Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 05, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-38416 | |
Entity Registrant Name | ORGENESIS INC. | |
Entity Central Index Key | 0001460602 | |
Entity Tax Identification Number | 98-0583166 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 20271 Goldenrod Lane | |
Entity Address, City or Town | Germantown | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20876 | |
City Area Code | (480) | |
Local Phone Number | 659-6404 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ORGS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,537,366 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 28,431 | $ 44,923 |
Restricted cash | 481 | 645 |
Accounts receivable, net | 17,196 | 3,085 |
Prepaid expenses and other receivables | 1,399 | 1,070 |
Grants receivable | 168 | 169 |
Inventory | 173 | 185 |
Total current assets | 47,848 | 50,077 |
NON-CURRENT ASSETS: | ||
Deposits | 361 | 296 |
Investments in associates, net | 160 | 175 |
Property, plant and equipment, net | 4,100 | 3,073 |
Intangible assets, net | 12,435 | 13,023 |
Operating lease right-of-use assets | 1,253 | 1,474 |
Goodwill | 8,599 | 8,745 |
Other assets | 802 | 821 |
Total non-current assets | 27,710 | 27,607 |
TOTAL ASSETS | 75,558 | 77,684 |
CURRENT LIABILITIES: | ||
Accounts payable | 5,212 | 8,649 |
Accrued expenses and other payables | 2,553 | 792 |
Income tax payable | 7 | 7 |
Employees and related payables | 1,971 | 1,463 |
Advance payments on account of grant | 1,137 | 692 |
Short-term loans and current maturities of long-term loans | 145 | |
Contract liabilities | 59 | 59 |
Current maturities of finance leases | 19 | 19 |
Current maturities of operating leases | 479 | 485 |
Current maturities of convertible loans | 6,719 | 3,974 |
Total current liabilities | 18,156 | 16,285 |
LONG-TERM LIABILITIES: | ||
Non-current operating leases | 792 | 1,020 |
Convertible loans | 4,656 | 7,200 |
Retirement benefits obligation | 98 | 74 |
Non-current finance leases | 52 | 64 |
Other long-term liabilities | 304 | 313 |
Total long-term liabilities | 5,902 | 8,671 |
TOTAL LIABILITIES | 24,058 | 24,956 |
EQUITY: | ||
Common stock, par value $0.0001 per share, 145,833,334 shares authorized, 24,537,366 and 24,223,093 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 3 | 3 |
Additional paid-in capital | 143,197 | 140,397 |
Accumulated other comprehensive income | 519 | 748 |
Treasury stock 262,090 and 55,309 shares as of June 30, 2021 and December 31, 2020, respectively | (1,159) | (250) |
Accumulated deficit | (91,197) | (88,319) |
Equity attributable to Orgenesis Inc. | 51,363 | 52,579 |
Non-controlling interest | 137 | 149 |
Total equity | 51,500 | 52,728 |
TOTAL LIABILITIES AND EQUITY | $ 75,558 | $ 77,684 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 145,833,334 | 145,833,334 |
Common stock, shares issued | 24,537,366 | 24,223,093 |
Common stock, shares outstanding | 24,537,366 | 24,223,093 |
Treasury stock, shares | 262,090 | 55,309 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Income) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenues | $ 9,818 | $ 1,470 | $ 18,050 | $ 2,855 |
Revenues from related party | 727 | 279 | 1,884 | 772 |
Total revenues | 10,545 | 1,749 | 19,934 | 3,627 |
Cost of services and other research and development expenses | 9,727 | 24,963 | 15,854 | 29,836 |
Amortization of intangible assets | 239 | (52) | 477 | 171 |
Selling, general and administrative expenses | 2,901 | 3,611 | 5,869 | 7,129 |
Other income, net | (3) | (1) | (28) | (4) |
Operating loss | 2,319 | 26,772 | 2,238 | 33,505 |
Financial expenses, net | 406 | 337 | 639 | 666 |
Share in net loss of associated companies | 15 | |||
Loss from continuing operation before income taxes | 2,725 | 27,109 | 2,892 | 34,171 |
Tax expenses (income) | 12 | (2) | (35) | |
Net loss from continuing operation | 2,725 | 27,121 | 2,890 | 34,136 |
Net income from discontinued operations, net of tax | (6,721) | (83,186) | ||
Net loss (income) | 2,725 | 20,400 | 2,890 | (49,050) |
Net loss (income) attributable to non-controlling interests from continuing operation | (66) | 6 | (12) | (33) |
Net income attributable to non-controlling interests from discontinued operations | (492) | |||
Net loss (income) attributable to Orgenesis Inc. | $ 2,659 | $ 20,406 | $ 2,878 | $ (49,575) |
Loss (Earnings) per share: | ||||
Basic and diluted from continuing operations | $ 0.11 | $ 1.26 | $ 0.12 | $ 1.73 |
Basic and diluted from discontinued operations | (0.31) | (4.52) | ||
Basic and diluted | $ 0.11 | $ 0.95 | $ 0.12 | $ (2.79) |
Weighted average number of shares used in computation of Basic and Diluted loss (earnings) per share: | ||||
Basic and diluted | 24,365,746 | 21,515,254 | 24,279,826 | 19,648,042 |
Comprehensive loss (income): | ||||
Net loss from continuing operations | $ 2,725 | $ 27,121 | $ 2,890 | $ 34,136 |
Net loss (income) from discontinued operations, net of tax | (6,721) | (83,186) | ||
Other comprehensive loss (income)- translation adjustments | (48) | (247) | 229 | 397 |
Release of translation adjustment due to sale of subsidiary | (194) | |||
Comprehensive loss (income) | 2,677 | 20,153 | 3,119 | (48,847) |
Comprehensive income attributed to non-controlling interests from continuing operations | (66) | 6 | (12) | (33) |
Comprehensive income attributed to non-controlling interests from discontinued operations | (492) | |||
Comprehensive loss (income) attributed to Orgenesis Inc. | $ 2,611 | $ 20,159 | $ 3,107 | $ (49,372) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Receipts On Account Of Shares To Be Allotted [Member] | AOCI Attributable to Parent [Member] | Treasury Shares [Member] | Retained Earnings [Member] | Parent [Member] | Noncontrolling Interest [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 2 | $ 94,691 | $ 213 | $ (89,429) | $ 5,477 | $ 601 | $ 6,078 | ||
Balance, shares at Dec. 31, 2019 | 16,140,962 | ||||||||
Stock-based compensation to employees and directors | 910 | 910 | 910 | ||||||
Stock-based compensation to service providers | 787 | 787 | 787 | ||||||
Stock-based compensation to service providers, shares | 270,174 | ||||||||
Stock-based compensation for Tamir purchase agreement | 17,748 | 17,748 | 17,748 | ||||||
Balance, shares | 3,400,000 | ||||||||
Beneficial conversion feature of convertible loans | 42 | 42 | 42 | ||||||
Sale of subsidiaries | (413) | (413) | |||||||
Adjustment to redemption value of redeemable non-controlling interest | 5,160 | 5,160 | 5,160 | ||||||
Issuance of shares and warrants | 8,438 | 8,438 | $ 8,438 | ||||||
Balance, shares | 2,200,000,000 | ||||||||
Exercise of options | 300 | 300 | $ 300 | ||||||
Balance, shares | 83,334 | ||||||||
Comprehensive income (loss) for the period | (203) | 49,575 | 49,372 | (33) | 49,339 | ||||
