Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
reported financial results and operational highlights for the
period ended December 31, 2021.
Financial Highlights
- Mesoblast completed a refinancing of
its senior secured debt facility with a new US$90 million five-year
facility provided by funds managed by Oaktree Capital Management,
L.P.
- Cash on hand at the end of the quarter
was US$94.8 million, with up to an additional US$40 million
available to be drawn down from existing financing facilities
subject to certain milestones
- Total Operating Activities saw a 40%
reduction in net cash usage on the comparative quarter last year,
to US$18.2 million in the current quarter
- Regulatory and manufacturing activities
related to the planned Biologics License Application (BLA)
resubmission for remestemcel-L in steroid-refractory acute graft
versus host disease (SR-aGVHD) in children accounted for over half
of this cash usage
- Revenues in the quarter were US$2.4
million, primarily from TEMCELL® HS Inj.1 royalties on sales for
SR-aGvHD in Japan, which increased 7% on the comparative quarter
last year
Operational Highlights
Activities supporting potential resubmission of the Biologics
License Application (BLA) for remestemcel-L in the treatment of
children with steroid-refractory acute graft versus host disease
(SR-aGVHD):
- Appointed Dr. Eric Rose as the
Company’s Chief Medical Officer (CMO). Dr. Rose brings to Mesoblast
an extensive record of excellence in clinical development and
successful interactions at the highest levels with key regulatory,
industry and government stakeholders including the United States
Food and Drug Administration (FDA), the National Institutes of
Health (NIH), and the Biomedical Advanced Research and Development
Authority (BARDA)
- Held meeting with
the FDA’s Office of Tissues and Advanced Therapies (OTAT) to
address potency assay and chemistry, manufacturing, and controls
(CMC) items identified in the complete response letter (CRL) for
remestemcel-L in the treatment of SR-aGVHD in children
- FDA indicated that
the in vitro immunomodulatory activity Mesoblast intends to measure
for potency of the product is reasonable and that the relevance of
this activity to clinical outcomes should be established
- Mesoblast has now
generated substantial new data that it believes establish the
relevance of the proposed potency assay measuring remestemcel-L’s
in vitro anti-inflammatory and immunomodulatory activity to the in
vivo clinical effect of the product in the Phase 3 trial in
children with SR-aGVHD, including survival and biomarkers of in
vivo activity
- Mesoblast will
provide these new data to FDA and address all other outstanding
items as required for resubmission of the BLA
- Mesoblast continues
to be in a well-established process with FDA’s Center for Biologics
Evaluation and Research (CBER), and if the resubmission is
accepted, FDA will consider the adequacy of the clinical data in
the context of the related CMC issues noted above.
Activities regarding the rexlemestrocel-L Phase 3 programs in
chronic low back pain (CLBP) and chronic heart failure (CHF):
- During the period, Mesoblast
received feedback from the FDA’s OTAT on the Phase 3 program for
CLBP and plans to conduct an additional US Phase 3 trial which may
support submissions for potential approval in both the US and
EU
- Following review of the completed
Phase 3 trial data, OTAT agreed with Mesoblast’s proposal for pain
reduction at 12 months as the primary endpoint of the next trial,
with functional improvement and reduction in opioid use as
secondary endpoints
- Received feedback from FDA’s OTAT
confirming that reduction in major adverse cardiovascular events
(MACE) of cardiovascular mortality or irreversible morbidity
(non-fatal heart attack or stroke) is an acceptable clinically
meaningful endpoint for determining the treatment benefit of
rexlemestrocel-L for patients with chronic heart failure and low
ejection fraction (HFrEF)
- Preparing formal submission to FDA of the detailed analyses of
outcomes in high-risk HFrEF patients with diabetes and/or
myocardial ischemia to agree on a potential pathway to
approval
Board Update
As foreshadowed at the Annual General Meeting in November 2021,
the two long standing Australia-based non-executive directors will
retire from the Board over a 6-12 month period. As such, Mr Donal
O’Dwyer retires from the Board today.
Mesoblast’s Chief Executive, Silviu Itescu said, “I would like
to thank Donal for his tenure since 2004 and specifically his
vision, dedication, and commitment in supporting Mesoblast’s
objectives to bring important and potentially life-saving therapies
to market.”
