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MESOBLAST LTD filed this Form 6-K on 08/31/2018
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Exhibit 99.1






Melbourne, Australia; August 30, 2018; and New York, USA, August 29, 2018: Mesoblast Limited (ASX: MSB; Nasdaq: MESO) today reported strong financial results and provided operational highlights for the fourth quarter and full-year ended June 30, 2018 (FY2018).


Key financial results for the 12 months ended June 30, 2018



Revenues significantly increased to US$17.3 million in FY2018 compared with US$2.4 million in FY2017


Commercialization revenues from sales of TEMCELL®1 HS Inj. in Japan increased by 152%


Significant reduction in loss after tax by US$41.5 million (54%) to US$35.3 million in FY2018 from US$76.8 million in FY2017


Substantial reduction in operating cash outflows in FY2018 of US$20.5 million (21%) compared with FY2017


Pro-forma cash on June 30, 2018 was US$116.8 million including:



US$37.8 million balance sheet cash



US$39.0 million from NovaQuest Capital Management through a strategic financing agreement in July 2018, and



US$40.0 million from Tasly Pharmaceutical Group through agreements entered into in July 2018, subject to filing with the State Administration of Foreign Exchange


An additional US$50.0 million may be available under existing arrangements with Hercules Capital and NovaQuest, subject to achievement of certain milestones.


Corporate highlights


Mesoblast entered into a strategic alliance with Tasly Pharmaceutical Group for the development, manufacture and commercialization of MPC-150-IM and MPC-25-IC in the treatment and prevention of chronic heart failure and heart attacks in China.


Mesoblast granted TiGenix NV (now fully owned by Takeda Pharmaceutical Co. Ltd) exclusive access to certain of its patents to support global commercialization of Alofisel® in the local treatment of fistulae. This product is the first allogeneic mesenchymal stem cell therapy to receive approval from the European Commission. As consideration, Mesoblast will receive up to €20 million in payments, as well as single digit royalties on net sales.


Mesoblast accessed non-dilutive capital for commercialization of MSC-100-IV (remestemcel-L) through credit facilities with Hercules Capital and NovaQuest.


New non-executive Directors Joseph R. Swedish and Shawn Cline Tomasello joined the Board of Directors, bringing substantial commercial and transactional healthcare expertise.


Operational highlights and anticipated upcoming milestones


MSC-100-IV (remestemcel-L) for pediatric steroid-refractory acute Graft Versus Host Disease (SR-aGVHD):



The Phase 3 primary endpoint was successfully met


The primary endpoint of Day 28 overall response rate to remestemcel-L treatment was 69%, a statistically significant increase compared to the protocol-defined historical control rate of 45% (p=0.0003)


Day 100 survival results demonstrated 87% survival rate for Day 28 responders (33/38), and an overall survival rate of 75% (41/55)





Mesoblast Limited
ABN 68 109 431 870

Corporate Headquarters

Level 38

55 Collins Street

Melbourne 3000

Victoria Australia


T +61 3 9639 6036

F +61 3 9639 6030

United States Operations

505 Fifth Avenue

Third Floor

New York, NY 10017



T +1 212 880 2060

F +1 212 880 2061


20 Biopolis Way

#05-01 Centros

Biopreneur 3



T +65 6570 0635

F +65 6570 0176














Copyright © 2015 Mesoblast Inc.