valneva a commercial stage biotech company focused on ... · + global je vaccines market valued at...
TRANSCRIPT
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.
January 2018 Valneva - Company Presentation 2
Valneva has two main value drivers
January 2018 Valneva - Company Presentation 3
Combination of strong revenues and high value R&D assets
Other
Repeated double digit product sales growth
A valuable R&D pipeline
Expected FY 2017 revenues
IXIARO®/ JESPECT® €58-62m
Other
DUKORAL®
€27m
Total revenues
€105 – €115m
Valneva’s mid-term strategy
January 2018 Valneva - Company Presentation 4
To become the leading commercial stage vaccine biotech
Products
Growing revenues from existing and future
products to €200m and beyond
R&D
Investing in innovative R&D programs to meet unmet
medical needs
Financials
Achieving financial sustainability including
cash-generation
Growth
Generating organic growth complemented by targeted acquisition and licensing
strategies
2022 strategy
World class leadership team
Valneva - Company Presentation 5
Thomas Lingelbach
President & CEO
+ CEO of Intercell since 2011
+ Managing Director for Novartis Vaccines &
Diagnostics Germany
+ Vice President of Global Industrial
Operations at Chiron Vaccines
+ 25 years in vaccine industry
Franck Grimaud
President & CBO
+ CEO and co-founder of Vivalis since 1999
+ Responsible for Groupe Grimaud’s
development in Asia
+ 20 years in Corporate Business Development
and lifesciences
Frédéric Jacotot
General Counsel
+ VP Legal & IP and General Counsel
of Valneva since September 2013
+ Division Counsel at Abbott
+ 25 years as a legal expert in the
pharmaceutical 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
Wolfgang Bender, MD, PhD
CMO
+ Senior international positions at various large
pharmas including Novartis, Takeda, Pfizer
and Hoechst
+ Experiences in scientific-medical affairs, drug
development and general management of
vaccines and pharmaceuticals
+ 30 years of experience
January 2018
Two commercial products in key indications for travelers
January 2018 Valneva - Company Presentation 6
Japanese Encephalitis
+ The leading cause of viral neurological disease
& disability in Asia1
+ A rare disease, but associated with high
individual morbidity and mortality rate2
› Estimated 68,000 symptomatic cases in Asia
each year3
› Between 0.1% and 4% of infections lead to
clinical disease4
› Fatal in 20-30% of symptomatic cases1
› Half of the survivors are left with neurological
sequelae1
Cholera and ETEC
+ Cholera causes the most severe form of diarrhea
› Estimated 3 – 5 million cases and 100,000 to
120,000 deaths per year5
+ ETEC is the most frequent form of traveler’s
diarrhea
› Estimated 5 – 18 million reported cases per year6
+ Cholera and ETEC transmission through
ingestion of contaminated food or water
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;
Designed to provide protection against life-threatening diseases
Valneva manages > 70% of its product sales through its own,
highly capable commercial organization
January 2018 Valneva - Company Presentation 7
USA
• Commercial Head with 25+ years of commercial experience (GSK, Dynavax)
Canada
• Commercial Head with over 24 years of sales
and marketing experience (Merck, Novartis)
Austria
• Commercial Head with 15 years of sales & marketing
experience (Abbott, GSK, Eli Lilly)
Nordic Countries
• Commercial Head with 30 years of sales & marketing
experience (Aventis, Amgen, Sanofi Pasteur)
UK
• Commercial Head with 15 years of sales & marketing
experience (Sanofi, AstraZeneca, Novartis)
IXIARO®/JESPECT®
January 2018 Valneva - Company Presentation 8
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
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;
The only JE vaccine approved in the US and Europe
Market potential
+ 279 million travelers to Asia in 20153
› Travelers to Asia expected to grow by 4.4% per
year3
+ Global JE vaccines market valued at ~€150-200m4
› Traveler 65%, Military 15%, Endemic 20%4
+ Significant growth potential in key markets
Commercial position
+ Currently, no effective treatment for the disease2
+ Valneva’s vaccine is the only approved vaccine
available for US and EU travelers
+ Supply agreement in place with US military and
strong track record of repeat contracts
+ Chinese/Asian manufacturers mainly serve local
public markets
Gross margin
46%
IXIARO®/JESPECT®
January 2018 Valneva - Company Presentation 9
1 unaudited 2017 figures
US is the biggest market
Ongoing double digit revenue growth and increasing gross margin
Nine-Months1 FY 2020
60%
U.S. will remain main market
+ Volume growth in existing markets
+ Growth focused on key travelers
vaccine markets
Margin will improve further
+ Fixed manufacturing cost structure to
translate into margin growth
