Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
reported financial, corporate and operational highlights for the
nine months ended March 31, 2020. Cash on hand at March 31, 2020
was US$60.1 million (A$97.3 million) and in May 2020, pro forma
cash on hand was approximately US$150 million (A$235 million) after
adjusting for a US$90 million (A$138 million) capital raise.
Mesoblast Chief Executive Dr Silviu Itescu stated: “This past
quarter has underscored the value of our lead product candidate
remestemcel-L and the experience we have gained in its use over
recent years in patients with severe cytokine release
syndromes.
“Our Biologics License Application for marketing approval of
RYONCILTM (remestemcel-L) in children with steroid-refractory acute
graft versus host disease is currently under priority review by the
United States Food and Drug Administration (FDA), and we hope to be
able to make the product available to patients suffering with this
life-threatening inflammatory condition during 2020. We are also
proud to be developing remestemcel-L as a potential very important
therapy in the battle against COVID-19. A Phase 3 randomized
controlled trial in the United States is underway to confirm the
remarkable pilot data from compassionate use of remestemcel-L in
COVID-19 infected patients with moderate to severe acute
respiratory distress syndrome (ARDS), and to definitively determine
whether this product candidate can contribute meaningfully to this
urgent, unmet medical need.”
Financial Highlights for the Nine Months of FY2020
Compared with the Nine Months of FY2019:
- 113% increase in revenues to US$31.5 million, compared with
US$14.8 million, comprising:o 81% growth in royalty revenues to
US$5.9 million from sales of TEMCELL HS Inj.®1 by Mesoblast’s
licensee for steroid-refractory acute graft versus host disease
(SR-aGVHD) in Japan, compared with US$3.3 million.o 127% increase
in milestone revenues to US$25.0 million from strategic
partnerships compared to US$11.0 million.
- 34% reduction in loss after tax (US$45.3 million compared with
US$69.1 million) driven by:o 113% increase in total revenueso 15%
decrease in research and development spend (US$40.9 million
compared with US$48.4 million)
- Cash on hand at March 31, 2020 was US$60.1 million
- Pro forma cash on hand is approximately US$150 million, with
the additional US$90 million capital raised in May 2020
- Up to an additional US$67.5 million may be available through
existing financing facilities and strategic partnerships over next
12 months
- Capital will be used for the:o commercial launch of RYONCIL for
acute GVHD o scale-up of manufacturing for projected increase in
capacity requirements for maturing pipeline, including GVHD label
extensions and COVID-19 ARDSo clinical programs supporting label
extension strategies and regulatory approvals of Phase 3
assets.
Operational
and Corporate Highlights for the Nine Months of
FY2020:
- The United States Food and Drug Administration (FDA) accepted
for priority review the Company’s Biologics License Application
(BLA) to seek approval of its lead allogeneic cell therapy
remestemcel-L2 for steroid-refractory acute graft versus host
disease (SR-aGVHD) in children under the brand name
RYONCILTM.3
- The FDA set a Prescription Drug User Fee Act (PDUFA) action
date of September 30, 2020, and if approved, Mesoblast will make
RYONCIL immediately available in the United
States.
- Mesoblast continues to build a targeted commercial team and
inventory for potential launch of RYONCIL in the United States,
with the continued increase in revenues from sales of TEMCELL in
Japan informing the projected uptake of
RYONCIL.
- Based on the extensive safety and efficacy data for
remestemcel-L in SR-aGVHD and similar cytokine release in both
SR-aGVHD and ARDS, Mesoblast submitted an Investigational New Drug
(IND) application for use of remestemcel-L in the treatment of
patients with moderate to severe ARDS caused by COVID-19, which was
cleared by the FDA.
- Promising results were seen with remestemcel-L under
FDA-sanctioned emergency compassionate use in COVID-19 patients
with moderate to severe ARDS, where nine of 12 ventilator-dependent
patients were able to come off ventilators within a median of 10
days and were discharged from hospital.
- On the back of these results, a 300-patient Phase 3 randomized
controlled trial in patients with moderate to severe ARDS from
COVID-19 was initiated in up to 30 sites across North America, with
planned interim analyses that may result in stopping the trial
early for efficacy or
futility.
