0001144204-19-023895 | 10-Q | XBRL Viewer | Protalix Biotherapeutics INC

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2019	May 01, 2019
Document and Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q1
Entity Registrant Name	Protalix BioTherapeutics, Inc.
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Trading Symbol	PLX
Entity Common Stock, Shares Outstanding		148,382,299
Entity Emerging Growth Company	false
Entity Small Business	true

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
CURRENT ASSETS:
Cash and cash equivalents	$ 30,363	$ 37,808
Accounts receivable – Trade	8,565	4,729
Other assets	1,706	1,877
Inventories	6,707	8,569
Total current assets	47,341	52,983
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT	1,801	1,758
PROPERTY AND EQUIPMENT, NET	6,058	6,390
OPERATING LEASE RIGHT OF USE ASSETS	5,844	0
Total assets	61,044	61,131
Accounts payable and accruals:
Trade	5,870	5,211
Other	10,480	10,274
Operating lease liabilities	1,257
Contracts liability	9,429	9,868
Total current liabilities	27,036	25,353
LONG TERM LIABILITIES:
Convertible notes	48,670	47,966
Contracts liability	32,979	33,027
Liability for employee rights upon retirement	2,426	2,374
Operating lease liabilities	4,498
Other long term liabilities	5,290	5,292
Total long term liabilities	93,863	88,659
Total liabilities	120,899	114,012
CAPITAL DEFICIENCY	(59,855)	(52,881)
Total liabilities net of capital deficiency	$ 61,044	$ 61,131

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($)
shares in Thousands, $ in Thousands

3 Months Ended

Mar. 31, 2019

Mar. 31, 2018

COST OF GOODS SOLD

$ (2,045)

$ (2,924)

RESEARCH AND DEVELOPMENT EXPENSES (1)

^[1]

(11,701)

(7,286)

Less - grants

843

RESEARCH AND DEVELOPMENT EXPENSES, NET

(11,698)

(6,443)

SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)

^[2]

(2,230)

(2,498)

OPERATING LOSS

(5,534)

(5,151)

FINANCIAL EXPENSES

(1,920)

(2,220)

FINANCIAL INCOME

190

132

FINANCIAL EXPENSES, NET

(1,730)

(2,088)

LOSS FOR THE PERIOD

$ (7,264)

$ (7,239)

NET LOSS PER SHARE OF COMMON STOCK – BASIC AND DILUTED

$ (0.05)

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE-BASIC AND DILUTED

148,382,299

145,305,982

Goods [Member]

REVENUES

$ 3,530

$ 4,553

License and R&D Services [Member]

REVENUES

$ 6,909

$ 2,161

[1]	(1) Includes share-based compensation
[2]	(2) Includes share-based compensation

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 178	$ 42
Selling, General and Administrative Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 112	$ 20

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CAPITAL DEFICIENCY - USD ($)
$ in Thousands

3 Months Ended

Mar. 31, 2019

Mar. 31, 2018

Balance

$ (52,881)

$ (29,457)

Balance (in shares)

^[1]

148,382,299

143,728,797

Share-based compensation related to stock options

$ 290

$ 46

Share-based compensation related to restricted stock award

$ 16

Share-based compensation related to restricted stock award (in shares)

^[1]

29,898

Convertible notes conversions

$ 1,192

Convertible notes conversions (in shares)

^[1]

1,811,260

Net loss for the period

(7,264)

$ (7,239)

Balance

$ (59,855)

$ (35,442)

Balance (in shares)

^[1]

148,382,299

145,569,955

Common Stock [Member]

Balance

$ 148

$ 144

Share-based compensation related to restricted stock award

^[2]

Convertible notes conversions

Balance

148

146

Additional Paid-in Capital [Member]

Balance

269,524

266,495

Share-based compensation related to stock options

290

Share-based compensation related to restricted stock award

Convertible notes conversions

1,190

Balance

269,814

267,747

Accumulated Deficit [Member]

Balance

(322,553)

(296,096)

Net loss for the period

(7,264)

(7,239)

Balance

$ (329,817)

$ (303,335)

[1]	Common Stock, $0.001 par value; Authorized – as of March 31, 2019 and 2018 - 250,000,000.
[2]	* Represents an amount less than $1.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CAPITAL DEFICIENCY [Parenthetical] - $ / shares	Mar. 31, 2019	Mar. 31, 2018
Common Stock, Par or Stated Value Per Share	$ 0.001	$ 0.001
Common Stock, Shares Authorized	250,000,000	250,000,000