The Mesoblast Board and management team wish to thank Donal for
his invaluable contributions and wish him well in the future.
DETAILED PRODUCT ACTIVITIES FOR THE PERIOD
Late-Stage Clinical Pipeline
A graphic accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/a21e2f2b-2122-4564-a693-1b5a8431a9f6
Remestemcel-L
Steroid-refractory acute graft versus host disease
(SR-aGVHD) in children:
Mesoblast met with FDA’s OTAT to address the appropriateness of
a potency assay related to remestemcel-L’s proposed
immunomodulatory mechanism of action as well as the approach to
outstanding CMC items identified in the CRL. OTAT indicated that
Mesoblast’s approach to address outstanding CMC items is
reasonable, that the in vitro immunomodulatory activity of
remestemcel-L proposed by Mesoblast as a measure of its potency is
a reasonable critical quality attribute (CQA) for the product in
the treatment of children with SR-aGVHD, and the relevance of this
immunomodulatory activity to clinical outcomes should be
established.
The relevance of remestemcel-L’s activity on severe inflammation
was most recently shown in results from an investigator-initiated
study, published in the peer-reviewed journal Bone Marrow
Transplantation2, in children with SR-aGVHD stratified by baseline
levels of inflammatory biomarkers. The study compared outcomes in
25 children from Mesoblast’s Phase 3 trial of remestemcel-L in
SR-aGVHD with 27 closely matched children from the Mount Sinai
Acute GVHD International Consortium (MAGIC)3 who participated in a
prospective natural history study and were matched for the Phase 3
trial entry criteria. The objective of the study was to evaluate
whether remestemcel-L improved outcomes in children with highest
risk of death, namely those with baseline MAGIC Algorithm
Probability (MAP) biomarker levels ≥0.29, a level associated with
significant GI inflammation and damage, and which is predictive of
poor treatment responses and very high mortality in SR-aGVHD.
In children with MAP ≥0.29, treatment with remestemcel-L
resulted in 67% Day 28 Overall Response and 64% Day 180 overall
survival compared with 10% Day 28 Overall Response and 10% Day 180
survival in the MAGIC cohort (both p=0.01) when treated with
various biologics, including ruxolitinib. These results showed that
remestemcel-L provided a significant benefit in terms of both
response and survival in children with the highest levels of
inflammation and at greatest risk of death.
Mesoblast has now generated substantial new data that it
believes establish the relevance of the proposed potency assay
measuring remestemcel-L’s in vitro anti-inflammatory and
immunomodulatory activity to the in vivo clinical effect of the
product in the Phase 3 trial in children with SR-aGVHD, including
survival and biomarkers of in vivo activity.
Mesoblast will provide these new data to OTAT and address all
other outstanding items as required for resubmission of the
BLA.
Mesoblast continues to be in a well-established process with
FDA’s Center for Biologics Evaluation and Research (CBER), and if
the resubmission is accepted, CBER will consider the adequacy of
the clinical data in the context of the related CMC issues noted
above.
Inflammatory Bowel Disease (IBD) - Ulcerative Colitis
& Crohn’s Colitis
The immunomodulatory effects of remestemcel-L on GI inflammation
is being further evaluated in a randomized, controlled study of
remestemcel-L by direct endoscopic delivery to areas of
inflammation in patients with medically refractory ulcerative
colitis or Crohn’s colitis. Results from an interim analysis of the
first patient cohort showed that a single local delivery of
remestemcel-L by colonoscopy resulted in rapid mucosal healing and
disease remission in these refractory patients at high risk of
progression to surgery. These results were presented at the 17th
Congress of European Crohn’s and Colitis Organisation (ECCO) by the
trial’s lead investigator Dr. Amy L. Lightner, Associate Professor
of Surgery in the Department of Colon and Rectal Surgery at
Cleveland Clinic and were published in the Journal of Crohn's and
Colitis.4,5
The study at Cleveland Clinic will randomize up to 48 patients
with medically refractory ulcerative colitis or Crohn’s colitis in
a 2:1 fashion to receive a single intervention with remestemcel-L
or placebo. Medically refractory ulcerative colitis and Crohn’s
colitis patients are defined as having active disease for at least
6 months and having lost response to at least one monoclonal
antibody (anti-TNF or anti-integrin).6,7
Key results of the interim analysis performed in the first 12
enrolled patients were as follows:
- Colonoscopic delivery of remestemcel-L
was not associated with any treatment-related adverse events
- All ulcerative colitis patients treated
with remestemcel-L had improved clinical and endoscopy scores
within two weeks, as defined by the Mayo clinical score and Mayo
endoscopic severity (MES) score, and all achieved clinical and
endoscopic remission by six weeks
- All ulcerative colitis patients were
extremely satisfied or satisfied with remestemcel-L treatment at
three months, based on the inflammatory bowel disease patient
reported treatment impact (IBD-PRTI), and response was described as
excellent or good in all patients
- All Crohn’s colitis patients treated
with remestemcel-L showed treatment remissions or responses by
three months, as measured by the Simple Endoscopy Score for Crohn’s
Disease (SES-CD) (mean score 17 at baseline decreased to 5 at three
months)
- Remestemcel-L treatment resulted in
reduction of fecal calprotectin, a validated biomarker of disease
activity,8 from mean of 231 at baseline to 67 at three months,
indicative of remission
- In controls with ulcerative colitis and
Crohn’s colitis over three months, endoscopy scores increased,
fecal calprotectin levels increased from a mean of 330 to 505, and
clinical responses were described as poor or unchanged
Acute Respiratory Distress Syndrome (ARDS) due to
COVID-19
High infection rates continue and new variants of COVID-19 are
emerging globally. Hospitalizations remain high with significant
numbers of patients in ICU and on ventilators. The ongoing
mortality rates underline the high unmet clinical need for new
therapies in hospitalized patients who are at risk of developing
ARDS.
Mesoblast has met with the FDA in regard to potential emergency
use authorization (EUA) for remestemcel-L in the treatment of
ventilator-dependent patients with moderate or severe ARDS due to
COVID-19. The FDA advised Mesoblast that an additional clinical
study in COVID ARDS would be required which, if statistically
positive, could provide a dataset in conjunction with the recently
completed 222 patient clinical study that might be sufficient to
support an EUA. Mesoblast intends to move forward with the pivotal
trial for EUA, with reference to the aGVHD BLA for product potency
assay in place prior to trial commencement.
Rexlemestrocel-L
Chronic Low Back Pain (CLBP) associated with
Degenerative Disc Disease (DDD)
There is a significant need for a safe, effective, and durable
opioid-sparing treatment in patients with CLBP associated with
degenerative disc disease. Mesoblast recently presented 36-month
follow-up results from the 404-patient, three-arm, Phase 3 trial in
patients with CLBP associated with DDD, which showed durable
reduction in back pain lasting at least three years from a single
intra-discal injection of rexlemestrocel-L+hyaluronic acid (HA)
carrier.
Results presented from this trial showed that:
- Durable reduction in pain through 36
months was greatest in the pre-specified population with CLBP of
shorter duration than the study median of 68 months (n=194),
suggesting that greatest benefits may be seen when the therapy is
administered earlier in the disease process when there is active
inflammation and before irreversible fibrosis of the intervertebral
disc has occurred
- Pain reduction through 36 months was
also seen in the subset of patients using opioids at baseline
(n=168) with the rexlemestrocel-L+HA group having substantially
greater reduction at all time points compared with saline
controls
- Among patients on opioids at baseline,
despite instructions to maintain existing therapies throughout the
trial, at 36 months 28% who received rexlemestrocel-L + HA were not
taking an opioid compared with 8% of saline treated controls
(nominal p value 0.0075)
During the period, Mesoblast received feedback from the FDA’s
OTAT on the Phase 3 program for CLBP and plans to conduct an
additional US Phase 3 trial which may support submissions for
potential approval in both the US and EU. Following review of the
completed Phase 3 trial data, OTAT agreed with Mesoblast’s proposal
for pain reduction at 12 months as the primary endpoint of the next
trial, with functional improvement and reduction in opioid use as
secondary endpoints.
Chronic Heart Failure
Data from the landmark DREAM-HF randomized, controlled Phase 3
trial of rexlemestrocel-L in 565 patients with chronic heart
failure and low ejection fraction (HFrEF) were presented as a late
breaking presentation at the AHA annual Scientific Sessions during
a featured program titled ‘Building on the Foundations of
Treatment: Advances in Heart Failure Therapy.’