Ending balance, value at Jun. 30, 2020 | $ 2 | 128,076 | 10 | (39,854) | 88,234 | 155 | 88,389 | ||
Balance, shares at Jun. 30, 2020 | 22,094,470 | ||||||||
Beginning balance, value at Mar. 31, 2020 | $ 2 | 109,197 | (237) | (19,448) | 89,514 | 149 | 89,663 | ||
Balance, shares at Mar. 31, 2020 | 18,361,050 | ||||||||
Stock-based compensation to employees and directors | 284 | 284 | 284 | ||||||
Stock-based compensation to service providers | 547 | 547 | 547 | ||||||
Stock-based compensation to service providers, shares | 250,086,000 | ||||||||
Stock-based compensation for Tamir purchase agreement | 17,748 | 17,748 | 17,748 | ||||||
Balance, shares | 3,400,000 | ||||||||
Exercise of options | 300 | 300 | 300 | ||||||
Balance, shares | 83,334 | ||||||||
Comprehensive income (loss) for the period | 247 | (20,406) | (20,159) | 6 | (20,153) | ||||
Ending balance, value at Jun. 30, 2020 | $ 2 | 128,076 | 10 | (39,854) | 88,234 | 155 | 88,389 | ||
Balance, shares at Jun. 30, 2020 | 22,094,470 | ||||||||
Beginning balance, value at Dec. 31, 2020 | $ 3 | 140,397 | 748 | (250) | (88,319) | 52,579 | 149 | 52,728 | |
Balance, shares at Dec. 31, 2020 | 24,167,784 | ||||||||
Stock-based compensation to employees and directors | 612 | 612 | 612 | ||||||
Stock-based compensation to service providers | 276 | 276 | 276 | ||||||
Stock-based compensation to service providers, shares | |||||||||
Balance, shares | |||||||||
Exercise of options | 50 | 50 | 50 | ||||||
Balance, shares | 8,750 | ||||||||
Issuance of Shares due to exercise of warrants | 1,862 | 1,862 | 1,862 | ||||||
Issuance of Shares due to exercise of warrants, shares | 305,523 | ||||||||
Repurchase of treasury stock | (909) | (909) | (909) | ||||||
Repurchase of treasury stock, shares | (206,781) | ||||||||
Comprehensive income (loss) for the period | (229) | (2,878) | (3,107) | (12) | (3,119) | ||||
Ending balance, value at Jun. 30, 2021 | $ 3 | 143,197 | 519 | (1,159) | (91,197) | 51,363 | 137 | 51,500 | |
Balance, shares at Jun. 30, 2021 | 24,275,276 | ||||||||
Beginning balance, value at Mar. 31, 2021 | $ 3 | 142,449 | 424 | 471 | (260) | (88,538) | 54,549 | 203 | 54,752 |
Balance, shares at Mar. 31, 2021 | 24,411,791 | ||||||||
Stock-based compensation to employees and directors | 292 | 292 | 292 | ||||||
Stock-based compensation to service providers | 32 | 32 | 32 | ||||||
Issuance of Shares due to exercise of warrants | 424 | (424) | |||||||
Issuance of Shares due to exercise of warrants, shares | 67,960 | ||||||||
Repurchase of treasury stock | (899) | (899) | (899) | ||||||
Repurchase of treasury stock, shares | (204,475) | ||||||||
Comprehensive income (loss) for the period | 48 | (2,659) | (2,611) | (66) | (2,677) | ||||
Ending balance, value at Jun. 30, 2021 | $ 3 | $ 143,197 | $ 519 | $ (1,159) | $ (91,197) | $ 51,363 | $ 137 | $ 51,500 | |
Balance, shares at Jun. 30, 2021 | 24,275,276 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income (loss) | $ (2,890) | $ 49,050 | |
Adjustments required to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation | 888 | 1,697 | |
Stock-based compensation for Tamir Purchase Agreement | 17,048 | ||
Capital loss (gain), net | 20 | 14 | |
Gain on disposal of subsidiaries | (97,020) | ||
Share in losses of associated company | 15 | ||
Depreciation and amortization expenses | 918 | 739 | |
Effect of exchange differences on inter-company balances | 59 | 124 | |
Net changes in operating leases | (13) | (9) | |
Interest expenses accrued on loans and convertible loans (including amortization of beneficial conversion feature) | 200 | 201 | |
Changes in operating assets and liabilities: | |||
Increase in accounts receivable | (14,087) | (2,453) | |
Decrease (increase) in inventory | 7 | (123) | |
Increase in other assets | (8) | (20) | |
Increase in prepaid expenses and other accounts receivable | (371) | (512) | |
Decrease in accounts payable | (3,422) | (4,748) | |
Increase in accrued expenses and other payables | 1,768 | 13,451 | |
Increase in employee and related payables | 541 | 12 | |
Decrease in contract liabilities | (64) | ||
Change in advance payments and receivables on account of grant, net | 328 | (156) | |
Decrease in deferred taxes liability | (65) | ||
Net cash used in operating activities | (16,047) | (22,834) | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Increase in loan to JV with a related party | (500) | ||
Sale of property and equipment | 4 | ||
Purchase of property and equipment | (1,542) | (974) | |
Proceed from sale of subsidiaries | 104,222 | ||
Investment in deposits | (20) | ||
Repayment from deposits | 20 | ||
Net cash provided by (used in) investing activities | (1,562) | 102,772 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Repurchase of treasury stock | (909) | ||
Proceeds from issuance of shares and warrants (net of transaction costs) | 1,912 | 8,738 | |
Proceeds from issuance of convertible loans (net of transaction costs) | 250 | ||
Repayment of convertible loans and convertible bonds | (2,400) | ||
Repayment of short and long-term debt | (10) | (430) | |
Other financing activities | 1 | ||
Net cash provided by financing activities | 993 | 6,159 | |
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (16,616) | 86,097 | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | (40) | (43) | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD | 45,568 | 12,041 | |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD (*) | [1] | 28,912 | 98,095 |
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES | |||
Finance leases of property, plant and equipment | 363 | ||
Right-of-use assets obtained in exchange for new operating lease liabilities, net | 231 | ||
Purchase of property, plant and equipment change included in accounts payable | (9) | 200 | |
Acquisition of other asset | $ 700 | ||
