Document and Entity Information
| Document and Entity Information - shares | 3 Months Ended | |
| Mar. 31, 2021 | May 10, 2021 | |
| Document and Entity Information | ||
| Document Type | 10-Q | |
| Document Quarterly Report | true | |
| Document Transition Report | false | |
| Document Period End Date | Mar. 31, 2021 | |
| Entity File Number | 001-33357 | |
| Entity Registrant Name | PROTALIX BIOTHERAPEUTICS, INC. | |
| Entity Incorporation, State or Country Code | DE | |
| Entity Tax Identification Number | 65-0643773 | |
| Entity Address, Address Line One | 2 University Plaza | |
| Entity Address, Address Line Two | Suite 100 | |
| Entity Address, City or Town | Hackensack | |
| Entity Address, State or Province | NJ | |
| Entity Address, Postal Zip Code | 07601 | |
| City Area Code | (201) | |
| Local Phone Number | 696-9345 | |
| Title of 12(b) Security | Common stock, $0.001 par value | |
| Trading Symbol | PLX | |
| Security Exchange Name | NYSEAMER | |
| Entity Current Reporting Status | Yes | |
| Entity Interactive Data Current | Yes | |
| Entity Filer Category | Non-accelerated Filer | |
| Entity Small Business | true | |
| Entity Emerging Growth Company | false | |
| Entity Shell Company | false | |
| Entity Common Stock, Shares Outstanding | 45,382,831 | |
| Entity Central Index Key | 0001006281 | |
| Current Fiscal Year End Date | --12-31 | |
| Document Fiscal Year Focus | 2021 | |
| Document Fiscal Period Focus | Q1 | |
| Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
| CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
| CURRENT ASSETS: | ||
| Cash and cash equivalents | $ 19,830 | $ 18,265 |
| Short-term bank deposits | 50,600 | 20,280 |
| Accounts receivable - Trade | 4,599 | 2,000 |
| Other assets | 1,754 | 2,096 |
| Inventories | 13,915 | 13,082 |
| Total current assets | 90,698 | 55,723 |
| NON-CURRENT ASSETS: | ||
| Funds in respect of employee rights upon retirement | 1,776 | 1,799 |
| Property and equipment, net | 4,828 | 4,845 |
| Operating lease right of use assets | 5,490 | 5,567 |
| Total assets | 102,792 | 67,934 |
| Accounts payable and accruals: | ||
| Trade | 6,376 | 7,221 |
| Other | 15,167 | 13,926 |
| Operating lease liabilities | 1,386 | 1,420 |
| Contracts liability | 2,560 | 5,394 |
| Convertible notes | 55,372 | 54,427 |
| Promissory note | 4,086 | |
| Total current liabilities | 80,861 | 86,474 |
| LONG TERM LIABILITIES: | ||
| Contracts liability | 858 | 1,716 |
| Liability for employee rights upon retirement | 2,224 | 2,263 |
| Operating lease liabilities | 4,319 | 4,467 |
| Other long term liabilities | 26 | 51 |
| Total long term liabilities | 7,427 | 8,497 |
| Total liabilities | 88,288 | 94,971 |
| STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) | 14,504 | (27,037) |
| Total liabilities and stockholders' equity (net of capital deficiency) | $ 102,792 | $ 67,934 |
CONDENSED CONSOLIDATED STATEMEN
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | ||
| Mar. 31, 2021 | Mar. 31, 2020 | ||
| TOTAL REVENUE | $ 11,320 | $ 21,646 | |
| COST OF GOODS SOLD | [1] | (4,765) | (3,426) |
| RESEARCH AND DEVELOPMENT EXPENSES, NET | [2] | (7,122) | (10,340) |
| SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | [3] | (3,138) | (3,187) |
| OPERATING INCOME (LOSS) | (3,705) | 4,693 | |
| FINANCIAL EXPENSES | (2,156) | (3,229) | |
| FINANCIAL INCOME | 335 | 203 | |
| FINANCIAL EXPENSES - NET | (1,821) | (3,026) | |
| OTHER INCOME | 51 | ||
| NET INCOME (LOSS) FOR THE PERIOD | $ (5,475) | $ 1,667 | |
| EARNINGS (LOSS) PER SHARE OF COMMON STOCK - BASIC AND DILUTED | $ (0.14) | $ 0.10 | |
| WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE - BASIC AND DILUTED | 39,933,972 | 17,381,074 | |
| Goods [Member] | |||
| TOTAL REVENUE | $ 4,511 | $ 5,031 | |
| License and R&D Services [Member] | |||
| TOTAL REVENUE | $ 6,809 | $ 16,615 | |
| [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 | |
| Mar. 31, 2021 | Mar. 31, 2020 | |
| Cost of Sales [Member] | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Share-based compensation | $ 109 | |
| Research and Development Expenses [Member] | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Share-based compensation | 210 | $ 78 |
