Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2020shares | |
Document Information Line Items | |
Entity Registrant Name | Gamida Cell Ltd. |
Document Type | 20-F |
Current Fiscal Year End Date | --12-31 |
Entity Common Stock, Shares Outstanding | 59,000,153 |
Amendment Flag | false |
Entity Central Index Key | 0001600847 |
Entity Current Reporting Status | Yes |
Entity Voluntary Filers | No |
Entity Filer Category | Accelerated Filer |
Entity Well-known Seasoned Issuer | No |
Document Period End Date | Dec. 31, 2020 |
Document Fiscal Year Focus | 2020 |
Document Fiscal Period Focus | FY |
Entity Emerging Growth Company | true |
Entity Shell Company | false |
Entity Ex Transition Period | false |
Document Annual Report | true |
Document Shell Company Report | false |
Document Transition Report | false |
Entity File Number | 001-38716 |
Entity Incorporation, State or Country Code | L3 |
Entity Interactive Data Current | Yes |
Consolidated Statements of Fina
Consolidated Statements of Financial Position - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 127,170 | $ 41,838 |
Marketable securities | 13,559 | |
Prepaid expenses and other current assets | 2,815 | 1,306 |
Total current assets | 129,985 | 56,703 |
NON-CURRENT ASSETS: | ||
Property, plant and equipment, net | 18,238 | 6,298 |
Right-of-use assets | 6,474 | 5,133 |
Other assets | 786 | 641 |
Total non-current assets | 25,498 | 12,072 |
Total assets | 155,483 | 68,775 |
CURRENT LIABILITIES: | ||
Trade payables | 6,329 | 1,164 |
Employees and payroll accruals | 4,705 | 3,443 |
Current maturities of lease liabilities | 2,532 | 1,870 |
Accrued expenses and other payables | 7,988 | 4,918 |
Total current liabilities | 21,554 | 11,395 |
NON-CURRENT LIABILITIES: | ||
Liabilities presented at fair value | 12,043 | 5,221 |
Employee benefit liabilities, net | 768 | 773 |
Lease liability | 5,378 | 4,101 |
Liability to Israel Innovation Authority (IIA) | 17,003 | 12,302 |
Total non-current liabilities | 35,192 | 22,397 |
CONTINGENT LIABILITIES AND COMMITMENTS | ||
Share capital - | ||
Ordinary shares of NIS 0.01 par value - Authorized: 100,000,000 shares at December 31, 2020 and 2019; Issued and outstanding: 59,000,153 and 33,670,926 shares at December 31, 2020 and 2019, respectively | 166 | 92 |
Share premium | 375,280 | 238,992 |
Capital reserve due to actuarial loss | (441) | (541) |
Reserve from financial assets measured at FVTOCI | 4 | |
Accumulated deficit | (276,268) | (203,564) |
Total shareholders’ equity | 98,737 | 34,983 |
Total liabilities and shareholders’ equity | $ 155,483 | $ 68,775 |
Consolidated Statements of Fi_2
Consolidated Statements of Financial Position (Parentheticals) - ₪ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of financial position [abstract] | ||
Ordinary shares, par value (in New Shekels per share) | ₪ 0.01 | ₪ 0.01 |
Ordinary shares, authorized | 100,000,000 | 100,000,000 |
Ordinary shares, issued | 59,000,153 | 33,670,926 |
Ordinary shares, outstanding | 59,000,153 | 33,670,926 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | |||
Research and development expenses, net | $ 41,385 | $ 31,462 | $ 22,045 |
Commercial activities | 8,748 | 4,692 | |
General and administrative expenses | 12,167 | 12,091 | 11,599 |
Operating loss | 62,300 | 48,245 | 33,644 |
Financial expenses | 10,640 | 3,325 | 20,259 |
Financial income | (236) | (17,149) | (1,042) |
Loss before taxes on income (tax benefit) | 72,704 | 34,421 | 52,861 |
Taxes on income (tax benefit) | (70) | 70 | |
Net loss | 72,704 | 34,351 | 52,931 |
Items that will be reclassified subsequently to profit or loss: | |||
Actuarial net gain (loss) of defined benefit plans | (100) | 464 | (2) |
Changes in the fair value of marketable securities | 4 | (47) | 9 |
Total comprehensive loss | $ 72,608 | $ 34,768 | $ 52,938 |
Net loss per share: | |||
Basic net loss per share (in Dollars per share) | $ 1.66 | $ 1.17 | $ 10.53 |
Diluted net loss per share (in Dollars per share) | $ 1.66 | $ 1.69 | $ 10.53 |
Consolidated Statements of Chan
Consolidated Statements of Changes In Equity - USD ($) $ in Thousands | Ordinary shares | Preferred shares | Share Premium | Reserve from financial assets measured at FVTOCI | Capital reserve due to actuarial losses | Accumulated deficit | Total |
Balance at Dec. 31, 2017 | $ 2 | $ 38 | $ 139,311 | $ (34) | $ (79) | $ (116,282) | $ 22,956 |
Balance (in Shares) at Dec. 31, 2017 | 689,898 | 14,154,743 | |||||
Net loss | (52,931) | (52,931) | |||||
Other comprehensive loss | (9) | 2 | (7) | ||||
Total comprehensive loss | (9) | 2 | (52,931) | (52,938) | |||
Issuance of additional Preferred shares following anti-dilution protection | $ 8 | (8) | |||||
Issuance of additional Preferred shares following anti-dilution protection (in Shares) | 3,134,546 | ||||||
Exercise of options | 2 | 2 | |||||
Exercise of options (in Shares) | 9,692 | ||||||
Conversion of Preferred shares | $ 46 | $ (46) | |||||
Conversion of Preferred shares (in Shares) | 17,289,289 | (17,289,289) | |||||
Issuance of Ordinary shares in initial public offering, net of issuance expenses of $5,947 | $ 18 | 47,223 | 47,241 | ||||
Issuance of Ordinary shares in initial public offering, net of issuance expenses of $5,947 (in Shares) | 6,648,368 | ||||||
Exercise of warrants | $ 1 | 3,850 | 3,851 | ||||
Exercise of warrants (in Shares) | 293,489 | ||||||
Share-based compensation | 3,575 | 3,575 | |||||
Balance at Dec. 31, 2018 | $ 67 | 193,953 | (43) | (77) | (169,213) | 24,687 | |
Balance (in Shares) at Dec. 31, 2018 | 24,930,736 | ||||||
Net loss | (34,351) | (34,351) | |||||
Other comprehensive loss | 47 | (464) | (417) | ||||
Total comprehensive loss | 47 | (464) | (34,351) | (34,768) | |||
Issuance of Ordinary shares in a secondary offering, net of issuance expenses of $694 | $ 23 | 37,117 | 37,140 | ||||
Issuance of Ordinary shares in a secondary offering, net of issuance expenses of $694 (in Shares) | 8,050,000 | ||||||
Exercise of options | $ 1 | 131 | 132 | ||||
Exercise of options (in Shares) | 480,878 | ||||||
Exercise of warrants | $ 1 | 2,923 | 2,924 | ||||
Exercise of warrants (in Shares) | 209,312 | ||||||
Share-based compensation | 4,868 | 4,868 | |||||
Balance at Dec. 31, 2019 | $ 92 | 238,992 | 4 | (541) | (203,564) | $ 34,983 | |
Balance (in Shares) at Dec. 31, 2019 | 33,670,926 | 33,670,926 | |||||
Net loss | (72,704) | $ (72,704) | |||||
Other comprehensive loss | (4) | 100 | 96 | ||||
Total comprehensive loss | $ (4) | 100 | (72,704) | (72,608) | |||
Issuance of Ordinary shares in a secondary offering, net of issuance expenses of $694 | $ 72 | 132,776 | 132,848 | ||||
Issuance of Ordinary shares in a secondary offering, net of issuance expenses of $694 (in Shares) | 24,677,084 | ||||||
Exercise of options | $ 2 | 648 | 650 | ||||
Exercise of options (in Shares) | 652,143 | ||||||
Share-based compensation | 2,864 | 2,864 | |||||
Balance at Dec. 31, 2020 | $ 166 | $ 375,280 | $ (441) | $ (276,268) | $ 98,737 | ||
Balance (in Shares) at Dec. 31, 2020 | 59,000,153 | 59,000,153 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes In Equity (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Changes In Equity [Abstract] | |||
Issuance expenses | $ 10,902 | $ 694 | $ 5,947 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (72,704) | $ (34,351) | $ (52,931) |
Adjustments to the profit or loss items: | |||
Depreciation of property, equipment and right-of-use assets | 2,397 | 2,143 | 269 |
Financial loss (income), net | 483 | (775) | (858) |
Share-based compensation | 2,864 | 4,868 | 3,575 |
Change in employee benefit liabilities, net | 94 | 126 | (15) |
Amortization of premium on marketable securities | 4 | 184 | 272 |
Revaluation of liabilities presented at fair value | 6,822 | (15,904) | 17,600 |
Revaluation of liability to IIA | 4,302 | 2,531 | 2,037 |
16,966 | (6,827) | 22,880 | |
Increase (decrease) in other receivables, prepaid expenses and other assets | (1,626) | (150) | 942 |
Increase (decrease) in trade payables | 5,083 | (821) | (405) |
Increase in accrued expenses and other payables | 3,454 | 2,807 | 2,296 |
6,911 | 1,836 | 2,833 | |
Cash received during the year for: | |||
Interest received | 361 | 1,546 | 792 |
Interest paid | (161) | (134) | |
Net cash used in operating activities | (48,627) | (37,930) | (26,426) |
Cash flows from investing activities: | |||
Purchase of property, plant and equipment | (11,804) | (3,055) | (1,645) |
Purchase of marketable securities | (32,021) | (10,905) | |
Proceeds from bank deposits | 5,000 | ||
Investment in restricted bank deposits | (158) | (150) | |
Proceeds from maturity of marketable securities | 13,551 | 38,742 | |
Proceeds from sale of marketable securities | 4,949 | ||
Net cash provided by (used in) investing activities | 1,589 | 3,666 | (2,751) |
Cash flows from financing activities: | |||
Proceeds from secondary offerings, net | 133,316 | 37,140 | |
Receipt of grants from the IIA | 399 | 224 | 612 |
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net | (238) | 47,479 | |
Payment of lease liabilities | (1,985) | (1,529) | |
Proceeds from exercise of options | 650 | 132 | 2 |
Net cash provided by financing activities | 132,380 | 35,729 | 48,093 |
Exchange differences on balances of cash and cash equivalents | (10) | 101 | 31 |
Increase in cash and cash equivalents | 85,332 | 1,566 | 18,947 |
Cash and cash equivalents at beginning of year | 41,838 | 40,272 | 21,325 |
Cash and cash equivalents at end of year | 127,170 | 41,838 | 40,272 |
Significant non-cash transactions: | |||
Lease liabilities arising from new right-of-use asset | 3,409 | ||
IIA liability for grants to be received | 103 | 7 | |
Exercise of warrants liabilities to equity | 2,924 | 3,851 | |
Issuance expenses on credit | 468 | 238 | |
Purchase of property, plant and equipment on credit | $ 415 | $ 1,255 |
General
General | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of general information about financial statements [text block] [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. Gamida Cell Ltd. (the “Company”), founded in 1998, is an advanced cell therapy company committed to finding cures for patients with blood cancers and serious blood diseases. The Company develops novel curative treatments using stem cells and Natural Killer (NK) cells. b. The Company has created a novel NAM cell expansion technology platform that is designed to enhance the number and functionality of allogenic donor cells. This proprietary therapeutic platform may enable the development of therapies with the potential to improve treatment outcomes beyond what is possible with current donor-derived therapies. The lead product candidate, omidubicel, is an advanced cell therapy in development as a potential life-saving treatment option for patients in need of a bone marrow transplant (BMT). In May 2020, the Company reported that omidubicel met its primary endpoint in an international, randomized, multi-center Phase 3 clinical study in 125 patients with high-risk hematologic malignancies undergoing bone marrow transplant and who had no available matched donor. The study evaluated the safety and efficacy of omidubicel compared to standard umbilical cord blood. BMT with a graft derived from bone marrow or peripheral blood cells of a matched donor is currently the standard of care treatment for many of these patients, but there is a significant unmet need for patients who cannot find a fully matched donor. In October 2020, the Company reported that omidubicel met all three of its secondary endpoints. All three secondary endpoints demonstrated a statistically significant improvement among patients who received omidubicel compared to the comparator group. Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has received orphan drug designation in the U.S. and in Europe. In addition to omidubicel, the Company is developing GDA-201, an investigational NK cell-based cancer immunotherapy to be used in combination with standard-of-care therapeutic antibodies. NK cells have potent anti-tumor properties and have the advantage over other oncology cell therapies of not requiring genetic matching, potentially enabling NK cells to serve as a universal donor-based therapy when combined with certain antibodies. GDA-201 is currently in an investigator-sponsored Phase 1/2 study for the treatment of relapsed or refractory non-Hodgkin lymphoma (NHL). In December 2020, the Company reported updated and expanded results from the Phase 1 clinical study at the Annual Meeting of the American Society of Hematology, or ASH. The data from the first 35 patients demonstrated that GDA-201 was clinically active and generally well tolerated. Among the 19 patients with NHL, 13 complete responses and one partial response were observed, with an overall response rate of 74 percent and a complete response rate of 68 percent. c. The Company is devoting substantially all of its efforts toward research and development activities. In the course of such activities, the Company has sustained operating losses and expects such losses to continue in the foreseeable future. The Company’s accumulated deficit as of December 31, 2020 was $276,268 and negative cash flows from operating activities during the year ended December 31, 2020 was $ 48,627. The Company’s management plan is to seek for additional financing as required to fund its operations until achieving positive cash flows. Refer to Note 15 in respect to subsequent event. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern. d. Definitions: In these financial statements: The Company - Gamida Cell Ltd. and its subsidiary Subsidiary Gamida Cell Inc. Incorporated in 2000 and intended to focus on sales and marketing upon product approval Related parties - As defined in IAS 24 Dollar - U.S. dollar |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of initial application of standards or interpretations [abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES The following accounting policies have been applied consistently in the financial statements for all periods presented, unless otherwise stated. a. Basis of presentation of the financial statements: These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). The consolidated financial statements have been prepared on a cost basis, except for available for sale financial assets and financial liabilities that have been measured at fair value through profit or loss. The Company has elected to present profit or loss items using the function of expense method. b. Consolidated financial statements: The consolidated financial statements comprise the financial statements of the Company and its subsidiary. The financial statements of the Company are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform accounting policies by all companies in the group. Significant intra-group balances, transactions and gains or losses resulting from intra-group are eliminated in full in the consolidated financial statements. c. Functional currency, presentation currency and foreign currency: 1. Functional currency and presentation currency: The presentation currency of the financial statements is the U.S. dollar. The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. 2. Transactions, assets and liabilities in foreign currency: Transactions denominated in foreign currency are recorded upon initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period to the functional currency at the exchange rate at that date. Exchange rate differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in foreign currency are translated at the exchange rate at the date of the transaction. Non-monetary assets and liabilities denominated in foreign currency and measured at fair value are translated to the functional currency using the exchange rate prevailing at the date when the fair value was determined. d. Cash and cash equivalents: Cash and cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of investment or with a maturity of more than three months, but which are redeemable on demand without penalty and which form part of the Company’s cash management. e. Short-term deposits and restricted deposits: Short-term deposits are bank deposits with an original maturity of more than three months from the date of investment and which do not meet the definition of cash equivalents. The deposits are presented according to their terms of deposit. Restricted deposit is primarily invested in highly liquid deposits. Restricted deposit amounted to $152 as of December 31, 2020 and 2019 and is included in prepaid expenses and other current assets on the statements of financial position. f. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants,excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. (**) As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a change in accounting estimate. An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal. g. Research and development costs: Research expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate: the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company’s intention to complete the intangible asset and use or sell it; the Company’s ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company’s ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company’s development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred. h. Impairment of non-financial assets: The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss. An impairment loss of an asset is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years, and its recoverable amount. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize any impairment of non-financial assets. i. Government investment grants: Government grants are recognized when there is reasonable assurance that the grants will be received and the Company will comply with the related conditions. Government grants received from the Israel Innovation Authority (“IIA”) (formerly, the Office of the Chief Scientist in Israel (“OCS”)) are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales. If no such economic benefits are expected, the royalty obligation is treated as a contingent liability in accordance with IAS 37. At the end of each reporting period, the Company evaluates, based on its best estimate of future sales, whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid and accordingly, no royalties will be required to be paid. If there is such reasonable assurance, the appropriate amount of the liability is derecognized and recorded in profit or loss as a revaluation of research and development expenses. If the estimate of future sales indicates that there is no such reasonable assurance, the appropriate amount of the liability that reflects expected future royalty payments is recognized with a corresponding adjustment to financial expenses or income. Changes in the amount of liability as a result of changes in the future royalty payments is recognized with a corresponding adjustment to research and development expense. As of December 31, 2020 and 2019, the Company has determined that future economic benefits are expected from its research and development projects and recorded a liability for its entire contingent obligation to the IIA. Grants received from the IIA which are recognized as a liability are accounted for as forgivable loans, in accordance with IAS 20 (Revised), pursuant to the provisions of IFRS 9, “Financial Instruments”. Accordingly, when the liability for the loan is first recognized, it is measured at fair value using a discount rate that reflects a market rate of interest which in the Company’s case was determined to be 20%, 30% and 28% for 2020, 2019 and 2018, respectively. The difference between the amount of the grants received and the fair value of the liability is accounted for upon recognition of the liability as a government grant and recognized as a reduction of research and development expenses. For the years ended December 31, 2020, 2019 and 2018, no royalties were paid with respect to grants received from the IIA. Payments will be treated as a reduction of the liability. Grants of $1,108, $871 and $2,425 were approved during 2020, 2019 and 2018, respectively. Grant receivable is $103 and $7 as of December 31, 2020 and 2019, respectively, and is included in prepaid expenses and other current assets in the statements of financial position. j. Provisions: A provision in accordance with IAS 37 is recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. k. Share-based payment transactions: The Company’s employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions: The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair value is determined using an acceptable option pricing model. With respect to other service providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments. In cases where the fair value of the goods or services received as consideration of equity instruments cannot be measured, it is measured by reference to the fair value of the equity instruments granted. The cost of equity-settled transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the performance and/or service conditions are to be satisfied, ending on the date on which the relevant employees become fully entitled to the award (the “Vesting Period”). No expense is recognized for awards that do not ultimately vest. l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. Lease liabilities: At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company’s incremental borrowing rate. The lease payments include fixed payments (including in -substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects the Company’s intention to exercise the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. After the commencement date, the Company measures the lease liability using the effective interest rate method. r. New and amended standards and interpretations The Company applied for the first-time certain standards and amendments, which are effective for annual periods beginning on or after 1 January 2020. The Company has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective. Amendments to IAS 1 and IAS 8 Definition of Material The amendments provide a new definition of material that states, “information is material if omitting, misstating or obscuring it could reasonably be expected to influence decisions that the primary users of general purpose financial statements make on the basis of those financial statements, which provide financial information about a specific reporting entity.” The amendments clarify that materiality will depend on the nature or magnitude of information, either individually or in combination with other information, in the context of the financial statements. A misstatement of information is material if it could reasonably be expected to influence decisions made by the primary users. These amendments had no impact on the consolidated financial statements, nor is there expected to be any future impact on the Company. Amendments to IFRS 16 Covid-19 Related Rent Concessions On May 28, 2020, the IASB issued Covid-19-Related Rent Concessions - amendment to IFRS 16 Leases. The amendments provide relief to lessees from applying IFRS 16 guidance on lease modification accounting for rent concessions arising as a direct consequence of the Covid-19 pandemic. As a practical expedient, a lessee may elect not to assess whether a Covid-19 related rent concession from a lessor is a lease modification. A lessee that makes this election accounts for any change in lease payments resulting from the Covid-19 related rent concession the same way it would account for the change under IFRS 16, if the change were not a lease modification. The amendment applies to annual reporting periods beginning on or after 1 June 2020. Earlier application is permitted. This amendment had no impact on the consolidated financial statements of the Company. |
Significant Accounting Judgment
Significant Accounting Judgments, Estimates and Assupmtions Used in the Preparation of the Financial Statements | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of accounting judgements and estimates [text block] [Abstract] | |
SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUPMTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS | NOTE 3:- SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS The key assumptions made in the financial statements concerning uncertainties at the end of the reporting period and the critical estimates computed by the Company that may result in a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below. - Government grants: Government grants received from the IIA are recognized as a liability if future economic benefits are expected from the research and development activity that will result in royalty-bearing sales. There is uncertainty regarding the estimated future cash flows and the estimated discount rate used to measure the amortized cost of the liability. - Determining the fair value of an unquoted financial liabilities: The fair value of unquoted financial liabilities in Level 3 of the fair value hierarchy is determined using valuation techniques including projected cash flows discounted at current rates applicable for items with similar terms and risk characteristics. Changes in estimated projected cash flows and discount rates, after consideration of risk factors such as liquidity risk, credit risk and volatility, are liable to affect the fair value of these liabilities. |
Cash and Cash Equivalents
Cash and Cash Equivalents | 12 Months Ended |
Dec. 31, 2020 | |
Cash and cash equivalents [abstract] | |
CASH AND CASH EQUIVALENTS | NOTE 4:- CASH AND CASH EQUIVALENTS December 31, 2020 2019 Cash for immediate withdrawal $ 4,283 $ 2,307 Cash equivalents - short-term deposits (1) 122,887 39,531 $ 127,170 $ 41,838 (1) The cash equivalents are short-term bank deposits denominated in USD and bear interest at an average annual rate of 0.01% and 1.7% as of December 31, 2020 and 2019, respectively. |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of property, plant and equipment [text block] [Abstract] | |
PROPERTY, PLANT AND EQUIPMENT, NET | NOTE 5:- PROPERTY, PLANT AND EQUIPMENT, NET Composition and movement: 2020 Machinery Office furniture and equipment Leasehold improvements Production Plant in process Total Cost: Balance at January 1, 2020 $ 3,366 $ 580 $ 1,191 $ 4,429 $ 9,566 Additions 179 47 351 11,720 12,297 Balance at December 31, 2020 3,545 627 1,542 16,149 21,863 Accumulated depreciation: Balance at January 1, 2020 1,936 421 911 - 3,268 Depreciation 206 71 80 - 357 Balance at December 31, 2020 2,142 492 991 - 3,625 Property and equipment, net at December 31, 2020 1,403 135 551 16,149 18,238 2019 Machinery Office furniture and equipment Leasehold improvements Production Plant in process Total Cost: Balance at January 1, 2019 $ 3,154 $ 535 $ 1,099 $ 468 $ 5,256 Additions 212 45 92 3,961 4,310 Balance at December 31, 2019 3,366 580 1,191 4,429 9,566 Accumulated depreciation: Balance at January 1, 2019 1,753 345 847 - 2,945 Depreciation 183 76 64 - 323 Balance at December 31, 2019 1,936 421 911 - 3,268 Property and equipment, net at December 31, 2019 $ 1,430 $ 159 $ 280 $ 4,429 $ 6,298 |
Right-of-Use Assets and Lease L
Right-of-Use Assets and Lease Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of quantitative information about leases for lessee [abstract] | |
