Valneva SE · EURONEXT:VLA
Valneva — Q1 2021 Earnings Presentation
27 slides from Valneva's earnings presentation, May 20, 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 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. The Valneva shares may not be offered or sol
Slide 3: Agenda
Agenda Introduction Business Update Financial Report Q1 2021 Newsflow Q&A Valneva Q1 2021 Analyst Presentation May 20, 2021 3
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 vaccine
Slide 5: Agenda
Agenda Introduction Business Update Financial Report Q1 2021 Newsflow Q&A Valneva Q1 2021 Analyst Presentation May 20, 2021 5
Slide 6: VLA15 – Multivalent Lyme Disease Vaccine Candidate
VLA15 – Multivalent Lyme Disease Vaccine Candidate Only Program in Advanced Clinical Development Today 1 FDA Fast Track Designation granted Initial results reported from Phase 2 trials1, 2 2 Accelerated pediatric trial (VLA15-221) initiated in March 20213 Multivalent vaccine (six serotypes) to prote
Slide 7: VLA15: Development Outlook
VLA15: Development Outlook Phase 2 trial (VLA15-221) in adults and pediatric subjects initiated1 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 triggered a milestone payment of $10 million, upon dosing of the
Slide 8: VLA2001 – The Only Inactivated Vaccine in Clinical Development in Europe
VLA2001 – The Only Inactivated Vaccine in Clinical Development in Europe : Adjuvanted with CpG1018 UK government deal worth up to €1.4 billion1 with development and manufacturing funding; 1 ongoing dialogue with other potential customers acceleration enabled through use of Valneva’s FDA-registered f
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 Valneva Austria GmbH Page 1 of 1 ( Protocol: VLA2001-201 Figure 1.1.1 Solicited Adverse Events Within 7 Days After First Vaccination ( Safety Analysis Set (N=153) Generally well tolerated ac
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 Seroconversion as Measured by IgG Against S-protein (ELISA) More than 90% of all trial participants 100 developed significant levels of Proportion of Subjects with Seroconversion in T
Slide 11: VLA2001 Generated Neutralizing Antibody Titers at or Above Convalescent Sera Levels
VLA2001 Generated Neutralizing Antibody Titers at or Above Levels Generally Seen in Convalescent Sera in Phase 1/2 Valneva Austria GmbH Page 1 of 1 ( Valneva Austria GmbH Page 1 of 1 Valneva Protocol: ( VLA2001-201 Austria GmbH Page 1 of 1 ( Protocol: VLA2001-201 Protocol: VLA2001-201 Figure 1.2.2 F
Slide 12: Immunogenicity Summary – Cellular Response Induced
Immunogenicity Summary – Cellular Response Induced S-protein Exploratory endpoints evaluated T-cell responses by IFNgamma ELISpot analysis against S-protein, Membrane-protein and Nucleocapsid-protein. Reactive Non-reactive At Day 36, in the high dose group: 1 M-protein 76% of study participants (3
Slide 13: VLA2001: Development Outlook
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 immuni
Slide 14: VLA1553 – Only Chikungunya Vaccine Candidate in Phase 3 Today
VLA1553 – Only Chikungunya Vaccine Candidate in Phase 3 Today Phase 3 trial VLA1553-301 fully enrolled1; Use of surrogate marker for Ph3 endpoint 1 confirmed by FDA2; Accelerated Approval Pathway confirmed3 Potentially eligible for Priority Review Voucher4; FDA Fast Track5 and EMA PRIME6 2 designati
Slide 15: VLA1553: Development Outlook
VLA1553: Development Outlook Pivotal Phase 3 Trial - Topline Read-out Expected Mid-2021 Phase 3 Clinical Development Program underway Pivotal Phase 3 safety and immunogenicity trial in 4,131 healthy volunteers fully enrolled1 Topline read-out on Day 29 (based on surrogate of protection) mid-2021
Slide 16: Agenda
Agenda Introduction Business Update Financial Report Q1 2021 Newsflow Q&A Valneva Q1 2021 Analyst Presentation May 20, 2021 16
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 Outlook 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 causing havoc in some key destinations (e.g. India) Ongoing p
Slide 19: Q1 2021 Sales Adversely Affected by the COVID-19 Pandemic
Q1 2021 Sales Adversely Affected by the COVID-19 Pandemic Q1 2021 Product Sales (unaudited) DUKORAL® €0.1m TPP1 Product sales² €2.7m -51% AER / -48% CER IXIARO® JESPECT® Travel Net €1.0m Direct sales product sales 98% €16.1m Gross margin³ IXIARO® 41.7% US Military €12.3m AER: Actual exchange rates,
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) €m Q1 2021 Q1 2020 Product sales 16.1 32.7 Revenues from collaboration, licensing and services 7.1 2.5 Revenues 23.2 35.2 Cost of goods (9.6) (10.7) Cost of services (5.1) (2.1) Research and develop
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 €m Q1 2021 Q1 2021 Q1 2021 Group COVID only excl. COVID Product sales 16.1 16.1 Revenues from collaboration, licensing and services 7.1 7.1 Revenues 23.2 23.2 Cost of goods (9.6) (0.2) (9.4) Cost of se
Slide 22: Balance Sheet Statement
Balance Sheet Statement Per March 31, 2021 – before US IPO effects on Cash & Equity 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 & equipment 51,030 34,779 + Other non-current assets 28,353
Slide 23: Agenda
Agenda Introduction Business Update Financial Report Q1 2021 Newsflow Q&A Valneva Q1 2021 Analyst Presentation May 20, 2021 23
Slide 24: Key Upcoming Catalysts and Potential Inflection Points
Key Upcoming Catalysts and Potential Inflection Points 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 vaccine candidate VLA1553 Initial Phase 3 data expected mid
Slide 25: Supplemental Disclosures Regarding Non-IFRS Financial Measures
Supplemental Disclosures Regarding Non-IFRS Financial Measures EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tools. EBITDA is defined as earnings (loss) from continuing operations befor
Slide 26: Agenda
Agenda Introduction Business Update Financial Report Q1 2021 Newsflow Q&A Valneva Q1 2021 Analyst Presentation May 20, 2021 26
Slide 27: Thank you
Thank you Merci Danke Tack WaAvalneva