Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 12, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2022 | |
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, $0.001 par value | |
Trading Symbol | PLX | |
Security Exchange Name | NYSEAMER | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 49,753,409 | |
Entity Central Index Key | 0001006281 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 12,492 | $ 38,985 |
Short-term bank deposits | 16,082 | |
Accounts receivable - Trade | 2,022 | 3,442 |
Other assets | 2,597 | 1,285 |
Inventories | 16,507 | 17,954 |
Total current assets | 49,700 | 61,666 |
NON-CURRENT ASSETS: | ||
Funds in respect of employee rights upon retirement | 1,403 | 2,077 |
Property and equipment, net | 4,768 | 4,962 |
Operating lease right of use assets | 4,769 | 4,960 |
Total assets | 60,640 | 73,665 |
Accounts payable and accruals: | ||
Trade | 6,991 | 6,986 |
Other | 12,663 | 16,433 |
Operating lease liabilities | 1,083 | 1,207 |
Contracts liability | 10,223 | 8,550 |
Total current liabilities | 30,960 | 33,176 |
LONG TERM LIABILITIES: | ||
Convertible notes | 28,033 | 27,887 |
Contracts liability | 5,895 | 11,790 |
Liability for employee rights upon retirement | 1,748 | 2,472 |
Operating lease liabilities | 3,893 | 4,376 |
Total long term liabilities | 39,569 | 46,525 |
Total liabilities | 70,529 | 79,701 |
COMMITMENTS | ||
CAPITAL DEFICIENCY | (9,889) | (6,036) |
Total liabilities net of capital deficiency | $ 60,640 | $ 73,665 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | ||
TOTAL REVENUE | $ 8,753 | $ 6,427 | $ 24,838 | $ 17,747 | |
COST OF GOODS SOLD | [1] | (4,087) | (4,733) | (10,121) | (9,498) |
RESEARCH AND DEVELOPMENT EXPENSES | [2] | (7,579) | (7,689) | (16,346) | (14,811) |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | [3] | (2,611) | (3,171) | (5,765) | (6,309) |
OPERATING LOSS | (5,524) | (9,166) | (7,394) | (12,871) | |
FINANCIAL EXPENSES | (623) | (2,203) | (1,242) | (4,240) | |
FINANCIAL INCOME | 813 | 128 | 1,016 | 344 | |
FINANCIAL INCOME (EXPENSES) - NET | 190 | (2,075) | (226) | (3,896) | |
OTHER INCOME | 51 | ||||
NET LOSS FOR THE PERIOD | $ (5,334) | $ (11,241) | $ (7,620) | $ (16,716) | |
LOSS PER SHARE OF COMMON STOCK - BASIC | $ (0.11) | $ (0.25) | $ (0.16) | $ (0.39) | |
LOSS PER SHARE OF COMMON STOCK - DILUTED | $ (0.11) | $ (0.25) | $ (0.16) | $ (0.39) | |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC | 47,327,952 | 45,436,907 | 46,589,976 | 42,744,426 | |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - DILUTED | 47,327,952 | 45,436,907 | 46,589,976 | 42,744,426 | |
Goods | |||||
TOTAL REVENUE | $ 3,382 | $ 3,243 | $ 12,410 | $ 7,754 | |
License and R&D Services | |||||
TOTAL REVENUE | $ 5,371 | $ 3,184 | $ 12,428 | $ 9,993 | |
[1] (1) Includes share-based compensation (2) Includes share-based compensation (3) Includes share-based compensation |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Cost of goods sold | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 28 | $ 43 | $ 22 | $ 152 |
Research and development expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | 85 | 160 | 161 | 370 |
Selling, general and administrative expenses | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based compensation | $ 175 | $ 375 | $ 941 | $ 872 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total | |
Beginning balance at Dec. 31, 2020 | $ 35 | $ 320,280 | $ (347,352) | $ (27,037) | |
Beginning balance (in shares) at Dec. 31, 2020 | [1] | 34,765,280 | |||
Issuance of common stock, net of issuance cost | $ 9 | 37,616 | 37,625 | ||
Issuance of common stock, net of issuance cost (in shares) | [1] | 8,749,999 | |||
Issuance of common stock under the Sales Agreement, net | $ 2 | 8,573 | 8,575 | ||
Issuance of common stock under the Sales Agreement, net (in shares) | [1] | 1,867,552 | |||
Share-based compensation related to stock options | 832 | 832 | |||
Share-based compensation related to restricted stock awards | 562 | 562 | |||
Exercise of warrants (in shares) | [1] | 173,816 | |||
Net loss for the period | (16,716) | (16,716) | |||
Ending balance at Jun. 30, 2021 | $ 46 | 367,863 | (364,068) | 3,841 | |
Ending balance (in shares) at Jun. 30, 2021 | [1] | 45,556,647 | |||
Beginning balance at Mar. 31, 2021 | $ 46 | 367,285 | (352,827) | 14,504 | |
Beginning balance (in shares) at Mar. 31, 2021 | [1] | 45,382,831 | |||
Share-based compensation related to stock options | 322 | 322 | |||
Share-based compensation related to restricted stock awards | 256 | 256 | |||
Exercise of warrants (in shares) | [1] | 173,816 | |||
Net loss for the period | (11,241) | (11,241) | |||
Ending balance at Jun. 30, 2021 | $ 46 | 367,863 | (364,068) | 3,841 | |
Ending balance (in shares) at Jun. 30, 2021 | [1] | 45,556,647 | |||
Beginning balance at Dec. 31, 2021 | $ 46 | 368,852 | (374,934) | (6,036) | |
Beginning balance (in shares) at Dec. 31, 2021 | [1] | 45,556,647 | |||
Issuance of common stock under the Sales Agreement, net | $ 3 | 2,638 | 2,641 | ||
Issuance of common stock under the Sales Agreement, net (in shares) | [1] | 2,395,823 | |||
Share-based compensation related to stock options | 293 | 293 | |||
Share-based compensation related to restricted stock awards | 831 | 831 | |||
Share-based compensation related to restricted stock awards (in shares) | [1] | 759,482 | |||
Exercise of warrants | 2 | 2 | |||
Exercise of warrants (in shares) | [1] | 1,000 | |||
Net loss for the period | (7,620) | (7,620) | |||