| Selling, General and Administrative Expenses [Member] | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Share-based compensation | $ 497 | $ 353 |
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 | 14,838,213 | |||
| Issuance of common stock and warrants, net of issuance cost | $ 18 | 41,325 | 41,343 | |
| Issuance of common stock and warrants, net of issuance cost (in shares) | 17,604,423 | |||
| Note receivable from issuance of common stock and warrants | (4,000) | (4,000) | ||
| Share-based compensation related to stock options | 431 | 431 | ||
| Net (loss) income for the period | 1,667 | 1,667 | ||
| Ending balance at Mar. 31, 2020 | $ 33 | 308,248 | (339,162) | (30,881) |
| Ending balance (in shares) at Mar. 31, 2020 | 32,442,636 | |||
| Beginning balance at Dec. 31, 2020 | $ 35 | 320,280 | (347,352) | (27,037) |
| Beginning balance (in shares) at Dec. 31, 2020 | 34,765,280 | |||
| Issuance of common stock, net of issuance cost | $ 9 | 37,616 | 37,625 | |
| Issuance of common stock, net of issuance cost (in shares) | 8,749,999 | |||
| Issuance of common stock under the Sales Agreement, net | $ 2 | 8,573 | 8,575 | |
| Issuance of common stock under the Sales Agreement, net (in shares) | 1,867,552 | |||
| Share-based compensation related to stock options | 510 | 510 | ||
| Share-based compensation related to restricted stock awards | 306 | 306 | ||
| Net (loss) income for the period | (5,475) | (5,475) | ||
| Ending balance at Mar. 31, 2021 | $ 46 | $ 367,285 | $ (352,827) | $ 14,504 |
| Ending balance (in shares) at Mar. 31, 2021 | 45,382,831 |
CONDENSED CONSOLIDATED STATEM_4
| CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) (Parenthetical) - $ / shares | Mar. 31, 2021 | Mar. 31, 2020 |
| CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKOLDERS' 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 | 3 Months Ended | |
| Mar. 31, 2021 | Mar. 31, 2020 | |
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||
| Net income (loss) | $ (5,475) | $ 1,667 |
| Adjustments required to reconcile net income (loss) to net cash used in operating activities: | ||
| Share-based compensation | 816 | 431 |
| Depreciation | 286 | 376 |
| Financial income, net (mainly exchange differences) | (168) | (241) |
| Changes in accrued liability for employee rights upon retirement | 42 | 44 |
| Loss (gain) on amounts funded in respect of employee rights upon retirement | (14) | 59 |
| Gain on sale of fixed assets | (51) | |
| Amortization of debt issuance costs and debt discount | 945 | 820 |
| Changes in operating assets and liabilities: | ||
| Decrease in contracts liability (including non-current portion) | (3,692) | (7,171) |
| Increase in accounts receivable and other assets | (2,282) | (4,091) |
| Changes in right of use assets | 42 | 10 |
| Increase in inventories | (833) | (1,333) |
| Increase in accounts payable and accruals | 575 | 2,611 |
| Decrease in other long term liabilities | (25) | (299) |
| Net cash used in operating activities | (9,834) | (7,117) |
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||
| Purchase of bank deposits | (37,835) | (35,000) |
| Proceeds from sale of short-term deposits | 7,500 | |
| Purchase of property and equipment | (386) | (66) |
| Proceeds from sale of property and equipment | 53 | |
| Decrease in restricted deposit | 12 | 22 |
| Amounts funded in respect of employee rights upon retirement, net | (28) | (35) |
| Net cash used in investing activities | (30,684) | (35,079) |
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||
| Net payment for promissory note | (4,086) | |
| Proceeds from issuance of common stock and warrants, net | 37,625 | 38,607 |
| Proceeds from issuance of common stock under the Sales Agreement, net | 8,575 | |
| Net cash provided by financing activities | 42,114 | 38,607 |
| EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (31) | (37) |
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 1,565 | (3,626) |
| BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 18,265 | 17,792 |
| BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 19,830 | 14,166 |
| SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
| Purchase of property and equipment | 202 | 147 |
| Right of use assets obtained in exchange for new operating lease liabilities | 122 | 233 |
| Note receivable from issuance of common stock and warrants, net of issuance cost | $ 2,736 | |
| SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | ||
| Interest received | $ 136 | |
SIGNIFICANT ACCOUNTING POLICIES
| SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
| Mar. 31, 2021 | |
| SIGNIFICANT ACCOUNTING POLICIES | |
| SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® 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. A BLA for PRX-102 for the treatment of adult patients with Fabry disease was submitted to the U.S. Food and Drug Administration (the “FDA”) on May 27, 2020 under the FDA’s Accelerated Approval pathway, which was subsequently accepted by the FDA and granted Priority Review designation. The FDA also indicated in its BLA filing communication letter that it did not plan to hold an advisory committee meeting to discuss the application. 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 FDA regarding the BLA. 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 Protalix’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve the 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, or COVID-19, the FDA reviewed records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that agalsidase beta (Fabrazyme ® 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 is subject to an exclusive worldwide license agreement with SarcoMed USA, Inc. (“SarcoMed”) 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; (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 February 10, 2021, the Company entered into an exclusive worldwide license agreement with 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. Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. The Company is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed has the right to terminate the license agreement if the parties do not successfully do so. On February 17, 2021, the Company issued and sold 8,749,999 shares of its common stock, par value $0.001 per share (the “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, Inc. (“BofA Securities”) acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager. On March 29, 2021, the Company made a payment of approximately $4.0 million to Pfizer Inc. (“Pfizer”) satisfying the outstanding promissory note payable to Pfizer in full. On October 1, 2020, the Company entered into an ATM Equity Offering SM 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 complete amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. Subsequent to March 31, 2021, the Company signed a binding term sheet with Chiesi, pursuant to which the parties reached certain agreements including a $10.0 million payment by Chiesi prior to June 30, 2021 in exchange for the reduction of a longer-term regulatory milestone payment set forth in the Chiesi EX-US Agreement by $25.0 million. All other regulatory and commercial milestone payments remain unchanged. 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 March 31, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. The Company expects that such cash and cash equivalents and bank deposits will be sufficient to satisfy the full payment of the principal amount of the Company’s 7.50% convertible secured promissory notes due November 15, 2021 equal to $57.9 million, unless the notes are refinanced, restructured or converted before that date. 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. Earnings (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 10,694,517 and 26,769,693 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding convertible notes and outstanding warrants for the three months ended March 31, 2020 and 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 | 3 Months Ended |
| Mar. 31, 2021 | |
| INVENTORIES | |
| INVENTORIES | NOTE 2 - INVENTORIES Inventories at March 31, 2021 and December 31, 2020 consisted of the following: March 31, December 31, ( U.S. dollars in thousands) 2021 2020 Raw materials $ 3,427 $ 3,347 Work in progress 2,273 2,887 Finished goods 8,215 6,848 Total inventory $ 13,915 $ 13,082 |
