Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 15, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Entity File Number | 001-33357 | ||
Entity Registrant Name | PROTALIX BIOTHERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 65-0643773 | ||
Entity Address, Address Line One | 2 University Plaza | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, City or Town | Hackensack | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 07601 | ||
City Area Code | 201 | ||
Local Phone Number | 696-9345 | ||
Title of 12(b) Security | Common stock, $0.001 par value | ||
Trading Symbol | PLX | ||
Security Exchange Name | NYSEAMER | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 46,316,129 | ||
Entity Central Index Key | 0001006281 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Voluntary Filers | No | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 85.1 | ||
Auditor Name | Kesselman & Kesselman C.P.A.s | ||
Auditor Firm ID | 1309 | ||
Auditor Location | Tel Aviv, Israel | ||
ICFR Auditor Attestation Flag | false |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 38,985 | $ 18,265 |
Short-term bank deposits | 20,280 | |
Accounts receivable - Trade | 3,442 | 2,000 |
Other assets | 1,285 | 2,096 |
Inventories | 17,954 | 13,082 |
Total current assets | 61,666 | 55,723 |
NON-CURRENT ASSETS: | ||
Funds in respect of employee rights upon retirement | 2,077 | 1,799 |
Property and equipment, net | 4,962 | 4,845 |
Operating lease right of use assets | 4,960 | 5,567 |
Total assets | 73,665 | 67,934 |
Accounts payable and accruals: | ||
Trade | 6,986 | 7,221 |
Other | 16,433 | 13,926 |
Operating lease liabilities | 1,207 | 1,420 |
Contracts liability | 8,550 | 5,394 |
Convertible notes | 54,427 | |
Promissory note | 4,086 | |
Total current liabilities | 33,176 | 86,474 |
LONG TERM LIABILITIES: | ||
Convertible notes | 27,887 | |
Contracts liability | 11,790 | 1,716 |
Liability for employee rights upon retirement | 2,472 | 2,263 |
Operating lease liabilities | 4,376 | 4,467 |
Other long term liabilities | 51 | |
Total long term liabilities | 46,525 | 8,497 |
Total liabilities | 79,701 | 94,971 |
COMMITMENTS | ||
CAPITAL DEFICIENCY | ||
Common Stock, $0.001 par value: Authorized - as of December 31, 2020 and 2021, 120,000,000 shares; issued and outstanding - as of December 31, 2020 and 2021, 34,765,280 and 45,556,647 shares, respectively | 46 | 35 |
Additional paid-in capital | 368,852 | 320,280 |
Accumulated deficit | (374,934) | (347,352) |
Total capital deficiency | (6,036) | (27,037) |
Total liabilities net of capital deficiency | $ 73,665 | $ 67,934 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
CONSOLIDATED BALANCE SHEETS | ||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 |
Common Stock, issued | 45,556,647 | 34,765,280 |
Common Stock, outstanding | 45,556,647 | 34,765,280 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
TOTAL REVENUE | $ 38,350 | $ 62,898 | $ 54,693 |
COST OF GOODS SOLD | (16,349) | (10,873) | (10,895) |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (29,734) | (38,167) | (44,616) |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (12,729) | (11,148) | (9,899) |
OPERATING INCOME (LOSS) | (20,462) | 2,710 | (10,717) |
FINANCIAL EXPENSES | (7,521) | (9,671) | (7,966) |
FINANCIAL INCOME | 401 | 438 | 407 |
FINANCIAL EXPENSES - NET | (7,120) | (9,233) | (7,559) |
NET LOSS FOR THE YEAR | $ (27,582) | $ (6,523) | $ (18,276) |
LOSS PER SHARE OF COMMON STOCK - BASIC | $ (0.62) | $ (0.22) | $ (1.23) |
LOSS PER SHARE OF COMMON STOCK - DILUTED | $ (0.62) | $ (0.22) | $ (1.23) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC | 44,140,233 | 29,148,047 | 14,838,213 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - DILUTED | 44,140,233 | 29,148,047 | 14,838,213 |
Goods [Member] | |||
TOTAL REVENUE | $ 16,749 | $ 16,236 | $ 15,866 |
License and R&D Services [Member] | |||
TOTAL REVENUE | $ 21,601 | $ 46,662 | $ 38,827 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Beginning balance at Dec. 31, 2018 | $ 15 | $ 269,657 | $ (322,553) | $ (52,881) |
Beginning balance (in shares) at Dec. 31, 2018 | 14,838,213 | |||
Share-based compensation related to stock options | 835 | 835 | ||
Net loss | (18,276) | (18,276) | ||
Ending balance at Dec. 31, 2019 | $ 15 | 270,492 | (340,829) | (70,322) |
Ending balance (in shares) at Dec. 31, 2019 | 14,838,213 | |||
Issuance of common stock and warrants, net of issuance cost | $ 18 | 41,325 | 41,343 | |
Issuance of common stock and warrants, net of issuance cost (in shares) | 17,604,423 | |||
Issuance of common stock under the Sales Agreement, net | $ 1 | 4,866 | 4,867 | |
Issuance of common stock under the Sales Agreement, net (in shares) | 1,428,571 | |||
Share-based compensation related to stock options | 2,264 | 2,264 | ||
Share-based compensation related to restricted stock awards | $ 1 | 861 | 862 | |
Share-based compensation related to restricted stock awards (in shares) | 694,073 | |||
Exercise of warrants | 472 | 472 | ||
Exercise of warrants (in shares) | 200,000 | |||
Net loss | (6,523) | (6,523) | ||
Ending balance at Dec. 31, 2020 | $ 35 | 320,280 | (347,352) | (27,037) |
Ending balance (in shares) at Dec. 31, 2020 | 34,765,280 | |||
Issuance of common stock, net of issuance cost | $ 9 | 37,616 | 37,625 | |
Issuance of common stock, net of issuance cost (in shares) | 8,749,999 | |||
Issuance of common stock under the Sales Agreement, net | $ 2 | 8,573 | 8,575 | |
Issuance of common stock under the Sales Agreement, net (in shares) | 1,867,552 | |||
Share-based compensation related to stock options | 1,405 | 1,405 | ||
Share-based compensation related to restricted stock awards | 970 | 970 | ||
Exercise of warrants (in shares) | 173,816 | |||
Reacquisition of equity component of convertible notes | (12,019) | (12,019) | ||
Equity component of convertible notes, net of transaction costs | 12,027 | 12,027 | ||
Net loss | (27,582) | (27,582) | ||
Ending balance at Dec. 31, 2021 | $ 46 | $ 368,852 | $ (374,934) | $ (6,036) |
Ending balance (in shares) at Dec. 31, 2021 | 45,556,647 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net loss | $ (27,582) | $ (6,523) | $ (18,276) |
Adjustments required to reconcile net loss to net cash used in operating activities: | |||
Share-based compensation | 2,375 | 3,126 | 835 |
Depreciation | 1,118 | 1,302 | 1,617 |
Financial income, net (mainly exchange differences) | 417 | 171 | 378 |
Changes in accrued liability for employee rights upon retirement | 133 | (494) | (10) |
Gain on amounts funded in respect of employee rights upon retirement | (100) | (28) | (58) |
Gain on sale of fixed assets | (51) | ||
Loss on extinguishment of convertible notes | 831 | ||
Amortization of debt issuance costs and debt discount | 2,673 | 3,470 | 2,991 |
Changes in operating assets and liabilities: | |||
Increase (decrease) in contracts liability (including non-current portion) | 13,230 | (26,205) | (9,580) |
Decrease (increase) in accounts receivable and other assets | (1,032) | 2,091 | 188 |
Changes in right of use assets | 241 | 95 | (110) |
Decrease (increase) in inventories | (4,872) | (4,927) | 414 |
Increase in accounts payable and accruals | 2,385 | 2,274 | 2,735 |
Decrease in other long term liabilities | (51) | (458) | (482) |
Net cash used in operating activities | (10,285) | (26,106) | (19,358) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Investment in bank deposits | (37,835) | (20,000) | |
Proceeds from sale of short-term deposits | 57,835 | ||
Purchase of property and equipment | (1,459) | (655) | (627) |
Proceeds from sale of property and equipment | 53 | ||
Decrease (increase) in restricted deposit | 436 | 384 | (259) |
Amounts funded in respect of employee rights upon retirement, net | (109) | 319 | 3 |
Net cash provided by (used in) investing activities | 18,921 | (19,952) | (883) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Payment for convertible notes redemption and transactions costs | (30,036) | ||
Payment for promissory note | (4,086) | (215) | |
Proceeds from issuance of common stock and warrants, net | 37,625 | 41,343 | |
Proceeds from issuance of common stock under the Sales Agreement, net | 8,575 | 4,867 | |
Exercise of warrants | 472 | ||
Net cash provided by financing activities | 12,078 | 46,467 | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | 6 | 64 | 225 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 20,720 | 473 | (20,016) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 18,265 | 17,792 | 37,808 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR | 38,985 | 18,265 | 17,792 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | |||
Purchase of property and equipment | 94 | 317 | 98 |
Right of use assets obtained in exchange for new operating lease liabilities | 309 | 632 | 388 |
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | |||
Interest paid | 3,410 | 4,344 | 4,344 |
Interest received | $ 379 | $ 438 | $ 407 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
SIGNIFICANT ACCOUNTING POLICIES | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® On August 25, 2021, the Company completed exchanges (the “Exchanges”) of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) with institutional note holders of a substantial majority of the 2021 Notes. The Exchanges involved the exchange of an aggregate of $54.65 million principal amount of the Company’s outstanding 2021 Notes for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the closing date. The initial conversion rate for the 2024 Notes is 563.2216 shares of common stock, par value $0.001 per share (the “Common Stock”), for each $1,000 principal amount of 2024 Notes (equivalent to an initial conversion price of approximately $1.7755 per share of the Common Stock), subject to adjustment in certain circumstances. This initial conversion price represents a premium of approximately 32.5% relative to the closing price of the Common Stock on the NYSE American on August 13, 2021. See also note 10. The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies which are referred to as the BALANCE BRIDGE BRIGHT BRIDGE BRIGHT On February 7, 2022, a Marketing Authorization Application (“MAA”) for PRX-102 was submitted to, and subsequently validated by, the European Medicines Agency (“EMA”). The submission was made after the October 8, 2021 meeting the Company held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the then anticipated MAA submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of the planned MAA submission for PRX-102. On April 28, 2021, the Company, together with its development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), announced that the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (the “FDA”) regarding the biologics license application (“BLA”) for PRX-102 for the treatment of adult patients with Fabry disease. The PRX-102 BLA was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package. In the CRL, the FDA noted that an inspection of the Company’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve a resubmitted BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained in the letter that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to the novel coronavirus disease (“COVID-19”), the FDA reviewed records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that Fabrazyme (agalsidase beta), a therapy used to treat Fabry patients, was recently converted to full approval and is now an “available therapy,” which must be addressed in the context of any potential resubmission of a BLA for PRX-102. The Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The planned data package for the BLA resubmission, given the changed regulatory landscape in the United States, will include the final two-year analyses of the BALANCE In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates: (1) alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, which has successfully completed a phase II efficacy and safety study; the Company’s exclusive worldwide license agreement with SarcoMed USA Inc. with respect to PRX-110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery expired during 2021; we are continuing to evaluate potential strategic marketing partnerships and collaboration programs with biotechnology and pharmaceutical companies for this product candidate for various respiratory indications; (2) PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat refractory gout; and (3) PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases. Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of its Common Stock having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the Sales Agreement, the Company terminated the ATM Equity Offering SM the term of the sales agreement with BofA Securities, the Company sold a total of 3,296,123 shares of Common Stock for total gross proceeds of approximately $13.8 million. On February 17, 2021, the Company closed a public offering of its Common Stock, raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering. BofA Securities acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager. On March 18, 2020, the Company completed a private placement of its Common Stock and warrants. In connection with the offering, the Company issued 17,604,423 unregistered shares of Common Stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of Common Stock at an exercise price of $2.36 per share. The warrants were exercisable commencing six months following their issuance for a period of five years from the date of issuance. For accounting purposes, the warrants are classified as equity considering the warrants’ terms. The net proceeds generated from the private placement were approximately $41.3 million, after deducting advisory fees and other estimated offering expenses. On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States. Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs, and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment provided in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company received the payment in June 2021. The Company also agreed to negotiate certain manufacturing related matters. Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) in accordance with the exclusive license and supply agreement entered into between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues. On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), for taliglucerase alfa. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil. COVID-19, which was declared by the World Health Organization to be a global pandemic on March 11, 2020, has had numerous adverse effects on the global economy. To date, the Company's clinical trials have not been adversely affected by COVID-19, although certain practices the Company has adopted in its offices and facilities in an effort to promote social distancing have resulted in minor delays in the performance of administrative activities outside of the clinical programs. The Company continues to face uncertainty as to the degree and duration of that impact going forward. The Company does not know the length of time that the pandemic and related disruptions will continue, the impact of governmental regulations or easement of regulations in response to the strengthening or weakening of the pandemic, or the degree of overall potentially permanent changes in consumer behavior that may be caused by the pandemic. The Company believes that its cash and cash equivalents as of December 31, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. b. Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. As applicable to these consolidated financial statements, the most significant estimates relate to revenue recognition. The severity, magnitude and duration, as well as the economic consequences, of the COVID-19 pandemic, are uncertain, rapidly changing and difficult to predict. As a result, the accounting estimates and assumptions may change over time in response to COVID-19. d. Functional currency The dollar is the currency of the primary economic environment in which the operations of the Company and its Subsidiaries are conducted. The Company’s revenues are derived in dollars. Most of the Company’s expenses and capital expenditures are incurred in dollars, and the major source of the Company’s financing has been provided in dollars. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items (stated below) reflected in the statements of operations, the following exchange rates are used: (i) for transactions – exchange rates at the transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) – historical exchange rates. Currency translation gains and losses are recorded as financial income or expenses, as appropriate. e. Cash equivalents The Company considers all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents. f. Accounts Receivables Accounts receivable have been reduced by an allowance for doubtful accounts. The Company maintains the allowance for estimated losses resulting from the inability of the Company’s customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result of the Company’s ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations. No write-off activity and recoveries for the periods presented were recognized. g. Inventories Inventories are valued at the lower of cost or net realizable value. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis. Cost of finished products is determined as follows: the value of the raw and packaging materials component is determined primarily using the “moving average” basis; the value of the labor and overhead component is determined on an average basis over the production period. Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions. h. Property and equipment 1. Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2. The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows: Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 Leasehold improvements are amortized by the straight-line method over the shorter of (i) the expected lease term and (ii) the estimated useful life of the improvements. i. Impairment in value of long-lived assets The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected future cash flows of definite life assets (undiscounted and without interest charges) is less than the carrying amount of such assets, the Company recognizes an impairment loss, and writes down the assets to their estimated fair values. j. Income taxes 1. Deferred income taxes Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of the differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. The Company used statutory tax rates of 21% and 23%. See also Note 12. 2. Uncertainty in income taxes Tax benefits recognized in the financial statements are those that the Company’s management deems at least more likely than not to be sustained, based on technical merits. The amount of benefits recorded for these tax benefits is measured as the largest benefit the Company’s management deems more likely than not to be sustained. k. Revenue Recognition The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer. 1. Revenues from selling products The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery). 2. Revenues from Chiesi Agreements The Company has identified two performance obligations in the Chiesi agreements as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing. The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug. The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation. Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method. 3. Revenue from R&D services Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service. l. Research and development costs Research and development costs are expensed as incurred and consist primarily of personnel, subcontractors and consultants (mainly in connection with clinical trials), facilities, equipment and supplies for research and development activities. Grants received by the Israeli Subsidiary from the National Authority for Technological Innovation (“NATI”) are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company or the Subsidiaries will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. In connection with purchases of assets, amounts assigned to intangible assets to be used in a particular research and development project that have no alternative future use are charged to research and development costs at the purchase date. Costs incurred for performing research and development services are included in research and development expenses. m. Concentration of credit risks and trade receivable Financial instruments that potentially subject the Company to concentration of credit risk consist principally of bank deposits. The Company’s deposits are instruments with highly rated financial institutions, mainly in Israeli banks, and, as a matter of policy, limits the amounts of credit exposure to any one financial institution. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these instruments. The Company’s trade receivables represent amounts to be received from its customers. The Company does not require its customers to post collateral with respect to receivables. As of December 31, 2021, the accounts receivables balance was composed of $2.2 million from Fiocruz and $1.2 million from Chiesi. n. Share-based compensation The Company accounts for share-based payment awards classified as equity awards, including stock-based option awards and restricted stock units, using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. This option pricing model requires estimates as to the option’s expected term and the price volatility of the underlying stock. The Company measures compensation expense for the based on the market value of the underlying stock at the date of grant The Company elected to recognize compensation cost for awards to employees with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach. Options granted to consultants and other service providers are recognized over the related service period using the straight-line method. The Company elects to account for forfeitures as they occur. o. Net loss per share Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of the Company’s Common Stock outstanding for each period. The calculation of diluted LPS does not include approximately 7,838,120, 22,850,682 and 28,502,017 shares of Common Stock underlying outstanding options, warrants and convertible notes for the fiscal years ended December 31, 2019, 2020 and 2021, respectively, because the effect would be anti-dilutive. p. Convertible notes The outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The 2021 Notes were accounted for partially as liability and equity components of the instrument and partially as a debt host contract with an embedded derivative resulting from the conversion feature. During the year ended December 31, 2017, the embedded derivative was reclassified to additional paid in capital. The 2024 Notes were accounted for as a liability (debt) and equity component (conversion option) as the convertible notes may be settled wholly or partly in cash, at the option of the Company, when converted. Issuance costs regarding the issuance of the 2021 Notes, as well as the debt discount and debt issuance costs from the issuance of the 2024 Notes, were deferred and amortized over the applicable convertible notes period using the effective interest rate. As of December 31, 2021, a total of $28.75 million aggregate principal amount of the 2024 Notes were outstanding. In addition, as of December 31, 2021, none of the 2021 Notes were outstanding. q. Leases The Company adopted ASC 842 on January 1, 2019, using a modified retrospective transition approach, with certain practical expedients, and as a result did not adjust prior periods. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC 842-10-25-2. If any of these five criteria is met, the Company classifies the lease as a finance lease. Otherwise, the Company classifies the lease as an operating lease. The Company does not have any finance leases. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating and finance lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. The Company elected the package of transition practical expedients permitted under the transition guidance within the new standard which, among other things, allows the Company to carryforward the historical lease classification. The lease standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases with a term shorter than 12 months. This means, for those leases, the Company does not recognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate the lease. The Company recognizes lease expenses over the lease term on a straight-line basis. The depreciable life of leasehold improvements is limited by the expected lease term, unless there is a transfer of title or a purchase option for the leased asset reasonably certain of exercise. Additionally, following the adoption of ASC 842 and in subsequent measurements, the Company applies the portfolio approach to account for the operating lease ROU assets and liabilities for certain car leases and incremental borrowing rates. r. Recently issued accounting pronouncements, not yet adopted In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” In addition, in January 2021, the FASB issued ASU 2021-01, “Reference Rate Reform (Topic 848) - Scope.” The amendments in these ASUs apply to all entities that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. Together, these ASUs provide optional expedients and exceptions for applying generally accepted accounting principles (GAAP) to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The expedients and exceptions provided by the amendments do not apply to contract modifications made and hedging relationships entered into or evaluated after December |
COMMERCIALIZATION AGREEMENTS
COMMERCIALIZATION AGREEMENTS | 12 Months Ended |
Dec. 31, 2021 | |
COMMERCIALIZATION AGREEMENTS | |
COMMERCIALIZATION AGREEMENTS | NOTE 2 - COMMERCIALIZATION AGREEMENTS a. In October 2015, the Company entered into the Amended Pfizer Agreement with Pfizer. Pursuant to the amendment, the Company granted Pfizer an exclusive license in the entire world, including Israel but excluding Brazil. Pfizer acquired all the information, knowledge and permission to manufacture and sell Elelyso. Protalix Ltd. also agreed to provide Pfizer with: 1. Manufacturing and supply of the drug substance for its incorporation into the licensed product in consideration of an agreed price per unit. 2. Assistance in arranging for the manufacture of the drug substance by Pfizer or by alternative supplier chosen by Pfizer in consideration of an agreed hourly rate plus reimbursement of expenses. Promissory note – as of the date of the amendment, the Company owed Pfizer $4.3 million as a result of the accumulated losses incurred by the Collaboration Operation. Following the new agreements, the Company committed to pay Pfizer the principal sum of the debt at the earlier of (a) November 12, 2020 and (b) the date upon which it becomes due pursuant to any event of default, as defined. In September 2020, the Company amended the outstanding $4.3 million promissory note payable to Pfizer by November 2020 to extend the maturity date to the earlier of (a) January 31, 2022 and (b) the date that the Company receives any milestone payment from Chiesi, if at all, subject to certain conditions and exceptions. The amendment also provides that the Company shall make a payment of $430,000 to Pfizer. The payment was creditable against the principal amount of the note, in whole or in part, if the Company satisfied the note in full on or prior to September 30, 2021, depending on the date the note is satisfied. As of December 31, 2020, the promissory note was classified to current liabilities. On March 29, 2021, the Company paid approximately $4.0 million to Pfizer satisfying the promissory note in full. b. Under the terms of the Chiesi Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets outside of the United States. At the effective date, Protalix Ltd. had maintained the exclusive commercialization rights to the drug in the United States, which rights were subsequently granted to Chiesi in July 2018. Protalix Ltd. will be mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted and (ii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests. The consideration consists of the following: 1. Upfront, non-refundable payment of $25.0 million. 2. Additional payments of up to $25.0 million in development costs, capped at $10.0 million per year. 3. Payments for additional studies, as may be approved from time to time by Chiesi. 4. Milestone payments of up to $320.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Agreement. 5. Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 35% of Chiesi’s average selling price of the drug, depending on the amount of annual sales. 6. Protalix Ltd. will be the sole manufacturer of the drug. Chiesi does not have sublicensing rights (except for certain territories). In July 2018, Protalix Ltd. entered into the Chiesi U.S. Agreement with respect to the commercialization of the drug for the treatment of Fabry disease. Under the terms of the Chiesi U.S. Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets in the United States. Protalix Ltd. will be mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted, (ii) continuing certain clinical development efforts in relation to the drug after a regulatory approval is granted and (iii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests. The consideration consists of the following: 1. Upfront, non-refundable payment of $25.0 million. 2. Additional payments of up to $20.0 million in development costs, capped at $7.5 million per year. 3. Payments for additional studies, as may be approved from time to time by Chiesi. 4. Milestone payments of up to $760.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Agreement, which has been reduced to $735.0 million. 5. Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 40% of Chiesi’s average selling price of the drug, depending on the amount of annual sales. 6. Protalix will be the sole manufacturer of the drug. Chiesi does not have sublicensing rights. As of December 31, 2021, the Company has received, or is entitled to receive, the following payments from Chiesi: 1. Upfront payments equal to $50.0 million, in the aggregate. 2. Payments equal to $45.0 million in consideration for development services performed. 3. Payments equal to approximately $33.6 million in connection with the performance of extension studies. 4. Payment equal to $10.0 million in lieu of certain milestone payments. During 2019, 2020 and 2021, the Company recognized revenues of approximately $4.5 million, $3.5 million and $0.6 million, respectively, related to the then $10.0 million future milestone payment. The Company assessed the likelihood of achieving the milestone using the most likely amount method and evaluated for the constraint by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The $10.0 million payment was received in June 2021. c. d. On March 16, 2020, the Company agreed to conduct a feasibility study with Kirin Holdings Company, Limited (“Kirin”) to evaluate the production of a novel complex protein utilizing ProCellEx ® , the Company’s proprietary plant cell-based protein expression system. Under the agreement, Kirin was obligated to bear the costs of conducting cell line engineering and protein expression studies on the target protein. In addition, the contract provided Kirin with an option to a future service for which the Company received a non-refundable payment in the amount of $1.0 million. During the year ended December 31, 2021, the Company completed its obligations under the agreement and the agreement expired, including the o ption to provide additional services. Following the expiration of the option, the Company recognized as revenue the $1.0 million received in March 2020 . |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT | |
PROPERTY AND EQUIPMENT | NOTE 3 - PROPERTY AND EQUIPMENT a. December 31, ( U.S. dollars in thousands 2020 2021 Laboratory equipment $ 17,422 $ 18,237 Furniture and computer equipment 2,687 2,718 Leasehold improvements 16,659 16,759 $ 36,768 $ 37,714 Less – accumulated depreciation and amortization (31,923) (32,752) $ 4,845 $ 4,962 b. |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORIES | |
INVENTORIES | NOTE 4 - INVENTORIES a. Inventories at December 31, 2020 and 2021 consisted of the following: December 31, ( U.S. dollars in thousands) 2020 2021 Raw materials $ 3,347 $ 3,166 Work in progress 2,887 3,262 Finished goods 6,848 11,526 Total inventory $ 13,082 $ 17,954 b. |
LIABILITY FOR EMPLOYEE RIGHTS U
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2021 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 5 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT The Israeli Subsidiary is required to make a severance payment upon dismissal of an employee or upon termination of employment in certain circumstances. The severance pay liability to the employees (based upon length of service and the latest monthly salary - one month’s salary for each year employed) is recorded on the Company’s balance sheets under “Liability for employee rights upon retirement.” The liability is recorded as if it were payable at each balance sheet date on an undiscounted basis. The liability is funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the Company’s balance sheets under “Funds in respect of employee rights upon retirement.” These policies are the Company’s assets. However, under labor agreements and subject to certain limitations, any policy may be transferred to the ownership of the individual employee for whose benefit the funds were deposited. In the years ended December 31, 2019, 2020 and 2021, the Company deposited approximately $143,000, $121,000 and $108,000, respectively, with insurance companies in connection with its severance payment obligations. In accordance with the current employment agreements with certain employees, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s rights upon retirement. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company’s balance sheets, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plans”). The amounts of severance pay expenses were approximately $784,000, $885,000 and $990,000 for each of the years ended December 31, 2019, 2020 and 2021, respectively, of which approximately $642,000, $747,000 and $857,000 in the years ended December 31, 2019, 2020 and 2021, respectively, were in respect of the Contribution Plans. Gain on amounts funded in respect of employee rights upon retirement totaled approximately $58,000, $28,000 and $100,000 for the years ended December 31, 2019, 2020 and 2021, respectively. The Company expects to contribute approximately $984,000 in the year ending December 31, 2022 to insurance companies in connection with its severance liabilities for its operations for that year, approximately $868,000 of which will be contributed to one or more Contribution Plans. During the five-year period following December 31, 2021, the Company expects to pay future benefits to four employees upon each such employee’s normal retirement age. The Company anticipates that the benefits payable will be approximately $72,000. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS | |
