Orgenesis Achieves Revenue of $7.2 Million for the First Quarter of 2022
May 24 2022 - 7:00AM
Orgenesis Inc. (NASDAQ: ORGS)
(“Orgenesis” or the “Company”), a global biotech company working to
unlock the full potential of cell and gene therapies, today
provided a business update for first quarter ended March 31, 2022.
Recent
highlights:
- Expanded POCare
with Johns Hopkins University through creation of the Maryland
Center for Cell Therapy Manufacturing
- Reached
milestone in collaboration with Hospital Infantil Universitario
Niño Jesús in Madrid
- Awarded €4M
European Innovation Council Pathfinder Grant
Vered Caplan, CEO of Orgenesis, said, “We are
completing the first phase of the rollout of our POCare Platform,
as we have now built a robust network of POCare centers across
Europe, Asia and the Middle East, and are focusing on
implementation of our POCare supply strategy in the US. Each of our
POCare centers serve as hubs for their respective territories. We
have cost effectively executed this model through partnerships with
leading hospitals and centers of excellence in the field of cell
and gene therapies, which provide us an immediate revenue stream
related to process development, technology transfer, setup, and
validation of both our POCare systems and Orgenesis Mobile
Processing Units and Labs (OMPULs). In turn, we have built out
significant capacity to support our anticipated growth.”
“We are now entering the second phase of our
rollout. Specifically, we are conducting work related to
validation, process development, and supply for clinical trials of
advanced therapies utilizing our POCare platform and OMPULs. As
these activities ramp up, we expect to benefit from recurring
revenue streams, based on long term contracts for the next two to
three years. Moreover, if any one of these therapies is granted
regulatory approval, we believe that the revenue potential is
significant since our POCare strategy positions us as a long term
industrial partner. We are currently working to expand our capacity
to supply products for over 10 distinct clinical programs. We
believe our approach is highly scalable and provides us
diversification across multiple revenue generating contracts. As
our customers’ needs grow, our goal is to be well prepared to add
new capacity utilizing our OMPUL-based approach, within 3-6 months
versus the 18-24 months typical for building out additional
cleanroom-based manufacturing capacity.”
“Overall, we are witnessing dramatic capacity
constraints across the industry. We believe our model is uniquely
positioned to address the challenges of current centralized
production through a highly innovative decentralized model, which
lowers costs, streamlines logistics, and expands capacity. We are
overcoming the growing pains and challenges arising from our rapid
transformation and believe that our model is essential and
sustainable. This is best evidenced by our existing contract
pipeline—which has total potential revenue in excess of $75 million
for the next two years, as well as our capacity to continually
expand our revenue generating relationships with additional biotech
companies, therapy developers and other providers such as hospitals
and academic centers.”
The complete financial results for the first
quarter of 2022 are available on the Company’s website in its Form
10-Q, which has been filed with the Securities and Exchange
Commission.
About OrgenesisOrgenesis is a
global biotech company working to unlock the full potential of cell
and gene therapies (CGTs) in an affordable and accessible format at
the point of care. The Orgenesis POCare Platform is comprised of
three enabling components: a pipeline of licensed POCare
Therapeutics that are processed and produced in closed, automated
POCare Technology systems across a collaborative POCare Network.
Orgenesis identifies promising new therapies and leverages its
POCare Platform to provide a rapid, globally harmonized pathway for
these therapies to reach and treat large numbers of patients at
lowered costs through efficient, scalable, and decentralized
production. The POCare Network brings together patients, doctors,
industry partners, research institutes and hospitals worldwide to
achieve harmonized, regulated clinical development and production
of the therapies. www.orgenesis.com.