RIGHT-OF-USE ASSETS AND LEASE LIABILITIES | NOTE 6:- RIGHT-OF-USE ASSETS AND LEASE LIABILITIES Set out below, are the carrying amounts of the Company’s right-of-use assets and lease liabilities and the movements during the year: Right-of-use assets Offices and labs Vehicles Production plant Total Lease liabilities As of January 1, 2020 $ 934 $ 175 $ 4,024 $ 5,133 $ 5,971 Depreciation expense (1,318 ) (201 ) (521 ) (2,040 ) - Interest expense - - - - 707 Additions 3,282 127 - 3,409 3,402 Payments - - - - (2,145 ) Other - (27 ) (1 ) (28 ) (25 ) As of December 31, 2020 $ 2,898 $ 74 $ 3,502 $ 6,474 $ 7,910 The Company has entered into commercial, real estate lease agreements which consist of the office building and production plant. The leases are under non-cancellable terms and mature over one to seven years. The Company rents vehicles under an operating lease agreement, for a fixed monthly fee of $23. The leases are under non-cancellable terms and mature over one to three years. The future minimum lease fees payable as of December 31, 2020 are as follows: First year $ 2,363 Second through fifth years 4,650 After fifth year 1,304 $ 8,317 The Company has several lease contracts that include extension and termination options. These options are negotiated by management to provide flexibility in managing the leased-asset portfolio and align with the Company’s business needs. Management exercises significant judgement in determining whether these extension and termination options are reasonably certain to be exercised. As of December 31, 2020, the Company does not expect to exercise the options. The Company also has a lease of office space with lease terms of 12 months or less with a low value. The Company applies the ‘short-term lease’ recognition exemption for this lease. The total lease expense attributed to this lease for the year ended December 31, 2020, was $33. Following are the amortization periods of the right-of-use assets by class of underlying asset: % Production plant 11 Offices and labs 50 Vehicles 33 - 100 |
Accrued Expenses and Other Paya
Accrued Expenses and Other Payables | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of accrued expenses and other liabilities [text block] [Abstract] | |
ACCRUED EXPENSES AND OTHER PAYABLES | NOTE 7:- ACCRUED EXPENSES AND OTHER PAYABLES December 31, 2020 2019 Subcontractors $ 609 $ 1,131 Clinical activities 4,841 2,010 Professional services 1,943 349 Production plant in process 415 1,255 Other 180 173 $ 7,988 $ 4,918 |
Liabilities Presented At Fair V
Liabilities Presented At Fair Value | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of fair value measurement [text block] [Abstract] | |
LIABILITIES PRESENTED AT FAIR VALUE | NOTE 8:- LIABILITIES PRESENTED AT FAIR VALUE a . W On June 18, 2017, the Company signed a Series F Preferred Share Purchase Agreement (“SPA”) with existing and new investors. According to the SPA and upon the closing that occurred on July 9, 2017, the Company issued 4,274,363 Preferred F-1 shares, nominal value NIS 0.01 each, at $9.44 per share, accompanied by the issuance of warrants to purchase 2,564,619 Preferred F-2 shares, nominal value NIS 0.01, with an exercise price of $11.33 per share, in exchange for an aggregate proceeds of $40,350. The issuance costs of $585 associated with the equity transaction have been charged directly to the consolidated statements of changes in equity and the issuance costs associated with the issuance of the warrants of $216 have been charged directly to the statement of comprehensive income or loss. According to the SPA, the warrants to purchase Preferred F-2 shares are subject to a conversion ratio to be adjusted as defined in the SPA and to non-standard anti-dilution protection provisions and a cashless exercise mechanism and therefore accounted for as a financial liability which was measured at fair value through profit or loss. Upon the closing of the IPO as described in note 10b, 2,564,619 warrants to purchase Preferred F-2 shares were automatically converted into warrants to purchase 4,323,978 Ordinary shares, nominal value NIS 0.01, with an exercise price of $6.72 per share and an expiration date of the earlier of: July 3, 2022, or a Deemed Liquidation event as described in the Company’s Articles of Association (“AOA”). In December 2018, the Company issued a total of 293,489 Ordinary shares pursuant to the cashless exercise of 607,044 warrants. In 2019, the Company issued a total of 209,312 Ordinary shares pursuant to the cashless exercise of 403,422 warrants. The Company measured the fair value of the warrants by using the Option Pricing Method utilized in a Black and Scholes simulation model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected time until liquidation. Expected volatility was calculated based upon the Company’s historical share price. The expected time until liquidation is the period in which liquidation event will occurred subject to the Company’s expectations. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. b. Warrants to purchase Company’s shares: Year ended December 31, 2020 2019 2018 Ordinary shares Ordinary shares Ordinary shares Risk-free interest rate 0.1 % 1.7 % 2.5 % Expected volatility 76 % 80 % 80 % Expected life (in years) 1.5 2.5 3.5 Expected dividend yield 0 0 0 c. Changes in the fair value of warrants classified as Level 3 in the fair value hierarchy: Fair value of warrants to purchase Ordinary shares Balance at January 1, 2019 $ 24,049 Exercise of warrants (2,924 ) Revaluation of financial derivatives (15,904 ) Balance at December 31, 2019 5,221 Revaluation of financial derivatives 6,822 Balance at December 31, 2020 $ 12,043 |
Contingent Liabilities and Comm
Contingent Liabilities and Commitments | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of commitments and contingent liabilities [text block] [Abstract] | |
CONTINGENT LIABILITIES AND COMMITMENTS | NOTE 9:- CONTINGENT LIABILITIES AND COMMITMENTS The Company is obligated to pay royalties to the IIA at the rates of 3% to 3.5% on sales proceeds from products developed through the grants received from the IIA. The maximum amount of royalties payable to the IIA is limited to 100% of the grants received, linked to the dollar and bearing interest at the LIBOR rate. The obligation to pay these royalties is contingent on actual sales of the products and in the absence of such sales, no payment is required. The Company expects to incur sales that will trigger payments of royalties starting 2022. As of December 31, 2020, the Company’s aggregate contingent obligations for payments to IIA, based on royalty-bearing participation received or accrued amounted to $39,635 (including interest of $6,579). |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of share capital, reserves and other equity interest [text block] [Abstract] | |
SHAREHOLDERS’ EQUITY | NOTE 10:- SHAREHOLDERS’ EQUITY a. Rights attached to the shares: 1. Ordinary shares: Subject to our current AOA, the holders of Ordinary shares have the right to receive notices to attend and vote in general meetings of the Company’s shareholders, and the right to share in dividends and other distributions upon liquidation. a. On October 30, 2018, the Company closed an Initial Public Offering (“IPO”) of its Ordinary shares on the Nasdaq, under the symbol “GMDA” which resulted in the sale of 6,250,000 Ordinary shares at a public offering price of $8 per share, before underwriting discounts. The underwriters purchased 398,368 additional shares at a public offering price of $8 per share. The Company received net proceeds from the IPO of $47,241 (net of issuance costs and underwriting discounts of $5,947). Upon the closing of the IPO, all of the Company’s outstanding Preferred shares automatically converted into 17,289,289 Ordinary shares. b. On July 1, 2019, the Company closed a follow-on offering (“offering”) of its Ordinary shares on the Nasdaq, which resulted in the sale of 7,000,000 Ordinary shares at a public offering price of $5 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 1,050,000 additional shares at a public offering price of $5 per share and exercised in full their option to purchase an additional 1,050,000 Ordinary shares at the public offering price of $5 per share. The exercise of the underwriters’ option closed on July 8, 2019. The Company received net proceeds from the offering of $37,140 (net of issuance costs and underwriting discounts of $3,110). c. On May 21, 2020, the Company closed a second follow-on offering of its Ordinary shares on the Nasdaq, which resulted in the sale of 13,333,334 ordinary shares at a public offering price of $4.50 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 2,000,000 additional shares at a public offering price of $4.50 per share and exercised in full their option to purchase such shares. The exercise of the underwriters’ option closed on May 26, 2020. The Company received net proceeds from the offering of $63,860 (net of issuance costs and underwriting discounts of $5,140). d. On December 17, 2020, the Company closed a third follow-on offering of its Ordinary shares on the Nasdaq, which resulted in the sale of 8,125,000 Ordinary shares at a public offering price of $8 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 1,218,750 additional shares at a public offering price of $8 per share and exercised in full their option to purchase such shares. The exercise of the underwriters’ option closed on December 17, 2020. The Company received net proceeds from the offering of $68,988 (net of issuance costs and underwriting discounts of $5,762). |
Share-Based Payment
Share-Based Payment | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of share-based payment arrangements [text block] [Abstract] | |
SHARE-BASED PAYMENT | NOTE 11:- SHARE-BASED PAYMENT a. Option plans: On November 23, 2014, the Company’s Board of Directors approved, subject to the approval of the shareholders, to create a new class of shares of the Company, Ordinary C shares, nominal value NIS 0.01 each and to classify 1,500,000 Ordinary shares for such class of shares, whereby 1,152,044 of such shares will be for the allocation to the Company’s employees under the new, amended 2014 Israel Share Option Plan (“2014 Plan”). The exercise price of the options granted under the plans may not be less than the nominal value of the shares into which the options are exercised. The options vest primarily over three years. There are no cash settlement alternatives. On December 29, 2014, the Company’s shareholders meeting ratified and approved the aforesaid decisions. On January 23, 2017, the Company’s Board of Directors approved the Company’s 2017 Share Incentive Plan (the “2017 Plan”), and the subsequent grant of options to the Company’s employees, officers and directors. Pursuant to the 2017 Plan, the Company initially reserved for issuance of 312,867 Ordinary shares, nominal value NIS 0.01 each. Contemporaneously, the Company’s Board of Directors approved the termination of the Company’s 2014 Plan and the extension of the exercise period of the outstanding options to Ordinary C shares to expire on January 2020 instead of January 2018. On February 28, 2017, the Company’s shareholders approved the 2017 Plan. On June 26, 2017, and on December 28, 2017, the Company’s Board of Directors approved the reservation of additional 463,384 and 559,764 Ordinary shares, respectively, for issuance under the 2017 Plan (totaling, including previous plans, an aggregate of 1,338,015 Ordinary Shares). On May 5, 2019, the Company’s Board of Directors approved to extend the exercise period of all of the 2014 Plan options to purchase Ordinary shares of the Company, and held by certain current employees and officers of the Company, such that the Options shall expire in January 2022 in lieu of January 2020. The Company estimates the fair value of stock options granted using the Binominal option-pricing model. The option-pricing model requires a number of assumptions, of which the most significant are the expected stock price volatility and the expected option term. Expected volatility was calculated based upon the Company’s historical share price and historical volatilities of similar entities in the related sector index. The expected term of the options granted is derived from output of the option valuation model and represents the period of time that options granted are expected to be outstanding. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The Company has historically not paid dividends and has no foreseeable plans to pay dividends. The following table lists the inputs to the Binomial option-pricing model used for the fair value measurement of equity-settled share options for the above plans for the years 2020, 2019 and 2018: Year ended December 31, 2020 2019 2018 Dividend yield (%) 0 0 0 Expected volatility of the share prices (%) 74%-79% 78%-84% 93%-95% Risk-free interest rate (%) 0.6-1.38 1.92-2.63 2.63-2.88 Based on the above inputs, the fair value of the options was determined at $2.65-$4.28 per option at the grant date. b. Movement during the year: 2020 2019 Number of options Weighted average exercise price Number of options Weighted average exercise price USD USD Outstanding at beginning of year 3,405,188 4.76 3,197,616 3.07 Granted 1,492,700 4.91 790,300 8.82 Expired 74,744 8.60 39,094 5.21 Exercised 652,143 1.00 480,878 0.27 Forfeited 278,287 7.94 62,756 6.16 Share options outstanding at end of year 3,892,714 5.15 3,405,188 4.76 Share options exercisable at end of year 2,161,439 4.45 1,865,572 2.68 c. As of December 31, 2020, there are $3,776 of total unrecognized costs related to non-vested share-based compensation that are expected to be recognized over a period of up to four years. |
Taxes on Income
Taxes on Income | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of income tax [text block] [Abstract] | |
