Protalix BioTherapeutics (PLX) 10-Q 15 Nov 21 2021 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2021	Nov. 01, 2021
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2021
Entity File Number	001-33357
Entity Registrant Name	PROTALIX BIOTHERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	65-0643773
Entity Address, Address Line One	2 University Plaza
Entity Address, Address Line Two	Suite 100
Entity Address, City or Town	Hackensack
Entity Address, State or Province	NJ
Entity Address, Postal Zip Code	07601
City Area Code	201
Local Phone Number	696-9345
Title of 12(b) Security	Common stock, $0.001 par value
Trading Symbol	PLX
Security Exchange Name	NYSEAMER
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		45,556,647
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
CURRENT ASSETS:
Cash and cash equivalents	$ 10,642	$ 18,265
Short-term bank deposits	38,017	20,280
Accounts receivable - Trade	5,561	2,000
Other assets	2,274	2,096
Inventories	14,730	13,082
Total current assets	71,224	55,723
NON-CURRENT ASSETS:
Funds in respect of employee rights upon retirement	1,948	1,799
Property and equipment, net	5,065	4,845
Operating lease right of use assets	5,245	5,567
Total assets	83,482	67,934
Accounts payable and accruals:
Trade	8,436	7,221
Other	14,694	13,926
Operating lease liabilities	1,235	1,420
Contracts liability	15,160	5,394
Convertible notes	3,239	54,427
Promissory note		4,086
Total current liabilities	42,764	86,474
LONG TERM LIABILITIES:
Convertible notes	27,816
Contracts liability	5,895	1,716
Liability for employee rights upon retirement	2,353	2,263
Operating lease liabilities	4,441	4,467
Other long term liabilities		51
Total long term liabilities	40,505	8,497
Total liabilities	83,269	94,971
STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)	213	(27,037)
Total liabilities and stockholders' equity (net of capital deficiency)	$ 83,482	$ 67,934

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
		Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
TOTAL REVENUE		$ 12,054	$ 10,790	$ 29,801	$ 43,403
COST OF GOODS SOLD	[1]	(3,703)	(2,868)	(13,201)	(8,121)
RESEARCH AND DEVELOPMENT EXPENSES	[2]	(7,282)	(7,688)	(22,093)	(27,214)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES	[3]	(2,954)	(2,816)	(9,263)	(8,197)
OPERATING LOSS		(1,885)	(2,582)	(14,756)	(129)
FINANCIAL EXPENSES		(2,410)	(1,973)	(6,613)	(7,150)
FINANCIAL INCOME		96	118	403	359
FINANCIAL EXPENSES - NET		(2,314)	(1,855)	(6,210)	(6,791)
OTHER INCOME				51
NET LOSS FOR THE PERIOD		$ (4,199)	$ (4,437)	$ (20,915)	$ (6,920)
LOSS PER SHARE OF COMMON STOCK - BASIC		$ (0.09)	$ (0.14)	$ (0.48)	$ (0.25)
LOSS PER SHARE OF COMMON STOCK - DILUTED		$ (0.09)	$ (0.14)	$ (0.48)	$ (0.25)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC		45,556,647	32,863,788	43,761,769	27,758,104
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - DILUTED		45,556,647	32,863,788	43,761,769	27,758,104
Goods [Member]
TOTAL REVENUE		$ 4,506	$ 3,296	$ 12,260	$ 11,975
License and R&D Services [Member]
TOTAL REVENUE		$ 7,548	$ 7,494	$ 17,541	$ 31,428
[1]	(1) Includes share-based compensation
[2]	(2) Includes share-based compensation
[3]	(3) Includes share-based compensation

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Cost of Sales [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 65		$ 217
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	154	$ 562	524	$ 635
Selling, General and Administrative Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 344	$ 852	$ 1,216	$ 1,477