The trial’s co-principal investigator Dr Emerson Perin, Medical
Director of Texas Heart Institute, and Clinical Professor, Baylor
College of Medicine, presented new results from the landmark study
showing a significant relationship between presence of systemic
inflammation as quantified by high-sensitivity C-reactive protein
(hs-CRP) and treatment benefit with rexlemestrocel-L on risk of
major adverse cardiovascular events (MACE) of cardiovascular
mortality, heart attack or stroke.
In addition, FDA provided guidance that confirmed a reduction in
incidence of cardiovascular mortality or irreversible morbidity
(non-fatal heart attack or stroke) is a clinically meaningful
acceptable endpoint in patients with chronic HFrEF and encouraged
Mesoblast to identify the highest-risk group with greatest
likelihood of beneficial response to intervention with
rexlemestrocel-L in the DREAM-HF Phase 3 trial.
In line with this guidance, Mesoblast performed additional
analyses of MACE outcomes in pre-specified high-risk patient groups
from the landmark DREAM-HF trial, and the results were presented in
December at the 18th Global CardioVascular Clinical Trialists Forum
(CVCT) in Washington DC.
The data showed that:
- While a single rexlemestrocel-L dose on
top of maximal standard of care therapies reduced the composite
3-point MACE in all 537 patients by 33% (p=0.02) over a mean
follow-up of 30 months, a hierarchical analysis across
pre-specified high-risk subgroups showed greatest benefit in
patients with diabetes and/or myocardial ischemia (hazard ratio
0.63, p=0.019)
- Among control patients with HFrEF
(n=276) all of whom were treated with maximal available standard of
care therapies, risk of 3-point MACE was 1.9-fold higher in
controls with diabetes and/or myocardial ischemia (n=192) than
controls with neither diabetes nor myocardial ischemia (n=84),
p=0.02. This confirmed the ongoing high-risk of 3-point MACE in
control patients with diabetes and/or myocardial ischemia due to
micro- and macro-vascular disease despite receiving optimal
standard of care therapies
- Compared to control patients,
rexlemestrocel-L reduced the incidence of 3-point MACE by 37%
overall in NYHA class II or III HFrEF patients with diabetes and/or
myocardial ischemia (n=385, p=0.02) and by 54% in those with
diabetes and/or myocardial ischemia who had evidence of systemic
inflammation, as defined by elevated baseline levels of hs-CRP
>2mg/L (n=212, p=0.003).
Diabetes Mellitus is not only a significant risk factor in the
onset of heart failure, it also increases the risk of mortality and
morbidity in patients who have existing heart failure.,9-11 Type 2
diabetes causes structural heart disease and heart failure through
myocardial ischemia involving small and large vessels. Importantly,
inflammation which is a critical component of the pathophysiology
of the disease is also known to accelerate large vessel
atherosclerosis.9
Mesoblast will submit for formal FDA review the new data
analyses showing the reduction in mortality and irreversible
morbidity by rexlemestrocel-L in HFrEF patients with diabetes
and/or myocardial ischemia, to agree on a potential pathway to
approval.
FINANCIAL RESULTS FOR THE PERIOD ENDED DECEMBER 31, 2021
(SECOND QUARTER FY2022)
- Total Revenue was
US$2.4 million for the second quarter FY2022, primarily from
TEMCELL® HS Inj.1 royalties on sales for SR-aGvHD in Japan, which
increased 7% on the comparative quarter last year
- In November Mesoblast completed a
refinancing of its senior secured debt facility with a new US$90
million five-year facility provided by funds managed by Oaktree
Capital Management, L.P.
- Cash on hand at the
end of the quarter was US$94.8 million, with up to an additional
US$40 million available to be drawn down from existing financing
facilities subject to certain milestones.
- Net operating cash
usage was US$18.2 million for the second quarter FY2022, a
reduction of 40% or US$12.4 million on the comparative
quarter.
- Research & Development
expenses reduced by US$4.0 million (28%), down to US$10.2
million for the second quarter FY2022 from US$14.2 million for the
second quarter FY2021 as clinical trial activities for our COVID-19
ARDS, CLBP and CHF product candidates reduced given clinical trial
recruitment and data analysis is now complete.