[1] | See Note 3 for information regarding the discontinued operation. |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 – DESCRIPTION OF BUSINESS a. General Orgenesis Inc., a Nevada corporation, is a global biotech company working to unlock the potential of cell and gene therapies (“CGTs”) in an affordable and accessible treatments, processes, and systems. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMP”). The Company mostly focusses on autologous therapies, with processes and systems that are developed for each therapy using a closed and automated processing system approach that is validated for compliant production near the patient at their point of care for treatment of the patient. This approach has the potential to overcome the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies due to their cost prohibitive nature and complex logistics to deliver the treatments to patients (ultimately limiting the number of patients that can have access to, or can afford, these therapies). To achieve these goals, the Company has developed a Point of Care Platform comprised of three enabling components: a pipeline of licensed POCare Therapies that are designed to be processed and produced, automated closed POCare technology systems, and a collaborative POCare Network. The Company is working to provide a more efficient and scalable pathway for advanced therapies to reach patients more rapidly at lowered costs. The Company also draws on extensive medical expertise to identify promising new autologous therapies to leverage within the POCare Platform either via ownership or licensing. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide with a goal of achieving harmonized, regulated clinical development and production of the therapies. The Company has worked to develop and validate POCare Technologies that can be combined within mobile production units for advanced therapies. The Company has made significant investments in the development of several types of Orgenesis Mobile Processing Units and Labs (“OMPULs”) with the expectation of use and/or distribution through our POCare Network of partners, collaborators, and joint ventures. As of the date of this report, the OMPULs are still in the development stage. OMPULs are designed for the purpose of validation, development, performance of clinical trials, manufacturing and/or processing of potential or approved cell and gene therapy products in a safe, reliable, and cost-effective manner at the point of care, as well as the manufacturing of such CGTs in a consistent and standardized manner in all locations. The design delivers a potential industrial solution for the Company to deliver CGTs to practically any clinical institution at the point of care. Until December 31, 2019, the Company operated the POCare Platform as one of two business separate business segments. The Company’s other business segment was a Contract Development and Manufacturing Organization (“CDMO”) platform, providing contract manufacturing and development services for biopharmaceutical companies (the “CDMO Business”). The CDMO platform was historically operated mainly through majority-owned Masthercell Global (which consisted mainly of the following two subsidiaries: MaSTherCell S.A. in Belgium and Masthercell U.S., LLC in the United States (collectively, “Masthercell”)). In February 2020, the Company sold its entire equity interests in Masthercell Global Inc. (the “Masthercell Business”), which comprised the majority of the Company’s CDMO Business, to Catalent Pharma Solutions, Inc. (the “Masthercell Sale”). The Company determined that the Masthercell Business (“Discontinued Operation”) met the criteria to be classified as a discontinued operation as of the first quarter of 2020. The Discontinued Operation includes the vast majority of the previous CDMO Business (See Note 3). The Company has continued to grow its infrastructure and expand its processing sites into new markets and jurisdictions. In addition, the Company has been investing manpower and financial resources to focus on developing, manufacturing and rolling out several types of OMPULs to be used and/or distributed through our POCare Network of partners, collaborators, and joint ventures. The Chief Executive Officer is the Company’s chief operating decision-maker who reviews financial information prepared on a consolidated basis. Effective from the first quarter of 2020, all of the Company’s continuing operations are in one segment, being the point-of-care business via our POCare Platform. Therefore, no segment report has been presented. The Company currently conducts its core CGT business operations through itself and its subsidiaries which are all wholly-owned except as otherwise stated (collectively, the “Subsidiaries”). The Subsidiaries are as follows: ● United States: Orgenesis Maryland Inc. (the “U.S. Subsidiary”) is the center of activity in North America currently focused on setting up of the POCare Network. ● Koligo Therapeutics Inc. (“Koligo”) is a Kentucky corporation that was acquired in 2020 and is currently focused on developing the POCare network and therapies. ● European Union: Orgenesis Belgium SRL (the “Belgian Subsidiary”) and Orgenesis Germany GmbH (incorporated in 2021), (the “German subsidiary”) are currently focused on process development and preparation of European clinical trials. ● Orgenesis Switzerland Sarl (the “Swiss subsidiary”) incorporated in 2020 is currently focused on providing management services to the Company. ● Israel: Orgenesis Ltd. (the “Israeli Subsidiary”) is a provider of regulatory, clinical and pre-clinical services, and Orgenesis Biotech Israel Ltd. (“OBI”) is a provider of cell-processing services in Israel. ● Korea: Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”), is a provider of processing and pre-clinical services in Korea. The Company owns 94.12 These condensed consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries (and in 2020 includes the Discontinued Operation). The Company’s common stock, par value $ 0.0001 As used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless otherwise specified, all amounts are expressed in United States Dollars. b. Liquidity As of June 30, 2021, the Company has accumulated losses of approximately $ 91 Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and expected level of expenditures for at least 12 months from the date of the issuance of these financial statements. If there are further increases in operating costs for facilities expansion, research and development, commercial and clinical activity or decreases in revenues from customers, the Company may decide to seek additional financing. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
