Valneva Se · EURONEXT:VLA
Valneva — Investor Presentation (December 2019)
25 slides from Valneva's investor presentation, December 2019
Slide 1: Advancing Vaccines for Better Lives
Advancing Vaccines for Better Lives Company Presentation – December 2019
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: Valneva – Highlights and key information
Valneva – Highlights and key information Valneva is a biotech company developing and commercializing vaccines for infectious diseases with major unmet needs › > €100m product sales revenues1 › Cash flow positive1 Specializes in important, high value niches › Travel vaccines › Technological compe
Slide 4: VLA's profitable commercial business supports R&D programs
VLA’s profitable commercial business supports R&D programs Product sales growth 2017-2018 16% (CER); Innovative R&D pipeline in areas of Repeated double-digit sales growth expected 2018-2019 major unmet need 2018 Full-year results DUKORAL® Direct sales €30.4m 81.2% Gross Product sales margin Lyme di
Slide 5: Strong operational performance for 9M 2019
Strong operational performance for 9M 2019 DUKORAL® Product sales growth €19.8m 22% AER / 18% CER Net TPP1 Direct sales product sales €2.4m 86% €86.4m Gross margin2 IXIARO®/ 65.2% JESPECT® €64.2m CER: At constant exchange rates; 1 Third party products sold by Valneva‘s commercial organization, 2 Gro
Slide 6: IXIARO/JESPECT: Only vaccine against Japanese encephalitis
IXIARO®/JESPECT® Only vaccine against Japanese encephalitis (JE) in US, Canada and Europe IXIARO®/JESPECT® IXIARO®/JESPECT®: US accounts for >65% of sales Designed to protect travelers and military against 9M ‘19 product sales analysis JE, the leading cause of viral neurological disease & disabili
Slide 7: DUKORAL: Only cholera (ETEC) vaccine approved in EU, Canada and Australia
DUKORAL® Only cholera (ETEC1) vaccine approved in EU, Canada and Australia DUKORAL® DUKORAL®: Canada accounts for over 55% of sales For the prevention of diarrhea caused by Vibrio 9M ‘19 product sales analysis cholera and/or heat-labile toxin producing enterotoxigenic Escherichia coli (ETEC)1 Othe
Slide 8: Lyme disease is a serious unmet medical need
Lyme disease is a serious unmet medical need VLA15 is the only vaccine candidate in clinical development today 1 Multivalent vaccine (six serotypes) to protect against Lyme disease in N. America and Europe Targets OspA of Lyme borrelia, preventing spirochetes from migrating through the tick’s 2 mid-
Slide 9: Overview of Lyme disease
Overview of Lyme disease Severe tick-transmitted infection with high prevalence in N. America & Europe Tickborne disease (Vector-Ixodes ticks) Caused by Borrelia burgdorferi spirochete (resides in gut of tick – migrates to salivary gland – enters host during feeding) Early signs and symptoms (
Slide 10: Lyme disease epidemiology
Lyme disease epidemiology One of the fastest-spreading vector-borne illnesses in the Northern hemisphere Annual Reported Cases of Lyme Disease in the US1 Estimated Cases ~ 300,000 cases in US (p.a.)2 ~ 200,000 cases in EU (p.a.)3 Most-affected US regions: 95% of US cases in 2016 occurred in
Slide 11: VLA15: Phase 2 – Optimizing dose and schedule
VLA15: Phase 2 – Optimizing dose and schedule Observer-blind, randomized, placebo-controlled, Phase 2 studies conducted in the US and EU1 Phase 2 Study VLA15-201 819 subjects in two studies with run-in phase Primary objective: Safety and immunogenicity data four weeks after completed schedule Second
Slide 12: Lyme disease vaccine candidate VLA15: Phase 2 on track
Lyme disease vaccine candidate VLA15: Phase 2 on track Patient recruitment for both Phase 2 studies completed September 2019 Process for a late stage development & commercialization partner initiated Phase 2 on track to provide first data by mid 2020 Initial Data: Day 85 after base immunization sc