FAIR VALUE MEASUREMENT
| FAIR VALUE MEASUREMENT | 3 Months Ended |
| Mar. 31, 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 March 31, 2021, the carrying amounts of short-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% 2021 Notes as of March 31, 2021 is approximately $59.8 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, 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 Stock price (USD) 4.46 Expected term 0.63 Risk free rate 0.05 % Volatility 71.89 % Yield 11.54 % |
REVENUES
| REVENUES | 3 Months Ended |
| Mar. 31, 2021 | |
| REVENUES | |
| REVENUES | NOTE 4 – REVENUES The following table summarizes the Company’s disaggregation of revenues: Three Months Ended March 31, ( U.S. dollars in thousands) 2021 2020 Pfizer $ 4,511 $ 2,016 Brazil $ — $ 3,015 Total revenues from selling goods $ 4,511 $ 5,031 Revenues from license and R&D services $ 6,809 $ 16,615 During the three months ended March 31, 2020, the Company recorded revenue in the amount of $6.7 million following a change in estimate of the total costs expected to be incurred in connection with the Chiesi Agreements. |
PROMISSORY NOTE
| PROMISSORY NOTE | 3 Months Ended |
| Mar. 31, 2021 | |
| PROMISSORY NOTE | |
| PROMISSORY NOTE | NOTE 5 – PROMISSORY NOTE In September 2020, the Company amended the outstanding $4.3 million promissory note payable to Pfizer by November 2020 to extend the maturity date to the earlier of (a) January 31, 2022 and (b) the date that the Company receives any milestone payment from Chiesi, if at all, subject to certain conditions and exceptions. The amendment also required that the Company make a payment of $430,000 to Pfizer. The payment was creditable against the principal amount of the note, in whole or in part, if the Company was to satisfy the note in full on or prior to September 30, 2021, depending on the date the note is satisfied. On March 29, 2021, the Company made a payment of approximately $4.0 million to Pfizer satisfying the note in full. |
SIGNIFICANT ACCOUNTING POLICI_2
| SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
| Mar. 31, 2021 | |
| SIGNIFICANT ACCOUNTING POLICIES | |
| General | a. General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® ® 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. A BLA for PRX-102 for the treatment of adult patients with Fabry disease was submitted to the U.S. Food and Drug Administration (the “FDA”) on May 27, 2020 under the FDA’s Accelerated Approval pathway, which was subsequently accepted by the FDA and granted Priority Review designation. The FDA also indicated in its BLA filing communication letter that it did not plan to hold an advisory committee meeting to discuss the application. 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 FDA regarding the BLA. 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 Protalix’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve the 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, or COVID-19, the FDA reviewed records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that agalsidase beta (Fabrazyme ® 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 is subject to an exclusive worldwide license agreement with SarcoMed USA, Inc. (“SarcoMed”) 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; (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 February 10, 2021, the Company entered into an exclusive worldwide license agreement with 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. Under the terms of the agreement, SarcoMed will be responsible for the identification and selection of pharmaceutical candidates under the license, and the clinical research and development of such candidates. The Company is entitled to an initial cash payment of $3.5 million, subject to certain conditions, and to additional regulatory and commercial milestone payments and tiered royalties on net sales of products that are commercialized under the license agreement. In addition to the foregoing, the parties