Valneva Se · EURONEXT:VLA
Valneva — Q1 2021 Earnings Presentation
27 slides from Valneva's earnings presentation, May 21, 2021
Slide 1: Valneva Reports Q1 2021 Financial Results and Business Update
Valneva Reports Q1 2021 Financial Results and Business Update Analyst Presentation May 20, 2021
Slide 2: Disclaimer
Disclaimer Valneva Q1 2021 Analyst Presentation May 20, 2021 2 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 un
Slide 3: Agenda
Agen d a Valneva Q1 2021 Analyst Presentation May 20, 2021 3 Introduction Business Update Financial Report Q1 2021 Newsflow Q&A
Slide 4: Valneva Reports Q1 2021 Financial Results and Business Update
Valneva Reports Q1 2021 Financial Results and Business Update ▪ Excellent progress on clinical programs ▪ Initiation of additional Phase 2 trial to accelerate pediatric development for Lyme vaccine ▪ Initiation of pivotal Phase 3 clinical trial for COVID - 19 vaccine; participation in COVID - 19 vac
Slide 5: Agenda
Agen d a Valneva Q1 2021 Analyst Presentation May 20, 2021 5 Introduction Business Update Financial Report Q1 2021 Newsflow Q&A
Slide 6: VLA15 – Multivalent Lyme Disease Vaccine Candidate
FDA Fast Track Designation granted Multivalent vaccine (six serotypes) to protect against Lyme disease in the United States and Europe Follows proven Mechanism of Action for a Lyme disease vaccine Initial results reported from Phase 2 trials 1, 2 Accelerated pediatric trial (VLA15 - 221) initiated i
Slide 7: VLA15: Development Outlook
VLA15: Development Outlook Valneva Q1 2021 Analyst Presentation May 20, 2021 7 Phase 2 trial (VLA15 - 221) in adults and pediatric subjects initiated 1 ▪ Trial to include participants from 5 - 65 years of age and a reduced immunization schedule (Month 0 - 6 compared to Month 0 - 2 - 6) ▪ The trial t
Slide 8: VLA2001 – The Only Inactivated COVID-19 Vaccine in Clinical Development in Europe
UK government deal worth up to €1.4 billion 1 with development and manufacturing funding; ongoing dialogue with other potential customers Program acceleration enabled through use of Valneva’s FDA - registered facility in UK; commercial manufacturing commenced January 2021 3 2 Phase 1/2 clinical tria
Slide 9: VLA2001 Was Well Tolerated in Phase 1/2
VLA2001 Was Well Tolerated in Phase 1/2 Safety Profile Within the Expected Range for an Inactivated Vaccine ▪ Generally well tolerated across all dose groups tested, no sa f e t y con c erns ident i fied by an independent Data Safety Monitoring Board. ▪ N o statistic a l ly sig n ificant di f f eren
Slide 10: VLA2001 Was Highly Immunogenic in Phase 1/2
VLA2001 Was Highly Immunogenic in Phase 1/2 > 90% of Trial Participants Developed Significant Levels of Antibodies Per - Protocol Analysis Set, Table 14.3.5.1, Table 14.3.6.1 ▪ More than 90% of all trial participants developed significant levels of antibodies to the SARS - CoV - 2 virus spike protei
Slide 11: VLA2001 Generated Neutralizing Antibody Titers Comparable to Convalescent Sera
VLA2001 Generated Neutralizing Antibody Titers at or Above Levels Generally Seen in Convalescent Sera in Phase 1/2 ▪ Dose dependent response, statistically significant higher Geometric Mean Titers (GMTs) in high dose group compared to low and medium dose groups. ▪ In high dose group, GMT of neutrali
Slide 12: Immunogenicity Summary – Cellular Response Induced
Immunogenicity Summary – Cellular Response Induced Exploratory endpoints evaluated T - cell responses by IFNgamma ELISpot analysis against S - protein, M embrane - protein and N ucleocapsid - protein. At Day 36, in the high dose group: ▪ 76 % of study participants ( 34 / 45 ) were reactive 1 against
Slide 13: VLA2001: Development Outlook – Pivotal Phase 3 Trial Ongoing
Pivotal Phase 3 is a randomized, observer - blind, controlled, comparative immunogenicity trial in ~ 4,000 adults ▪ Immunological comparison against a licensed vaccine to reasonably predict efficacy (superiority of VLA2001 in a two - dose immunization schedule four weeks apart - GMTs of neutralising