- Results from 70 patients with end-stage ischemic heart failure
and a Left Ventricular Assist Device (LVAD), a sub-study of 159
patients randomized to either Revascor® or saline, were presented
at the 2020 American College of Cardiology Virtual Scientific
Sessions, and showed a beneficial effect on LVAD weaning, hospital
readmissions for heart failure, and major mucosal bleeding
events.
- In the Phase 3 randomized controlled trial of Revascor for
advanced heart failure, final study visits for all surviving
patients have been completed, ongoing quality review of all data is
being completed at the study sites, with a data readout planned for
mid-2020.
- Mesoblast continues to collaborate with Grünenthal on the
clinical protocol for a confirmatory Phase 3 trial in Europe for
MPC-06-ID in chronic low back pain due to degenerative disc
disease, with the results of this and the US Phase 3 trial expected
to support both FDA and European Medicines Agency regulatory
approvals.
Major Operational Milestones for the Next 12
Months
Remestemcel-L for SR-aGVHD and Other Inflammatory
Diseases
- FDA has set a Prescription Drug User Fee Act (PDUFA) action
date for RYONCIL in the treatment of pediatric SR-aGVHD of
September 30, 2020
- If approved, US launch of RYONCIL planned for Q4 2020
- Execute lifecycle extension strategy with
investigator-initiated and sponsored clinical trials for pediatric
and adult systemic inflammatory diseases.
Remestemcel-L for Acute Respiratory
Distress Syndrome (ARDS) in COVID-19
- Complete recruitment of Phase 3 trial
- Interim analyses planned which could result in stopping the
trial early for efficacy or futility. First interim analysis when
30% of patients reach the primary endpoint
- Expansion into additional causes of ARDS including influenza
and bacterial infection
- Establish strategic partnerships for manufacturing and
commercialization.4
REVASCOR for Advanced and
End-Stage Heart Failure
- In the Phase 3 randomized controlled trial of Revascor for
advanced heart failure, final study visits for all surviving
patients have been completed, ongoing quality review of all data is
being completed at the study sites, with a data readout planned for
mid-2020
- Initiate confirmatory trial in ischemic end-stage heart failure
patients.
MPC-06-ID for Chronic Low Back Pain
- In the Phase 3 randomized controlled trial of MPC-06-ID for
chronic low back pain due to degenerative disc disease, final study
visits for all patients have been completed, ongoing quality review
of all data is being completed at the study sites, with a data
readout planned for mid-2020
- Work together with Grünenthal to complete clinical protocol
design, obtain regulatory input, and receive clearance from
European regulatory authorities to begin European Phase 3
trial.
Manufacturing
- Scale up of manufacturing to meet projected increase in
capacity requirements for maturing pipeline, including GVHD label
extensions and COVID-19 ARDS
- Implement proprietary xeno-free technologies to increase yields
and output
- Plan for long-term move to 3D bioreactors to reduce labor and
improve manufacturing efficiencies
Lead Program
Updates RYONCIL™
(remestemcel-L) for Steroid-refractory Acute GVHD in
Children
- The FDA has accepted for priority review the BLA for RYONCIL
under the product candidate’s existing Fast Track designation. If
approved, this product is expected to be launched in the US in Q4
2020.
- Three peer-reviewed articles on distinct clinical trials of
RYONCIL for the treatment of acute GVHD were published in the
May issue of Biology of Blood and Marrow Transplantation, the
official publication of the American Society for Transplantation
and Cellular Therapy.
- Results from these three trials show a consistent pattern of
safety and efficacy for RYONCIL (remestemcel-L) in patients
with the greatest levels of inflammation and the most severe
grades of acute GVHD. These clinical outcomes provide a compelling
rationale for use of remestemcel-L in children and adults with
other conditions associated with severe inflammation and cytokine
release, including acute respiratory distress syndrome (ARDS) and
systemic vascular manifestations of COVID-19 infection.
