Valneva - a commercial stage biotech company focused on developing innovative, life-saving vaccines - Company Presentation January 2018
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Valneva – a commercial stage biotech company focused on developing innovative, life-saving vaccines Company Presentation January 2018
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 sold in the USA. The offer and sale of the Valneva shares has not been and will not be registered under the 1933 US Securities Act, as amended. Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of the United States. Financial statements and information may be prepared according to accounting standards which may not be comparable to those used generally by companies in the United States. This presentation includes only summary information and does not purport to be comprehensive. Any information in this presentation is purely indicative and subject to modification at any time. Valneva does not warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, or any of their affiliates, directors, officers, advisors and employees shall bear any liability for any loss arising from any use of this presentation. Certain information and statements included in this presentation are not historical facts but are forward-looking statements. The forward-looking statements (a) are based on current beliefs, expectations and assumptions, including, without limitation, assumptions regarding present and future business strategies and the environment in which Valneva operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance or achievements to be materially different from those expressed or implied by these forward-looking statements, (b) speak only as of the date this presentation is released, and (c) are for illustrative purposes only. Investors are cautioned that forward-looking information and statements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Valneva. Valneva - Company Presentation January 2018 2
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 January 2018 3
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
complemented by targeted
sustainability including 2022 strategy acquisition and licensing
cash-generation
strategies
Valneva - Company Presentation January 2018 4
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 President of Global Industrial + 20 years in Corporate Business Development
Operations at Chiron Vaccines and lifesciences
+ 25 years in vaccine industry
David Lawrence
CFO
+ CFO of vaccine biotech company Acambis
+ VP Finance at Chiron Vaccines and GSK
+ Non-executive Board experience
+ 25 years of experience in vaccines and
lifesciences
Frédéric Jacotot Wolfgang Bender, MD, PhD
General Counsel CMO
+ VP Legal & IP and General Counsel + Senior international positions at various large
of Valneva since September 2013 pharmas including Novartis, Takeda, Pfizer
+ Division Counsel at Abbott and Hoechst
+ 25 years as a legal expert in the + Experiences in scientific-medical affairs, drug
pharmaceutical industry development and general management of
vaccines and pharmaceuticals
+ 30 years of experience
Valneva - Company Presentation January 2018 5
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 million cases and 100,000 to
120,000 deaths per year5
+ A rare disease, but associated with high
individual morbidity and mortality rate2 + ETEC is the most frequent form of traveler’s
› Estimated 68,000 symptomatic cases in Asia diarrhea
each year3 › Estimated 5 – 18 million reported cases per year6
› Between 0.1% and 4% of infections lead to
clinical disease4 + Cholera and ETEC transmission through
› Fatal in 20-30% of symptomatic cases1 ingestion of contaminated food or water
› Half of the survivors are left with neurological
sequelae1
1 Solomon T et al. J. Neurol. Neurosurg. Psychiatry 2000;68:405-415; 2 CDC. MMWR 2010;59:1-27; 3 WHO. Bull World Health Organ 2011; 89:766–774E; 4 van den Hurk AF et al.
Annu Rev Entomol 2009;54:17-35; 5 WHO cholera factsheet February 2014; 6 Lundkvist J, Steffen R, Jonsson B. Cost-benefit of WC/rBS oral cholera vaccine for vaccination against
ETEC-caused travellers' diarrhea. J Travel Med 2009; 16(1):28-34;
Valneva - Company Presentation January 2018 6
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 Countries
• Commercial Head with 30 years of sales & marketing
experience (Aventis, Amgen, Sanofi Pasteur)
Austria
• Commercial Head with 15 years of sales & marketing
experience (Abbott, GSK, Eli Lilly)
USA
• Commercial Head with 25+ years of commercial
experience (GSK, Dynavax)
Valneva - Company Presentation January 2018 7
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 potential
+ Currently, no effective treatment for the disease2 + 279 million travelers to Asia in 20153
+ Valneva’s vaccine is the only approved vaccine › Travelers to Asia expected to grow by 4.4% per
available for US and EU travelers year3
+ Supply agreement in place with US military and + Global JE vaccines market valued at ~€150-200m4
strong track record of repeat contracts › Traveler 65%, Military 15%, Endemic 20%4
+ Chinese/Asian manufacturers mainly serve local + Significant growth potential in key markets
public markets
1 Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this
vaccine is licensed. The currently available presentation for IXIARO ® can be used in children from 3 years of age. Prior to availability of the new presentation, no attempt should be made
to adjust the syringe volume or to administer a 0.25mL/3µg dose in children less than 3 years of age; 2 CDC. MMWR 2010;59:1-27; 3 UNWTO Tourism Highlights 2016; 4 Nomura Code
estimates (October 2012) and Valneva Management estimates;
Valneva - Company Presentation January 2018 8