Slide 14: VLA1553 – Only Chikungunya Vaccine Candidate in Phase 3 Today
VLA1553 – Only Chikungunya Vaccine Candidate in Phase 3 Today Note : Photo credit : James Gathany . 1 Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Tria l 2 Valneva Announces Publication of 2020 Universal Registration Docu
Slide 15: VLA1553: Development Outlook – Pivotal Phase 3 Trial
VLA1553: Development Outlook Pivotal Phase 3 Trial - Topline Read - out Expected Mid - 2021 1 Valneva Completes Recruitment for Pivotal Phase 3 Trial of Chikungunya Vaccine Candidate and Initiates Antibody Persistence Trial 2 Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single -
Slide 16: Agenda
Agen d a Valneva Q1 2021 Analyst Presentation May 20, 2021 16 Introduction Business Update Financial Report Q1 2021 Newsflow Q&A
Slide 17: Strong Cash Position of €235.9 million at End of March
Strong Cash Position of €235.9 million at End of March to be Complemented by Proceeds from Global Offering Cash and cash equivalents of €235.9 million at March 31, 2021 ▪ The increase in liquid funds compared to December 31, 2020 results from payments made by the UK Government within the framework o
Slide 18: Results Dynamics and Outlook
Results Dynamics and Out look Valneva Q1 2021 Analyst Presentation May 20, 2021 18 Total revenues, excluding VLA2001, expected in range of €80 million to €105 million Revenue guidance, excluding COVID - 19, updated taking into account ongoing impacts of COVID - 19 on travel industry ▪ Variants causi
Slide 19: Q1 2021 Sales Adversely Affected by the COVID-19 Pandemic
IXIARO ® US Military €12.3m TPP 1 €2.7m IXI A R O ® JESPE CT ® Travel €1.0m Q1 2021 Sales Adversely Affected by the COVID - 19 Pandemic Q1 2021 Product Sales (unaudited) Direct sales 98% Gross margin³ 41.7 % Product sales² - 51% AE R / - 48% CER AER: Actual exchange rates, CER: Constant exchange rat
Slide 20: EBITDA Loss Reflecting Increasing R&D Expenses / Lower Sales
EBITDA Loss Reflecting Increasing R&D Expenses / Lower Sales Q1 2021 Profit & Loss Report (unaudited) Valneva Q1 2021 Analyst Presentation May 20, 2021 20 1 EBITDA is a non - IFRS financial measure. A reconciliation to operating profit (loss), the most directly comparable financial measures calculat
Slide 21: Effect of SARS-CoV-2 Program on Group P&L
Effect of SARS - CoV - 2 program on Group P&L COVID - 19 Program Reported as Separate Segment as of 2021 Valneva Q1 2021 Analyst Presentation May 20, 2021 21 1 EBITDA is a non - IFRS financial measure. A reconciliation to operating profit (loss), the most directly comparable financial measures calcu
Slide 22: Balance Sheet Statement
Balance Sheet Statement Per March 31, 2021 – before US IPO effects on Cash & Equity Valneva Q1 2021 Analyst Presentation May 20, 2021 22 ASSETS Mar 31, 2021 Dec 31, 2020 NON - CURRENT ASSETS 157,132 140,737 + Intangible Assets 35,156 35,409 + Right Of Use Assets 42,592 43,374 + Property, plant & equ
Slide 23: Agenda
Agen d a Valneva Q1 2021 Analyst Presentation May 20, 2021 23 Introduction Business Update Financial Report Q1 2021 Newsflow Q&A
Slide 24: Key Upcoming Catalysts and Potential Inflection Points
Key Upcoming Catalysts and Potential Inflection Points Valneva Q1 2021 Analyst Presentation May 20, 2021 24 Lyme disease vaccine candidate VLA15 ▪ Further Phase 2 milestones and read - outs during 2021; Phase 2 study VLA15 - 221, including pediatric development, initiated March 2021 Chikungunya vacc
Slide 25: Supplemental Disclosures Regarding Non-IFRS Financial Measures
Supplemental Disclosures Regarding Non - IFRS Financial Measures Valneva Q1 2021 Analyst Presentation May 20, 2021 25 EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provide additional analytical tools. EBITDA is defin
Slide 26: Agenda
Agen d a Valneva Q1 2021 Analyst Presentation May 20, 2021 26 Introduction Business Update Financial Report Q1 2021 Newsflow Q&A
Slide 27: Thank you
Thank you Merci Danke Tack ‘WAvalneva