Mesoblast Reports Financial Results and Operational Highlights for the Period Ended September 30, 2022
November 22 2022 - 6:00PM
Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in
allogeneic cellular medicines for inflammatory diseases, today
reported operational highlights and financial results for the
period ended September 30, 2022 and provided an update on upcoming
milestones.
“The substantial and durable long-term survival
over four years we have reported today in children with SR-aGVHD
treated with remestemcel-L in our Phase 3 trial underscore the many
lives that could potentially be saved by making this therapy
available as soon as possible to children with the most common
life-threatening complication after bone marrow transplantation”
said Dr. Silviu Itescu, Chief Executive of Mesoblast.
“These new long-term survival data reaffirm the
potential significance of remestemcel-L as a life-saving therapy
for children with SR-aGVHD and are a cornerstone of the company’s
BLA resubmission to the FDA for approval of remestemcel-L in the
treatment of children with SR-aGVHD. The lack of any approved
treatments for children under 12 means that there is an urgent need
for a therapy that improves the dismal survival outcomes in
children. We are at a pivotal juncture, we believe we have
appropriately addressed issues raised by FDA in the complete
response, and we are well funded in preparation for a potential
first product approval and launch by mid-year.”
FINANCIAL HIGHLIGHTS
- Cash: Cash
reserves as at September 30th were US$85.5 million. Up to an
additional US$40.0 million may be drawn from existing financing
facilities subject to achieving certain milestones, with current
discussions to extend the period for the drawdown option.
- Net cash usage for
operating activities in the quarter was US$14.3 million; this
represented a 22% reduction (US$3.9 million) on the comparative
quarter in FY2022, and a 47% reduction (US$12.5 million) on the
comparative quarter in FY2021.
- Revenue from
royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our
licensee for the quarter were US$1.4 million. For the 12-month
period ended September 30, 2022 royalties were US$7.7 million, and
on a constant currency basis2 US$9.0 million, a 9% increase on the
comparative period.
- Expenditure for
R&D, Manufacturing and Management & Administration
inclusive of non-cash items, were US$17.5 million, a decrease of
23% (US$5.2 million) for the quarter ended September 30, 2022 on
the comparative quarter.
OPERATIONAL HIGHLIGHTS AND NEAR-TERM
MILESTONES
Remestemcel-L
Biologics License Application (BLA) resubmission to the US Food
and Drug Administration (FDA) for the treatment of children with
steroid-refractory graft versus host disease (SR-aGVHD)
- Survival outcomes have not improved
over the past two decades for children or adults with the most
severe forms of SR-aGVHD.3-6 The lack of any approved treatments
for children under 12 means that there is an urgent need for a
therapy that improves the dismal survival outcomes in
children.
- In light of the unmet need,
remestemcel-L has been granted Fast Track Designation and BLA
Priority Review from the FDA.
- A major milestone in the Company’s
complete response to the FDA was the submission at the end of the
last quarter of substantial new information on clinical and potency
assay items to the Investigational New Drug (IND) file for
remestemcel-L in the treatment of children with SR-aGVHD, as guided
by FDA.
- Mesoblast has optimized a potency
assay that was in place at the time of the Phase 3 trial and which
demonstrates a relationship between the product’s activity in-vitro
and its effects on survival in the Phase 3 trial.
- Additionally, Mesoblast has now
generated data from the expanded access program (EAP 275) of 241
children which confirm the ability of the in-vitro potency assay to
measure product activity relevant to survival outcomes.
- Today Mesoblast provided new
results from a four-year observational survival study performed by
the Center for International Blood and Marrow Transplant Research
(CIBMTR) on 51 evaluable patients with SR-aGVHD who were enrolled
in Mesoblast’s phase 3 clinical trial of remestemcel-L.
- Overall survival in the
remestemcel-L cohort was 63% at 1 year, 51% at 2 years, and 49% at
4 years, while across four recently published studies of children
or adults with SR-aGVHD who received best available therapy (BAT)
or the only FDA-approved agent for adults survival rates of 40-49%
at 1 year and 25%-38% at 2 years were seen. 7-10
- The new long-term survival data
provide assurance that the short-term day 28 responses and early
survival through 180 days in the 54-patient Phase 3 trial in
children with SR-aGVHD previously presented to FDA in the original
BLA submission are unlikely to have arisen by chance and are a
cornerstone of the BLA resubmission.
- Mesoblast is working towards a
potential US approval for remestemcel-L and first product launch in
H1 CY2023.
- Additional indications for which
remestemcel-L is being developed include acute respiratory distress
syndrome and inflammatory bowel disease.
