Mesoblast Limited (Nasdaq: MESO; ASX: MSB) today reported strong
operational progress and financial highlights for the fourth
quarter and full-year ended June 30, 2019 (FY2019).
Mesoblast Chief Executive Dr Silviu Itescu stated:
“The Company is well positioned to deliver substantial shareholder
value in the coming year. Our expenditure over the 2019 financial
year has been specifically targeted at advancing our lead cell
therapy candidates towards commercialization. We are excited about
the planned readouts of our major Phase 3 trials in chronic heart
failure and low back pain, and are also especially pleased with the
growth in revenues on graft versus host disease (GVHD) product
sales in Japan as we progress the United States Food and Drug
Administration (FDA) filing process to seek approval of our GVHD
product in the United States market.”
Continued Growth in Revenues from Japan
Royalties
The Company is pleased to report continued growth in revenues
from royalties on sales of TEMCELL® HS. Inj.1 in Japan for
steroid-refractory acute graft versus host disease (aGVHD) by
Mesoblast licensee JCR Pharmaceuticals Co. Ltd. Revenues from
royalties on TEMCELL sales increased by 37% to US$5.0 million for
the fiscal year. In the most recent quarter, revenues from
royalties increased by 54% to US$1.7 million. Total revenue was
stable at US$16.7 million in FY2019 compared with US$17.3 million
in FY2018.
Capital Strategy
Cash on hand was US$50.4 million (A$71.9 million) at June 30,
2019.
In addition, Mesoblast may have access to additional sources of
capital, as follows:
- Under its agreements with Hercules Capital, Inc. and NovaQuest
Capital Management, LLC., the Company has up to US$35.0 million
available subject to achievement of certain milestones.
- Mesoblast has entered into a Subscription Commitment Letter
with its largest institutional shareholder, M&G Investment
Management, for US$15.0 million in Mesoblast ordinary shares,
exercisable by the Company on or before 31 December 2019, subject
to customary diligence and with pricing to be agreed at the time
Mesoblast gives notice.
- The Company will receive further milestone and royalty payments
from its existing strategic partners JCR, Takeda Pharmaceuticals
Company Ltd. and Tasly Pharmaceutical Group.
- Mesoblast remains in advanced negotiations with a number of
additional potential commercial partners regarding transactions and
access to non-dilutive capital2.
- Mesoblast has extended its fully discretionary equity facility
with Kentgrove Capital of up to A$120.0 million (approximately
US$82.0 million) for the next 24 months.
Graft Versus Host Disease
There are more than 30,000 allogeneic bone marrow transplants
performed annually worldwide3, primarily in patients being treated
for blood cancers. The most severe forms of the disease, Grades C/D
or III/IV, are frequently refractory to steroid therapy and
associated with mortality rates as high as 90%4,5.
There are no approved therapies for aGVHD in the
United States for children under 12.
In Mesoblast’s Phase 3 trial of 55 children with aGVHD - 89% of
whom had Grade C/D disease - treatment with remestemcel-L resulted
in a six-month survival of 69%. In addition, achievement of an
Overall Response at Day 28, which occurred in 69% of patients,
predicted highest survival at Day 100 and Day 180, which was 85%
and 79%, respectively. The trial successfully met its primary
endpoint of increased Day 28 Overall Response compared with a
protocol-defined historical control rate of 45% (p=0.0003). These
data are consistent with prior results from an Expanded Access
Program in 241 children where remestemcel-L was used as salvage
therapy after failure of steroids and other agents.
Remestemcel-L is administered to patients in a series of
intravenous infusions. Remestemcel-L has demonstrated
immunomodulatory properties to counteract the inflammatory
processes that are implicated in aGVHD by down-regulating the
production of pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
Potential United States Market for
Remestemcel-L
The product adoption and reimbursement seen in the Japan GVHD
market for TEMCELL informs Mesoblast’s United States commercial
strategy for remestemcel-L in aGVHD. The Company believes that the
United States addressable market opportunity for remestemcel-L in
aGVHD in children and adults is approximately eight times larger
than Japan given differences in population size, incidence of
aGVHD, and relative pharmacoeconomics6,7,8,9.