CONDENSED CONSOLIDATED STATEM_3

CONDENSED 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, 2019		$ 15	$ 270,492	$ (340,829)	$ (70,322)
Beginning balance (in shares) at Dec. 31, 2019	[1]	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)	[1]	17,604,423
Share-based compensation related to stock options			1,607		1,607
Share-based compensation related to restricted stock awards			505		505
Share-based compensation related to restricted stock awards (in shares)	[1]	694,073
Exercise of warrants			472		472
Exercise of warrants (in shares)	[1]	200,000
Net loss for the period				(6,920)	(6,920)
Ending balance at Sep. 30, 2020		$ 33	314,401	(347,749)	(33,315)
Ending balance (in shares) at Sep. 30, 2020	[1]	33,336,709
Beginning balance at Jun. 30, 2020		$ 33	308,515	(343,312)	(34,764)
Beginning balance (in shares) at Jun. 30, 2020	[1]	32,442,636
Share-based compensation related to stock options			909		909
Share-based compensation related to restricted stock awards			505		505
Share-based compensation related to restricted stock awards (in shares)	[1]	694,073
Exercise of warrants			472		472
Exercise of warrants (in shares)	[1]	200,000
Note receivable payment			4,000		4,000
Net loss for the period				(4,437)	(4,437)
Ending balance at Sep. 30, 2020		$ 33	314,401	(347,749)	(33,315)
Ending balance (in shares) at Sep. 30, 2020	[1]	33,336,709
Beginning balance at Dec. 31, 2020		$ 35	320,280	(347,352)	(27,037)
Beginning balance (in shares) at Dec. 31, 2020	[1]	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)	[1]	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]	1,867,552
Share-based compensation related to stock options			1,176		1,176
Share-based compensation related to restricted stock awards			781		781
Exercise of warrants (in shares)	[1]	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 for the period				(20,915)	(20,915)
Ending balance at Sep. 30, 2021		$ 46	368,434	(368,267)	213
Ending balance (in shares) at Sep. 30, 2021	[1]	45,556,647
Beginning balance at Jun. 30, 2021		$ 46	367,863	(364,068)	3,841
Beginning balance (in shares) at Jun. 30, 2021	[1]	45,556,647
Share-based compensation related to stock options			344		344
Share-based compensation related to restricted stock awards			219		219
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 for the period				(4,199)	(4,199)
Ending balance at Sep. 30, 2021		$ 46	$ 368,434	$ (368,267)	$ 213
Ending balance (in shares) at Sep. 30, 2021	[1]	45,556,647
[1]	Common stock, $0.001 par value; Authorized – as of September 30, 2021 and 2020 - 120,000,000 shares.

CONDENSED CONSOLIDATED STATEM_4

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) (Parenthetical) - $ / shares	Sep. 30, 2021	Sep. 30, 2020
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY)
Common Stock, Par or Stated Value Per Share	$ 0.001	$ 0.001
Common Stock, Shares Authorized	120,000,000	120,000,000

CONDENSED CONSOLIDATED STATEM_5

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (20,915)	$ (6,920)
Adjustments required to reconcile net loss to net cash used in operating activities:
Share-based compensation	1,957	2,112
Depreciation	859	1,011
Financial income, net (mainly exchange differences)	118	(284)
Changes in accrued liability for employee rights upon retirement	100	(488)
Gain on amounts funded in respect of employee rights upon retirement	(75)	(11)
Gain on sale of fixed assets	(51)
Loss on extinguishment of convertible notes	831
Amortization of debt issuance costs and debt discount	2,569	2,548
Changes in operating assets and liabilities:
Increase (decrease) in contracts liability (including non-current portion)	13,945	(15,062)
Decrease (increase) in accounts receivable and other assets	(4,075)	783
Changes in right of use assets	168	53
Increase in inventories	(1,648)	(5,126)
Increase in accounts payable and accruals	1,070	3,291
Decrease in other long term liabilities	(51)	(463)
Net cash used in operating activities	(5,198)	(18,556)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of bank deposits	(37,835)	(27,500)
Proceeds from sale of short-term deposits	20,000
Purchase of property and equipment	(1,011)	(380)
Proceeds from sale of property and equipment	53
Decrease (increase) in restricted deposit	359	(4)
Amounts funded in respect of employee rights upon retirement, net	(81)	340
Net cash used in investing activities	(18,515)	(27,544)
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment for convertible notes redemption and transactions costs	(25,990)
Net payment for promissory note	(4,086)
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
Exercise of warrants		472
Net cash provided by financing activities	16,124	41,815
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(34)	26
NET DECREASE IN CASH AND CASH EQUIVALENTS	(7,623)	(4,259)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	18,265	17,792
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	10,642	13,533
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	387	95
Right of use assets obtained in exchange for new operating lease liabilities	309	564
Transactions costs in connection with the exchange of convertible notes	774
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Interest paid	3,288	2,172
Interest received	$ 445	$ 68