COMMITMENTS | NOTE 6 - COMMITMENTS a. Royalty Commitments The Company is obligated to pay royalties to NATI on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from NATI or its predecessor, the Office of the Israeli Innovation Authority (IIA). At the time the grants were received, successful development of the related projects was not assured. In the case of failure of a project that was partly financed as described above, the Company is not obligated to pay any such royalties or repay funding received from NATI or the IIA. Under the terms of the applicable funding arrangements, royalties of 3% to 6% are payable on the sale of products developed from projects funded by NATI or the IIA, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received (dollar linked), plus, commencing upon January 1, 2001, interest at an annual rate based on LIBOR. In addition, if the Company receives approval to manufacture products developed with government grants outside the State of Israel, it will be required to pay an increased total amount of royalties (possibly up to 300% of the grant amounts plus interest), depending on the manufacturing volume that is performed outside the State of Israel, and, possibly, an increased royalty rate. Royalty expenses to NATI or the IIA are included in the statement of operations as a component of the cost of revenues and were approximately $1.4 million, $911,000 and $1.2 million during the years ended December 31, 2019, 2020 and 2021, respectively. At December 31, 2020 and 2021, the maximum total royalty amount payable by the Company under these funding arrangements is approximately $39.8 million and $38.6 million, respectively (without interest, assuming 100% of the funds are payable). b. Subcontracting Agreements The Company has entered into sub-contracting agreements with several clinical providers and consultants in Israel, the United States and certain other countries in connection with its primary product development process. As of December 31, 2021, total commitments under said agreements were approximately $0.9 million. |
OPERATING LEASES
OPERATING LEASES | 12 Months Ended |
Dec. 31, 2021 | |
OPERATING LEASES | |
OPERATING LEASES | NOTE 7 - OPERATING LEASES The Company is a party to several lease agreements for its facilities, the latest of which has been extended until 2026. The Company has the option to extend certain of such agreements on one additional occasion for an additional five-year period. During the extended lease period, the aggregate monthly rental payments will increase by 7.5%-10% for the option. The Company expects to exercise the final option in future periods. As of December 31, 2021, the Company provided bank guarantees of approximately $496,000, in the aggregate, to secure the fulfillment of its obligations under the lease agreements. The Company entered into several three-year leases for vehicles which are regularly amended as new vehicles are leased. The following table sets forth data regarding the Company’s operating leases for the years ended December 31, 2019, 2020 and 2021: Year ended December 31, ( U.S. dollars in thousands) 2019 2020 2021 Operating lease costs $ 1,219 $ 1,382 $ 1,632 Cash paid for amounts included in the measurement of lease liabilities 1,329 1,289 1,391 Weighted average remaining lease term (in years) 10.5 9.5 8.9 Weighted average discount rate 12.7 % 12.7 % 12.8 % The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of December 31, 2021: ( U.S. dollars in thousands) December 31, 2021 2022 $ 1,207 2023 $ 1,025 2024 $ 872 2025 $ 853 2026 $ 848 2027 and thereafter $ 4,528 Total undiscounted cash flows $ 9,333 Less: imputed interest $ 3,750 Present value of operating lease liabilities $ 5,583 |
REVENUE
REVENUE | 12 Months Ended |
Dec. 31, 2021 | |
REVENUE | |
REVENUE | NOTE 8 - REVENUE The following table summarizes the Company’s disaggregation of revenues: Year Ended December 31, ( U.S. dollars in thousands) 2019 2020 2021 Pfizer $ 6,722 $ 8,105 $ 10,160 Brazil $ 9,144 $ 8,000 $ 6,400 Chiesi - $ 131 $ 189 Total revenues from selling goods $ 15,866 $ 16,236 $ 16,749 Revenues from license and R&D services $ 38,827 $ 46,662 $ 21,601 During the year ended December 31, 2021, and following the CRL received from the FDA and other understandings with Chiesi, the Company changed its estimate for total costs expected to be incurred until satisfying the performance obligation under the Chiesi Agreements. This resulted in reduced revenues recognized in respect of this performance obligation in 2021. |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2021 | |
SHARE CAPITAL | |
SHARE CAPITAL | NOTE 9 - SHARE CAPITAL a. Rights of the Company’s Common Stock The Company’s Common Stock is listed on the NYSE American and on the Tel Aviv Stock Exchange. Each share of Common Stock is entitled to one vote. The holders of shares of Common Stock are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. Since its inception, the Company has not declared any dividends. b. Reverse stock split On December 9, 2019, the Company’s stockholders approved an amendment to the Company’s Certificate of Incorporation, as amended, to, among other things, effect a reverse stock split at a ratio of one-for-ten c. Stock based compensation On December 14, 2006, the Board of Directors adopted the Protalix BioTherapeutics, Inc. 2006 Stock Incentive Plan, as amended (the “Plan”). The Plan has since been amended to, among other things, increase the number of shares of Common Stock available under the Plan to 5,725,171 shares. The grant of options to Israeli employees under the Plan is subject to the terms stipulated by Sections 102 and 102A of the Israeli Income Tax Ordinance. Each option grant made to an Israeli citizen is subject to the track chosen by the Company, either Section 102 or Section 102A of the Israeli Income Tax Ordinance, and pursuant to the terms thereof, the Company is not allowed to claim, as an expense for tax purposes, the amounts credited to employees as a benefit, including amounts recorded as salary benefits in the Company’s accounts, in respect of options granted to employees under the Plan, with the exception of the work-income benefit component, if any, determined on the grant date. For Israeli non-employees, the share option plan is subject to Section 3(i) of the Israeli Income Tax Ordinance. As of December 31, 2021, 1,786,256 shares of Common Stock remain available for grant under the Plan. For purposes of determining the fair value of the options and restricted stock unit granted to employees and non-employees, the Company’s management uses the fair value of the Common Stock. During the three years ended December 31, 2021, the Company granted options and shares of restricted stock to certain employees and non-employees as follows: 1. Options and restricted stock units granted to employees: a) Below is a table summarizing all of the options and restricted stock grants to employees during the three years ended December 31, 2021: No. of options or Fair value restricted stock Exercise Vesting at grant (U.S. dollars Expiration Year of grant granted price period in thousands) period 2019 160,000 $ 4.69 4 years $ 449 10 years 2019 80,000 $ 2.00 4 years $ 97 10 years 2020 196,995 $ 3.59 4 years $ 482 10 years 2020 760,311 $ 3.66 4 years $ 1,893 10 years 2020 129,771 $ 3.73 4 years $ 329 10 years 2020 694,073 $ n/a 4 years $ 2,492 10 years 2020 122,656 $ 3.59 4 years $ 299 10 years 2021 50,000 $ 1.57 4 years $ 55 10 years Set forth below are grants made by the Company to employees (including related parties) during the three-year period ended December 31, 2021 (a portion of such grants appear in the table above): In June 2019, the Company granted to its Chief Executive Officer 10-year options to purchase, in the aggregate, 160,000 shares of Common Stock under the Plan. The options have an exercise price equal to $4.69 per share, vest over a four-year period in 16 equal quarterly increments. Vesting of the options is subject to acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $449,000 based on the following weighted average assumptions: share price equal to $4.69; dividend yield of 0%; expected volatility of 65.3%; risk-free interest rates of 1.8%; and expected life of six years. In September 2019, the Company granted to its Chief Financial Officer 10-year options to purchase, in the aggregate, 80,000 shares of Common Stock under the Plan. The options have an exercise price equal to $2.00 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options is subject to acceleration in full upon a Corporate Transaction or a Change in Control, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option pricing model to be approximately $97,000 based on the following weighted average assumptions: share price equal to $2.00; dividend yield of 0%; expected volatility of 66.48%; risk-free interest rates of 1.695%; and expected life of six years. In addition, contingent upon certain conditions, the chief financial officer is entitled to a grant of restricted stock units with an aggregate value of $100,000, on an annual basis. On August 11, 2020, the Company granted the following: I. 447,927 shares of restricted Common Stock to its President and Chief Executive Officer under the Plan. The restricted shares vest over a four-year period in 16 equal quarterly increments and are subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control II. 246,146 shares of restricted Common Stock to its Sr. Vice President, Chief Financial Officer under the Plan. Of the shares, 27,855 shares vested on September 22, 2020. The remaining 218,291 of the shares vest in 16 equal, quarterly increments over a four-year period, commencing upon the date of grant and are subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, and are subject to certain other terms and conditions. The Company estimated the fair value of the restricted stock on the date of grant to be approximately $900,000. III. 10-year options to purchase 122,656 shares of Common Stock to the Company’s Sr. Vice President, Operations under the Plan. The options have an exercise price equal to $3.59 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the Sr. Vice President, Operations are subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, and are subject to certain other terms and conditions. The Company’s President and Chief Executive Officer may, in his discretion, grant options to the Company’s Sr. Vice President, Operations to purchase additional shares if the Company effects certain transactions in which it issues additional shares of Common Stock. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $300,000 based on the following weighted average assumptions: share price equal to $3.59; dividend yield of 0%; expected volatility of 80.51%; risk-free interest rate of 0.365%; and expected life of six years. On July 5, 2020, the Company granted 10-year options to purchase 129,771 shares of Common Stock to the Company’s Vice President, Research and Development under the Plan. The options have an exercise price equal to $3.73 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the Vice President, Research and Development is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $329,000 based on the following weighted average assumptions: share price equal to $3.73; dividend yield of 0%; expected volatility of 80.60%; risk-free interest rate of 0.395%; and expected life of six years. On June 7, 2020, the Company granted the following: I. 10-year options to purchase 196,995 shares of Common Stock to the Company’s Sr. Vice President and Chief Development Officer under the Plan. The options have an exercise price equal to $3.59 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the Sr. Vice President and Chief Development Officer are subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company’s President and Chief Executive Officer may, in his discretion, grant options to the Company’s Sr. Vice President and Chief Development Officer to purchase additional shares if the Company effects certain transactions in which it issues additional shares of Common Stock. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $500,000 based on the following weighted average assumptions: share price equal to $3.59; dividend yield of 0%; expected volatility of 80.43%; risk-free interest rate of 0.59%; and expected life of six years. II. 10-year options to purchase 760,311 shares of Common Stock, in the aggregate, to certain of the Company’s employees under the Plan. The options granted have an exercise price equal to $3.66 per share and vest over a four-year period in 16 equal quarterly increments. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $1.9 million based on the following weighted average assumptions: share price equal to $3.66; dividend yield of 0%; expected volatility of 80.49%; risk-free interest rate of 0.45%; and expected life of six years. On July 25, 2021, the Company granted to a new employee, with the approval of the Company’s compensation committee, 10-year options to purchase 50,000 shares of Common Stock under the Plan. The options have an exercise price equal to $1.57 per share and vest over a four-year period in 16 equal quarterly increments. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $55,000 based on the following weighted average assumptions: share price equal to $1.57; dividend yield of 0%; expected volatility of 84.30%; risk-free interest rate of 0.88%; and expected life of six years. b) The total unrecognized compensation cost of employee stock options at December 31, 2021 is approximately $1.7 million. The unrecognized compensation cost of employee stock options is expected to be recognized over a weighted average period of 0.9 years. During the three years ended December 31, 2021, there were no exercises of stock options, and the Company did not realize any tax benefit in connection with any exercises. 2. Options granted to directors: On February 3, 2020, the Company granted 10-year options to purchase 240,000 shares of Common Stock to the Chairman of the Company’s Board of Directors under the Plan. The options have an exercise price equal to $3.70 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the Chairman of the Board is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $593,000 based on the following weighted average assumptions: share price equal to $3.70; dividend yield of 0%; expected volatility of 76.91%; risk-free interest rate of 1.4%; and expected life of six years. On January 20, 2020, the Company granted 10-year options to purchase a total of 200,000 shares of Common Stock to five of the Company’s independent directors under the Plan. The options have an exercise price equal to $3.55 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the directors is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $475,000 based on the following weighted average assumptions: share price equal to $3.55; dividend yield of 0%; expected volatility of 76.62%; risk-free interest rate of 1.685%; and expected life of six years. 3. A summary of share option plans, and related information, under all of the Company’s equity incentive plans for the year ended December 31, 2021, and the effect of share-based compensation on the statement of operations for the years ended December 31, 2019, 2020 and 2021, is as follows: a) Options granted to employees: Year ended December 31, 2021 Weighted Number average of exercise options price Outstanding at beginning of year 2,087,275 $ 5.66 Changes during the year: Granted 50,000 1.57 Forfeited and expired 318,255 11.00 Outstanding at end of year 1,819,020 $ 4.61 Exercisable at end of year 961,940 $ 5.47 b) Restricted stock granted to employees: Year Ended December 31, 2021 Number of Restricted Stock Outstanding at beginning of year 624,580 Changes during the year: Vested 166,553 Non vested at end of year 458,027 c) Options granted to consultants, directors, and other service providers: Year ended December 31, 2021 Weighted Number average of exercise options price Outstanding at beginning of year 464,375 $ 3.74 Changes during the year: Expired 24,375 5.60 Outstanding at end of year 440,000 3.63 Exercisable at end of year 192,500 $ 3.63 d) The following tables summarize information concerning outstanding and exercisable options as of December 31, 2021: December 31, 2021 Options outstanding Options exercisable Number of Weighted Weighted options average average outstanding remaining Number of remaining Exercise at end of contractual options contractual prices year life exercisable* life $1.57 50,000 9.57 3,125 9.57 $2.00 80,000 7.73 45,000 7.73 $3.55 200,000 8.06 87,500 8.06 $3.59 319,651 8.51 112,203 8.50 $3.66 641,718 7.71 280,835 6.74 $3.70 240,000 8.10 105,000 8.10 $3.73 129,771 8.52 40,553 8.52 $4.69 160,000 7.50 100,000 7.50 $5.10 215,030 5.69 181,749 5.50 $5.60 130,000 6.71 105,625 6.71 $17.20 92,850 2.93 92,850 2.93 2,259,020 1,154,440 * As of December 31, 2021, all outstanding, exercisable options had exercise prices that exceed the fair market value of the Common Stock as of such date . e) The following table illustrates the effect of share-based compensation on the statement of operations: Year ended December 31, (U.S. dollars in thousands) 2019 2020 2021 Cost of goods sold $ 269 Research and development expenses $ 513 $ 1,036 648 Selling, general and administrative expenses 322 2,090 1,458 $ 835 $ 3,126 $ 2,375 d. Private and 144A Offerings On March 18, 2020, the Company completed a private placement to certain existing and new institutional and other accredited investors (the “Purchasers”) in reliance on the exemption from registration set forth in Section 4(2) of the Securities Act. The Company sold approximately 17.6 million unregistered shares of Common Stock to the Purchasers at a price per share of $2.485. The Company generated gross proceeds equal to approximately $43.7 million in the Private Placement. Each share of Common Stock issued was accompanied by a warrant to purchase one share of Common Stock at an exercise price equal to $2.36. During the year ended December 31, 2020 On June 7, 2021, the Company issued 173,816 shares of Common Stock in connection with the cashless exercise of a warrant to purchase 2,816,901 shares of Common Stock issued in the transaction. The Company did not generate any proceeds from the cashless exercise. e. At-the-Market (ATM) Offering On July 2, 2021, the Company entered into the Sales Agreement with the Agent. Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent ATM Shares having an aggregate offering price of up to $20.0 million. The Company has no obligation to sell any of the Shares, and may at any time suspend sales under the Sales Agreement or terminate the Sales Agreement in accordance with its terms. The Agent is entitled to a commission of up to 3.0% of the aggregate gross proceeds from the ATM Shares sold. As of December 31, 2021, the Company sold no ATM Shares under the Sales Agreement. During the year ended December 31, 2021, but prior to the termination of the BofA Agreement, the Company sold 1,867,552 shares of Common Stock under the BofA Agreement. The Company generated gross proceeds equal to approximately $8.8 million in connection with such sales. f. Public Offering On February 17, 2021, the Company issued and sold 8,749,999 shares of Common Stock in an underwritten public offering at a price to the public of $4.60 per share for gross proceeds of approximately $40.2 million before deducting the underwriting discount and estimated expenses of the offering. The above included the exercise of the underwriters’ over-allotment option to purchase 1,141,304 shares of Common Stock. |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 12 Months Ended |
