Valneva SE · EURONEXT:VLA
Valneva — Investor Presentation (July 2019)
27 slides from Valneva's investor presentation, July 2019
Slide 1: Advancing Vaccines for Better Lives
Advancing Vaccines for Better Lives Company Presentation – July 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: Valneva's mid-term strategy
Valneva’s mid-term strategy To become the leading commercial stage vaccine biotech R&D Commercial Products Investing in innovative R&D Growing product sales programs to address major revenues to €200m and unmet needs beyond Financial Strategic Growth Use proceeds from Organic growth commercial busin
Slide 5: Valneva's profitable commercial business funds R&D programs
Valneva’s profitable commercial business funds 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 Product sales €103.5m Other DUKORAL® €30.4m Direct sales IXIARO®/ 81
Slide 6: Valneva's R&D pipeline
Valneva’s R&D pipeline Focusing on vaccines with major unmet need Product Discovery Pre- IND Phase 1 Phase 2 Phase 3 Market research clinical enabling research Japanese Marketed vaccines encephalitis Cholera (ETEC)1 Lyme disease Clinical candidates Chikungunya Zika Clostridium difficile 1 Indication
Slide 7: IXIARO/JESPECT: Only vaccine against Japanese encephalitis in US, Canada and Europe
IXIARO®/JESPECT® Only vaccine against Japanese encephalitis (JE) in US, Canada and Europe IXIARO®/JESPECT® IXIARO®/JESPECT®: US accounts for >50% of sales + Designed to protect travelers and military against 2018 product sales analysis JE, the leading cause of viral neurological disease & disability
Slide 8: 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 >50% of sales + For the prevention of diarrhea caused by Vibrio 2018 product sales analysis cholera and/or heat-labile toxin producing enterotoxigenic Escherichia coli (ETEC)1 Others +
Slide 9: Lyme disease is a serious unmet medical issue
Lyme disease is a serious unmet medical issue 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 10: 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 11: Lyme disease epidemiology
Lyme disease epidemiology The most common vector-borne illness 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 Northern US sta
Slide 12: 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 VLA15-201 820 subjects in two studies with run-in phase Primary objective: Safety and immunogenicity data four weeks after completed schedule Second
Slide 13: Lyme vaccine candidate VLA15 – next steps
Lyme vaccine candidate VLA15 – next steps Current outline for Phase 3 clinical development plan* Phase 2 expected to provide first data by mid-2020 › Initial Data: Day 85 after short schedule: dose determination › Alternative schedule data expected late 2020 › Booster studies with additional 12 mont
Slide 14: Chikungunya is a severe, emerging outbreak disease
Chikungunya is a severe, emerging outbreak disease 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 chik
Slide 15: Chikungunya epidemiology
Chikungunya epidemiology Countries and territories where chikungunya cases have been reported (as of May 29, 2018)1 1 https://www.cdc.gov/chikungunya/geo/index.html Valneva - Company Presentation July 2019 15
Slide 16: Chikungunya Phase 1 study (VLA1553-101) – Interim results
Chikungunya Phase 1 study (VLA1553-101) – Interim results Excellent immunogenicity and safety profile up to Month 71 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 l
Slide 17: VLA1553: Development considerations and steps
VLA 1553: Development considerations and steps Outline for potential accelerated clinical development plan* FDA Fast Track granted to VLA1553 vaccine candidate Phase 1 first unblinded data reported May 2019 Day 28 safety and immunogenicity after single dose Viremia data at Days 3, 7 and 14 p
Slide 18: Financial outlook
Financial outlook Continued double-digit sales growth, higher R&D investment to support clinical development 2018 2019 Product sales €103.5m €115m - €125m revenues Total revenues €113.0m €125m - €135m R&D investments €25.3m €35m - €40m Gross margin 60.7% > 60% Net operating 24.1% 25% - 35% margin1 E
Slide 19: 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 20: Recent and upcoming newsflow in 2019
Recent and upcoming newsflow in 2019 On track to deliver 15-20% CER product sales growth expected in 2019 Successful outcome of Phase 2 run-in for Lyme disease vaccine candidate (VLA15) - DSMB has cleared two dosage levels for further clinical development Excellent Phase 1 data for chikungunya vacci
Slide 21: Appendices
Appendices
Slide 22: Strengthening institutional shareholder base with blue-chip healthcare investors
VLA continuously strengthening its institutional shareholder base with blue-chip healthcare investors January 2018 October 2018 May 2019 + Number of ordinary shares: + Number of ordinary shares: + Number of ordinary shares: 90.9m 77.6m 90.9m + Shareholder structure1: + Shareholder structure1: + Shar
Slide 23: 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 24: Phase 1 study (VLA15-101) – Immunogenicity
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 Booster
Slide 25: Chikungunya: Vector prevalence and disease outbreaks
Chikungunya: Vector prevalence and disease outbreaks Rezza & Weaver 2019 Valneva - Company Presentation July 2019 25
Slide 26: VLA84: Unpartnered Clostridium difficile vaccine candidate
VLA84: Unpartnered Clostridium difficile vaccine candidate Vaccine targeting healthcare-associated diarrhea, an increasing threat to the elderly in a $1 billion market1 Clostridium difficile (C. diff) Valneva’s vaccine candidate VLA84 + Single most common pathogen of acute healthcare- + One of two l
Slide 27: Thank you
Thank you Merci Danke Tack WAvalneva