SIGNIFICANT ACCOUNTING POLICIES

SIGNIFICANT ACCOUNTING POLICIES	9 Months Ended
	Sep. 30, 2021
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES	NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® On August 25, 2021, the Company completed exchanges (the “Exchanges”) of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) with institutional note holders of a substantial majority of the 2021 Notes. The Exchanges involved the exchange of an aggregate of $54.65 million principal amount of the Company’s outstanding 2021 Notes for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the closing date. The initial conversion rate for the 2024 Notes is 563.2216 shares of Common Stock 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. The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies which are referred to as the BALANCE BRIDGE BRIGHT BRIDGE BRIGHT BALANCE On April 28, 2021, the Company, together with its development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), announced that they received 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 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 (the “FFDCA”) 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 agalsidase beta (Fabrazyme ® 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 Protalix and Chiesi also announced that a meeting was held with the Rapporteur and Co-Rapporteur of the European Medicines Agency (“EMA”) on October 8, 2021 regarding PRX-102. At the meeting, Chiesi and Protalix discussed the scope of the anticipated Marketing Authorization Application (“MAA”) submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission for PRX-102. This is an important step in the necessary pre-submission activities leading up to a MAA submission. Based on the interim analysis of the 12-month data generated from the BALANCE BRIGHT BRIDGE 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. (“SarcoMed”) 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 the three months ended September 30, 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, par value $0.001 per share (the “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 On February 17, 2021, the Company issued and sold 8,749,999 shares of its Common Stock in an underwritten public offering 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 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, capped at $10.0 million per year, 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, subject to a maximum of $7.5 million per year, 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 full 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 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment 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 in accordance with the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement (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. We continue 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 and bank deposits as of September 30, 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 accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2020, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. There have been no material changes in our significant accounting policies as described in our consolidated financial statements for the year ended December 31, 2020. c. 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 attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 26,905,842 and 21,405,733 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding 2021 Notes and outstanding warrants for the three and nine months ended September 30, 2020, respectively, and 27,962,842 and 26,847,081 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding 2021 Notes, 2024 Notes and outstanding warrants for the three and nine months ended September 30, 2021, respectively, because their effect would be anti-dilutive. d. 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. Revenue from Chiesi Agreements The Company has identified two performance obligations in 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. ​

INVENTORIES

INVENTORIES	9 Months Ended
	Sep. 30, 2021
INVENTORIES
INVENTORIES	NOTE 2 - INVENTORIES Inventories at September 30, 2021 and December 31, 2020 consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ ( U.S. dollars in thousands) ​ 2021 ​ 2020 ​ Raw materials ​ $ 3,170 ​ $ 3,347 ​ Work in progress ​ 3,507 ​ ​ 2,887 ​ Finished goods ​ 8,053 ​ ​ 6,848 ​ Total inventory ​ $ 14,730 ​ $ 13,082 ​ ​

