Medicago Investor Presentation - October 20, 2009

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Medicago Investor Presentation - October 20, 2009

  1. 1. Investor Presentation October 2009 Andy Sheldon President & CEO Pierre Labbé VP & CFO
  2. 2. 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. 2
  3. 3. Company overview Focus Influenza vaccines Non-transgenic tobacco plants & Technology VLPs Headquarters + GMP facility Quebec City, Canada Employees 60 Patents issued or pending 170+ Pandemic vaccine – Phase I Product pipeline Seasonal vaccine - Preclinical 3
  4. 4. 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 4
  5. 5. Medicago pandemic vaccine = first responder solution 10 months Cases 4 months Vaccine supply ply sup ne t- va plan e cin cci sed go ac dv ba dica p p se su g-ba ly Me Eg 0 1 2 3 4 5 6 7 8 9 10 Months Pandemic Pandemic first 5 strain identified wave begins
  6. 6. 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 6
  7. 7. Real-life scenario with influenza A (H1N1) Egg‐based technology Medicago technology April 24 : Identification of  Preparation of vaccine  genetic  strain sequence of A (H1N1) Optimization of virus  May 4: Genetic  growth conditions  material introduced  into plants Virus injected in eggs and incubated May 4‐8: Plants  incubated in greenhouse  Virus purified and  for vaccine production inactivated May 15: First  Vaccine filling and  purified vaccine lot release 7 7 months 14 days
  8. 8. Novel vaccine technology - Virus Like Particles (VLPs) Influenza Virus HA spikes Medicago purified VLP • Ability to produce influenza VLPs using genetic sequence of only one gene of the influenza virus (Hemagglutinin) • No genetic material (non-infectious) 8 • Cross-protection against different strains of influenza
  9. 9. Lead product: H5N1 VLP vaccine Immunogenicity study in key ferret model Criteria for licensure of influenza Medicago results vaccines * % 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 High level of antibodies after single dose of 5ug 9 *Criteria according to CHMP - European Committee for Medicinal Products for Human Use
  10. 10. Cross protection against different strains of influenza Type A Subtype H1, H2, H3, … or lineage Medicago’s vaccine is formulated with H5 H5 this strain Clade clade 1 clade 2 Viet-Nam H5 Subclade Indonesia clade 2.1 H5 Turkey clade 2.2 H5 10 clade 2.3
  11. 11. Lethal challenge study in ferrets with VietNam strain 100 80 % s u r v i v a l r a te 60 40 20 0 -2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 11 Day after challenge
  12. 12. Pandemic flu vaccine path to market Start multi-site Start Phase I Phase II IND submission Q3 09 Q4 09 Q1 10 Q2 10 Q3 10 Q4 10 2011 2012 2013 Potential commercialization 6-month Phase II Phase I safety data results results 12
  13. 13. International development strategy Genopole® (France) Agreement for commercial facility in France o 10 M € (capital) & 3 M € Provide countries (operations) worldwide with a rapid, o Subject to successful Phase I affordable and effective o Pandemic and seasonal manufacturing solution influenza vaccines within their borders Ajanta Pharma (India) Tabuk Pharma (Saudi) 13
  14. 14. Manufacturing made easier Medicago* $ 10 M CAPEX > $ 200 M 100 Staff 1000 4 weeks From strain to vaccine 6 months 20 m doses Capacity 55 m doses 12-18 months Time to double capacity 36-48 months Virtually Eggs supply Surge capacity limitation unlimited shortage 14 *expected figures when plant is optimized Egg-based
  15. 15. 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 PMI 46.4% Share ownership Avenir Luzerne (Credit Agricole) 5.3% Management & BOD 3.4% Cash position (Oct. 1, 09) 11 mos. 15
