0001558370-22-004823 | 10-K | XBRL Viewer | Protalix Biotherapeutics INC

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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 (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 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 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 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

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^® protein expression system (“ProCellEx”). To date, the Company has successfully developed taliglucerase alfa (marketed under the name BioManguinhos alfataliglicerase in Brazil and certain other Latin American countries and Elelyso^® in the rest of the territories) for the treatment of Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets. The Company has a number of product candidates in varying stages of the clinical development process. The Company’s strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.

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 study, the BRIDGE study and the BRIGHT study. The BRIDGE and BRIGHT studies have been completed, and the last patient from the BALANCE study received the final dose of the study in October 2021. In addition, the phase III clinical program includes two extension studies in which subjects that participated in our phase I/II clinical trials and our phase III clinical trials may enroll and continue to be treated with PRX-102. The studies are designed to evaluate the potential superiority of PRX-102 over current therapies in a head-to-head study and a switch-over study, evaluate the potential for improved efficacy and better quality of life for patients with Fabry disease and evaluate the safety of our drug/therapy.

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 study. The Company intends to continue to work collaboratively with the FDA to resolve the issues noted in the CRL and provide a new, alternative drug to Fabry patients.

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 Sales Agreement (the “BofA Agreement”) it had entered into on October 1, 2020 with BofA Securities, Inc. (“BofA Securities”). During

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 restricted stock units 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 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.

COMMERCIALIZATION AGREEMENTS

12 Months Ended

Dec. 31, 2021

COMMERCIALIZATION AGREEMENTS

COMMERCIALIZATION AGREEMENTS

NOTE 2 - COMMERCIALIZATION AGREEMENTS

a. On November 30, 2009, Protalix Ltd. and Pfizer entered into the Pfizer Agreement (as amended in June 2013) pursuant to which Pfizer was granted an exclusive, worldwide license to develop and commercialize taliglucerase alfa, except for Israel and Brazil. Under the Pfizer Agreement Protalix was entitled to 40% of the results (profits or losses) earned on Pfizer’s sales of taliglucerase alfa.

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:

Manufacturing and supply of the drug substance for its incorporation into the licensed product in consideration of an agreed price per unit.

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. In October 2017, Protalix Ltd. entered into the Chiesi Ex-U.S. Agreement with respect to the commercialization of pegunigalsidase alfa (hereafter – the drug) for the treatment of Fabry disease.

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:

Upfront, non-refundable payment of $25.0 million.

Additional payments of up to $25.0 million in development costs, capped at $10.0 million per year.

Payments for additional studies, as may be approved from time to time by Chiesi.

Milestone payments of up to $320.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Agreement.

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.

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:

Upfront, non-refundable payment of $25.0 million.

Additional payments of up to $20.0 million in development costs, capped at $7.5 million per year.

Payments for additional studies, as may be approved from time to time by Chiesi.

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.

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.

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:

Upfront payments equal to $50.0 million, in the aggregate.

Payments equal to $45.0 million in consideration for development services performed.

Payments equal to approximately $33.6 million in connection with the performance of extension studies.

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. On June 18, 2013, Protalix Ltd. entered into the Brazil Agreement with Fiocruz for BioManguinhos. 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 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. Approximately 25% of adult Gaucher patients in Brazil are currently treated with BioManguinhos alfataliglicerase. The Company is discussing with Fiocruz potential actions that Fiocruz may take to comply with its purchase obligations and, based on such discussions, the Company will determine what it believes to be the course of action that is in the best interest of the Company.

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 option 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

12 Months Ended

Dec. 31, 2021

PROPERTY AND EQUIPMENT

PROPERTY AND EQUIPMENT

NOTE 3 - PROPERTY AND EQUIPMENT

a. Composition of property and equipment grouped by major classifications is as follows:


	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. Depreciation in respect of property and equipment totaled approximately $1.6 million, $1.3 million and $1.1 million for the years ended December 31, 2019, 2020 and 2021, respectively.

INVENTORIES

12 Months Ended

Dec. 31, 2021

INVENTORIES

INVENTORIES

NOTE 4 - INVENTORIES

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. During the years ended December 31, 2019, 2020 and 2021, the Company recorded approximately $0.5 million, $0.3 million and $0.4 million, respectively, for write-down of inventory under cost of goods sold.

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.

- Definition

The entire disclosure for retirement benefits.

+ References

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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

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

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

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

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. The ratio was determined by the Company’s Board of Directors on December 5, 2019 and the reverse stock split became effective at midnight December 19, 2019. All share and per share amounts included in the consolidated financial statements have been adjusted retrospectively to reflect the effect of the reverse stock split.