Remestemcel-L for COVID-19 ARDS
- During the period March-April 2020, 12 ventilator-dependent
COVID-19 patients with moderate/severe COVID-19 ARDS were treated
with two infusions of remestemcel-L within the first five days
under emergency compassionate use at New York City’s Mt Sinai
hospital. Nine patients successfully came off ventilator support at
a median of 10 days and were discharged from hospital.
- These results contrast with only 9% of ventilator-dependent
COVID-19 patients being able to come off ventilators with standard
of care treatment at two major referral hospital networks in New
York during the same time period. This compassionate use treatment
experience has informed the design of the clinical protocol for the
randomized, placebo-controlled Phase 3 trial of remestemcel-L in
ventilator-dependent COVID-19 moderate/severe ARDS patients in
Northern America.5-6
- First patients have been dosed in the Phase 3 randomized
placebo-controlled trial in the United States of remestemcel-L in
COVID-19 infected patients with moderate to severe ARDS on
ventilator support. Enrollment is underway in up to 30 leading
medical centers across North America and is expected to complete
within three to four months, with interim analyses planned which
could result in stopping the trial early for efficacy or
futility.
- The trial will randomize up to 300 ventilator-dependent
patients in intensive care units to either remestemcel-L or placebo
(1:1) on top of maximal care, in line with specific guidance
provided by the FDA for robust statistical analysis. The primary
endpoint is all-cause mortality within 30 days of randomization,
with the key secondary endpoint being the number of days alive and
off mechanical support.
REVASCOR for Advanced and End-stage Heart
Failure
- Results of 70 patients with end-stage ischemic heart failure
and a Left Ventricular Assist Device (LVAD), from 159 patients
randomized to either Revascor® or saline, were presented at the
2020 American College of Cardiology Virtual Scientific Sessions,
and showed a beneficial effect on LVAD weaning, hospital
readmissions for heart failure, and major mucosal bleeding events.
The trial’s independent investigators concluded that these findings
may reflect the effect of Revascor on angiogenesis, inflammation
and endothelial dysfunction, and warranted further clinical
research. End-stage ischemic heart failure patients with LVADs are
older and have co-morbidities such as diabetes, thereby closely
resembling the majority of patients in the 566-patient Phase 3
trial for advanced heart failure. The full results from these 70
patients will be published in a peer-reviewed journal.
- Final study visits for all patients enrolled in the 566-patient
Phase 3 randomized controlled trial of Revascor for advanced heart
failure have been completed, ongoing quality review of all data is
being completed at the study sites, and data readout is planned for
mid-2020.
- Mesoblast and the International Center for Health Outcomes
Innovation Research (InCHOIR) at the Icahn School of Medicine at
Mount Sinai in New York have agreed on a clinical protocol for a
confirmatory Phase 3 trial of REVASCOR in the treatment of patients
with end-stage ischemic heart failure and a left ventricular assist
device (LVAD), in line with FDA guidance. This product is being
developed for these patients under existing FDA Regenerative
Medicine Advanced Therapy (RMAT) and Orphan Drug Designations.
MPC-06-ID for Chronic Low Back Pain
- Final study visits for all patients have been completed in the
Phase 3 trial with ongoing quality review of all data being
completed at the study sites. More than 400 patients were
randomized in this United States trial, with a data readout planned
for mid-2020.
- Grünenthal and Mesoblast continue to collaborate on the
clinical protocol for a confirmatory Phase 3 trial in Europe, with
the results of the two Phase 3 trials expected to support both FDA
and European Medicines Agency regulatory approvals for MPC-06-ID in
chronic low back pain due to degenerative disc disease.