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (7,264)	$ (7,239)
Adjustments required to reconcile net loss to net cash used in operating activities:
Share based compensation	290	62
Depreciation	405	430
Financial expenses, net (mainly exchange differences)	20	28
Changes in accrued liability for employee rights upon retirement	(24)	(124)
Gain on amounts funded in respect of employee rights upon retirement		(44)
Net loss in connection with conversions of convertible notes		218
Amortization of debt issuance costs and debt discount	704	619
Issuance of shares for interest payment in connection with conversions of convertible notes		205
Changes in operating assets and liabilities:
Increase (decrease) in contracts liability (including non-current portion)	(487)	18
Increase in accounts receivable and other assets	(3,608)	(3,512)
Changes in right of use assets	(36)
Decrease in inventories	1,862	814
Increase (decrease) in accounts payable and accruals	864	(1,009)
Increase (decrease) in other long term liabilities	(2)	121
Net cash used in operating activities	(7,276)	(9,413)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment	(170)	(249)
Increase in restricted deposit	(214)	(188)
Amounts funded in respect of employee rights upon retirement, net	13	109
Net cash used in investing activities	(371)	(328)
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	202	(103)
NET DECREASE IN CASH AND CASH EQUIVALENTS	(7,445)	(9,844)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	37,808	51,163
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	30,363	41,319
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	$ 128	342
Convertible notes conversions		987
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Interest paid		$ 145

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES

General

Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (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 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.

The Company’s product pipeline currently includes, among other candidates:

(1) pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder;

(2) alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of Cystic Fibrosis, to be administered by inhalation; and

(3) OPRX-106, the Company’s oral antiTNF product candidate which is being developed as an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein.

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 October 19, 2017, Protalix Ltd. and Chiesi Farmaceutici S.p.A. (“Chiesi”) entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Chiesi was granted 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 the 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 an additional up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments.

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.

Since its approval by the FDA, taliglucerase alfa has been marketed by 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, 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 Fiocruz, an arm of the Brazilian MoH, for taliglucerase alfa. Fiocruz’s purchases of 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 alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with alfataliglicerase in Brazil.

Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months from the date of approval of the financial statements as of March 31, 2019, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing.

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, 2018, filed by the Company with the Commission. The comparative balance sheet at December 31, 2018 has been derived from the audited financial statements at that date.

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, par value $0.001 per share (the “Common Stock”), outstanding for each period.

Diluted LPS is calculated in continuing operations. The calculation of diluted LPS does not include 73,800,491 and 78,202,020 shares of Common Stock underlying outstanding options and restricted shares of Common Stock and shares issuable upon conversion of outstanding convertible notes for the three months ended March 31, 2018 and 2019, respectively, because the effect would be anti-dilutive.

Recently adopted standards

In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard requires a lessee to record assets and liabilities on its balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the lessee’s income statement. The Company adopted this standard as of January 1, 2019 on a modified retrospective basis and will not restate comparative periods. The Company will elect the package of 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 Company made an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company recognized those lease payments in its statements of operations on a straight-line basis over the lease period.

As of the adoption date, the Company recognized an operating lease asset and liability of $5.9 million and $5.7 million, respectively, as of January 1, 2019 on its balance sheet.

Newly issued accounting pronouncements

In June 2018, the FASB issued ASU 2018-07, “Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-based Payment Accounting” that expands the scope of ASC Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of ASC Topic 718 to nonemployee awards except for certain exemptions specified in ASU 2018-07. The guidance is effective for fiscal years beginning after December 15, 2018, including interim reporting periods within that fiscal year. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company does not expect the adoption of ASU 2018-07 to have a material impact on its financial statements.

INVENTORIES

3 Months Ended

Mar. 31, 2019

Inventory Disclosure [Abstract]

INVENTORIES

NOTE 2 - INVENTORIES

Inventories at March 31, 2019 and December 31, 2018 consisted of the following:

	March 31,		December 31,
( U.S. dollars in thousands)	2019		2018
Raw materials	$	3,047	$	3,792
Work in progress		45
Finished goods		3,615		4,777
Total inventory	$	6,707	$	8,569

During the year ended December 31, 2018 and the three months ended March 31, 2019, the Company recorded approximately $

1.1

million and $

65,000

, respectively, for write-down of inventory under cost of goods sold.