agreed to commence negotiation of clinical and commercial supply agreements for alidornase alfa. As part of the arrangement, the parties agreed to negotiate and sign a supply agreement within 60 days of the execution of the license agreement, and SarcoMed has the right to terminate the license agreement if the parties do not successfully do so. On February 17, 2021, the Company issued and sold 8,749,999 shares of its common stock, par value $0.001 per share (the “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, Inc. (“BofA Securities”) acted as book-running manager for the offering with Oppenheimer & Co. acting as co-manager. On March 29, 2021, the Company made a payment of approximately $4.0 million to Pfizer Inc. (“Pfizer”) satisfying the outstanding promissory note payable to Pfizer in full. On October 1, 2020, the Company entered into an ATM Equity Offering SM 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 complete amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. Subsequent to March 31, 2021, the Company signed a binding term sheet with Chiesi, pursuant to which the parties reached certain agreements including a $10.0 million payment by Chiesi prior to June 30, 2021 in exchange for the reduction of a longer-term regulatory milestone payment set forth in the Chiesi EX-US Agreement by $25.0 million. All other regulatory and commercial milestone payments remain unchanged. 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 March 31, 2021 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. The Company expects that such cash and cash equivalents and bank deposits will be sufficient to satisfy the full payment of the principal amount of the Company’s 7.50% convertible secured promissory notes due November 15, 2021 equal to $57.9 million, unless the notes are refinanced, restructured or converted before that date. |
| 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. |
| Earnings (loss) per share | c. Earnings (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 10,694,517 and 26,769,693 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of outstanding convertible notes and outstanding warrants for the three months ended March 31, 2020 and 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) | 3 Months Ended |
| Mar. 31, 2021 | |
| INVENTORIES | |
| Schedule of Inventory | March 31, December 31, ( U.S. dollars in thousands) 2021 2020 Raw materials $ 3,427 $ 3,347 Work in progress 2,273 2,887 Finished goods 8,215 6,848 Total inventory $ 13,915 $ 13,082 |
FAIR VALUE MEASUREMENT (Tables)
| FAIR VALUE MEASUREMENT (Tables) | 3 Months Ended |
| Mar. 31, 2021 | |
| Notes 2021 [Member] | |
| Schedule of liability component based on income approach | 2021 Notes Stock price (USD) 4.46 Expected term 0.63 Risk free rate 0.05 % Volatility 71.89 % Yield 11.54 % |
REVENUES (Tables)
| REVENUES (Tables) | 3 Months Ended |
| Mar. 31, 2021 | |
| REVENUES | |
| Schedule of Company's disaggregation of revenues | Three Months Ended March 31, ( U.S. dollars in thousands) 2021 2020 Pfizer $ 4,511 $ 2,016 Brazil $ — $ 3,015 Total revenues from selling goods $ 4,511 $ 5,031 Revenues from license and R&D services $ 6,809 $ 16,615 |
SIGNIFICANT ACCOUNTING POLICI_3
| SIGNIFICANT ACCOUNTING POLICIES (Details) | May 14, 2021USD ($) | Mar. 29, 2021USD ($) | Feb. 17, 2021USD ($)$ / sharesshares | Feb. 10, 2021USD ($) | Oct. 01, 2020USD ($) | Sep. 30, 2020USD ($) | Oct. 31, 2015 | Mar. 31, 2021USD ($)agreement$ / sharesshares | Mar. 31, 2020$ / sharesshares | Dec. 31, 2020USD ($) | Jul. 23, 2018USD ($) | Oct. 19, 2017USD ($) |
| 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 | |||||||||
| Gross proceeds | $ 40,200,000 | $ 8,575,000 | ||||||||||
| Additional capital that the company can raise | 37,625,000 | |||||||||||
| Shares Issued, Price Per Share | $ / shares | $ 4.60 | |||||||||||
| Payment for promissory note | 4,086,000 | |||||||||||
| Convertible Debt, Current | $ 55,372,000 | $ 54,427,000 | ||||||||||
| Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 26,769,693 | 10,694,517 | ||||||||||
| ATM Shares | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Gross proceeds | $ 8,800,000 | |||||||||||