- Manufacturing
expense were US$6.6 million for the second quarter FY2022,
compared to US$6.5 million for the second quarter FY2021. During
the quarter we continued to build our pre-launch inventory levels
of remestemcel-L to support the long-term commercial supply for
SR-aGVHD and COVID ARDS.We expect to recognize the US$28.0 million
balance of remestemcel-L pre-launch inventory, and the balance of
any further production completed at that time, on our balance sheet
if we receive FDA approval.
- Management and
Administration expenses were stable at US$7.8 million and
US$7.9m for the second quarters FY2022 and FY2021
respectively.
- Remeasurement of Contingent
Consideration reduced to a loss of US$0.3 million for the
second quarter FY2022 whereas a gain of US$1.5 million was
recognized in the second quarter FY2021 as a result of revaluing
future third party payments.
- Fair value movement of
warrants a gain of US$2.2 million in the second quarter
FY2022, compared to Nil for the second quarter FY2021.
- Finance Costs for
borrowing arrangements with Hercules, NovaQuest and Oaktree were
US$5.4 million for the second quarter FY2022, compared to US$1.1
million for the second quarter FY2021. The increase was primarily
due to the recognition of a non-cash gain on revaluation of our
borrowings in the comparative quarter.
Loss after tax for the second quarter FY2022
was US$25.9 million compared to US$25.7 million for the second
quarter FY2021.The net loss attributable to ordinary shareholders
was 4.00 US cents per share for the second quarter FY2022, compared
with 4.38 US cents per share for the second quarter FY2021.
Conference Call
There will be a webcast today, beginning at 5.00pm EST
(Thursday, February 24); 9.00am AEDT (Friday, February 25). It can
be accessed via: https://webcast.openbriefing.com/8499/
The archived webcast will be available on the Investor page of
the Company’s website: www.mesoblast.com
About Mesoblast
Mesoblast is a world leader in developing allogeneic
(off-the-shelf) cellular medicines for the treatment of severe and
life-threatening inflammatory conditions. The Company has leveraged
its proprietary mesenchymal lineage cell therapy technology
platform to establish a broad portfolio of late-stage product
candidates which respond to severe inflammation by releasing
anti-inflammatory factors that counter and modulate multiple
effector arms of the immune system, resulting in significant
reduction of the damaging inflammatory process.
Mesoblast has a strong and extensive global intellectual
property portfolio with protection extending through to at least
2041 in all major markets. 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 is developing product candidates for distinct
indications based on its remestemcel-L and rexlemestrocel-L stromal
cell technology platforms. Remestemcel-L is being developed for
inflammatory diseases in children and adults including steroid
refractory acute graft versus host disease and moderate to severe
acute respiratory distress syndrome. Rexlemestrocel-L is in
development for advanced chronic 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 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
References / Footnotes
- TEMCELL® HS Inj. is a registered trademark of JCR
Pharmaceuticals Co. Ltd.
- Kasikis S., et al. Mesenchymal stromal cell therapy induces
high responses and survival in children with steroid refractory
GVHD and poor risk. Bone Marrow Transplantation 2021;
https://doi.org/10.1038/s41409-021-01442-3
- Mount Sinai Acute GVHD International Consortium (MAGIC) - a
group of ten BMT centers throughout the US and Europe whose purpose
is to conduct ground-breaking clinical trials in GVHD, including
developing informative biorepositories that assist in developing
treatments that can guide GVHD therapy
- Lightner A., et al. A Phase IB/IIA study of remestemcel-L, an
allogeneic bone marrow derived mesenchymal stem cell product, for
the treatment of medically refractory Crohn’s colitis: A
preliminary analysis. Journal of Crohn's and Colitis, Volume 16,
Issue Supplement_1, January 2022, Pages i412–i413,
https://doi.org/10.1093/ecco-jcc/jjab232.555
- Lightner A., et al. A Phase IB/IIA study of remestemcel-L, an
allogeneic bone marrow derived mesenchymal stem cell product, for
the treatment of medically refractory ulcerative colitis: An
interim analysis. Journal of Crohn's and Colitis, Volume 16, Issue
Supplement_1, January 2022, Pages i398–i399,
https://doi.org/10.1093/ecco-jcc/jjab232.534
- Abreu MT and Sandborn WJ. Defining Endpoints and Biomarkers in
Inflammatory Bowel Disease: Moving the Needle Through Clinical
Trial Design. Gastroenterology 2020;159:2013–2018
- Daperno M, et al. Development and validation of a new,
simplified endoscopic activity score for Crohn’s disease: the
SES-CD. Gastrointest Endosc 2004;60:505–512.
