Post on 29-Jul-2015
Investor PresentationAugust 2009
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Forward-Looking Statements
• All statements, other than statements of historical facts, included in this presentation regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words “believe”, “anticipate”, “estimate”, “plan”, “expect”, “intend”, “may”, “project”, “will”, “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated or implied by forward-looking statements, including the factors discussed under “Risk Factors” and in other sections of the prospectus. These factors and the other cautionary statements made in the prospectus should be read as being applicable to all related forward-looking statements wherever they appear in this presentation.
• Our statements of “belief” in respect of our product and partner product candidates are based primarily upon our results derived to date from our research and development program. We believe that we have a reasonable scientific basis upon which we have made such statements. It is not possible, however, to predict, based upon studies in vitro and animal studies whether a new therapeutic agent or technology will be proved to be safe and/or effective in humans. We cannot assure that the particular results expected by us will occur.
• Any forward-looking statements and statements of “belief” represent our estimates only as of the date of the prospectus and should not be relied upon as representing our estimates as of any subsequent date. Except as required by law, we do not assume any obligation to update any forward looking statements or statements of “belief”. We disclaim any intention or obligation to update or revise any forward-looking statements or statements of “belief”, whether as a result of new information, future events or otherwise.
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Medicago at a glance
Focus Influenza vaccines
Headquarters + cGMP facility Quebec City, QC
Employees 60
Patents (issued or pending) +170
Stock listing TSX-V : MDG
Recent price (August 4, 09) $0.46
Shares outstanding 93 M
Market cap (approx.) $41 M
Cash position (August 1, 09) 12 mos.
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Vaccines: an attractive market segment
$21 billion2008 world vaccine
market
13% growth over 2006
New cost-effective manufacturing platforms (plants, insect cells)
High probability of R&D success
High profit margins
Heightened awareness of value of effective vaccination
Increased government funding
Source: Datamonitor, Kalorama
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1918
1956
Spanish Flu
Asian Flu
Influenza: a constant threat
1968
Hong Kong Flu
H5N1
Today ?
Swine flu (H1N1)
3 pandemics every century…
25,000,000 deaths
70,000deaths
34,000 deaths
+250 deaths since 2003
+450deaths to date
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Pandemic Influenza vaccine supply challenges
• Current technologies not fast enough to be ahead of pandemic wave• 4-6 months before first dose available• 2-dose products may delay protection until pandemic wave has passed
• Limited number of facilities worldwide• Mainly US, Canada, UK, Germany, France & Italy (4 manufacturers)• Borders will likely close• 8-12 months before vaccine available for developing world
• Current approved vaccines require 2 doses to provide protection
• Stockpiled vaccines might not be formulated with correct pandemic strain
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“Early attempts at pandemic vaccine manufacture are so far producing two to four times less antigen than seasonal flu strains, raising the threat that the world’s production capacity is actually much less than hoped”(Nature News, July 21, 2009)
“FDA Officials said today that vaccine makers are only getting ~30% as much vaccine from H1N1 strains than they normally do when developing the seasonal flu vaccine” (FierceVaccines, July 23, 2009)
“GlaxoSmithKline says that it should be able to supply governments with what they need by early 2010” (FierceVaccines, July 23, 2009)
“The WHO has unofficially estimated that the world's labs may only be able to produce around 900 million doses for the A(H1N1) strain per year, for a planet that is home to 6.8 billion people. And there are already signs that the wealthiest countries will snap up more than their fair share in the rush to halt the outbreak, while Africa, Asia and Latin American will struggle to secure adequate amounts of vaccine.” (AFP, July 27, 2009)
“Only newer technologies, such as but not limited to virus-like particles, have the potential to produce tens of millions of dosages rapidly”(John M. Barry, White Paper on Novel H1N1, Massachusetts Institute of Technology, July 2009)
Current pandemic influenza challenges
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Med
icag
o pl
ant-
base
dva
ccin
e su
pply
4 months
Medicago pandemic vaccine = First responder solution
0 1 2 3 4 5 6 7 8 9
Pandemicstrain identified
Pandemic first wave begins
Months
Vaccine supplyCases
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Egg-
base
dva
ccin
e
supp
ly
10 months
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Real-life scenario with influenza A (H1N1)
Medicago technologyEgg‐based technology
14 days7 months
Preparation of vaccine strain
Virus injected in eggsand incubated
Optimization of virus growth conditions
Vaccine filling and release
Virus purified and inactivated
April 24 : Identification of genetic sequence of A (H1N1)
May 8: Genetic material introduced into plants
May 8‐12: Plants incubated in greenhouse for vaccine production
May 15: First purified vaccine lot
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Manufacturing platform – ProficiaTM
Fast, inexpensive and easily scalable• From plants to vaccines in 5 days• Start production of any new
pandemic vaccine in 1 month• Substrate easy to supply (plants in
greenhouses)• Simple process and manufacturing
facilities
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Vaccine Technology -VLP: Virus Like Particles
• Ability to produce influenza virus-like particles in plants using only one gene of the influenza virus (Hemagglutinin)
• Particles resemble influenza virus but with no genetic material (non-infectious)
Influenza Virus
Medicago purified VLP
HA spikes
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Medicago strategy
Clinical development of pandemic and seasonal Influenza vaccines • Initiate Phase I (pandemic candidate)• Leverage clinical results of pandemic to accelerate development
of seasonal candidate• Execute agreements with target countries to enable domestic
vaccine production infrastructure
Explore other VLP opportunities outside of influenza
• VLPExpress: high throughput platform that will accelerate discovery and development
– leverages technology platform to address multiple applications• Value added development and manufacturing for selected
partners in vaccines, biofuels, biodefense, antibodies
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AType
H1, H2, H3, …Subtypeor lineage
H5 clade 2Clade H5
clade 1
Subclade H5 clade 2.1
H5 clade 2.2
H5 clade 2.3
Viet-Nam
Turkey
Indonesia
Lead product: H5N1 VLP vaccine
Cross protection against different strains of influenza
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Lethal challenge study in ferrets with Viet Nam strain
Lead product: H5N1 VLP vaccine
0
20
40
60
80
100
-2 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Day after challenge
%su
rviv
alra
te
15
Days CHMP CriteriasStudy group
5 µg
14(post
1st inj.)
