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6-K
MESOBLAST LTD filed this Form 6-K on 08/31/2018
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meso-ex991_36.htm

Exhibit 99.1

 

 

 

MESOBLAST REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

 

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:

 

o

US$37.8 million balance sheet cash

 

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

 

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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

 

www.mesoblast.com

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

USA

 

T +1 212 880 2060

F +1 212 880 2061

Asia

20 Biopolis Way

#05-01 Centros

Biopreneur 3

SINGAPORE 138668

 

T +65 6570 0635

F +65 6570 0176

 

 

 

 

 

 

 

 

 

 

 

 

 



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