Slide 1: Financial Year 2015 Full Year Results
For personal use only Financial Year 2015 Full Year Results 17 August 2015
Slide 2: Cautionary Note Regarding 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 cannot be predicted or quantifi
Slide 3: Key Achievements in FY15
Key Achievements in FY15 For personal use only MPC-150-IM - Chronic Heart Failure (CHF) Recruiting well across North American sites Potential for early completion of the ongoing Phase 3 trial with FDA’s acceptance of demonstration of overwhelming efficacy Ambitious MPC-06-ID - Chronic Discogenic
Slide 4: Key Achievements in FY15 (2)
Key Achievements in FY15 (2) Phase 2 trial in diabetic kidney disease completed enrollment with For personal use only Portfolio Targeting results demonstrating preservation or improvement in renal Inflammatory function over at least 24 weeks Diseases - a Major Biologic refractory Rheumatoid Arth
Slide 5: Five Product Candidates in Active Phase Programs or Phase 3-ready
Five Product Candidates in Active Phase 3 Programs or Phase 3-ready For personal use only 5
Slide 6: MPC-150-IM: Phase 2 Trial Results in CHF Identifies Optimal Therapeutic Dose
MPC-150-IM: Phase 2 Trial Results in CHF Identifies Optimal Therapeutic Dose For personal use only P<0.05 P<0.05 Over 36 months: MPC-150-IM had significantly greater probability of remaining free of heart failure-related major adverse cardiovascular events (HF- MACE) vs. controls (0% vs. 33%, p =
Slide 7: MPC-150-IM: Phase 3 Trial Design Targets Patients with High Risk of HF-MACE
MPC-150-IM: Phase 3 Trial Design Targets Patients with High Risk of HF-MACE For personal use only MPC-150-IM reduces incidence and recurrent episodes of HF-MACE Objective is to treat those patients who are most likely to respond to MPC- 150-IM and who are at a high risk of recurrent HF-MACE En
Slide 8: MPC-150-IM: Potential for Early Completion of Ongoing Phase 3 Trial
MPC-150-IM: Potential for Early Completion of Ongoing Phase 3 Trial with FDA’s Acceptance of Demonstration of Overwhelming Efficacy For personal use only Key conclusions regarding the ongoing Phase 3 trial were: – There will be a reduction in the total number of subjects to be recruited for the on
Slide 9: Portfolio Targeting Inflammatory Diseases - a Major Emerging Opportunity
Portfolio Targeting Inflammatory Diseases - a Major Emerging Opportunity Mesenchymal Lineage Adult Stem Cells (MLCs*) have receptors that For personal use only respond to pro-inflammatory signals, inducing release of multiple anti inflammatory mediators MLCs thereby target multiple immune pathwa
Slide 10: MLCs for Treatment of Chronic Inflammatory Diseases
MLCs for Treatment of Chronic Inflammatory Diseases Inflammation-dependent induction in MPC and role in regulating the function For personal use only of both Th17 cells and macrophages IL-6 e.g., , IDO e.g., , IDO 10
Slide 11: MLCs for Treatment of Chronic Inflammatory Diseases
MLCs for Treatment of Chronic Inflammatory Diseases MPC-300-IV - Diabetic Kidney Disease For personal use only – Randomized, placebo controlled, dose-escalating study in 30 patients completed – Demonstrated preservation or improvement in renal function over at least 24 weeks relative to controls –
Slide 12: MPC-300-IV: Diabetic Kidney Disease Phase 2 Results – IL-6
MPC-300-IV: Diabetic Kidney Disease Phase 2 Results – Treatment Related Effects on the Inflammatory Marker IL-6 and Therapeutic Response in Patients with High Baseline IL-6 Levels MPC by Dose Group Pooled MPC For personal use only C h a n g e fr o m B a s e lin e a t W e e k 1 2 4 Median (IQR) at Ba
Slide 13: Scalable Manufacturing Capabilities: Partnership with Lonza
Scalable Manufacturing Capabilities: Partnership with Lonza For personal use only Manufacturing objectives Distinct manufacturing processes for each product Commercial scale processes with batch-to-batch consistency and reproducible release criteria Ensure commercial product supply is aligned
Slide 14: Update on Scalable Manufacturing Capabilities and Strategy
pdate on Scalable Manufacturing Capabilities and Strategy Significant Progress in Manufacturing For personal use only 1 2 3 4 5 Key stages in manufacturing and distribution Procure bone Create master Expand to Formulate, Distribute process marrow from cell banks therapeutic package and healthy, youn
Slide 15: FY15 Profit and Loss
FY15 Profit and Loss AUDm For personal use only As Reported Constant Currency (cc) 30 June 30 June Change % Change % 2015 2014 Revenue from Continuing Operations 23.7 26.0 (2.3) (9) (4.2) (16) Other Income 18.8 11.1 7.7 69 (5.2) (47) Expenses from Continuing Operations 161.9 118.1 (43.8) (37) (33.2)
Slide 16: FY15 $161.9m Expenses From Continuing Operations
FY15 $161.9m Expenses From Continuing Operations AUDm 5% For personal use only 7% 20% 15% 22% 48% 80% 85% 18% USD AUD/Other Cash Non Cash R&D Manufacturing Management & Admin Finance Costs Other • R&D expenditure has • Underlying USD • 15% Non cash content increased by 40% as we denominated content
Slide 17: FY15 Cash Flow and Cash Position
FY15 Cash Flow and Cash Position AUDm 30 June 2015 30 June 2014 For personal use only Cash on hand 144.1 196.4 Operating Cash Outflows (121.7) (81.9) Investing Cash Outflows (5.6) (40.8) Financing Cash Inflows 59.4 2.4 Net decrease in cash prior to Exchange Effects (67.9) (120.2) Exchange rate adjus
Slide 18: Outlook for the Next Months
Outlook for the Next 12 Months MPC-150-IM CHF For personal use only Ongoing Phase 3 clinical program continues to enroll Phase 3 trial interim analysis completed Phase 3 program broadened to include Europe and other jurisdictions MPC-06-ID CDLBP Ongoing Phase 3 clinical program continues to
Slide 19: Questions?
For personal use only Questions?