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
private,
20%
Split of 2016 product sales
2016 2017 2020
Revenue growth driven by U.S. will remain main market
Margin will improve further
+ Increased product adoption in the US + Volume growth in existing markets
+ Fixed manufacturing cost structure to
(private) and in Europe + Growth focused on key travelers translate into margin growth
+ Further geographic expansion vaccine markets
1 unaudited 2017 figures
Valneva - Company Presentation January 2018 9
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 against cholera only
+ Designed to protect adults and children from two
years of age who will be visiting endemic areas
Commercial position Market potential
+ Only approved cholera vaccine available for + 363 million travelers to Asia/South America/Africa
European, Canadian and Australian travelers in 20152
+ Global Cholera/ETEC vaccines market valued at
› WHO pre-qualification widely used in other
€283m3
countries
+ Ongoing travel to risk regions, improved awareness
› Asian manufacturers predominantly serve local and travel recommendation updates to drive growth
markets and primarily for cholera only + Canada, Sweden, Australia account for ~75% of
Dukoral® sales
1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing,
safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. 2 UNWTO Tourism Highlights 2016; 3 ETEC/ Cholera = global
predicted demand, source: PATH/bvgh “The Case for Investment in ETEC vaccines”, March 2011 and VacZine Analytics TD 2011
Valneva - Company Presentation January 2018 10DUKORAL®
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 product sales
2016 2017 2020
Continuous strong revenue growth Existing markets will remain key Future margin improvement expected
+ Increased travel to endemic regions + Growth opportunities through + Fixed manufacturing cost structure to
geographic expansion
+ Awareness campaigns for HCPs & translate into volume leverage
+ Increased product adoption through
lay public effects
possible label extensions/ harmonization
1 unaudited 2017 figures
Valneva - Company Presentation January 2018 11Valneva’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 proprietary*
Phase I entry
Chikungunya proprietary
Emergent
Zika BioSolutions
1 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl.
dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (E. Coli) bacterium. / *Potential opt-in by GSK / co-development
Valneva - Company Presentation January 2018 12VLA15: 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 Northern
Hemisphere (~400,000 cases in 2015 in US3 and at least + Multivalent, protein subunit-
~200,000 cases per year in Europe4) based vaccine
+ Delayed or inadequate treatment can lead to disabling + Targets the outer surface protein
sequels A (OspA) of Borrelia (proven
mode of action)
Phase I trial ongoing in US & EU Acceleration towards Phase II
+ Pre-clinical testing completed + Phase I data expected to be reported in Q1/ 2018,
› Data showed that the vaccine has the potential to provide immediately followed by Phase II initiation6)
protection against the majority of Borrelia species + Phase II preparations and consultations process
pathogenic for humans5 initiated
+ FDA Fast Track Designation received + Medical need for Lyme vaccine steadily increasing as
+ Phase I ongoing - subject enrolment completed the disease footprint widens7
1 Company estimate supported by independent market studies; 2 Stanek et al. 2012, The Lancet 379:461–473; 3 As estimated by the CDC based on reported cases in 2015; 4 Estimated
from available national data. Number largely underestimated based on WHO Europe Lyme Report as case reporting is highly inconsistent in Europe and many LB infections go undiagnosed;
ECDC tick-borne-diseases-meeting-report; 5 http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113294; 6 Subject to Phase I results and regulatory approvals.
7 New Scientist, Lyme disease is set to explode and we still don’t have a vaccine; March 29, 2017 https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-
and-you-cant-protect-yourself/
Valneva - Company Presentation January 2018 13VLA15 – 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-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 live attenuated virus
+ Outbreaks inin Asia,
Asia, Africa
Africa &
& Europe,
Europe, most
most recently
recently vaccine (∆5nsP3)2
+ Outbreaks
spread to the Americas (> 180,000 reported cases in
spread
2016) 1 to the Americas (> 180,000 reported cases in + Grown on Vero cells
2016) 1
+ Disease outbreak with high attack rates, up to 50% of + Protective against various
+ Disease outbreak
those infected with highprolonged
experience attack rates, up to 50%
symptoms orof
long
those infected experience prolonged or long term CHIKV outbreak
term sequels
symptoms phylogroups & strains3
Current development status VLA1553 (IND-enabling) Phase I to be initiated in Q1 2018
+ Pre-clinical testing completed + Phase I to evaluate safety and immunogenicity in
› Data from non-human primates (NHP) have shown that approx. 120 subjects and to confirm antibody
the vaccine has a good safety profile and the potential to persistence (≥6m)
provide long term protection against Chikungunya after a + Primary target population are travelers to endemic
single immunization regions and military; public endemic market and
+ Program under IND emergency stockpiling as secondary target populations
+ Preparations for Phase I initiation completed
1 PAHA/WHO data: Number of reported cases of Chikungunya Fever in the Americas - EW 33 (August 19, 2016); 2 CHIKV LR2006-OPY1 infectious clone was attenuated by deleting large
part of gene coding nsP3 (alphavirus-replicase; 3 Hallengärd et al. 2013. J Virology 88:2858–2866.
