Full Press Release Details
Orgenesis First Quarter 2019 Revenue Increases 177% to a
Company Expands Point of Care Platform; Benefits from Growing
Cell and Gene Therapy Market
GERMANTOWN, MD May 9, 2019
Orgenesis Inc. (NASDAQ: ORGS) ( Orgenesis or the Company ), a developer, manufacturer and service provider of
advanced cell therapies, today reported financial results and provided a
business update for the fiscal first quarter ended March 31, 2019. As a result
of the Company s change in its fiscal year end from November 30 to December 31,
the Company is reporting a December 2018 fiscal month transition period and is
comparing the results for the three months ended March 31, 2019, to the three
months ended February 28, 2018.
Fiscal Q1 2019 financial highlights include:
Revenue increased 177% to $7.3 million, as compared to $2.6 million for
the three months ended February 28, 2018
Gross profit increased 198% to $3.0 million, as compared to $992,000 for
the three months ended February 28, 2018
Ended quarter with $14.4 million of cash and approximately $21.4 million
of shareholders equity
Vered Caplan, CEO of Orgenesis, commented, Our financial
performance is indicative of the rapid growth in the cell and gene therapy
market. The revenue increase we are experiencing at Orgenesis is a direct result
of the expanding capacity of our Contract Development and Manufacturing
Organization ( CDMO ) business to meet the growing demand by providing high
quality services to our client base.
We have made significant strides with respect to our Point of
Care ( POCare ) platform, said Ms. Caplan. We have aligned ourselves with key regional
partners in order to establish a network of leading healthcare facilities to
enable our autologous cell therapy platform. This division is driving further
value for Orgenesis shareholders through collaboration and out licensing
agreements. We believe this additional value will become increasingly visible in
our future financial performance.
We achieved strong year-over-year revenue growth of 177%, with
revenue increasing to a record $7.3 million for the first quarter of 2019. In
order to meet the growing demand for our CDMO services, we are establishing a
new, state-of-the-art production site within the Gosselies Biopark in Belgium,
which will expand our CDMO capacity with the goal of serving the needs of
commercial-stage customers. We are also establishing a new 30,000 square foot
manufacturing facility in Houston, Texas, to dramatically expand our presence
within North America, said Caplan.
Through its POCare platform, Orgenesis continues to align with
regional partners in order to establish a network of leading healthcare
facilities to develop autologous cell and gene therapies. Orgenesis recently
entered into an out licensing and collaboration agreement with HekaBio K.K. for
Japan. Orgenesis entered into an agreement with TheraCell for the clinical
development and commercialization of cell and gene therapies in certain European
countries and recently announced an agreement with Columbia University to
develop a cellular vaccination product platform for pancreatic, hepatic and
cholangiocarcinoma cancers. Orgenesis also partnered with ExcellaBio for exosome related technologies, as well as Digilab to develop
industrial 3D printing capability for cellular structures and tissues for
Orgenesis is a biotechnology company specializing in the
development, manufacturing and provision of technologies and services in the
cell and gene therapy industry. The Company operates through two platforms: (i)
a POCare cell therapy platform ( PT ) and (ii) a CDMO platform conducted through
its subsidiary, Masthercell Global. Through its PT business, the Company s aim
is to further the development of Advanced Therapy Medicinal Products ( ATMPs )
through collaborations and in-licensing with other pre-clinical and
clinical-stage biopharmaceutical companies and research and healthcare
institutes to bring such ATMPs to patients. The Company out-licenses these ATMPs
through regional partners to whom it also provides regulatory, pre-clinical and
training services to support their activity in order to reach patients in a
point-of-care hospital setting. Through the Company s CDMO platform, it is
focused on providing contract manufacturing and development services for
biopharmaceutical companies. The CDMO platform operates through Masthercell
Global, which currently consists of MaSTherCell in Belgium, Atvio in Israel and
subsidiaries in South Korea and in the United States, each having unique
know-how and expertise for manufacturing in a multitude of cell types.
Additional information is available at: 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,
the success of our reorganized CDMO operations, the success of our partnership
with Great Point Partners, our ability to achieve and maintain overall
profitability, the sufficiency of working capital to realize our business plans,
the development of our transdifferentiation technology as therapeutic treatment
for diabetes which could, if successful, be a cure for Type 1 Diabetes; our
technology not functioning as expected; our ability to retain key employees; our
ability to satisfy the rigorous regulatory requirements for new procedures; our
competitors developing better or cheaper alternatives to our products 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 November 30, 2018, 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.