Notice Regarding Forward-Looking
Statements This press release contains forward-looking
statements which are made pursuant to the safe harbor provisions of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities and Exchange Act of 1934, as amended. These
forward-looking statements involve substantial uncertainties and
risks and are based upon our current expectations, estimates and
projections and reflect our beliefs and assumptions based upon
information available to us at the date of this release. We caution
readers that forward-looking statements are predictions based on
our current expectations about future events. These forward-looking
statements are not guarantees of future performance and are subject
to risks, uncertainties and assumptions that are difficult to
predict. Our actual results, performance or achievements could
differ materially from those expressed or implied by the
forward-looking statements as a result of a number of factors,
including, but not limited to, our reliance on, and our ability to
grow, our point-of-care cell therapy platform and OMPUL business,
our ability to achieve and maintain overall profitability, our
ability to manage our research and development programs that are
based on novel technologies, our ability to control key elements
relating to the development and commercialization of therapeutic
product candidates with third parties, the timing of completion of
clinical trials and studies, the availability of additional data,
outcomes of clinical trials of our product candidates, the
potential uses and benefits of our product candidates, our ability
to manage potential disruptions as a result of the COVID-19
pandemic, the sufficiency of working capital to realize our
business plans and our ability to raise additional capital, the
development of our POCare strategy, our trans differentiation
technology as therapeutic treatment for diabetes, the technology
behind our in-licensed ATMPs not functioning as expected, our
ability to further our CGT development projects, either directly or
through our JV partner agreements, and to fulfill our obligations
under such agreements, our license agreements with other
institutions, our ability to retain key employees, our competitors
developing better or cheaper alternatives to our products, risks
relating to legal proceedings against us and the risks and
uncertainties discussed under the heading "RISK FACTORS" in Item 1A
of our Annual Report on Form 10-K for the fiscal year ended
December 31, 2021, and in our other filings with the Securities and
Exchange Commission. We undertake no obligation to revise or update
any forward-looking statement for any reason.
IR contact for Orgenesis:Crescendo
Communications, LLCTel: 212-671-1021Orgs@crescendo-ir.com
Communications contact for
OrgenesisImage Box CommunicationsNeil Hunter / Michelle
BoxallTel +44 (0)20 8943
4685neil@ibcomms.agency / michelle@ibcomms.agency
ORGENESIS INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(U.S. Dollars, in
thousands, except share and per share
amounts)(Unaudited)
|
|
As of
|
|
|
March 31,2022
|
|
|
|
December 31,2021
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
$
|
1,123
|
|
|
$
|
5,473
|
|
Restricted cash
|
|
490
|
|
|
|
501
|
|
Accounts receivable, net
|
|
17,075
|
|
|
|
15,245
|
|
Prepaid expenses and other receivables
|
|
1,438
|
|
|
|
1,188
|
|
Convertible Loan receivables-related parties
|
|
2,969
|
|
|
|
3,064
|
|
Loans receivable
|
|
802
|
|
|
|
-
|
|
Grants receivable
|
|
-
|
|
|
|
169
|
|
Inventory
|
|
113
|
|
|
|
118
|
|
Total current assets
|
|
24,010
|
|
|
|
25,758
|
|
|
|
|
|
|
|
|
|
NON-CURRENT ASSETS:
|
|
|
|
|
|
|
|
Deposits
|
$
|
358
|
|
|
$
|
363
|
|
Investments in and loans to associated entities
|
|
1,574
|
|
|
|
584
|
|
Loans receivable
|
|
-
|
|
|
|
821
|
|
Property, plant and equipment, net
|
|
11,104
|
|
|
|
10,271
|
|
Intangible assets, net
|
|
11,539
|
|
|
|
11,821
|
|
Operating lease right-of-use assets
|
|
886
|
|
|
|
1,015
|
|
Goodwill
|
|
8,329
|
|
|
|
8,403
|
|
Other assets
|
|
738
|
|
|
|
805
|
|
Total non-current assets
|
|
34,528
|
|
|
|
34,083
|
|
TOTAL ASSETS
|
$
|
58,538
|
|
|
$
|
59,841
|
|
ORGENESIS INC.CONDENSED
CONSOLIDATED BALANCE SHEETS (Cont’d)(U.S. Dollars,
in thousands, except share and per share
amounts)(Unaudited)
|
|
As of
|
|
|
March 31,2022
|
|
|
December 31,2021
|
Liabilities and Equity
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
Accounts payable
|
$
|
6,933
|
|
|
$
|
5,238
|
|
Accrued expenses and other payables
|
|
1,076
|
|
|
|
485
|
|
Income tax payable
|
|
91
|
|
|
|
54
|
|
Employees and related payables
|
|
2,041
|
|
|
|
1,907
|
|
Advance payments on account of grant
|
|
1,216
|
|
|
|
1,238
|
|
Contract liabilities
|
|
70
|
|
|
|
59
|
|
Current maturities of finance leases
|
|
18
|
|
|
|
18
|
|
Current maturities of operating leases
|
|
451
|
|
|
|
481
|
|
Current maturities of convertible loans
|
|
3,357
|
|
|
|
5,885
|
|
Total current liabilities
|
|
15,253
|
|
|
|
15,365
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
Non-current operating leases
|
$
|
461
|
|
|
$
|
561
|
|
Convertible loans
|
|
7,544
|
|
|
|
4,854
|
|
Retirement benefits obligation
|
|
105
|
|
|
|
101
|
|
Non-current finance leases
|
|
36
|
|
|
|
41
|
|
Other long-term liabilities
|
|
282
|
|
|
|
288
|
|
Total long-term liabilities
|
|
8,428
|
|
|
|
5,845
|
|
TOTAL LIABILITIES
|
|
23,681
|
|
|
|
21,210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY:Common stock of $0.0001 par value:
Authorized at March 31, 2022 and December 31, 2021: 145,833,334
shares; Issued at March 31, 2022 and December 31, 2021: 25,107,323
and 24,567,366 shares, respectively; Outstanding at March 31, 2022
and December 31, 2021: 24,820,756 and 24,280,799 shares,
respectively.