Dec. 31, 2021 | |
CONVERTIBLE NOTES | |
CONVERTIBLE NOTES | NOTE 10 - CONVERTIBLE NOTES On August 25, 2021, the Company completed the Exchanges of a substantial majority of the Company’s outstanding 2021 Notes with certain institutional note holders. The Exchanges involved the exchange of an aggregate of $54.65 million principal amount of the Company’s outstanding 2021 Notes for an aggregate of $28.75 million principal amount of newly issued 2024 Notes, $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the issue date. The initial conversion rate for the 2024 Notes is 563.2216 shares of Common Stock for each $1,000 principal amount of 2024 Notes (equivalent to an initial conversion price of approximately $1.7755 per share of the Common Stock), subject to adjustment in certain circumstances, which is based on a 32.5% premium to the closing price of the Common Stock on the NYSE American at the close of trading on August 13, 2021, the exchange date. a. 7.5% Convertible Notes Due 2021 (“2021 Notes”) On December 1, 2016, the Company entered into a note purchase agreement with institutional investors, which held part of the 2018 Notes (the “2016 Purchasers”), relating to the sale by the Company of $22.5 million aggregate principal amount of 7.50% Senior Secured Convertible Notes due 2021 in a private placement pursuant to Section 4(a)(2) under the Securities Act. Concurrently with the consummation of the private placement of the 2021 Notes, the Company entered into a privately negotiated exchange agreement (the “2016 Exchange Agreement”) with certain existing note holders identified therein to exchange $54.1 million aggregate principal amount of the Company’s outstanding 2018 Notes for (i) $40.186 million aggregate principal amount of 2021 Notes, (ii) 2,384,673 shares of Common Stock and (iii) cash, equal to the accrued and unpaid interest on the 2018 Notes and any fractional shares. The closing date of the purchase agreement and the 2016 Exchange Agreement was December 7, 2016. The issuance of the 2021 Notes and shares in the exchange and the private placement were made in reliance on the exemption from the registration requirements of the Securities Act pursuant to Section 4(a)(2) thereof. The net proceeds from the private placement were $19.7 million, after deducting the placement agent’s fees and the Company’s estimated offering expenses. In connection with the completion of the exchange and the private placement, the Company entered into the Indenture, dated as of December 7, 2016, with the guarantors party thereto, The Bank of New York Mellon Trust Company, N.A., as trustee and Wilmington Savings Fund Society, FSB, as collateral agent On July 24, 2017, the Company entered into another note purchase agreement with certain institutional investors relating to the private issuance and sale by the Company of $10.0 million in aggregate principal amount of its 2021 Notes. The 2021 Notes were issued pursuant to the 2016 Indenture. The net proceeds from this purchase agreement were $9.5 million, after deducting the Company’s offering expenses. On November 15, 2021, all the then outstanding 2021 Notes matured and were paid in full, and the 2016 Indenture expired. The following table sets forth total interest expense recognized related to the 2021 Notes: Year Ended December 31, (U.S. Dollars in thousands) 2019 2020 2021 Contractual interest expense $ 4,344 $ 4,344 $ 2,855 Debt discount amortization 2,991 3,470 2,575 Loss from extinguishment 831 Other expenses 1,300 Total $ 7,335 $ 9,114 $ 6,261 b. 7.5% Convertible Notes Due 2024 (“2024 Notes”) The 2024 Notes were issued pursuant to an indenture entered into between the Company, the guarantors party thereto, The Bank of New York Mellon Trust Company, N.A., as trustee and Wilmington Savings Fund Society, FSB, as collateral agent (the “2021 Indenture”). Interest on the Notes will be paid semi-annually at a rate of 7.50% per annum. The Notes will mature three years after the issuance thereof, unless earlier purchased, converted, exchanged or redeemed and are guaranteed by the Company’s subsidiaries. The 2024 Notes are secured by perfected liens on all of the assets of the Company and its subsidiaries. For accounting purposes, as the terms of the 2021 Notes and the 2024 Notes are substantially different, the Exchanges were considered an extinguishment of debt. The Company allocated the fair value of the consideration transferred to the participating note holders between the 2021 Notes and their equity component based on the fair value of the liability component before the extinguishment, and the remainder was allocated to the equity component. As a result, the Company recognized a loss from extinguishment in the statement of operations equal to $0.8 million due to derecognition of the liability component and a reduction of stockholders’ equity of $12.2 million. The Company accounted for the 2024 Notes as a liability (debt) and equity component (conversion option) as the convertible notes may be settled wholly or partly in cash, at the option of the Company, when converted. The equity component with respect to the cash conversion feature net of transaction costs of approximately $12.0 million was recognized in the Company’s additional paid in capital. Transaction costs in the amount of approximately $869,000 were allocated to the liability and equity component. The debt discount and debt issuance costs regarding the issuance of the 2024 Notes are deferred and amortized over the convertible notes period using the effective interest rate. Holders may convert their 2024 Notes at any time. The initial conversion rate for the 2024 Notes is 563.2216 shares of Common Stock for each $1,000 principal amount of 2024 Notes (equivalent to an initial conversion price of approximately $1.7755 per share of the Common Stock). Upon conversion, the Company may settle the 2024 Notes by paying or delivering, as the case may be, cash, shares of Common Stock or a combination thereof, at the Company’s election. To date, there has been no conversion of 2024 Notes. As of December 31, 2021, a total of $28.75 million aggregate principal amount of the 2024 Notes were outstanding. Prior to the maturity date, the Company may redeem in cash: a) b) To date, there has been no redemption of 2024 Notes. The 2024 Notes are guaranteed by the Restricted Subsidiaries (as defined in the 2024 Indenture) and are secured by a first-priority security interest in all of the present and after-acquired assets of the Company and each of the Restricted Subsidiaries (the “Collateral”), including, but not limited to, (i) 100% of the capital stock of the Guarantors (as defined in the 2024 Indenture) and each Restricted Subsidiary of the Company that is held by the Company or any Restricted Subsidiary, (ii) intellectual property, including all copyrights, copyright licenses, patents, patent licenses, software, trademarks, trademark licenses and trade secrets and other proprietary information, including, but not limited to, domain names, (iii) all cash, deposit accounts, securities accounts, commodities accounts and contract rights, (iv) all real property and leased property, subject to applicable minimum thresholds, as set forth in the 2024 Indenture, and (v) all other tangible and intangibles of the Company and the Guarantors. In connection with the grant of such liens, the Company entered into certain agreements with both Wilmington Savings Fund Society, FSB, as collateral agent in the United States, and with Altshuler Shaham Trusts Ltd., as security trustee in Israel. The 2024 Indenture restricts the ability of the Company, the Subsidiaries and any future subsidiaries to make certain investments, including transfers of the Company’s assets that constitute collateral securing the 2024 Notes, in its existing and future foreign subsidiaries, subject to certain exceptions. Upon (i) the occurrence of a fundamental change (as defined in the 2024 Indenture) or (ii) if the Company calls the 2024 Notes for redemption as described below (either event, a “make-whole fundamental change”) and a holder elects to convert its 2024 Notes in connection with such make-whole fundamental change, the Company will, in certain circumstances, increase the conversion rate by a number of additional shares (the “Additional Shares”). In no event will the conversion rate exceed the maximum conversion rate, which is 746.2686 shares per $1,000 principal amount of 2024 Notes, which amount is inclusive of repayment of the principal of the 2024 Notes. If a fundamental change occurs at any time, holders will have the right, at their option, to require the Company to purchase for cash any or all of the 2024 Notes, or any portion of the principal amount thereof, that is equal to $1,000 or an integral multiple of $1,000 in excess thereof, on a date of the Company’s choosing that is not less than 20 calendar days nor more than 35 calendar days after the date of the applicable fundamental change company notice. The price the Company is required to pay for a 2024 Note is equal to 100% of the principal amount of such 2024 Note plus accrued and unpaid interest, if any, to, but excluding, the fundamental change purchase date. Under the terms of the 2024 Indenture, the Company is required to meet certain covenants including the requirement to result in the acceleration of the payment of the notes or in additional interest payments. As of December 31, 2021, the Company was in compliance with all covenants. The Company prepared a valuation of the fair value of the 2024 Notes and 2021 Notes (a Level 3 valuation) as of August 25, 2021. The value was estimated by implementing the binomial model. The liability component was valued based on the Income Approach. The following parameters were used: 2021 Notes 2024 Notes Stock price (USD) 1.34 1.34 Expected term 0.23 3.03 Risk free rate 0.05 % 0.44 % Volatility 78.95 % 91.35 % Yield 7.87 % 7.66 % The following table sets forth total interest expense recognized related to the 2024 Notes: ( U.S. dollars in thousands December 31, 2021 Contractual interest expense $ 767 Amortization of debt issuance costs and debt discount 97 Total $ 864 |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 12 Months Ended |
Dec. 31, 2021 | |
FAIR VALUE MEASUREMENT | |
FAIR VALUE MEASUREMENT | NOTE 11 - FAIR VALUE MEASUREMENT The Company discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value. The fair value of the outstanding $28.75 million 2024 Notes as of December 31, 2021 is approximately $33.3 million based on a level 3 measurement. The Company prepared the valuation of the fair value of the 2024 Notes (a Level 3 valuation) as of December 31, 2021. The value of these notes were estimated by implementing the binomial model. The liability component was valued based on the Income Approach. The following parameters were used: 2024 Notes Stock price (USD) 0.83 Expected term 2.67 Risk free rate 0.90 % Volatility 92.79 % Yield 10.31 % |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2021 | |
TAXES ON INCOME | |
TAXES ON INCOME | NOTE 12 - TAXES ON INCOME a. The Company Protalix BioTherapeutics, Inc. is taxed according to U.S. tax laws. The Company’s income is taxed in the United States at the rate of up to 21%. On December 22, 2017, the Tax Cuts and Jobs Act (the “Act”) was enacted into law. The new legislation represents fundamental and dramatic modifications to the U.S. tax system. The Act contained several key tax provisions that impacted the Company including the reduction of the maximum U.S. federal corporate income tax rate from 35% to 21%, effective January 1, 2018. Other significant changes under the Act included, among others, a one-time repatriation tax on accumulated foreign earnings, a limitation of net operating loss (“NOL”) deduction to 80% of taxable income, and indefinite carryover of post-2017 NOLs. The Act also repealed the corporate alternative minimum tax for tax years beginning after December 31, 2017. Losses generated prior to January 1, 2018 will still be subject to the 20-year carryforward limitation and the alternative minimum tax. Other impacts due to the Act included the repeal of the domestic manufacturing deduction, modification of taxation of controlled foreign corporations, a base erosion anti-abuse tax, modification of interest expense limitation rules, modification of limitation on deductibility of excessive executive compensation, and taxation of global intangible low-taxed income. Modification of interest expense limitation rules under the Act provides generally that for taxable years 2019-2022 interest expense deduction shall be limited to 30% of the EBITDA and for taxable years 2022 onwards to 30% of EBIT. Disallowed interest deduction may be carried forward indefinitely. The Company believes that any potential impact (if applicable) of this limitation will be offset by utilization of available NOLs. U.S. GAAP requires that the impact of tax legislation be recognized in the period in which the law was enacted. The Company believes that all future profits of its subsidiaries will be indefinitely reinvested or that there is no expectation to distribute any taxable dividends from these subsidiaries. The determination of the amount of the unrecognized deferred tax liability related to the undistributed earnings is estimated as an immaterial amount. b. Protalix Ltd. The Company as a “foreign-investment company” measures its results for tax purposes in dollar based on Income Tax Regulations (Bookkeeping Principles of Foreign Invested Companies and of Certain Partnerships and the Determination of Their Taxable Income), 1986. The Israeli Subsidiary is taxed according to Israeli tax laws: 1. Tax rates The income of the Israeli Subsidiary, other than income from “Approved Enterprises,” is taxed in Israel at the regular corporate tax rates. The corporate tax rate was 23% for 2019 and thereafter. Capital gain on a sale of assets is subject to capital gain tax according to the corporate tax rate in effect in the year during which the assets are sold. 2. The Law for the Encouragement of Capital Investments, 1959 (the “Encouragement of Capital Investments Law”) Under the Encouragement of Capital Investments Law, including Amendment No. 60 to the Encouragement of Capital Investments Law as published in April 2005, by virtue of the “Approved Enterprise” or “Benefited Enterprise” status the Israeli Subsidiary is entitled to various tax benefits as follows: a. Reduced tax rates Income derived from the Approved Enterprise during a 10-year period commencing upon the year in which the enterprise first realizes taxable income is tax exempt, provided that the maximum period to which it is restricted by the Encouragement of Capital Investments Law has not elapsed. The Israeli Subsidiary has an “Approved Enterprise” plan since 2004 and “Benefited Enterprise” plan since 2009. The period of benefits in respect of the main enterprise of the Company has not yet commenced. The period during which the Company is entitled to benefits in connection with the Benefited Enterprise expires in 2022. If the Israeli Subsidiary subsequently pays a dividend out of income derived from the “Approved Enterprise” or “Benefited Enterprise” during the tax exemption period, it will be subject to tax on the gross amount distributed (including the company tax on these amounts), at the rate which would have been applicable if such income not been exempted. b. Accelerated depreciation The Israeli Subsidiary is