Financial Results for the Nine Months
Ended March 31, 2020 (nine months of FY2020):
Loss after tax reduced by US$23.7 million to
US$45.3 million for the nine months of FY2020 compared to US$69.1
million for the nine months of FY2019 as detailed below:
- Revenues increased US$16.7 million to US$31.5
million for the nine months of FY2020, compared to US$14.8 million
for the nine months of FY2019.o Milestone revenue increased by
US$14.0 million due to the up-front milestone payment of US$15.0
million received for the strategic partnership with Grünenthal GmbH
in the nine months of FY2020. In the nine months of FY2019 we
recognized US$1.0 million of cumulative sales milestones for sales
of TEMCELL in Japan. Additionally, we recognized US$10.0 million of
milestone revenue in the nine months of FY2020 and FY2019 in
relation to our partnership with Tasly in China.o Royalty revenue
on sales of TEMCELL in Japan increased US$2.7 million (81%) to
US$5.9 million for the nine months of FY2020 compared with US$3.3
million for the nine months of FY2019.
- Research and Development expenses decreased by
US$7.5 million to US$40.9 million for the nine months of FY2020,
compared to US$48.4 million for the nine months of FY2019. This
US$7.5 million decrease was due to a reduction in third party costs
for our Phase 3 advanced heart failure, chronic low back pain and
GVHD clinical trials as enrolment is now complete and activities
are decreasing.
- Manufacturing expenses increased by US$2.5
million to US$15.4 million for the nine months of FY2020, compared
to US$12.9 million for the nine months of FY2019 due to increased
expenditure on pre-launch inventory for the potential launch of
RYONCIL.
- Management and Administration expenses
increased US$2.0 million to US$18.0 million for the nine months of
FY2020, compared with US$16.0 million for the nine months of
FY2019.
- Finance Costs for our borrowing arrangements
with Hercules and NovaQuest were US$9.8 million for the nine months
of FY2020, compared to US$7.9 million for the nine months of
FY2019, an increase of US$1.9 million.
- Income tax benefit increased
by US$0.4 million to US$6.2 million in the nine months of FY2020,
compared with US$5.8 million in the nine months of FY2019 in
relation to deferred tax liabilities recognized on the balance
sheet during the period.
Additional components of loss after income tax also include
movements in other items which did not impact current cash
reserves, including fair value remeasurement of contingent
consideration for which we recognized a gain on remeasurement of
US$1.3 million in the nine months of FY2020 compared to a loss of
US$3.4 million in the nine months of FY2019 due to the revaluation
of contingent consideration in each relevant period.
The net loss attributable to ordinary shareholders was 8.66 US
cents per share for the nine months of FY2020, compared with 14.02
US cents per share for the nine months of FY2019.
Financial Results for the Three Months Ended March 31,
2020 (third quarter FY2020):
Loss after tax reduced by US$9.7 million to
US$15.3 million for the third quarter FY2020 compared to US$25.0
million for the third quarter FY2019 as detailed below:
- Revenues increased US$11.0 million to US$12.2
million for the third quarter FY2020, compared to US$1.2 million
for the third quarter FY2019.o US$10.0 million milestone revenue
recognized in the third quarter FY2020 in relation to our
partnership with Tasly in China.o Royalty revenue on sales of
TEMCELL in Japan increased US$1.0 million (99%) to US$2.1 million
for the third quarter FY2020 compared with US$1.0 million for the
third quarter FY2019.
- Research and Development expenses of US$14.4
million remained consistent for the third quarter FY2020 compared
with the third quarter FY2019.
- Manufacturing expenses increased by US$4.4
million to US$7.6 million for the third quarter FY2020, compared to
US$3.2 million for the third quarter FY2019 due to increased
expenditure on pre-launch inventory for the potential launch of
RYONCIL.
- Management and Administration expenses
increased US$0.5 million to US$5.7 million for the third quarter
FY2020, compared with US$5.2 million for the third quarter
FY2019.
- Finance Costs for our borrowing arrangements
with Hercules and NovaQuest were US$3.4 million for the third
quarter FY2020, compared to US$2.8 million for the third quarter
FY2019, an increase of US$0.6 million.
- Income tax benefit decreased
by US$0.3 million to US$1.9 million in the third quarter FY2020,
compared with US$2.2 million in the third quarter FY2019 in
relation to deferred tax liabilities recognized on the balance
sheet during the period.