Mesoblast is preparing for potential product launch in the
United States of remestemcel-L for aGVHD in children. Health
economics and outcomes research data presented by Mesoblast at the
24th European Hematology Association Congress indicated that
pediatric aGVHD may result in significant deterioration in quality
of life and additional direct healthcare costs of an average of up
to US$500,000 per patient. This represents a significant commercial
opportunity for Mesoblast’s first potential product launch in the
United States.
Filing for FDA approval
The rolling Biologics License Application (BLA) submission to
the FDA is underway and we expect to complete the filing in CY2019.
Remestemcel-L has received Fast Track designation for aGVHD and
under this designation Mesoblast can request a priority review once
its BLA filing is accepted by the FDA.
Commercial Activities for Potential
Launch in United States
In line with our expected timelines for potential United States
launch of remestemcel-L, Mesoblast has increased expenditure on
commercial manufacturing activities and commercial team ramp up in
parallel with its FDA filing activities.
Life Cycle Strategy for Remestemcel-L
Mesoblast intends to expand its clinical program into the adult
aGVHD segment. In addition, an investigator-initiated study
evaluating remestemcel-L in children is planned in the United
States for chronic GVHD.
Mesoblast has the right to use all safety and efficacy data
generated by JCR in Japan for TEMCELL to support its life cycle
strategy for remestemcel-L in the United States and other major
healthcare markets. JCR has filed to extend marketing approval for
TEMCELL in wound healing in patients with Epidermolysis Bullosa,
and is evaluating the use of TEMCELL for the treatment of newborns
who lack sufficient blood supply and oxygen to the brain, a
condition termed hypoxic ischemic encephalopathy.
Chronic Heart Failure
Advanced Heart Failure
In the United States alone, of more than 6.5 million patients
with chronic heart failure, there are more than 1.3 million
patients with advanced stage of the disease who have high rates of
morbidity and mortality despite maximal existing therapies10. This
well-defined major treatment gap in these needy patients is a
potential multi-billion dollar market opportunity for Mesoblast.
The objective of treatment with Mesoblast’s allogeneic cell therapy
Revascor is to prevent or delay further progression of heart
failure or death.
The American Heart Association journal Circulation Research11
recently published a Special Article highlighting the important
potential clinical benefits of Revascor as an immunotherapy in
patients with advanced chronic heart failure, stating that there is
a biologic rationale for the use of Revascor in targeting cardiac
inflammation in order to improve heart failure outcomes.
In a post-hoc analysis of an earlier Phase 2 trial published in
Circulation Research12, it was found that control patients with
very enlarged hearts (left ventricular end systolic volume
>100ml) deteriorated most rapidly, while similar patients
receiving Revascor were protected against disease progression.
These Phase 2 findings identified the patient population most
likely to benefit from Revascor and guided the clinical trial
design for the subsequent Phase 3 study.
In Mesoblast’s randomized, placebo-controlled Phase 3 trial,
enrollment of 566 patients has been completed across 55 centers in
North America. The trial’s primary endpoint is reduction in heart
failure-related hospital admissions, and the key secondary endpoint
is reduction in terminal cardiac events.
Revascor was successful in April 2017 in a pre-specified
futility analysis of the Phase 3 trial’s primary efficacy endpoint
in the first 270 patients enrolled in the trial.
Currently, approximately 90% of events in this Phase 3 trial
have been accrued and validated. Mesoblast expects the trial to
accrue all the requisite primary events by the end of CY2019 with
readouts planned during the first half of CY2020.
End-stage Heart Failure
In the United States, over 60,000 patients annually suffer from
end-stage heart failure13, and despite optimal medical therapy
these patients have a one-year mortality exceeding 50%14. The
only options to increase survival in these patients are the use of
heart transplants or left ventricular assist devices (LVADs). The
use of LVADs is gaining momentum, with approximately 5,500 LVADs
implanted annually in the United States15,16,17.
In patients implanted with an LVAD, endothelial dysfunction and
reduced blood flow caused by severe inflammation result in a
compensatory abnormal network of blood vessels in the
gastrointestinal tract, with potentially life-threatening bleeding
in up to 40% of patients17,18. Mesoblast believes that Revascor may
address the severe inflammation that leads to these major bleeding
complications.