entitled to claim accelerated depreciation, as provided by Israeli law, in the first five years of operation of each asset, in respect of buildings, machinery and equipment used by the Approved Enterprise and the Benefited Enterprise. c. Conditions for entitlement to the benefits The Israeli Subsidiary’s entitlement to the benefits described above is subject to its fulfillment of conditions stipulated by the law, rules and regulations published thereunder, and the instruments of approval for the specific investment in an approved enterprise. Failure by the Israeli Subsidiary to comply with these conditions may result in the cancellation of the benefits, in whole or in part, and the Subsidiary may be required to refund the amount of the benefits with interest. The Israeli Subsidiary received a final implementation approval with respect to its “Approved Enterprise” from the Investment Center. d. Amendment of the Law for the Encouragement of Capital Investments, 1959 In recent years, several amendments have been made to the Encouragement of Capital Investments Law which have enabled new alternative benefit tracks, subject to certain conditions. The Encouragement of Capital Investments Law was amended as part of the Economic Policy Law for the years 2011-2012 (amendment 68 to the Encouragement of Capital Investments Law), which was passed by the Israeli Knesset on December 29, 2010. The amendment sets alternative benefit tracks to those currently in effect under the provisions of the Encouragement of Capital Investments Law. On December 29, 2016, Amendment 73 to the Encouragement of Capital Investments Law was published. This amendment sets new benefit tracks, inter alia, “Preferred Technological Enterprise” and “Special Preferred Technological Enterprise” (the “Capital Investments Law Amendment”). To date, the Company has elected not to have the Capital Investments Law Amendment apply to the Company. c. Tax losses carried forward to future years As of December 31, 2021 and 2020, the Company had aggregate NOL carry-forwards equal to approximately $247.9 million and $231.4 million, respectively, that are available to reduce future taxable income as follows: 1. The Company The Company’s carry-forward NOLs, equal to approximately $36.1 million and $30.9 million as of December 31, 2021 and 2020, respectively, may be restricted under Section 382 of the Internal Revenue Code (“IRC”). IRC Section 382 applies whenever a corporation with NOL experiences an ownership change. As a result of IRC Section 382, the taxable income for any post change year that may be offset by a pre-change NOL may not exceed the general IRC Section 382 limitation, which is the fair market value of the pre-change entity multiplied by the IRC long-term tax exempt rate. Significant judgment is required in determining any valuation allowance recorded against deferred tax assets. In assessing the need for a valuation allowance, the Company considered all available evidence, including past operating results, the most recent projections for taxable income, and prudent and feasible tax planning strategies. The Company reassesses its valuation allowance periodically and if future evidence allows for a partial or full release of the valuation allowance, a tax benefit will be recorded accordingly. 2. Protalix Ltd. At December 31, 2021 and 2020, the Israeli Subsidiary had approximately $211.8 million and $200.5 million, respectively, of carry-forward NOLs that are available to reduce future taxable income with no limited period of use. d. Deferred income taxes: The components of the Company’s net deferred tax assets at December 31, 2020 and 2021 were as follows: December 31, ( U.S. dollars in thousands 2020 2021 In respect of: Research and development expenses $ 9,598 $ 7,217 Other timing differences 40 (1,989) Net operating loss carry forwards 54,122 56,292 Valuation allowance (63,760) (61,520) - - Deferred taxes are computed using the tax rates expected to be in effect when those differences reverse. e. Reconciliation of the theoretical tax expense to actual tax expense The main reconciling item between the statutory tax rate of the Company and the effective rate is the provision for a full valuation allowance in respect of tax benefits from carry forward tax losses due to the uncertainty of the realization of such tax benefits (see above). f. Tax assessments In accordance with the Income Tax Ordinance, as of December 31, 2021, all of Protalix Ltd.’s tax assessments through tax year 2016 are considered final. A summary of open tax years by major jurisdiction is presented below: Jurisdiction: Years: Israel 2017-2021 United States (*) 2017-2021 (*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2021 | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 13 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION Balance sheets: December 31, ( U.S. dollars in thousands 2020 2021 a. Other assets: Institutions $ 771 $ 311 Restricted deposits 436 Prepaid expenses 841 905 Sundry 48 69 $ 2,096 $ 1,285 December 31, ( U.S. dollars in thousands 2020 2021 b. Accounts payable and accruals – other: Payroll and related expenses $ 1,460 $ 1,562 Interest payable 555 767 Provision for vacation 1,526 1,506 Accrued expenses 9,586 11,981 Royalties payable 482 522 Property and equipment suppliers 317 95 $ 13,926 $ 16,433 |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | NOTE 14 - RELATED PARTY TRANSACTIONS Year Ended December 31, ( U.S. dollars in thousands 2019 2020 2021 Compensation (including share-based compensation) to the non-executive directors $ 444 $ 814 $ 475 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 15 - SUBSEQUENT EVENTS a. On February 25, 2022, the Company granted (i) 637,531 shares of restricted Common Stock to its President and Chief Executive Officer and (ii) 121,951 shares of restricted Common Stock to its Sr. Vice President, Chief Financial Officer, both under the Plan. b. On January 12, 2022 and February 2, 2022, the Company collected approximately $1.2 million from expense reimbursements in connection with its collaboration with Chiesi. On March 22, 2022, the Company collected approximately $2.2 million from sales of alfataliglicerase to Fiocruz. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
SIGNIFICANT ACCOUNTING POLICIES | |
General | a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® On August 25, 2021, the Company completed exchanges (the “Exchanges”) of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) with institutional note holders of a substantial majority of the 2021 Notes. The Exchanges involved the exchange of an aggregate of $54.65 million principal amount of the Company’s outstanding 2021 Notes for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the closing date. The initial conversion rate for the 2024 Notes is 563.2216 shares of common stock, par value $0.001 per share (the “Common Stock”), for each $1,000 principal amount of 2024 Notes (equivalent to an initial conversion price of approximately $1.7755 per share of the Common Stock), subject to adjustment in certain circumstances. This initial conversion price represents a premium of approximately 32.5% relative to the closing price of the Common Stock on the NYSE American on August 13, 2021. See also note 10. The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies which are referred to as the BALANCE BRIDGE BRIGHT BRIDGE BRIGHT On February 7, 2022, a Marketing Authorization Application (“MAA”) for PRX-102 was submitted to, and subsequently validated by, the European Medicines Agency (“EMA”). The submission was made after the October 8, 2021 meeting the Company held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the then anticipated MAA submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of the planned MAA submission for PRX-102. On April 28, 2021, the Company, together with its development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), announced that the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (the “FDA”) regarding the biologics license application (“BLA”) for PRX-102 for the treatment of adult patients with Fabry disease. The PRX-102 BLA was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package. In the CRL, the FDA noted that an inspection of the Company’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve a resubmitted BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained in the letter that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to the novel coronavirus disease (“COVID-19”), the FDA reviewed records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that Fabrazyme (agalsidase beta), a therapy used to treat Fabry patients, was recently converted to full approval and is now an “available therapy,” which must be addressed in the context of any potential resubmission of a BLA for PRX-102. The Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The planned data package for the BLA resubmission, given the changed regulatory landscape in the United States, will include the final two-year analyses of the BALANCE In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates: (1) alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, which has successfully completed a phase II efficacy and safety study; the Company’s exclusive worldwide license agreement with SarcoMed USA Inc. with respect to PRX-110 for use in the treatment of any human respiratory disease or condition including, but not limited to, sarcoidosis, pulmonary fibrosis, and other related diseases via inhaled delivery expired during 2021; we are continuing to evaluate potential strategic marketing partnerships and collaboration programs with biotechnology and pharmaceutical companies for this product candidate for various respiratory indications; (2) PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat refractory gout; and (3) PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases. Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of its Common Stock having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the Sales Agreement, the Company terminated the ATM Equity Offering SM the term of the sales agreement with BofA Securities, the Company sold a total of 3,296,123 shares of Common Stock for total gross proceeds of approximately $13.8 million. On February 17, 2021, the Company closed a public offering of its Common Stock, raising gross proceeds of approximately $40.2 million at a price equal to $4.60 per share, before deducting the underwriting discount and estimated expenses of the offering. BofA Securities acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager. On March 18, 2020, the Company completed a private placement of its Common Stock and warrants. In connection with the offering, the Company issued 17,604,423 unregistered shares of Common Stock at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of Common Stock at an exercise price of $2.36 per share. The warrants were exercisable commencing six months following their issuance for a period of five years from the date of issuance. For accounting purposes, the warrants are classified as equity considering the warrants’ terms. The net proceeds generated from the private placement were approximately $41.3 million, after deducting advisory fees and other estimated offering expenses. On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States. Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs, and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment provided in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company received the payment in June 2021. The Company also agreed to negotiate certain manufacturing related matters. Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) in accordance with the exclusive license and supply agreement entered into between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues. On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), for taliglucerase alfa. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil. COVID-19, which was declared by the World Health Organization to be a global pandemic on March 11, 2020, has had numerous adverse effects on the global economy. To date, the Company's clinical trials have not been adversely affected by COVID-19, although certain practices the Company has adopted in its offices and facilities in an effort to promote social distancing have resulted in minor delays in the performance of administrative activities outside of the clinical programs. The Company continues to face uncertainty as to the degree and duration of that impact going forward. The Company does not know the length of time that the pandemic and related disruptions will continue, the impact of governmental regulations or easement of regulations in response to the strengthening or weakening of the pandemic, or the degree of overall potentially permanent changes in consumer behavior that may be caused by the pandemic. The Company believes that its cash and cash equivalents as of December 31, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. |
Basis of presentation | b. Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). |
Use of estimates in the preparation of financial statements | c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. As applicable to these consolidated financial statements, the most significant estimates relate to revenue recognition. The severity, magnitude and duration, as well as the economic consequences, of the COVID-19 pandemic, are uncertain, rapidly changing and difficult to predict. As a result, the accounting estimates and assumptions may change over time in response to COVID-19. |
Functional currency | d. Functional currency The dollar is the currency of the primary economic environment in which the operations of the Company and its Subsidiaries are conducted. The Company’s revenues are derived in dollars. Most of the Company’s expenses and capital expenditures are incurred in dollars, and the major source of the Company’s financing has been provided in dollars. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items (stated below) reflected in the statements of operations, the following exchange rates are used: (i) for transactions – exchange rates at the transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) – historical exchange rates. Currency translation gains and losses are recorded as financial income or expenses, as appropriate. |
Cash equivalents | e. Cash equivalents The Company considers all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents. |
Accounts Receivables | f. Accounts Receivables Accounts receivable have been reduced by an allowance for doubtful accounts. The Company maintains the allowance for estimated losses resulting from the inability of the Company’s customers to make required payments. The allowance represents the current estimate of lifetime expected credit losses over the remaining duration of existing accounts receivable considering current market conditions and supportable forecasts when appropriate. The estimate is a result of the Company’s ongoing evaluation of collectability, customer creditworthiness, historical levels of credit losses, and future expectations. No write-off activity and recoveries for the periods presented were recognized. |
Inventories | g. Inventories Inventories are valued at the lower of cost or net realizable value. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis. Cost of finished products is determined as follows: the value of the raw and packaging materials component is determined primarily using the “moving average” basis; the value of the labor and overhead component is determined on an average basis over the production period. Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions. |
Property and equipment | h. Property and equipment 1. Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2. The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows: Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 Leasehold improvements are amortized by the straight-line method over the shorter of (i) the expected lease term and (ii) the estimated useful life of the improvements. |
Impairment in value of long-lived assets | i. Impairment in value of long-lived assets The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected future cash flows of definite life assets (undiscounted and without interest charges) is less than the carrying amount of such assets, the Company recognizes an impairment loss, and writes down the assets to their estimated fair values. |
Income taxes | j. Income taxes 1. Deferred income taxes Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of the differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. The Company used statutory tax rates of 21% and 23%. See also Note 12. 2. Uncertainty in income taxes Tax benefits recognized in the financial statements are those that the Company’s management deems at least more likely than not to be sustained, based on technical merits. The amount of benefits recorded for these tax benefits is measured as the largest benefit the Company’s management deems more likely than not to be sustained. |
Revenue recognition | k. Revenue Recognition The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer. 1. Revenues from selling products The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery). 2. Revenues from Chiesi Agreements The Company has identified two performance obligations in the Chiesi agreements as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing. The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug. The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation. Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method. 3. Revenue from R&D services Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service. |