Additional components of loss after income tax also include
movements in other items which did not impact current cash
reserves, including fair value remeasurement of contingent
consideration for which we recognized a gain on remeasurement of
US$2.2 million in the third quarter FY2020 compared to a loss of
US$2.7 million in the third quarter FY2019 due to the revaluation
of contingent consideration in each relevant period.
The net loss attributable to ordinary shareholders was 2.84 US
cents per share for the third quarter FY2020, compared with 5.00 US
cents per share for the third quarter FY2019.
WebcastThere will be a webcast today on the
financial results beginning at 8am, Thursday May 28 AEST
and 6pm, Wednesday, May 27, 2020 EDT.
The live webcast can be accessed via
https://webcast.boardroom.media/mesoblast-limited/20200526/NaNmesoblast-q3-financial-results.
To access the call only, dial 1 855 881 1339 (US), 1800 870 643
or 1800 809 971 (Australia) or +61 2 9007 3187 (outside of the US
and Australia). The conference identification code is 10007263.
The archived webcast will be available on the Investor page of
the Company’s website www.mesoblast.com.
References1. TEMCELL HS. Inj.® is a registered
trademark of JCR Pharmaceuticals Co. Ltd.2. United States Adopted
Name (USAN) assigned to Mesoblast’s ex vivo cultured allogeneic
human mesenchymal stem cells.3. RYONCIL has been accepted by the
FDA as the brand name for Mesoblast’s remestemcel-L product.4.
Mesoblast does not make any representation or give any assurance
that such partnering transactions will be concluded.5. Petrilli CM
et al. Factors associated with hospitalization and critical illness
among 4,103 patients with Covid-19 disease in New York City.
MedRxiv 2020 doi.
https://www.medrxiv.org/content/10.1101/2020.04.08.20057794v1.full.pdf6.
Richardson S et al. Presenting characteristics, comorbidities, and
outcomes among 5700 patients hospitalized with COVID-19 in the New
York City area. JAMA 2020. doi:10.1001/jama.2020.6775.
About MesoblastMesoblast Limited (ASX:MSB;
Nasdaq:MSB) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of commercial products and late-stage
product candidates. The Company’s proprietary manufacturing
processes yield industrial-scale, cryopreserved, off-the-shelf,
cellular medicines. These cell therapies, with defined
pharmaceutical release criteria, are planned to be readily
available to patients worldwide.
Mesoblast’s Biologics License Application to seek approval of
its product candidate RYONCIL™ (remestemcel-L) for pediatric
steroid-refractory acute graft versus host disease (acute GVHD) has
been accepted for priority review by the United States Food and
Drug Administration (FDA), and if approved, product launch in the
United States is expected in 2020. Remestemcel-L is also being
developed for other inflammatory diseases in children and adults
including moderate to severe acute respiratory distress syndrome.
Mesoblast is completing Phase 3 trials for its product candidates
for advanced heart failure and chronic low back pain. Two products
have been commercialized in Japan and Europe by Mesoblast’s
licensees, and the Company has established commercial partnerships
in Europe and China for certain Phase 3 assets.
Mesoblast has a strong and extensive global intellectual
property (IP) portfolio with protection extending through to at
least 2040 in all major markets. This IP position is expected to
provide the Company with substantial commercial advantages as it
develops its product candidates for these conditions.
Mesoblast has locations in Australia, the United States and
Singapore and is listed on the Australian Securities Exchange (MSB)
and on the Nasdaq (MESO). For more information, please see
www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter:
@Mesoblast
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.
Release authorized by the Chief Executive, as approved by the
Board of Directors.
