Slide 1: Strategic Update and Financial Results for the Three Months Ended 30 September 2015
Strategic Update and Financial Results for the Three Months Ended 30 September 2015 December 2015
Slide 2: Cautionary Note Regarding Forward-Looking Statements
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, levels of activity, perf
Slide 3: Mesoblast - a global leader in cell based medicines
Mesoblast ‐ a global leader in cell based medicines Disruptive technology platform: proprietary, allogeneic, “off‐the‐shelf” adult stem cells with predictable therapeutic properties Established late stage portfolio of distinct and advanced product candidates Targeted markets with high unmet medical
Slide 4: Focused company with strong cash reserves to meet key corporate objectives
Focused company with strong cash reserves to meet key corporate objectives • Successfully completed US listing with access to world’s largest sophisticated healthcare investor pool and analysts • Financing raised USD $63.5m (net proceeds) which significantly augmented existing cash reserves of USD $
Slide 5: Product candidates target diseases with high unmet needs
Product candidates target diseases with high unmet needs Three Tier 1 Product Candidates in Phase 3 Programs Update 5
Slide 6: MSC-100-IV / TEMCELL HS Inj.: Product Launch Plans in aGVHD
MSC‐100‐IV / TEMCELL® HS Inj. : Product Launch Plans in aGVHD Japan (TEMCELL® HS Inj.): 2016 Expected Revenues • Our licensee JCR Pharmaceuticals Co. to launch TEMCELL® HS Inj. in Japan for adult and pediatric aGVHD in Q1 2016 • Japan’s National Health Insurance (NHI) set reimbursement for TEMCELL®
Slide 7: MSC-100-IV / TEMCELL HS Inj.: Acute Graft vs Host Disease - Market Opportunity
MSC‐100‐IV / TEMCELL® HS Inj. : Acute Graft vs Host Disease – Market Opportunity 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). ~30,000 allogeneic BMTs performed globally each y
Slide 8: 2016-2018 Tier 1 Product Candidate Deliverables
2016 ‐ 2018 Tier 1 Product Candidate Deliverables 2016 2017 2018 Product Candidate Programs Anticipated Milestones Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 H1 H2 Temcell® HS Inj. Launch in Japan US Pediatric Phase 3 Interim Analysis (IA) Top MSC‐100‐IV / Acute Graft Versus Host Line Results Temcell® HS Inj. Disease
Slide 9: Profit and Loss - Increased revenue and reduced expenditure
Profit and Loss – Increased revenue and reduced expenditure USDm 3 months 3 months % ending ending Change 30 Sep 2015 30 Sep 2014 Revenue 7.5 7.0 0.5 7.8 Loss Before Income Tax 13.2 15.5 2.3 15.3 Revenue increased by 7% ($0.5m) vs comparative period in FY14: • Milestone revenue of $3.5m has been rec
Slide 10: Increased cash reserves and reduced operating cash burn
Increased cash reserves and reduced operating cash burn USDm Q1 Q4 FY2016 FY2015 USD m 3 months ended 3 months ended 30 Sep 2015 30 June 2015 Net Cash Outflows in Operating Activities (28.1) (27.3) Cash at the end of the period 77.8 110.7 • Recent US listing has added $63.5m (net proceeds) in Novemb
Slide 11: Company focused on delivery and communication of key corporate objectives
Company focused on delivery and communication of key corporate objectives • Materially strengthened cash reserves post US listing and financing • First royalties from TEMCELL product sales expected in Q1 2016 • Focused allocation of resources on Tier 1 product candidates • Quarterly cash outflows ex
Slide 12: Appendix
Appendix Historical Financial Results in USD
Slide 13: Retranslation of Historical Financials to USD
Retranslation of Historical Financials to USD As announced the reporting currency for Mesoblast has changed from Australian dollars to US dollars, commencing with the 2015/16 financial year • The first reported results in US dollars are these results for the three months ended 30 September 2015 • To
Slide 14: Profit and Loss - FY2012 to FY2015
Profit and Loss – FY 2012 to FY2015 USDm FY12 FY13 H1 H2 FY14 Q1 Q2 Q3 Q4 FY15 FY = Fiscal Years ended 30 June 14 14 15 15 15 15 Revenue 39.6 29.3 12.4 11.0 23.4 7.0 4.4 4.2 4.2 19.8 Research & Development (37.8) (48.5) (23.2) (27.7) (50.9) (12.9) (17.8) (13.4) (18.5) (62.6) Manufacturing Commercial
Slide 15: Cash Flows - FY2012 to FY2015
Cash Flows – FY 2012 to FY2015 USDm FY12 FY13 H1 H2 FY14 Q1 Q2 Q3 Q4 FY15 FY = Fiscal Years ended 30 June 14 14 15 15 15 15 Milestone payment received ‐ ‐ ‐ ‐ ‐ ‐ 2.0 ‐ ‐ 2.0 R&D tax incentive received ‐ ‐ ‐ 8.7 8.7 ‐ ‐ ‐ 4.5 4.5 Payments to suppliers and employees (66.8) (69.8) (50.4) (47.0) (97.4)
Slide 16: Balance Sheets - FY2012 to FY2015
Balance Sheets – FY 2012 to FY2015 USDm FY12 FY13 H1 14 FY14 H1 15 FY15 FY = Fiscal Years ended 30 June Cash and cash equivalents 209.5 292.5 223.9 185.0 122.4 110.7 Current receivables 10.9 11.2 15.2 5.7 7.5 4.0 Other current assets 0.3 4.1 4.0 1.2 3.9 7.8 Current assets 220.7 307.8 243.1 191.9 133