View Filing Data

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2020	May 24, 2020
Document and Entity Information
Document Type	10-Q
Document Period End Date	Mar. 31, 2020
Entity Registrant Name	Protalix BioTherapeutics, Inc.
Trading Symbol	PLX
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		32,442,636
Entity Central Index Key	0001006281
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q1
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
CURRENT ASSETS:
Cash and cash equivalents	$ 14,166	$ 17,792
Short-term bank deposits	22,509	0
Accounts receivable - Trade	8,876	4,700
Other assets	2,728	1,832
Inventories	9,488	8,155
Total current assets	57,767	32,479
NON-CURRENT ASSETS:
Long-term bank deposits	12,505	0
Funds in respect of employee rights upon retirement	1,879	1,963
Property and equipment, net	5,012	5,273
Operating lease right of use assets	5,713	5,677
Total non-current assets	25,109	12,913
Total assets	82,876	45,392
Accounts payable and accruals:
Trade	9,430	6,495
Other	13,757	11,905
Operating lease liabilities	1,126	1,139
Contracts liability	19,014	16,335
Promissory Note	4,301	4,301
Total current liabilities	47,628	40,175
LONG TERM LIABILITIES:
Convertible notes	51,777	50,957
Contracts liability	7,130	16,980
Liability for employee rights upon retirement	2,531	2,565
Operating lease liabilities	4,481	4,528
Other long term liabilities	210	509
Total long term liabilities	66,129	75,539
Total liabilities	113,757	115,714
COMMITMENTS
Total capital deficiency	(30,881)	(70,322)
Total liabilities net of capital deficiency	$ 82,876	$ 45,392

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
REVENUES	$ 21,646	$ 10,439
COST OF GOODS SOLD	(3,426)	(2,045)
RESEARCH AND DEVELOPMENT EXPENSES, NET (1)	(10,340)	(11,698)
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2)	(3,187)	(2,230)
OPERATING INCOME (LOSS)	4,693	(5,534)
FINANCIAL EXPENSES	(3,229)	(1,920)
FINANCIAL INCOME	203	190
FINANCIAL EXPENSES, NET	(3,026)	(1,730)
NET INCOME (LOSS) FOR THE PERIOD	$ 1,667	$ (7,264)
EARNINGS (LOSS) PER SHARE OF COMMON STOCK-BASIC AND DILUTED	$ 0.10	$ (0.50)
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC AND DILUTED	17,381,074	14,838,213
Goods [Member]
REVENUES	$ 5,031	$ 3,530
License and R&D Services [Member]
REVENUES	$ 16,615	$ 6,909

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CAPITAL DEFICIENCY - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Beginning balance	$ (70,322)	$ (52,881)
Issuance of common stock and warrants, net of issuance cost	41,343
Note receivable from issuance of common stock and warrants	(4,000)
Share-based compensation	431	290
Net income (loss) for the period	1,667	(7,264)
Ending balance	(30,881)	(59,855)
Common Stock [Member]
Beginning balance	$ 15	$ 15
Beginning balance (in shares)	14,838,213	14,838,213
Issuance of common stock and warrants, net of issuance cost	$ 18
Issuance of common stock and warrants, net of issuance cost (in shares)	17,604,423
Ending balance	$ 33	$ 15
Ending balance (in shares)	32,442,636	14,838,213
Additional Paid-in Capital [Member]
Beginning balance	$ 270,492	$ 269,657
Issuance of common stock and warrants, net of issuance cost	41,325
Note receivable from issuance of common stock and warrants	(4,000)
Share-based compensation	431	290
Ending balance	308,248	269,947
Accumulated Deficit [Member]
Beginning balance	(340,829)	(322,553)
Net income (loss) for the period	1,667	(7,264)
Ending balance	$ (339,162)	$ (329,817)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss)	$ 1,667	$ (7,264)
Adjustments required to reconcile net income (loss) to net cash used in operating activities:
Share based compensation	431	290
Depreciation	376	405
Financial expenses (income), net (mainly exchange differences)	(241)	20
Changes in accrued liability for employee rights upon retirement	44	(24)
Loss on amounts funded in respect of employee rights upon retirement	59
Amortization of debt issuance costs and debt discount	820	704
Changes in operating assets and liabilities:
Decrease in contracts liability (including non-current portion)	(7,171)	(487)
Increase in accounts receivable and other assets	(4,091)	(3,608)
Changes in right of use assets	10	(36)
Decrease (increase) in inventories	(1,333)	1,862
Increase in accounts payable and accruals	2,611	864
Decrease in other long term liabilities	(299)	(2)
Net cash used in operating activities	(7,117)	(7,276)
CASH FLOWS FROM INVESTING ACTIVITIES:
Increase in bank deposits (including long-term deposits)	(35,000)
Purchase of property and equipment	(66)	(170)
Decrease (increase) in restricted deposit	22	(214)
Amounts funded in respect of employee rights upon retirement, net	(35)	13
Net cash used in investing activities	(35,079)	(371)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants, net of issuance cost	38,607
Net cash provided by financing activities	38,607
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(37)	202
NET DECREASE IN CASH AND CASH EQUIVALENTS	(3,626)	(7,445)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	17,792	37,808
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD	14,166	30,363
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS:
Purchase of property and equipment	147	$ 128
Right of use assets obtained in exchange for new operating lease liabilities	233
Note receivable from issuance of common stock and warrants, net of issuance cost	$ 2,736

SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2020

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

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; and

(3)

OPRX‑106, the Company’s oral anti-TNF 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 May 28, 2020, the Company, together with Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., the Company’s development and commercialization partner (“Chiesi”), announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (the “FDA”) for pegunigalsidase alfa for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway.

On March 18, 2020, the Company completed a private placement of common stock and warrants. In connection with the offering, the Company issued 17,604,423 unregistered shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a purchase price per share of $2.485 and warrants to purchase an additional 17,604,423 shares of Common Stock at an exercise price of $2.36 per share. The warrants are exercisable commencing six months following their issuance for a period of five years from the date of issuance. For accounting purposes, the warrants are classified as equity considering the warrants’ terms.

The net proceeds committed from the private placement were approximately $41.3 million, after deducting advisory fees and other estimated offering expenses.

In April and May, 2020, the Company collected total proceeds of approximately $9.0 million from accounts receivable outstanding at March 31, 2020. Total proceeds of approximately $4.7 million in connection with its collaboration with Chiesi, total proceeds of approximately $3.0 million from sales of alfataliglicerase to Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), and total proceeds of approximately $1.3 million from sales of drug substance to Pfizer Inc. (“Pfizer”).

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.

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, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues.

On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fiocruz 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.

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, 2019, filed by the Company with the U.S Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2019 has been derived from the audited financial statements at that date.

c.Earnings (loss) per share

Basic and diluted earnings per share (“EPS”) are computed by dividing net income (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 EPS does not include 7,826,946 and 10, 694,517 shares of Common Stock underlying outstanding options and restricted shares of Common Stock and shares issuable upon conversion of outstanding convertible notes and outstanding warrants for the three months ended March 31, 2019 and 2020, respectively, because their effect would be anti-dilutive.

The computation of basic and diluted net income (loss) per common stock was adjusted retrospectively for all periods presented to reflect the Company’s reverse stock split at a ratio of one-for-ten, effective as of December 19, 2019.

d.Revenue recognition

Effective January 1, 2018, the Company adopted 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 obligation in Chiesi agreements as follows: (1) the license and research and development services and (2) 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.

e. Other assets

Other assets include $1.0 million in connection with the March 2020 private placement of Common Stock and warrants, which was received after the quarter-end.

f. Recently issued accounting pronouncements

In June 2016, the Financial Accounting Standards Board issued an Accounting Standards Update that supersedes the existing impairment model for most financial assets to a current expected credit loss model. The new guidance requires an entity to recognize an impairment allowance equal to its current estimate of all contractual cash flows the entity does not expect to collect. The Company adopted this guidance effective January 1, 2020, with no material impact on its consolidated financial statements.

FAIR VALUE MEASUREMENT

3 Months Ended

Mar. 31, 2020

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. The fair value of the convertible notes derivative is based on Level 3 measurement.

As of March 31, 2020, the carrying amounts of short-term and long-term deposits approximate their fair values due to the stated interest rates, which approximate market rates.

The fair value of the $57.9 million aggregate principal amount of the Company’s outstanding 7.50% convertible promissory notes due November 2021 (the “2021 Notes”) as of March 31, 2020 is approximately $56.2 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, 2020. 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)	2.35
Expected term	1.63
Risk free rate	0.23	%
Volatility	100.57	%
Yield	15.41	%

- 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

SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2020

SIGNIFICANT ACCOUNTING POLICIES

General

a.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;

(2)

alidornase alfa, or PRX‑110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase; and

(3)

The net proceeds committed from the private placement were approximately $41.3 million, after deducting advisory fees and other estimated offering expenses.