FAIR VALUE MEASUREMENT

FAIR VALUE MEASUREMENT	9 Months Ended
	Sep. 30, 2021
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT	NOTE 3 – FAIR VALUE MEASUREMENT The Company measures fair value and 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. As of September 30, 2021, the carrying amounts of short-term deposits approximate their fair values due to the stated interest rates, which approximate market rates. Based on a Level 3 measurement, as of September 30, 2021, the fair value of the $3.27 million aggregate principal amount of the Company’s outstanding 2021 Notes is approximately $3.4 million and the fair value of the $28.75 million aggregate principal amount of the Company’s outstanding 2024 Notes is approximately $39.8 million. The Company prepared a valuation of the fair value of the Company’s outstanding 2021 Notes and 2024 Notes (a Level 3 valuation) as of September 30, 2021. The value of these notes 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) 1.33 ​ ​ 1.33 ​ Expected term 0.13 ​ ​ 2.92 ​ Risk free rate 0.04 % ​ 0.50 % Volatility 81.16 % ​ 91.77 % Yield 6.74 % ​ 8.99 % ​

REVENUES

REVENUES	9 Months Ended
	Sep. 30, 2021
REVENUES
REVENUES	NOTE 4 – REVENUES The following table summarizes the Company’s disaggregation of revenues: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ ​ Nine Months Ended September 30, ​ ( U.S. dollars in thousands) 2021 2020 ​ ​ ​ 2021 2020 ​ Pfizer ​ $ 1,135 ​ $ 3,165 ​ ​ ​ $ 7,883 ​ $ 5,844 ​ Brazil ​ $ 3,200 ​ $ — ​ ​ ​ $ 4,188 ​ $ 6,000 ​ Chiesi ​ $ 171 ​ $ 131 ​ ​ ​ $ 189 ​ $ 131 ​ Total revenues from selling goods ​ $ 4,506 ​ $ 3,296 ​ ​ ​ $ 12,260 ​ $ 11,975 ​ Revenues from license and R&D services ​ $ 7,548 ​ $ 7,494 ​ ​ ​ $ 17,541 ​ $ 31,428 ​ ​ During the nine months ended September 30, 2021 and 2020, the Company recognized revenues of approximately $16.5 million and $31.4 million, respectively, During the three months ended September 30, 2021 and 2020, the Company recognized revenues of approximately $ million and $ million, respectively, . During the nine months ended September 30, 2021, and following the CRL received from the FDA, the Company changed its estimate for total costs expected to be incurred until satisfying the performance obligation under the Chiesi Agreements. This resulted in a reduction to accumulated revenues recognized in respect of this performance obligation in the amount of $4.1 million. During the three months ended September 30, 2021, the Company completed its obligations under a feasibility study it entered into with Kirin Holdings Company, Limited (“Kirin”) on March 16, 2020, and the agreement expired, including the option to provide additional services. Following the expiration of the option, the Company recognized as revenue during the three-month period ended September 30, 2021 the $1.0 million payment received in March 2020.

CONVERTIBLE NOTES

CONVERTIBLE NOTES	9 Months Ended
	Sep. 30, 2021
CONVERTIBLE NOTES
CONVERTIBLE NOTES	NOTE 5 – 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. 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. 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. Under the terms of the indentures governing each of the 2021 Notes and 2024 Notes, The Company is required to maintain a minimum cash balance of at least $7.5 million. In addition, under the exchange a $3.27 million, For accounting purposes, as the terms of the 2021 Notes and the 2024 Notes are substantially different, the Exchanges are 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 of $54.8 million and the repurchase of the original equity component for $12.0 million. All of the Company’s outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board 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 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 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. ​ 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 % ​

STOCK TRANSACTIONS

STOCK TRANSACTIONS	9 Months Ended
	Sep. 30, 2021
STOCK TRANSACTIONS
STOCK TRANSACTIONS	NOTE 6 – STOCK TRANSACTIONS 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 Company’s Amended and Restated 2006 Employee Stock Incentive Plan, as amended. 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% for all years; expected volatility of 84.3%; risk-free interest rate of 0.88%; and expected life of six years.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2021
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	NOTE 7 – SUBSEQUENT EVENTS On October 13, 2021, the Company collected approximately $1.2 million from expense reimbursements in connection with its collaboration with Chiesi. On October 14, 2021, the Company collected approximately $1.1 million from sales to Pfizer and on October 15, 2021, the Company collected approximately $3.2 million from sales of alfataliglicerase to Fiocruz. On November 9, 2021, the Company delivered the necessary funds under the indenture governing the 2021 Notes to effectively discharge the remaining outstanding 2021 Notes. In accordance with ASC 855 “Subsequent Events” the Company evaluated subsequent events through the date the condensed consolidated financial statements were issued. The Company concluded that no other subsequent events have occurred that would require recognition or disclosure in the condensed consolidated financial statements. ​