TAXES ON INCOME | NOTE 12:- TAXES ON INCOME a. Tax rates applicable to the income of the Company: 1. Corporate tax rates: Taxable income of the Israeli parent is subject to the Israeli corporate tax at the rate of 23% in 2020 and 2019. Non-Israeli subsidiary are taxed according to the tax laws in their respective countries of residence. 2. Income subject to tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Law”): The Law for Encouragement of Capital Investments, 1959 (the “Investment Law”) provides tax benefits for Israeli companies meeting certain requirements and criteria. The Investment Law has undergone certain amendments and reforms in recent years. The Israeli parliament enacted a reform to the Investment Law, effective January 2011. According to the reform, a flat rate tax applies to companies eligible for the “Preferred Enterprise” status. In order to be eligible for Preferred Enterprise status, a company must meet minimum requirements to establish that it contributes to the country’s economic growth and is a competitive factor for the gross domestic product. The Company’s Israeli operations elected “Preferred Enterprise” status, starting in 2017. Benefits granted to a Preferred Enterprise include reduced tax rates.. As part of the Economic Efficiency Law (Legislative Amendments for Accomplishment of Budgetary Targets for Budget Years 2017-2018), 5777-2016, the tax rate for Area A will be 7.5% in 2017 onwards. In other regions, the tax rate is 16%. Preferred Enterprises in peripheral regions will be eligible for Investment Center grants, as well as the applicable reduced tax rates. b. The Law for the Encouragement of Industry (Taxation), 1969: The Company has the status of an “industrial company”, under this law. According to this status and by virtue of regulations published thereunder, the Company is entitled to claim a deduction of accelerated depreciation on equipment used in industrial activities, as determined in the regulations issued under the Inflationary Law. The Company is also entitled to amortize a patent or knowhow usage right that is used in the enterprise’s development or promotion, to deduct listed share issuance expenses and to file consolidated financial statements under certain conditions. c. Net operating losses carryforward: The Company has net operating losses and capital losses for tax purposes as of December 31, 2020, of $174,548 and $507, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period. As of December 31, 2020, the U.S. subsidiary has net operating losses carryforwards of $8,967 for federal tax purposes. d. Final tax assessments: The Company’s tax assessments through the 2014 tax year are considered final. e. Deferred taxes: The Company did not recognize deferred tax assets in the Company’s consolidated financial statements for the years ended December 31, 2020 and 2019 for carryforward losses and other temporary differences because their utilization in the foreseeable future is not probable. |
Selected Statements of Comprehe
Selected Statements of Comprehensive Income Data | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of additional information [text block] [Abstract] | |
SELECTED STATEMENTS OF COMPREHENSIVE INCOME DATA | NOTE 13:- SELECTED STATEMENTS OF COMPREHENSIVE LOSS DATA a. Research and development expenses, net: Year ended December 31, 2020 2019 2018 Salaries and social benefits $ 11,017 $ 8,307 $ 5,016 Share-based payment 1,185 1,600 705 Subcontractors 21,880 16,752 12,695 Materials 4,622 3,700 3,610 Depreciation 1,314 1,220 195 Other 871 970 1,725 Revaluation of royalty liability, net of receipt of royalty bearing grants 496 (1,087 ) (1,901 ) Total research and development expenses, net $ 41,385 $ 31,462 $ 22,045 b. Commercial activities: Year ended December 31, 2020 2019 Salaries and social benefits $ 2,665 $ 1,559 Share-based payment 230 879 Professional services 5,800 2,075 Other 53 179 Total commercial expenses, net $ 8,748 $ 4,692 The commercial activities were established in 2019. c. General and administrative expenses: Year ended December 31, 2020 2019 2018 Salaries and social benefits $ 3,641 $ 3,488 $ 4,788 Share-based payment 1,449 2,389 2,870 Professional services 5,307 3,833 2,802 Rent, maintenance and other expenses 693 1,458 1,065 Depreciation 1,077 923 74 Total general and administrative expenses $ 12,167 $ 12,091 $ 11,599 d. Finance expenses: Revaluation of IIA liability $ 3,000 $ 2,531 $ 2,037 Revaluation of warrants 6,822 - 17,600 Bank charges, interest expense and other fees 37 32 68 Interest expense related to lease liability 707 758 - Foreign currency translation adjustments 74 4 554 Total finance expenses $ 10,640 $ 3,325 $ 20,259 e. Finance income: Interest income $ 236 $ 1,245 $ 877 Revaluation of warrants - 15,904 - Foreign currency translation adjustments - - 165 Total finance income $ 236 $ 17,149 $ 1,042 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of related party [text block] [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 14:- RELATED PARTY TRANSACTIONS Benefits to key executive personnel: Year ended December 31, 2020 2019 2018 Short-term benefits $ 3,821 $ 3,550 $ 2,106 Other long-term benefits - - 63 Share-based payment 2,197 3,714 2,542 $ 6,018 $ 7,264 $ 4,711 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of earnings per share [text block] [Abstract] | |
NET LOSS PER SHARE | NOTE 15:- NET LOSS PER SHARE Details of the number of shares and loss used in the computation of net loss per share: Year ended December 31, 2020 2019 2018 Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company For the computation of basic loss 43,725,584 72,704 29,459,395 34,351 5,025,213 52,931 Effect of potential dilutive Ordinary shares (warrants) - - 196,428 15,904 - - For the computation of diluted loss 43,725,584 72,704 29,655,823 50,255 5,025,213 52,931 The effect of 2,161,439 and 3,313,512 of options and warrants, respectively, was anti-dilutive for the year ended December 31,2020. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of events after reporting period [text block] [Abstract] | |
SUBSEQUENT EVENT | NOTE 16:- SUBSEQUENT EVENT On February 16, 2021, the Company announced the sale of $75 million of exchangeable senior notes due in 2026 (the “notes”) to Highbridge Capital Management, LLC. The notes were sold at 100% of the principal amount thereof, are senior unsecured obligations of the Company and its wholly owned subsidiary and will accrue interest at a rate of 5.875% per year. Subject to certain limitations, the holders of the notes can elect to exchange the notes for the Company’s Ordinary shares at an initial exchange rate of 56.3063 shares per $1,000 principal amount of notes (equivalent to an exchange price of $17.76 per share). The Company may redeem all or a portion of the notes for cash, at its option, at 100% of the principal amount plus accrued and unpaid interest on the notes to be redeemed if the closing price of its Ordinary shares has been at least 130% of the exchange price for at least 20 trading days during any 30 consecutive trading day period. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of presentation of the financial statements | a. Basis of presentation of the financial statements: These consolidated financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). The consolidated financial statements have been prepared on a cost basis, except for available for sale financial assets and financial liabilities that have been measured at fair value through profit or loss. The Company has elected to present profit or loss items using the function of expense method. |
Consolidated financial statements | Consolidated financial statements: The consolidated financial statements comprise the financial statements of the Company and its subsidiary. The financial statements of the Company are prepared as of the same dates and periods. The consolidated financial statements are prepared using uniform accounting policies by all companies in the group. Significant intra-group balances, transactions and gains or losses resulting from intra-group are eliminated in full in the consolidated financial statements. c. |
Functional currency, presentation currency and foreign currency | Functional currency, presentation currency and foreign currency: 1. Functional currency and presentation currency: The presentation currency of the financial statements is the U.S. dollar. The functional currency is the currency that best reflects the economic environment in which the Company and its subsidiary operates and conducts their transactions. Most of the Company’s costs are incurred in U.S. dollar. In addition, the Company’s financing activities are incurred in U.S. dollars. The Company’s management believes that the functional currency of the Company is the U.S. dollar. 2. Transactions, assets and liabilities in foreign currency: Transactions denominated in foreign currency are recorded upon initial recognition at the exchange rate at the date of the transaction. After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at the end of each reporting period to the functional currency at the exchange rate at that date. Exchange rate differences are recognized in profit or loss. Non-monetary assets and liabilities measured at cost in foreign currency are translated at the exchange rate at the date of the transaction. Non-monetary assets and liabilities denominated in foreign currency and measured at fair value are translated to the functional currency using the exchange rate prevailing at the date when the fair value was determined. d. Cash and cash equivalents: Cash and cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of investment or with a maturity of more than three months, but which are redeemable on demand without penalty and which form part of the Company’s cash management. e. Short-term deposits and restricted deposits: Short-term deposits are bank deposits with an original maturity of more than three months from the date of investment and which do not meet the definition of cash equivalents. The deposits are presented according to their terms of deposit. Restricted deposit is primarily invested in highly liquid deposits. Restricted deposit amounted to $152 as of December 31, 2020 and 2019 and is included in prepaid expenses and other current assets on the statements of financial position. f. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants,excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. (**) As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a change in accounting estimate. An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal. g. Research and development costs: Research expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate: the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company’s intention to complete the intangible asset and use or sell it; the Company’s ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company’s ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company’s development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred. h. Impairment of non-financial assets: The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss. An impairment loss of an asset is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years, and its recoverable amount. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize any impairment of non-financial assets. i. Government investment grants: Government grants are recognized when there is reasonable assurance that the grants will be received and the Company will comply with the related conditions. Government grants received from the Israel Innovation Authority (“IIA”) (formerly, the Office of the Chief Scientist in Israel (“OCS”)) are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales. If no such economic benefits are expected, the royalty obligation is treated as a contingent liability in accordance with IAS 37. At the end of each reporting period, the Company evaluates, based on its best estimate of future sales, whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid and accordingly, no royalties will be required to be paid. If there is such reasonable assurance, the appropriate amount of the liability is derecognized and recorded in profit or loss as a revaluation of research and development expenses. If the estimate of future sales indicates that there is no such reasonable assurance, the appropriate amount of the liability that reflects expected future royalty payments is recognized with a corresponding adjustment to financial expenses or income. Changes in the amount of liability as a result of changes in the future royalty payments is recognized with a corresponding adjustment to research and development expense. As of December 31, 2020 and 2019, the Company has determined that future economic benefits are expected from its research and development projects and recorded a liability for its entire contingent obligation to the IIA. Grants received from the IIA which are recognized as a liability are accounted for as forgivable loans, in accordance with IAS 20 (Revised), pursuant to the provisions of IFRS 9, “Financial Instruments”. Accordingly, when the liability for the loan is first recognized, it is measured at fair value using a discount rate that reflects a market rate of interest which in the Company’s case was determined to be 20%, 30% and 28% for 2020, 2019 and 2018, respectively. The difference between the amount of the grants received and the fair value of the liability is accounted for upon recognition of the liability as a government grant and recognized as a reduction of research and development expenses. For the years ended December 31, 2020, 2019 and 2018, no royalties were paid with respect to grants received from the IIA. Payments will be treated as a reduction of the liability. Grants of $1,108, $871 and $2,425 were approved during 2020, 2019 and 2018, respectively. Grant receivable is $103 and $7 as of December 31, 2020 and 2019, respectively, and is included in prepaid expenses and other current assets in the statements of financial position. j. Provisions: A provision in accordance with IAS 37 is recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. k. Share-based payment transactions: The Company’s employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions: The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair value is determined using an acceptable option pricing model. With respect to other service providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments. In cases where the fair value of the goods or services received as consideration of equity instruments cannot be measured, it is measured by reference to the fair value of the equity instruments granted. The cost of equity-settled transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the performance and/or service conditions are to be satisfied, ending on the date on which the relevant employees become fully entitled to the award (the “Vesting Period”). No expense is recognized for awards that do not ultimately vest. l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. |
