GERMANTOWN, Md., May 09, 2019 (GLOBE NEWSWIRE) -- 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 clinical use.
About Orgenesis
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:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
ORGS@crescendo-ir.com
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CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars in Thousands)
(Unaudited)
| As of | |||||||||
| March 31, 2019 | December 31, 2018 | November 30, 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)
(Unaudited)
| As of | |||||||||||||
| March 31, 2019 | December 31, 2018 | November 30, 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 | |||||||
ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(U.S. Dollars in Thousands, Except Share and Loss Per Share Amounts)
(Unaudited)
| Three Months Ended | Transition Period One-Month Ended | |||||||||||
| March 31, | February 28, | December 31, | ||||||||||
| 2019 | 2018 | 2018 | ||||||||||
| REVENUES | $ | 7,301 | $ | 2,636 | $ | 1,852 | ||||||
| COST OF REVENUES | 4,344 | 1,644 | 1,221 | |||||||||
| GROSS PROFIT | 2,957 | 992 | 631 | |||||||||
| RESEARCH AND DEVELOPMENT EXPENSES, net | 5,150 | 766 | 1,431 | |||||||||
| AMORTIZATION OF INTANGIBLE ASSETS | 517 | 436 | 179 | |||||||||
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | 5,600 | 3,344 | 1,984 | |||||||||
| OTHER INCOME, net | (37 | ) | (316 | ) | - | |||||||
| OPERATING LOSS | 8,273 | 3,238 | 2,963 | |||||||||
| FINANCIAL EXPENSES, net | 140 | 2,681 | 27 | |||||||||
| SHARE IN NET INCOME OF ASSOCIATED COMPANY | - | (46 | ) | - | ||||||||
| LOSS BEFORE INCOME TAXES | 8,413 | 5,873 | 2,990 | |||||||||
| TAX (INCOME) EXPENSES | 37 | (396 | ) | (83 | ) | |||||||
| NET LOSS | 8,450 | 5,477 | 2,907 | |||||||||
| NET INCOME (LOSS) ATTRIBUTABLE TO NON-CONTROLLING INTERESTS (INCLUDING REDEEMABLE) | (139 | ) | 134 | (163 | ) | |||||||
| NET LOSS ATTRIBUTABLE TO ORGENESIS INC. | 8,311 | 5,611 | 2,744 | |||||||||
| LOSS PER SHARE: | ||||||||||||
| Basic | $ | 0.55 | $ | 0.52 | $ | 0.19 | ||||||
| Diluted | $ | 0.55 | $ | 0.52 | $ | 0.19 | ||||||
| WEIGHTED AVERAGE NUMBER OF SHARES USED IN COMPUTATION OF BASIC AND DILUTED EARNINGS (LOSS) PER SHARE: | ||||||||||||
| Basic | 15,571,568 | 10,775,877 | 15,423,040 | |||||||||
| Diluted | 15,571,568 | 10,775,877 | 15,423,040 | |||||||||
| COMPREHENSIVE LOSS: | ||||||||||||
| Net loss | $ | 8,450 | $ | 5,477 | $ | 2,907 | ||||||
| Other comprehensive (income) loss - translation adjustments | 484 | (707 | ) | (244 | ) | |||||||
| Comprehensive loss | 8,934 | 4,770 | 2,663 | |||||||||
| Comprehensive (income) loss attributed to non-controlling interests (including redeemable) | (139 | ) | 134 | (163 | ) | |||||||
| COMPREHENSIVE LOSS ATTRIBUTED TO ORGENESIS INC. | $ | 8,795 | $ | 4,904 | $ | 2,500 | ||||||