~70%
Split of 2016 product sales
IXIARO®/JESPECT® revenues
(in €m)
40.1
53.2 45.9
~58-62
Revenue growth driven by
+ Increased product adoption in the US
(private) and in Europe
+ Further geographic expansion
CAGR
>10%
2016 2017 2020
2015 FY 2016 2020
CAGR
>15%
US military,
40%
US private,
20%
Europe, 30%
Other countries,
10%
DUKORAL®
January 2018 Valneva - Company Presentation 10
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
Market potential
+ 363 million travelers to Asia/South America/Africa in 20152
+ Global Cholera/ETEC vaccines market valued at €283m3
+ Ongoing travel to risk regions, improved awareness and travel recommendation updates to drive growth
+ 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
The only cholera (ETEC1) vaccine available in EU, Canada & Australia
Commercial position
+ Only approved cholera vaccine available for
European, Canadian and Australian travelers
› WHO pre-qualification widely used in other
countries
› Asian manufacturers predominantly serve local
markets and primarily for cholera only
Gross margin Canada is the biggest market
DUKORAL®
January 2018 Valneva - Company Presentation 11
1 unaudited 2017 figures
Excellent sales growth in key markets
Split of 2016 product sales
Future margin improvement expected
+ Fixed manufacturing cost structure to
translate into volume leverage
effects
Existing markets will remain key
+ Growth opportunities through
geographic expansion
+ Increased product adoption through
possible label extensions/ harmonization
13%
46%
>55%
2015 FY 2016 2020
CAGR
10-15%
DUKORAL® revenues
(in €m)
Nine-Months1 FY 2020
14.9
24.7
19.9
CAGR
5-10%
Continuous strong revenue growth
+ Increased travel to endemic regions
+ Awareness campaigns for HCPs &
lay public
~27
2016 2017 2020
Canada; 50%
Nordics; 20%
Australia/New Zealand; 10%
Other countries;
20%
Valneva’s pipeline
January 2018 Valneva - Company Presentation 12
Focusing on vaccines with high unmet medical need
Product Candidate Discovery
research
Pre-clinical
research
IND
enabling
Phase I Phase II Phase III Market Partner
Ma
rkete
d
va
cc
ine
s Japanese
Encephalitis
Cholera (ETEC1)
Cli
nic
al
ca
nd
ida
tes
Clostridium
difficile TBD
Lyme disease proprietary*
Ph
as
e I e
ntr
y
Chikungunya proprietary
Zika Emergent
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
January 2018 Valneva - Company Presentation 13
+ Pre-clinical testing completed
› Data showed that the vaccine has the potential to provide
protection against the majority of Borrelia species
pathogenic for humans5
+ FDA Fast Track Designation received
+ Phase I ongoing - subject enrolment completed
+ Phase I data expected to be reported in Q1/ 2018,
immediately followed by Phase II initiation6)
+ Phase II preparations and consultations process
initiated
+ Medical need for Lyme vaccine steadily increasing as
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/
Phase I trial ongoing in US & EU
Acceleration towards Phase II
+ Transmitted by Ixodes ticks2, causing Lyme
+ Most common vector borne illness in the Northern
Hemisphere (~400,000 cases in 2015 in US3 and at least
~200,000 cases per year in Europe4)
+ Delayed or inadequate treatment can lead to disabling
sequels
Lyme disease
+ Only active clinical program, no
vaccine on the market
+ Multivalent, protein subunit-
based vaccine
+ Targets the outer surface protein
A (OspA) of Borrelia (proven
mode of action)
Valneva’s vaccine candidate
VLA15: the only Lyme disease vaccine in clinical development
Market potential of approximately €700m - €800m1
VLA15 – Phase I Study
Observer-blind, partially randomized, dose escalation study
January 2018 Valneva - Company Presentation 14
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 M12;
Immunogenicity
TREATMENT
Visit 0 1 2 3 4 5 6 7 8
Day (Month) -14 0 7 28(1) 56(2) 84(3) 180(6) 236(8) 365 (12)
VLA15 90 µg w/o Alum
VLA15 90 µg w/ Alum
VLA15 48 µg w/o Alum
VLA15 48 µg w/ Alum
30 subjects
Estimated
Primary Endpoint
Safety
Interim Analysis
VLA15 12 µg w/ Alum
VLA15 12 µg w/o Alum
FOLLOW-UP SCREENING
30 subjects
30 subjects
30 subjects
30 subjects
30 subjects
Final Analysis
January 2018 Valneva - Company Presentation 15
+ Pre-clinical testing completed
› Data from non-human primates (NHP) have shown that
the vaccine has a good safety profile and the potential to
provide long term protection against Chikungunya after a
single immunization
+ Program under IND
+ Preparations for Phase I initiation completed
+ Phase I to evaluate safety and immunogenicity in
approx. 120 subjects and to confirm antibody
persistence (≥6m)
+ Primary target population are travelers to endemic
regions and military; public endemic market and
emergency stockpiling as secondary target populations
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.