Rexlemestrocel-L
Chronic low back pain associated with
degenerative disc disease:
- Working towards FDA clearance by
year end 2022 to commence the second Phase 3 trial for potential
marketing approval in chronic lower back pain due to degenerative
disc disease.
- Mesoblast gained alignment with the
FDA on key metrics for the Phase 3 study in patients with
CLBP.
- The primary endpoint for the study
will be reduction in pain at 12 months, in line with FDA
discussions and feedback.
Chronic heart failure with reduced ejection
fraction (HFrEF) in NYHA class II/III patients through to end-stage
III/IV patients with a left ventricular assist device (LVAD):
- Recent data from Phase 3 trial of
565 patients with HFrEF showed a single intervention with
rexlemestrocel-L improves left ventricular ejection fraction (LVEF)
at 12 months, preceding long-term reduction in major adverse
cardiovascular events (MACE).
- LVEF improvement at 12 months may
be an appropriate early surrogate endpoint for long term reduction
in MACE.
- Plan to meet with FDA next quarter
under existing regenerative medicine advanced therapy (RMAT)
designation to discuss common mechanism of action in HFrEF
including those with LVADs, and potential pathway to marketing
approval.
FINANCIAL RESULTS FOR THE PERIOD ENDED
SEPTEMBER 30, 2022 (FIRST QUARTER FY2023)
- Cash reserves as
at September 30th were US$85.5 million. Up to an additional US$40.0
million may be drawn from existing financing facilities subject to
achieving certain milestones, with current discussions to extend
the period for the drawdown option.
- Net cash usage for
operating activities in the quarter was US$14.3 million; this
represented a 22% reduction (US$3.9 million) on the comparative
quarter in FY2022, and a 47% reduction (US$12.5 million) on the
comparative quarter in FY2021.
- Revenue from
royalties on sales of TEMCELL® HS Inj.1 sold in Japan by our
licensee for the quarter were US$1.4 million and US$1.8 million on
a constant currency basis. For the 12-month period ended September
30, 2022 royalties were US$7.7 million, and on a constant currency
basis2 US$9.0 million, a 9% increase on the comparative period.In
the comparative quarter, there was one-off milestone revenue of
US$1.2 million from Takeda for Japan approval of Alofisel®
(darvadstrocel) for perianal fistulas.
- Research & Development
expenses reduced by US$3.6 million (38%), down to US$5.7
million for the first quarter FY2023 compared to US$9.3 million for
the first quarter FY2022 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
expenses reduced by US$2.7 million (35%), down to
US$4.8 million for the first quarter FY2023 compared to US$7.5
million for the first quarter FY2022. During the quarter we
continued pre-launch manufacturing activities and product testing
for remestemcel-L to support the potential commercial launch for
SR-aGVHD.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 increased by
US$1.0 million (17%), up to US$6.9 million for the first quarter
FY2023 compared to US$5.9 million for the first quarter FY2022
primarily due to an increase in non-cash share-based payments and
insurance costs.
- Remeasurement of Contingent
Consideration gains increased to US$4.5 million in the
first quarter FY2023 compared to a gain of US$0.3 million for the
first quarter FY2022 reflecting a reduction in future third party
payments.
- Fair value movement of
warrants: recognized a loss of US$0.4 million in the first
quarter FY2023 compared to Nil in the first quarter FY2022.
- Finance Costs for
borrowing arrangements with our lenders, Oaktree and NovaQuest,
were US$4.5 million (actual cash interest paid US$1.2 million) for
the first quarter FY2023, compared to US$3.7 million (actual cash
interest paid US$1.2 million) for the first quarter FY2022.
- Loss after tax for
the first quarter FY2023 was US$16.9 million compared to US$22.6
million for the first quarter FY2022. The net loss attributable to
ordinary shareholders was 2.43 US cents per share for the first
quarter FY2023, compared with 3.49 US cents per share for the first
quarter FY2022.
Conference CallThere will be a
webcast today, beginning at 8.30am AEDT (Wednesday, November 23);
4.30pm ET (Tuesday, November 22). It can be accessed via:
https://webcast.openbriefing.com/9143/
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 allogeneic stromal cell technology platforms.
Remestemcel-L is being developed for inflammatory diseases in
children and adults including steroid refractory acute graft versus
host disease, biologic-resistant inflammatory bowel disease, and
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.
- TEMCELL sales by our Licensee are
recorded in Japanese Yen before being translated into USD for the
purposes of calculating the royalty paid to Mesoblast. Results have
been adjusted for the movement of the USD to Japanese Yen exchange
rate from 1USD:110.2Yen for the 12 months ended September 30, 2021
to 1USD:129.2Yen for the 12 months ended September 30, 2022.