  16. 16. Philip Morris International Partnership Secure resources to complete first clinical phase in 2009 $15.975 M Medicago investment PMI brings expertise in relation to tobacco genetics, genomics, and cultivation Interested in exploring adjacent 46.4% ownership technologies PMI of MDG Synergies with current field of knowledge and R&D activities 16
  17. 17. Upcoming newsflow Pandemic vaccines International development - Phase I results - Additional developments &/or - 6-month safety data firm agreements - Start of Phase II Seasonal vaccine Corporate -Immunogenicity study in -Award of grant(s) mice -Financing activities to support Phase II 17
  18. 18. Management Mr. Andy Sheldon, 20 years managerial experience in the vaccine sector including President and CEO approval of new products and signing of pandemic plan Shire Biologics, Biochem Pharma, Institut Mérieux, Smithkline Beecham, Ayerst-Wyeth Dr. Louis-Philippe Vézina, 20 years experience in research in agronomy, molecular biology and protein production Laval University, Agriculture & AgriFood Chief Scientific Officer Canada Mr. Pierre Labbé, 20 years of financial experience in public and private companies: Chief Financial Officer Virginia Mines (TSX:VGQ), Sequoia Minerals Inc. and Mazarin Inc.(TSX-V:MAZ.H), Agrinove, and agrifood cooperative, Coopers & Lybrand Ms. Irene Clement, 27 years experience in the biotech industry at Sanofi-Pasteur, Shire Biologics, ID Biomedical, GSK; obtained & maintained Acting VP Regulatory Affairs several licenses (30 products in 70 countries) Ms. Nathalie Landry, 17 years of experience in the biotech industry. Previous VP Product Development experience in a biotech company holding various positions in R & D and product development. Ms. Brigitte Barbeau, 20 years experience in QA/QC in commercial production of VP Manufacturing influenza vaccines GSK Biologicals, ID Biomedical, Shire Biologics Mr. Frederic Ors, 11 years experience in biotech business development, IP VP Business Development management, and licensing in Europe and North America 18
  19. 19. Board of Directors Dr. Randal Chase, Former President, Shire Biologics, Aventis Pasteur Chairman of the Board Former Director of Acambis (London and NASDAQ) and BioJect (NASDAQ) Mr. Pierre Des Marais II, Former board member: Rothmans, Imperial Oil, RBC, Director Sleeman Breweries, CN Railways, Carling O’Keefe, Canadair and Air Canada Mr. Jonathan R. Goodman, President and Chief Executive Officer, Paladin Labs Inc. Director (TSX) Mr. Pierre Seccareccia, Corporate Director Former President PricewaterhouseCoopers, Montreal Director Mr. Pierre Marc Johnson, Lawyer, physician, former Premier of Quebec and former Director professor of law at McGill University. Sits on boards of ACE Aviation Holdings Corporation, Air Canada and Holcim Canada Mr. Andy Sheldon, CEO – Medicago Inc Director Former VP Sale & Marketing Shire Biologics (NASDAQ) Dr. Louis-Philippe Vézina, CSO - Medicago Inc. Director 19
  20. 20. 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 20
  21. 21. Additional information
  22. 22. 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 22
  23. 23. Pandemic Influenza vaccine industry Lowest dose to achieve CHMP criteria Adjv. In ferrets In humans Vaccine Company type 1st dose 2nd dose 1st dose 2nd dose 7.5 µg (2/3 • 3.8 µg criteria) 3.8 µg • Cross-react. 3.8 µg GSK Split Yes NONE protected vs (1/3 criteria) heterol. challenge • 1.9 µg Yes NA NA NONE • Cross-react. SANOFI Split • None except 45 µg in No NA NA NONE children • 7.5 µg (2/3 criteria) NOVARTIS Subunit Yes NA NA NA Rec. • 90 µg did not met PSC No NA NA NA protein 1/40 criteria VLP • 45 µg met at least NOVAVAX HA+NA+ No NONE 15 µg NA 2/3 criteria. Phase M1 I/IIa = 15, 45, 90 µg • 1-5 µg + AlOH MEDICAGO VLP HA Yes 5 µg 1 µg 5 µg + AlOH • Higher doses - AlOH 23 (1) One whole inactivated vaccine from St-Jude provided HI titer after 1st dose in ferrets NA; Data not available

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