For further information, please contact:
MediaJulie
MeldrumT: +61 3 9639 6036E:julie.meldrum@mesoblast.com |
Kristen BothwellT: +1 917 613
5434E:kbothwell@rubenstein.com |
InvestorsSchond
GreenwayT: +212 880 2060E: schond.greenway@mesoblast.com |
Paul Hughes T: +61 3 9639
6036E: paul.hughes@mesoblast.com |
Consolidated Income Statement
|
Three Months EndedMarch 31, |
|
|
Nine Months EndedMarch 31, |
|
(in U.S. dollars, in
thousands, except per share amount) |
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenue |
|
12,201 |
|
|
|
1,249 |
|
|
|
31,455 |
|
|
|
14,755 |
|
Research & development |
|
(14,379 |
) |
|
|
(14,407 |
) |
|
|
(40,922 |
) |
|
|
(48,380 |
) |
Manufacturing
commercialization |
|
(7,612 |
) |
|
|
(3,193 |
) |
|
|
(15,456 |
) |
|
|
(12,910 |
) |
Management and
administration |
|
(5,730 |
) |
|
|
(5,256 |
) |
|
|
(17,960 |
) |
|
|
(15,998 |
) |
Fair value remeasurement of
contingent consideration |
|
2,158 |
|
|
|
(2,718 |
) |
|
|
1,276 |
|
|
|
(3,352 |
) |
Other operating income and
expenses |
|
(442 |
) |
|
|
(82 |
) |
|
|
(28 |
) |
|
|
(1,060 |
) |
Finance costs |
|
(3,414 |
) |
|
|
(2,768 |
) |
|
|
(9,853 |
) |
|
|
(7,906 |
) |
Loss before income
tax |
|
(17,218 |
) |
|
|
(27,175 |
) |
|
|
(51,488 |
) |
|
|
(74,851 |
) |
Income tax benefit |
|
1,955 |
|
|
|
2,205 |
|
|
|
6,158 |
|
|
|
5,778 |
|
Loss attributable to the
owners of Mesoblast Limited |
|
(15,263 |
) |
|
|
(24,970 |
) |
|
|
(45,330 |
) |
|
|
(69,073 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses per share from
continuing operations attributable to the ordinary equity holders
of the Group: |
Cents |
|
|
Cents |
|
|
Cents |
|
|
Cents |
|
Basic - losses per share |
|
(2.84 |
) |
|
|
(5.00 |
) |
|
|
(8.66 |
) |
|
|
(14.02 |
) |
Diluted - losses per share |
|
(2.84 |
) |
|
|
(5.00 |
) |
|
|
(8.66 |
) |
|
|
(14.02 |
) |
Consolidated Statement of Comprehensive
Income
|
Three Months EndedMarch 31, |
|
|
Nine Months EndedMarch 31, |
|
(in U.S. dollars, in
thousands) |
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Loss for the period |
|
(15,263 |
) |
|
|
(24,970 |
) |
|
|
(45,330 |
) |
|
|
(69,073 |
) |
Other comprehensive
(loss)/income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that may be reclassified to
profit and loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial assets at fair value
through other comprehensive income |
|
94 |
|
|
|
85 |
|
|
|
(551 |
) |
|
|
280 |
|
Exchange differences on
translation of foreign operations |
|
(361 |
) |
|
|
79 |
|
|
|
(405 |
) |
|
|
(104 |
) |
Other comprehensive income/(loss)
for the period, net of tax |
|
(267 |
) |
|
|
164 |
|
|
|
(956 |
) |
|
|
176 |
|
Total comprehensive
losses attributable to the owners of Mesoblast
Limited |
|
(15,530 |
) |
|
|
(24,806 |
) |
|
|
(46,286 |
) |
|
|
(68,897 |
) |
Consolidated Balance Sheet
|
|
|
|
|
|
|
|
(in U.S. dollars, in
thousands) |
As ofMarch 31, 2020 |
|
|
As ofJune
30, 2019 |
|
Assets |
|
|
|
|
|
|
|
Current
Assets |
|
|
|
|
|
|
|
Cash & cash equivalents |
|
60,077 |
|
|
|
50,426 |
|
Trade & other
receivables |
|
3,001 |
|
|
|
4,060 |
|
Prepayments |
|
6,315 |
|
|
|
8,036 |
|
Total Current
Assets |
|
69,393 |
|
|
|
62,522 |
|
|
|
|
|
|
|
|
|
Non-Current
Assets |
|
|
|
