Valneva Se · EURONEXT:VLA
Valneva — H1 2021 Earnings Presentation
24 slides from Valneva's earnings presentation, Aug 10, 2021
Slide 1: Valneva Reports H1 2021 Financial Results and Provides Business Update
Valneva Reports H1 2021 Financial Results and Provides Business Update Analyst Presentation August 10, 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 . Valneva is a European company . Information
Slide 3: Agenda
Agenda August 10, 2021 Valneva H1 2021 Analyst Presentation 3 Introduction Business Update Financial Report H1 2021 Newsflow Q&A
Slide 4: Major R&D objectives achieved
Valneva Reports H1 2021 Financial Results and Provides Business Update August 10, 2021 Valneva H1 2021 Analyst Presentation 4 Major R&D objectives achieved ▪ Positive topline Phase 3 results for chikungunya vaccine candidate VLA1553 › World’s first ever Phase 3 trial results for a chikungunya vaccin
Slide 5: Agenda
Agenda August 10, 2021 Valneva H1 2021 Analyst Presentation 5 Introduction Business Update Financial Report H 1 2021 Newsflow Q&A
Slide 6: VLA1553-301: Primary Endpoint Met
0 10 20 30 40 50 60 70 80 90 100 Seroprotection Rate Percentage of subjects with seroprotective CHIKV neutralizing antibody titer Seroprotection Rate At Day 29 in Baseline Seronegative Subjects , Per - Protocol Population Placebo VLA1553 Total VLA1553-Younger Adults VLA1553-Elderly VLA1553 - 301: Pr
Slide 7: VLA1553-301: High Neutralizing Antibodies
VLA1553 - 301: High Neutralizing Antibodies August 10, 2021 Valneva H1 2021 Analyst Presentation 7 Chikungunya virus neutralizing antibody titers were determined using a µPRNT 50 assay . Values below the quantification limit are set to 10. Highly Immunogenic Across All Age Groups Including Elderly 1
Slide 8: VLA1553 Well Tolerated Across All Age Groups
VLA1553 - Well Tolerated Across All A ge Groups Safety was evaluated in 3,082 participants who received VLA1553 ▪ Independent Data Safety Monitoring Board continuously monitored the study and identified no safety concerns ▪ Safety profile consistent with Phase 1: › Majority of solicited adverse even
Slide 9: VLA1553: Development Outlook
VLA1553: Development Outlook August 10, 2021 Valneva H1 2021 Analyst Presentation 9 1 Valneva Announces Positive Phase 3 Pivotal Results for its Single - Shot Chikungunya Vaccine Candidate ; 2 Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single - Shot Chikungunya Vaccine Candidat
Slide 10: VLA15 – Multivalent Lyme Disease Vaccine Candidate
Exclusive , worldwide partnership with Pfizer 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 , Recr
Slide 11: VLA15: Development Progress
VLA15: Development Progress August 10, 2021 Valneva H1 2021 Analyst Presentation 11 VLA15 - 221 recruitment completed with a total of 625 participants, 5 to 65 years of age, randomized 2 ▪ The trial triggered a milestone payment of $10 million, upon dosing of the first subject, from Pfizer to Valnev
Slide 12: VLA2001 – The Only Inactivated Vaccine in Clinical Development in Europe
UK government deal worth up to €1.4 billion 1 with development and manufacturing funding ; ongoing dialogue with the European Commission P rogram acceleration enabled through use of Valneva’s FDA - registered facility in UK; commercial manufacturing commenced January 2021 2 2 Phase 1/2 clinical tria
Slide 13: Cov-Compare (VLA2001-301) Phase 3 trial
August 10, 2021 Valneva H1 2021 Analyst Presentation 13 “ Cov - Compare ” (VLA2001 - 301) is a randomized , observer - blind , controlled , comparative immunogenicity trial in over 4,000 adults ▪ Immunological comparison against a licensed vaccine to reasonably predict efficacy ( superiority of VLA2
Slide 14: Agenda
Agenda August 10, 2021 Valneva H1 2021 Analyst Presentation 14 Introduction Business Update Financial Report H1 2021 Newsflow Q&A
Slide 15: Results Dynamics and Outlook
Results Dynamics and Out look Updated guidance including COVID - 19 expected ▪ Ongoing Phase 3 trials and regulatory discussions ▪ Role of VLA2001 as a booster ▪ Studying variants in order to be in a position to produce variant - based vaccines ▪ Ongoing discussions with EC Valneva reconfirms its 20
Slide 16: H1 2021 Sales Adversely Affected by the COVID-19 Pandemic
IXIARO ® US Military €22.3m TPP 1 €5.9m IXIARO ® JESPECT ® Travel €3.1m H1 2021 Sales Adversely Affected by the COVID - 19 Pandemic August 10, 2021 Valneva H1 2021 Analyst Presentation 16 Direct sales 98% Gross margin³ 39.2 % Product sales (Unaudited)² - 22% AER / - 19% CER AER: Actual exchange rate
Slide 17: EBITDA Loss Reflecting Increasing R&D Expenses
EBITDA Loss Reflecting Increasing R&D Expenses H1 2021 Profit & Loss Report ( unaudited) August 10, 2021 Valneva H1 2021 Analyst Presentation 17 1 EBITDA is a non - IFRS financial measure . A reconciliation to operating profit (loss), the most directly comparable financial measures calculated in acc
Slide 18: Effect of COVID Program on Group P&L
Effect of COVID - 19 P rogram on Group P&L COVID - 19 P rogram R eported as Separate Segment as of 2021 August 10, 2021 Valneva H1 2021 Analyst Presentation 18 €m H1 2021 Group H1 2021 COVID only H1 2021 excl. COVID Product sales 31.8 31.8 Revenues from collaboration, licensing and services 15.7 15.
Slide 19: Strong Cash Position of €329.8 million at End of June
Strong Cash Position of € 329.8 million at End of June August 10, 2021 Valneva H1 2021 Analyst Presentation 19 Balance Sheet as of June 30, 2021 ASSETS Jun 30, 2021 Dec 31, 2020 NON - CURRENT ASSETS 183,145 140,737 + Intangible Assets 34,424 35,409 + Right Of Use Assets 48,239 43,374 + Property, pla
Slide 20: Agenda
Agenda August 10, 2021 Valneva H1 2021 Analyst Presentation 20 Introduction Business Update Financial Report H 1 2021 Newsflow Q&A
Slide 21: Key Upcoming Catalysts and Potential Inflection Points
Key Upcoming Catalysts and Potential Inflection Points August 10, 2021 Valneva H1 2021 Analyst Presentation 21 Lyme disease vaccine candidate VLA15 ▪ Further Phase 2 milestones and read - outs Chikungunya vaccine candidate VLA1553 ▪ Final Phase 3 trial results ▪ Topline data of clinical lot - to - l
Slide 22: 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 provide additional analytical tools. EBITDA is defined as earnings (loss) from continuing operations befo
Slide 23: Agenda
Agenda August 10, 2021 Valneva H1 2021 Analyst Presentation 23 Introduction Business Update Financial Report H 1 2021 Newsflow Q&A
Slide 24: Thank you
Thank you Merci Danke Tack ‘WAvalneva