- 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.
- HRSA Transplant Activity Report,
CIBMTR, 2019
- Westin, J., Saliba, RM., Lima, M.
(2011) Steroid-refractory acute GVHD: predictors and outcomes.
Advances in Hematology.
- 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.
- Rashidi A et al. Outcomes and
predictors of response in steroid-refractory acute
graft-versus-host disease: single-center results from a cohort of
203 patients. Biol Blood Bone Marrow Transplant 2019;
25(11):2297-2302.
- MacMillan ML et al. Pediatric acute
GVHD: clinical phenotype and response to upfront steroids. Bone
Marrow Transplant 2020; 55(1): 165-171
- Zeiser R et al. Ruxolitinib for
Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J
Med 2020;382:1800-10.
- Jagasia M et al. Ruxolitinib for
the treatment of steroid-refractory acute GVHD (REACH1): a
multicenter, open-label phase 2 trial. Blood. 2020 May 14; 135(20):
1739–1749.
Forward-Looking StatementsThis
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 |
BlueDot Media |
T: +61 3 9639 6036 |
Steve Dabkowski |
E: investors@mesoblast.com |
T: +61 419 880 486 |
|
E: steve@bluedot.net.au |
|
|
|
Rubenstein |
|
Tali Mackay |
|
E: tmackay@rubenstein.com |
Consolidated Income Statement |
|
|
Three Months EndedSeptember
30, |
|
(in U.S. dollars, in
thousands, except per share amount) |
|
2022 |
|
|
2021 |
|
Revenue |
|
|
1,503 |
|
|
|
3,594 |
|
Research &
development |
|
|
(5,744 |
) |
|
|
(9,328 |
) |
Manufacturing
commercialization |
|
|
(4,866 |
) |
|
|
(7,537 |
) |
Management and
administration |
|
|
(6,898 |
) |
|
|
(5,878 |
) |
Fair value remeasurement of
contingent consideration |
|
|
4,468 |
|
|
|
280 |
|
Fair value remeasurement of
warrant liability |
|
|
(401 |
) |
|
|
— |
|
Other operating income and
expenses |
|
|
(504 |
) |
|
|
(178 |
) |
Finance costs |
|
|
(4,497 |
) |
|
|
(3,660 |
) |
Loss before income
tax |
|
|
(16,939 |
) |
|
|
(22,707 |
) |
Income tax
benefit/(expense) |
|
|
55 |
|
|
|
62 |
|
Loss attributable to
the owners of Mesoblast Limited |
|
|
(16,884 |
) |
|
|
(22,645 |
) |
|
|
|
|
|
|
|
|
|
Losses per share from
continuing operations attributableto the ordinary
equity holders of the Group: |
|
Cents |
|
|
Cents |
|
Basic - losses per share |
|
|
(2.43 |
) |
|
|
(3.49 |
) |
Diluted - losses per
share |
|
|
(2.43 |
) |
|
|
(3.49 |
) |
Consolidated Statement of Comprehensive
Income |
|
|
Three Months EndedSeptember
30, |
|
(in U.S. dollars, in
thousands) |
|
2022 |
|
|
2021 |
|
Loss for the period |
|
|
(16,884 |
) |
|
|
(22,645 |
) |
Other comprehensive
(loss)/income |
|
|
|
|
|
|
|
|
Items that may be reclassified
to profit and loss |
|
|
|
|
|
|
|
|
Exchange differences on
translation of foreign operations |
|
|
(159 |
) |
|
|
(349 |
) |
Items that will not be
reclassified to profit and loss |
|
|
|
|
|
|
|
|
Financial assets at fair value
through other comprehensive income |
|
|
86 |
|
|
|
154 |
|
Other comprehensive
(loss)/income for the period, net of tax |
|
|
(73 |
) |
|
|
(195 |
) |
Total comprehensive
losses attributable to theowners of Mesoblast
Limited |
|
|
(16,957 |
) |
|
|
(22,840 |
) |
Consolidated Balance Sheet |
|
|
As ofSeptember 30, |
|
|
As ofJune 30, |
|
(in U.S. dollars, in
thousands) |
|
2022 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
|
|
Current
Assets |
|
|
|
|
|
|
|
|
Cash & cash
equivalents |
|
|
85,502 |
|
|
|
60,447 |
|
Trade & other
receivables |
|
|
3,863 |
|
|
|
4,403 |
|
Prepayments |
|
|
3,595 |