Cash and cash equivalents | Cash and cash equivalents: Cash and cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three months or less from the date of investment or with a maturity of more than three months, but which are redeemable on demand without penalty and which form part of the Company’s cash management. e. Short-term deposits and restricted deposits: Short-term deposits are bank deposits with an original maturity of more than three months from the date of investment and which do not meet the definition of cash equivalents. The deposits are presented according to their terms of deposit. Restricted deposit is primarily invested in highly liquid deposits. Restricted deposit amounted to $152 as of December 31, 2020 and 2019 and is included in prepaid expenses and other current assets on the statements of financial position. f. Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants,excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. (**) As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a change in accounting estimate. An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal. g. Research and development costs: Research expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate: the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company’s intention to complete the intangible asset and use or sell it; the Company’s ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company’s ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company’s development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred. h. Impairment of non-financial assets: The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss. An impairment loss of an asset is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years, and its recoverable amount. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize any impairment of non-financial assets. i. Government investment grants: Government grants are recognized when there is reasonable assurance that the grants will be received and the Company will comply with the related conditions. Government grants received from the Israel Innovation Authority (“IIA”) (formerly, the Office of the Chief Scientist in Israel (“OCS”)) are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales. If no such economic benefits are expected, the royalty obligation is treated as a contingent liability in accordance with IAS 37. At the end of each reporting period, the Company evaluates, based on its best estimate of future sales, whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid and accordingly, no royalties will be required to be paid. If there is such reasonable assurance, the appropriate amount of the liability is derecognized and recorded in profit or loss as a revaluation of research and development expenses. If the estimate of future sales indicates that there is no such reasonable assurance, the appropriate amount of the liability that reflects expected future royalty payments is recognized with a corresponding adjustment to financial expenses or income. Changes in the amount of liability as a result of changes in the future royalty payments is recognized with a corresponding adjustment to research and development expense. As of December 31, 2020 and 2019, the Company has determined that future economic benefits are expected from its research and development projects and recorded a liability for its entire contingent obligation to the IIA. Grants received from the IIA which are recognized as a liability are accounted for as forgivable loans, in accordance with IAS 20 (Revised), pursuant to the provisions of IFRS 9, “Financial Instruments”. Accordingly, when the liability for the loan is first recognized, it is measured at fair value using a discount rate that reflects a market rate of interest which in the Company’s case was determined to be 20%, 30% and 28% for 2020, 2019 and 2018, respectively. The difference between the amount of the grants received and the fair value of the liability is accounted for upon recognition of the liability as a government grant and recognized as a reduction of research and development expenses. For the years ended December 31, 2020, 2019 and 2018, no royalties were paid with respect to grants received from the IIA. Payments will be treated as a reduction of the liability. Grants of $1,108, $871 and $2,425 were approved during 2020, 2019 and 2018, respectively. Grant receivable is $103 and $7 as of December 31, 2020 and 2019, respectively, and is included in prepaid expenses and other current assets in the statements of financial position. j. Provisions: A provision in accordance with IAS 37 is recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. k. Share-based payment transactions: The Company’s employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions: The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair value is determined using an acceptable option pricing model. With respect to other service providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments. In cases where the fair value of the goods or services received as consideration of equity instruments cannot be measured, it is measured by reference to the fair value of the equity instruments granted. The cost of equity-settled transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the performance and/or service conditions are to be satisfied, ending on the date on which the relevant employees become fully entitled to the award (the “Vesting Period”). No expense is recognized for awards that do not ultimately vest. l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. |
Short-term deposits and restricted deposits | Short-term deposits and restricted deposits: Short-term deposits are bank deposits with an original maturity of more than three months from the date of investment and which do not meet the definition of cash equivalents. The deposits are presented according to their terms of deposit. Restricted deposit is primarily invested in highly liquid deposits. Restricted deposit amounted to $152 as of December 31, 2020 and 2019 and is included in prepaid expenses and other current assets on the statements of financial position. f. |
Property and equipment | Property, plant and equipment: Property, plant and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment losses and any related investment grants,excluding day-to-day servicing expenses. Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows: % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. (**) As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for prospectively as a change in accounting estimate. An item of property, plant and equipment is derecognized upon disposal or when no future economic benefits are expected from its use or disposal. g. |
Research and development costs | Research and development costs: Research expenditures are recognized in profit or loss when incurred. An intangible asset arising from a development project or from the development phase of an internal project is recognized if the Company can demonstrate: the technical feasibility of completing the intangible asset so that it will be available for use or sale; the Company’s intention to complete the intangible asset and use or sell it; the Company’s ability to use or sell the intangible asset; how the intangible asset will generate future economic benefits; the availability of adequate technical, financial and other resources to complete the intangible asset; and the Company’s ability to measure reliably the expenditure attributable to the intangible asset during its development. Since the Company’s development projects are often subject to regulatory approval procedures and other uncertainties, the conditions for the capitalization of costs incurred before receipt of approvals are not normally satisfied and therefore, development expenditures are recognized in profit or loss when incurred. h. |
Impairment of non-financial assets | Impairment of non-financial assets: The Company evaluates the need to record an impairment of the carrying amount of non-financial assets whenever events or changes in circumstances indicate that the carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. The recoverable amount of an asset that does not generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit or loss. An impairment loss of an asset is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years, and its recoverable amount. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize any impairment of non-financial assets. i. |
Government investment grants | Government investment grants: Government grants are recognized when there is reasonable assurance that the grants will be received and the Company will comply with the related conditions. Government grants received from the Israel Innovation Authority (“IIA”) (formerly, the Office of the Chief Scientist in Israel (“OCS”)) are recognized upon receipt as a liability if future economic benefits are expected from the project that will result in royalty-bearing sales. If no such economic benefits are expected, the royalty obligation is treated as a contingent liability in accordance with IAS 37. At the end of each reporting period, the Company evaluates, based on its best estimate of future sales, whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid and accordingly, no royalties will be required to be paid. If there is such reasonable assurance, the appropriate amount of the liability is derecognized and recorded in profit or loss as a revaluation of research and development expenses. If the estimate of future sales indicates that there is no such reasonable assurance, the appropriate amount of the liability that reflects expected future royalty payments is recognized with a corresponding adjustment to financial expenses or income. Changes in the amount of liability as a result of changes in the future royalty payments is recognized with a corresponding adjustment to research and development expense. As of December 31, 2020 and 2019, the Company has determined that future economic benefits are expected from its research and development projects and recorded a liability for its entire contingent obligation to the IIA. Grants received from the IIA which are recognized as a liability are accounted for as forgivable loans, in accordance with IAS 20 (Revised), pursuant to the provisions of IFRS 9, “Financial Instruments”. Accordingly, when the liability for the loan is first recognized, it is measured at fair value using a discount rate that reflects a market rate of interest which in the Company’s case was determined to be 20%, 30% and 28% for 2020, 2019 and 2018, respectively. The difference between the amount of the grants received and the fair value of the liability is accounted for upon recognition of the liability as a government grant and recognized as a reduction of research and development expenses. For the years ended December 31, 2020, 2019 and 2018, no royalties were paid with respect to grants received from the IIA. Payments will be treated as a reduction of the liability. Grants of $1,108, $871 and $2,425 were approved during 2020, 2019 and 2018, respectively. Grant receivable is $103 and $7 as of December 31, 2020 and 2019, respectively, and is included in prepaid expenses and other current assets in the statements of financial position. j. |
Provisions | Provisions: A provision in accordance with IAS 37 is recognized when the Company has a present obligation (legal or constructive) as a result of a past event, it is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made of the amount of the obligation. k. |
Share-based payment transactions | Share-based payment transactions: The Company’s employees and other service providers are entitled to remuneration in the form of equity-settled share-based payment transactions. Equity-settled transactions: The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair value is determined using an acceptable option pricing model. With respect to other service providers, the cost of the transactions is measured at the fair value of the goods or services received as consideration for equity instruments. In cases where the fair value of the goods or services received as consideration of equity instruments cannot be measured, it is measured by reference to the fair value of the equity instruments granted. The cost of equity-settled transactions is recognized in profit or loss, together with a corresponding increase in equity, during the period which the performance and/or service conditions are to be satisfied, ending on the date on which the relevant employees become fully entitled to the award (the “Vesting Period”). No expense is recognized for awards that do not ultimately vest. l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. |
Financial instruments | l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. |
Employee benefit liabilities | l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. |
Leases | l. Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. Lease liabilities: At the commencement date of the lease, the Company recognizes lease liabilities measured at the present value of lease payments to be made over the lease term discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company’s incremental borrowing rate. The lease payments include fixed payments (including in -substance fixed payments) less any lease incentives receivable, variable lease payments that depend on an index or a rate and amounts expected to be paid under residual value guarantees. The lease payments also include the exercise price of a purchase option reasonably certain to be exercised by the Company and payments of penalties for terminating a lease, if the lease term reflects the Company’s intention to exercise the option to terminate. Variable lease payments that do not depend on an index or a rate are recognized as expenses in the period in which the event or condition that triggers the payment occurs. After the commencement date, the Company measures the lease liability using the effective interest rate method. |