Research and development costs | l. Research and development costs Research and development costs are expensed as incurred and consist primarily of personnel, subcontractors and consultants (mainly in connection with clinical trials), facilities, equipment and supplies for research and development activities. Grants received by the Israeli Subsidiary from the National Authority for Technological Innovation (“NATI”) are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company or the Subsidiaries will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. In connection with purchases of assets, amounts assigned to intangible assets to be used in a particular research and development project that have no alternative future use are charged to research and development costs at the purchase date. Costs incurred for performing research and development services are included in research and development expenses. |
Concentration of credit risks and trade receivable | m. Concentration of credit risks and trade receivable Financial instruments that potentially subject the Company to concentration of credit risk consist principally of bank deposits. The Company’s deposits are instruments with highly rated financial institutions, mainly in Israeli banks, and, as a matter of policy, limits the amounts of credit exposure to any one financial institution. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these instruments. The Company’s trade receivables represent amounts to be received from its customers. The Company does not require its customers to post collateral with respect to receivables. As of December 31, 2021, the accounts receivables balance was composed of $2.2 million from Fiocruz and $1.2 million from Chiesi. |
Share-based compensation | n. Share-based compensation The Company accounts for share-based payment awards classified as equity awards, including stock-based option awards and restricted stock units, using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company calculates the fair value of stock-based option awards on the date of grant using the Black-Scholes option pricing model. This option pricing model requires estimates as to the option’s expected term and the price volatility of the underlying stock. The Company measures compensation expense for the based on the market value of the underlying stock at the date of grant The Company elected to recognize compensation cost for awards to employees with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach. Options granted to consultants and other service providers are recognized over the related service period using the straight-line method. The Company elects to account for forfeitures as they occur. |
Net loss per share | o. Net loss per share Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of the Company’s Common Stock outstanding for each period. The calculation of diluted LPS does not include approximately 7,838,120, 22,850,682 and 28,502,017 shares of Common Stock underlying outstanding options, warrants and convertible notes for the fiscal years ended December 31, 2019, 2020 and 2021, respectively, because the effect would be anti-dilutive. |
Convertible notes | p. Convertible notes The outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The 2021 Notes were accounted for partially as liability and equity components of the instrument and partially as a debt host contract with an embedded derivative resulting from the conversion feature. During the year ended December 31, 2017, the embedded derivative was reclassified to additional paid in capital. The 2024 Notes were accounted for as a liability (debt) and equity component (conversion option) as the convertible notes may be settled wholly or partly in cash, at the option of the Company, when converted. Issuance costs regarding the issuance of the 2021 Notes, as well as the debt discount and debt issuance costs from the issuance of the 2024 Notes, were deferred and amortized over the applicable convertible notes period using the effective interest rate. As of December 31, 2021, a total of $28.75 million aggregate principal amount of the 2024 Notes were outstanding. In addition, as of December 31, 2021, none of the 2021 Notes were outstanding. |
Leases | q. Leases The Company adopted ASC 842 on January 1, 2019, using a modified retrospective transition approach, with certain practical expedients, and as a result did not adjust prior periods. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the statement of operations. The Company determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC 842-10-25-2. If any of these five criteria is met, the Company classifies the lease as a finance lease. Otherwise, the Company classifies the lease as an operating lease. The Company does not have any finance leases. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating and finance lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. The Company elected the package of transition practical expedients permitted under the transition guidance within the new standard which, among other things, allows the Company to carryforward the historical lease classification. The lease standard also provides practical expedients for an entity’s ongoing accounting. The Company elected the short-term lease recognition exemption for all leases with a term shorter than 12 months. This means, for those leases, the Company does not recognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate the lease. The Company recognizes lease expenses over the lease term on a straight-line basis. The depreciable life of leasehold improvements is limited by the expected lease term, unless there is a transfer of title or a purchase option for the leased asset reasonably certain of exercise. Additionally, following the adoption of ASC 842 and in subsequent measurements, the Company applies the portfolio approach to account for the operating lease ROU assets and liabilities for certain car leases and incremental borrowing rates. |
Recently issued accounting pronouncements, not yet adopted | r. Recently issued accounting pronouncements, not yet adopted In August 2020, the FASB issued ASU 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the impact of the adoption of this standard on its consolidated financial statements. In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848) - Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” In addition, in January 2021, the FASB issued ASU 2021-01, “Reference Rate Reform (Topic 848) - Scope.” The amendments in these ASUs apply to all entities that have contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. Together, these ASUs provide optional expedients and exceptions for applying generally accepted accounting principles (GAAP) to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The expedients and exceptions provided by the amendments do not apply to contract modifications made and hedging relationships entered into or evaluated after December 31, 2022, except for hedging relationships existing as of December 31, 2022, that an entity has elected certain optional expedients for and that are retained through the end of the hedging relationship. These ASUs were effective upon issuance and may be applied prospectively to contract modifications and hedging relationships entered into or evaluated through December 31, 2022. The adoption of this standard is not expected to have material impact on the Company's consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of Useful Life | Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
PROPERTY AND EQUIPMENT | |
Schedule of Property and Equipment | December 31, ( U.S. dollars in thousands 2020 2021 Laboratory equipment $ 17,422 $ 18,237 Furniture and computer equipment 2,687 2,718 Leasehold improvements 16,659 16,759 $ 36,768 $ 37,714 Less – accumulated depreciation and amortization (31,923) (32,752) $ 4,845 $ 4,962 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
INVENTORIES | |
Schedule of Inventory | December 31, ( U.S. dollars in thousands) 2020 2021 Raw materials $ 3,347 $ 3,166 Work in progress 2,887 3,262 Finished goods 6,848 11,526 Total inventory $ 13,082 $ 17,954 |
OPERATING LEASES (Tables)
OPERATING LEASES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
OPERATING LEASES | |
Schedule of Operating Leases | The following table sets forth data regarding the Company’s operating leases for the years ended December 31, 2019, 2020 and 2021: Year ended December 31, ( U.S. dollars in thousands) 2019 2020 2021 Operating lease costs $ 1,219 $ 1,382 $ 1,632 Cash paid for amounts included in the measurement of lease liabilities 1,329 1,289 1,391 Weighted average remaining lease term (in years) 10.5 9.5 8.9 Weighted average discount rate 12.7 % 12.7 % 12.8 % |
Schedule of Maturity Analysis of Operating Leases | The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of December 31, 2021: ( U.S. dollars in thousands) December 31, 2021 2022 $ 1,207 2023 $ 1,025 2024 $ 872 2025 $ 853 2026 $ 848 2027 and thereafter $ 4,528 Total undiscounted cash flows $ 9,333 Less: imputed interest $ 3,750 Present value of operating lease liabilities $ 5,583 |
REVENUE (Tables)
REVENUE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
REVENUE | |
Schedule of Company's Disaggregation of Revenues | The following table summarizes the Company’s disaggregation of revenues: Year Ended December 31, ( U.S. dollars in thousands) 2019 2020 2021 Pfizer $ 6,722 $ 8,105 $ 10,160 Brazil $ 9,144 $ 8,000 $ 6,400 Chiesi - $ 131 $ 189 Total revenues from selling goods $ 15,866 $ 16,236 $ 16,749 Revenues from license and R&D services $ 38,827 $ 46,662 $ 21,601 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SHARE CAPITAL | |
Schedule of Options and Restricted Stocks Granted | No. of options or Fair value restricted stock Exercise Vesting at grant (U.S. dollars Expiration Year of grant granted price period in thousands) period 2019 160,000 $ 4.69 4 years $ 449 10 years 2019 80,000 $ 2.00 4 years $ 97 10 years 2020 196,995 $ 3.59 4 years $ 482 10 years 2020 760,311 $ 3.66 4 years $ 1,893 10 years 2020 129,771 $ 3.73 4 years $ 329 10 years 2020 694,073 $ n/a 4 years $ 2,492 10 years 2020 122,656 $ 3.59 4 years $ 299 10 years 2021 50,000 $ 1.57 4 years $ 55 10 years |
Summary of Stock Option Activity | Year ended December 31, 2021 Weighted Number average of exercise options price Outstanding at beginning of year 2,087,275 $ 5.66 Changes during the year: Granted 50,000 1.57 Forfeited and expired 318,255 11.00 Outstanding at end of year 1,819,020 $ 4.61 Exercisable at end of year 961,940 $ 5.47 |
Summary of Restricted Stock Activity | Year Ended December 31, 2021 Number of Restricted Stock Outstanding at beginning of year 624,580 Changes during the year: Vested 166,553 Non vested at end of year 458,027 |
Summary of Options Granted to Consultants, Directors, and Other Service Providers | Year ended December 31, 2021 Weighted Number average of exercise options price Outstanding at beginning of year 464,375 $ 3.74 Changes during the year: Expired 24,375 5.60 Outstanding at end of year 440,000 3.63 Exercisable at end of year 192,500 $ 3.63 |
Summary of Share Options Outstanding and Exercisable | December 31, 2021 Options outstanding Options exercisable Number of Weighted Weighted options average average outstanding remaining Number of remaining Exercise at end of contractual options contractual prices year life exercisable* life $1.57 50,000 9.57 3,125 9.57 $2.00 80,000 7.73 45,000 7.73 $3.55 200,000 8.06 87,500 8.06 $3.59 319,651 8.51 112,203 8.50 $3.66 641,718 7.71 280,835 6.74 $3.70 240,000 8.10 105,000 8.10 $3.73 129,771 8.52 40,553 8.52 $4.69 160,000 7.50 100,000 7.50 $5.10 215,030 5.69 181,749 5.50 $5.60 130,000 6.71 105,625 6.71 $17.20 92,850 2.93 92,850 2.93 2,259,020 1,154,440 |
Schedule of Stock-Based Compensation Expense in Statement of Operations | Year ended December 31, (U.S. dollars in thousands) 2019 2020 2021 Cost of goods sold $ 269 Research and development expenses $ 513 $ 1,036 648 Selling, general and administrative expenses 322 2,090 1,458 $ 835 $ 3,126 $ 2,375 |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes 2021 and 2024 | |
Schedule of Fair Value Assumptions | The following parameters were used: 2021 Notes 2024 Notes Stock price (USD) 1.34 1.34 Expected term 0.23 3.03 Risk free rate 0.05 % 0.44 % Volatility 78.95 % 91.35 % Yield 7.87 % 7.66 % |
2021 Notes | |
Schedule of Interest Expense Recognized | The following table sets forth total interest expense recognized related to the 2021 Notes: Year Ended December 31, (U.S. Dollars in thousands) 2019 2020 2021 Contractual interest expense $ 4,344 $ 4,344 $ 2,855 Debt discount amortization 2,991 3,470 2,575 Loss from extinguishment 831 Other expenses 1,300 Total $ 7,335 $ 9,114 $ 6,261 |
2024 Notes | |
Schedule of Fair Value Assumptions | 2024 Notes Stock price (USD) 0.83 Expected term 2.67 Risk free rate 0.90 % Volatility 92.79 % Yield 10.31 % |
Schedule of Interest Expense Recognized | The following table sets forth total interest expense recognized related to the 2024 Notes: ( U.S. dollars in thousands December 31, 2021 Contractual interest expense $ 767 Amortization of debt issuance costs and debt discount 97 Total $ 864 |
FAIR VALUE MEASUREMENT (Tables)
FAIR VALUE MEASUREMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Notes 2021 and 2024 | |
Schedule of Fair Value Assumptions | The following parameters were used: 2021 Notes 2024 Notes Stock price (USD) 1.34 1.34 Expected term 0.23 3.03 Risk free rate 0.05 % 0.44 % Volatility 78.95 % 91.35 % Yield 7.87 % 7.66 % |
2024 Notes | |
Schedule of Fair Value Assumptions | 2024 Notes Stock price (USD) 0.83 Expected term 2.67 Risk free rate 0.90 % Volatility 92.79 % Yield 10.31 % |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
TAXES ON INCOME | |
Schedule of Deferred Tax Assets | The components of the Company’s net deferred tax assets at December 31, 2020 and 2021 were as follows: December 31, ( U.S. dollars in thousands 2020 2021 In respect of: Research and development expenses $ 9,598 $ 7,217 Other timing differences 40 (1,989) Net operating loss carry forwards 54,122 56,292 Valuation allowance (63,760) (61,520) - - |
Schedule of Open Tax Years | Jurisdiction: Years: Israel 2017-2021 United States (*) 2017-2021 (*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
SUPPLEMENTARY FINANCIAL STATE_2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | |
Supplemental Information, Balance Sheets | December 31, ( U.S. dollars in thousands 2020 2021 a. Other assets: Institutions $ 771 $ 311 Restricted deposits 436 Prepaid expenses 841 905 Sundry 48 69 $ 2,096 $ 1,285 December 31, ( U.S. dollars in thousands 2020 2021 b. Accounts payable and accruals – other: Payroll and related expenses $ 1,460 $ 1,562 Interest payable 555 767 Provision for vacation 1,526 1,506 Accrued expenses 9,586 11,981 Royalties payable 482 522 Property and equipment suppliers 317 95 $ 13,926 $ 16,433 |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | |
Schedule of Related Party Transactions | Year Ended December 31, ( U.S. dollars in thousands 2019 2020 2021 Compensation (including share-based compensation) to the non-executive directors $ 444 $ 814 $ 475 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Useful Life) (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Laboratory Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
Furniture [Member] | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 10 years |
Furniture [Member] | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 15 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Additional Information) (Details) | Jul. 02, 2021USD ($) | Jun. 07, 2021shares | Feb. 17, 2021USD ($)$ / sharesshares | Mar. 18, 2020USD ($)$ / sharesshares | Jul. 23, 2018USD ($) | Oct. 19, 2017USD ($) | Oct. 31, 2015 | Dec. 31, 2021USD ($)item$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019shares | Aug. 25, 2021$ / shares | Dec. 01, 2016 |
Significant Accounting Policies [Line Items] | ||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||||
Shares Issued, Price Per Share | $ / shares | $ 4.60 | |||||||||||
Share price | $ / shares | $ 4.60 | |||||||||||
Gross proceeds | $ 40,200,000 | $ 8,575,000 | $ 4,867,000 | |||||||||
Number of shares issued (in shares) | shares | 8,749,999 | |||||||||||
Proceeds from private placement | $ 41,300,000 | |||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 28,502,017 | 22,850,682 | 7,838,120 | |||||||||
Operating Lease, Right-of-Use Asset | $ 4,960,000 | $ 5,567,000 | ||||||||||
Operating Lease, Liability | 5,583,000 | |||||||||||
Accounts receivable - Trade | 3,442,000 | $ 2,000,000 | ||||||||||
Fiocruz [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Accounts receivable - Trade | 2,200,000 | |||||||||||
Chiesi [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Accounts receivable - Trade | $ 1,200,000 | |||||||||||
2021 Notes | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Interest rate (as a percent) | 7.50% | 7.50% | 7.50% | |||||||||
Aggregate principal amount | $ 0 | |||||||||||
2024 Notes | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | |||||||||||
Interest rate (as a percent) | 7.50% | 7.50% | ||||||||||
Aggregate principal amount | $ 28,750,000 | |||||||||||
Minimum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Tax Rate Assumption Related To Deferred Tax Difference Reversal | 23.00% | |||||||||||
Maximum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Tax Rate Assumption Related To Deferred Tax Difference Reversal | 21.00% | |||||||||||