BASIS OF PRESENTATION | NOTE 2 - BASIS OF PRESENTATION a. Basis of presentation The accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (“SEC”). The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2020, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included. b. Significant accounting policies The accounting policies adopted are consistent with those of the previous financial year except as described below: POC Development Services Revenue recognized under contracts for POC development services may, in some contracts, represent multiple performance obligations (where promises to the customers are distinct) in circumstances in which the work packages are not interrelated or the customer is able to complete the services performed. For arrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligations based on their relative standalone selling prices. The Company recognizes revenue when, or as, it satisfies a performance obligation. At contract inception, the Company determines whether the services are transferred over time or at a point in time. Performance obligations that have no alternative use and that the Company has the right to payment for performance completed to date, at all times during the contract term, are recognized over time. All other performance obligations are recognized as revenues by the company at a point of time (upon completion) . In addition, during the three months ended June 30, 2021, the Company started providing support services to its customers. These revenues are recognized as and when the services are provided because the customer simultaneously receives and consumes the benefits provided. Also included in POC development services is Hospital supplies revenue which is derived principally from the sale or lease of products and the performance of services to hospitals or other medical providers. Revenue is earned and recognized when product and services are received by the customer. Recently issued accounting pronouncements, not yet adopted In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company is currently evaluating the impact of adopting this standard. Use of Estimates in the Preparation of Financial Statements The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses and determining whether an acquisition is a business combination or a purchase of asset. Actual results could differ from those estimates. The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We examined the impact of COVID-19 on our financial statements, and although there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates. Reclassifications Certain reclassifications have been made to the prior year’s financial statements to conform to the current year presentation. These reclassifications had no net effect on previously reported results of operations. Revision of Previously Reported Consolidated Financial Statements In connection with the preparation of the company’s consolidated financial statements for the fiscal year ended December 31, 2020, the Company identified an immaterial error originating in the first quarter of 2020 related to the gain calculation on the sale of Masthercell. The Company did not adjust the gain calculation for the reversal of previously-recorded accretion adjustments to the carrying amount of the Redeemable Non-Controlling Interest (NCI) in the amount of $ 5,574 The following table summarizes the impact of the revision on additional paid-in capital and net income from discontinued operations, net of tax for the six months ended June 30, 2020: SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS As reported Adjustment As revised (in thousands) Net income from discontinued operations, net of tax $ 88,760 $ (5,574 ) $ 83,186 Additional paid-in capital 122,502 5,574 128,076 |
DISCONTINUED OPERATION
DISCONTINUED OPERATION | 6 Months Ended |
Jun. 30, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
DISCONTINUED OPERATION | NOTE 3 – DISCONTINUED OPERATION On February 2, 2020, the Company completed the Masthercell Sale and determined that the Masthercell Business met the criteria to be classified as a discontinued operation. The financial results of the Masthercell Business are presented as income from discontinued operations, net of tax on the Company’s Condensed Consolidated Statement of Comprehensive Loss (Income). The following table presents the financial results associated with the Masthercell Business operation as reflected in the Company’s Condensed Consolidated Comprehensive loss (Income) (in thousands): SCHEDULE OF DISCONTINUED FINANCIAL STATEMENTS The period from January 1, 2020 until the disposal date OPERATIONS Revenues $ 2,556 Cost of revenues 1,482 Cost of research and development and research and development services, net 7 Amortization of intangible assets 137 Selling, general and administrative expenses 1,896 Other expenses, net 305 Operating loss 1,271 Financial income, net (29 ) Loss before income taxes 1,242 Tax expenses (30 ) Net loss from discontinuing operation, net of tax $ 1,212 DISPOSAL Gain on disposal before income taxes $ 97,020 Provision for income taxes (12,622 ) Gain on disposal $ 84,398 Net profit from discontinuing operation, net of tax $ 83,186 The following table represents the components of the cash flows from discontinued operations (in thousands): The period from January 1, 2020 until the disposal date Net cash flows used in operating activities $ (2,409 ) Net cash flows used in investing activities $ (579 ) Net cash flows used in financing activities $ (51 ) Disaggregation of Revenue The following table disaggregates the Company’s revenues by major revenue streams related to discontinued operations (in thousands): SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS The period from January 1, 2020 until the disposal date Revenue stream: Cell process development services $ 2,556 Total $ 2,556 |
EQUITY
EQUITY | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
EQUITY | NOTE 4 – EQUITY During the six months period ended June 30, 2021, the Company received approximately $ 1.9 6.24 305,523 During the six months ended June 30, 2021, the Company received $ 50 8,750 5.56 |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK-BASED COMPENSATION | NOTE 5 – STOCK-BASED COMPENSATION Options Granted to Employees The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2021 to June 30, 2021: SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES No. of Options Granted Exercise Price Vesting Period Fair Value at Grant ( in thousands Expiration Period Employees 125,000 $ 5.12 Quarterly over a period of two years 412 10 The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2021 to June 30, 2021 Value of one common share $ 5.12 Dividend yield 0 % Expected stock price volatility 77 % Risk free interest rate 0.96 % Expected term (years) 5.56 |
LOSS (EARNINGS) PER SHARE
LOSS (EARNINGS) PER SHARE | 6 Months Ended |
Jun. 30, 2021 | |
Loss (Earnings) per share: | |
LOSS (EARNINGS) PER SHARE | NOTE 6 – LOSS (EARNINGS) PER SHARE The following table sets forth the calculation of basic and diluted loss per share for the period indicated: SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands, except per share data) Basic and diluted: Net loss from continuing operations attributable to Orgenesis Inc. $ 2,659 $ 27,127 $ 2,878 $ 34,103 Net income from discontinued operations attributable to Orgenesis Inc. for earning per share - (6,721 ) - (83,678 ) Adjustment of redeemable non-controlling interest to redemption amount - - - (5,160 ) Basic: Net income (loss) available to common stockholders - (6,721 ) - (88,838 ) Net (income) loss attributable to Orgenesis Inc. for loss (earning) per share 2,659 20,406 2,878 (54,735 ) Weighted average number of common shares outstanding 24,365,746 21,515,254 24,279,826 19,648,042 Loss per common share from continuing operations $ 0.11 $ 1.26 $ 0.12 $ 1.73 Earnings per common share from discontinued operations $ - $ (0.31 ) $ - $ (4.52 ) Net loss (earnings) per share $ 0.11 $ 0.95 $ 0.12 $ (2.79 ) |