In November 2018, United States National Institutes of Health
investigators presented results of a 159-patient randomized
placebo-controlled Phase 2 clinical trial at the American Heart
Association Scientific Sessions. In the Phase 2 trial, a single
intra-myocardial injection of Revascor at the time of LVAD
implantation resulted in a 76% reduction in major GI bleeding
events and 65% reduction in related hospitalizations in the overall
patient population studied. In a post-hoc analysis in patients with
an ischemic cause of their heart failure, these effects of Revascor
were even greater, as well as an observed significant increase in
the ability to wean off device support, suggesting strengthening of
the native heart muscle.
The FDA recently provided guidance on the pathway for marketing
authorization of Revascor in this indication.
Key outcomes were:
- FDA reiterated that a reduction in major gastrointestinal
bleeding events and/or epistaxis, collectively termed major mucosal
bleeding events, is an important clinical outcome in patients
implanted with an LVAD.
- FDA confirmed that data from the recently completed 159-patient
placebo-controlled trial showing that Revascor reduced major
mucosal bleeding events can support product marketing
authorization through a BLA, with confirmatory clinical trial data.
- FDA agreed on a confirmatory Phase 3 trial of Revascor in LVAD
patients, with a primary endpoint of reduction in major mucosal
bleeding events, and key secondary endpoints demonstrating
improvement in various parameters of cardiovascular function.
Revascor is being developed for these patients under existing
FDA Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug
designations.
The confirmatory trial is planned to be conducted with the
International Center for Health Outcomes Innovation Research
(InCHOIR) at the Icahn School of Medicine at Mount Sinai in
New York, in line with an existing Memorandum of Understanding. It
is expected to be initiated before the end of
CY2019. Chronic
Low Back Pain
Approximately 3.2 million patients in the United
States alone suffer from chronic low back pain due to moderate
degenerative disc disease19. After failure of conservative measures
(medication, injections, epidural steroid, physical therapy etc.),
there is a need for treatments that both reduce pain and improve
function over a sustained period of time.
In post-hoc results from an earlier randomized,
placebo-controlled Phase 2 trial in 100 patients, data showed that
a single intra-discal injection of MPC-06-ID resulted in over a
three-fold increase relative to saline controls in successfully
achieving a composite endpoint consisting of 50% improvement in low
back pain and 15 point improvement in function at both 12 and 24
months with no treatment or surgical interventions at the treated
level through 24 months. In this study, 37% of patients treated
with MPC-06-ID compared with 10% in the control group achieved this
composite endpoint over two years.
This composite endpoint is the primary endpoint in the Phase 3
clinical trial for chronic low back pain which completed enrollment
in March 2018 with 404 patients randomized 2:1 to receive either
MPC-06-ID or saline control. Follow-up of patients in the
Phase 3 trial of MPC-06-ID is continuing to a 24-month assessment
of safety and efficacy. All patients will have completed 24 months
of follow-up by the first quarter of CY 2020, with readouts planned
mid-CY2020.
Board and Senior Executive Appointments in Line with
Commercialization Plans
As Mesoblast transitions to a commercial stage company, there
have been two key additions to its Board of Directors and the
appointment of a new Chief Medical Officer.
Joseph R. Swedish has been appointed as Mesoblast’s
non-executive Chairman and Shawn Tomasello as a non-executive
Director.
Mr Swedish most recently served as Chairman, President and CEO
of Anthem Inc., a Fortune 29 company and the leading health
benefits provider in the U.S. He also serves on the boards of IBM
Corporation, CDW Corporation, Proteus Digital Health, and
Centrexion Therapeutics. Ms Tomasello was Chief Commercial Officer
at leading immuno-oncology cell therapy company Kite Pharma, where
she played a pivotal role in its acquisition in 2017 by Gilead
Sciences. Prior to this she served as Chief Commercial Officer at
Pharmacyclics, Inc., which was acquired in 2015 by AbbVie, Inc. Ms
Tomasello previously was President of the Americas, Hematology and
Oncology at Celgene Corporation. Ms Tomasello currently serves on
the Board of Directors of Centrexion Therapeutics, Oxford
BioTherapeutics and Diplomat Rx.
