GERMANTOWN, Md., May 10, 2023 (GLOBE NEWSWIRE) -- 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 Orgenesis
Orgenesis 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, LLC
Tel: 212-671-1021
Orgs@crescendo-ir.com
Communications contact for Orgenesis
IB Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@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 | ||