REVENUES
REVENUES | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
REVENUES | NOTE 7 – REVENUES Disaggregation of Revenue The following table disaggregates the Company’s revenues by major revenue streams. SCHEDULE OF DISAGGREGATION OF REVENUE Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands) Revenue stream: POC and hospital services (Mainly POC) $ 9,074 $ 1,174 $ 18,328 $ 3,025 Cell process development services 1,471 575 1,606 602 Total $ 10,545 $ 1,749 $ 19,934 $ 3,627 A breakdown of the revenues per customer constituted at least 10% of revenues is as follows: SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands) Revenue earned: Customer A $ 3,207 $ 906 $ 4,163 $ 1,280 Customer B 1,739 - 4,130 - Customer C 2,119 319 3,276 806 Customer D 936 - 2,582 - Customer E 1,216 237 2,009 733 Contract Assets and Liabilities Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due from customers. The activity for trade receivables is comprised of: SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES June 30, 2021 June 30, 2020 Six Months Ended June 30, 2021 June 30, 2020 (in thousands) Balance as of beginning of period $ 3,085 $ 1,831 Additions 20,347 2,944 Collections (6,260 ) (828 ) Exchange rate differences 24 3 Balance as of end of period $ 17,196 $ 3,950 The activity for contract liabilities is comprised of: SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES June 30, 2021 June 30, 2020 Six Months Ended June 30, 2021 June 30, 2020 (in thousands) Balance as of beginning of period $ 59 $ 325 Additions - 597 Realizations - (760 ) Balance as of end of period $ 59 $ 162 |
TRANSACTIONS DURING THE PERIOD
TRANSACTIONS DURING THE PERIOD | 6 Months Ended |
Jun. 30, 2021 | |
Transactions During Period | |
TRANSACTIONS DURING THE PERIOD | NOTE 8 – TRANSACTIONS DURING THE PERIOD Johns Hopkins University During the three months ended June 30, 2021, the Company and Johns Hopkins University entered into a sublease and construction agreement for the establishment of a clinical therapeutic development and point of care center in Maryland of approximately 6,830 510 260 324 10 The Company has an option to renew the sublease for two additional periods of five years Neuro-Immunotherapy Exclusive License Agreement During the three months ended June 30, 2021, the Company entered into an exclusive license agreement in the field of neuro-immunotherapy. Pursuant to the agreement, the Company received an exclusive, worldwide, sublicensable, royalty-bearing license of certain technology and patents for the purpose of developing, manufacturing, using, and commercializing the licenced technology. Royalties of between 0.5 5 15 12 2.0 36 2 Celleska Pty Ltd During the three months ended June 30, 2021, the Company and Celleska Pty Ltd., an Australian company (“Celleska”), entered into a Joint Venture Agreement (“AJVA”) to facilitate the collaboration in the field of Cell and Gene therapies development and development of the Company’s worldwide POCare network in Australia. Under the AJVA, the Company will hold a 50 5 10 5 Each party shall receive royalties in an amount of ten percent (10%) of the net sales generated by the AJVE and/or its sublicensees. In addition, Company shall receive an exclusive, sublicensable, royalty-bearing, right and license to Celleska’s background intellectual property as required solely to manufacture, distribute and market and sell Celleska products outside the territory of Australia in consideration for royalties in an amount of ten percent (10%) of the net sales generated by the Company or its sublicensees with respect to sale of Celleska products. Once the AJVE is profitable, the Company will be entitled (in addition to any of its rights as the holder of the AJVE) to an additional share of fifteen percent (15%) of the AJVE’s GAAP profit after tax, over and above all rights granted pursuant to Company’s participating interest in the AJVE. As of June 30, 2021 the AJVE had not yet been incorporated. Savicell On June 14, 2021 the Company and Savicell Ltd (“Savicell”) entered into a collaboration agreement (the “Savicell Agreement”) to collaborate in the evaluation, continued development, validation, and use of Savicell’s platform designed for the early detection and diagnosis of diseases and conditions and for quality control and monitoring purposes, in conjunction with the Company’s systems. Pursuant to the Savicell Agreement, the Company shall provide to Savicell funding for performance of certain tasks agreed upon by the parties in a work plan. In consideration for such funding, Savicell shall supply the Company with products developed under the Savicell Agreement at preferential rates and grant to the Company a worldwide exclusive licence to sell such products in the Company’s point-of-care network of hospitals, clinics and institutions for quality control and monitoring of manufacturing and processing of autologous immune cells manipulated by cell and gene therapies, subject to a royalty of 10 Stromatis Pharma On June 15, 2021, the Company and Stromatis Pharma Inc. (“Stromatis”) entered into a Collaboration and Sublicense Agreement (the “Stromatis Agreement”) to collaborate in refining methods for GMP manufacturing of CAR-T/CAR-NK CT109; and the development and validation of the Stromatis technology as it relates to the CAR-T/CAR-NK CT109 antibody up to and inclusive of filing of Investigational New Drug Application relating to Stromatis’ CAR-T/CAR-NK CT109 antibody (“Licensed Product”), in accordance with the agreed project plan (“Project”). The Company will fund the Project by providing Stromatis an amount of up to $ 1.2 5 12 500 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 9 – SUBSEQUENT EVENTS 1. In July 2021 the Company via the Belgian subsidiary invested approximately $ 260 The Company will hold 51 2. On July 28, 2021, the Compensation Committee of the Board of Directors awarded a discretionary bonus to Vered Caplan, the Chief Executive Officer of the Company, in the amount of $ 3.6 |
BASIS OF PRESENTATION (Policies
BASIS OF PRESENTATION (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
