Valneva Se · EURONEXT:VLA
Valneva — Q3 2023 Earnings Presentation
21 slides from Valneva's earnings presentation, Nov 9, 2023
Slide 1: 9-Month Financial Results Analyst Presentation
A LEADING SPECIALTY VACCINE COMPANY 9-MONTH FINANCIAL RESULTS ANALYST PRESENTATION NOVEMBER 9, 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 9M 2023 Financial Outlook Newsflow Q&A Valneva – 9M 2023 Analyst Presentation November 09, 2023 3
Slide 4: Valneva Reports 9-Month 2023 Results and Provides Corporate Updates
Valneva Reports 9-Month 2023 Results and Provides Corporate Updates R&D Highlights ▪ Progressing towards potential licensure 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 of
Slide 5: Agenda: Business Update
Agenda Introduction Business Update Financial Report 9M 2023 Financial Outlook Newsflow Q&A Valneva – 9M 2023 Analyst Presentation November 09, 2023 5
Slide 6: Potential to Deliver the World's First Chikungunya Vaccine This Month
Potential to Deliver the World’s First Chikungunya Vaccine This Month 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 – me
Slide 7: 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 8: 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 9: 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 10: Phase 3 Trial Updates
Phase 3 Trial Updates Conducted in partnership with Pfizer VALOR Vaccine Efficacy Study Pediatric Safety Study1 ▪ First Subject In achieved in August 2022 ▪ First Subject In achieved December 2022 ▪ Enrollment ongoing (~5600/9000) enrolled in US, CA, NL, ▪ Enrollment (US only) completed June 2023 DE
Slide 11: 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 12: 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 13: Agenda: Financial Report 9M 2023
Agenda Introduction Business Update Financial Report 9M 2023 Financial Outlook Newsflow Q&A Valneva – 9M 2023 Analyst Presentation November 09, 2023 13
Slide 14: 9M 2023 Financials: Product Sales of €106.1m
9M 2023 Financials: Product Sales of €106.1m Travel channel showing continued, significant recovery €m (unaudited) 9M 2023 9M 2022 9M 2022 % at CER* at CER IXIARO®/JESPECT® 50.3 22.9 22.2 126.7% DUKORAL® 21.1 9.2 8.7 142.7% Third party products 29.1 18.4 18.0 61.1% Total product sales (excl. COVID-1
Slide 15: 9M 2023 Financials: Income Statement
9M 2023 Financials: Income Statement €m (unaudited) 9M 2023 9M 2022 Product sales 106.1 74.4 Other Revenues 5.7 175.5 Revenues 111.8 249.9 Cost of goods and services (74.8) (202.7) Research and development expenses (42.2) (75.4) Marketing and distribution expenses (33.9) (13.1) General and administr
Slide 16: Agenda: Financial Outlook
Agenda Introduction Business Update Financial Report 9M 2023 Financial Outlook Newsflow Q&A Valneva – 9M 2023 Analyst Presentation November 09, 2023 16
Slide 17: Updated 2023 Financial Guidance Reflects Lower R&D Expenditure
Updated 2023 Financial Guidance Reflects Lower R&D Expenditure 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
Slide 18: Agenda: Newsflow
Agenda Introduction Business Update Financial Report 9M 2021 Financial Outlook Newsflow Q&A Valneva 9M 2023 Analyst Presentation November 09, 2023 18
Slide 19: Key Upcoming Catalysts and News flow H2 2023 – H1 2024
Key Upcoming Catalysts and News flow H2 2023 – H1 2024 Chikungunya vaccine candidate VLA1553 ▪ PDUFA action date, potential BLA approval by end of November ▪ Adolescent immunogenicity results in November 2023 ▪ Additional 24-month antibody persistence data in Q4 ▪ ACIP recommendation expected Q1 202
Slide 20: 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 ▪ Potential label expansion for VLA1553 after initial IXIARO® IXIARO® IXIAR
Slide 21: Thank you
Thank you Merci Danke Tack