Mesoblast Limited · ASX:MSB
Mesoblast — H1 FY2015 Earnings Presentation
27 slides from Mesoblast's earnings presentation, Feb 12, 2015
Slide 1: Half Year 2015 Financial Results
For personal use only Half Year 2015 Financial Results February 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: Our Competitive Strengths
Our Competitive Strengths For personal use only 1 Disruptive platform based on allogeneic, “off-the-shelf” adult stem cells 2 Five product candidates that are in active Phase 3 programs or are Phase 3-ready 3 Substantial intellectual property covering products, uses, and manufacturing 4 Scalable man
Slide 4: Disruptive Technology Platform
Disruptive Technology Platform For personal use only Mesenchymal Lineage Adult Stem Cell (MLCs) technology platform – Highly purified, immunoselected Stro-1/Stro-3 positive Mesenchymal Precursor Cells (MPCs), earliest precursors – Culture-expanded Mesenchymal Stem Cells (MSCs), progeny of earliest
Slide 5: MLC Product Development Strategy
MLC Product Development Strategy For personal use only Multiple mechanisms of action may Proprietary manufacturing processes facilitate therapeutic effects in diseases utilized to create distinct product with high unmet needs candidates with specific technical attributes Independent, Delineated Prod
Slide 6: Focus on Bringing Late Stage Product Candidates to Market
Focus on Bringing Late Stage Product Candidates to Market For personal use only Products with mid term revenue opportunity MPC-150-IM: Congestive Heart Failure (CHF) MPC-06-ID: Chronic Discogenic Low Back Pain (CDLBP) MSC-100-IV: GVHD Robust Development Portfolio E.g. MPC-300-IV: Biologic Re
Slide 7: Broad Portfolio – Five Product Candidates in Phase 3 or Phase 3 Ready
Broad Portfolio – Five Product Candidates in Phase 3 or Phase 3 Ready For personal use only This chart is figurative and does not purport to show individual trial progress within a clinical program. For product registration purposes, Phase 3 programs may require more than one trial. 6
Slide 8: First half FY15 highlights – Focus on Key Product Candidates and Manufacturing
First half FY15 highlights – Focus on Key Product Candidates and Manufacturing • Phase 3 trial in advanced CHF patients, with expected higher HF-MACE event rates, is For personal use only MPC-150-IM recruiting well across North American sites Congestive Heart Failure • Phase 3 CHF trial enriched wit
Slide 9: Cash Position AUDm
Cash Position AUDm Half Year For personal use only Cash Reserves 31 Dec 2014 30 June 2014 Movement Cash and Cash equivalents 149.2 196.4 (47.2) Cash Flows 31 Dec 2014 30 June 2014 Change Net Cash outflows 58.3 67.6 (9.3) Extract of items in Net Cash outflows (above): Cash outflows from operating act
Slide 10: Financial Results AUDm
Financial Results AUDm 31 Dec 14 31 Dec 13 Change % For personal use only Revenue from Continuing Operations 12.9 13.9 (1.0) (7%) Commercialization revenue 10.8 8.2 2.6 32% Interest revenue 2.1 5.7 (3.6) (63%) Other Income 12.9 6.9 6.0 87% Research & development tax incentive 3.5 5.8 (2.3) (40%) Fo
Slide 11: MPC-150-IM: Congestive Heart Failure (CHF) – Market Opportunity
MPC-150-IM: Congestive Heart Failure (CHF) – Market Opportunity For personal use only MPC-150-IM is in development for patients with New York Heart Association (NYHA) Class II to IV congestive heart failure Market opportunity Gap in treatment options Targeted physician population 5.1 million peopl
Slide 12: 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 At 6 months post treatment, there was a dose dependent effect on left ventricular remodeling, For personal use only with the 150 million cell dose (MPC-150-IM) showing the greatest effect compared to controls Over 36 mo
Slide 13: MPC-150-IM: Optimizing the Phase 3 Target Population for High Risk HF-MACE
MPC-150-IM: Optimizing the Phase 3 Target Population for High Risk HF-MACE Patients with more advanced NYHA Class II/III CHF continue to represent the greatest For personal use only unmet medical need due to highest risk of HF-MACE We believe MPC-150-IM will show the greatest benefit in patients
Slide 14: 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 The Phase 3 CHF trial is recruiting well across multiple North American sites For personal use only Double-blinded, 1:1 randomized, sham-procedure-controlled, in approximately 1,730 patients, evaluating a single dose of