Basis of presentation

b.Basis of presentation

Earnings (loss) per share

c.Earnings (loss) per share

Revenue recognition

d.Revenue recognition

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.

1.Revenues from selling products

The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).

2.Revenue from Chiesi Agreements

Revenue from additional research and development services ordered by Chiesi, is recognized over time using the cost-to-cost method.

3.Revenue from R&D services

Other assets

e. Other assets

Other assets include $1.0 million in connection with the March 2020 private placement of Common Stock and warrants, which was received after the quarter-end.

Recently issued accounting pronouncements

f. Recently issued accounting pronouncements

SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ / shares in Units, $ in Millions			1 Months Ended			2 Months Ended	3 Months Ended
	Mar. 18, 2020	Dec. 19, 2019	Jul. 23, 2018	Oct. 19, 2017	Oct. 31, 2015	May 31, 2020	Mar. 31, 2020	Mar. 31, 2019
Significant Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount							10,694,517	7,826,946
Net proceeds from private placement	$ 41.3
Subsequent Event [Member]
Significant Accounting Policies [Line Items]
Total proceeds from accounts receivable outstanding						$ 9.0
Total proceeds from accounts receivable outstanding - Chiesi						4.7
Subsequent Event [Member] \| Alfataliglicerase [Member]
Significant Accounting Policies [Line Items]
Total proceeds from accounts receivable outstanding - Fiocruz						3.0
Subsequent Event [Member] \| Drug Substance [Member]
Significant Accounting Policies [Line Items]
Total proceeds from accounts receivable outstanding - Pfizer						$ 1.3
Private Placement [Member]
Significant Accounting Policies [Line Items]
Common Stock, Par or Stated Value Per Share	$ 0.001
Number of shares issued (in shares)	17,604,423
Par value (in dollars per share)	$ 0.001
Purchase price (in dollars per share)	$ 2.485
Number of warrants issued (in shares)	17,604,423
Exercise price of warrants (in dollars per share)	$ 2.36
Exercise of warrants, commencement period	6 months
Term of warrants	5 years
Reverse stock split ratio		1-for-10
Receivable from issuance of common stock and warrants							$ 1.0
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 Non-Creditable Payment Receivable			$ 25.0
Additional Amounts Payable To Cover Development Costs			20.0
Maximum Entitlement Of Development Costs To Cover Per Year			7.5
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones			$ 760.0
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 Non-Creditable Payment Receivable				$ 25.0
Additional Amounts Payable To Cover Development Costs				25.0
Maximum Entitlement Of Development Costs To Cover Per Year				10.0
Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones				$ 320.0
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%

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Research and Development Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 78	$ 178
Selling, General and Administrative Expenses [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Share-based compensation	$ 353	$ 112

INVENTORIES (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
INVENTORIES
Raw materials	$ 3,424	$ 3,607
Work in progress	759	552
Finished goods	5,305	3,996
Total inventory	$ 9,488	$ 8,155

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, 2020 $ / shares
Stock price (USD)	$ 2.35
Expected term	1 year 7 months 17 days
Risk free rate	0.23%
Volatility	100.57%
Yield	15.41%

FAIR VALUE MEASUREMENT - Additional Information (Details) - Seven Point Five Percentage Convertible Notes [Member] $ in Millions	Mar. 31, 2020 USD ($)
Interest rate (as a percent)	7.50%
Fair Value, Inputs, Level 3 [Member]
Convertible Debt, Fair Value Disclosures	$ 56.2
Long-term Debt, Gross	$ 57.9

REVENUES - Company's disaggregation of revenues (Details) - USD ($) $ in Thousands		3 Months Ended
	Mar. 16, 2020	Mar. 31, 2020	Mar. 31, 2019
Revenues		$ 21,646	$ 10,439
Non refundable payments not yet recognized to revenues	$ 1,000
Pfizer [Member]
Revenues		2,016	1,356
Brazil [Member]
Revenues		3,015	2,174
Chiesi US Agreement [Member]
Revenue recognized due to change in estimate of total costs expected to be incurred		6,700
Goods [Member]
Revenues		5,031	3,530
License and R&D Services [Member]
Revenues		$ 16,615	$ 6,909