SIGNIFICANT ACCOUNTING POLICI_2

SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2021
SIGNIFICANT ACCOUNTING POLICIES
General	a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® On August 25, 2021, the Company completed exchanges (the “Exchanges”) of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) with institutional note holders of a substantial majority of the 2021 Notes. The Exchanges involved the exchange of an aggregate of $54.65 million principal amount of the Company’s outstanding 2021 Notes for an aggregate of $28.75 million principal amount of newly issued 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), $25.90 million in cash, and approximately $1.1 million in cash representing accrued and unpaid interest through the closing date. The initial conversion rate for the 2024 Notes is 563.2216 shares of Common Stock 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. The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies which are referred to as the BALANCE BRIDGE BRIGHT BRIDGE BRIGHT BALANCE On April 28, 2021, the Company, together with its development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), announced that they received 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 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 (the “FFDCA”) 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 agalsidase beta (Fabrazyme ® 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 Protalix and Chiesi also announced that a meeting was held with the Rapporteur and Co-Rapporteur of the European Medicines Agency (“EMA”) on October 8, 2021 regarding PRX-102. At the meeting, Chiesi and Protalix discussed the scope of the anticipated Marketing Authorization Application (“MAA”) submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of a planned MAA submission for PRX-102. This is an important step in the necessary pre-submission activities leading up to a MAA submission. Based on the interim analysis of the 12-month data generated from the BALANCE BRIGHT BRIDGE 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. (“SarcoMed”) 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 the three months ended September 30, 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, par value $0.001 per share (the “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 On February 17, 2021, the Company issued and sold 8,749,999 shares of its Common Stock in an underwritten public offering 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 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, capped at $10.0 million per year, 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, subject to a maximum of $7.5 million per year, 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 full 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 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment 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 in accordance with the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement (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. We continue 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 and bank deposits as of September 30, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.
Basis of presentation	b. Basis of presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2020, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date. There have been no material changes in our significant accounting policies as described in our consolidated financial statements for the year ended December 31, 2020.
Loss per share	c. 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 attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 26,905,842 and 21,405,733 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding 2021 Notes and outstanding warrants for the three and nine months ended September 30, 2020, respectively, and 27,962,842 and 26,847,081 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding 2021 Notes, 2024 Notes and outstanding warrants for the three and nine months ended September 30, 2021, respectively, because their effect would be anti-dilutive.
Revenue recognition	d. 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. Revenue from Chiesi Agreements The Company has identified two performance obligations in 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.

INVENTORIES (Tables)

INVENTORIES (Tables)	9 Months Ended
	Sep. 30, 2021
INVENTORIES
Schedule of Inventory	Inventories at September 30, 2021 and December 31, 2020 consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ ( U.S. dollars in thousands) ​ 2021 ​ 2020 ​ Raw materials ​ $ 3,170 ​ $ 3,347 ​ Work in progress ​ 3,507 ​ ​ 2,887 ​ Finished goods ​ 8,053 ​ ​ 6,848 ​ Total inventory ​ $ 14,730 ​ $ 13,082 ​

FAIR VALUE MEASUREMENT (Tables)

FAIR VALUE MEASUREMENT (Tables) - Notes 2021 and 2024	9 Months Ended
	Sep. 30, 2021
Schedule of liability component based on income approach	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 %
Fair Value, Inputs, Level 3
Schedule of liability component based on income approach	The Company prepared a valuation of the fair value of the Company’s outstanding 2021 Notes and 2024 Notes (a Level 3 valuation) as of September 30, 2021. The value of these notes 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) 1.33 ​ ​ 1.33 ​ Expected term 0.13 ​ ​ 2.92 ​ Risk free rate 0.04 % ​ 0.50 % Volatility 81.16 % ​ 91.77 % Yield 6.74 % ​ 8.99 %