Mesoblast’s new Chief Medical Officer, Dr Fred Grossman, brings
a wealth of commercial experience gained from numerous leadership
roles at global pharmaceutical companies. He has over 20 years of
industry experience, and has held key leadership positions at major
global pharmaceutical companies, including Eli Lilly, Johnson &
Johnson (J&J), Bristol-Myers Squibb (BMS), Sunovion, and
Glenmark. During his career, he has managed global clinical
development, pharmacovigilance, medical affairs and clinical
operations for innovative product development, as well as FDA
approvals and post-market support for numerous blockbuster,
specialty and generic products. Dr Grossman has led and built teams
in the United States, Europe and Japan with responsibility for
global medical affairs, global clinical development, health
economics and outcomes research and global drug safety.
Manufacturing
Mesoblast is developing patent-protected product
candidates for a range of inflammatory and immune-mediated
conditions using a scalable, allogeneic (off-the-shelf) cellular
medicine platform technology.
The Company’s manufacturing activities meet stringent criteria
set by international regulatory agencies, including the FDA and
EMA. Mesoblast’s product candidates contain well-characterized cell
populations, and our robust quality assurance processes ensures
final product with batch-to-batch consistency and reproducibility
as measured by well-established product release assays.
Mesoblast has proprietary technology that facilitates the
increase in yields necessary for the long-term commercial supply of
our product candidates, and next generation manufacturing processes
using three-dimensional bioreactors to reduce labour and drive down
cost of goods.
Intellectual Property
Mesoblast continues to protect and expand its
extensive estate of patent rights and intellectual property with
approximately 995 patents and patent applications across 68 patent
families. These patents relate principally to compositions of
matter, methods of manufacture, and uses/indications of mesenchymal
lineage cells.
More specifically, the Company’s patent estate includes issued
patent and patent applications in major markets, including, but not
limited to, the United States, Europe, Japan and China. The patents
that Mesoblast has obtained, and continue to apply for, cover
mesenchymal lineage cell technologies and product candidates
derived from these technologies, irrespective of the tissue source,
including bone marrow, adipose, placenta, umbilical cord and dental
pulp.
Among the indication-specific issued or pending
patents covering product candidates derived from the Company’s
mesenchymal lineage cells are those which are directed to its lead
product candidates for aGVHD, advanced heart failure, chronic low
back pain, as well as chronic auto-immune conditions such as
rheumatoid arthritis. Mesoblast also has issued and pending patents
covering other pipeline indications, including diabetic kidney
disease, inflammatory bowel disease (e.g. Crohn’s disease),
neurologic diseases, eye diseases and additional orthopedic
diseases. In addition, the Company has in-licensed patents covering
complementary technologies, such as other types of mesenchymal
lineage cells, cell surface modification technologies, pay-loading
technology and protein and gene technologies, as part of its
strategy to expand its targeted disease applications and manage the
life cycle of its current lead programs.
Licensing agreements with JCR, Tasly and Takeda highlight the
strength of Mesoblast's extensive intellectual property portfolio
covering mesenchymal lineage cells. Mesoblast will continue to use
its patents to prosecute its commercial rights as they relate to
its core strategic product portfolio. When consistent with the
Company’s strategic objectives, it may consider providing third
parties with commercial access to its patent portfolio.
Detailed Financial Results for the Year Ended June 30,
2019
- Revenues were US$16.7 million for FY2019,
compared to US$17.3 million for FY2018. Revenues comprised:•
US$10.0 million revenue recognized in FY2019 in relation to
establishing a partnership with Tasly in China, compared with
US$11.8 million revenue recognized in FY2018 in relation to the
patent license agreement with Takeda Pharmaceutical Company
Limited.• US$6.0 million royalties and milestone revenues
recognized in FY2019 from sales of TEMCELL by JCR compared with
US$5.1 million in FY2018, an increase of US$0.9 million. Royalty
revenue on sales of TEMCELL increased by 37% for FY2019 compared to
FY2018.
- Research and Development expenses were US$59.8
million for FY2019, compared to US$65.9 million for FY2018. This
US$6.1 million decrease was due to a reduction in third party costs
in our Phase 3 clinical trials.
- Manufacturing expenses were US$15.4 million
for FY2019, compared to US$5.5 million for FY2018, an increase of
US$9.9 million for commercial manufacturing investment primarily to
support the potential launch of remestemcel-L.
- Management and Administration expenses were
US$21.6 million for FY2019, compared to US$21.9 million for FY2018,
a decrease of US$0.3 million.