Slide 15: MPC-06-ID: Chronic Discogenic Low Back Pain (CDLBP) – Market Opportunity
MPC-06-ID: Chronic Discogenic Low Back Pain (CDLBP) – Market Opportunity MPC-06-ID is in development for the treatment of chronic discogenic low back pain (CDLBP) lasting >6 months For personal use only as a result of moderate degenerative intervertebral disc disease Market opportunity Gap in treatm
Slide 16: MPC-06-ID: Phase 2 Trial Results Support Progress into Phase 3
MPC-06-ID: Phase 2 Trial Results Support Progress into Phase 3 Phase 2 Trial Design For personal use only – Randomised, blinded, placebo-controlled, multi-centre trial in 100 patients – Evaluated intra-discal injection of two separate doses: 6 million MPCs (MPC-06-ID), and 18 million MPCs (both admi
Slide 17: MPC-06-ID: CDLBP – Composite Endpoint for Phase 3
MPC-06-ID: CDLBP – Composite Endpoint for Phase 3 Treatment options for CDLBP must address both decreased pain and improved function, defined For personal use only as a Minimal Clinically Important Difference (MCID) in both pain (VAS) and function (ODI) A responder is defined by both regulatory
Slide 18: MSC-100-IV: Graft vs Host Disease (GVHD) – Market Opportunity
MSC-100-IV: Graft vs Host Disease (GVHD) – Market Opportunity MSC-100-IV is in development for pediatric and adults with acute GVHD following allogeneic For personal use only hematopoietic stem cell transplant (HSCT) who have failed to respond to steroid treatment Market opportunity No approved trea
Slide 19: MSC-100-IV: Evidence of Efficacy in GVHD
MSC-100-IV: Evidence of Efficacy in GVHD For personal use only Pediatric Patients 1 Adult Patients 2 - Expanded Access Program in US has treated in excess of 200 - In a randomized, placebo-controlled Phase 3 trial, MSC-100- patients IV significantly improved overall responses in the adult subset - I
Slide 20: MSC-100-IV/JR-031: Product Launch Plans in GVHD
MSC-100-IV/JR-031 : Product Launch Plans in GVHD Japan For personal use only JCR Pharmaceuticals Co Ltd., our GVHD partner in Japan, filed for regulatory approval for JR-031 in Japan in September 2014 and was granted orphan drug priority review North America Canada – Manufacturing and Commercial
Slide 21: MPC-300-IV for Treatment of Chronic Inflammatory Diseases
MPC-300-IV for Treatment of Chronic Inflammatory Diseases For personal use only eg , IDO eg , IDO 20
Slide 22: MPC-300-IV: Biologic Refractory Rheumatoid Arthritis – Market Opportunity
MPC-300-IV: Biologic Refractory Rheumatoid Arthritis– Market Opportunity Ongoing randomized, controlled Phase 2 Trial in 48 patients with biologic refractory rheumatoid For personal use only arthritis, comparing two doses of MPC-300-IV against placebo Market opportunity Gap in treatment options Targ
Slide 23: MPC-300-IV: Diabetic Kidney Disease – Market Opportunity
MPC-300-10-IV: Diabetic Kidney Disease – Market Opportunity Targeted physician population For personal use only Market opportunity Gap in treatment options 40-50% of all diabetes patients (19 Standard of care (SOC) Renin Patients with Stages 3B-4 are million in 2013 in US) develop renal Angiot
Slide 24: MPC-300-IV for Treatment of Chronic Inflammatory Diseases
MPC-300-IV for Treatment of Chronic Inflammatory Diseases For personal use only Three Phase 2 clinical trials, 138 patients, three chronic inflammatory conditions Type 2 Diabetes with inadequately controlled glucose, 60 patients – Completed – Randomized, placebo controlled dose-escalating study co
Slide 25: Scalable Manufacturing Capabilities: Objectives and Update on Development
Scalable Manufacturing Capabilities: Objectives and Update on Development Manufacturing objectives For personal use only Distinct Update manufacturing on Scalable processes for each Manufacturing product and Strategy Capabilities Commercial scale processes with batch-to-batch consistency and rep
Slide 26: Significant Upcoming Milestones by Calendar Year
Significant Upcoming Milestones by Calendar Year Product Candidate Programs Anticipated Milestones 2015 2016 2017 2018 For personal use only Phase 3 enrollment for first interim analysis (IA) complete 2Q 2015 Class II and III Phase 3 first IA results 1Q 2016 Congestive Heart Failure Phase 3 second i
Slide 27: Questions / Thank you
For personal use only Questions / Thank you 26