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Investor PresentationOctober 2009
Andy SheldonPresident & CEO
Pierre LabbéVP & CFO
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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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Company overview
Focus Influenza vaccines
TechnologyNon-transgenic tobacco plants &
VLPs
Headquarters + GMP facility Quebec City, Canada
Employees 60
Patents issued or pending 170+
Product pipelinePandemic vaccine – Phase I
Seasonal vaccine - Preclinical
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Pandemic influenza vaccine supply challenges
Speed :― Current technologies not fast enough to be ahead of pandemic wave― Up to 7 months before first dose available― 2-dose egg-based products may delay protection until pandemic wave
has passed
Capacity : ― Non-availability of vaccines for 90% of world population― 8-12 months before vaccine available for developing world Limited
number of facilities worldwide: US, Canada, UK, Germany, France & Italy (4 manufacturers)
Yield: ― Virus might not grow well in current manufacturing settings― Swine flu yielding 25-50% less than current products
Efficacy:― Stockpiled vaccines might not match correct pandemic strain ― Current approved vaccines do not provide cross-protection
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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
10
Egg-
base
dva
ccin
e
supp
ly
10 months
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A rapid manufacturing platform for proteins and vaccines
• From plants to vaccines in 5 days
• Start commercial production of any new vaccine in less than 4 weeks
• Substrate easy to supply (plants in greenhouses)
• Scale-up only requires additional greenhouse space
• Potential to produce biosimilars, enzymes for biofuels, biodefense products and antibodies
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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 4: Genetic material introduced into plants
May 4‐8: Plants incubated in greenhouse for vaccine production
May 15: First purified vaccine lot
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Novel vaccine technology - Virus Like Particles (VLPs)
• Ability to produce influenza VLPs using genetic sequence of only one gene of the influenza virus (Hemagglutinin)
• No genetic material (non-infectious)• Cross-protection against different strains of influenza
Influenza Virus
Medicago purified VLP
HA spikes
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Criteria for licensure of influenza vaccines *
Medicago results
% 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
*Criteria according to CHMP - European Committee for Medicinal Products for Human Use
High level of antibodies after single dose of 5ug
Lead product: H5N1 VLP vaccine
Immunogenicity study in key ferret model
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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
Cross protection against different strains of influenza
Medicago’s vaccine is
formulated with this strain
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Lethal challenge study in ferrets with VietNam strain
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
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Pandemic flu vaccine path to market
Q3 09 Q1 10 Q2 10 2011Q4 09
Start Phase I
Phase I results
Start multi-site Phase II
Phase II results
Q3 10 Q4 10 2012
IND submission
Potential commercialization
6-month safety data
2013
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International development strategy
Provide countries worldwide with a rapid, affordable and effective manufacturing solution within their borders
Genopole® (France) Agreement for commercial facility in France
o 10 M € (capital) & 3 M €(operations)
o Subject to successful Phase I o Pandemic and seasonal
influenza vaccines
Ajanta Pharma (India)
Tabuk Pharma (Saudi)
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CAPEX$ 10 M > $ 200 M
Staff100 1000
From strain to vaccine 6 months4 weeks
Capacity20 m doses 55 m doses
Time to double capacity12-18 months 36-48 months
Surge capacity limitationVirtually unlimited
Eggs supply shortage
Medicago*
Egg-based*expected figures when plant is optimized
Manufacturing made easier
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Financial summary
Public since August 2006
Stock listing TSX-V : MDG
Recent price (Oct. 19, 09) $0.63
52 week hi-low $0.82 -$0.15
Shares outstanding (b/fd) 97 M / 157 M
Market cap (approx.) $61 M
Average daily volume (last 6 months) 700,000 shares
Share ownershipPMI 46.4%
Avenir Luzerne (Credit Agricole) 5.3%Management & BOD 3.4%
Cash position (Oct. 1, 09) 11 mos.
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Philip Morris International Partnership
Medicago $15.975 M investment
Secure resources to complete first clinical phase in 2009
PMI brings expertise in relation to tobacco genetics, genomics, and cultivation
PMI 46.4% ownership of MDG
Interested in exploring adjacent technologies
Synergies with current field of knowledge and R&D activities
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Upcoming newsflow
Pandemic vaccines International development
- Phase I results
- 6-month safety data
- Start of Phase II
- Additional developments &/or firm agreements
Seasonal vaccine Corporate
-Immunogenicity study in mice
-Award of grant(s)
-Financing activities to support Phase II
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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, Smithkline Beecham, Ayerst-Wyeth
Dr. Louis-Philippe Vézina,Chief Scientific Officer
20 years experience in research in agronomy, molecular biology and protein production Laval University, Agriculture & AgriFood Canada
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. Pierre Marc Johnson,Director
Lawyer, physician, former Premier of Quebec and former professor of law at McGill University. Sits on boards of ACE Aviation Holdings Corporation, Air Canada and HolcimCanada
Mr. Andy Sheldon,Director
CEO – Medicago IncFormer VP Sale & Marketing Shire Biologics (NASDAQ)
Dr. Louis-Philippe Vézina,Director
CSO - Medicago Inc.
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Summary of Medicago’s advantages
• Fast, inexpensive and easily scalable manufacturing solution
• Lower dosage and cross-protection
• Successful international development strategy with near-term commercial opportunities
• Highly credible partner
• 170+ patents filed &/or pending
Additional information
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Phase I overview
• Dose-escalating study to evaluate safety, tolerability and immune response
• 48 subjects - age 18-60
• Evaluating doses of 5, 10 and 20 micrograms
• Two doses, injected 21 days apart
• Location - Vaccine Evaluation Center of McGill University in Montreal, Canada, under the supervision of Dr. Brian Ward
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Lowest dose to achieve CHMP criteria
In ferrets In humansCompany Vaccine
typeAdjv.
1st dose 2nd dose 1st dose 2nd dose
GSK Split Yes NONE
7.5 µg (2/3 criteria) 3.8 µg protected vsheterol. challenge
3.8 µg (1/3 criteria)
• 3.8 µg• Cross-react.
Yes NA NA NONE• 1.9 µg• Cross-react.
SANOFI Split
No NA NA NONE• None except 45 µg in children
NOVARTIS Subunit Yes NA NA NA• 7.5 µg (2/3 criteria)
PSCRec. protein
No NA NA NA• 90 µg did not met 1/40 criteria
NOVAVAXVLP HA+NA+M1
No NONE 15 µg NA• 45 µg met at least 2/3 criteria. Phase I/IIa = 15, 45, 90 µg
MEDICAGO VLP HA Yes 5 µg 1 µg 5 µg + AlOH• 1-5 µg + AlOH• Higher doses - AlOH
(1) One whole inactivated vaccine from St-Jude provided HI titer after 1st dose in ferrets NA; Data not available
Pandemic Influenza vaccine industry