Slide 1: 2012 Half Year Results
For personal use only 2012 Half Year Results 27 February 2012
Slide 2: Forward looking statements
Forward looking statements For personal use only CAUTIONARY NOTE REGARDING FORWARD‐LOOKING STATEMENTS This presentation, including any comments made during or following the presentation, may contain forward‐looking statements that are inherently subject to risks and uncertainties, some of which cann
Slide 3: Financial review
Financial review For personal use only Brian Jamieson, Non‐Executive Chairman 3
Slide 4: Six month financials – key points
6 month financials – key points Cash: For personal use only – strong cash position ($241m) to support future product development Revenue: – includes ongoing allocation of upfront payment received from Teva – prior period includes “one off” accounting gain on acquisition of Angioblast Systems E
Slide 5: Six month financials (A$m)
6 month financials (A$m) For personal use only Half‐year Half‐year 2011 2010 Revenue from continuing operations 18.7 2.3 Other income 0.3 101.6 19.0 103.9 Research & development expense 22.8 3.6 Management & administration expense 13.8 5.7 Share of losses of equity accounted associate ‐ 1.5 36.6 10.
Slide 6: Business overview
Business overview For personal use only Silviu Itescu, Chief Executive 6
Slide 7: Building a successful biologics life sciences company by managing corporate risk
Building a successful biologics life sciences company by understanding and managing corporate risk For personal use only Proprietary platform technology delivers multi‐product pipeline – multiple shots on goal – not dependent on success of any one product – enables sequenced development to adjust
Slide 8: Our unique adult stem cells
Our unique adult stem cells For personal use only immunoselected, purified adult mesenchymal precursor cells – no ethical or safety issues associated with embryonic stem cells – robust global patent portfolio – Stro‐1 expression defines earliest, most potent precursor of mesenchymal lineage easy
Slide 9: Teva strategic alliance
Teva strategic alliance For personal use only Teva has exclusive worldwide commercialization rights to selected cardiovascular and neurologic indications, holds 19.9% stake in Mesoblast Teva responsible for funding Phase 2b and Phase 3 clinical development Mesoblast retains all manufacturing r
Slide 10: Lonza manufacturing alliance is central to profitability
Lonza manufacturing alliance is central to profitability For personal use only State‐of‐the‐art manufacturing plant via strategic alliance with Lonza Lonza will supply clinical and long‐term commercial MPC product needs globally Lonza to construct a purpose‐built manufacturing facility exclusive
Slide 11: Program Update
For personal use only 11 Program Update
Slide 12: "Off-the-shelf" product franchises driving value creation
“Off‐the‐shelf” product franchises driving value creation IND clearance FDA approval For personal use only Lead products Pre‐clinical Phase II Phase III Cardiovascular product Congestive heart failure Acute myocardial infarction Chronic refractory angina Neurologic products Stroke/Parkinson’s/MS Dia
Slide 13: Congestive heart failure – positive results presented at AHA 2011
Congestive heart failure – positive results presented at American Heart Association 2011 Annual Meeting For personal use only “In general, Phase 3 studies should use endpoints such as mortality and cardiovascular or heart failure hospitalizations, whereas endpoints, such as ejection fraction, that h
Slide 14: Intravenous product franchise
Intravenous product franchise For personal use only High value products using systemic administration Multiple applications: – Type 2 diabetes, and its complications (renal, liver, cardiac) – Lung diseases (e.g. inflammatory conditions, asthma) – Inflammatory joint diseases e.g. (rheumatoid arth
Slide 15: Allogeneic MPCs for treatment of type 2 diabetes
Allogeneic MPCs For Treatment Of Type 2 Diabetes For personal use only Postulated Mechanisms of Action ‐ anti‐inflammatory effects systemically (reduce CRP, IL‐1) ‐ pancreas as target (directly via homing or indirectly via secretion of factors) ‐ peripheral endocrine organs as targets (e.g. bones,
Slide 16: Human Stro-1+ MPC increase islet numbers and restore insulin production in mouse islets
Human Stro‐1+ MPC Increase Islet Numbers, Increase Glucose Sensing Beta Cells, and Restore insulin Production In Mouse islets Damaged by STZ 180 For personal use only islet density (H&E stained) 160 P=0.008 1.0 P=0.0012 140 Glut‐2+ cells/islet Islet numbers/mm2 120 0.8 100 0.6 80 0.4 60 40 0.2 20 0.
Slide 17: Allogeneic MPC in obese non-human primates with type 2 diabetes
Allogeneic MPC In Obese Non‐Human Primates With Type 2 Diabetes For personal use only Single Intravenous MPC Injection Causes Dose‐Dependent Glucose Reduction Over 3 Months 300 250 * * Fasting Blood Glucoe mg/dL 200 150 Pre‐Treatment Baseline Mean Fasting Glucose over 12 weeks post‐MPC treatment 100
Slide 18: Single IV dose maintains reduced glucose levels for 6 months in monkeys
A Single IV Dose of 0.3, 1, or 2 Million MPC/Kg Maintains Reduced Glucose Levels For 6 Months In Obese Cynomolgous Monkeys With Type 2 Diabetes For personal use only 20 Change in fasting glucose from baseline (mg/dL) 0 ‐20 * saline control ‐40 0.1 million MPC/kg 0.3,1,2 million MPC/kg ‐60 ‐80 ‐100 *
Slide 19: Single IV dose reduces glucose and CRP levels for 6 months
Single IV Dose [0.3, 1 or 2 million] MPC/kg Reduces Glucose, CRP Levels For 6 Months 10 Mean Change In Glucose Levels Over 6 Months 0 For personal use only Change in fasting blood glucose compared to baseline (mg/dL) ‐10 ‐20 ‐30 ‐40 ‐50 * 0.1 million MPC/kg vs saline controls: p=0.05 ‐60 * ** [0.3,1
Slide 20: Clinical program in type 2 diabetes
Clinical Program In Type 2 Diabetes For personal use only Non‐human primate data show sustained 6‐month durability of glucose lowering effect by single intravenous injection of allogeneic MPC at 0.3, 1 or 2 million MPC/kg; Accompanying sustained reductions in CRP levels suggest a potential cardi
Slide 21: Value inflexion points – near term
Value inflexion points – near term For personal use only Teva + Mesoblast to commence Phase 3 trial for congestive heart failure completion of Phase 2 spinal fusion trials completion of Phase 2 disc repair trial interim Phase 2 diabetes data expanding the intravenous product franchise, e.g
Slide 22: Leading the world in novel adult stem cell therapies
For personal use only Leading the world in novel adult stem cell therapies