Mesoblast Limited · ASX:MSB
Mesoblast — H1 FY2016 Earnings Presentation
18 slides from Mesoblast's earnings presentation, Feb 17, 2016
Slide 1: Financial Results for the First Half and Second Quarter Ended 31 December 2015
For personal use only Financial Results for the First Half And Second Quarter Ended 31 December 2015 February 2016
Slide 2: Cautionary Note Regarding Forward-Looking Statements
For personal use only CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, le
Slide 3: Agenda
Agenda For personal use only FINANCIAL RESULTS OVERVIEW REVIEW OF OPERATIONS OUR FOCUS, OUR COMMITMENT 3
Slide 4: Financial Results Overview
Agenda For personal use only FINANCIAL RESULTS OVERVIEW 4
Slide 5: Financial Highlights for the Six Months Ended December 15
Financial Highlights for the Six Months Ended 31 December 2015 US$m For personal use only • Cash on hand at 31 December 2015 - $120.8 million • Q2 FY2016 Cash outflow ($19.8) reduced by >25% in comparison to Q1 FY2016 ($28.1) and Q4 FY2015 ($27.3) • For the six months ended 31 December 2015, loss be
Slide 6: Profit and Loss - Expenditure Reduced Over Prior Period
Profit and Loss - Expenditure Reduced Over Prior Period US$m For personal use only 6 months 6 months ending ending $ Change % 31 Dec 2015 31 Dec 2014 Revenue 11.5 11.3 0.2 2% Loss Before Income Tax (35.5) (43.4) 7.9 18% Revenue increased by 2% ($0.2) vs comparative period in FY15: • Milestone revenu
Slide 7: Cash Management
Cash Management US$m Q2 Q1 Q4 For personal use only FY2016 FY2016 FY2015 3 months 3 months 3 months ended ended ended 31 Dec 2015 30 Sep 2015 30 Jun 2015 Net Cash Outflows in Operating Activities (19.8) (28.1) (27.3) Cash at the end of the period 120.8 77.8 110.7 Strengthened cash position • US IPO
Slide 8: Review of Operations
Agenda For personal use only REVIEW OF OPERATIONS 8
Slide 9: Operational highlights for the six months ended December 2015
Operational highlights for the six months ended 31 December 2015 • Recruitment of all three Tier 1 Phase 3 Clinical trials progressing well in the US, including MPC-150-IM for Chronic For personal use only Heart Failure (CHF), MPC-06-ID for Chronic Low Back Pain (CLBP), and MSC-100-IV for Acute Graf
Slide 10: Product Candidates in Major Markets with High Unmet Need
Product Candidates in Major Markets with High Unmet Need First Product on market - Three Tier 1 Product Candidates in Phase 3 Programs For personal use only Update 10
Slide 11: MPC-150-IM: Phase 3 Trial Recruiting Well and Targets Advanced Heart Failure
MPC-150-IM: Phase 3 Trial Recruiting Well and Targets Advanced Heart Failure where Medical Need is Greatest For personal use only Patients with large baseline Left Ventricular End Systolic Volumes (LVESV) and advanced heart failure are at highest risk of recurrent Heart Failure - Related Major Adv
Slide 12: MPC-150-IM: Phase 3 Heart Failure Program Trial Size Reduced
MPC-150-IM: Phase 3 Heart Failure Program Trial Size Reduced For personal use only Following our commercial partner’s discussions with FDA, the ongoing Phase 3 program in patients with advanced heart failure, and a high risk of recurrent HF-MACE, is planned to be optimized as follows: Revised prim
Slide 13: MPC-300-IV: Biologic Refractory Rheumatoid Arthritis – Market Opportunity
MPC-300-IV: Biologic Refractory Rheumatoid Arthritis (RA) – 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 There are 5.3 million prevalent cases in
Slide 14: MPC-300-IV: Biologic Refractory Rheumatoid Arthritis Trial Design
MPC-300-IV: Biologic Refractory Rheumatoid Arthritis (RA) Trial Design For personal use only Double-blind, randomized, placebo-controlled, two-dose escalating trial in the US Designed to evaluate safety and explore efficacy of MPC treatment in 48 patients with active RA randomized 2:1 to either
Slide 15: MPC-300-IV: Rheumatoid Arthritis First Cohort Results
MPC-300-IV: Biologic Refractory Rheumatoid Arthritis (RA) - First Cohort Results For personal use only Cell infusions were well tolerated with no cell-related adverse events The trial’s 12 week, pre-specified ACR20 efficacy endpoint was achieved by 47% of all MPC-treated patients and by 60% of M
Slide 16: Our Focus, Our Commitment
Agenda For personal use only OUR FOCUS, OUR COMMITMENT 16
Slide 17: Product Candidate Deliverables (Calendar Year)
Tier 1 Product Candidate Deliverables (Calendar Year) 2016 2017 For personal use only Product Candidate Programs Anticipated Milestones Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Temcell® HS Inj. Launch in Japan US Pediatric Phase 3 Interim Analysis (IA) Top Line Results MSC-100-IV / Acute Graft Versus Host Phase 3 pr
Slide 18: Corporate Deliverables
Corporate Deliverables For personal use only First royalties from TEMCELL product sales in Japan expected in Q1 CY 2016 Complete Tier 1 Phase 3 programs on schedule Deliver commercial manufacturing in support of product candidate launches Deliver on commercial partnerships Continued focus