GERMANTOWN, Md., Nov. 04, 2021 (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, today reported financial results for the third quarter ended September 30, 2021.
Vered Caplan, CEO of Orgenesis, stated, “We are making steady progress rolling out our POCare Platform, as illustrated by our solid revenue growth. Specifically, revenue for the first nine months of 2021 increased to $28.6 million, compared to just $5.3 million for the same period last year. To put the Company’s growth in perspective, our revenue run rate is nearly on par with our former Masthercell CDMO operations at the time of its sale. However, we believe the new POCare platform is far more advanced, cost effective, and scalable.”
“Feedback from within the industry has been encouraging as our POCare platform addresses many of the key challenges facing the industry, including capacity constraints and excessive costs. By producing personalized cell and gene therapies (CGTs) at the point of care, we believe we are able to add new capacity within months instead of years. At the same time, we are advancing the roll out of our Orgenesis Mobile Processing Units & Labs (OMPULs), which are fully integrated, all-in-one bioprocessing units that can be rapidly deployed as a standardized industrial cleanroom alternative at the point of care.”
“While our current revenues reflect the validation phase of our roll-out strategy, we expect to increasingly benefit from revenue sharing and royalty agreements with our respective partners as we potentially advance the respective point-of-care therapies being developed. Importantly, we believe our new model of decentralized supply of cell and gene therapies, based on standardization of the manufacturing environment, represents an attractive and commercially viable path forward for the industry, to unlock the full potential of CGTs.”
“We continue to expand our global network through collaborations with some of the leading research centers, hospitals and biotech companies around the world, such as Johns Hopkins University in the U.S., as well as recent additions in Italy and Spain. We are integrating over 30 therapies, in various development stages, into our POCare platform, spanning immuno-oncology, anti-viral, metabolic/auto-immune diseases, tissue regeneration and more.”
The Company’s complete financial results are available in the Company’s Form 10-Q filed with the Securities and Exchange Commission on November 4, 2021 which is available at www.sec.gov and on the Company’s website.
Conference Call
The Company plans to host a conference call at 8:30 AM Eastern Time today, November 4, 2021, to discuss the Company’s financial results for the third quarter ended September 30, 2021, as well as the Company’s corporate progress and other developments.
The conference call will be available via telephone by dialing toll free 877-545-0320 for U.S. callers or for international callers +1 973-528-0002 and by entering access code: 236477. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/43447 or on the Company’s Investor Events section of the website here.
A webcast replay will be available on the Company’s Investor Events section of the website (https://ir.orgenesis.com/events#/) through Friday, November 4, 2022. A telephone replay of the call will be available approximately one hour following the call, through Thursday, November 18, 2021 and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 43447.
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. The Orgenesis Point of Care 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. Learn more about the work Orgenesis is doing 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, our reliance on, and our ability to grow, our point-of-care cell therapy platform, 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 coronavirus outbreak, the sufficiency of working capital to realize our business plans, 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 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, 2020, 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:
David Waldman
Crescendo Communications, LLC
Tel: 212-671-1021
ORGS@crescendo-ir.com
Media contact for Orgenesis
Image Box Communications
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars in thousands)
(Unaudited)
| As of | |||||
| September 30, | December 31, | ||||
| Assets | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | $ | 14,917 | $ | 44,923 | |
| Restricted cash | 487 | 645 | |||
| Accounts receivable, net * | 15,950 | 3,085 | |||
| Prepaid expenses and other receivables | 1,667 | 1,070 | |||
| Convertible loan to related party | 3,018 | - | |||
| Grants receivable | 169 | 169 | |||
| Inventory | 133 | 185 | |||
| Total current assets | 36,341 | 50,077 | |||
| NON-CURRENT ASSETS: | |||||
| Deposits | $ | 358 | $ | 296 | |
| Investments in associates, net | 397 | 175 | |||
| Property, plant and equipment, net | 5,706 | 3,073 | |||
| Intangible assets, net | 12,064 | 13,023 | |||
| Operating lease right-of-use assets | 1,122 | 1,474 | |||
| Goodwill | 8,414 | 8,745 | |||
| Other assets | 802 | 821 | |||
| Total non-current assets | 28,863 | 27,607 | |||
| TOTAL ASSETS | $ | 65,204 | $ | 77,684 | |
* Including related party in the amount of $1,069 thousand and $744 thousand as of September 30, 2021 and as of December 31, 2020, respectively.
ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)
(U.S. Dollars in thousands)
(Unaudited)
| As of | |||||||
| September 30, | December 31, | ||||||
| Liabilities and Equity | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 3,056 | $ | 8,649 | |||
| Accrued expenses and other payables | 2,474 | 792 | |||||
| Income tax payable | 74 | 7 | |||||
| Employees and related payables | 1,919 | 1,463 | |||||
| Advance payments on account of grant | 1,108 | 692 | |||||
| Short-term loans and current maturities of long-term loans | - | 145 | |||||
| Contract liabilities | 59 | 59 | |||||
| Current maturities of finance leases | 18 | 19 | |||||
| Current maturities of operating leases | 476 | 485 | |||||
| Current maturities of convertible loans | 4,382 | 3,974 | |||||
| Total current liabilities | 13,566 | 16,285 | |||||
| LONG-TERM LIABILITIES: | |||||||
| Non-current operating leases | $ | 665 | $ | 1,020 | |||
| Convertible loans | 7,277 | 7,200 | |||||
| Retirement benefits obligation | 98 | 74 | |||||
| Non-current finance leases | 47 | 64 | |||||
| Other long-term liabilities | 290 | 313 | |||||
| Total long-term liabilities | 8,377 | 8,671 | |||||
| TOTAL LIABILITIES | 21,943 | 24,956 | |||||
| EQUITY: | 3 | 3 | |||||
| Additional paid-in capital | 145,338 | 140,397 | |||||
| Accumulated other comprehensive income | 290 | 748 | |||||
| Treasury stock 262,090 and 55,309 shares as of September | (1,159 | ) | (250 | ) | |||
| Accumulated deficit | (101,356 | ) | (88,319 | ) | |||
| Equity attributable to Orgenesis Inc. | 43,116 | 52,579 | |||||
| Non-controlling interest | 145 | 149 | |||||
| Total equity | 43,261 | 52,728 | |||||
| TOTAL LIABILITIES AND EQUITY | $ | 65,204 | $ | 77,684 | |||
The accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME)
(U.S. Dollars in thousands, except share and loss per share amounts)
(Unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, 2021 | September 30, 2020 | September 30, 2021 | September 30, 2020 | |||||||||||||
| Revenues | $ | 7,606 | $ | 1,450 | $ | 25,656 | $ | 4,305 | ||||||||
| Revenues from related party | 1,070 | 279 | 2,954 | 1,051 | ||||||||||||
| Total revenues | 8,676 | 1,729 | 28,610 | 5,356 | ||||||||||||
| Cost of services and other research and development expenses | 10,007 | 6,951 | 25,861 | 36,787 | ||||||||||||
| Amortization of intangible assets | 236 | 87 | 713 | 258 | ||||||||||||
| Selling, general and administrative expenses | 6,092 | 4,042 | 11,961 | 11,171 | ||||||||||||
| Other income, net | (3 | ) | (5 | ) | (31 | ) | (9 | ) | ||||||||
| Operating loss | 7,656 | 9,346 | 9,894 | 42,851 | ||||||||||||
| Financial expenses, net * | 2,410 | 238 | 3,049 | 904 | ||||||||||||
| Share in net loss of associated companies | 18 | - | 33 | - | ||||||||||||
| Loss from continuing operations before income taxes | 10,084 | 9,584 | 12,976 | 43,755 | ||||||||||||
| Tax expenses (income) | 67 | (18 | ) | 65 | (53 | ) | ||||||||||
| Net loss from continuing operations | 10,151 | 9,566 | 13,041 | 43,702 | ||||||||||||
| Net income from discontinued operations, net of tax | - | (7,132 | ) | - | (90,318 | ) | ||||||||||
| Net loss (income) | 10,151 | 2,434 | 13,041 | (46,616 | ) | |||||||||||
| Net loss (income) attributable to non-controlling interests from continuing operations | 8 | (7 | ) | (4 | ) | (40 | ) | |||||||||
| Net income attributable to non-controlling interests from discontinued operations | - | - | - | (492 | ) | |||||||||||
| Net loss (income) attributable to Orgenesis Inc. | $ | 10,159 | $ | 2,427 | $ | 13,037 | $ | (47,148 | ) | |||||||
| Loss (Earnings) per share: | ||||||||||||||||
| Basic and diluted from continuing operations | $ | 0.42 | $ | 0.43 | $ | 0.54 | $ | 2.13 | ||||||||
| Basic and diluted from discontinued operations | $ | - | $ | (0.32 | ) | $ | - | $ | (4.69 | ) | ||||||
| Basic and diluted | $ | 0.42 | $ | 0.11 | $ | 0.54 | $ | (2.56 | ) | |||||||
| Weighted average number of shares used in computation of Basic and Diluted loss (earnings) per share: | ||||||||||||||||
| Basic and diluted | 24,275,276 | 22,094,470 | 24,278,292 | 20,469,470 | ||||||||||||
| Comprehensive loss (income): | ||||||||||||||||
| Net loss from continuing operations | $ | 10,151 | $ | 9,566 | $ | 13,041 | $ | 43,702 | ||||||||
| Net income from discontinued operations, net of tax | - | (7,132 | ) | - | (90,318 | ) | ||||||||||
| Other comprehensive loss (income)- translation adjustments | 229 | (282 | ) | 458 | 115 | |||||||||||
| Release of translation adjustment due to sale of subsidiary | - | - | - | (194 | ) | |||||||||||
| Comprehensive loss (income) | 10,380 | 2,152 | 13,499 | (46,695 | ) | |||||||||||
| Comprehensive (loss) income attributed to non-controlling interests from continuing operations | 8 | (7 | ) | (4 | ) | (40 | ) | |||||||||
| Comprehensive income attributed to non-controlling interests from discontinued operations | - | - | - | (492 | ) | |||||||||||
| Comprehensive loss (income) attributed to Orgenesis Inc. | $ | 10,388 | $ | 2,145 | $ | 13,495 | $ | (47,227 | ) | |||||||
* Including loss from extinguishment in connection with convertible loan restructuring in the amount of $ 1,865 thousand for the three and nine months ended September 30, 2021.