|
|
|
4,987 |
|
Total Current
Assets |
|
|
92,960 |
|
|
|
69,837 |
|
|
|
|
|
|
|
|
|
|
Non-Current
Assets |
|
|
|
|
|
|
|
|
Property, plant and
equipment |
|
|
1,786 |
|
|
|
2,045 |
|
Right-of-use assets |
|
|
7,730 |
|
|
|
7,920 |
|
Financial assets at fair value
through other comprehensive income |
|
|
1,843 |
|
|
|
1,758 |
|
Other non-current assets |
|
|
1,902 |
|
|
|
1,930 |
|
Intangible assets |
|
|
578,275 |
|
|
|
578,652 |
|
Total Non-Current
Assets |
|
|
591,536 |
|
|
|
592,305 |
|
Total
Assets |
|
|
684,496 |
|
|
|
662,142 |
|
|
|
|
|
|
|
|
|
|
Liabilities |
|
|
|
|
|
|
|
|
Current
Liabilities |
|
|
|
|
|
|
|
|
Trade and other payables |
|
|
17,663 |
|
|
|
23,079 |
|
Provisions |
|
|
19,455 |
|
|
|
17,906 |
|
Borrowings |
|
|
5,489 |
|
|
|
5,017 |
|
Lease liabilities |
|
|
3,609 |
|
|
|
3,186 |
|
Warrant liability |
|
|
2,586 |
|
|
|
2,185 |
|
Total Current
Liabilities |
|
|
48,802 |
|
|
|
51,373 |
|
|
|
|
|
|
|
|
|
|
Non-Current
Liabilities |
|
|
|
|
|
|
|
|
Provisions |
|
|
9,853 |
|
|
|
12,523 |
|
Borrowings |
|
|
94,186 |
|
|
|
91,617 |
|
Lease liabilities |
|
|
6,348 |
|
|
|
7,085 |
|
Deferred consideration |
|
|
2,500 |
|
|
|
2,500 |
|
Total Non-Current
Liabilities |
|
|
112,887 |
|
|
|
113,725 |
|
Total
Liabilities |
|
|
161,689 |
|
|
|
165,098 |
|
Net
Assets |
|
|
522,807 |
|
|
|
497,044 |
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
|
Issued Capital |
|
|
1,207,734 |
|
|
|
1,165,309 |
|
Reserves |
|
|
70,873 |
|
|
|
70,651 |
|
(Accumulated losses)/retained
earnings |
|
|
(755,800 |
) |
|
|
(738,916 |
) |
Total
Equity |
|
|
522,807 |
|
|
|
497,044 |
|
Consolidated Statement of Cash Flows |
|
|
Three Months EndedSeptember
30, |
|
(in U.S. dollars, in
thousands) |
|
2022 |
|
|
2021 |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Commercialization revenue
received |
|
|
2,219 |
|
|
|
1,995 |
|
Government grants and tax
incentives received |
|
|
— |
|
|
|
24 |
|
Payments to suppliers and
employees (inclusive of goods and services tax) |
|
|
(16,566 |
) |
|
|
(20,222 |
) |
Interest received |
|
|
60 |
|
|
|
4 |
|
Net cash (outflows) in
operating activities |
|
|
(14,287 |
) |
|
|
(18,199 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
investing activities |
|
|
|
|
|
|
|
|
Investment in fixed
assets |
|
|
(153 |
) |
|
|
(99 |
) |
Payments for licenses |
|
|
(50 |
) |
|
|
— |
|
Net cash (outflows) in
investing activities |
|
|
(203 |
) |
|
|
(99 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from
financing activities |
|
|
|
|
|
|
|
|
Payment of transaction costs
from borrowings |
|
|
(151 |
) |
|
|
(100 |
) |
Interest and other costs of
finance paid |
|
|
(1,381 |
) |
|
|
(1,407 |
) |
Proceeds from issue of
shares |
|
|
45,065 |
|
|
|
147 |
|
Payments for share issue
costs |
|
|
(2,565 |
) |
|
|
(104 |
) |
Payments for lease
liabilities |
|
|
(670 |
) |
|
|
(686 |
) |
Net cash
inflows/(outflows) by financing activities |
|
|
40,298 |
|
|
|
(2,150 |
) |
|
|
|
|
|
|
|
|
|
Net increase/(decrease) in
cash and cash equivalents |
|
|
25,808 |
|
|
|
(20,448 |
) |
Cash and cash equivalents at
beginning of period |
|
|
60,447 |
|
|
|
136,881 |
|
FX (loss) on the translation
of foreign bank accounts |
|
|
(753 |
) |
|
|
(477 |
) |
Cash and cash
equivalents at end of period |
|
|
85,502 |
|
|
|
115,956 |
|
Mesoblast (NASDAQ:MESO)
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From Jun 2024 to Jul 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jul 2023 to Jul 2024