Current development status VLA1553 (IND-enabling)
Phase I to be initiated in Q1 2018
+ Transmitted by Aedes mosquitoes, causing
Chikungunya disease
+ Outbreaks in Asia, Africa & Europe, most recently spread to the Americas (> 180,000 reported cases in 2016) 1
+ Disease outbreak with high attack rates, up to 50% of those infected experience prolonged or long term symptoms
Chikungunya virus (CHIKV)
+ Monovalent, single dose,
live attenuated virus
vaccine (∆5nsP3)2
+ Grown on Vero cells
+ Protective against various
CHIKV outbreak
phylogroups & strains3
Valneva’s vaccine candidate
VLA1553: Chikungunya vaccine
A potential single-shot vaccine against a spreading threat
+ Chikungunya virus is a Togaviridae virus, transmitted by Aedes mosquitoes
+ Outbreaks in Asia, Africa & Europe, most recently spread to the Americas (> 180,000 reported cases in 2016) 1
+ Disease outbreak with high attack rates, up to 50% of those infected experience prolonged symptoms or long term sequels
January 2018 Valneva - Company Presentation 16
+ Pre-clinical testing demonstrated excellent purity, in-vivo neutralization and overall a biological, chemical and physical profile comparable to IXIARO®
+ Phase I preparation ongoing
+ Co-development deal with Emergent BioSolutions including opt-in post Phase I (in exchange for a €5m opt-in milestone payment; potential additional milestones of up to €44m* and royalties on future sales)
+ Phase I to evaluate safety and immunogenicity. First
data expected in 2018
+ Priority for people traveling to or living in endemic
regions, including potential preparedness for
stockpiling
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
Current development status VLA1601 (PIV)
Phase I to be initiated in Q1 2018
Zika virus
+ Highly purified inactivated
vaccine (PIV)
+ Developed using Valneva’s
proven and licensed
inactivated JE vaccine
platform
Valneva’s vaccine candidate
VLA1601: Zika vaccine
Valneva & Emergent BioSolutions joining forces to accelerate development
+ Zika virus is a Flavivirus, transmitted by Aedes mosquitoes1
+ Most common symptoms are flu-like symptoms lasting between two to seven days. No specific treatment available
+ Scientific consensus that Zika virus causes microcephaly / severe brain defects in newborns / Guillain-Barré syndrom2 in adults
2017 Financial Outlook
Continued revenue growth and positive EBITDA
* Due to external R&D costs expected later in the year
Product sales
€97.9m Revenues
R&D expenditure
EBITDA
January 2018 Valneva - Company Presentation 17
€105 – 115m up to 17% growth vs.
