Valneva a commercial stage biotech company focused on ... · + Global JE vaccines market valued at ~ ... 2015 FY 2016 2020 CAGR >15% US military, 40% US private, 20% Europe, ... (E

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


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


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


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


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


experience (Aventis, Amgen, Sanofi Pasteur)

UK


experience (Sanofi, AstraZeneca, Novartis)

IXIARO®/JESPECT®


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®


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®


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®


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


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


+ 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

http://www.plosone.org/article/info:doi/10.1371/journal.pone.0113294

https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/

























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 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



30 subjects

Estimated

Primary Endpoint

Safety

Interim Analysis



FOLLOW-UP SCREENING

30 subjects

30 subjects

30 subjects

30 subjects

30 subjects

Final Analysis


+ 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


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


+ 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


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

http://www.who.int/mediacentre/factsheets/zika/en/

http://www.who.int/mediacentre/factsheets/zika/en/

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


€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


+ 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


+ 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


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)


43.8 42.2

30/09/2017 31/12/2016

(7.8)

(46.5)


(32.1) (30.0)


EBITDA*

12.3

3.5


Lyme disease


Six strains account for over 95% of cases

Spread of Lyme across the US


400,000 estimated cases in the US annually – CDC 2017

Source : Centers for Disease Control and Prevention

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.

Thank you

Merci

Danke

Tack

Documents

Valneva a commercial stage biotech company focused on ... · + Global JE vaccines market valued at ~ ... 2015 FY 2016 2020 CAGR >15% US military, 40% US private, 20% Europe, ... (E