- Finance Costs of US$11.3 million in interest
expenses were recognized for FY2019, of which US$4.6 million was
paid in cash, compared with US$1.8 million for FY2018, in relation
to financial agreements with Hercules and NovaQuest.
Additional components of loss after income tax also include
movements in other items which did not impact current cash
reserves, such as income tax benefits, fair value remeasurement of
contingent consideration, remeasurement of borrowing arrangements
and foreign exchange movements within other operating income and
expenses.
In FY2019, the net loss attributable to ordinary shareholders
was 18.16 cents per share for FY2019, compared with a loss per
share of 7.58 cents for FY2018. There was an after tax loss of
US$89.8 million in FY2019, compared to US$35.3 million for FY2018.
The increase in the loss is primarily due to commercial
manufacturing investment of US$9.9 million to support potential
launch of remestemcel-L, and an increase of US$9.5 million in
finance costs. Additionally, in the FY2018 comparative period, the
Company recognized a one-off non-cash income tax benefit of US$23.0
million primarily due to a revaluation of tax liabilities given
changes in tax rates and a non-cash US$10.5 million gain on
remeasurement of contingent consideration for reduction of future
payments to third parties.
Conference Call Details
There will be a webcast today on the financial results beginning
at 8am AEST (Friday August 30, 2019); 6pm EDT (Thursday August 29,
2019). It can be accessed via
https://s1.c-conf.com/diamondpass/mesoblast-10001891-invite.html
To access the call only, dial 1800 558 698 (toll-free
Australia), 1 855 881 1339 (toll-free U.S.), or +61 2 9007 3187
(outside of the U.S. and Australia). The conference identification
code is 10001891.
The archived webcast will be available on the Investor page of
the Company’s website: www.mesoblast.com
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
References1. TEMCELL® HS Inj. is a registered
trademark of JCR Pharmaceuticals Co. Ltd.2. Mesoblast does not make
any representation or give any assurance that such a partnering
transaction will be concluded.3. Niederwieser D, Baldomero H, Szer
J. (2016) Hematopoietic stem cell transplantation activity
worldwide in 2012 and a SWOT analysis of the Worldwide Network for
Blood and Marrow Transplantation Group including the global survey.
4. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory
acute GVHD: predictors and outcomes. Advances in Hematology. 5. Axt
L, Naumann A, Toennies J (2019) Retrospective single center
analysis of outcome, risk factors and therapy in steroid refractory
graft-versus-host disease after allogeneic hematopoietic cell
transplantation. Bone Marrow Transplantation. 6. Japanese Data
Center for Hematopoietic Cell Transplantation
(JDCHCT) - Activities and Outcomes of Hematopoietic Cell
Transplantation in Japan 2018.7. Westin, J., Saliba, RM., Lima, M.
(2011) Steroid-refractory acute GVHD: predictors and outcomes.
Advances in Hematology.8. CIBMTR Current Uses and Outcomes of
Hematopoietic Cell Transplantation 2017 Summary. Passweg
JR, Baldomero, H (2016) Hematopoietic stem cell
transplantation in Europe 2014: more than 40,000 transplants
annually.9. Risk factors for acute GVHD and survival after
hematopoietic cell transplantation -
Blood 2012 119:296-307; Madan Jagasia et al.10.
AHA’s 2017 Heart Disease and Stroke Statistics.11.Phase 3 DREAM-HF
Trial of Mesenchymal Precursor Cells in Chronic Heart Failure; A
Review of Biological Plausibility and Implementation of Flexible
Clinical Trial Design; Circulation Research, July 2019 12. A Phase
II Dose-Escalation Study of Allogeneic Mesenchymal Precursor Cells
in Patients with Ischemic or Non-ischemic Heart Failure;
Circulation Research, July 2015.13. Gustafsson F, Rogers JG. Left
ventricular assist device therapy in advanced heart failure:
patient selection and outcomes. European Journal of Heart Failure
2017;19:595-602. 14. United Network for Organ Sharing. 15. Agency
for Healthcare Research and Quality–Healthcare Cost and Utilization
Project–Claims Analysis ICD- 37. 16. Data on file. 17. Chatterjee
A, Feldmann C, Hanke JS (2018);The momentum of HeartMate 3: a novel
active magnetically levitated centrifugal left ventricular assist
device (LVAD). J Thorac Dis 10 (Suppl 15): S1790-S1793. 18. Mehra,
MR Salerno C, Cleveland JC (2018) Health care resources use and
cost implications in the MOMENTUM 3 long-term outcome study: a
randomized controlled trial of a magnetically levitated cardiac
pump in advanced heart failure. 19. Decision Resources: Chronic
Pain December 2015.