REVENUES (Tables)

REVENUES (Tables)	9 Months Ended
	Sep. 30, 2021
REVENUES
Schedule of Company's disaggregation of revenues	The following table summarizes the Company’s disaggregation of revenues: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ ​ Nine Months Ended September 30, ​ ( U.S. dollars in thousands) 2021 2020 ​ ​ ​ 2021 2020 ​ Pfizer ​ $ 1,135 ​ $ 3,165 ​ ​ ​ $ 7,883 ​ $ 5,844 ​ Brazil ​ $ 3,200 ​ $ — ​ ​ ​ $ 4,188 ​ $ 6,000 ​ Chiesi ​ $ 171 ​ $ 131 ​ ​ ​ $ 189 ​ $ 131 ​ Total revenues from selling goods ​ $ 4,506 ​ $ 3,296 ​ ​ ​ $ 12,260 ​ $ 11,975 ​ Revenues from license and R&D services ​ $ 7,548 ​ $ 7,494 ​ ​ ​ $ 17,541 ​ $ 31,428 ​

CONVERTIBLE NOTES (Tables)

CONVERTIBLE NOTES (Tables)	9 Months Ended
	Sep. 30, 2021
Notes 2021 and 2024
Schedule of liability component based on income approach	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 %

SIGNIFICANT ACCOUNTING POLICI_3

SIGNIFICANT ACCOUNTING POLICIES (Details)	Aug. 25, 2021USD ($)$ / sharesshares	Jul. 02, 2021USD ($)$ / sharesshares	May 13, 2021USD ($)	Feb. 17, 2021USD ($)$ / sharesshares	Jul. 23, 2018USD ($)	Oct. 19, 2017USD ($)	Oct. 31, 2015	Sep. 30, 2021USD ($)agreement$ / sharesshares	Sep. 30, 2020$ / sharesshares	Sep. 30, 2021USD ($)agreement$ / sharesshares	Sep. 30, 2020$ / sharesshares	Dec. 31, 2020USD ($)
Significant Accounting Policies [Line Items]
Number of shares issued (in shares) | shares				8,749,999
Common Stock, Par or Stated Value Per Share | $ / shares								$ 0.001	$ 0.001	$ 0.001	$ 0.001
Gross proceeds				$ 40,200,000						$ 8,575,000
Shares Issued, Price Per Share | $ / shares				$ 4.60
Net payment for convertible notes										25,990,000
Convertible Debt, Current								$ 3,239,000		$ 3,239,000		$ 54,427,000
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares								27,962,842	26,905,842	26,847,081	21,405,733
Maintain of Minimum Cash Balance								$ 7,500,000		$ 7,500,000
ATM Shares
Significant Accounting Policies [Line Items]
Number of shares issued (in shares) | shares		3,296,123
Common Stock, Par or Stated Value Per Share | $ / shares		$ 0.001
Sale of stock, maximum offering price		$ 20,000,000
Gross proceeds		$ 13,800,000
2021 Notes
Significant Accounting Policies [Line Items]
Principal amount	$ 54,650,000
2024 Notes
Significant Accounting Policies [Line Items]
Interest rate (as a percent)	7.50%							7.50%		7.50%
Net payment for convertible notes	$ 25,900,000
Convertible notes exchange in cash, accrued and unpaid interest	$ 1,100,000
Debt Instrument Convertible Conversion Share Number | shares	563.2216
Debt Instrument Convertible Base Value For Conversion Rate	$ 1,000
Debt Instrument, Convertible, Conversion Price | $ / shares	$ 1.7755
Percentage of Premium to Closing Price of Stock	32.50%
Principal amount	$ 28,750,000
Amended Pfizer Agreement | Protalix Bio Therapeutics Incorporation [Member] | Brazil [Member]
Significant Accounting Policies [Line Items]
Collaborative Arrangement Revenues and Expenses Sharing Percentage							100.00%
Chiesi Agreements
Significant Accounting Policies [Line Items]
Revenue, Performance Obligation, Number | agreement								2		2
Chiesi US Agreement [Member]
Significant Accounting Policies [Line Items]
Additional Amounts Payable To Cover Development Costs					$ 20,000,000
Maximum Entitlement Of Development Costs To Cover Per Year					7,500,000
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones					$ 760,000,000
Chiesi US Agreement [Member] | Minimum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage					15.00%
Chiesi US Agreement [Member] | Maximum
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage					40.00%
Chiesi Ex US Agreement [Member]
Significant Accounting Policies [Line Items]
Additional Amounts Payable To Cover Development Costs						$ 25,000,000
Maximum Entitlement Of Development Costs To Cover Per Year						10,000,000
Agreement Amendment Payment Receivable			$ 10,000,000
Change In Amount Receivable For Achievement Of Regulatory And Commercial Milestones			$ 25,000,000
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones						$ 320,000,000
Chiesi Ex US Agreement [Member] | Minimum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage						15.00%
Chiesi Ex US Agreement [Member] | Maximum
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage						35.00%
Chiesi US Agreement and Chiesi Ex US Agreement [Member]
Significant Accounting Policies [Line Items]
Upfront Nonrefundable Non-Creditable Payment Receivable					$ 25,000,000	$ 25,000,000

