Valneva Se · EURONEXT:VLA
Valneva — J.P. Morgan Healthcare Conference 2018
26 slides from Valneva's conference presentation, January 2018
Slide 1: Valneva – a commercial stage biotech company focused on developing life-saving vaccines
Valneva – a commercial stage biotech company focused on developing innovative, life-saving vaccines Company Presentation January 2018
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 has two main value drivers
Valneva has two main value drivers Combination of strong revenues and high value R&D assets Repeated double digit product sales growth A valuable R&D pipeline Other IXIARO®/ JESPECT® DUKORAL® €58-62m €27m Total revenues €105 – €115m Other Expected FY 2017 revenues Valneva - Company Presentation Janu
Slide 4: Valneva's mid-term strategy
Valneva’s mid-term strategy To become the leading commercial stage vaccine biotech Products R&D Growing revenues from Investing in innovative R&D existing and future programs to meet unmet products to €200m and medical needs beyond Growth Financials Generating organic growth Achieving financial comp
Slide 5: World class leadership team
World class leadership team Thomas Lingelbach Franck Grimaud President & CEO President & CBO + CEO of Intercell since 2011 + CEO and co-founder of Vivalis since 1999 + Managing Director for Novartis Vaccines & + Responsible for Groupe Grimaud’s Diagnostics Germany development in Asia + Vice Presiden
Slide 6: Two commercial products in key indications for travelers
Two commercial products in key indications for travelers Designed to provide protection against life-threatening diseases Japanese Encephalitis Cholera and ETEC + The leading cause of viral neurological disease + Cholera causes the most severe form of diarrhea & disability in Asia1 › Estimated 3 – 5
Slide 7: Valneva manages >70% of product sales through its own commercial organization
Valneva manages > 70% of its product sales through its own, highly capable commercial organization Canada UK • Commercial Head with over 24 years of sales • Commercial Head with 15 years of sales & marketing and marketing experience (Merck, Novartis) experience (Sanofi, AstraZeneca, Novartis) Nordic
Slide 8: IXIARO/JESPECT: The only JE vaccine approved in the US and Europe
IXIARO®/JESPECT® The only JE vaccine approved in the US and Europe Japanese Encephalitis vaccine + Designed to protect travelers and military against JE + Indicated for active immunization against JE in adults, adolescents, children and infants aged two months and older1 Commercial position Market p
Slide 9: IXIARO/JESPECT: Ongoing double digit revenue growth and increasing gross margin
IXIARO®/JESPECT® Ongoing double digit revenue growth and increasing gross margin Nine-Months1 FY 2020 2015 FY 2016 2020 IXIARO®/JESPECT® revenues US is the biggest market Gross margin (in €m) CAGR Other >10% countries, CAGR ~58-62 10% >15% US ~70% military, 40% 60% Europe, 30% 46% 53.2 45.9 40.1 US
Slide 10: DUKORAL: The only cholera (ETEC) vaccine available in EU, Canada & Australia
DUKORAL® The only cholera (ETEC1) vaccine available in EU, Canada & Australia DUKORAL® + For the prevention of diarrhea caused by Vibrio cholera (cholera) and/or heat-labile toxin producing enterotoxigenic Escherichia coli (ETEC)1 + In several markets, including EU, currently indicated to protect ag
Slide 11: DUKORAL: Excellent sales growth in key markets
DUKORAL® Excellent sales growth in key markets Nine-Months1 FY 2020 2015 FY 2016 2020 DUKORAL® revenues Canada is the biggest market Gross margin (in €m) CAGR Other 5-10% countries; 20% ~27 CAGR Australia/New 10-15% Zealand; 10% 24.7 Canada; 50% >55% Nordics; 20% 46% 19.9 14.9 13% Split of 2016 prod
Slide 12: Valneva's pipeline
Valneva’s pipeline Focusing on vaccines with high unmet medical need Product Candidate Discovery Pre-clinical IND Phase I Phase II Phase III Market Partner research research enabling Japanese Marketed vaccines Encephalitis Cholera (ETEC1) Clostridium candidates TBD Clinical difficile Lyme disease pr