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, and ability to access, 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 6036E:
julie.meldrum@mesoblast.com |
T: +1 212 880 2060E:
schond.greenway@mesoblast.com |
|
|
Consolidated Income Statement
|
(unaudited) |
|
|
(audited) |
|
|
Three Months
EndedJune 30, |
|
|
Year Ended June 30, |
|
(in U.S. dollars, in
thousands, except per share amount) |
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenue |
|
1,967 |
|
|
|
1,700 |
|
|
|
16,722 |
|
|
|
17,341 |
|
Research & development |
|
(11,435 |
) |
|
|
(17,539 |
) |
|
|
(59,815 |
) |
|
|
(65,927 |
) |
Manufacturing
commercialization |
|
(2,448 |
) |
|
|
(2,121 |
) |
|
|
(15,358 |
) |
|
|
(5,508 |
) |
Management and
administration |
|
(5,627 |
) |
|
|
(5,219 |
) |
|
|
(21,625 |
) |
|
|
(21,907 |
) |
Fair value remeasurement of
contingent consideration |
|
(2,912 |
) |
|
|
2,661 |
|
|
|
(6,264 |
) |
|
|
10,541 |
|
Other operating income and
expenses |
|
(26 |
) |
|
|
69 |
|
|
|
(1,086 |
) |
|
|
1,312 |
|
Finance costs |
|
(3,422 |
) |
|
|
(1,406 |
) |
|
|
(11,328 |
) |
|
|
(1,829 |
) |
Loss before income
tax |
|
(23,903 |
) |
|
|
(21,855 |
) |
|
|
(98,754 |
) |
|
|
(65,977 |
) |
Income tax benefit |
|
3,177 |
|
|
|
1,021 |
|
|
|
8,955 |
|
|
|
30,687 |
|
Loss attributable to the
owners of Mesoblast Limited |
|
(20,726 |
) |
|
|
(20,834 |
) |
|
|
(89,799 |
) |
|
|
(35,290 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses per share from
continuing operations attributable to the
ordinary equity holders of the Group: |
Cents |
|
|
Cents |
|
|
Cents |
|
|
Cents |
|
Basic - losses per share |
|
(4.15 |
) |
|
|
(4.39 |
) |
|
|
(18.16 |
) |
|
|
(7.58 |
) |
Diluted - losses per share |
|
(4.15 |
) |
|
|
(4.39 |
) |
|
|
(18.16 |
) |
|
|
(7.58 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Comprehensive Income
|
(unaudited) |
|
|
(audited) |
|
|
Three Months
EndedJune 30, |
|
|
Year Ended June 30, |
|
(in U.S. dollars, in
thousands) |
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Loss for the period |
|
(20,726 |
) |
|
|
(20,834 |
) |
|
|
(89,799 |
) |
|
|
(35,290 |
) |
Other comprehensive
(loss)/income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified to
profit and loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in the fair value of
financial assets |
|
(284 |
) |
|
|
183 |
|
|
|
(4 |
) |
|
|
324 |
|
Exchange differences on
translation of foreign operations |
|
(33 |
) |
|
|
(334 |
) |
|
|
(137 |
) |
|
|
(903 |
) |
Other comprehensive (loss)/income
for the period, net of tax |
|
(317 |
) |
|
|
(151 |
) |
|
|
(141 |
) |
|
|
(579 |
) |
Total comprehensive
losses attributable to the owners of
Mesoblast Limited |
|
(21,043 |
) |
|
|
(20,985 |
) |
|
|
(89,940 |
) |
|
|
(35,869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheet
|
(audited)As of June 30, |
|
(in U.S. dollars, in
thousands) |
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
Current
Assets |
|
|
|
|
|
|
|
Cash & cash equivalents |
|
50,426 |
|
|
|
37,763 |
|
Trade & other
receivables |
|
4,060 |
|
|
|
50,366 |
|
Prepayments |
|
8,036 |
|
|
|
12,942 |
|
Total Current
Assets |
|
62,522 |
|
|
|