POC Development Services | POC Development Services Revenue recognized under contracts for POC development services may, in some contracts, represent multiple performance obligations (where promises to the customers are distinct) in circumstances in which the work packages are not interrelated or the customer is able to complete the services performed. For arrangements that include multiple performance obligations, the transaction price is allocated to the identified performance obligations based on their relative standalone selling prices. The Company recognizes revenue when, or as, it satisfies a performance obligation. At contract inception, the Company determines whether the services are transferred over time or at a point in time. Performance obligations that have no alternative use and that the Company has the right to payment for performance completed to date, at all times during the contract term, are recognized over time. All other performance obligations are recognized as revenues by the company at a point of time (upon completion) . In addition, during the three months ended June 30, 2021, the Company started providing support services to its customers. These revenues are recognized as and when the services are provided because the customer simultaneously receives and consumes the benefits provided. Also included in POC development services is Hospital supplies revenue which is derived principally from the sale or lease of products and the performance of services to hospitals or other medical providers. Revenue is earned and recognized when product and services are received by the customer. |
Recently issued accounting pronouncements, not yet adopted | Recently issued accounting pronouncements, not yet adopted In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company is currently evaluating the impact of adopting this standard. |
Use of Estimates in the Preparation of Financial Statements | Use of Estimates in the Preparation of Financial Statements The preparation of our consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses and determining whether an acquisition is a business combination or a purchase of asset. Actual results could differ from those estimates. The full extent to which the COVID-19 pandemic may directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We examined the impact of COVID-19 on our financial statements, and although there is currently no major impact, there may be changes to those estimates in future periods. Actual results may differ from these estimates. |
Reclassifications | Reclassifications Certain reclassifications have been made to the prior year’s financial statements to conform to the current year presentation. These reclassifications had no net effect on previously reported results of operations. |
Revision of Previously Reported Consolidated Financial Statements | Revision of Previously Reported Consolidated Financial Statements In connection with the preparation of the company’s consolidated financial statements for the fiscal year ended December 31, 2020, the Company identified an immaterial error originating in the first quarter of 2020 related to the gain calculation on the sale of Masthercell. The Company did not adjust the gain calculation for the reversal of previously-recorded accretion adjustments to the carrying amount of the Redeemable Non-Controlling Interest (NCI) in the amount of $ 5,574 The following table summarizes the impact of the revision on additional paid-in capital and net income from discontinued operations, net of tax for the six months ended June 30, 2020: SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS As reported Adjustment As revised (in thousands) Net income from discontinued operations, net of tax $ 88,760 $ (5,574 ) $ 83,186 Additional paid-in capital 122,502 5,574 128,076 |
BASIS OF PRESENTATION (Tables)
BASIS OF PRESENTATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS | The following table summarizes the impact of the revision on additional paid-in capital and net income from discontinued operations, net of tax for the six months ended June 30, 2020: SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS As reported Adjustment As revised (in thousands) Net income from discontinued operations, net of tax $ 88,760 $ (5,574 ) $ 83,186 Additional paid-in capital 122,502 5,574 128,076 |
DISCONTINUED OPERATION (Tables)
DISCONTINUED OPERATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Discontinued Operations and Disposal Groups [Abstract] | |
SCHEDULE OF DISCONTINUED FINANCIAL STATEMENTS | The financial results of the Masthercell Business are presented as income from discontinued operations, net of tax on the Company’s Condensed Consolidated Statement of Comprehensive Loss (Income). The following table presents the financial results associated with the Masthercell Business operation as reflected in the Company’s Condensed Consolidated Comprehensive loss (Income) (in thousands): SCHEDULE OF DISCONTINUED FINANCIAL STATEMENTS The period from January 1, 2020 until the disposal date OPERATIONS Revenues $ 2,556 Cost of revenues 1,482 Cost of research and development and research and development services, net 7 Amortization of intangible assets 137 Selling, general and administrative expenses 1,896 Other expenses, net 305 Operating loss 1,271 Financial income, net (29 ) Loss before income taxes 1,242 Tax expenses (30 ) Net loss from discontinuing operation, net of tax $ 1,212 DISPOSAL Gain on disposal before income taxes $ 97,020 Provision for income taxes (12,622 ) Gain on disposal $ 84,398 Net profit from discontinuing operation, net of tax $ 83,186 The following table represents the components of the cash flows from discontinued operations (in thousands): The period from January 1, 2020 until the disposal date Net cash flows used in operating activities $ (2,409 ) Net cash flows used in investing activities $ (579 ) Net cash flows used in financing activities $ (51 ) |
SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS | The following table disaggregates the Company’s revenues by major revenue streams related to discontinued operations (in thousands): SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS The period from January 1, 2020 until the disposal date Revenue stream: Cell process development services $ 2,556 Total $ 2,556 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES | The table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January 1, 2021 to June 30, 2021: SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES No. of Options Granted Exercise Price Vesting Period Fair Value at Grant ( in thousands Expiration Period Employees 125,000 $ 5.12 Quarterly over a period of two years 412 10 |
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS | The fair valuation of these option grants is based on the following assumptions: SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS During the Period from January 1, 2021 to June 30, 2021 Value of one common share $ 5.12 Dividend yield 0 % Expected stock price volatility 77 % Risk free interest rate 0.96 % Expected term (years) 5.56 |