Slide 13: VLA15: the only Lyme disease vaccine in clinical development
VLA15: the only Lyme disease vaccine in clinical development Market potential of approximately €700m - €800m1 Lyme disease Valneva’s vaccine candidate + Transmitted by Ixodes ticks2, causing Lyme + Only active clinical program, no vaccine on the market + Most common vector borne illness in the North
Slide 14: VLA15 – Phase I Study
VLA15 – Phase I Study Observer-blind, partially randomized, dose escalation study Phase I study conducted in US and EU 6 groups, 3 doses, 2 formulations ▪ Primary objective: Safety and tolerability to Month 3 180 subjects aged 18-<40 years ▪ Secondary objectives: Safety and tolerability until M1
Slide 15: VLA1553: Chikungunya vaccine
VLA1553: Chikungunya vaccine A potential single-shot vaccine against a spreading threat Chikungunya virus (CHIKV) Valneva’s vaccine candidate Chikungunyabyvirus + Transmitted Aedesis amosquitoes, Togaviridaecausing virus, transmitted by + Monovalent, single dose, Aedes mosquitoes Chikungunya disease
Slide 16: VLA1601: Zika vaccine
VLA1601: Zika vaccine Valneva & Emergent BioSolutions joining forces to accelerate development Zika virus Valneva’s vaccine candidate + Zika virus is a Flavivirus, transmitted by Aedes + Highly purified inactivated mosquitoes1 vaccine (PIV) + Most common symptoms are flu-like symptoms lasting + Deve
Slide 17: 2017 Financial Outlook
2017 Financial Outlook Continued revenue growth and positive EBITDA 2016 Actual 2017 Outlook Growth up to 17% growth vs. Revenues €97.9m €105 – 115m 2016 IXIARO® €53.2m €58 – 62m 10 – 15% Product sales DUKORAL® €24.7m €27m c.10% R&D expenditure €24.6m €23 – 25m* – EBITDA €2.8m €10 – 13m x3.5 to x4.5
Slide 18: Valneva 2018 – Exciting upcoming newsflow
Valneva 2018 – Exciting upcoming newsflow + Further sales growth and increasing commercial margin + Chikungunya Phase I commencement in Q1 2018 + Zika Phase I commencement in Q1 2018, data by year end + Lyme Phase I results at end of Q1 2018 followed by Phase II + Lyme R&D/Investor Day(s) in H1 2018
Slide 19: Appendices
Appendices
Slide 20: Valneva: A fully integrated vaccine company
Valneva: A fully integrated vaccine company Corporate profile About Valneva Stock information + Created in May 2013 through the merger of Vivalis + Main Listing = Euronext (Paris) SA and Intercell AG; + Number of ordinary shares: 77.6m › Incorporated in Lyon, France + Current Market cap: ~ €230m + I
Slide 21: Pre-commercial product: Clostridium difficile vaccine
Pre-commercial product: Clostridium difficile vaccine Vaccine targeting healthcare-associated diarrhea, an increasing threat to the elderly in a $1 billion market5 Clostridium difficile (C. diff) Valneva’s vaccine candidate VLA84 + Single most common pathogen of acute healthcare- + One of three late
Slide 22: Strong nine months 2017 financial results
Strong nine months 2017 financial results Comparison to nine months 2016 (IFRS, € million, unaudited) Total Revenues COGS R&D Expenses Nine Months 2017 Nine Months 2016 Nine Months 2017 Nine Months 2016 (15.1) (18.7) (30.0) (32.1) 79.8 70.7 Nine Months 2017 Nine Months 2016 EBITDA* Net profit/loss C
Slide 23: Lyme disease: Six strains account for over 95% of cases
Lyme disease Six strains account for over 95% of cases Valneva - Company Presentation January 2018 23
Slide 24: Spread of Lyme across the US
Spread of Lyme across the US 400,000 estimated cases in the US annually – CDC 2017 Source : Centers for Disease Control and Prevention Valneva - Company Presentation January 2018 24
Slide 25: Lyme Borreliosis in Europe
Lyme Borreliosis in Europe Epidemiology Overview – Countries ranked by total number of cases The above number of cases and incidence rates are indicative of the presence for LB in the respective country, however, countries cannot be compared as surveillance methods differ. Valneva - Company Presenta
Slide 26: Thank you
Thank you Merci Danke Tack WAvalneva