Slide 1: Valneva Reports Full Year 2021 Results and Provides Corporate Updates
Valneva Reports Full Year 2021 Results and Provides Corporate Updates Analyst Presentation March 24, 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
Slide 3: Agenda
Agenda March 24, 2022 Valneva FY 2021 Analyst Presentation 3 Introduction Business Update Financial Report FY 2021 Newsflow Q&A Financial Outlook
Slide 4: Valneva Reports Full Year 2021 Results and Provides Corporate Updates
Valneva Reports Full Year 2021 Results and Provides Corporate Updates March 24, 2022 Valneva FY 2021 Analyst Presentation 4 Excellent progress in all clinical programs ▪ Lyme disease : Further positive Phase 2 results reported, including booster response; Phase 3 dose and schedule selected ▪ COVID -
Slide 5: Agenda
Agenda March 24, 2022 Valneva FY 2021 Analyst Presentation 5 Introduction Business Update Financial Report FY 2021 Newsflow Q&A Financial Outlook
Slide 6: VLA15: Multivalent Lyme Disease Vaccine Candidate
Follows proven Mechanism of Action for a Lyme disease vaccine FDA Fast Track Designation granted Topline results reported from Phase 2 trials 1,2,3 , incl. booster response 4 ; Phase 3 schedule selected; Topline pediatric data expected in Q2 2022 Multivalent vaccine (six serotypes) to protect agains
Slide 7: VLA15: Development Progress and Outlook
VLA15: Development Progress and Outlook Valneva - Company Presentation 7 VLA15 - 221 recruited 625 randomized participants, 5 to 65 years of age 2 ▪ Three - dose priming schedule selected for use in adults for Phase 3, based on stronger immune response vs. two - dose schedule; s ub - analysis report
Slide 8: VLA1553: Single Shot Chikungunya Vaccine Candidate
VLA1553: Single Shot Chikungunya Vaccine Candidate Most Advanced Chikungunya Vaccine Program worldwide March 2022 Valneva - Company Presentation 8 Note : Photo credit : James Gathany . 1 Valneva Announces Positive Phase 3 Pivotal Results for its Single - Shot Chikungunya Vaccine Candidate ; 2 Valnev
Slide 9: VLA1553: Development Outlook
VLA1553: Development Outlook Valneva - Company Presentation 9 1 Valneva Successfully Completes Pivotal Phase 3 Trial of Single - Shot Chikungunya Vaccine Candidate ; 2 Valneva Announces Positive Lot - to - Lot Consistency Trial Results for its Single - Shot Chikungunya Vaccine Candidate ; 3 Valneva
Slide 10: VLA2001: Inactivated COVID-19 Vaccine Candidate
Bahraini NHRA Emergency Use Authorization received March 2022 2 ; EMA and UK MHRA rolling reviews ongoing 2 P ivotal Phase 3 showed superiority vs. AstraZeneca’s Vaxzevria and significantly more favorable tolerability 5 ; Positive topline homologous booster data reported 6 ; Shown to neutralize Omic
Slide 11: VLA2001: Pivotal Phase 3 Cov-Compare Study Results
VLA2001: Pivotal Phase 3 “ Cov - Compare Study” Results EMA and UK MHRA Rolling Reviews Ongoing Valneva - Company Presentation 11 Immunogenicity • VLA2001 was generally well tolerated: o Significantly more favorable profile compared to AZD1222 o Participants 30 years and above reported significantly
Slide 12: VLA2001: Current Purchase Agreements and Grants
Valneva - Company Presentation 12 ▪ 24 . 3 million doses to be supplied in the second and third quarters of 2022 ; EC has the option to increase its initial purchase, the remainder of which would be delivered in 2023 VLA2001: Current Purchase Agreements and Grants First EU Deliveries expected in Q2
Slide 13: VLA2001: Planned Label Extensions and Future Clinical Studies
VLA2001: Planned Label Extensions Ongoing and Future Clinical Studies Expected To Strengthen Product Profile Valneva - Company Presentation 13 Primary Immunization 18 - 55 yrs . Primary Immunization 2 - 11 yrs . Target Product Profile Strategic value development P andemic P hase P ost - P andemic P
Slide 14: Agenda
Agenda March 24, 2022 Valneva FY 2021 Analyst Presentation 14 Introduction Business Update Financial Report FY 2021 Newsflow Q&A Financial Outlook
Slide 15: Full Year 2021 Financials: Total Revenues of €348m
IXIARO ® US Military €38.0m Third Party Products 1 €15.4m IXIARO ® / JESPECT ® Travel market €7.1m Full Year 2021 Financials: Total Revenues of €348m Growth attributed to recognized revenues from terminated UK agreement March 24, 2022 Valneva FY 2021 Analyst Presentation 15 DUKORAL ® €2.4m Direct sa
Slide 16: Full Year 2021 Financials: Product Sales of €63m
Full Year 2021 Financials: Product Sales of €63m Continued pandemic impact on travel industry, strong increase in third party product sales March 24, 2022 Valneva FY 2021 Analyst Presentation 16 €m FY 2021 ( audited ) FY 2020 ( audited ) % IXIARO ® /JESPECT ® 45.1 48.5 - 6.9% DUKORAL ® 2.4 13.3 - 81
Slide 17: Full Year 2021 Financials: EBITDA of -€47.1m
Full year 2021 Financials : EBITDA of - €47.1m Reflects Pandemic Impact on Sales and Significant R&D Investments March 24, 2022 Valneva FY 2021 Analyst Presentation 17 1 FY EBITDA was calculated by excluding € 14 . 3 million ( 2020 : € 9 . 9 million) of depreciation and amortization from the € 61 .
