Slide 1: Operational Highlights and Financial Results for the Year Ending June 30, 2018
For personal use only Operational Highlights and Financial Results for the Year Ending June 30, 2018 August 2018 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 disruptive 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 Disruptive Technology Industrial Scale Multiple Revenue Platform1 Manufacturing Generating Products & Phase 3 Assets Immuno-selected, culture Unique cell properties enable 2 approved products expanded cellular medicines large scal
Slide 5: Disruptive cellular medicine technology
Disruptive cellular medicine technology For personal use only STRO-1+ Mesenchymal Precursor Cells (MPCs) are at the apex of the hierarchy of mesenchymal lineage cells STRO-1/STRO-3 immuno-selection provides a homogeneous population of MPCs with receptors that respond to activating inflammation a
Slide 6: Commercial translation capabilities
Commercial translation capabilities Technology positioned for scalable, industrialized manufacturing For personal use only Immune privileged nature of mesenchymal lineage cells enables allogeneic “off the shelf” product candidates Culture expansion scalable to produce anticipated commercial quan
Slide 7: Commercial products and clinical pipeline
Commercial products and clinical pipeline Using Mesoblast’s intellectual property and technology platform For personal use only PLATFORM PRODUCT THERAPEUTIC AREA APPROVAL COMMERCIAL RIGHTS MARKETED MSC TEMCELL® Acute GVHD 1st allogeneic regen med approved in Japan Japan (Bone Marrow) HS Inj1 MSC (
Slide 8: Strategic partnership in cardiology in China
Strategic partnership in cardiology in China For personal use only Tasly Pharmaceuticals to receive exclusive rights and will fund all development, manufacturing and commercialization activities for MPC-150-IM for the treatment or prevention of chronic heart failure and MPC-25-IC for the treatment
Slide 9: Financials
For personal use only Financials | 9| 9
Slide 10: Significant increase in revenue
Significant increase in revenue Revenue for the year ending June 30, 2018 (US$m) For personal use only For the year ending June 30, 2018 June 30, 2017 $Change % Commercialization revenue 3.6 1.4 2.2 152% Milestone revenue 13.3 0.5 12.8 NM Interest revenue 0.4 0.5 (0.1) (22%) Total revenue 17.3 2.4 1
Slide 11: Significant reduction in loss after tax
Significant reduction in loss after tax Profit and Loss for the year ending June 30, 2018 (US$m) For personal use only For the year ending June 30, 2018 June 30, 2017 $Change % Total revenue 17.3 2.4 14.9 NM Research and development (65.9) (58.9) (7.0) 12% Manufacturing (5.5) (12.1) 6.6 (54%) Manage
Slide 12: Significant reduction in operating cash outflows
Significant reduction in operating cash outflows Cash flow highlights (US$m) For personal use only For the year ending June 30, 2018 June 30, 2017 $Change %Change Operating net cash outflows (75.0) (95.5) 20.5 (21%) Investing net cash (outflows)/inflows (1.2) 0.1 (1.3) NM Financing net cash inflows
Slide 13: Cash position strengthened through strategic transactions
Cash position strengthened through strategic transactions Balance sheet cash (US$m) For personal use only June 30, 2018 June 30, 2017 $Change Reported Cash on Hand 37.8 45.8 (8.0) NovaQuest financing agreement 39.0 - 39.0 Tasly strategic alliance 40.0 - 40.0 Pro forma Cash on Hand 116.8 45.8 71.0
Slide 14: Strategic financing transactions
Strategic financing transactions For personal use only US$75 million non-dilutive, four-year credit facility US$40 million non-dilutive, eight-year credit facility and US$10 million equity investment in June 2018 US$35 million drawn on closing in March 2018 US$30 million drawn and US$10 mill
Slide 15: MSC-100-IV (remestemcel-L) for Steroid-Refractory Acute GVHD
For personal use only MSC-100-IV (remestemcel-L) for Steroid-Refractory Acute Graft vs Host Disease | 15 | 15
Slide 16: Remestemcel-L: market opportunity for acute GVHD