101,071 |
|
|
|
|
|
|
|
|
|
Non-Current
Assets |
|
|
|
|
|
|
|
Property, plant and
equipment |
|
826 |
|
|
|
1,084 |
|
Financial assets at fair value
through other comprehensive income |
|
2,317 |
|
|
|
2,321 |
|
Other non-current assets |
|
3,324 |
|
|
|
3,361 |
|
Intangible assets |
|
583,126 |
|
|
|
584,606 |
|
Total Non-Current
Assets |
|
589,593 |
|
|
|
591,372 |
|
Total
Assets |
|
652,115 |
|
|
|
692,443 |
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
|
|
Trade and other payables |
|
13,060 |
|
|
|
18,921 |
|
Provisions |
|
7,264 |
|
|
|
5,082 |
|
Borrowings |
|
14,007 |
|
|
|
— |
|
Deferred consideration |
|
10,000 |
|
|
|
— |
|
Total Current
Liabilities |
|
44,331 |
|
|
|
24,003 |
|
|
|
|
|
|
|
|
|
Non-Current
Liabilities |
|
|
|
|
|
|
|
Deferred tax liability |
|
11,124 |
|
|
|
20,079 |
|
Provisions |
|
48,329 |
|
|
|
42,956 |
|
Borrowings |
|
67,279 |
|
|
|
59,397 |
|
Total Non-Current
Liabilities |
|
126,732 |
|
|
|
122,432 |
|
Total
Liabilities |
|
171,063 |
|
|
|
146,435 |
|
Net Assets |
|
481,052 |
|
|
|
546,008 |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
Issued Capital |
|
910,405 |
|
|
|
889,481 |
|
Reserves |
|
40,638 |
|
|
|
36,719 |
|
(Accumulated losses)/retained
earnings |
|
(469,991 |
) |
|
|
(380,192 |
) |
Total
Equity |
|
481,052 |
|
|
|
546,008 |
|
|
|
|
|
|
|
|
|
Consolidated Statement of Cash Flows
|
(audited)Year endedJune
30, |
|
(in U.S. dollars, in
thousands) |
2019 |
|
|
2018 |
|
Cash
flows from operating activities |
|
|
|
|
|
|
|
Commercialization revenue received |
|
4,359 |
|
|
|
3,019 |
|
Milestone payment received |
|
26,409 |
|
|
|
7,125 |
|
Research and development tax incentive received |
|
1,654 |
|
|
|
— |
|
Payments to suppliers and employees (inclusive of goods
and services tax) |
|
(86,294 |
) |
|
|
(84,682 |
) |
Interest received |
|
726 |
|
|
|
367 |
|
Interest and other costs of finance paid |
|
(4,641 |
) |
|
|
(816 |
) |
Income taxes (paid) |
|
(3 |
) |
|
|
(25 |
) |
Net cash (outflows) in operating
activities |
|
(57,790 |
) |
|
|
(75,012 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
Investment in fixed assets |
|
(279 |
) |
|
|
(201 |
) |
Payments for contingent
consideration |
|
(721 |
) |
|
|
(952 |
) |
Rental deposits received |
|
— |
|
|
|
— |
|
Net cash inflows/(outflows) in investing
activities |
|
(1,000 |
) |
|
|
(1,153 |
) |
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
Proceeds from borrowings |
|
43,572 |
|
|
|
31,704 |
|
Payments of transaction costs from borrowings |
|
(1,614 |
) |
|
|
(392 |
) |
Proceeds from issue of shares |
|
30,258 |
|
|
|
40,566 |
|
Payments for share issue costs |
|
(608 |
) |
|
|
(3,265 |
) |
Net cash inflows by financing activities |
|
71,608 |
|
|
|
68,613 |
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in cash and cash equivalents |
|
12,818 |
|
|
|
(7,552 |
) |
Cash and cash equivalents at beginning of period |
|
37,763 |
|
|
|
45,761 |
|
FX gain/(losses) on the translation of foreign bank
accounts |
|
(155 |
) |
|
|
(446 |
) |
Cash and cash equivalents at end of
period |
|
50,426 |
|
|
|
37,763 |
|
|
|
|
|
|
|
|
|
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