LOSS (EARNINGS) PER SHARE (Tabl
LOSS (EARNINGS) PER SHARE (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Loss (Earnings) per share: | |
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE | The following table sets forth the calculation of basic and diluted loss per share for the period indicated: SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands, except per share data) Basic and diluted: Net loss from continuing operations attributable to Orgenesis Inc. $ 2,659 $ 27,127 $ 2,878 $ 34,103 Net income from discontinued operations attributable to Orgenesis Inc. for earning per share - (6,721 ) - (83,678 ) Adjustment of redeemable non-controlling interest to redemption amount - - - (5,160 ) Basic: Net income (loss) available to common stockholders - (6,721 ) - (88,838 ) Net (income) loss attributable to Orgenesis Inc. for loss (earning) per share 2,659 20,406 2,878 (54,735 ) Weighted average number of common shares outstanding 24,365,746 21,515,254 24,279,826 19,648,042 Loss per common share from continuing operations $ 0.11 $ 1.26 $ 0.12 $ 1.73 Earnings per common share from discontinued operations $ - $ (0.31 ) $ - $ (4.52 ) Net loss (earnings) per share $ 0.11 $ 0.95 $ 0.12 $ (2.79 ) |
REVENUES (Tables)
REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF DISAGGREGATION OF REVENUE | The following table disaggregates the Company’s revenues by major revenue streams. SCHEDULE OF DISAGGREGATION OF REVENUE Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands) Revenue stream: POC and hospital services (Mainly POC) $ 9,074 $ 1,174 $ 18,328 $ 3,025 Cell process development services 1,471 575 1,606 602 Total $ 10,545 $ 1,749 $ 19,934 $ 3,627 |
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER | A breakdown of the revenues per customer constituted at least 10% of revenues is as follows: SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER Three Months Ended Six Months Ended June 30, 2021 June 30, 2020 June 30, 2021 June 30, 2020 (in thousands) Revenue earned: Customer A $ 3,207 $ 906 $ 4,163 $ 1,280 Customer B 1,739 - 4,130 - Customer C 2,119 319 3,276 806 Customer D 936 - 2,582 - Customer E 1,216 237 2,009 733 |
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES | The activity for trade receivables is comprised of: SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES June 30, 2021 June 30, 2020 Six Months Ended June 30, 2021 June 30, 2020 (in thousands) Balance as of beginning of period $ 3,085 $ 1,831 Additions 20,347 2,944 Collections (6,260 ) (828 ) Exchange rate differences 24 3 Balance as of end of period $ 17,196 $ 3,950 |
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES | The activity for contract liabilities is comprised of: SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES June 30, 2021 June 30, 2020 Six Months Ended June 30, 2021 June 30, 2020 (in thousands) Balance as of beginning of period $ 59 $ 325 Additions - 597 Realizations - (760 ) Balance as of end of period $ 59 $ 162 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($) $ / shares in Units, $ in Millions | Jun. 30, 2021 | Dec. 31, 2020 |
Discounted Future Net Cash Flows Relating to Proved Oil and Gas Reserves [Line Items] | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Accumulated losses | $ 91 | |
CureCell Co. Ltd [Member] | ||
Discounted Future Net Cash Flows Relating to Proved Oil and Gas Reserves [Line Items] | ||
Equity method investment, ownership percentage | 94.12% |
SCHEDULE OF REVISION OF PREVIOU
SCHEDULE OF REVISION OF PREVIOUSLY REPORTED CONSOLIDATED FINANCIAL STATEMENTS (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Net income from discontinued operations, net of tax | $ 6,721 | $ 83,186 | |||
Additional paid-in capital | $ 143,197 | 128,076 | $ 143,197 | 128,076 | $ 140,397 |
Previously Reported [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Net income from discontinued operations, net of tax | 88,760 | ||||
Additional paid-in capital | 122,502 | 122,502 | |||
Revision of Prior Period, Adjustment [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Net income from discontinued operations, net of tax | (5,574) | ||||
Additional paid-in capital | $ 5,574 | $ 5,574 |
BASIS OF PRESENTATION (Details
BASIS OF PRESENTATION (Details Narrative) | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Accounting Policies [Abstract] | |
Adjustment redeemable non-controlling interest | $ 5,574 |
SCHEDULE OF DISCONTINUED FINANC
SCHEDULE OF DISCONTINUED FINANCIAL STATEMENTS (Details) $ in Thousands | 1 Months Ended |
Feb. 02, 2020USD ($) | |
Discontinued Operations and Disposal Groups [Abstract] | |
Disposal Group, Including Discontinued Operation, Revenue | $ 2,556 |
Cost of revenues | 1,482 |
Cost of research and development and research and development services, net | 7 |
Amortization of intangible assets | 137 |
Selling, general and administrative expenses | 1,896 |
Other expenses, net | 305 |
Operating loss | 1,271 |
Financial income, net | (29) |
Loss before income taxes | 1,242 |
Tax expenses | (30) |
Net loss from discontinuing operation, net of tax | 1,212 |
Gain on disposal before income taxes | 97,020 |
Provision for income taxes | (12,622) |
Gain on disposal | 84,398 |
Net profit from discontinuing operation, net of tax | 83,186 |
Net cash flows used in operating activities | (2,409) |
Net cash flows used in investing activities | (579) |
Net cash flows used in financing activities | $ (51) |
SCHEDULE OF DISAGGREGATION OF R
SCHEDULE OF DISAGGREGATION OF REVENUE RELATED TO DISCONTINUED OPERATIONS (Details) $ in Thousands | 1 Months Ended |
Feb. 02, 2020USD ($) | |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |
Disposal Group, Including Discontinued Operation, Revenue | $ 2,556 |
Cell Process Development Services [Member] | |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |
Disposal Group, Including Discontinued Operation, Revenue | $ 2,556 |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Number of shares issued for common stock | 305,523 | ||
Stock issued during period, value, stock options exercised | $ 300 | $ 50 | $ 300 |
Weighted average price per shares | $ 5.56 | ||
Common Stock [Member] | |||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||
Warrant to purchase of common stock | $ 1,900 | ||
Warrant exercise price | $ 6.24 | ||
Exercise of stock option, shares | 83,334 | 8,750 | 83,334 |
SCHEDULE OF EMPLOYEE STOCK OWNE
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES (Details) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
Fair value at grant | $ | $ 412 |
Employees [Member] | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
No. of options granted | shares | 125,000 |
Exercise price | $ / shares | $ 5.12 |
Stock options vesting period description | two years |
