Mesoblast Limited · ASX:MSB
Mesoblast — Q1 FY2017 Earnings Presentation
27 slides from Mesoblast's earnings presentation, Nov 15, 2016
Slide 1: Financial Results for the First Quarter Ended September 30, 2016
For personal use only Financial Results for the First Quarter Ended September 30, 2016 November 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 OPERATIONAL UPDATE TIMELINES 3
Slide 4: Agenda: Financial Results
Agenda For personal use only FINANCIAL RESULTS 4
Slide 5: Q1 FY Financial Highlights
Q1 FY 17 Financial Highlights US$m For personal use only At September 30, 2016, the Company had cash reserves of $60.4 million As previously announced, a fully discretionary equity facility has been established for up to $A120 million/$US90 million over 36 months In order to absorb the increme
Slide 6: Operational Streamlining and Re-Prioritization of Assets
Operational Streamlining and Re-Prioritization of Assets US$m As previously indicated in July, the Company is planning to absorb the incremental costs of For personal use only the MPC-150-IM program in FY17 through a range of cost reduction initiatives. To date, the following initiatives have been e
Slide 7: FY17 Cash Flows and Cash Position
FY17 Cash Flows and Cash Position US$m 30 Sep 2016 30 Sep 2015 $ Change % For personal use only Cash on hand 60.4 77.8 (17.4) Cash flows for the quarter: Operating cash outflows (20.8) (28.1) 7.3 (26%) Investing cash outflows (0.3) (1.5) 1.2 (81%) Financing cash (outflows)/inflows (0.1) 0.2 (0.3) (1
Slide 8: FY17 Profit and Loss
FY17 Profit and Loss US$m 30 Sep 2016 30 Sep 2015 $ Change % For personal use only Revenue 0.4 7.5 (7.1) (95%) Research and Development (14.0) (11.1) (2.9) 26% Manufacturing Commercialization (3.3) (6.2) 2.9 (47%) Management & Administration (5.5) (5.5) 0.1 (1%) Contingent Consideration — 3.7 (3.7)
Slide 9: Agenda: Operational Update
Agenda For personal use only OPERATIONAL UPDATE 9
Slide 10: Diversified Pipeline of Product Candidates for High Unmet Needs
Diversified Pipeline of Product Candidates for High Unmet Needs First Product on market - Three Tier 1 Product Candidates in Phase 3 For personal use only 10
Slide 11: MPC-150-IM: Chronic Heart Failure – Market Opportunity
MPC-150-IM: Chronic Heart Failure (CHF) – Market Opportunity MPC-150-IM is in development for patients with New York Heart Association Class II-IV CHF For personal use only 5.7m patients (prevalence rate of 2% of the population) diagnosed with CHF in the US1 Market 915,000 new cases diagnosed in
Slide 12: MPC-150-IM: Operational Update
MPC-150-IM: Operational Update For personal use only • Phase 3 trial for 600 patients with advanced heart failure is recruiting well across North American sites; over 300 patients enrolled • After reviewing patient data in April and October 2016, the trial’s DSMB has maintained its recommendation th
Slide 13: MPC-06-ID: CLBP Due to Degenerative Disc Disease – Market Opportunity
MPC-06-ID: CLBP Due to Degenerative Disc Disease – Market Opportunity MPC-06-ID is in development for the treatment of chronic low back pain (CLBP) lasting >6 For personal use only months as a result of moderate degenerative intervertebral disc disease Over approximately 7m patients in the US are
Slide 14: MPC-06-ID: Operational Update
MPC-06-ID: Operational Update For personal use only The current 360 patient Phase 3 trial is actively recruiting across US sites The 24-month results from the Company’s 100-patient Phase 2 trial of MPC-06-ID for treatment of chronic low back pain were presented at the 24th Annual Scientific Meet
Slide 15: 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 approximately 5.3 million prev
Slide 16: MPC-300-IV: Operational Update