Amended Pfizer Agreement | Protalix Bio Therapeutics Incorporation [Member] | Brazil [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Collaborative Arrangement Revenues Expenses Sharing Percentage | 100.00% | |||||||||||
Chiesi US Agreement and Chiesi Ex US Agreement [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Non-refundable Payment Receivable | $ 25,000,000 | $ 50,000,000 | ||||||||||
Revenue, Performance Obligation, Number | item | 2 | |||||||||||
Chiesi US Agreement [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Non-refundable Payment Receivable | $ 25,000,000 | 25,000,000 | ||||||||||
Additional Amounts Payable To Cover Development Costs | $ 20,000,000 | |||||||||||
Chiesi US Agreement [Member] | Minimum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Payment On Net Sales Percentage | 15.00% | 15.00% | ||||||||||
Chiesi US Agreement [Member] | Maximum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Payment On Net Sales Percentage | 40.00% | 40.00% | ||||||||||
Chiesi Ex US Agreement [Member] | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Non-refundable Payment Receivable | 25,000,000 | |||||||||||
Additional Amounts Payable To Cover Development Costs | $ 25,000,000 | |||||||||||
Chiesi Ex US Agreement [Member] | Minimum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Payment On Net Sales Percentage | 15.00% | 15.00% | ||||||||||
Chiesi Ex US Agreement [Member] | Maximum | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Payment On Net Sales Percentage | 35.00% | 35.00% | ||||||||||
ATM Shares | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Sale Of Stock Maximum Offering Price | $ 20,000,000 | |||||||||||
Number of shares issued (in shares) | shares | 0 | |||||||||||
Private Placement | ||||||||||||
Significant Accounting Policies [Line Items] | ||||||||||||
Share price | $ / shares | $ 2.485 | |||||||||||
Number of shares issued (in shares) | shares | 173,816 | 17,604,423 | 200,000 | |||||||||
Purchase price (in dollars per share) | $ / shares | $ 2.485 | |||||||||||
Number of warrants issued (in shares) | shares | 17,604,423 | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.36 | |||||||||||
Exercise of warrants, commencement period | 6 months | |||||||||||
Term of warrants | 5 years | |||||||||||
Proceeds from private placement | $ 43,700,000 |
COMMERCIALIZATION AGREEMENTS (D
COMMERCIALIZATION AGREEMENTS (Details) - USD ($) | May 13, 2021 | Mar. 29, 2021 | Mar. 16, 2020 | Sep. 30, 2020 | Mar. 31, 2020 | Jul. 23, 2018 | Oct. 19, 2017 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 30, 2021 | Oct. 31, 2015 | Nov. 30, 2009 |
Promissory note | $ 4,086,000 | ||||||||||||
Payment for promissory note | $ 4,086,000 | 215,000 | |||||||||||
Brazil [Member] | |||||||||||||
Percentage Of Adult Gaucher Patients Treated With alfataliglicerase | 25.00% | ||||||||||||
Pfizer [Member] | |||||||||||||
Collaborative Arrangement Profit Share Percentage | 40.00% | ||||||||||||
Debt Instrument, Face Amount | $ 4,300,000 | ||||||||||||
Promissory note | $ 4,300,000 | ||||||||||||
Payment on notes payable | $ 430,000 | ||||||||||||
Payment for promissory note | $ 4,000,000 | ||||||||||||
Chiesi US Agreement and Chiesi Ex US Agreement [Member] | |||||||||||||
Non-refundable Payment Receivable | $ 25,000,000 | $ 50,000,000 | |||||||||||
Agreement Amendment Payment Receivable | 10,000,000 | $ 10,000,000 | |||||||||||
Payments in consideration for development services performed | 45,000,000 | ||||||||||||
Payments in connection with performance of additional studies | 33,600,000 | ||||||||||||
Recognized revenues related to non-refundable payment | 600,000 | 3,500,000 | $ 4,500,000 | ||||||||||
Future milestone payment | $ 10,000,000 | $ 10,000,000 | |||||||||||
Chiesi US Agreement [Member] | |||||||||||||
Non-refundable Payment Receivable | $ 25,000,000 | 25,000,000 | |||||||||||
Additional Amounts Payable To Cover Development Costs | 20,000,000 | ||||||||||||
Maximum Entitlement Of Development Costs To Cover Per Year | 7,500,000 | ||||||||||||
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones | $ 760,000,000 | $ 735,000,000 | |||||||||||
Chiesi US Agreement [Member] | Maximum | |||||||||||||
Payment On Net Sales Percentage | 40.00% | 40.00% | |||||||||||
Chiesi US Agreement [Member] | Minimum | |||||||||||||
Payment On Net Sales Percentage | 15.00% | 15.00% | |||||||||||
Chiesi Ex US Agreement [Member] | |||||||||||||
Non-refundable Payment Receivable | 25,000,000 | ||||||||||||
Additional Amounts Payable To Cover Development Costs | 25,000,000 | ||||||||||||
Maximum Entitlement Of Development Costs To Cover Per Year | 10,000,000 | ||||||||||||
Agreement Amendment Payment Receivable | $ 10,000,000 | ||||||||||||
Change In Amount Receivable For Achievement Of Regulatory And Commercial Milestones | $ 25,000,000 | ||||||||||||
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones | $ 320,000,000 | ||||||||||||
Chiesi Ex US Agreement [Member] | Maximum | |||||||||||||
Payment On Net Sales Percentage | 35.00% | 35.00% | |||||||||||
Chiesi Ex US Agreement [Member] | Minimum | |||||||||||||
Payment On Net Sales Percentage | 15.00% | 15.00% | |||||||||||
Kirin Holdings Company, Limited [Member] | |||||||||||||
Recognized revenues related to non-refundable payment | $ 1,000,000 | ||||||||||||
Non-Refundable Future Service Payment | $ 1,000,000 |
PROPERTY AND EQUIPMENT (Schedul
PROPERTY AND EQUIPMENT (Schedule of Property and Equipment) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 37,714 | $ 36,768 |
Less - accumulated depreciation and amortization | (32,752) | (31,923) |
Property, Plant and Equipment, Net, Total | 4,962 | 4,845 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 18,237 | 17,422 |
Furniture And Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 2,718 | 2,687 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 16,759 | $ 16,659 |
PROPERTY AND EQUIPMENT (Additio
PROPERTY AND EQUIPMENT (Additional Information) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
PROPERTY AND EQUIPMENT | |||
Depreciation | $ 1,118 | $ 1,302 | $ 1,617 |
INVENTORIES (Schedule of Invent
INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
INVENTORIES | ||
Raw materials | $ 3,166 | $ 3,347 |
Work in progress | 3,262 | 2,887 |
Finished goods | 11,526 | 6,848 |
Total inventory | $ 17,954 | $ 13,082 |
INVENTORIES (Additional Informa
INVENTORIES (Additional Information) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
INVENTORIES | |||
Inventory Write-down | $ 0.4 | $ 0.3 | $ 0.5 |
LIABILITY FOR EMPLOYEE RIGHTS_2
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($)employee | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Employee severance obligation payments | $ 108,000 | $ 121,000 | $ 143,000 |
Severance expense | 990,000 | 885,000 | 784,000 |
Contributions | 857,000 | 747,000 | 642,000 |
Gain for the period | $ 100,000 | $ 28,000 | $ 58,000 |
Number of benefit eligible employees | employee | 4 | ||
Benefits Payable During Next Five Years | $ 72,000 | ||
Contribution to Insurance Companies [Member] | |||
Defined Benefit Plan, Expected Future Employer Contributions, Next Fiscal Year | 984,000 | ||
Contribution to Defined Contribution Plans [Member] | |||
Defined Benefit Plan, Expected Future Employer Contributions, Next Fiscal Year | $ 868,000 |
COMMITMENTS (Details)
COMMITMENTS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Arrangement Other than Collaborative [Member] | |||
Commitments And Contingencies [Line Items] | |||
Subcontracting commitment amount | $ 900,000 | ||
Royalty Agreement Terms [Member] | Office of the Israeli Innovation Authority [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalty expense included in cost of revenue | $ 1,200,000 | $ 911,000 | $ 1,400,000 |
Minimum | Royalty Agreement Terms [Member] | Office of the Israeli Innovation Authority [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalties based on sale of products developed from funded projects, percentage | 3.00% | ||
Maximum | Royalty Agreement Terms [Member] | Office of the Israeli Innovation Authority [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalties based on sale of products developed from funded projects, percentage | 6.00% | ||
Accrued royalties | $ 38,600,000 | $ 39,800,000 | |
Percentage of Royalties to Grant Received | 100.00% | 100.00% | 100.00% |
Maximum | Royalty Agreement Terms [Member] | Outside of Israel [Member] | |||
Commitments And Contingencies [Line Items] | |||
Percentage of Royalties to Grant Received | 300.00% |
OPERATING LEASES (Schedule of O
OPERATING LEASES (Schedule of Operating Leases) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
OPERATING LEASES | |||
Operating lease costs | $ 1,632 | $ 1,382 | $ 1,219 |
Cash paid for amounts included in the measurement of lease liabilities | $ 1,391 | $ 1,289 | $ 1,329 |
Weighted average remaining lease term (in years) | 8 years 10 months 24 days | 9 years 6 months | 10 years 6 months |
Weighted average discount rate | 12.80% | 12.70% | 12.70% |
OPERATING LEASES (Schedule of M
OPERATING LEASES (Schedule of Maturity Analysis of Operating Leases) (Details) $ in Thousands | Dec. 31, 2021USD ($) |
OPERATING LEASES | |
2022 | $ 1,207 |
2023 | 1,025 |
2024 | 872 |
2025 | 853 |
2026 | 848 |
2027 and thereafter | 4,528 |
Total undiscounted cash flows | 9,333 |
Less: imputed interest | 3,750 |
Present value of operating lease liabilities | $ 5,583 |
OPERATING LEASES (Additional In
OPERATING LEASES (Additional Information) (Details) | 12 Months Ended |
Dec. 31, 2021USD ($)item | |
Disclosure of Leases Operating [Line Items] | |
Lessee, Operating Lease, Option to Extend | true |
Lessee Operating Lease, Number Of Renewal Term Extensions | item | 1 |
Operating lease, term of agreement | 5 years |
Security Deposit | $ | $ 496,000 |
Vehicles [Member] | |
Disclosure of Leases Operating [Line Items] | |
Operating lease, term of agreement | 3 years |
Minimum | |
Disclosure of Leases Operating [Line Items] | |
Percentage of Change in Operating Lease Monthly Rental Payments | 7.50% |
Maximum | |
Disclosure of Leases Operating [Line Items] | |
Percentage of Change in Operating Lease Monthly Rental Payments | 10.00% |
REVENUE (Details)
REVENUE (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues | $ 38,350 | $ 62,898 | $ 54,693 |
Goods [Member] | |||
Revenues | 16,749 | 16,236 | 15,866 |
Goods [Member] | Pfizer [Member] | |||
Revenues | 10,160 | 8,105 | 6,722 |
Goods [Member] | Brazil [Member] | |||
Revenues | 6,400 | 8,000 | 9,144 |
Goods [Member] | Chiesi [Member] | |||
Revenues | 189 | 131 | |
License and R&D Services [Member] | |||
Revenues | $ 21,601 | $ 46,662 | $ 38,827 |
SHARE CAPITAL (Schedule of Opti
SHARE CAPITAL (Schedule of Options and Restricted Stocks Granted) (Details) - Option to purchase shares of common stock - USD ($) | Jul. 25, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 50,000 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 55,000 | |||
Exercise Price 4.69 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 160,000 | |||
Exercise price | $ 4.69 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 449,000 | |||
Expiration period | 10 years | |||
Exercise Price 2.00 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 80,000 | |||
Exercise price | $ 2 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 97,000 | |||
Expiration period | 10 years | |||
Exercise Price 3.59 One | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 196,995 | |||
Exercise price | $ 3.59 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 482,000 | |||
Expiration period | 10 years | |||
Exercise Price 3.66 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 760,311 | |||
Exercise price | $ 3.66 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 1,893,000 | |||
Expiration period | 10 years | |||
Exercise Price 3.73 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 129,771 | |||
Exercise price | $ 3.73 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 329,000 | |||
Expiration period | 10 years | |||
No Exercise Price | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 694,073 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 2,492,000 | |||
Expiration period | 10 years | |||
Exercise Price 3.59 Two | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 122,656 | |||
Exercise price | $ 3.59 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 299,000 | |||
Expiration period | 10 years | |||
Exercise Price 1.57 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted | 50,000 | |||
Exercise price | $ 1.57 | |||
Vesting period | 4 years | |||
Fair value at grant | $ 55,000 | |||
Expiration period | 10 years |
SHARE CAPITAL (Summary of Stock
SHARE CAPITAL (Summary of Stock Option Activity) (Details) - Option to purchase shares of common stock - $ / shares | Jul. 25, 2021 | Dec. 31, 2021 |
Number of options | ||
Granted (in shares) | 50,000 | |
Weighted average exercise price | ||
Exercisable at end of year | $ 1.57 | |
Employee | ||
Number of options | ||
Outstanding at beginning of year | 2,087,275 | |
Granted (in shares) | 50,000 | |
Forfeited and Expired | 318,255 | |
Outstanding at end of year | 1,819,020 | |
Exercisable at end of year | 961,940 | |
Weighted average exercise price | ||
Outstanding at beginning of year | $ 5.66 | |
Granted | 1.57 | |
Forfeited and Expired | 11 | |
Outstanding at end of year | 4.61 | |
Exercisable at end of year | $ 5.47 |
SHARE CAPITAL (Summary of Restr
SHARE CAPITAL (Summary of Restricted Stock Activity) (Details) - Employee - Restricted Stock | 12 Months Ended |
Dec. 31, 2021shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of year | 624,580 |
Vested | 166,553 |
Non vested at end of year | 458,027 |
SHARE CAPITAL (Summary of Optio
SHARE CAPITAL (Summary of Options Granted to Consultants, Directors, and Other Service Providers) (Details) - Option to purchase shares of common stock - $ / shares | Jul. 25, 2021 | Dec. 31, 2021 |
Number of options or restricted stock | ||
Granted (in shares) | 50,000 | |
Weighted average exercise price | ||
Exercisable at end of year | $ 1.57 | |
Options granted to consultants, directors and other service providers | ||
Number of options or restricted stock | ||
Outstanding at beginning of year | 464,375 | |
Expired | 24,375 | |
Outstanding at end of year | 440,000 | |
Exercisable at end of year | 192,500 | |
Weighted average exercise price | ||
Outstanding at beginning of year | $ 3.74 | |
Expired | 5.60 | |
Outstanding at end of year | 3.63 | |
Exercisable at end of year | $ 3.63 |
SHARE CAPITAL (Summary of Share
SHARE CAPITAL (Summary of Share Options Outstanding and Exercisable) (Details) - Option to purchase shares of common stock | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of options outstanding at end of year | 2,259,020 |
Number of options exercisable | 1,154,440 |
Exercise Price 1.57 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 1.57 |
Number of options outstanding at end of year | 50,000 |
Weighted average remaining contractual life | 9 years 6 months 25 days |
Number of options exercisable | 3,125 |
Weighted average remaining contractual life | 9 years 6 months 25 days |
Exercise Price 2.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 2 |
Number of options outstanding at end of year | 80,000 |
Weighted average remaining contractual life | 7 years 8 months 23 days |
Number of options exercisable | 45,000 |
Weighted average remaining contractual life | 7 years 8 months 23 days |
Exercise Price 3.55 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.55 |
Number of options outstanding at end of year | 200,000 |
Weighted average remaining contractual life | 8 years 21 days |
Number of options exercisable | 87,500 |
Weighted average remaining contractual life | 8 years 21 days |
Exercise Price 3.59 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.59 |
Number of options outstanding at end of year | 319,651 |
Weighted average remaining contractual life | 8 years 6 months 3 days |
Number of options exercisable | 112,203 |
Weighted average remaining contractual life | 8 years 6 months |
Exercise Price 3.66 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.66 |
Number of options outstanding at end of year | 641,718 |
Weighted average remaining contractual life | 7 years 8 months 15 days |
Number of options exercisable | 280,835 |
Weighted average remaining contractual life | 6 years 8 months 26 days |
Exercise Price 3.70 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.70 |
Number of options outstanding at end of year | 240,000 |
Weighted average remaining contractual life | 8 years 1 month 6 days |
Number of options exercisable | 105,000 |
Weighted average remaining contractual life | 8 years 1 month 6 days |
Exercise Price 3.73 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.73 |
Number of options outstanding at end of year | 129,771 |
Weighted average remaining contractual life | 8 years 6 months 7 days |
Number of options exercisable | 40,553 |
Weighted average remaining contractual life | 8 years 6 months 7 days |
Exercise Price 4.69 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 4.69 |
Number of options outstanding at end of year | 160,000 |
Weighted average remaining contractual life | 7 years 6 months |
Number of options exercisable | 100,000 |
Weighted average remaining contractual life | 7 years 6 months |
Exercise Price 5.10 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 5.10 |
Number of options outstanding at end of year | 215,030 |
Weighted average remaining contractual life | 5 years 8 months 8 days |
Number of options exercisable | 181,749 |
Weighted average remaining contractual life | 5 years 6 months |
