Slide 1: Operational Highlights and Financial Results for the Half Year Ended December 31, 2018
For personal use only Operational Highlights and Financial Results for the Half Year Ended December 31, 2018 February 2019 Nasdaq: MESO ASX: MSB
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: Our Mission
For personal use only Our Mission Mesoblast is committed to bring to market innovative cellular medicines to treat serious and life-threatening illnesses |3
Slide 4: Premier Global Cellular Medicines Company
Premier Global Cellular Medicines Company For personal use only Innovative Technology Late Stage Pipeline Commercialization Platform1 Upcoming BLA submission for Building focused U.S. sales force Innovative technology targets the Steroid-Refractory Acute GVHD for GVHD product launch most sever
Slide 5: Corporate Highlights for the Half Year
Corporate Highlights for the Half Year For personal use only Remestemcel-L for Steroid Refractory Acute Graft Versus Host Disease After demonstrating strong survival benefits through Day 180, held two successful end-of-phase meetings with the FDA covering clinical and manufacturing aspects of the
Slide 6: Corporate Highlights for the Half Year
Corporate Highlights for the Half Year For personal use only Financial Strengthened cash position through both corporate transactions and strategic financing - US$92 million pro forma cash on hand Completed transaction with Tasly to establish a cardiovascular partnership in China, and received U
Slide 7: Financials
For personal use only Financials | |77
Slide 8: Pro Forma Cash Position of US$92 million
Pro Forma Cash Position of US$92 million For personal use only US$m December 31, June 30, 2018 2018 Reported Cash on Hand 77.0 37.8 NovaQuest financing agreement - 39.0 Tasly strategic partnership - 40.0 Hercules – 2nd tranche 15.0 - Pro forma cash on hand 92.0 116.8 Pro forma cash on hand at Dece
Slide 9: Significant reduction in Operating Net Cash Outflows
Significant reduction in Operating Net Cash Outflows For personal use only December 31, December 31, For the six months ending (US$m) 2018 2017 ` Operating net cash outflows (17.5) (35.2) Investing net cash outflows (0.1) (0.7) Financing net cash inflows 57.0 37.9 Net increase in cash 39.4 2.0 50%
Slide 10: Revenues – continued growth in royalties and milestone revenues
Revenues – continued growth in royalties and substantial milestone For personal use only revenues from corporate transactions December 31, December 31, For the six months ending (US$m) 2018 2017 Milestone revenue 11.0 12.8 Commercialization revenue 2.2 1.6 Interest revenue 0.3 0.2 Total revenue 13.5
Slide 11: Increased loss due to investment in manufacturing and financing
Increased loss due to investment in manufacturing and financing, and non-cash gains in comparable period from revaluation of tax and contingent consideration For personal use only December 31, December 31, Profit and Loss for the six months ending (US$m) 2018 2017 Total Revenue 13.5 14.6 Research an
Slide 12: Operational highlights for the half year ended December 31, 2018
For personal use only Operational highlights for the half year ended December 31, 2018 | 12
Slide 13: Commercial and Late-Stage Product Pipeline
Commercial and Late-Stage Product Pipeline For personal use only PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MARKETED TEMCELL® MSC Acute Graft Versus Host Japan 1st allogeneic regen med approved in Japan (Bone Marrow) HS Inj1 Disease MSC (Adipose) Alofisel®2 Perianal Fistula 1st a
Slide 14: Remestemcel-L: for SR Acute Graft Versus Host Disease
Remestemcel-L: for SR Acute Graft Versus Host Disease (aGVHD) For personal use only aGVHD is a life-threatening complication that occurs in ~50% of patients receiving Burden of allogeneic bone marrow transplants (BMT)1 Illness Steroid-refractory aGVHD is associated with mortality rates as high a
Slide 15: Remestemcel-L: Commercial strategy overview
Remestemcel-L for SR Acute Graft Versus Host Disease: Commercial strategy overview For personal use only TEMCELL® HS Inj. sales experience in Japan helps inform commercial strategy for the U.S. Fast Track designation provides eligibility for FDA priority review Commercialization strategy in pl
Slide 16: Revascor: Targeting patients with progressive heart failure
Revascor: Targeting patients with progressive heart failure despite maximal standard of care For personal use only Common Treatment Pathway in Progressive Heart Failure1 Mesoblast Target Market: Early ACEI or ARB Advanced Statins and End-Stage HF patients3 Beta blockers Re-vascularization or
Slide 17: Revascor: Commercial Opportunity for Advanced Heart Failure Market
Revascor: Commercial Opportunity for Advanced Heart Failure Market For personal use only ~ 8 million patients with chronic heart failure by 2030 in USA alone1 17-45% globally die within 1 year of hospital admission1 Burden of Illness/Limited Majority of advanced heart failure patients die with
Slide 18: Revascor: Phase 3 Trial for Advanced Heart Failure Fully Enrolled
Revascor: Phase 3 Trial for Advanced Heart Failure Fully Enrolled For personal use only Events-driven Phase 3 trial completes enrollment of 566 patients Evaluating a single dose of Revascor to reduce recurrent heart failure-related major adverse cardiac events such as heart failure-related hospi
Slide 19: Revascor: Commercial Opportunity in End-Stage Heart Failure with LVADs
Revascor: Commercial Opportunity for Use in End-Stage Heart Failure Patients with LVADs to Reduce Hospitalizations from GI Bleeding For personal use only In the USA, there are approximately 250,000–300,000 patients annually who Burden of suffer from advanced systolic heart failure (NYHA Class III–
Slide 20: MPCs Prolong Time-to-First Major GI Bleeding Event in LVAD Patients
MPCs Prolong Time-to-First Major GI Bleeding Event and Reduce Cumulative Major GI Bleeding Events in Two Confirmatory Randomized Controlled Trials in LVAD Patients1,2 For personal use only MPC (n = 20) Control (n = 10) P-value MPC (n = 106) Control (n = 53) P-value Event Rate Event Rate Event Rate E
Slide 21: MPCs Reduce Hospitalization Rate from GI Bleeding by 65%
MPCs Reduce Hospitalization Rate from GI Bleeding by 65% in 159-Patient Phase 2 Trial1 For personal use only 1 Presented at American Heart Association Scientific Sessions 2018. | 21
Slide 22: 21st Century Cures Expedited Approval Path for RMAT
21st Century Cures Legislates an Expedited Approval Path for Regenerative Medicine Advanced Therapies (RMAT) For personal use only Revascor (MPC-150-IM) Has Received RMAT Designation for Use In End-Stage Heart Failure Patients with LVADs Key benefits of the RMAT designation include: − Potential el
Slide 23: MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration
MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration For personal use only Back pain causes more disability than any other condition1 Burden of Inflicts substantial direct and indirect costs on the healthcare Illness system,1 including excessive use of opioids in this patient population2
Slide 24: Chronic Low Back Pain MPC-06-ID Post-Hoc Phase 2 Results
Chronic Low Back Pain MPC-06-ID Post-Hoc Phase 2 results over 24 months provide target endpoints for Phase 3 trial For personal use only A: Phase 2: Treatment Success Responders1,2 B: Phase 2: Treatment Success Responders1,2 at 12 Months at both 12 & 24 Months 50.0% 50.0% 45.0% 45.0% 46.6% p = 0.032
Slide 25: Key Milestones
Key Milestones For personal use only Remestemcel-L for Acute Graft Versus Host Disease Successfully met all efficacy and safety endpoints through six months Initiate BLA filing for marketing authorization following FDA meeting scheduled for April 2019 Build out efficient and targeted sales f