INVENTORIES (Details)

INVENTORIES (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
INVENTORIES
Raw materials	$ 3,170	$ 3,347
Work in progress	3,507	2,887
Finished goods	8,053	6,848
Total inventory	$ 14,730	$ 13,082

FAIR VALUE MEASUREMENT - The li

FAIR VALUE MEASUREMENT - The liability component was valued based on the Income Approach (Details) - Fair Value, Inputs, Level 3	Sep. 30, 2021Y$ / shares	Aug. 25, 2021Y$ / shares
2021 Notes | Share Price
Debt Instrument, Measurement Input | $ / shares	1.33	1.34
2021 Notes | Expected term
Debt Instrument, Measurement Input | Y	0.13	0.23
2021 Notes | Risk free rate
Debt Instrument, Measurement Input	0.04	0.05
2021 Notes | Volatility
Debt Instrument, Measurement Input	81.16	78.95
2021 Notes | Yield
Debt Instrument, Measurement Input	6.74	7.87
2024 Notes | Share Price
Debt Instrument, Measurement Input | $ / shares	1.33	1.34
2024 Notes | Expected term
Debt Instrument, Measurement Input | Y	2.92	3.03
2024 Notes | Risk free rate
Debt Instrument, Measurement Input	0.50	0.44
2024 Notes | Volatility
Debt Instrument, Measurement Input	91.77	91.35
2024 Notes | Yield
Debt Instrument, Measurement Input	8.99	7.66

FAIR VALUE MEASUREMENT - Additi

FAIR VALUE MEASUREMENT - Additional Information (Details) - Fair Value, Inputs, Level 3 $ in Thousands	Sep. 30, 2021USD ($)
2021 Notes
Short-term Debt	$ 3,270
Convertible Debt, Fair Value Disclosures	3,400
2024 Notes
Long-term Debt, Gross	28,750
Convertible Debt, Fair Value Disclosures	$ 39,800

REVENUES - Company's disaggrega

REVENUES - Company's disaggregation of revenues (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Revenues	$ 12,054	$ 10,790	$ 29,801	$ 43,403
Kirin Holdings Company, Limited [Member]
Revenues	1,000
Goods [Member]
Revenues	4,506	3,296	12,260	11,975
Goods [Member] | Pfizer [Member]
Revenues	1,135	3,165	7,883	5,844
Goods [Member] | Brazil [Member]
Revenues	3,200		4,188	6,000
Goods [Member] | Chiesi [Member]
Revenues	171	131	189	131
License and R&D Services [Member]
Revenues	7,548	7,494	17,541	31,428
License and R&D Services [Member] | Chiesi US Agreement and Chiesi Ex US Agreement [Member] | Change in Accounting Method Accounted for as Change in Estimate [Member]
Reduction To Accumulated Revenue Recognized			4,100
License and R&D Services [Member] | Chiesi Ex US Agreement [Member]
Revenues	$ 6,500	$ 7,500	$ 16,500	$ 31,400

