Orgenesis Provides Business Update for the First Quarter of 2023 and Reports Continued Progress on its POCare Strategy
May 10 2023 - 4:30PM
Orgenesis Inc. (NASDAQ: ORGS)
(“Orgenesis” or the “Company”), a global biotech company working to
unlock the full potential of cell and gene therapies (CGT), today
provided a business update for the first quarter ended March 31,
2023.
Vered Caplan, CEO of Orgenesis, said, “We
achieved revenue of approximately $7.0 million for the first
quarter of 2023, which reflects the continued progress of our
POCare strategy. We are currently focused on the
implementation of our quality systems, as well as our GMP processes
at the various POCare sites. We are also expanding our
international management team with the support of Metalmark, our
long-term partner and investor in our Morgenesis subsidiary.
We are working closely with international suppliers to standardize
production in our POCare platform to ensure we can provide the same
products and level of quality at each of our sites, including
optimizing the utilization of our existing capacity and the use of
the OMPULs. We are training additional teams around the
world, and have successfully implemented a certified academic
program to support additional recruitment and are performing
multiple tech transfers to additional sites for production-stage
products supplied at existing sites. Importantly, we are expanding
our business development efforts to engage global technology
providers in our efforts to provide the industry with a robust
standardized platform for the development and production of cell
and gene therapies.”
Ms. Caplan continued, “In addition to our POCare
Services platform, we are advancing our therapeutic pipeline,
leveraging government grants and funding from regional partners as
well as focusing on finding the optimal licensing and marketing
partners for some of the more advanced product candidates in our
pipeline. We believe that some of our assets have matured to a
stage where the company would benefit from strategic partnerships
which may further utilize our POCare platform.”
The complete financial results for the first
quarter of 2023 are available on the Company’s website in the
Company’s 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, 2022, 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
OrgenesisIB CommunicationsNeil Hunter / Michelle BoxallTel
+44 (0)20 8943
4685neil@ibcomms.agency / michelle@ibcomms.agency
(tables follow)
ORGENESIS
INC.CONSOLIDATED BALANCE
SHEETS(U.S. Dollars, in thousands)
|
|
As of |
|
|
March 31,2023 |
|
|
December 31,2022 |
Assets |
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
2,674 |
|
$ |
5,311 |
Restricted cash |
|
1,057 |
|
|
1,058 |
Accounts receivable, net |
|
37,739 |
|
|
36,183 |
Prepaid expenses and other receivables |
|
5,127 |
|
|
958 |
Convertible Loan receivables-related parties |
|
2,725 |
|
|
2,688 |
Inventory |
|
128 |
|
|
120 |
TOTAL CURRENT
ASSETS |
|
49,450 |
|
|
46,318 |
|
|
|
|
|
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
Deposits |
$ |
326 |
|
$ |
331 |
Investments and loans to associates |
|
136 |
|
|
135 |
Property, plant and equipment, net |
|
21,808 |
|
|
22,834 |
Intangible assets, net |
|
9,430 |
|
|
9,694 |
Operating lease right-of-use assets |
|
2,904 |
|
|
2,304 |
Goodwill |
|
8,069 |
|
|
8,187 |
Deferred tax |
|
100 |
|
|
103 |
Other assets |
|
1,044 |
|
|
1,022 |
TOTAL
NON-CURRENT ASSETS |
|
43,817 |
|
|
44,610 |
TOTAL
ASSETS |
$ |
93,267 |
|
$ |
90,928 |
ORGENESIS
INC.CONSOLIDATED BALANCE
SHEETS(U.S. Dollars, in thousands)
|
|
As of |
|
|
March 31,2023 |
|
|
December 31,2022 |
Liabilities and Equity |
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
4,387 |
|
|
$ |
4,429 |
|
Accrued expenses and other payables |
|
2,510 |
|
|
|
2,578 |
|
Income tax payable |
|