Exercise Price 5.60 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 5.60 |
Number of options outstanding at end of year | 130,000 |
Weighted average remaining contractual life | 6 years 8 months 15 days |
Number of options exercisable | 105,625 |
Weighted average remaining contractual life | 6 years 8 months 15 days |
Exercise Price 17.20 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 17.20 |
Number of options outstanding at end of year | 92,850 |
Weighted average remaining contractual life | 2 years 11 months 4 days |
Number of options exercisable | 92,850 |
Weighted average remaining contractual life | 2 years 11 months 4 days |
SHARE CAPITAL (Schedule of Stoc
SHARE CAPITAL (Schedule of Stock-Based Compensation Expense in Statement of Operations) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | $ 2,375 | $ 3,126 | $ 835 |
Cost of goods sold | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | 269 | ||
Research and development expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | 648 | 1,036 | 513 |
Selling, general and administrative expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Allocated Share-based Compensation Expense | $ 1,458 | $ 2,090 | $ 322 |
SHARE CAPITAL (Additional infor
SHARE CAPITAL (Additional information) (Details) | Jul. 25, 2021USD ($)item$ / sharesshares | Jul. 02, 2021USD ($)shares | Jun. 07, 2021shares | Feb. 17, 2021USD ($)$ / sharesshares | Sep. 22, 2020shares | Aug. 11, 2020USD ($)item$ / sharesshares | Jul. 05, 2020USD ($)item$ / sharesshares | Jun. 07, 2020USD ($)item$ / sharesshares | Mar. 18, 2020USD ($)$ / sharesshares | Feb. 03, 2020USD ($)item$ / sharesshares | Jan. 20, 2020USD ($)itemdirector$ / sharesshares | Dec. 09, 2019 | Dec. 07, 2016shares | Sep. 30, 2019USD ($)item$ / sharesshares | Jun. 30, 2019USD ($)item$ / sharesshares | Dec. 31, 2021USD ($)Voteshares | Dec. 31, 2020USD ($)shares | Dec. 31, 2021USD ($)Voteshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Common Stock, Number Of Voting Rights | Vote | 1 | 1 | ||||||||||||||||
Reverse stock split ratio | 0.1 | |||||||||||||||||
Shares of Common Stock remain available for grant under the plan | 1,786,256 | 1,786,256 | ||||||||||||||||
Unrecognized compensation cost | $ | $ 1,700,000 | $ 1,700,000 | ||||||||||||||||
Unrecognized weighted average period | 10 months 24 days | |||||||||||||||||
Exercised | 0 | |||||||||||||||||
Converted instrument, shares issued | 2,384,673 | |||||||||||||||||
Debt conversion converted instrument amount, cash | $ | $ 30,036,000 | |||||||||||||||||
Number of shares issued (in shares) | 8,749,999 | |||||||||||||||||
Share Price | $ / shares | $ 4.60 | |||||||||||||||||
Proceeds from private placement | $ | $ 41,300,000 | |||||||||||||||||
Proceeds from Warrant Exercises | $ | $ 472,000 | |||||||||||||||||
Gross proceeds | $ | $ 40,200,000 | $ 8,575,000 | $ 4,867,000 | |||||||||||||||
2006 Employee Stock Incentive Plan | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares authorized for issuance under share-based payment arrangement | 5,725,171 | 5,725,171 | ||||||||||||||||
Private Placement | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares issued (in shares) | 173,816 | 17,604,423 | 200,000 | |||||||||||||||
Share Price | $ / shares | $ 2.485 | |||||||||||||||||
Purchase price (in dollars per share) | $ / shares | $ 2.485 | |||||||||||||||||
Proceeds from private placement | $ | $ 43,700,000 | |||||||||||||||||
Number of shares per warrant issued | 2,816,901 | 1 | ||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.36 | |||||||||||||||||
Proceeds from Warrant Exercises | $ | $ 472,000 | |||||||||||||||||
ATM Shares | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares issued (in shares) | 0 | |||||||||||||||||
Sale of stock, maximum offering price | $ | $ 20,000,000 | |||||||||||||||||
ATM Shares | Maximum | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Commission (as a percent) | 3.00% | |||||||||||||||||
BofA Securities | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares issued (in shares) | 3,296,123 | 1,867,552 | ||||||||||||||||
Gross proceeds | $ | $ 13,800,000 | $ 8,800,000 | ||||||||||||||||
Over-Allotment Option | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number of shares issued (in shares) | 1,141,304 | |||||||||||||||||
Option to purchase shares of common stock | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 1.57 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 50,000 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 55,000 | |||||||||||||||||
Share price | $ / shares | $ 1.57 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 84.30% | |||||||||||||||||
Risk Free Interest Rate | 0.88% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Sr. Vice President And Chief Development Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.59 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 196,995 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 500,000 | |||||||||||||||||
Share price | $ / shares | $ 3.59 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 80.43% | |||||||||||||||||
Risk Free Interest Rate | 0.59% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Senior Vice President, Operations | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.59 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 122,656 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 300,000 | |||||||||||||||||
Share price | $ / shares | $ 3.59 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 80.51% | |||||||||||||||||
Risk Free Interest Rate | 0.365% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Vice President Research And Development | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.73 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 129,771 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 329,000 | |||||||||||||||||
Share price | $ / shares | $ 3.73 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 80.60% | |||||||||||||||||
Risk Free Interest Rate | 0.395% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Chief Executive Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 4.69 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 160,000 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 449,000 | |||||||||||||||||
Share price | $ / shares | $ 4.69 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 65.30% | |||||||||||||||||
Risk Free Interest Rate | 1.80% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Chief Financial Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 2 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 80,000 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 97,000 | |||||||||||||||||
Share price | $ / shares | $ 2 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 66.48% | |||||||||||||||||
Risk Free Interest Rate | 1.695% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Certain Employees | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.66 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 760,311 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 1,900,000 | |||||||||||||||||
Share price | $ / shares | $ 3.66 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 80.49% | |||||||||||||||||
Risk Free Interest Rate | 0.45% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Chairman, Board of Directors | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.70 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 240,000 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 593,000 | |||||||||||||||||
Share price | $ / shares | $ 3.70 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 76.91% | |||||||||||||||||
Risk Free Interest Rate | 1.40% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Option to purchase shares of common stock | Director | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Number Of Directors | director | 5 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||||||||||
Exercise Price (in dollars per share) | $ / shares | $ 3.55 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 200,000 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 475,000 | |||||||||||||||||
Share price | $ / shares | $ 3.55 | |||||||||||||||||
Dividend Yield | 0.00% | |||||||||||||||||
Expected Volatility Rate | 76.62% | |||||||||||||||||
Risk Free Interest Rate | 1.685% | |||||||||||||||||
Expected Term | 6 years | |||||||||||||||||
Restricted Stock Units | Chief Financial Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Aggregate value of Restricted Stock Units that will be granted, contingent upon certain conditions | $ | $ 100,000 | |||||||||||||||||
Restricted Stock | President and Chief Executive Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 447,927 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 1,600,000 | |||||||||||||||||
Restricted Stock | Senior Vice President And Chief Financial Officer | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 246,146 | |||||||||||||||||
Number of shares vested | 27,855 | |||||||||||||||||
Number of non-vested shares | 218,291 | |||||||||||||||||
Vesting period | 4 years | |||||||||||||||||
Number of equal quarterly increments | item | 16 | |||||||||||||||||
Fair value at grant | $ | $ 900,000 |
CONVERTIBLE NOTES (Schedule of
CONVERTIBLE NOTES (Schedule of Fair Value Assumptions) (Details) - Level 3 | Dec. 31, 2021$ / shares | Aug. 25, 2021 |
2021 Notes | Share Price. | ||
Debt Instrument, Measurement Input | 1.34 | |
2021 Notes | Expected term | ||
Debt Instrument, Measurement Input | 0.23 | |
2021 Notes | Risk free rate | ||
Debt Instrument, Measurement Input | 0.05 | |
2021 Notes | Volatility | ||
Debt Instrument, Measurement Input | 78.95 | |
2021 Notes | Yield | ||
Debt Instrument, Measurement Input | 7.87 | |
2024 Notes | Share Price. | ||
Debt Instrument, Measurement Input | 0.83 | 1.34 |
2024 Notes | Expected term | ||
Debt Instrument, Measurement Input | 2.67 | 3.03 |
2024 Notes | Risk free rate | ||
Debt Instrument, Measurement Input | 0.90 | 0.44 |
2024 Notes | Volatility | ||
Debt Instrument, Measurement Input | 92.79 | 91.35 |
2024 Notes | Yield | ||
Debt Instrument, Measurement Input | 10.31 | 7.66 |
CONVERTIBLE NOTES (Schedule o_2
CONVERTIBLE NOTES (Schedule of Interest Expense Recognized) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Loss on extinguishment of convertible notes | $ 831 | ||
Amortization of debt issuance costs and debt discount | 2,673 | $ 3,470 | $ 2,991 |
2021 Notes | |||
Contractual interest expense | 2,855 | 4,344 | 4,344 |
Debt discount amortization | 2,575 | 3,470 | 2,991 |
Loss on extinguishment of convertible notes | 831 | ||
Other expenses | 1,300 | ||
Total | 6,261 | $ 9,114 | $ 7,335 |
2024 Notes | |||
Contractual interest expense | 767 | ||
Amortization of debt issuance costs and debt discount | 97 | ||
Total | $ 864 |
CONVERTIBLE NOTES (Additional I
CONVERTIBLE NOTES (Additional Information) (Details) | Aug. 25, 2021USD ($)$ / sharesshares | Dec. 07, 2016USD ($)shares | Dec. 01, 2016USD ($) | Jul. 24, 2017USD ($) | Dec. 31, 2021USD ($)Dshares |
Net payment for convertible notes | $ 30,036,000 | ||||
Net proceeds from issuance of convertible notes | $ 9,500,000 | ||||
Loss on extinguishment of convertible notes | (831,000) | ||||
Reacquisition of equity component of convertible notes | 12,019,000 | ||||
Equity component of convertible notes, net of transaction costs | $ 12,027,000 | ||||
Converted instrument, shares issued | shares | 2,384,673 | ||||
2021 Notes | |||||
Face amount | $ 22,500,000 | $ 10,000,000 | |||
Debt Instrument Carrying Amount | $ 54,650,000 | ||||
Net proceeds from issuance of convertible notes | $ 19,700,000 | ||||
Interest rate | 7.50% | 7.50% | 7.50% | ||
Loss on extinguishment of convertible notes | $ (831,000) | ||||
Reacquisition of equity component of convertible notes | 12,200,000 | ||||
Aggregate principal amount | $ 0 | ||||
2024 Notes | |||||
Face amount | $ 28,750,000 | ||||
Net payment for convertible notes | 25,900,000 | ||||
Convertible notes exchange in cash, accrued and unpaid interest | 1,100,000 | ||||
Base value for conversion rate | $ 1,000 | ||||
Number of shares for basis conversion | shares | 563.2216 | ||||
Conversion price per share | $ / shares | $ 1.7755 | ||||
Percentage of Premium to Closing Price of Stock | 32.50% | ||||
Interest rate | 7.50% | 7.50% | |||
Mature term | 3 years | ||||
Reacquisition of equity component of convertible notes | $ 12,000,000 | ||||
Transactions costs in connection with the exchange of convertible notes | 869,000 | ||||
Minimum cash balance required | $ 7,500,000 | ||||
Maximum price per share of the conversion feature | shares | 746.2686 | ||||
Aggregate principal amount | $ 28,750,000 | ||||
Redemption, description | Prior to the maturity date, the Company may redeem in cash | ||||
Threshold trading days | D | 20 | ||||
Threshold consecutive trading days | D | 30 | ||||
Threshold Percentage Of Conversion Price | 130.00% | ||||
Aggregate percentage of principle amount | 15.00% | ||||
Amount of redemption of debt | $ 0 | ||||
Percentage of outstanding capital stock | 100.00% | ||||
Denomination of the principal amount of debt | $ 1,000 | ||||
Redemption price, percentage | 100.00% | ||||
2024 Notes | Minimum | |||||
Number of calendar days after the date of applicable fundamental change purchase date | D | 20 | ||||
2024 Notes | Maximum | |||||
Number of calendar days after the date of applicable fundamental change purchase date | D | 35 | ||||
4.5% Convertible Notes [Member] | |||||
Debt Instrument Carrying Amount | $ 54,100,000 | ||||
Convertible Notes Due Two Thousand Twenty One [Member] | |||||
Face amount | $ 40,186,000 |
FAIR VALUE MEASUREMENT (Schedul
FAIR VALUE MEASUREMENT (Schedule of Fair Value Assumptions) (Details) - 2024 Notes - Level 3 | Dec. 31, 2021$ / shares | Aug. 25, 2021 |
Share Price. | ||
Debt Instrument, Measurement Input | 0.83 | 1.34 |
Expected term | ||
Debt Instrument, Measurement Input | 2.67 | 3.03 |
Risk free rate | ||
Debt Instrument, Measurement Input | 0.90 | 0.44 |
Volatility | ||
Debt Instrument, Measurement Input | 92.79 | 91.35 |
Yield | ||
Debt Instrument, Measurement Input | 10.31 | 7.66 |
FAIR VALUE MEASUREMENT (Additio
FAIR VALUE MEASUREMENT (Additional Information) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Aug. 25, 2021 |
2021 Notes | ||
Debt Instrument Carrying Amount | $ 54,650 | |
Level 3 | 2024 Notes | ||
Debt Instrument Carrying Amount | $ 28,750 | |
Debt Instrument Fair Value | $ 33,300 |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
In respect of: | ||
Research and development expenses | $ 7,217 | $ 9,598 |
Other timing differences | (1,989) | 40 |
Net operating loss carry forwards | 56,292 | 54,122 |
Valuation allowance | (61,520) | (63,760) |
Total net deferred tax assets | $ 0 | $ 0 |
TAXES ON INCOME (Schedule of Op
TAXES ON INCOME (Schedule of Open Tax Years) (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Israel | Minimum | |
Income Tax Contingency [Line Items] | |
Open tax year | 2017 |
Israel | Maximum | |
Income Tax Contingency [Line Items] | |
Open tax year | 2021 |
United States | Minimum | |
Income Tax Contingency [Line Items] | |
Open tax year | 2017 |
United States | Maximum | |
Income Tax Contingency [Line Items] | |
Open tax year | 2021 |
TAXES ON INCOME (Additional Inf
TAXES ON INCOME (Additional Information) (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Line Items] | |||
Net operating loss carry forwards | $ 247.9 | $ 231.4 | |
Parent Company | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carry forwards | 36.1 | 30.9 | |
Protalix Ltd | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carry forwards | $ 211.8 | $ 200.5 | |
Protalix Ltd | Law for Amending the Israel Income Tax Ordinance, Tax Thereafter | |||
Income Tax Disclosure [Line Items] | |||
Statutory income tax rate | 23.00% | 23.00% | 23.00% |
Maximum | |||
Income Tax Disclosure [Line Items] | |||
Statutory income tax rate | 21.00% |
SUPPLEMENTARY FINANCIAL STATE_3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Other Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Other assets: | ||
Institutions | $ 311 | $ 771 |
Restricted deposits | 436 | |
Prepaid expenses | 905 | 841 |
Sundry | 69 | 48 |
Other assets | $ 1,285 | $ 2,096 |
SUPPLEMENTARY FINANCIAL STATE_4
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals - Other) (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accounts payable and accruals - other: | ||
Payroll and related expenses | $ 1,562 | $ 1,460 |
Interest payable | 767 | 555 |
Provision for vacation | 1,506 | 1,526 |
Accrued expenses | 11,981 | 9,586 |
Royalties payable | 522 | 482 |
Property and equipment suppliers | 95 | 317 |
Accounts payable and accruals - other | $ 16,433 | $ 13,926 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Compensation to the non-executive directors | |||
Related Party Transaction [Line Items] | |||
Compensation (including share based compensation) to the non-executive directors | $ 475 | $ 814 | $ 444 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent Event - USD ($) $ in Millions | Mar. 22, 2022 | Feb. 25, 2022 | Feb. 02, 2022 | Jan. 12, 2022 |
Restricted Stock | President and Chief Executive Officer | ||||
Subsequent Event [Line Items] | ||||
Granted | 637,531 | |||
Restricted Stock | Sr. Vice President And Chief Financial Officer | ||||
Subsequent Event [Line Items] | ||||
Granted | 121,951 | |||
Chiesi Agreements | ||||
Subsequent Event [Line Items] | ||||
Proceeds from expense reimbursements | $ 1.2 | $ 1.2 | ||
Brazil Agreement with Fiocruz | Alfataliglicerase | ||||
Subsequent Event [Line Items] | ||||
Proceeds from sales | $ 2.2 |