- Pathirana GW, et al. Faecal Calprotectin. Clin Biochem Rev.
2018 Aug; 39(3): 77–90.
- Dunlay SM., et al. Circulation. 2019;140:e294–e324
- Wang CCL et al. Circulation 2019; 139: 1741-1743.
- McGuire DK et al. JAMA Cardiol. 2021; 6:148-158.
Forward-Looking Statements
This press release 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 (including BLA
resubmission), 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.
For more information, please contact:
| Corporate
Communications / Investors |
Media |
| Paul Hughes |
Sumit Media |
| T: +61 3 9639 6036 |
Grant Titmus |
| E:
investors@mesoblast.com |
T: +61 419 388 161 |
| |
E: grant@sumitmedia.com.au |
| |
|
| |
Rubenstein |
| |
Nadine Woloshin |
| |
T: +1 917-699-9456 |
| |
E: nwoloshin@rubenstein.com |
Consolidated Income Statement
|
|
|
Three Months EndedDecember
31, |
|
|
Six Months EndedDecember 31, |
|
| (in U.S. dollars, in
thousands, except per share amount) |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
Revenue |
|
|
2,383 |
|
|
|
2,241 |
|
|
|
5,977 |
|
|
|
3,546 |
|
| Research
& development |
|
|
(10,198 |
) |
|
|
(14,238 |
) |
|
|
(19,526 |
) |
|
|
(33,516 |
) |
|
Manufacturing commercialization |
|
|
(6,590 |
) |
|
|
(6,450 |
) |
|
|
(14,127 |
) |
|
|
(18,374 |
) |
|
Management and administration |
|
|
(7,814 |
) |
|
|
(7,867 |
) |
|
|
(13,692 |
) |
|
|
(15,546 |
) |
| Fair
value remeasurement of contingent consideration |
|
|
(351 |
) |
|
|
1,462 |
|
|
|
(71 |
) |
|
|
16,569 |
|
| Fair
value remeasurement of warrant liability |
|
|
2,152 |
|
|
|
— |
|
|
|
2,152 |
|
|
|
— |
|
| Other
operating income and expenses |
|
|
(227 |
) |
|
|
296 |
|
|
|
(405 |
) |
|
|
395 |
|
| Finance
costs |
|
|
(5,380 |
) |
|
|
(1,062 |
) |
|
|
(9,040 |
) |
|
|
(3,966 |
) |
|
Loss before income tax |
|
|
(26,025 |
) |
|
|
(25,618 |
) |
|
|
(48,732 |
) |
|
|
(50,892 |
) |
| Income
tax benefit/(expense) |
|
|
80 |
|
|
|
(74 |
) |
|
|
142 |
|
|
|
656 |
|
|
Loss attributable to the owners of Mesoblast
Limited |
|
|
(25,945 |
) |
|
|
(25,692 |
) |
|
|
(48,590 |
) |
|
|
(50,236 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses per share from continuing operations
attributable to the ordinary equity holders
of the Group: |
|
Cents |
|
|
Cents |
|
|
Cents |
|
|
Cents |
|
| Basic -
losses per share |
|
|
(4.00 |
) |
|
|
(4.38 |
) |
|
|
(7.50 |
) |
|
|
(8.60 |
) |
| Diluted
- losses per share |
|
|
(4.00 |
) |
|
|
(4.38 |
) |
|
|
(7.50 |
) |
|
|
(8.60 |
) |
Consolidated Statement of Comprehensive
Income
|
|
|
Three Months EndedDecember
31, |
|
|
Six Months EndedDecember 31, |
|
| (in U.S. dollars, in
thousands) |
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
Loss for the period |
|
|
(25,945 |
) |
|
|
(25,692 |
) |
|
|
(48,590 |
) |
|
|
(50,236 |
) |
|
Other comprehensive (loss)/income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Items
that may be reclassified to profit and loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Exchange
differences on translation of foreign operations |
|
|
166 |
|
|
|
904 |
|
|
|
(183 |
) |
|
|
1,312 |
|
| Items