Deferred tax | Deferred taxes: Deferred taxes are recordedusing the liability method on temporary differences between the tax bases of assets and liabilities and their carrying amounts for financial reporting purposes at the reporting date. Deferred tax assets are recognized for all deductible temporary differences. Deferred tax assets are recognized to the extent that it is probable that taxable profit will be available against which the deductible temporary differences and unused tax losses can be utilized. Unrecognized deferred tax assets are re-assessed at each reporting date and are recognized to the extent that it becomes probable that future taxable profits will enable the deferred tax asset to be recovered. m. Employee benefit liabilities: The Company has several employee benefit plans: 1. Short-term employee benefits: Short-term employee benefits are benefits that are expected to be settled entirely before twelve months after the end of the annual reporting period in which the employees render the related services. These benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions and are recognized as expenses as the services are rendered. 2. Post-employment benefits: The plan is normally financed by contributions to insurance companies and classified as a defined benefit plan. The Company operates a defined benefit plan in respect of severance pay pursuant to the Severance Pay Law, 1963 (the “Law”). According to the Law, employees are entitled to severance pay upon dismissal or retirement. The liability for termination of employment is measured using the projected unit credit method. The amounts are presented based on discounted expected future cash flows using a discount rate determined by reference to market yields at the reporting date on high quality corporate bonds that are linked to the Consumer Price Index with a term that is consistent with the estimated term of the severance pay obligation. In respect of its severance pay obligation to certain of its employees, the Company makes current deposits in pension funds and insurance companies (the “Plan Assets”). Plan Assets comprise assets held by a long-term employee benefit fund or qualifying insurance policies. Plan Assets are not available to the Company’s creditors and cannot be returned directly to the Company. Actuarial gains and losses are recognized in other comprehensive income or loss retrospectively in the period in which they occur. n. Financial instruments: 1. Investment in marketable securities: Financial assets are measured upon initial recognition at fair value plus transaction costs that are directly attributable to the acquisition of the financial assets, except for financial assets measured at fair value through profit or loss in respect of which transaction costs are recorded in profit or loss. The Company classifies and measures debt instruments in the financial statements based on the following criteria: - The Company’s business model for managing financial assets; and - The contractual cash flow terms of the financial asset. The Company measured all of its marketable securities at fair value through other comprehensive income or loss. Debt instruments are measured at fair value through other comprehensive income when: The Company’s business model is to hold the financial assets in order to both collect their contractual cash flows and to sell the financial assets, and the contractual terms of the financial assets give rise on specified dates to cash flows that are solely payments of principal and interest on the principal amount outstanding. After initial recognition, the instruments in this category are measured at fair value. Gains or losses from fair value adjustments, excluding interest and exchange rate differences, are recognized in other comprehensive income or loss. The Company evaluates the loss allowance for financial debt instruments at the end of each reporting period . Marketable securities as of December 31, 2019, includes corporate and government debentures with no significant premium or discount. The investment in marketable securities, which are measured at fair value through other comprehensive income or loss is considered Level 2 measurement. The Company has realized its entire marketable securities investment portfolio during the year ended December 31, 2020. 2. Financial liabilities: Financial liabilities are recognized initially at fair value and, in the case of loans,borrowings and payables, net of directly attributed transaction costs. The Company’s financial liabilities include trade and other payables and warrants to shareholders. Warrants to shareholders can be exercised to a variable number of shares and therefore, such warrants are recorded as a financial liability and are measured at each balance sheet date at fair value. Gains or losses are recognized in profit or loss. a) Derecognition: A financial liability is derecognized when the obligation under the liability is discharged, cancelled or expired. b) Offsetting of financial instruments: Financial assets and financial liabilities are offset and the net amount is reported in the statements of financial position if there is enforceable legal right to offset the recognized amounts and there is an intention to settle on a net basis and realize the assets and settle the liabilities simultaneously. 3. Fair value: Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy. The carrying amounts of cash and cash equivalents, marketable securities, other receivables, short-term deposits, prepaid expenses and other current assets, trade payables,accrued expenses and other payables approximate their fair value due to the short-term maturity of such instruments. Regarding fair value of the liability to the IIA, refer to note 2i above. Fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use. The Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. All assets and liabilities measured at fair value or for which fair value is disclosed are categorized into levels within the fair value hierarchy based on the lowest level input that is significant to the entire fair value measurement: Level 1 — quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 — inputs other than quoted prices included within Level 1 that are observable either directly or indirectly. Level 3 — inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). U.S. dollars in thousands (except share and per share data) o. Leases: The Company assesses at contract inception whether a contract is, or contains, a lease i.e.. if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. 1. Right-of-use assets: The Company recognizes right-of-use assets at the commencement date of the lease (i.e., the date the underlying asset is available for use). Right-of-use assets are measured at cost, less accumulated depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost of right-of-use assets includes the amount of lease liabilities recognized, initial direct costs incurred, and lease payments made at or before the commencement date less any lease incentives received. Unless the Company is reasonably certain to obtain ownership of the leased asset at the end of the lease term, the recognized right-of-use asset is depreciated on a straight-line basis over the shorter of its estimated useful life and the lease term. Right-of- use assets are subject to impairment pursuant to the provision of International Accounting Standard 36 - Impairment of Assets. 2. |
New and amended standards and interpretations | r. New and amended standards and interpretations The Company applied for the first-time certain standards and amendments, which are effective for annual periods beginning on or after 1 January 2020. The Company has not early adopted any other standard, interpretation or amendment that has been issued but is not yet effective. Amendments to IAS 1 and IAS 8 Definition of Material The amendments provide a new definition of material that states, “information is material if omitting, misstating or obscuring it could reasonably be expected to influence decisions that the primary users of general purpose financial statements make on the basis of those financial statements, which provide financial information about a specific reporting entity.” The amendments clarify that materiality will depend on the nature or magnitude of information, either individually or in combination with other information, in the context of the financial statements. A misstatement of information is material if it could reasonably be expected to influence decisions made by the primary users. These amendments had no impact on the consolidated financial statements, nor is there expected to be any future impact on the Company. Amendments to IFRS 16 Covid-19 Related Rent Concessions On May 28, 2020, the IASB issued Covid-19-Related Rent Concessions - amendment to IFRS 16 Leases. The amendments provide relief to lessees from applying IFRS 16 guidance on lease modification accounting for rent concessions arising as a direct consequence of the Covid-19 pandemic. As a practical expedient, a lessee may elect not to assess whether a Covid-19 related rent concession from a lessor is a lease modification. A lessee that makes this election accounts for any change in lease payments resulting from the Covid-19 related rent concession the same way it would account for the change under IFRS 16, if the change were not a lease modification. The amendment applies to annual reporting periods beginning on or after 1 June 2020. Earlier application is permitted. This amendment had no impact on the consolidated financial statements of the Company. |
Significant Accounting Polici_2
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of significant accounting policies [text block] [Abstract] | |
Schedule of estimated useful life of property and equipment | % Machinery 10 - 15 Office, furniture and equipment 6 - 33 Leasehold improvements (*) Project in process- manufacturing plant (**) (*) Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. (**) As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Cash and cash equivalents [abstract] | |
Schedule of cash and cash equivalents | December 31, 2020 2019 Cash for immediate withdrawal $ 4,283 $ 2,307 Cash equivalents - short-term deposits (1) 122,887 39,531 $ 127,170 $ 41,838 (1) The cash equivalents are short-term bank deposits denominated in USD and bear interest at an average annual rate of 0.01% and 1.7% as of December 31, 2020 and 2019, respectively. |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of property, plant and equipment [text block] [Abstract] | |
Schedule of property plant and equipment, net | Machinery Office furniture and equipment Leasehold improvements Production Plant in process Total Cost: Balance at January 1, 2020 $ 3,366 $ 580 $ 1,191 $ 4,429 $ 9,566 Additions 179 47 351 11,720 12,297 Balance at December 31, 2020 3,545 627 1,542 16,149 21,863 Accumulated depreciation: Balance at January 1, 2020 1,936 421 911 - 3,268 Depreciation 206 71 80 - 357 Balance at December 31, 2020 2,142 492 991 - 3,625 Property and equipment, net at December 31, 2020 1,403 135 551 16,149 18,238 Machinery Office furniture and equipment Leasehold improvements Production Plant in process Total Cost: Balance at January 1, 2019 $ 3,154 $ 535 $ 1,099 $ 468 $ 5,256 Additions 212 45 92 3,961 4,310 Balance at December 31, 2019 3,366 580 1,191 4,429 9,566 Accumulated depreciation: Balance at January 1, 2019 1,753 345 847 - 2,945 Depreciation 183 76 64 - 323 Balance at December 31, 2019 1,936 421 911 - 3,268 Property and equipment, net at December 31, 2019 $ 1,430 $ 159 $ 280 $ 4,429 $ 6,298 |
Right-of-Use Assets and Lease_2
Right-of-Use Assets and Lease Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of quantitative information about leases for lessee [abstract] | |
Schedule of right-of-use assets and lease liabilities | Right-of-use assets Offices and labs Vehicles Production plant Total Lease liabilities As of January 1, 2020 $ 934 $ 175 $ 4,024 $ 5,133 $ 5,971 Depreciation expense (1,318 ) (201 ) (521 ) (2,040 ) - Interest expense - - - - 707 Additions 3,282 127 - 3,409 3,402 Payments - - - - (2,145 ) Other - (27 ) (1 ) (28 ) (25 ) As of December 31, 2020 $ 2,898 $ 74 $ 3,502 $ 6,474 $ 7,910 |
Schedule future minimum lease fees | First year $ 2,363 Second through fifth years 4,650 After fifth year 1,304 $ 8,317 |
Schedule of right-of-use assets by class of underlying asset | % Production plant 11 Offices and labs 50 Vehicles 33 - 100 |
Accrued Expenses and Other Pa_2
Accrued Expenses and Other Payables (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of accrued expenses and other liabilities [text block] [Abstract] | |
Schedule of accrued expenses and other payables | December 31, 2020 2019 Subcontractors $ 609 $ 1,131 Clinical activities 4,841 2,010 Professional services 1,943 349 Production plant in process 415 1,255 Other 180 173 $ 7,988 $ 4,918 |
Liabilities Presented At Fair_2
Liabilities Presented At Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of fair value measurement [text block] [Abstract] | |
Schedule of warrants to purchase preferred shares | Year ended December 31, 2020 2019 2018 Ordinary shares Ordinary shares Ordinary shares Risk-free interest rate 0.1 % 1.7 % 2.5 % Expected volatility 76 % 80 % 80 % Expected life (in years) 1.5 2.5 3.5 Expected dividend yield 0 0 0 |
Disclosure of fair value measurement of liabilities [text block] | Fair value of warrants to purchase Ordinary shares Balance at January 1, 2019 $ 24,049 Exercise of warrants (2,924 ) Revaluation of financial derivatives (15,904 ) Balance at December 31, 2019 5,221 Revaluation of financial derivatives 6,822 Balance at December 31, 2020 $ 12,043 |
Share-Based Payment (Tables)
Share-Based Payment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of share-based payment arrangements [text block] [Abstract] | |