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:

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, 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 $1.6 million.

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:

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

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

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, the Company issued 200,000 shares of Common Stock in connection with the cash exercise of a warrant issued in the transaction and generated proceeds equal to $472,000 from such exercises.

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.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI http://asc.fasb.org/extlink&oid=123467817&loc=SL123496158-112644

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Section S99
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-Section 50
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
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Reference 8: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

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 (the “2016 Indenture”). The 2021 Notes accrued interest at a rate of 7.50% per year. A portion of the interest payable was allowed to be made in shares of Common Stock at the Company’s election.

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)any or all of the 2024 Notes if, on or after March 31, 2023, the last reported sale price of the Common Stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days exceeds 130% of the conversion price on each applicable trading day, or

b)all of the 2024 Notes then outstanding if the aggregate principal amount of the 2024 Notes then outstanding is less than 15% of the aggregate principal amount of the notes issued on August 25, 2021.

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 maintain a minimum cash balance of at least $7.5 million. Failure to meet covenants can be considered an event of default and, accordingly, may

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

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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+ Details

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	%

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

TAXES ON INCOME

12 Months Ended

Dec. 31, 2021

TAXES ON INCOME

TAXES ON INCOME

NOTE 12 - TAXES ON INCOME

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:

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.

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:

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.

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.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

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+ Details

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

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

12 Months Ended

Dec. 31, 2021

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 15 - SUBSEQUENT EVENTS

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.

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 POLICIES (Policies)

12 Months Ended

Dec. 31, 2021

SIGNIFICANT ACCOUNTING POLICIES

General

a. General

In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates:

(1)

(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.

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.

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

Functional currency

d. Functional currency

Cash equivalents

e. Cash equivalents

Accounts Receivables

f. Accounts Receivables

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.

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

Income taxes

j. Income taxes

1. Deferred income taxes

2. Uncertainty in income taxes

Revenue recognition

k. Revenue Recognition

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

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

Research and development costs

l. Research and development costs

Concentration of credit risks and trade receivable

m. Concentration of credit risks and trade receivable

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 measures compensation expense for the restricted stock units based on the market value of the underlying stock at the date of grant.

The Company elects to account for forfeitures as they occur.

Net loss per share

o. Net loss per share

Convertible notes

p. Convertible notes

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.

Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the consolidated balance sheets.

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.

Recently issued accounting pronouncements, not yet adopted

r. Recently issued accounting pronouncements, not yet adopted

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)

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)

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)

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)

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)

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)

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)

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)

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 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 (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 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 POLICIES (Additional Information) (Details)					1 Months Ended			12 Months Ended
	Jul. 02, 2021 USD ($)	Jun. 07, 2021 shares	Feb. 17, 2021 USD ($) $ / shares shares	Mar. 18, 2020 USD ($) $ / shares shares	Jul. 23, 2018 USD ($)	Oct. 19, 2017 USD ($)	Oct. 31, 2015	Dec. 31, 2021 USD ($) item $ / shares shares	Dec. 31, 2020 USD ($) $ / shares shares	Dec. 31, 2019 shares	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 \| 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						$ 25,000,000.0		$ 50,000,000.0
Revenue, Performance Obligation, Number \| item								2
Chiesi US Agreement [Member]
Significant Accounting Policies [Line Items]
Non-refundable Payment Receivable					$ 25,000,000.0	25,000,000.0
Additional Amounts Payable To Cover Development Costs					$ 20,000,000.0
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						25,000,000.0
Additional Amounts Payable To Cover Development Costs						$ 25,000,000.0
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	$ 20,000,000.0
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 (Details) - USD ($)				1 Months Ended				12 Months Ended
COMMERCIALIZATION AGREEMENTS (Details) - USD ($)	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		$ 4,000,000.0
Chiesi US Agreement and Chiesi Ex US Agreement [Member]
Non-refundable Payment Receivable							$ 25,000,000.0	$ 50,000,000.0
Agreement Amendment Payment Receivable								10,000,000.0			$ 10,000,000.0
Payments in consideration for development services performed								45,000,000.0
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									$ 10,000,000.0	$ 10,000,000.0
Chiesi US Agreement [Member]
Non-refundable Payment Receivable						$ 25,000,000.0	25,000,000.0
Additional Amounts Payable To Cover Development Costs						20,000,000.0
Maximum Entitlement Of Development Costs To Cover Per Year						7,500,000
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones						$ 760,000,000.0		$ 735,000,000.0
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							25,000,000.0
Additional Amounts Payable To Cover Development Costs							25,000,000.0
Maximum Entitlement Of Development Costs To Cover Per Year							10,000,000.0
Agreement Amendment Payment Receivable	$ 10,000,000.0
Change In Amount Receivable For Achievement Of Regulatory And Commercial Milestones	$ 25,000,000.0
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones							$ 320,000,000.0
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					$ 1,000,000.0
Non-Refundable Future Service Payment			$ 1,000,000.0

