded by CEPI Adolescent Trial Design Initial Safety Data1 ▪ 754 Adolescents aged 12 to 17 years ▪ Generally well tolerated, including in individuals previously infected wit
Slide 10: VLA1553 Development Outlook
VLA1553 Development Outlook First chikungunya program worldwide to report pivotal trial results and antibody persistence Working collaboratively with FDA to align on post-approval Phase 4 program ▪ Phase 4 likely to set future standard for outbreak disease indications under FDA accelerated approval
Slide 11: 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 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 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 13: VLA15 Demonstrated Strong Immunogenicity Across 1,030 Adult and Pediatric 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 14: 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 15: VLA1601: Potential to be a Differentiated Zika Virus Vaccine Candidate
VLA1601: Potential to be a Differentiated Zika Virus Vaccine Candidate 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 ▪
Slide 16: Valneva's R&D Pipeline
Valneva’s R&D Pipeline Overview Development Program Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Commercial Next Inflection Point Partners Potential CEPI/ Butantan VLA15532: Potentially eligible for PRV BLA approval (LMIC) Chikungunya 4Q 2023 VLA153: Cohort 2 Lyme disease currently enrolling VLA84
Slide 17: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – HY 2023 Analyst Presentation September 21, 2023 17
Slide 18: H1 2023 Financials: Product Sales of €69.7m
H1 2023 Financials: Product Sales of €69.7m Travel channel showing continued, significant recovery €m (unaudited) H1 2023 H1 2022 H1 2022 % at CER* at CER IXIARO®/JESPECT® 30.3 12.3 12.1 150.8% DUKORAL® 17.1 5.8 5.5 213.0% Third party products 16.5 11.5 11.3 46.8% Total product sales (excl. COVID-19
Slide 19: H1 2023 Financials: Income Statement
H1 2023 Financials: Income Statement €m (unaudited) H1 2023 H1 2022 Product sales 69.7 33.3 Other Revenues 4.1 59.9 Revenues 73.7 93.2 Cost of goods and services (53.8) (171.5) Research and development expenses (26.0) (51.9) Marketing and distribution expenses (20.0) (7.8) General and administrative
Slide 20: Agenda
Agenda Introduction Business Update Financial Report FY 2023 Financial Outlook Newsflow Q&A Valneva – HY 2023 Analyst Presentation September 21, 2023 20
Slide 21: Reiterating 2023 Financial Guidance
Reiterating 2023 Financial Guidance Total revenues and other income expected between €220 to €260 million, including: • €130 to €150 million of product sales, including marginal COVID-19 vaccine sales under the Bahrain supply agreement • €90 to €110 million of other income • Approximately €20 millio
Slide 22: Agenda
Agenda Introduction Business Update Financial Report FY 2021 Financial Outlook Newsflow Q&A Valneva – HY 2023 Analyst Presentation September 21, 2023 22
Slide 23: Key Upcoming Catalysts and News flow 2H23 – 1H24
Key Upcoming Catalysts and News flow 2H23 – 1H24 Chikungunya vaccine candidate VLA1553 ▪ PDUFA action date, potential BLA approval by end of November ▪ Adolescent immunogenicity results in November 2023 ▪ EMA regulatory submissions in Q4 ▪ Additional 24-month antibody persistence data in Q4 ▪ ACIP r
Slide 24: Valneva is Poised for Substantial Growth
Valneva is Poised for Substantial Growth Led by potential new product launches 3-4 years 6-12 months 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 IXIARO® IXIARO® IXIARO® immine
Slide 25: Thank you
Thank you Merci Danke Tack