2016
2016 Actual Growth 2017 Outlook
€24.6m €23 – 25m* –
IXIARO® €53.2m
DUKORAL® €24.7m
€58 – 62m
€27m
10 – 15%
c.10%
€2.8m €10 – 13m
x3.5 to x4.5
vs. 2016
Valneva 2018 – Exciting upcoming newsflow
January 2018 Valneva - Company Presentation 18
+ Further sales growth and increasing commercial margin
+ Lyme Phase I results at end of Q1 2018 followed by Phase II
+ Lyme R&D/Investor Day(s) in H1 2018
+ Chikungunya Phase I commencement in Q1 2018
+ Zika Phase I commencement in Q1 2018, data by year end
Appendices
+ Main Listing = Euronext (Paris)
+ Number of ordinary shares: 77.6m
+ Current Market cap: ~ €230m
+ ISIN: FR0004056851
+ Shareholder structure:
Free Float
Groupe Grimaud
Bpifrance Participations
SA
7.5%
1.5% Other
registered shareholders
0.9% Management & employees
15.6%
64.8% 9.6%
Valneva: A fully integrated vaccine company
Corporate profile
January 2018 Valneva - Company Presentation 20
+ Created in May 2013 through the merger of Vivalis
SA and Intercell AG;
› Incorporated in Lyon, France
+ Expanded business by acquiring a commercial
product (Dukoral) from Crucell/Janssen in
February 2015
+ Operations in:
› US & Canada (S&M)
› Vienna, Austria (R&D, SG&A, QA/QC)
› Nantes & Lyon, France (R&D, SG&A)
› Solna, Sweden (Manufacturing, S&M)
› Livingston & London, UK (Manufacturing, S&M)
+ Over 430 employees
› Manufacturing, Quality & Supply
› R&D
› SG&A
1 Funds managed by MVM Life Science Partners
Stock information
About Valneva
MVM1
Pre-commercial product: Clostridium difficile vaccine
Valneva - Company Presentation 21
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
Vaccine targeting healthcare-associated diarrhea, an increasing
threat to the elderly in a $1 billion market5
+ Single most common pathogen of acute healthcare-
associated infections in the US1 (~ 450,000 cases of
annually and ~ 30,000 deaths2)
+ ~ 172,000 cases in EU member states per year3
+ Targeting primary prevention of C. difficile
› Current antibiotic treatments have significant limitations
with recurrence in ~20% of cases4
Clostridium difficile (C. diff)
+ One of three late stage vaccine
candidates
+ Modern, recombinant single subunit- toxin antigen (CTAB) expressed in e.coli w/o adjuvants
+ Potential distinct competitive advantages on industrialization/future manufacturing
Valneva’s vaccine candidate VLA84
+ Phase II completed - Phase III ready
+ Highly immunogenic in all age groups tested (strong
immune responses to both C. diff toxins A & B)
+ Good safety and tolerability profile confirmed
+ Comparable immunological profile to other CDI clinical
programs targeting primary prevention of CDI
+ Potential partners hesitant about level of Phase III investment required and investment-risk proposition
+ VLA to use first CDI vaccine approval and consider “Head to Head“ non inferiority Ph III on immunological correlate
+ New approval expected to substantially improve investment-risk proposition for own or partnered development to market
Current development status VLA84
New development & partnering approach
January 2018
Strong nine months 2017 financial results
January 2018 Valneva - Company Presentation 22
Comparison to nine months 2016 (IFRS, € million, unaudited)
*Calculated by excluding nine-month 2017 amortization, depreciation and impairment of €12.1m from the nine-month 2017 operating profit of €0.2m
79.8 70.7
Nine Months 2017 Nine Months 2016
Total Revenues
Net profit/loss
COGS
Cash position
R&D Expenses
(15.1) (18.7)
Nine Months 2017 Nine Months 2016
43.8 42.2
30/09/2017 31/12/2016
(7.8)
(46.5)
Nine Months 2017 Nine Months 2016
(32.1) (30.0)
Nine Months 2017 Nine Months 2016
EBITDA*
12.3
3.5
Nine Months 2017 Nine Months 2016
Lyme disease
January 2018 Valneva - Company Presentation 23
Six strains account for over 95% of cases
Spread of Lyme across the US
January 2018 Valneva - Company Presentation 24
400,000 estimated cases in the US annually – CDC 2017
Source : Centers for Disease Control and Prevention
Lyme Borreliosis in Europe
January 2018 Valneva - Company Presentation 25
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.
Thank you
Merci
Danke
Tack