Remestemcel-L (MSC-100-IV): market opportunity for 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 w
Slide 17: Operational Update: MSC-100-IV for steroid refractory aGVHD
Operational Update: MSC-100-IV (remestemcel-L) product candidate for steroid refractory aGVHD For personal use only Phase 3 study evaluated remestemcel-L in 55 children to improve overall response rate and survival − 89% of children had grade C/D disease, the most severe form and historically asso
Slide 18: GVHD pathway to market
GVHD pathway to market For personal use only Regulatory Final preparations for Biologics License Application (BLA) filing underway Expected pre-BLA meeting Q4 CY2018 Fast Track designation allows eligibility for priority review and rolling BLA review process Commercial Parallel track commerc
Slide 19: MPC-150-IM for Chronic Heart Failure
For personal use only MPC-150-IM for Chronic Heart Failure | 19 | 19
Slide 20: MPC-150-IM: Targeting advanced and end-stage heart failure
MPC-150-IM: Targeting patients with advanced and end-stage heart failure For personal use only Treatment Pathway in Progressive Heart Failure1 Early MPC-150-IM targets Advanced ACEI or ARB and End-Stage HF patients3 Statins Beta blockers Re-vascularization or valvular surgery New Oral Therap
Slide 21: MPC-150-IM: End-stage heart failure market opportunity
MPC-150-IM: End-stage heart failure market opportunity For personal use only 50k patients/year in the United States alone have end-stage heart failure1 Burden of 1-year mortality exceeds 50% in these patients Illness/Limited Only ~2K heart transplants are performed in U.S. annually due to limi
Slide 22: MPC-150-IM: End-stage heart failure clinical strategy
MPC-150-IM: End-stage heart failure clinical strategy For personal use only 159-patient, double-blind, placebo-controlled 2:1 randomized Phase 2b trial, evaluating safety and efficacy of a single injection of MPC-150-IM into the native myocardium of LVAD recipients Study funded by the US Nationa
Slide 23: MPC-150-IM: Advanced heart failure market opportunity
MPC-150-IM: Advanced heart failure market opportunity Est. >8 million patients with chronic heart failure by 2030 in US alone For personal use only Burden of 17-45% globally die within 1 year of hospital admission1 Illness/Limited Majority of advanced heart failure patients die within 5 years1
Slide 24: MPC-150-IM: Phase 3 trial in advanced heart failure
MPC-150-IM: Phase 3 trial in patients with advanced heart failure For personal use only 85% of patients enrolled in this events-driven Phase 3 trial Enrollment completion targeted by end CY18 Pre-specified interim futility analysis of the efficacy endpoint in the first 270 patients successfull
Slide 25: MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration
For personal use only MPC-06-ID for Chronic Low Back Pain due to Disc Degeneration | 25 | 25
Slide 26: MPC-06-ID: Chronic low back pain due to degenerative disc disease
MPC-06-ID: Chronic low back pain due to degenerative disc disease For personal use only Back pain causes more disability than any other condition1 Burden of Inflicts substantial direct and indirect costs on the healthcare system,1 including excessive use of opioids in this patient Illness popula
Slide 27: MPC-06-ID: Phase 3 trial in chronic low back pain
MPC-06-ID: Phase 3 trial in patients with chronic low back pain For personal use only Phase 3 study completed enrollment in March 2018 Over 400 patients were enrolled at 48 sites across the US and Australia Patients randomized 1:1:1 to receive saline, 6-million MPCs with hyaluronic acid and 6-
Slide 28: Milestones
For personal use only Milestones | 28 | 28
Slide 29: CY 2018 corporate milestones
CY 2018 corporate milestones For personal use only MSC-100-IV for Acute Graft versus Host Disease Successfully met Day 28 primary end point pediatric Phase 3 trial (Q1 CY18) Day 100 survival/safety data pediatric Phase 3 trial (Q2 CY18) Day 180 survival/safety data pediatric Phase 3 trial
Slide 30: Questions?
For personal use only Questions? | 30 | 30