that will not be reclassified to profit and loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial assets at fair value through other comprehensive
income |
|
|
112 |
|
|
|
(53 |
) |
|
|
266 |
|
|
|
28 |
|
| Other
comprehensive (loss)/income for the period, net of tax |
|
|
278 |
|
|
|
851 |
|
|
|
83 |
|
|
|
1,340 |
|
| Total comprehensive
losses attributable to the owners of
Mesoblast Limited |
|
|
(25,667 |
) |
|
|
(24,841 |
) |
|
|
(48,507 |
) |
|
|
(48,896 |
) |
Consolidated Balance Sheet
| |
|
As ofDecember 31, |
|
|
As ofJune 30, |
|
| (in U.S. dollars, in
thousands) |
|
2021 |
|
|
2021 |
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current Assets |
|
|
|
|
|
|
|
|
| Cash
& cash equivalents |
|
|
94,849 |
|
|
|
136,881 |
|
| Trade
& other receivables |
|
|
6,048 |
|
|
|
4,842 |
|
|
Prepayments |
|
|
7,900 |
|
|
|
6,504 |
|
|
Total Current Assets |
|
|
108,797 |
|
|
|
148,227 |
|
|
|
|
|
|
|
|
|
|
|
|
Non-Current Assets |
|
|
|
|
|
|
|
|
|
Property, plant and equipment |
|
|
2,470 |
|
|
|
3,021 |
|
|
Right-of-use assets |
|
|
9,033 |
|
|
|
9,119 |
|
|
Financial assets at fair value through other comprehensive
income |
|
|
2,347 |
|
|
|
2,080 |
|
| Other
non-current assets |
|
|
1,956 |
|
|
|
1,724 |
|
|
Intangible assets |
|
|
579,836 |
|
|
|
580,546 |
|
|
Total Non-Current Assets |
|
|
595,642 |
|
|
|
596,490 |
|
|
Total Assets |
|
|
704,439 |
|
|
|
744,717 |
|
| |
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
|
Current Liabilities |
|
|
|
|
|
|
|
|
| Trade
and other payables |
|
|
20,919 |
|
|
|
19,598 |
|
|
Provisions |
|
|
22,288 |
|
|
|
18,710 |
|
|
Borrowings |
|
|
5,203 |
|
|
|
53,200 |
|
| Lease
liabilities |
|
|
3,489 |
|
|
|
2,765 |
|
| Warrant
liability |
|
|
6,055 |
|
|
|
— |
|
|
Total Current Liabilities |
|
|
57,954 |
|
|
|
94,273 |
|
| |
|
|
|
|
|
|
|
|
|
Non-Current Liabilities |
|
|
|
|
|
|
|
|
| Deferred
tax liability |
|
|
— |
|
|
|
— |
|
|
Provisions |
|
|
13,992 |
|
|
|
17,017 |
|
|
Borrowings |
|
|
86,542 |
|
|
|
41,045 |
|
| Lease
liabilities |
|
|
7,942 |
|
|
|
8,485 |
|
| Deferred
consideration |
|
|
2,500 |
|
|
|
2,500 |
|
|
Total Non-Current Liabilities |
|
|
110,976 |
|
|
|
69,047 |
|
|
Total Liabilities |
|
|
168,930 |
|
|
|
163,320 |
|
|
Net Assets |
|
|
535,509 |
|
|
|
581,397 |
|
| |
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
| Issued
Capital |
|
|
1,163,586 |
|
|
|
1,163,153 |
|
|
Reserves |
|
|
68,082 |
|
|
|
65,813 |
|
|
(Accumulated losses)/retained earnings |
|
|
(696,159 |
) |
|
|
(647,569 |
) |
|
Total Equity |
|
|
535,509 |
|
|
|
581,397 |
|
Consolidated Statement of Cash Flows
| |
|
Six Months EndedDecember 31, |
|
| (in U.S. dollars, in
thousands) |
|
2021 |
|
|
2020 |
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
Commercialization revenue received |
|
|
5,531 |
|
|
|
1,972 |
|
|
Government grants and tax incentives received |
|
|
24 |
|
|
|
17 |
|
|
Payments to suppliers and employees (inclusive of goods and
services tax) |
|
|
(41,977 |
) |
|
|
(59,357 |
) |
|
Interest received |
|
|
4 |
|
|
|
16 |
|
|
Income taxes paid |
|
|
— |
|
|
|
(6 |
) |
|
Net cash (outflows) in operating activities |
|
|
(36,418 |
) |
|
|
(57,358 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