Contact for Orgenesis:
CONDENSED CONSOLIDATED BALANCE SHEETS
| As of | |||||||||
| March 31, | December 31, | November 30, | |||||||
| 2019 | 2018 | 2018 | |||||||
| Assets | |||||||||
| CURRENT ASSETS: | |||||||||
| Cash and cash equivalents | $ | 14,361 | $ | 14,612 | $ | 16,064 | |||
| Restricted cash | 401 | 387 | 392 | ||||||
| Accounts receivable, net | 5,975 | 3,226 | 4,151 | ||||||
| Prepaid expenses and other receivables | 986 | 1,132 | 913 | ||||||
| GPP receivable, see note 5 | - | 6,600 | 6,600 | ||||||
| Grants receivable | 217 | 441 | 441 | ||||||
| Inventory | 1,992 | 1,660 | 1,736 | ||||||
| Total current assets | 23,932 | 28,058 | 30,297 | ||||||
| NON-CURRENT ASSETS: | |||||||||
| Deposits | 569 | 143 | 85 | ||||||
| Loans to related party, see note 5 | 2,033 | 1,012 | 1,007 | ||||||
| Property and equipment, net | 12,783 | 12,458 | 11,901 | ||||||
| Intangible assets, net | 15,823 | 16,642 | 16,700 | ||||||
| Operating lease right-of-use assets | 14,354 | - | - | ||||||
| Goodwill | 15,002 | 15,266 | 15,165 | ||||||
| Other assets | 274 | 297 | 292 | ||||||
| Total non-current assets | 60,838 | 45,818 | 45,150 | ||||||
| TOTAL ASSETS | $ | 84,770 | $ | 73,876 | $ | 75,447 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Cont d)
(U.S. Dollars in Thousands)
| As of | |||||||||
| December | |||||||||
| March 31, | 31, | November 30, | |||||||
| 2019 | 2018 | 2018 | |||||||
| Liabilities and Equity | |||||||||
| CURRENT LIABILITIES: | |||||||||
| Accounts payable | $ | 5,522 | $ | 4,583 | $ | 3,804 | |||
| Accrued expenses and other payables | 1,525 | 1,499 | 2,060 | ||||||
| Employees and related payables | 3,034 | 3,052 | 3,006 | ||||||
| Related parties | 92 | - | - | ||||||
| Advance payments on account of grant | 1,510 | 1,603 | 1,724 | ||||||
| Short-term loans and current maturities of long- term loans | 631 | 641 | 647 | ||||||
| Contract liabilities | 7,533 | 5,175 | 5,317 | ||||||
| Current maturities of long-term finance leases | 232 | 226 | 209 | ||||||
| Current maturities of operating leases | 1,291 | - | - | ||||||
| Current maturities of convertible loans | 382 | 382 | 378 | ||||||
| Total current liabilities | 21,752 | 17,161 | 17,145 | ||||||
| LONG-TERM LIABILITIES: | |||||||||
| Non-current operating leases | 11,816 | - | - | ||||||
| Loans payable | 1,510 | 1,633 | 1,662 | ||||||
| Convertible loans | 1,242 | 1,214 | 1,038 | ||||||
| Retirement benefits obligation | 304 | 280 | 265 | ||||||
| Deferred taxes | 1,578 | 1,656 | 1,702 | ||||||
| Long-term finance leases | 641 | 661 | 638 | ||||||
| Other long-term liabilities | 293 | 297 | 195 | ||||||
| Total long-term liabilities | 17,384 | 5,741 | 5,500 | ||||||
| TOTAL LIABILITIES | 39,136 | 22,902 | 22,645 | ||||||
| COMMITMENTS | |||||||||
| REDEEMABLE NON-CONTROLLING INTEREST | 24,233 | 24,224 | 24,153 | ||||||
| EQUITY: | |||||||||
| Common stock of $0.0001 par value, 145,833,334 shares authorized, 16,102,000, 15,540,333 and 14,951,783 shares issued and outstanding as of March 31, 2019, December 31, 2018 and November 30, 2018, respectively | 2 | 2 | 1 | ||||||
| Additional paid-in capital | 94,049 | 90,597 | 88,082 | ||||||
| Receipts on account of shares to be allotted | - | - | 2,253 | ||||||
| Accumulated other comprehensive income | 185 | 669 | 425 | ||||||
| Accumulated deficit | (73,474 | ) | (65,163 | ) | (62,411 | ) | |||
| Equity attributable to Orgenesis Inc. | 20,762 | 26,105 | 28,350 | ||||||
| Non-controlling interest | 639 | 645 | 299 | ||||||
| Total equity | 21,401 | 26,750 | 28,649 | ||||||
| TOTAL LIABILITIES AND EQUITY | $ | 84,770 | $ | 73,876 | $ | 75,447 |