Ending balance at Jun. 30, 2022 | $ 49 | 372,616 | (382,554) | (9,889) | |
Ending balance (in shares) at Jun. 30, 2022 | [1] | 48,712,952 | |||
Beginning balance at Mar. 31, 2022 | $ 46 | 369,688 | (377,220) | (7,486) | |
Beginning balance (in shares) at Mar. 31, 2022 | [1] | 46,316,129 | |||
Issuance of common stock under the Sales Agreement, net | $ 3 | 2,638 | 2,641 | ||
Issuance of common stock under the Sales Agreement, net (in shares) | [1] | 2,395,823 | |||
Share-based compensation related to stock options | 144 | 144 | |||
Share-based compensation related to restricted stock awards | 144 | 144 | |||
Exercise of warrants | 2 | 2 | |||
Exercise of warrants (in shares) | [1] | 1,000 | |||
Net loss for the period | (5,334) | (5,334) | |||
Ending balance at Jun. 30, 2022 | $ 49 | $ 372,616 | $ (382,554) | $ (9,889) | |
Ending balance (in shares) at Jun. 30, 2022 | [1] | 48,712,952 | |||
[1]Common stock, $0.001 par value; Authorized – as of June 30, 2022 and 2021 - 120,000,000 shares. |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) (Parenthetical) - $ / shares | Jun. 30, 2022 | Jun. 30, 2021 |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (CAPITAL DEFICIENCY) | ||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (7,620) | $ (16,716) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 1,124 | 1,394 |
Depreciation | 538 | 574 |
Financial income, net (mainly exchange differences) | (952) | (121) |
Changes in accrued liability for employee rights upon retirement | (449) | 70 |
Loss (gain) on amounts funded in respect of employee rights upon retirement | 16 | (56) |
Gain on sale of fixed assets | (51) | |
Amortization of debt issuance costs and debt discount | 146 | 1,928 |
Changes in operating assets and liabilities: | ||
Increase (decrease) in contracts liability (including non-current portion) | (2,644) | 12,268 |
Decrease (increase) in accounts receivable and other assets | 76 | (1,587) |
Changes in right of use assets | (3) | 94 |
Decrease (increase) in inventories | 1,447 | (558) |
Decrease in accounts payable and accruals | (4,864) | (544) |
Decrease in other long term liabilities | (13) | |
Net cash used in operating activities | (13,185) | (3,318) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Investment in bank deposits | (16,000) | (37,835) |
Proceeds from sale of short-term deposits | 15,000 | |
Purchase of property and equipment | (357) | (667) |
Proceeds from sale of property and equipment | 53 | |
Decrease in restricted deposit | 359 | |
Amounts paid (funded) in respect of employee rights upon retirement, net | 457 | (54) |
Net cash used in investing activities | (15,900) | (23,144) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment for promissory note | (4,086) | |
Proceeds from issuance of common stock and warrants, net | 37,625 | |
Proceeds from issuance of common stock under the Sales Agreement, net | 2,641 | 8,575 |
Exercise of warrants | 2 | |
Net cash provided by financing activities | 2,643 | 42,114 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (51) | (35) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (26,493) | 15,617 |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 38,985 | 18,265 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 12,492 | 33,882 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
Purchase of property and equipment | 81 | 372 |
Right of use assets obtained in exchange for new operating lease liabilities | 99 | 232 |
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | ||
Interest paid | 1,120 | 2,172 |
Interest received | $ 93 | $ 307 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2022 | |
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, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies, referred to as the BALANCE BRIDGE BRIGHT On February 7, 2022, a Marketing Authorization Application (“MAA”) for PRX-102 was submitted to, and subsequently validated by, the European Medicines Agency (“EMA”). The submission was made after the October 8, 2021 meeting the Company held, together with the Company’s development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the then anticipated MAA submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of the planned MAA submission for PRX-102. On April 28, 2021, the Company, together with Chiesi, announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (the “FDA”) regarding the biologics license application (“BLA”) for PRX-102 for the treatment of adult patients with Fabry disease. The PRX-102 BLA was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package. In the CRL, the FDA noted that an inspection of the Company’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve a resubmitted BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained in the letter that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to the novel coronavirus disease (“COVID-19”), the FDA reviewed records under Section 704(a)(4) of the U.S. Federal Food, Drug, and Cosmetic Act (the “FFDCA”) in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that Fabrazyme ® The Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The planned data package for the BLA resubmission, given the changed regulatory landscape in the United States, will include the final two-year analyses of the BALANCE In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates: (1) alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, which has successfully completed a phase II efficacy and safety study; the Company is continuing to evaluate potential strategic marketing partnerships and collaboration programs with biotechnology and pharmaceutical companies for this product candidate for various respiratory indications; (2) PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat severe gout; and (3) PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases. Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”) which was amended on May 2, 2022. Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of its common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the Sales Agreement, the Company terminated the ATM Equity Offering SM On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States. Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs, capped at $10.0 million per year, and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, subject to a maximum of $7.5 million per year, and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the full amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. In accordance with the term sheet, Chiesi made a $10.0 million payment to the Company in the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company also agreed to negotiate certain manufacturing related matters. Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) under the initial Exclusive License and Supply Agreement (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 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 adopted during the earlier stages of the pandemic in its offices and facilities in an effort to promote social distancing resulted in minor delays in the performance of administrative activities outside of the clinical programs. 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 short-term bank deposits as of June 30, 2022 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. In addition, under the terms of the Company’s , the Company is required to maintain a minimum cash balance of at least $7.5 million. 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, 2021, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2021 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, 2021. c. Loss per share Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of Common Stock attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 32,960,732 and 32,982,043 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the outstanding 2024 Notes and the exercise of outstanding warrants for the three and six months ended June 30, 2022, respectively, and 25,874,641 and 26,322,164 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the Company’s then outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) and the exercise of outstanding warrants for the three and six months ended June 30, 2021, respectively, because their effect would be anti-dilutive. d. Revenue recognition The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer. 1. Revenues from selling products The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery). 2. Revenue from Chiesi Agreements The Company has identified two performance obligations in Chiesi agreements as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing. The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug. The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation. Revenue from additional research and development services ordered by Chiesi is recognized over time using the cost-to-cost method. 3. Revenue from R&D services Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service. |
INVENTORIES
INVENTORIES | 6 Months Ended |
Jun. 30, 2022 | |
INVENTORIES | |
INVENTORIES | NOTE 2 - INVENTORIES Inventories at June 30, 2022 and December 31, 2021 consisted of the following: June 30, December 31, ( U.S. dollars in thousands) 2022 2021 Raw materials $ 3,304 $ 3,166 Work in progress 3,296 3,262 Finished goods 9,907 11,526 Total inventory $ 16,507 $ 17,954 |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 6 Months Ended |
Jun. 30, 2022 | |
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 June 30, 2022, the carrying amounts of short-term deposits approximate their fair values due to the stated interest rates, which approximate market rates. Based on a Level 3 measurement, as of June 30, 2022, the fair value of the $28.75 million aggregate principal amount of the Company’s outstanding 2024 Notes is approximately $32.3 million. 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: 2024 Notes Stock price (USD) 1.09 Expected term 2.18 Risk free rate 2.94 % Volatility 75.34 % Yield 13.85 % |
REVENUES
REVENUES | 6 Months Ended |
Jun. 30, 2022 | |
REVENUES | |
REVENUES | NOTE 4 – REVENUES The following table summarizes the Company’s disaggregation of revenues: Three Months Ended June 30, Six Months Ended June 30, ( U.S. dollars in thousands) 2022 2021 2022 2021 Pfizer $ 3,382 $ 2,237 $ 6,738 $ 6,748 Brazil $ - $ 988 $ 5,454 $ 988 Chiesi $ - $ 18 $ 218 $ 18 Total revenues from selling goods $ 3,382 $ 3,243 $ 12,410 $ 7,754 Revenues from license and R&D services $ 5,371 $ 3,184 $ 12,428 $ 9,993 |
STOCK TRANSACTIONS
STOCK TRANSACTIONS | 6 Months Ended |
Jun. 30, 2022 | |
STOCK TRANSACTIONS | |