|
|
|
|
Property, plant and
equipment |
|
1,965 |
|
|
|
826 |
|
Right-of-use assets |
|
7,479 |
|
|
|
— |
|
Financial assets at fair value
through other comprehensive income |
|
1,766 |
|
|
|
2,317 |
|
Other non-current assets |
|
3,244 |
|
|
|
3,324 |
|
Intangible assets |
|
581,943 |
|
|
|
583,126 |
|
Total Non-Current
Assets |
|
596,397 |
|
|
|
589,593 |
|
Total
Assets |
|
665,790 |
|
|
|
652,115 |
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
|
|
Trade and other payables |
|
19,478 |
|
|
|
13,060 |
|
Provisions |
|
27,152 |
|
|
|
7,264 |
|
Borrowings |
|
27,000 |
|
|
|
14,007 |
|
Lease liabilities |
|
3,059 |
|
|
|
— |
|
Deferred consideration |
|
— |
|
|
|
10,000 |
|
Total Current
Liabilities |
|
76,689 |
|
|
|
44,331 |
|
|
|
|
|
|
|
|
|
Non-Current
Liabilities |
|
|
|
|
|
|
|
Deferred tax liability |
|
4,966 |
|
|
|
11,124 |
|
Provisions |
|
28,109 |
|
|
|
48,329 |
|
Borrowings |
|
59,951 |
|
|
|
67,279 |
|
Lease liabilities |
|
5,762 |
|
|
|
— |
|
Deferred consideration |
|
2,500 |
|
|
|
— |
|
Total Non-Current
Liabilities |
|
101,288 |
|
|
|
126,732 |
|
Total
Liabilities |
|
177,977 |
|
|
|
171,063 |
|
Net Assets |
|
487,813 |
|
|
|
481,052 |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
Issued Capital |
|
960,447 |
|
|
|
910,405 |
|
Reserves |
|
43,514 |
|
|
|
40,638 |
|
(Accumulated losses)/retained
earnings |
|
(516,148 |
) |
|
|
(469,991 |
) |
Total
Equity |
|
487,813 |
|
|
|
481,052 |
|
Consolidated Statement of Cash Flows
|
Nine Months
EndedMarch 31, |
|
(in U.S. dollars, in
thousands) |
2020 |
|
|
2019 |
|
Cash
flows from operating activities |
|
|
|
|
|
|
|
Commercialization revenue received |
|
5,579 |
|
|
|
3,321 |
|
Upfront and milestone payments received |
|
17,500 |
|
|
|
26,409 |
|
Research and development tax incentive received |
|
1,499 |
|
|
|
1,654 |
|
Payments to suppliers and employees (inclusive of goods and
services tax) |
|
(57,722 |
) |
|
|
(67,672 |
) |
Interest received |
|
533 |
|
|
|
493 |
|
Interest and other costs of finance paid |
|
(4,165 |
) |
|
|
(2,906 |
) |
Income taxes (paid)/refunded |
|
(7 |
) |
|
|
(3 |
) |
Net cash (outflows) in operating
activities |
|
(36,783 |
) |
|
|
(38,704 |
) |
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
Investment in fixed assets |
|
(1,305 |
) |
|
|
(202 |
) |
Payments for licenses |
|
(100 |
) |
|
|
— |
|
Net cash (outflows) in investing
activities |
|
(1,405 |
) |
|
|
(202 |
) |
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
Proceeds from borrowings |
|
— |
|
|
|
43,572 |
|
Payments of transaction costs from borrowings |
|
— |
|
|
|
(1,582 |
) |
Proceeds from issue of shares |
|
51,559 |
|
|
|
30,258 |
|
Payments for share issue costs |
|
(2,211 |
) |
|
|
(607 |
) |
Payment of lease liabilities |
|
(1,219 |
) |
|
|
— |
|
Net cash inflows by financing activities |
|
48,129 |
|
|
|
71,641 |
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
9,941 |
|
|
|
32,735 |
|
Cash and cash equivalents at beginning of period |
|
50,426 |
|
|
|
37,763 |
|
FX gains/(losses) on the translation of foreign bank
accounts |
|
(290 |
) |
|
|
(113 |
) |
Cash and cash equivalents at end of
period |
|
60,077 |
|
|
|
70,385 |
|
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