438 |
|
|
|
289 |
|
Employees and related payables |
|
1,856 |
|
|
|
1,860 |
|
Advance payments on account of grant |
|
1,590 |
|
|
|
1,578 |
|
Contract liabilities |
|
106 |
|
|
|
70 |
|
Current maturities of finance leases |
|
62 |
|
|
|
60 |
|
Current maturities of operating leases |
|
675 |
|
|
|
542 |
|
Short-term and current maturities of convertible loans |
|
2,314 |
|
|
|
4,504 |
|
TOTAL CURRENT
LIABILITIES |
|
13,938 |
|
|
|
15,910 |
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES: |
|
|
|
|
|
Non-current operating leases |
$ |
2,148 |
|
|
$ |
1,728 |
|
Convertible loans |
|
17,290 |
|
|
|
13,343 |
|
Retirement benefits obligation |
|
168 |
|
|
|
163 |
|
Long-term debt and finance leases |
|
79 |
|
|
|
95 |
|
Advance payments on account of grant |
|
70 |
|
|
|
144 |
|
Other long-term liabilities |
|
266 |
|
|
|
271 |
|
TOTAL LONG-TERM
LIABILITIES |
|
20,021 |
|
|
|
15,744 |
|
TOTAL
LIABILITIES |
|
33,959 |
|
|
|
31,654 |
|
|
|
|
|
|
|
REDEEMABLE
NON-CONTROLLING INTEREST |
|
30,203 |
|
|
|
30,203 |
|
EQUITY: |
|
|
|
|
|
Common stock of $0.0001 par
value:Authorized at March 31, 2023 and December 31, 2022:
145,833,334 shares; Issued at March 31, 2023 and December 31, 2022:
28,148,110 and 25,832,322 shares, respectively; Outstanding at
March 31, 2023 and December 31, 2022: 27,861,543 and
25,545,755 shares, respectively. |
|
3 |
|
|
|
3 |
|
Additional paid-in capital |
|
154,950 |
|
|
|
150,355 |
|
Accumulated other comprehensive income |
|
(311 |
) |
|
|
(270 |
) |
Treasury stock, 286,567 shares as of March 31, 2023 and December
31, 2022 |
|
(1,266 |
) |
|
|
(1,266 |
) |
Accumulated deficit |
|
(125,709 |
) |
|
|
(121,261 |
) |
Equity attributable to Orgenesis Inc. |
|
27,667 |
|
|
|
27,561 |
|
Non-controlling interest |
|
1,438 |
|
|
|
1,510 |
|
TOTAL
EQUITY |
|
29,105 |
|
|
|
29,071 |
|
TOTAL LIABILITIES AND
EQUITY |
$ |
93,267 |
|
|
$ |
90,928 |
|
ORGENESIS
INC.CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS(U.S. Dollars, in thousands, except share and
per share amounts)
|
Three Months Ended |
|
|
March
31, |
|
|
March 31, |
2023 |
|
2022 |
Revenue |
$ |
7,044 |
|
|
$ |
6,577 |
Revenue from related
party |
|
- |
|
|
|
635 |
Total revenues |
|
7,044 |
|
|
|
7,212 |
Cost of revenues |
|
2,722 |
|
|
|
714 |
Gross profit |
|
4,322 |
|
|
|
6,498 |
Cost of development services
and research and development expenses |
|
3,281 |
|
|
|
6,651 |
Amortization of intangible
assets |
|
207 |
|
|
|
232 |
Selling, general and
administrative expenses |
|
4,298 |
|
|
|
2,851 |
Operating loss |
|
3,464 |
|
|
|
3,236 |
Other income, net |
|
(2 |
) |
|
|
- |
Loss from extinguishment in
connection with convertible loan |
|
283 |
|
|
|
- |
Financial expenses, net |
|
644 |
|
|
|
213 |
Share in net loss of
associated companies |
|
2 |
|
|
|
547 |
Loss before income taxes |
|
4,391 |
|
|
|
3,996 |
Tax expense |
|
129 |
|
|
|
1 |
Net loss |
|
4,520 |
|
|
|
3,997 |
Net income attributable to
non-controlling interests |
|
(72 |
) |
|
|
12 |
Net loss attributable to
Orgenesis Inc. |
|
4,448 |
|
|
|
4,009 |
|
|
|
|
|
|
Loss per
share: |
|
|
|
|
|
Basic and diluted |
$ |
0.17 |
|
|
$ |
0.16 |
|
|
|
|
|
|
Weighted average
number of shares used in computation of Basic and Diluted loss per
share: |
|
|
|
|
|
Basic and diluted |
|
26,246,924 |
|
|
|
24,600,954 |
|
|
|
|
|
|
Comprehensive
loss: |
|
|
|
|
|
Net loss |
$ |
4,520 |
|
|
$ |
3,997 |
Other Comprehensive loss –
Translation adjustment |
|
41 |
|
|
|
151 |
Comprehensive loss |
|
4,561 |
|
|
|
4,148 |
Comprehensive income loss
attributed to non-controlling interests |
|
(72 |
) |
|
|
12 |
Comprehensive loss attributed
to Orgenesis Inc. |
$ |
4,489 |
|
|
$ |
4,160 |
Orgenesis (NASDAQ:ORGS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Orgenesis (NASDAQ:ORGS)
Historical Stock Chart
From Apr 2023 to Apr 2024