Expiration period | 10 years |
SCHEDULE OF STOCK OPTIONS, VALU
SCHEDULE OF STOCK OPTIONS, VALUATION ASSUMPTIONS (Details) - Employees [Member] | 6 Months Ended |
Jun. 30, 2021$ / shares | |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] | |
Value of one common share | $ 5.12 |
Dividend yield | 0.00% |
Expected stock price volatility | 77.00% |
Risk free interest rate | 0.96% |
Expected term (years) | 5 years 6 months 21 days |
SCHEDULE OF BASIC AND DILUTED L
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Loss (Earnings) per share: | ||||
Net loss from continuing operations attributable to Orgenesis Inc. | $ 2,659 | $ 27,127 | $ 2,878 | $ 34,103 |
Net income from discontinued operations attributable to Orgenesis Inc. for earning per share | (6,721) | (83,678) | ||
Adjustment of redeemable non-controlling interest to redemption amount | (5,160) | |||
Basic: Net income (loss) available to common stockholders | (6,721) | (88,838) | ||
Net (income) loss attributable to Orgenesis Inc. for loss (earning) per share | $ 2,659 | $ 20,406 | $ 2,878 | $ (54,735) |
Weighted average number of common shares outstanding | 24,365,746 | 21,515,254 | 24,279,826 | 19,648,042 |
Loss per common share from continuing operations | $ 0.11 | $ 1.26 | $ 0.12 | $ 1.73 |
Earnings per common share from discontinued operations | (0.31) | (4.52) | ||
Net loss (earnings) per share | $ 0.11 | $ 0.95 | $ 0.12 | $ (2.79) |
SCHEDULE OF DISAGGREGATION OF_2
SCHEDULE OF DISAGGREGATION OF REVENUE (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Total | $ 10,545 | $ 1,749 | $ 19,934 | $ 3,627 |
POC and Hospital Services (Mainly POC) [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total | 9,074 | 1,174 | 18,328 | 3,025 |
Cell Process Development Services [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Total | $ 1,471 | $ 575 | $ 1,606 | $ 602 |
SCHEDULE OF BREAKDOWN OF REVENU
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 9,818 | $ 1,470 | $ 18,050 | $ 2,855 |
Customers A [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 3,207 | 906 | 4,163 | 1,280 |
Customers B [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 1,739 | 4,130 | ||
Customer C [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 2,119 | 319 | 3,276 | 806 |
Customer D [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | 936 | 2,582 | ||
Customer E [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Revenues | $ 1,216 | $ 237 | $ 2,009 | $ 733 |
SCHEDULE OF ACTIVITY FOR TRADE
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | ||
Balance as of beginning of period | $ 3,085 | $ 1,831 |
Additions | 20,347 | 2,944 |
Collections | (6,260) | (828) |
Exchange rate differences | 24 | 3 |
Balance as of end of period | $ 17,196 | $ 3,950 |
SCHEDULE OF ACTIVITY FOR CONTRA
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | ||
Balance as of beginning of period | $ 59 | $ 325 |
Additions | 597 | |
Realizations | (760) | |
Balance as of end of period | $ 59 | $ 162 |
TRANSACTIONS DURING THE PERIOD
TRANSACTIONS DURING THE PERIOD (Details Narrative) $ in Thousands | Jun. 15, 2021USD ($) | Jun. 30, 2021USD ($)ft² | Jun. 30, 2021USD ($)ft² |
Sublease and Construction Agreement [Member] | Johns Hopkins University [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Area of land | ft² | 6,830 | 6,830 | |
Leasehold improvements advance amount | $ 510 | $ 510 | |
Annual rent | 260 | $ 260 | |
Increase in rent | $ 324 | ||
Lease term | 10 years | 10 years | |
Lease option to extend | The Company has an option to renew the sublease for two additional periods of five years each under the same terms and conditions. | ||
Renewal term | 5 years | 5 years | |
License Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
sublicense fees percentage | 12.00% | 12.00% | |
Investment term | 36 months | ||
License Agreement [Member] | Minimum [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Royalty of net sales, percentage | 0.50% | 0.50% | |
Invested amount for development | $ 2,000 | ||
License Agreement [Member] | Maximum [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Royalty of net sales, percentage | 5.00% | 5.00% | |
Royalty term | 15 years | ||
Sublicense lease net sale percentage | 2.00% | 2.00% | |
Joint Venture Agreement [Member] | Celleska Pty Ltd [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Equity ownership percentage | 50.00% | 50.00% | |
Minimum valuation amount | $ 5,000 | ||
Funds from each party | 10,000 | ||
Fund from party | $ 5,000 | ||
Venture agreement description | Each party shall receive royalties in an amount of ten percent (10%) of the net sales generated by the AJVE and/or its sublicensees. In addition, Company shall receive an exclusive, sublicensable, royalty-bearing, right and license to Celleska’s background intellectual property as required solely to manufacture, distribute and market and sell Celleska products outside the territory of Australia in consideration for royalties in an amount of ten percent (10%) of the net sales generated by the Company or its sublicensees with respect to sale of Celleska products. Once the AJVE is profitable, the Company will be entitled (in addition to any of its rights as the holder of the AJVE) to an additional share of fifteen percent (15%) of the AJVE’s GAAP profit after tax, over and above all rights granted pursuant to Company’s participating interest in the AJVE. As of June 30, 2021 the AJVE had not yet been incorporated. | ||
Savicell Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Royalty of net sales, percentage | 10.00% | 10.00% | |
Stromatis Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Revenue share percentage | 5.00% | ||
cost of services, other research and development expenses | $ 500 | ||
Stromatis Agreement [Member] | Maximum [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Royalty of net sales, percentage | 12.00% | ||
Invested amount for development | $ 1,200 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) $ in Thousands | Jul. 28, 2021 | Jul. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Subsequent Event [Line Items] | ||||
Investment | $ 160 | $ 175 | ||
Subsequent Event [Member] | Vered Caplan [Member] | Personal Employment Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Bonus | $ 3,600 | |||
Revacel Srl [Member] | BELGIUM | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Investment | $ 260 | |||
Equity incorporated description | The Company will hold 51% of the share capital of Revacel and have the right to appoint 2 members to the Revacel board of directors. The Company’s partner, Revatis SA, (a Belgian entity) will hold the remaining 49% and has the right to appoint 2 members to the Revacel board of directors. | |||
Equity ownership percentage | 51.00% |