Slide 13: Chikungunya is a major public health threat
Chikungunya is a major public health threat VLA1553 is a unique, differentiated single-shot vaccine candidate 1 Currently no preventive vaccines or effective antiviral treatments exist for chikungunya VLA1553 is a monovalent, single dose, live attenuated1 prophylactic vaccine targeting 2 chikungunya
Slide 14: Chikungunya Phase 1 study (VLA1553-101) – Final results
Chikungunya Phase 1 study (VLA1553-101) – Final results Excellent immunogenicity and safety profile up to Month 131 Immunogenicity Safety 100% Seroconversion Rate (SCR)2 achieved Generally safe in all dose groups at Day 14 after a single vaccination in all dose groups1 Well-tolerated in the lo
Slide 15: Competitive analysis of clinical stage chikungunya vaccine candidates
Competitive analysis of clinical stage chikungunya vaccine candidates Emergent (Paxvax)’s Phase 21 Themis’ Phase 22 Valneva’s Phase 13 Vaccine Virus-like particle (VLP) vaccine Measles-vectored Chikungunya vaccine (MV-CHIK), Monovalent, single dose, live-attenuated vaccine candidate VRC-CHKVLP059-00
Slide 16: Chikungunya vaccine candidate VLA1553 progressing rapidly
Chikungunya vaccine candidate VLA1553 progressing rapidly Up to $23.4m / €20.3m awarded by CEPI for late-stage development of VLA1553 Accelerate regulatory approval for use in regions where outbreaks occur Support WHO prequalification to facilitate broader access in lower/middle income countries
Slide 17: 2019 product sales guidance raised following strong 9M results
2019 product sales guidance raised following strong 9M results All other guidance confirmed despite GSK SAA termination impact 2019 9 Month 2019 9 Month Results Excluding GSK SAA 2019 Guidance Results termination impact Product sales revenues €86.4m - €125m - €130m Total revenues €81.4 €92.1 €125m -
Slide 18: Corporate Governance and Shareholder Structure
Corporate Governance and Shareholder Structure Management Board Stock Information Thomas Lingelbach, President & CEO Primary listing = Euronext (Paris) Franck Grimaud, President & CBO Number of ordinary shares: 90.9m David Lawrence, CFO Shareholder structure1: Wolfgang Bender, MD, PhD,
Slide 19: Upcoming newsflow
Upcoming newsflow Lyme partnering process Lyme disease vaccine candidate VLA15: Phase 2 execution on track for initial data mid-2020 Chikungunya vaccine candidate VLA1553: progressing towards potential accelerated development strategy; aiming for EoP2 FDA meeting Q1 2020 New IXIARO® contract with th
Slide 20: Appendices
Appendices
Slide 21: VLA continuously strengthening its institutional shareholder base
VLA continuously strengthening its institutional shareholder base with blue-chip healthcare investors January 2018 October 2018 November 2019 Number of ordinary shares: Number of ordinary shares: Number of ordinary shares: 90.9m 77.6m 90.9m Shareholder structure1: Shareholder structure1:
Slide 22: Vaccination against Lyme disease
Vaccination against Lyme disease Justification for a Lyme vaccine Vaccination with OspA has been proven to work in the past (Lymerix®, ImuLyme®) Disproven postulate1, restrictive recommendations and corporate decisions resulted in there being no Lyme vaccine available for humans since 2002 Delaye
Slide 23: Lyme Phase 1 study (VLA15-101) – Immunogenicity
Lyme Phase 1 study (VLA15-101) – Immunogenicity GMT for highest adjuvanted dose group between 61 (ST1) and 269 (ST2), substantial booster effect IgG GMT of Highest Adjuvanted Group (90µg + Alum) Before and After Primary Series and Booster Dose IgG GMT by Serotype over Time 1000 Post Primary Post Boo
Slide 24: Chikungunya: Vector prevalence and disease outbreaks
Chikungunya: Vector prevalence and disease outbreaks Rezza & Weaver 2019 Valneva - Company Presentation December 2019 24
Slide 25: Thank you
Thank you Merci Danke Tack ‘WAvalneva