|
|
3
|
|
|
|
3
|
|
Additional paid-in capital
|
|
146,290
|
|
|
|
145,916
|
|
Accumulated other comprehensive income
|
|
56
|
|
|
|
207
|
|
Treasury stock, 286,567 shares as of March 31, 2022 and December
31, 2021
|
|
(1,266
|
)
|
|
|
(1,266
|
)
|
Accumulated deficit
|
|
(110,381
|
)
|
|
|
(106,372
|
)
|
Equity attributable to Orgenesis Inc.
|
|
34,702
|
|
|
|
38,488
|
|
Non-controlling interest
|
|
155
|
|
|
|
143
|
|
Total equity
|
|
34,857
|
|
|
|
38,631
|
|
TOTAL LIABILITIES AND EQUITY
|
$
|
58,538
|
|
|
$
|
59,841
|
|
ORGENESIS INC.CONDENSED
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE
LOSS(U.S. Dollars in Thousands, Except Share
and Loss Per Share
Amounts)(Unaudited)
|
Three Months Ended
|
|
|
March 31,
|
|
|
|
March 31,
|
2022
|
|
2021
|
|
POC development services
|
$
|
5,689
|
|
|
$
|
7,987
|
|
POC development services from related party
|
|
635
|
|
|
|
1,157
|
|
Cell process development services and hospital services
|
|
888
|
|
|
|
245
|
|
Total revenues
|
|
7,212
|
|
|
|
9,389
|
|
Cost of revenues cell process development services and hospital
services
|
|
714
|
|
|
|
770
|
|
Cost of development services and research and development
expenses
|
|
6,651
|
|
|
|
5,357
|
|
Amortization of intangible assets
|
|
232
|
|
|
|
238
|
|
Selling, general and administrative expenses
|
|
2,851
|
|
|
|
2,968
|
|
Operating loss (income)
|
|
3,236
|
|
|
|
(56
|
)
|
Other income, net
|
|
-
|
|
|
|
(25
|
)
|
Financial expenses, net
|
|
213
|
|
|
|
233
|
|
Share in net loss of associated companies
|
|
547
|
|
|
|
15
|
|
Loss before income taxes
|
|
3,996
|
|
|
|
167
|
|
Tax (income) expense
|
|
1
|
|
|
|
(2
|
)
|
Net loss
|
|
3,997
|
|
|
|
165
|
|
Net loss attributable to non-controlling interests
|
|
12
|
|
|
|
54
|
|
Net loss attributable to Orgenesis Inc.
|
|
4,009
|
|
|
|
219
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
Basic and diluted
|
$
|
0.16
|
|
|
$
|
0.01
|
|
|
|
|
|
|
|
|
Weighted average number of shares used in computation of
Basic and Diluted loss per share:
|
|
|
|
|
|
|
Basic and diluted
|
|
24,600,954
|
|
|
|
24,192,951
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
Net loss
|
$
|
3,997
|
|
|
$
|
165
|
|
Other Comprehensive loss – Translation adjustment
|
|
151
|
|
|
|
277
|
|
Comprehensive loss
|
|
4,148
|
|
|
|
442
|
|
Comprehensive loss attributed to non-controlling interests
|
|
12
|
|
|
|
54
|
|
Comprehensive loss attributed to Orgenesis Inc.
|
$
|
4,160
|
|
|
$
|
496
|
|
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