Slide 18: Full Year 2021 Financials: Impact of COVID Program on P&L
Full Year 2021 Financials : Impact of COVID - 19 Program on P&L COVID - 19 reported as separate segment as of 2021 March 24, 2022 Valneva FY 2021 Analyst Presentation 18 1 FY EBITDA was calculated by excluding € 14 . 3 million ( 2020 : € 9 . 9 million) of depreciation and amortization from the € 61
Slide 19: Full Year 2021 Financials: Balance Sheet 2020/2021
March 24, 2022 Valneva FY 2021 Analyst Presentation 19 €m (2021 audited) December 31st, 2021 December 31st, 2020 NON - CURRENT ASSETS 231.5 140.7 - Property, Plant & Equipment 125.5 34.8 - Other Non - current Assets 106.0 106.0 CURRENT ASSETS 585.8 308.4 - Inventory 124.1 26.9 - Trade Receivables &
Slide 20: Full Year 2021 Financials: Balance Sheet 2020/2021 (cont.)
March 24, 2022 Valneva FY 2021 Analyst Presentation 20 €m (2021 audited) December 31st, 2021 December 31st, 2020 EQUITY 170.6 77.4 NON - CURRENT LIABILITIES 277.8 195.9 - Refund Liabilities 159.0 97.2 - Other Non - Current Liabilities 118.7 98.7 CURRENT LIABILITIES 369.0 175.9 - Trade Payables & Acc
Slide 21: Full Year 2021 Financials: Impact of Terminated UK Agreement
Full year 2021 Financials: Impact of Terminated UK Agreement Total cash considerations received * € 420m Reported as Other Revenue in 2021 € 253m Remaining on December 2021 Balance Sheet as Refund Liability € 167m - Refund Liability on Royalty Payments € 87m - Refund Liability on CAPEX advances € 80
Slide 22: Agenda
Agenda March 24, 2022 Valneva FY 2021 Analyst Presentation 22 Introduction Business Update Financial Report FY 2021 Newsflow Q&A Financial Outlook
Slide 23: Valneva 2022 Financial Guidance
Valneva 2022 Financial Guidance Substantial growth expected from anticipated COVID business March 24, 2022 Valneva FY 2021 Analyst Presentation 23 Total revenues expected between €430 to €590 million, including: • €350 to €500 million of COVID - 19 vaccine sales subject to regulatory approvals and d
Slide 24: Agenda
Agenda March 24, 2022 Valneva FY 2021 Analyst Presentation 24 Introduction Business Update Financial Report FY 2021 Newsflow Q&A Financial Outlook
Slide 25: Key Upcoming Catalysts and Newsflow in 2022
Key Upcoming Catalysts and Newsflow in 2022 Valneva - Company Presentation 25 Lyme disease vaccine candidate VLA15 ▪ First pediatric data expected in Q2 2022 ▪ Phase 3 trial initiation expected in Q3 2022 Chikungunya vaccine candidate VLA1553 ▪ Pre - submission process expected to commence in Q2 202
Slide 26: Thank you
Thank you Merci Danke Tack ‘WAvalneva