Schedule of fair value measurement of equity-settled share options | Year ended December 31, 2020 2019 2018 Dividend yield (%) 0 0 0 Expected volatility of the share prices (%) 74%-79% 78%-84% 93%-95% Risk-free interest rate (%) 0.6-1.38 1.92-2.63 2.63-2.88 |
Schedule of stock option activity | 2020 2019 Number of options Weighted average exercise price Number of options Weighted average exercise price USD USD Outstanding at beginning of year 3,405,188 4.76 3,197,616 3.07 Granted 1,492,700 4.91 790,300 8.82 Expired 74,744 8.60 39,094 5.21 Exercised 652,143 1.00 480,878 0.27 Forfeited 278,287 7.94 62,756 6.16 Share options outstanding at end of year 3,892,714 5.15 3,405,188 4.76 Share options exercisable at end of year 2,161,439 4.45 1,865,572 2.68 |
Selected Statements of Compre_2
Selected Statements of Comprehensive Income Data (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of additional information [text block] [Abstract] | |
Schedule of research and development expenses, net | Year ended December 31, 2020 2019 2018 Salaries and social benefits $ 11,017 $ 8,307 $ 5,016 Share-based payment 1,185 1,600 705 Subcontractors 21,880 16,752 12,695 Materials 4,622 3,700 3,610 Depreciation 1,314 1,220 195 Other 871 970 1,725 Revaluation of royalty liability, net of receipt of royalty bearing grants 496 (1,087 ) (1,901 ) Total research and development expenses, net $ 41,385 $ 31,462 $ 22,045 |
Schedule of commercial activities | Year ended December 31, 2020 2019 Salaries and social benefits $ 2,665 $ 1,559 Share-based payment 230 879 Professional services 5,800 2,075 Other 53 179 Total commercial expenses, net $ 8,748 $ 4,692 |
Schedule of commercial activities | Year ended December 31, 2020 2019 2018 Salaries and social benefits $ 3,641 $ 3,488 $ 4,788 Share-based payment 1,449 2,389 2,870 Professional services 5,307 3,833 2,802 Rent, maintenance and other expenses 693 1,458 1,065 Depreciation 1,077 923 74 Total general and administrative expenses $ 12,167 $ 12,091 $ 11,599 |
Schedule of finance expenses | Revaluation of IIA liability $ 3,000 $ 2,531 $ 2,037 Revaluation of warrants 6,822 - 17,600 Bank charges, interest expense and other fees 37 32 68 Interest expense related to lease liability 707 758 - Foreign currency translation adjustments 74 4 554 Total finance expenses $ 10,640 $ 3,325 $ 20,259 |
Schedule of finance income | Interest income $ 236 $ 1,245 $ 877 Revaluation of warrants - 15,904 - Foreign currency translation adjustments - - 165 Total finance income $ 236 $ 17,149 $ 1,042 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of related party [text block] [Abstract] | |
Schedule benefits to key executive personnel | Year ended December 31, 2020 2019 2018 Short-term benefits $ 3,821 $ 3,550 $ 2,106 Other long-term benefits - - 63 Share-based payment 2,197 3,714 2,542 $ 6,018 $ 7,264 $ 4,711 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of earnings per share [text block] [Abstract] | |
Schedule of number of shares and loss used in the computation of loss per share | Year ended December 31, 2020 2019 2018 Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company Weighted number of shares Net loss attributable to equity holders of the Company For the computation of basic loss 43,725,584 72,704 29,459,395 34,351 5,025,213 52,931 Effect of potential dilutive Ordinary shares (warrants) - - 196,428 15,904 - - For the computation of diluted loss 43,725,584 72,704 29,655,823 50,255 5,025,213 52,931 |
General (Details)
General (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of general information about financial statements [text block] [Abstract] | |||
Accumulated deficits | $ (276,268) | $ (203,564) | |
Cash flows from operating activities | $ (48,627) | $ (37,930) | $ (26,426) |
Significant Accounting Polici_3
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure of significant accounting policies [text block] [Abstract] | |||
Restricted deposits (in Dollars) | $ 152 | $ 152 | |
Discount rate | 20.00% | 30.00% | 28.00% |
Description of grants | Grants of $1,108, $871 and $2,425 were approved during 2020, 2019 and 2018, respectively. Grant receivable is $103 and $7 as of December 31, 2020 and 2019, respectively, and is included in prepaid expenses and other current assets in the statements of financial position. |
Significant Accounting Polici_4
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment | 12 Months Ended | |
Dec. 31, 2020 | ||
Machinery [member] | Bottom of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | 10.00% | |
Machinery [member] | Top of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | 15.00% | |
Office furniture and equipment [member] | Bottom of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | 6.00% | |
Office furniture and equipment [member] | Top of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | 33.00% | |
Leasehold improvements [member] | Bottom of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | [1] | |
Project in process - manufacturing plant [member] | Bottom of range [member] | ||
Significant Accounting Policies (Details) - Schedule of estimated useful life of property and equipment [Line Items] | ||
Annual depreciation rate | [2] | |
[1] | Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the Company and intended to be exercised) and the expected life of the improvement. | |
[2] | As of December 31, 2020, the manufacturing plant is under validation process and therefore is not yet ready for production. Depreciation of the manufacturing plant will commence upon completion of the validation process. |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash and cash equivalents [abstract] | ||
Average annual rate | 0.01% | 1.70% |
Cash and Cash Equivalents (De_2
Cash and Cash Equivalents (Details) - Schedule of cash and cash equivalents - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of cash and cash equivalents [Abstract] | |||
Cash for immediate withdrawal | $ 4,283 | $ 2,307 | |
Cash equivalents - short-term deposits | [1] | 122,887 | 39,531 |
Cash and cash equivalents, net | $ 127,170 | $ 41,838 | |
[1] | The cash equivalents are short-term bank deposits denominated in USD and bear interest at an average annual rate of 0.01% and 1.7% as of December 31, 2020 and 2019, respectively. |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net (Details) - Schedule of property plant and equipment, net - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cost: | ||
Beginning balance | $ 9,566 | $ 5,256 |
Additions | 12,297 | 4,310 |
Ending Balance | 21,863 | 9,566 |
Accumulated depreciation: | ||
Beginning balance | 3,268 | 2,945 |
Depreciation | 357 | 323 |
Ending Balance | 3,625 | 3,268 |
Property and equipment, net | 18,238 | 6,298 |
Machinery [Member] | ||
Cost: | ||
Beginning balance | 3,366 | 3,154 |
Additions | 179 | 212 |
Ending Balance | 3,545 | 3,366 |
Accumulated depreciation: | ||
Beginning balance | 1,936 | 1,753 |
Depreciation | 206 | 183 |
Ending Balance | 2,142 | 1,936 |
Property and equipment, net | 1,403 | 1,430 |
Office furniture and equipment [Member] | ||
Cost: | ||
Beginning balance | 580 | 535 |
Additions | 47 | 45 |
Ending Balance | 627 | 580 |
Accumulated depreciation: | ||
Beginning balance | 421 | 345 |
Depreciation | 71 | 76 |
Ending Balance | 492 | 421 |
Property and equipment, net | 135 | 159 |
Leasehold improvements [Member] | ||
Cost: | ||
Beginning balance | 1,191 | 1,099 |
Additions | 351 | 92 |
Ending Balance | 1,542 | 1,191 |
Accumulated depreciation: | ||
Beginning balance | 911 | 847 |
Depreciation | 80 | 64 |
Ending Balance | 991 | 911 |
Property and equipment, net | 551 | 280 |
Project in process [Member] | ||
Cost: | ||
Beginning balance | 4,429 | 468 |
Additions | 11,720 | 3,961 |
Ending Balance | 16,149 | 4,429 |
Accumulated depreciation: | ||
Beginning balance | ||
Depreciation | ||
Ending Balance | ||
Property and equipment, net | $ 16,149 | $ 4,429 |
Right-of-Use Assets and Lease_3
Right-of-Use Assets and Lease Liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Disclosure of quantitative information about leases for lessee [abstract] | |
Lease agreement, description | The Company rents vehicles under an operating lease agreement, for a fixed monthly fee of $23. The leases are under non-cancellable terms and mature over one to three years. |
Total lease expense | $ 33 |
Right-of-Use Assets and Lease_4
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Offices and labs [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities [Line Items] | |
Beginning Balance | $ 934 |
Depreciation expense | (1,318) |
Interest expense | |
Additions | 3,282 |
Payments | |
Other | |
Ending Balance | 2,898 |
Vechicles [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities [Line Items] | |
Beginning Balance | 175 |
Depreciation expense | (201) |
Interest expense | |
Additions | 127 |
Payments | |
Other | (27) |
Ending Balance | 74 |
Production Plant [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities [Line Items] | |
Beginning Balance | 4,024 |
Depreciation expense | (521) |
Interest expense | |
Additions | |
Payments | |
Other | (1) |
Ending Balance | 3,502 |
Total [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities [Line Items] | |
Beginning Balance | 5,133 |
Depreciation expense | (2,040) |
Interest expense | |
Additions | 3,409 |
Payments | |
Other | (28) |
Ending Balance | 6,474 |
Lease liabilities [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets and lease liabilities [Line Items] | |
Beginning Balance | 5,971 |
Depreciation expense | |
Interest expense | 707 |
Additions | 3,402 |
Payments | (2,145) |
Other | (25) |
Ending Balance | $ 7,910 |
Right-of-Use Assets and Lease_5
Right-of-Use Assets and Lease Liabilities (Details) - Schedule future minimum lease fees $ in Thousands | Dec. 31, 2020USD ($) |
Schedule future minimum lease fees [Abstract] | |
First year | $ 2,363 |
Second through fifth years | 4,650 |
After fifth year | 1,304 |
Future minimum lease fees payables | $ 8,317 |
Right-of-Use Assets and Lease_6
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets by class of underlying asset | 12 Months Ended |
Dec. 31, 2020 | |
Production Plant [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets by class of underlying asset [Line Items] | |
Right-of-use assets, percentage | 11.00% |
Offices and labs [Member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets by class of underlying asset [Line Items] | |
Right-of-use assets, percentage | 50.00% |
Vehicles [member] | Bottom of range [member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets by class of underlying asset [Line Items] | |
Right-of-use assets, percentage | 33.00% |
Vehicles [member] | Top of range [member] | |
Right-of-Use Assets and Lease Liabilities (Details) - Schedule of right-of-use assets by class of underlying asset [Line Items] | |
Right-of-use assets, percentage | 100.00% |
Accrued Expenses and Other Pa_3
Accrued Expenses and Other Payables (Details) - Schedule of accrued expenses and other payables - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of accrued expenses and other payables [Abstract] | ||
Subcontractors | $ 609 | $ 1,131 |
Clinical activities | 4,841 | 2,010 |
Professional services | 1,943 | 349 |
Production plant in process | 415 | 1,255 |
Other | 180 | 173 |
Total | $ 7,988 | $ 4,918 |
Liabilities Presented At Fair_3
Liabilities Presented At Fair Value (Details) - USD ($) | Jul. 09, 2017 | Dec. 31, 2019 | Dec. 31, 2018 |
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Issuance costs related to warrants (in Dollars) | $ 216,000 | ||
Number of warrants exercised | 403,422 | 607,044 | |
Exercise price of warrants (in Dollars) | $ 6.72 | ||
Series Preferred F1 Share [Member] | |||
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Issuance of series F-1 preferred shares, net of issuance costs | 4,274,363 | ||
Share price (in Dollars per share) | $ 9.44 | ||
Series Preferred F1 Share [Member] | Warrants [Member] | |||
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Exercise price of warrants (in Dollars per share) | $ 11.33 | ||
Series Preferred F2 Share [Member] | |||
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Number of warrants granted | 2,564,619 | ||
Series Preferred F2 Share [Member] | Warrants [Member] | |||
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Proceeds from issuance of shares (in Dollars) | $ 40,350,000 | ||
Issuance costs related to equity (in Dollars) | $ 585,000 | ||
Number of warrants exercised | 2,564,619 | ||
Ordinary shares [member] | |||
Liabilities Presented At Fair Value (Details) [Line Items] | |||
Increase (decrease) through exercise of warrants | 4,323,978 | 209,312 | 293,489 |
Liabilities Presented At Fair_4
Liabilities Presented At Fair Value (Details) - Schedule of warrants to purchase preferred shares - Preferred F-2 shares [Member] | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Liabilities Presented At Fair Value (Details) - Schedule of warrants to purchase preferred shares [Line Items] | |||
Risk-free interest rate | 0.10% | 1.70% | 2.50% |
Expected volatility | 76.00% | 80.00% | 80.00% |
Expected life (in years) | 1 year 6 months | 2 years 6 months | 3 years 6 months |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Liabilities Presented At Fair_5
Liabilities Presented At Fair Value (Details) - Schedule of changes in fair value of warrants - Level 3 of fair value hierarchy [member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Liabilities Presented At Fair Value (Details) - Schedule of changes in fair value of warrants [Line Items] | ||
Beginning balance | $ 5,221 | $ 24,049 |
Exercise of warrants | (2,924) | |
Revaluation of financial derivatives | 6,822 | (15,904) |
Ending Balance | $ 12,043 | $ 5,221 |
Contingent Liabilities and Co_2
Contingent Liabilities and Commitments (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure of commitments and contingent liabilities [text block] [Abstract] | |