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 (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 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 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 UPON RETIREMENT (Details)	12 Months Ended
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details)	Dec. 31, 2021 USD ($) employee	Dec. 31, 2020 USD ($)	Dec. 31, 2019 USD ($)
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) - USD ($)	12 Months Ended
COMMITMENTS (Details) - USD ($)	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 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 Maturity Analysis of Operating Leases) (Details) $ in Thousands	Dec. 31, 2021 USD ($)
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 Information) (Details)	12 Months Ended
OPERATING LEASES (Additional Information) (Details)	Dec. 31, 2021 USD ($) 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) - USD ($) $ in Thousands	12 Months Ended
REVENUE (Details) - USD ($) $ in Thousands	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

- Definition

Amount of revenue recognized from goods sold, services rendered, insurance premiums, or other activities that constitute an earning process. Includes, but is not limited to, investment and interest income before deduction of interest expense when recognized as a component of revenue, and sales and trading gain (loss).

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (SX 210.13-02(a)(4)(iii)(A))
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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-URI http://asc.fasb.org/extlink&oid=123359005&loc=d3e9031-108599

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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 470
-SubTopic 10
-Section S99
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-URI http://asc.fasb.org/extlink&oid=124359900&loc=SL124442552-122756

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
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+ Details

SHARE CAPITAL (Schedule of Options and Restricted Stocks Granted) (Details) - Option to purchase shares of common stock - USD ($)		12 Months Ended
	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				$ 2.00
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 Option Activity) (Details) - Option to purchase shares of common stock - $ / shares		12 Months Ended
	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		11.00
Outstanding at end of year		4.61
Exercisable at end of year		$ 5.47

SHARE CAPITAL (Summary of Restricted Stock Activity) (Details) - Employee - Restricted Stock	12 Months Ended
	Dec. 31, 2021 shares
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 Options Granted to Consultants, Directors, and Other Service Providers) (Details) - Option to purchase shares of common stock - $ / shares		12 Months Ended
	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 Options Outstanding and Exercisable) (Details) - Option to purchase shares of common stock	12 Months Ended
	Dec. 31, 2021 $ / shares shares
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	$ 2.00
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 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 information) (Details)														1 Months Ended		12 Months Ended		36 Months Ended
SHARE CAPITAL (Additional information) (Details)	Jul. 25, 2021 USD ($) item $ / shares shares	Jul. 02, 2021 USD ($) shares	Jun. 07, 2021 shares	Feb. 17, 2021 USD ($) $ / shares shares	Sep. 22, 2020 shares	Aug. 11, 2020 USD ($) item $ / shares shares	Jul. 05, 2020 USD ($) item $ / shares shares	Jun. 07, 2020 USD ($) item $ / shares shares	Mar. 18, 2020 USD ($) $ / shares shares	Feb. 03, 2020 USD ($) item $ / shares shares	Jan. 20, 2020 USD ($) item director $ / shares shares	Dec. 09, 2019	Dec. 07, 2016 shares	Sep. 30, 2019 USD ($) item $ / shares shares	Jun. 30, 2019 USD ($) item $ / shares shares	Dec. 31, 2021 USD ($) Vote shares	Dec. 31, 2020 USD ($) shares	Dec. 31, 2021 USD ($) Vote shares
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 \| $		$ 20,000,000.0
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														$ 2.00
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														$ 2.00
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 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 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 Information) (Details)				1 Months Ended	12 Months Ended
CONVERTIBLE NOTES (Additional Information) (Details)	Aug. 25, 2021 USD ($) $ / shares shares	Dec. 07, 2016 USD ($) shares	Dec. 01, 2016 USD ($)	Jul. 24, 2017 USD ($)	Dec. 31, 2021 USD ($) D shares
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	$ 10,000,000.0
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					$ 12,000,000.0
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 (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 (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 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 Open Tax Years) (Details)	12 Months Ended
TAXES ON INCOME (Schedule of Open Tax Years) (Details)	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 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 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 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 (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 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