Slide 1: Valneva Reports Q1 2022 Results and Provides Corporate Updates
Valneva Reports Q1 2022 Results and Provides Corporate Updates Analyst Presentation May 5, 2022
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 Q1 2022 Financial Outlook Newsflow Q&A Valneva Q1 2022 Analyst Presentation May 5, 2022 3
Slide 4: Valneva Reports Q1 2022 Results and Provides Corporate Updates
Valneva Reports Q1 2022 Results and Provides Corporate Updates Excellent progress on clinical programs Lyme disease: Further positive Phase 2 results reported, including first pediatric data COVID-19: MHRA Conditional Marketing Authorization received NHRA Emergency use authorization received
Slide 5: Agenda
Agenda Introduction Business Update Financial Report Q1 2022 Financial Outlook Newsflow Q&A Valneva Q1 2022 Analyst Presentation May 5, 2022 5
Slide 6: VLA15 – Multivalent Lyme Disease Vaccine Candidate
VLA15 – Multivalent Lyme Disease Vaccine Candidate Only Lyme Disease Program in Advanced Clinical Development Today 1 FDA Fast Track Designation granted 2 Exclusive, worldwide partnership with Pfizer Positive results reported from Phase 2 trials1,2,3, incl. first pediatric data 3 and booster respons
Slide 7: VLA15: Development Progress and Outlook
VLA15: Development Progress and Outlook Positive Phase 2 Results in Adults1,2,3,4 and Pediatric Participants5 Reported The Phase 2 trial VLA15-221 recruited 625 randomized participants, 5 to 65 years of age2 Strong immunogenicity profile for both adult and pediatric participants reported in Februa
Slide 8: VLA1553: Single Shot Chikungunya Vaccine Candidate
VLA1553: Single Shot Chikungunya Vaccine Candidate Most Clinically Advanced Chikungunya Vaccine Program Worldwide Final positive pivotal Phase 3 results1 and topline lot-to-lot data2 reported; Adolescent Phase 3 trial 1 initiated in January 20223 FDA Breakthrough Therapy4, Fast Track5 and EMA PRIME7
Slide 9: VLA1553: Development Outlook
VLA1553: Development Outlook Pre-submission Discussions with the US FDA Initiated First and only program to have reported positive Phase 3 results worldwide Six-month follow-up completed - all Phase 3 immunogenicity and safety endpoints met - seroprotection in 98.9% of participants after one month
Slide 10: VLA2001: Inactivated whole virus COVID-19 Vaccine Candidate
VLA2001: Inactivated whole virus COVID-19 Vaccine Candidate Only Inactivated COVID-19 Vaccine Program in the Clinics in Europe Builds on Valneva’s IXIARO® manufacturing technology combined with Dynavax’s CpG 1 1018 adjuvant1 UK MHRA Conditional Marketing Authorization2 and Bahraini NHRA Emergency Us
Slide 11: VLA2001: Planned Label Extensions
VLA2001: Planned Label Extensions Ongoing and Future Clinical Studies Expected To Strengthen Product Profile Primary Immunization 2-11 yrs. Primary Immunization Strategic value development 12-17 yrs. Target Product Profile Booster incl. mix/match Primary Immunization Potential switch to variant if 5
Slide 12: Agenda
Agenda Introduction Business Update Financial Report Q1 2022 Financial Outlook Newsflow Q&A Valneva Q1 2022 Analyst Presentation May 5, 2022 12
Slide 13: First Quarter 2022 Financials: Total Revenues of €21.8 million
First Quarter 2022 Financials: Total Revenues of €21.8 million First COVID-19 Product Sales Recognized in Q1 2022 DUKORAL® COVID €2.5m €3.8m €21.8m €23.2m IXIARO® Net US Military product sales €16.2m €16.1m €0.3m €16.2m TTP1 €5.6m IXIARO®/JESPECT® Travel market €3.9m Q1 2022 Q1 2021 Q1 2022 Q1 2021
Slide 14: First Quarter 2022 Financials: Product Sales of €16.2 million
First Quarter 2022 Financials: Product Sales of €16.2 million Private Travel Markets Showing Significant Recovery €m (unaudited) Q1 2022 Q1 2021 Q1 2021 Q1 2022 vs. at CER* Q1 2021 % IXIARO®/JESPECT® 4.2 13.3 14.2 -70.5% DUKORAL® 2.5 0.1 0.1 >2000% Third party products 5.6 2.7 2.7 +110.9% COVID 3.8
Slide 15: First Quarter 2022 Financials: Adjusted EBITDA of - €13.3 million
First Quarter 2022 Financials: Adjusted EBITDA of - €13.3 million Positive OPEX Effects Driven by Share-based Compensation Programs €m (unaudited) Q1 2022 Q1 2021 Product sales 16.2 16.1 Other Revenues 5.7 7.1 Revenues 21.8 23.2 Cost of goods and services (13.9) (14.7) Research and development expen
Slide 16: First Quarter 2022 Net Operating Profit
First Quarter 2022 Net Operating Profit Main P&L Movements Compared to Q1 2021 In € millions Valneva Q1 2022 Analyst Presentation May 5, 2022 16
Slide 17: First Quarter 2022 Financials: Impact of COVID-19 Program on P&L
First Quarter 2022 Financials: Impact of COVID-19 Program on P&L Negative Adjusted EBITDA Mostly Attributable to COVID-19 Investments €m (unaudited) Q1 2022 Q1 2022 Q1 2022 Group COVID only excl. COVID Product sales 16.2 3.8 12.4 Other Revenues 5.7 - 5.7 Revenues 21.8 3.8 18.0 Cost of goods and serv
Slide 18: Agenda
Agenda Introduction Business Update Financial Report Q1 2022 Financial Outlook Newsflow Q&A Valneva Q1 2022 Analyst Presentation May 5, 2022 18
Slide 19: Valneva 2022 Financial Guidance Confirmed
Valneva 2022 Financial Guidance Confirmed Total revenues expected to be in the range announced in February 2022 (€430 million to €590 million). Distribution of total revenues by category may differ from the figures announced in February considering the uncertainties on the timing of product deli
Slide 20: Agenda
Agenda Introduction Business Update Financial Report Q1 2022 Financial Outlook Newsflow Q&A Valneva Q1 2022 Analyst Presentation May 5, 2022 20
Slide 21: Key Upcoming Catalysts and Newsflow in 2022
Key Upcoming Catalysts and Newsflow in 2022 Lyme disease vaccine candidate VLA15 Phase 3 trial initiation expected in Q3 2022 Chikungunya vaccine candidate VLA1553 Final lot-to-lot Phase 3 data expected in Q2 2022 Biologics License Application (BLA) expected in H2 2022 COVID-19 vaccine candida
Slide 22: Thank you
Thank you Merci Danke Tack WaAvalneva