% 4-fold increase in HI titer >40% 100%
Mean geometric increase 2.5 15.6
% of HI titer of 1/40 70% 100%
Mean HI titer 78
* European Committee for Medicinal Products for Human Use (CHMP) criteria for licensure of influenza vaccines
High level of antibodies after single dose of 5ug in key ferret model
Immunogenicity study in ferrets
Lead product: H5N1 VLP vaccine
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2009 Milestones
Pandemic vaccine
H1N1 results from immunogenicity study in mice
Completion of preclinical studies
Submission of Medicago’s First CTA & Start Phase I with H5N1 Q3 09
Phase I results Q4 09
Seasonal vaccine
Immunogenicity study in mice Q4 09
International development
Pandemic vaccine production facility agreement with first country
Production facility agreement with Middle Eastern country 2009
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Philip Morris International Partnership
Medicago $15.975 M investment
Secure resources to initiate clinical development in 2009
PMI brings expertise in relation to tobacco genetics, genomics, and cultivation
PMI 49.8% ownership of MDG
Interested in exploring adjacent technologies
Synergies with current field of knowledge and R&D activities
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ManagementMr. Andy Sheldon, President and CEO
20 years managerial experience in the vaccine sector including approval of new products and signing of pandemic plan Shire Biologics, Biochem Pharma, Institut Mérieux, SmithklineBeecham, Ayerst-Wyeth
Dr. Louis-Philippe Vézina,Chief Scientific Officer
20 years experience in research in agronomy, molecular biology and protein production Laval University, Agriculture & AgriFoodCanada
Mr. Pierre Labbé,Chief Financial Officer
20 years of financial experience in public and private companies: Virginia Mines (TSX:VGQ), Sequoia Minerals Inc. and Mazarin Inc.(TSX-V:MAZ.H), Agrinove, and agrifood cooperative, Coopers & Lybrand
Ms. Irene Clement,Acting VP Regulatory Affairs
27 years experience in the biotech industry at Sanofi-Pasteur, Shire Biologics, ID Biomedical, GSK; obtained & maintained several licenses (30 products in 70 countries)
Ms. Nathalie Landry,VP Product Development
17 years of experience in the biotech industry. Previous experience in a biotech company holding various positions in R & D and product development.
Ms. Brigitte Barbeau,VP Manufacturing
20 years experience in QA/QC in commercial production of influenza vaccines GSK Biologicals, ID Biomedical, Shire Biologics
Mr. Frederic Ors,VP Business Development
11 years experience in biotech business development, IP management, and licensing in Europe and North America
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Board of Directors
Dr. Randal Chase, Chairman of the Board
Former President, Shire Biologics, Aventis PasteurFormer Director of Acambis (London and NASDAQ) and BioJect (NASDAQ)
Mr. Pierre Des Marais II,Director
Former board member: Rothmans, Imperial Oil, RBC, Sleeman Breweries, CN Railways, Carling O’Keefe, Canadair and Air Canada
Mr. Jonathan R. Goodman,Director
President and Chief Executive Officer, Paladin Labs Inc. (TSX)
Mr. Pierre Seccareccia,Director
Corporate DirectorFormer President PricewaterhouseCoopers, Montreal
Mr. Damien Levesque,Director
Director Avenir Luzerne
Mr. Andy Sheldon,Director
CEO – Medicago IncFormer VP Sale & Marketing Shire Biologics (NASDAQ)
Dr. Louis-Philippe Vézina,Director
CSO - Medicago Inc.