Valneva - Company Presentation January 2018 15VLA1601: 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 + Developed using Valneva’s
between two to seven days. No specific treatment proven and licensed
available
inactivated JE vaccine
+ Scientific consensus that Zika virus causes platform
microcephaly / severe brain defects in newborns /
Guillain-Barré syndrom2 in adults
Current development status VLA1601 (PIV) Phase I to be initiated in Q1 2018
+ Pre-clinical testing demonstrated excellent purity, in-vivo + Phase I to evaluate safety and immunogenicity. First
neutralization and overall a biological, chemical and physical data expected in 2018
profile comparable to IXIARO®
+ Phase I preparation ongoing + Priority for people traveling to or living in endemic
regions, including potential preparedness for
+ Co-development deal with Emergent BioSolutions
including opt-in post Phase I (in exchange for a €5m opt-in stockpiling
milestone payment; potential additional milestones of up to
€44m* and royalties on future sales)
1 https://www.cdc.gov/zika/transmission/index.html 2 http://www.who.int/mediacentre/factsheets/zika/en/ ; * Related to product development, approval, commercialization, and product sales,
and royalties on annual net sales
Valneva - Company Presentation January 2018 162017 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
vs. 2016
* Due to external R&D costs expected later in the year
Valneva - Company Presentation January 2018 17Valneva 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 Valneva - Company Presentation January 2018 18
Appendices
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
+ ISIN: FR0004056851
+ Expanded business by acquiring a commercial
product (Dukoral) from Crucell/Janssen in + Shareholder structure:
February 2015
Groupe
Grimaud
+ Operations in: 15.6%
› US & Canada (S&M)
Bpifrance
› Vienna, Austria (R&D, SG&A, QA/QC) 64.8% 9.6% Participations
Free Float
› Nantes & Lyon, France (R&D, SG&A) SA
7.5%
› Solna, Sweden (Manufacturing, S&M) MVM1
› Livingston & London, UK (Manufacturing, S&M)
1.5%
+ Over 430 employees 0.9% Other
› Manufacturing, Quality & Supply Management registered
& employees shareholders
› R&D
› SG&A
1 Funds managed by MVM Life Science Partners
Valneva - Company Presentation January 2018 20Pre-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 stage vaccine
associated infections in the US1 (~ 450,000 cases of candidates
annually and ~ 30,000 deaths2) + Modern, recombinant single subunit-
toxin antigen (CTAB) expressed in e.coli
+ ~ 172,000 cases in EU member states per year3
w/o adjuvants
+ Targeting primary prevention of C. difficile + Potential distinct competitive advantages
› Current antibiotic treatments have significant limitations on industrialization/future manufacturing
with recurrence in ~20% of cases4
Current development status VLA84 New development & partnering approach
+ Phase II completed - Phase III ready + Potential partners hesitant about level of Phase III
investment required and investment-risk proposition
+ Highly immunogenic in all age groups tested (strong
+ VLA to use first CDI vaccine approval and consider
immune responses to both C. diff toxins A & B) “Head to Head“ non inferiority Ph III on immunological
+ Good safety and tolerability profile confirmed correlate
+ Comparable immunological profile to other CDI clinical + New approval expected to substantially improve
programs targeting primary prevention of CDI investment-risk proposition for own or partnered
development to market
Source picture: www.123rf.com; 1 Magill S, Edwards J R, Bamberg W et al. Multistate Point-Prevalence Survey of Health Care–Associated Infections. New England Journal of Medicine
2014;370:1198-208; 2 Lessa et al, Burden of Clostridium difficile Infection in the United States. N Engl J Med 2015;372:825-34. 3 Clostridium difficile infection in Europe. A CDI Europe Report.;
4 Leffler et al, Clostridium difficile infection. N Engl J Med 2015;372:1539-48; 5 VacZine Analytics Clostridium difficile prophylactic vaccines Market View, January; 6 G. de Bruyn et al. Vaccine
34 (2016) 2170-2178; *EOP2 – end of Phase II
Valneva - Company Presentation January 2018 21Strong 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 Cash position
Nine Months 2017 Nine Months 2016
(7.8)
12.3
43.8
42.2
(46.5)
3.5
Nine Months 2017 Nine Months 2016 30/09/2017 31/12/2016
*Calculated by excluding nine-month 2017 amortization, depreciation and impairment of €12.1m from the nine-month 2017 operating profit of €0.2m
Valneva - Company Presentation January 2018 22Lyme disease Six strains account for over 95% of cases Valneva - Company Presentation January 2018 23
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
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 Presentation January 2018 25Thank you Merci Danke Tack
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