|
Investment in fixed assets |
|
|
(103 |
) |
|
|
(488 |
) |
|
Payments for intellectual property |
|
|
(26 |
) |
|
|
— |
|
|
Net cash (outflows) in investing activities |
|
|
(129 |
) |
|
|
(488 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
|
Proceeds from borrowings |
|
|
51,919 |
|
|
|
— |
|
|
Repayment of borrowings |
|
|
(55,458 |
) |
|
|
— |
|
|
Payment of transaction costs from borrowings |
|
|
(5,453 |
) |
|
|
— |
|
|
Interest and other costs of finance paid |
|
|
(2,951 |
) |
|
|
(2,771 |
) |
|
Proceeds from issue of shares |
|
|
209 |
|
|
|
9,565 |
|
|
Proceeds from issue of warrants |
|
|
8,081 |
|
|
|
— |
|
|
Payments for share issue costs |
|
|
(216 |
) |
|
|
(905 |
) |
|
Payments for lease liabilities |
|
|
(1,214 |
) |
|
|
(1,480 |
) |
|
Net cash inflows/(outflows) by financing
activities |
|
|
(5,083 |
) |
|
|
4,409 |
|
|
|
|
|
|
|
|
|
|
|
| Net
decrease in cash and cash equivalents |
|
|
(41,630 |
) |
|
|
(53,437 |
) |
| Cash
and cash equivalents at beginning of period |
|
|
136,881 |
|
|
|
129,328 |
|
| FX
gain/(losses) on the translation of foreign bank accounts |
|
|
(402 |
) |
|
|
1,637 |
|
|
Cash and cash equivalents at end of period |
|
|
94,849 |
|
|
|
77,528 |
|
| |
|
Three Months EndedDecember
31, |
|
| (in U.S. dollars, in
thousands) |
|
2021 |
|
|
2020 |
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
|
Commercialization revenue received |
|
|
3,536 |
|
|
|
1,290 |
|
|
Government grants and tax incentives received |
|
|
— |
|
|
|
— |
|
|
Payments to suppliers and employees (inclusive of goods and
services tax) |
|
|
(21,755 |
) |
|
|
(31,873 |
) |
|
Interest received |
|
|
— |
|
|
|
3 |
|
|
Income taxes paid |
|
|
— |
|
|
|
— |
|
|
Net cash (outflows) in operating activities |
|
|
(18,219 |
) |
|
|
(30,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
|
Investment in fixed assets |
|
|
(4 |
) |
|
|
(407 |
) |
|
Payments for intellectual property |
|
|
(26 |
) |
|
|
— |
|
|
Net cash (outflows) in investing activities |
|
|
(30 |
) |
|
|
(407 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
|
Proceeds from borrowings |
|
|
51,919 |
|
|
|
— |
|
|
Repayment of borrowings |
|
|
(55,458 |
) |
|
|
— |
|
|
Payment of transaction costs from borrowings |
|
|
(5,353 |
) |
|
|
— |
|
|
Interest and other costs of finance paid |
|
|
(1,544 |
) |
|
|
(1,382 |
) |
|
Proceeds from issue of shares |
|
|
62 |
|
|
|
1,431 |
|
|
Proceeds from issue of warrants |
|
|
8,081 |
|
|
|
— |
|
|
Payments for share issue costs |
|
|
(112 |
) |
|
|
(8 |
) |
|
Payments for lease liabilities |
|
|
(528 |
) |
|
|
(785 |
) |
|
Net cash inflows/(outflows) by financing
activities |
|
|
(2,933 |
) |
|
|
(744 |
) |
|
|
|
|
|
|
|
|
|
|
| Net
decrease in cash and cash equivalents |
|
|
(21,182 |
) |
|
|
(31,731 |
) |
| Cash
and cash equivalents at beginning of period (October 1) |
|
|
115,956 |
|
|
|
108,123 |
|
| FX
gain/(losses) on the translation of foreign bank accounts |
|
|
75 |
|
|
|
1,136 |
|
|
Cash and cash equivalents at end of period |
|
|
94,849 |
|
|
|
77,528 |
|
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jul 2023 to Jul 2024