FAIR VALUE MEASUREMENT

3 Months Ended

Mar. 31, 2019

Fair Value Disclosures [Abstract]

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. The fair value of the convertible notes derivative is based on Level

measurement.

The fair value of the $57.9

million

principal amount of the Company’s outstanding 7.50% convertible promissory notes due 2021 (the “2021 Notes”) as of March 31, 2019 is appro

ximately $64.5 million based on a Level 3 measurement.

The Company prepared a valuation of the fair value of the Company’s outstanding 2021 Notes (a Level 3 valuation) as of March 31, 2019. 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
Stock price (USD)			0.44
Expected term			2.63
Risk free rate			2.21%
Volatility			81.56%
Yield			12.6%

- 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

OPERATING LEASES

3 Months Ended

Mar. 31, 2019

Leases, Operating [Abstract]

OPERATING LEASES

NOTE 4 –

OPERATING LEASES

The Company is a party to a number of lease agreements for its facilities, the latest of which has been extended until 2021. The Company has the option to extend certain of such agreements on two additional occasions for additional five-year periods each, for a total of 10 additional years. During the extended lease period, the aggregate monthly rental payments will increase by 7.5% - 10% for each option. The Company expects to exercise these options in future periods. As of March 31, 2019, the Company provided bank guarantees of approximately $412,000, in the aggregate, to secure the fulfillment of its obligations under the lease agreements. As of December 31, 2018, the future minimum lease payments required under the operating leases for such premises are approximately $758,000, $758,000 and $621,000, for fiscal years 2019 through 2021, respectively.

The Company entered into several three-year leases for vehicles which are regularly amended as new vehicles are leased. As of December 31, 2018, the future minimum lease payments for the years ending December 31, 2019, 2020 and 2021 are approximately $474,000, $333,000 and $82,000, respectively.

The following table sets forth data regarding the Company’s operating leases for the three months ended March 31, 2019:

( U.S. dollars in thousands)	March 31, 2019
Operating lease costs	$	292
Cash paid for amounts included in the measurement of lease liabilities		328
Right of use assets obtained in exchange for new operating lease liabilities		52
Weighted average remaining lease term (in years)		10.84
Weighted average discount rate		12.58	%

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of March 31, 2019:

( U.S. dollars in thousands)	March 31, 2019
2019 (excluding the three months ended March 31, 2019)	$	947
2020	$	1,135
2021	$	888
2022	$	774
2023	$	770
After 2024	$	6,380
Total undiscounted cash flows	$	10,894
Less: imputed interest	$	5,139
Present value of lease liabilities	$	5,755

REVENUES

3 Months Ended

Mar. 31, 2019

Income Statement [Abstract]

REVENUES

NOTE 5 – REVENUES

The following table summarizes the Company’s disaggregation of revenues:

	Three months ended March 31,
(U.S. dollars in thousands)	2019		2018
Pfizer	$	1,356	$	1,980
Brazil	$	2,174	$	2,573
Total revenues from selling goods	$	3,530	$	4,553
Revenues from license and R&D services	$	6,909	$	2,161

The following table sets forth data regarding the Company’s contract liability:

	Three months ended March 31,
(U.S. dollars in thousands)	2019			2018
Contract liabilities at the beginning of the period	$	42,895		$	25,015
Additions during the period		6,422			2,179
Revenue recognized during the period		(6,909	)		(2,161	)
Contract liabilities at the end of the period	$	42,408		$	25,033

The following table represents the Company's unsatisfied performance obligation:

	March 31,
(U.S. dollars in thousands)	2019		2018
Unsatisfied performance obligation	$	64,581	$	91,033

SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2019

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

NOTE 6 – SUBSEQUENT EVENTS

The Company has evaluated subsequent events through the date on which the consolidated financial statements were available to be issued and no subsequent events were identified.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2019

Accounting Policies [Abstract]

General

The Company’s product pipeline currently includes, among other candidates:

(1) pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder;

Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the

“

Chiesi Agreements

”)

Basis of presentation

Net loss per share

Recently adopted standards

As of the adoption date, the Company recognized an operating lease asset and liability of $5.9 million and $5.7 million, respectively, as of January 1, 2019 on its balance sheet.