CONVERTIBLE NOTES (Details)

CONVERTIBLE NOTES (Details) - USD ($)	Aug. 25, 2021	Sep. 30, 2021	Sep. 30, 2021
Net payment for convertible notes			$ 25,990,000
Loss on extinguishment of convertible notes			(831,000)
Reacquisition of equity component of convertible notes		$ 12,019,000	12,019,000
Equity component of convertible notes, net of transaction costs		12,027,000	(12,027,000)
Transactions costs in connection with the exchange of convertible notes			774,000
Minimum cash balance required		7,500,000	7,500,000
Minimum unrestricted cash balance to be maintained		3,270,000	3,270,000
2021 Notes
Principal amount	$ 54,650,000
Loss on extinguishment of convertible notes			(800,000)
Derecognition of liability component		$ 54,800,000	54,800,000
Reacquisition of equity component of convertible notes			$ (12,000,000)
2024 Notes
Principal 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	563.2216
Conversion price per share	$ 1.7755
Percentage of Premium to Closing Price of Stock	32.50%
Interest rate	7.50%	7.50%	7.50%
Mature term			3 years
Equity component of convertible notes, net of transaction costs			$ 12,000,000
Transactions costs in connection with the exchange of convertible notes			$ 869,000

CONVERTIBLE NOTES (Fair Value I

CONVERTIBLE NOTES (Fair Value Income Approach) (Details) - Fair Value, Inputs, Level 3	Sep. 30, 2021Y$ / shares	Aug. 25, 2021Y$ / shares
2021 Notes | Share Price
Debt Instrument, Measurement Input | $ / shares	1.33	1.34
2021 Notes | Expected term
Debt Instrument, Measurement Input | Y	0.13	0.23
2021 Notes | Risk free rate
Debt Instrument, Measurement Input	0.04	0.05
2021 Notes | Volatility
Debt Instrument, Measurement Input	81.16	78.95
2021 Notes | Yield
Debt Instrument, Measurement Input	6.74	7.87
2024 Notes | Share Price
Debt Instrument, Measurement Input | $ / shares	1.33	1.34
2024 Notes | Expected term
Debt Instrument, Measurement Input | Y	2.92	3.03
2024 Notes | Risk free rate
Debt Instrument, Measurement Input	0.50	0.44
2024 Notes | Volatility
Debt Instrument, Measurement Input	91.77	91.35
2024 Notes | Yield
Debt Instrument, Measurement Input	8.99	7.66

STOCK TRANSACTIONS (Details)

STOCK TRANSACTIONS (Details) - 2006 Employee Stock Incentive Plan - New employee	Jul. 25, 2021USD ($)item$ / sharesshares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of award	10 years
Granted (in shares) | shares	50,000
Exercise Price (in dollars per share)	$ 1.57
Vesting Period	4 years
Number of equal quarterly increments | item	16
Grant Date Fair Value | $	$ 55,000
Share price	$ 1.57
Dividend Yield	0.00%
Expected Volatility Rate	84.30%
Risk Free Interest Rate	0.88%
Expected Term	6 years

SUBSEQUENT EVENTS (Details)

SUBSEQUENT EVENTS (Details) - Subsequent Event - USD ($) $ in Millions	Oct. 15, 2021	Oct. 14, 2021	Oct. 13, 2021
Chiesi Agreements
Subsequent Event [Line Items]
Proceeds from expense reimbursements			$ 1.2
Amended Pfizer Agreement
Subsequent Event [Line Items]
Proceeds from sales		$ 1.1
Brazil Agreement with Fiocruz | Alfataliglicerase
Subsequent Event [Line Items]
Proceeds from sales	$ 3.2