Mesoblast Quarterly Cash Flow Report
July 31 2019 - 6:00AM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today reported its
operational highlights and its quarterly cash flows for the fourth
quarter (fourth quarter FY2019) and 12 months ended June 30, 2019
(FY2019).
Mesoblast Chief Executive Dr Silviu Itescu stated:
“It is pleasing to see the growth in revenues achieved by our
Japanese partner in the treatment of acute graft versus host
disease in the first three years post launch. This augurs well for
the potential uptake of remestemcel-L in the treatment of GVHD, if
approved, in the United States.”
Key Highlights
- Increased revenues(1) of 54%(2) for
the quarter and 37%(3) for the year on sales of TEMCELL® HS.
Inj.(4) in Japan steroid-refractory acute graft versus host disease
(SR-aGVHD) by Mesoblast licensee JCR Pharmaceuticals Co. Ltd.
- Mesoblast initiated a rolling Biologics License Application
(BLA) with the United States Food and Drug Administration (FDA) for
remestemcel-L in the treatment of pediatric aGVHD; in preparation
for product launch, focus is on inventory and commercial team ramp
up.
- The FDA has granted Orphan Drug
Designation for the use of rexlemestrocel-L (Revascor) for the
prevention of post implantation mucosal bleeding in heart failure
patients implanted with a left ventricular assist device
(LVAD).
- In late July Mesoblast had a
positive meeting with the FDA to further define the registration
pathway for the use of Revascor in the treatment of heart failure
in patients with an LVAD, with formal minutes expected in coming
weeks.
- Cash on hand at June 30, 2019 was
US$50.4 million (A$71.9 million); additional capital of US$35.0
million may be available under existing arrangements with Hercules
Capital, Inc. and NovaQuest Capital Management, L.L.C.
- The Kentgrove Capital equity
facility for up to A$120.0 million (approx. US$85.0 million), which
can be used at Mesoblast’s discretion, has been extended for two
years.
- The Company remains in advanced
negotiations with a number of potential commercial partners
regarding potential transactions and access to non-dilutive
capital.(5)
(1)
Unaudited.(2) fourth quarter
FY2019 compared to the fourth quarter FY2018. Reported in
constant currency.(3) FY2019
year compared to the FY2018 year. Reported in constant
currency.(4) TEMCELL HS. Inj.
is a registered trademark of JCR Pharmaceuticals Co. Ltd.
(5) Mesoblast does not make any
representation or give any assurance that such a partnering
transaction will be concluded.
Commentary on Appendix 4C Cash Flow Report
Milestone receipts of US$26.4 million received
for FY2019 comprised:
- US$20.0 million receipts from milestones received in relation
to establishing a partnership with Tasly Pharmaceutical Group in
China.
- US$5.4 million (€5 million) receipts from milestones received
in relation to a patent license agreement with Takeda
Pharmaceutical Company Limited.
- US$1.0 million receipts from milestones received for JCR
reaching cumulative net sales milestones for sales of TEMCELL® in
Japan.
Royalty receipts received from sales of TEMCELL
in Japan for the treatment of aGVHD were US$1.0 million for the
fourth quarter FY2019 and US$4.4 million for FY2019. Royalty income
recognized as revenue for the fourth quarter FY2019 and FY2019 was
US$1.7 million and US$5.0 million respectively. The amounts
recognized as revenue in the periods are higher than the amounts
reported as cash received as royalty income recognized as revenue
in the fourth quarter will not be received until July 2019.
Research and Development payments of US$8.3
million for the fourth quarter and US$48.5 million in FY2019, with
costs being incurred in relation to Phase 3 programs in aGVHD,
advanced chronic heart failure and chronic low back pain due to
degenerative disc disease.
Manufacturing payments of US$4.3 million for
the fourth quarter and US$13.4 million for FY2019 for commercial
manufacturing investment to support potential launch of
remestemcel-L.
Total Operating Activities net cash usage was
US$19.1 million for the fourth quarter and US$57.8 million for
FY2019.
About Mesoblast Mesoblast
Limited (Nasdaq: MESO; ASX: MSB) is a world leader in developing
allogeneic (off-the-shelf) cellular medicines. The Company has
leveraged its proprietary technology platform to establish a broad
portfolio of late-stage product candidates with three product
candidates in Phase 3 trials – acute graft versus host disease,
chronic heart failure and chronic low back pain due to degenerative
disc disease. Through a proprietary process, Mesoblast selects rare
mesenchymal lineage precursor and stem cells from the bone marrow
of healthy adults and creates master cell banks, which can be
industrially expanded to produce thousands of doses from each donor
that meet stringent release criteria, have lot to lot consistency,
and can be used off-the-shelf without the need for tissue matching.
Mesoblast has facilities in Melbourne, New York, Singapore and
Texas and is listed on the Australian Securities Exchange (MSB) and
on the Nasdaq (MESO). www.mesoblast.com
Forward-Looking StatementsThis announcement
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, performance or achievements to differ
materially from any future results, levels of activity, performance
or achievements expressed or implied by these forward-looking
statements. We make such forward-looking statements pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995 and other federal securities laws. Forward-looking
statements should not be read as a guarantee of future performance
or results, and actual results may differ from the results
anticipated in these forward-looking statements, and the
differences may be material and adverse. Forward- looking
statements include, but are not limited to, statements about: the
initiation, timing, progress and results of Mesoblast’s preclinical
and clinical studies, and Mesoblast’s research and development
programs; Mesoblast’s ability to advance product candidates into,
enroll and successfully complete, clinical studies, including
multi-national clinical trials; Mesoblast’s ability to advance its
manufacturing capabilities; the timing or likelihood of regulatory
filings and approvals, manufacturing activities and product
marketing activities, if any; the commercialization of Mesoblast’s
product candidates, if approved; regulatory or public perceptions
and market acceptance surrounding the use of stem-cell based
therapies; the potential for Mesoblast’s product candidates, if any
are approved, to be withdrawn from the market due to patient
adverse events or deaths; the potential benefits of strategic
collaboration agreements and Mesoblast’s ability to enter into and
maintain established strategic collaborations; Mesoblast’s ability
to establish and maintain intellectual property on its product
candidates and Mesoblast’s ability to successfully defend these in
cases of alleged infringement; the scope of protection Mesoblast is
able to establish and maintain for intellectual property rights
covering its product candidates and technology; estimates of
Mesoblast’s expenses, future revenues, capital requirements and its
needs for additional financing; Mesoblast’s financial performance;
developments relating to Mesoblast’s competitors and industry; and
the pricing and reimbursement of Mesoblast’s product candidates, if
approved. You should read this press release together with our risk
factors, in our most recently filed reports with the SEC or on our
website. Uncertainties and risks that may cause Mesoblast’s actual
results, performance or achievements to be materially different
from those which may be expressed or implied by such statements,
and accordingly, you should not place undue reliance on these
forward-looking statements. We do not undertake any obligations to
publicly update or revise any forward-looking statements, whether
as a result of new information, future developments or
otherwise.
For further information, please contact:
Julie Meldrum |
Schond Greenway |
Corporate Communications |
Investor Relations |
Mesoblast |
Mesoblast |
T: +61 3 9639 6036 |
T: +1 212 880 2060 |
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jul 2023 to Jul 2024