Newly issued accounting pronouncements

INVENTORIES (Tables)

3 Months Ended

Mar. 31, 2019

Inventory Disclosure [Abstract]

Schedule of Inventory

Inventories at March 31, 2019 and December 31, 2018 consisted of the following:

	March 31,		December 31,
( U.S. dollars in thousands)	2019		2018
Raw materials	$	3,047	$	3,792
Work in progress		45
Finished goods		3,615		4,777
Total inventory	$	6,707	$	8,569

FAIR VALUE MEASUREMENT (Tables)

3 Months Ended

Mar. 31, 2019

Notes 2021 [Member]

Fair Value Measurements, Recurring and Nonrecurring

OPERATING LEASES (Tables)

3 Months Ended

Mar. 31, 2019

Leases, Operating [Abstract]

Lease, Cost

The following table sets forth data regarding the Company’s operating leases for the three months ended March 31, 2019:

( U.S. dollars in thousands)	March 31, 2019
Operating lease costs	$	292
Cash paid for amounts included in the measurement of lease liabilities		328
Right of use assets obtained in exchange for new operating lease liabilities		52
Weighted average remaining lease term (in years)		10.84
Weighted average discount rate		12.58	%

Lessee, Operating Lease, Liability, Maturity

The following table sets forth a maturity analysis of the Company’s operating lease liabilities as of March 31, 2019:

( U.S. dollars in thousands)	March 31, 2019
2019 (excluding the three months ended March 31, 2019)	$	947
2020	$	1,135
2021	$	888
2022	$	774
2023	$	770
After 2024	$	6,380
Total undiscounted cash flows	$	10,894
Less: imputed interest	$	5,139
Present value of lease liabilities	$	5,755

REVENUES (Tables)

3 Months Ended

Mar. 31, 2019

Income Statement [Abstract]

Statements of operations

The following table summarizes the Company’s disaggregation of revenues:

	Three months ended March 31,
(U.S. dollars in thousands)	2019		2018
Pfizer	$	1,356	$	1,980
Brazil	$	2,174	$	2,573
Total revenues from selling goods	$	3,530	$	4,553
Revenues from license and R&D services	$	6,909	$	2,161

Contract with Customer, Asset and Liability [Table Text Block]

The following table sets forth data regarding the Company’s contract liability:

	Three months ended March 31,
(U.S. dollars in thousands)	2019			2018
Contract liabilities at the beginning of the period	$	42,895		$	25,015
Additions during the period		6,422			2,179
Revenue recognized during the period		(6,909	)		(2,161	)
Contract liabilities at the end of the period	$	42,408		$	25,033

Revenue, Remaining Performance Obligation, Amount [Table Text Block]

The following table represents the Company's unsatisfied performance obligation:

	March 31,
(U.S. dollars in thousands)	2019		2018
Unsatisfied performance obligation	$	64,581	$	91,033

SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands	1 Months Ended		3 Months Ended
	Jul. 23, 2018	Oct. 19, 2017	Mar. 31, 2019	Mar. 31, 2018	Jan. 01, 2019	Dec. 31, 2018	Oct. 31, 2015
Significant Accounting Policies [Line Items]
Common Stock, Par or Stated Value Per Share			$ 0.001	$ 0.001
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount			78,202,020	73,800,491
Operating Lease, Right-of-Use Asset			$ 5,844		$ 5,900	$ 0
Operating Lease, Liability			$ 5,755		$ 5,700
Amended Pfizer Agreement [Member] \| Protalix Bio Therapeutics Incorporation [Member] \| Brazil [Member]
Significant Accounting Policies [Line Items]
Collaborative Arrangement Revenues and Expenses Sharing Percentage							100.00%
Chiesi US Agreement [Member]
Significant Accounting Policies [Line Items]
Upfront Nonrefundable Noncreditable Payment Receivable	$ 25,000
Additional Amounts Payable To Cover Development Costs	20,000
Maximum Entitlement Of Development Costs To Cover Per Year	7,500
Additional AmountPayable For Achievement Of Regulatory And Commercial Milestones	$ 760,000
Chiesi US Agreement [Member] \| Minimum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage	15.00%
Chiesi US Agreement [Member] \| Maximum [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage	40.00%
Chiesi Ex US Agreement [Member]
Significant Accounting Policies [Line Items]
Upfront Nonrefundable Noncreditable Payment Receivable		$ 25,000
Maximum Entitlement Of Development Costs To Cover Per Year		10,000
Additional AmountPayable For Achievement Of Regulatory And Commercial Milestones		$ 320,000
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 [Member]
Significant Accounting Policies [Line Items]
Payment On Net Sales Percentage		35.00%

INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Dec. 31, 2018
Raw materials	$ 3,047	$ 3,792
Work in progress	45
Finished goods	3,615	4,777
Total inventory	$ 6,707	$ 8,569

INVENTORIES (Details Textual) - USD ($)	3 Months Ended	12 Months Ended
INVENTORIES (Details Textual) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Inventory Write-down	$ 65,000	$ 1,100,000

FAIR VALUE MEASUREMENT (The liability component was valued based on the Income Approach) (Details) - 2021 Notes [Member] - Fair Value, Inputs, Level 3 [Member]	3 Months Ended
	Mar. 31, 2019 $ / shares
Stock price (USD)	$ 0.44
Expected term	2 years 7 months 17 days
Risk free rate	2.21%
Volatility	81.56%
Yield	12.60%

FAIR VALUE MEASUREMENT (Narrative) (Details) $ in Millions	Mar. 31, 2019 USD ($)
Seven Point Five Percentage Convertible Notes 2021 [Member]
Debt Instrument, Interest Rate, Stated Percentage	7.50%
Fair Value, Inputs, Level 3 [Member] \| Seven Point Five Percentage Convertible Notes [Member]
Convertible Debt, Fair Value Disclosures	$ 64.5
Debt Instrument, Face Amount	$ 57.9

OPERATING LEASES (Lease, Cost) (Details) $ in Thousands	3 Months Ended
OPERATING LEASES (Lease, Cost) (Details) $ in Thousands	Mar. 31, 2019 USD ($)
Disclosure of Leases Operating [Line Items]
Operating lease costs	$ 292
Cash paid for amounts included in the measurement of lease liabilities	328
Right of use assets obtained in exchange for new operating lease liabilities	$ 52
Weighted average remaining lease term (in years)	10 years 10 months 2 days
Weighted average discount rate	12.58%

OPERATING LEASES (Lessee, Operating Lease, Liability, Maturity) (Details) - USD ($) $ in Thousands	Mar. 31, 2019	Jan. 01, 2019
Disclosure of Leases Operating [Line Items]
2019 (excluding the three months ended March 31, 2019)	$ 947
2020	1,135
2021	888
2022	774
2023	770
After 2024	6,380
Total undiscounted cash flows	10,894
Less: imputed interest	5,139
Present value of lease liabilities	$ 5,755	$ 5,700

OPERATING LEASES (Narrative) (Details)	3 Months Ended
OPERATING LEASES (Narrative) (Details)	Mar. 31, 2019 USD ($)
Minimum [Member]
Disclosure of Leases Operating [Line Items]
Percentage of Change in Operating Lease Monthly Rental Payments	7.50%
Maximum [Member]
Disclosure of Leases Operating [Line Items]
Percentage of Change in Operating Lease Monthly Rental Payments	10.00%
Vehicle Lease [Member]
Disclosure of Leases Operating [Line Items]
Operating Leases, Future Minimum Payments Due, Next Twelve Months	$ 474,000
Operating Leases, Future Minimum Payments, Due in Two Years	333,000
Operating Leases, Future Minimum Payments, Due in Three Years	82,000
Lease Agreements [Member]
Disclosure of Leases Operating [Line Items]
Operating Leases, Future Minimum Payments Due, Next Twelve Months	758,000
Operating Leases, Future Minimum Payments, Due in Two Years	758,000
Operating Leases, Future Minimum Payments, Due in Three Years	621,000
Security Deposit	$ 412,000

REVENUES (Statements of operations) (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Pfizer [Member]
Revenues	$ 1,356	$ 1,980
Brazil [Member]
Revenues	2,174	2,573
Goods [Member]
Revenues	3,530	4,553
License and R&D Services [Member]
Revenues	$ 6,909	$ 2,161

REVENUES (Contract With Customer Asset And Liability) (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Contract liabilities at the beginning of the period	$ 42,895	$ 25,015
Additions during the period	6,422	2,179
Revenue recognized during the period	(6,909)	(2,161)
Contract liabilities at the end of the period	$ 42,408	$ 25,033

REVENUES (Unsatisfied Performance Obligations) (Detail) - USD ($) $ in Thousands	Mar. 31, 2019	Mar. 31, 2018
Unsatisfied performance obligation	$ 64,581	$ 91,033