Royalties percentage, description | The Company is obligated to pay royalties to the IIA at the rates of 3% to 3.5% on sales proceeds from products developed through the grants received from the IIA. The maximum amount of royalties payable to the IIA is limited to 100% of the grants received, linked to the dollar and bearing interest at the LIBOR rate. |
Royalties, description | As of December 31, 2020, the Company’s aggregate contingent obligations for payments to IIA, based on royalty-bearing participation received or accrued amounted to $39,635 (including interest of $6,579). |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - $ / shares | 1 Months Ended | |||
Dec. 17, 2020 | May 21, 2020 | Jul. 01, 2019 | Oct. 30, 2018 | |
Disclosure of share capital, reserves and other equity interest [text block] [Abstract] | ||||
Ordinary shares | 7,000,000 | 6,250,000 | ||
Offering price per share | $ 5 | $ 8 | ||
Underwriters description | On December 17, 2020, the Company closed a third follow-on offering of its Ordinary shares on the Nasdaq, which resulted in the sale of 8,125,000 Ordinary shares at a public offering price of $8 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 1,218,750 additional shares at a public offering price of $8 per share and exercised in full their option to purchase such shares. The exercise of the underwriters’ option closed on December 17, 2020. The Company received net proceeds from the offering of $68,988 (net of issuance costs and underwriting discounts of $5,762). | On May 21, 2020, the Company closed a second follow-on offering of its Ordinary shares on the Nasdaq, which resulted in the sale of 13,333,334 ordinary shares at a public offering price of $4.50 per share, before underwriting discounts. The underwriters had a 30-day option to purchase up to 2,000,000 additional shares at a public offering price of $4.50 per share and exercised in full their option to purchase such shares. The exercise of the underwriters’ option closed on May 26, 2020. The Company received net proceeds from the offering of $63,860 (net of issuance costs and underwriting discounts of $5,140). | The underwriters had a 30-day option to purchase up to 1,050,000 additional shares at a public offering price of $5 per share and exercised in full their option to purchase an additional 1,050,000 Ordinary shares at the public offering price of $5 per share. The exercise of the underwriters’ option closed on July 8, 2019. The Company received net proceeds from the offering of $37,140 (net of issuance costs and underwriting discounts of $3,110). | The underwriters purchased 398,368 additional shares at a public offering price of $8 per share. The Company received net proceeds from the IPO of $47,241 (net of issuance costs and underwriting discounts of $5,947). Upon the closing of the IPO, all of the Company’s outstanding Preferred shares automatically converted into 17,289,289 Ordinary shares. |
Share-Based Payment (Details)
Share-Based Payment (Details) | 12 Months Ended | ||||||
Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2020₪ / sharesshares | Dec. 31, 2019₪ / sharesshares | Dec. 28, 2017shares | Jun. 26, 2017shares | Jan. 23, 2017₪ / sharesshares | Nov. 23, 2014shares | |
Share-Based Payment (Details) [Line Items] | |||||||
Authorized | 100,000,000 | 100,000,000 | |||||
Shares issued | 59,000,153 | 33,670,926 | |||||
Par value (in New Shekels per share) | ₪ / shares | ₪ 0.01 | ₪ 0.01 | |||||
Share based compensation non vested (in Dollars) | $ | $ 3,776 | ||||||
Option vesting period | 4 years | ||||||
Ordinary C Share [Member] | |||||||
Share-Based Payment (Details) [Line Items] | |||||||
Authorized | 1,500,000 | ||||||
Bottom of range [member] | |||||||
Share-Based Payment (Details) [Line Items] | |||||||
Weighted average grant-date fair value (in Dollars per share) | $ / shares | $ 2.65 | ||||||
Top of range [member] | |||||||
Share-Based Payment (Details) [Line Items] | |||||||
Weighted average grant-date fair value (in Dollars per share) | $ / shares | $ 4.28 | ||||||
2014 Israel Share Option Plan [Member] | Ordinary C Share [Member] | |||||||
Share-Based Payment (Details) [Line Items] | |||||||
Shares issued | 1,152,044 | ||||||
2017 Share incentive Plan [Member] | |||||||
Share-Based Payment (Details) [Line Items] | |||||||
Par value (in New Shekels per share) | ₪ / shares | ₪ 2,017 | ||||||
Number of shares reserved for issuance | 1,338,015 | 559,764 | 463,384 | 312,867 |
Share-Based Payment (Details) -
Share-Based Payment (Details) - Schedule of fair value measurement of equity-settled share options | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-Based Payment (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | |||
Dividend yield (%) | 0.00% | 0.00% | 0.00% |
Bottom of range [member] | |||
Share-Based Payment (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | |||
Expected volatility of the share prices (%) | 74.00% | 78.00% | 93.00% |
Risk-free interest rate (%) | 0.60% | 1.92% | 2.63% |
Top of range [member] | |||
Share-Based Payment (Details) - Schedule of fair value measurement of equity-settled share options [Line Items] | |||
Expected volatility of the share prices (%) | 79.00% | 84.00% | 95.00% |
Risk-free interest rate (%) | 1.38% | 2.63% | 2.88% |
Share-Based Payment (Details)_2
Share-Based Payment (Details) - Schedule of stock option activity - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of stock option activity [Abstract] | ||
Number of options Outstanding at beginning of year (in Shares) | 3,405,188 | 3,197,616 |
Weighted average exercise price, Outstanding at beginning of year | $ 4.76 | $ 3.07 |
Number of options, Granted during the year (in Shares) | 1,492,700 | 790,300 |
Weighted average exercise price, Granted during the year | $ 4.91 | $ 8.82 |
Number of options, Expired during the year (in Shares) | 74,744 | 39,094 |
Weighted average exercise price, Expired during the year | $ 8.60 | $ 5.21 |
Number of options, Exercised during the year (in Shares) | 652,143 | 480,878 |
Weighted average exercise price, Exercised during the year | $ 1 | $ 0.27 |
Number of options, Forfeited during the year (in Dollars) | $ 278,287 | $ 62,756 |
Weighted average exercise price, Forfeited during the year | $ 7.94 | $ 6.16 |
Number of options, Share options outstanding at end of year (in Shares) | 3,892,714 | 3,405,188 |
Weighted average exercise price, Share options outstanding at end of year | $ 5.15 | $ 4.76 |
Number of options, Share options exercisable at end of year (in Shares) | 2,161,439 | 1,865,572 |
Weighted average exercise price, Share options exercisable at end of year | $ 4.45 | $ 2.68 |
Taxes on Income (Details)
Taxes on Income (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure of income tax [text block] [Abstract] | ||
Israeli corporate income tax | 23.00% | 23.00% |
Description of corporate tax rate | Benefits granted to a Preferred Enterprise include reduced tax rates.. As part of the Economic Efficiency Law (Legislative Amendments for Accomplishment of Budgetary Targets for Budget Years 2017-2018), 5777-2016, the tax rate for Area A will be 7.5% in 2017 onwards. In other regions, the tax rate is 16%. Preferred Enterprises in peripheral regions will be eligible for Investment Center grants, as well as the applicable reduced tax rates. | |
Description of net carryforward tax losses | The Company has net operating losses and capital losses for tax purposes as of December 31, 2020, of $174,548 and $507, respectively, which may be carried forward and offset against taxable income in the future for an indefinite period. | |
Net operating losses carryforwards | $ 8,967 |
Selected Statements of Compre_3
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | $ 41,385 | $ 31,462 | $ 22,045 |
Salaries and social benefits [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 11,017 | 8,307 | 5,016 |
Share-based payment [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 1,185 | 1,600 | 705 |
Subcontractors [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 21,880 | 16,752 | 12,695 |
Materials [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 4,622 | 3,700 | 3,610 |
Depreciation [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 1,314 | 1,220 | 195 |
Other [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | 871 | 970 | 1,725 |
Revaluation of royalty liability, net of receipt of royalty bearing grants [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of research and development expenses, net [Line Items] | |||
Total research and development expenses, net | $ 496 | $ (1,087) | $ (1,901) |
Selected Statements of Compre_4
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities [Line Items] | ||
Total commercial expenses, net | $ 8,748 | $ 4,692 |
Salaries and social benefits [Member] | ||
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities [Line Items] | ||
Total commercial expenses, net | 2,665 | 1,559 |
Share-based payment [Member] | ||
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities [Line Items] | ||
Total commercial expenses, net | 230 | 879 |
Professional services [Member] | ||
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities [Line Items] | ||
Total commercial expenses, net | 5,800 | 2,075 |
Other [Member] | ||
Selected Statements of Comprehensive Income Data (Details) - Schedule of commercial activities [Line Items] | ||
Total commercial expenses, net | $ 53 | $ 179 |
Selected Statements of Compre_5
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | $ 12,167 | $ 12,091 | $ 11,599 |
Salaries and social benefits [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | 3,641 | 3,488 | 4,788 |
Share-based payment [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | 1,449 | 2,389 | 2,870 |
Professional services [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | 5,307 | 3,833 | 2,802 |
Rent, maintenance and other expenses [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | 693 | 1,458 | 1,065 |
Depreciation [Member] | |||
Selected Statements of Comprehensive Income Data (Details) - Schedule of general and administrative expenses [Line Items] | |||
Total general and administrative expenses | $ 1,077 | $ 923 | $ 74 |
Selected Statements of Compre_6
Selected Statements of Comprehensive Income Data (Details) - Schedule of finance expenses - Financial assets at fair value through other comprehensive income, category [member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Selected Statements of Comprehensive Income Data (Details) - Schedule of finance expenses [Line Items] | |||
Revaluation of IIA liability | $ 3,000 | $ 2,531 | $ 2,037 |
Revaluation of warrants | 6,822 | 17,600 | |
Bank charges, interest expense and other fees | 37 | 32 | 68 |
Interest expense related to lease liability | 707 | 758 | |
Foreign currency translation adjustments | 74 | 4 | 554 |
Total finance expenses | $ 10,640 | $ 3,325 | $ 20,259 |
Selected Statements of Compre_7
Selected Statements of Comprehensive Income Data (Details) - Schedule of finance income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of finance income [Abstract] | |||
Interest income | $ 236 | $ 1,245 | $ 877 |
Revaluation of warrants | 15,904 | ||
Foreign currency translation adjustments | 165 | ||
Total finance income | $ 236 | $ 17,149 | $ 1,042 |
Related Party Transactions (Det
Related Party Transactions (Details) - Schedule benefits to key executive personnel - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule benefits to key executive personnel [Abstract] | |||
Short-term benefits | $ 3,821 | $ 3,550 | $ 2,106 |
Other long-term benefits | 63 | ||
Share-based payment | 2,197 | 3,714 | 2,542 |
Benefits to key executive personnel | $ 6,018 | $ 7,264 | $ 4,711 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) | 12 Months Ended |
Dec. 31, 2020shares | |
Disclosure of earnings per share [text block] [Abstract] | |
Anti-dilutive effect of options | 2,161,439 |
Anti-dilutive effect of warrants | 3,313,512 |
Net Loss Per Share (Details) -
Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of loss per share - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
For the computation of basic loss [Member] | |||
Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of loss per share [Line Items] | |||
Weighted Number of Shares | 43,725,584 | 29,459,395 | 5,025,213 |
Net loss Attributed to equity holders of the Company | $ 72,704 | $ 34,351 | $ 52,931 |
Effect of potential dilutive ordinary shares (Warrants) [Member] | |||
Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of loss per share [Line Items] | |||
Weighted Number of Shares | 196,428 | ||
Net loss Attributed to equity holders of the Company | $ 15,904 | ||
For the computation of diluted loss [Member] | |||
Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of loss per share [Line Items] | |||
Weighted Number of Shares | 43,725,584 | 29,655,823 | 5,025,213 |
Net loss Attributed to equity holders of the Company | $ 72,704 | $ 50,255 | $ 52,931 |
Subsequent Event (Details)
Subsequent Event (Details) | 1 Months Ended |
Feb. 16, 2021 | |
Subsequent Events [Member] | |
Subsequent Event (Details) [Line Items] | |
Subsequent events, description | the Company announced the sale of $75 million of exchangeable senior notes due in 2026 (the “notes”) to Highbridge Capital Management, LLC. The notes were sold at 100% of the principal amount thereof, are senior unsecured obligations of the Company and its wholly owned subsidiary and will accrue interest at a rate of 5.875% per year. Subject to certain limitations, the holders of the notes can elect to exchange the notes for the Company’s Ordinary shares at an initial exchange rate of 56.3063 shares per $1,000 principal amount of notes (equivalent to an exchange price of $17.76 per share). The Company may redeem all or a portion of the notes for cash, at its option, at 100% of the principal amount plus accrued and unpaid interest on the notes to be redeemed if the closing price of its Ordinary shares has been at least 130% of the exchange price for at least 20 trading days during any 30 consecutive trading day period. |