MPC-300-IV: Operational Update For personal use only The Phase 2 trial of Mesoblast’s intravenous product candidate, MPC-300-IV, in biologic refractory rheumatoid arthritis has completed enrollment and results of the 12 week primary endpoint were released in August 2016. An intravenous infusion of
Slide 17: MSC-100-IV / TEMCELL HS Inj.: Acute Graft vs Host Disease
MSC-100-IV / TEMCELL® HS Inj. : Acute Graft vs Host Disease MSC-100-IV / TEMCELL® HS Inj. is targeting pediatric and adult patients with acute Graft Versus Host Disease (aGVHD) following allogeneic Bone Marrow Transplant (BMT) For personal use only ~30,000 allogeneic BMTs performed globally (~20K
Slide 18: MSC-100-IV North America aGVHD Market Opportunity
MSC-100-IV North America aGVHD Market Opportunity Target Population 2015 Source For personal use only • US: estimated from 2013 CIBMTR (table 6) Allogeneic Hematopoietic Stem Cell Transplants 10,200 • Canada: estimate based on general population size and US transplant activity per 10m Epidemiology A
Slide 19: MSC-100-IV: Concentrated High Volume Centers Provide Low Cost Commercial Structure
MSC-100-IV: Concentrated High Volume Centers Provide Compelling Low Cost Commercial Structure1 For personal use only Top Pediatric Transplant Centers Top Adult Transplant Centers There are 65 centers in the country that There are 108 centers in the country that conduct allogeneic transplants in
Slide 20: MSC-100-IV: Product Development Strategy
MSC-100-IV: Product Development Strategy Manufacturing For personal use only – Optimised process – modernized and harmonized – Commercial readiness for launch Pediatrics – Complete targeted Phase 3, 60 patient open label clinical trial in SR-aGVHD for accelerated approval pathway (US) – Market d
Slide 21: MSC-100-IV: Trial in Children with Steroid Refractory Acute GVHD
MSC-100-IV: Phase 3 Trial in Children with Steroid Refractory Acute Graft vs Host Disease (SR-aGVHD) For personal use only MSC-100-IV as first line therapy in children with MSC-100-IV in children with SR-aGVHD who failed SR-aGVHD (Day 28 response) multiple other modalities (Day 100 survival) Open-la
Slide 22: MSC-100-IV: Pediatric GVHD001/GVHD002 Phase 3 Study
MSC-100-IV: Graft vs Host Disease: Pediatric GVHD001/GVHD002 Phase 3 Study Phase 3 study ongoing, ~ 40 sites planned1 For personal use only – Multi-center, Single-Arm, Open-Label to evaluate efficacy and safety to day 100 (study 001) and from day 100 to day 180 (study 002) – At least 60 pediatric
Slide 23: GVHD001 Interim Futility Analysis Method and Results - November 2016
GVHD001 Interim Futility Analysis Method and Results- November 2016 For personal use only Predefined Bayesian futility rule that determined the predictive probability of success using the primary endpoint of Day 28 overall response Method determined the likelihood of obtaining a statistically si
Slide 24: Other Operational Highlights
Other Operational Highlights For personal use only Award: In recognition of the Company’s continued clinical achievements, it was awarded the Frost & Sullivan Asia Pacific 2016 Cell Therapy Company of the Year award. The Frost & Sullivan awards identify and honor the best-in- class companies that
Slide 25: Agenda: Timelines
25 For personal use only Agenda TIMELINES
Slide 26: Product Candidate Deliverables Timeline
Tier 1 Product Candidate Deliverables (Calendar Year) 2016 2017 For personal use only Product Candidate Programs Milestones Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 3 Enrollment Complete Class II and III Heart Failure MPC-150-IM Interim Results Class IV Heart Failure Requiring Phase 2b trial results LVAD Top l
Slide 27: Thank You and Questions
For personal use only Thank You and Questions