| Issuance of common stock under the Sales Agreement, net (in shares) | shares | 1,867,552 | |||||||||||
| Sale of stock, maximum offering price | $ 30,000,000 | |||||||||||
| ATM Shares | Scenario, Plan [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Additional capital that the company can raise | $ 16,200,000 | |||||||||||
| Seven Point Five Percentage Convertible Notes [Member] | Convertible Notes Payable [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Interest rate (as a percent) | 7.50% | |||||||||||
| Debt Instrument, Face Amount | $ 57,900,000 | |||||||||||
| Amended Pfizer Agreement [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Payment for promissory note | $ 4,000,000 | $ 430,000 | ||||||||||
| 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 Agreements [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Revenue, Performance Obligation, Number | agreement | 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 [Member] | ||||||||||||
| 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 | |||||||||||
| Additional Amount Payable For Achievement Of Regulatory And Commercial Milestones | 320,000,000 | |||||||||||
| Chiesi Ex US Agreement [Member] | Subsequent Event [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Agreement Amendment Payment Receivable | $ 10,000,000 | |||||||||||
| Change In Amount Receivable For Achievement Of Regulatory And Commercial Milestones | $ (25,000,000) | |||||||||||
| 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 [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| Payment On Net Sales Percentage | 35.00% | |||||||||||
| SarcoMed USA, Inc. Agreement [Member] | ||||||||||||
| Significant Accounting Policies [Line Items] | ||||||||||||
| License Agreement, Initial Cash Payment | $ 3,500,000 | |||||||||||
| Term to sign supply agreement | 60 days | |||||||||||
| 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 | Mar. 31, 2021 | Dec. 31, 2020 |
| INVENTORIES | ||
| Raw materials | $ 3,427 | $ 3,347 |
| Work in progress | 2,273 | 2,887 |
| Finished goods | 8,215 | 6,848 |
| Total inventory | $ 13,915 | $ 13,082 |
FAIR VALUE MEASUREMENT - The li
| FAIR VALUE MEASUREMENT - The liability component was valued based on the Income Approach (Details) - 2021 Notes [Member] - Fair Value, Inputs, Level 3 [Member] | Mar. 31, 2021$ / shares |
| Measurement Input, Share Price [Member] | |
| Debt Instrument, Measurement Input | 4.46 |
| Measurement Input, Expected Term [Member] | |
| Debt Instrument, Measurement Input | 0.63 |
| Measurement Input, Risk Free Interest Rate [Member] | |
| Debt Instrument, Measurement Input | 0.05 |
| Measurement Input, Price Volatility [Member] | |
| Debt Instrument, Measurement Input | 71.89 |
| Measurement Input, Yield [Member] | |
| Debt Instrument, Measurement Input | 11.54 |
FAIR VALUE MEASUREMENT - Additi
| FAIR VALUE MEASUREMENT - Additional Information (Details) - Fair Value, Inputs, Level 3 [Member] - Seven Point Five Percentage Convertible Notes [Member] $ in Millions | Mar. 31, 2021USD ($) |
| Long-term Debt, Gross | $ 57.9 |
| Debt Instrument, Interest Rate, Stated Percentage | 7.50% |
| Convertible Debt, Fair Value Disclosures | $ 59.8 |
REVENUES - Company's disaggrega
| REVENUES - Company's disaggregation of revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
| Mar. 31, 2021 | Mar. 31, 2020 | |
| Revenues | $ 11,320 | $ 21,646 |
| Goods [Member] | ||
| Revenues | 4,511 | 5,031 |
| Goods [Member] | Pfizer [Member] | ||
| Revenues | 4,511 | 2,016 |
| Goods [Member] | Brazil [Member] | ||
| Revenues | 3,015 | |
| License and R&D Services [Member] | ||
| Revenues | $ 6,809 | 16,615 |
| 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] | ||
| Revenues | $ 6,700 | |
PROMISSORY NOTE (Details)
| PROMISSORY NOTE (Details) - USD ($) | Mar. 29, 2021 | Sep. 30, 2020 | Mar. 31, 2021 | Dec. 31, 2020 |
| Promissory note | $ 4,086,000 | |||
| Repayments of Notes Payable | $ 4,086,000 | |||
| Amended Pfizer Agreement [Member] | ||||
| Promissory note | $ 4,300,000 | |||
| Repayments of Notes Payable | $ 4,000,000 | $ 430,000 |