STOCK TRANSACTIONS | NOTE 5 – SHARE CAPITAL a) Authorized Capital On June 30, 2022, the Company held its 2022 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders, among other matters, approved an amendment to the Company’s Certificate of Incorporation, as amended, to increase the number of shares of Common Stock authorized for issuance from 120,000,000 to 144,000,000 (the “Charter Amendment”). The Charter Amendment was filed with the Secretary of State of the State of Delaware on August 2, 2022. b) Stock based compensation 1) On February 25, 2022, the Company granted, with the approval of the Company’s compensation committee, the following: I. 637,531 shares of restricted Common Stock to its President, Chief Executive Officer under the Company’s Amended and Restated 2006 Employee Stock Incentive Plan, as amended (the “Plan”). The Company estimated the fair value of the restricted stock on the date of grant to be approximately $523,000. II. 121,951 shares of restricted Common Stock to its Sr. Vice President, Chief Financial Officer under the Plan. The Company estimated the fair value of the restricted stock on the date of grant to be approximately $100,000. 2) On June 30, 2022, the Company granted 10-year options to purchase 40,000 shares of Common Stock to a new director serving on the Company’s Board of Directors under the Plan. The options have an exercise price equal to $1.09 per share and vest over a four-year period in 16 equal quarterly increments. Vesting of the options granted to the director is subject to automatic acceleration in full upon a Corporate Transaction or a Change in Control, as those terms are defined in the Plan, and are subject to certain other terms and conditions. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $32,000 based on the following weighted average assumptions: share price equal to $1.09; dividend yield of 0% for all years; expected volatility of 85.95%; risk-free interest rate of 3.025%; and expected life of six years. 3) At the Annual Meeting, the Company’s stockholders, among other matters, adopted amendments to the Plan to increase the number of shares of Common Stock available under the Plan from 5,725,171 shares to 8,475,171 shares and to amend certain other terms of the Plan. c) At-the-Market (ATM) Offering During the quarter ended June 30, 2022, the Company sold, in the aggregate, 2,395,823 shares of Common Stock under the Sales Agreement. The Company generated aggregate gross proceeds equal to approximately $2.8 million in connection with such sales. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2022 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | NOTE 6 – SUBSEQUENT EVENTS On August 1, 2022, the Company granted 10-year options to purchase 160,000 shares of Common Stock to a new employee of the Company under the Plan. The options have an exercise price equal to $1.06 per share and vest over a four-year period in 16 equal quarterly increments. The Company estimated the fair value of the options on the date of grant using the Black-Scholes option-pricing model to be approximately $124,000 based on the following weighted average assumptions: share price equal to $1.06; dividend yield of 0% for all years; expected volatility of 85.95%; risk-free interest rate of 2.65%; and expected life of six years. During July and August 2022, the Company sold, in the aggregate, 1,040,457 shares of Common Stock under the Sales Agreement. The Company generated aggregate gross proceeds equal to approximately $1,152,650 in connection with such sales. On July 17, 2022, the Company collected approximately $1.1 million from sales to Pfizer. On July 18, 2022, the Company collected approximately $1.1 million from expense reimbursements in connection with its collaboration with Chiesi. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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, which is the subject of a phase III clinical program. The PRX-102 phase III clinical program includes three separate studies, referred to as the BALANCE BRIDGE BRIGHT On February 7, 2022, a Marketing Authorization Application (“MAA”) for PRX-102 was submitted to, and subsequently validated by, the European Medicines Agency (“EMA”). The submission was made after the October 8, 2021 meeting the Company held, together with the Company’s development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”), with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102. At the meeting, Chiesi and the Company discussed the scope of the then anticipated MAA submission for the European Union, and the Rapporteur and Co-Rapporteur were generally supportive of the planned MAA submission for PRX-102. On April 28, 2021, the Company, together with Chiesi, announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (the “FDA”) regarding the biologics license application (“BLA”) for PRX-102 for the treatment of adult patients with Fabry disease. The PRX-102 BLA was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. The CRL did not report any concerns relating to the potential safety or efficacy of PRX-102 in the submitted data package. In the CRL, the FDA noted that an inspection of the Company’s manufacturing facility in Carmiel, Israel, including the FDA’s subsequent assessment of any related FDA findings, is required before the FDA can approve a resubmitted BLA. Due to travel restrictions, the FDA was unable to conduct the required inspection during the review cycle. The FDA explained in the letter that it will continue to monitor the public health situation as well as travel restrictions, and is actively working to define an approach for scheduling outstanding inspections. With respect to the third-party facility in Europe at which fill and finish processes are performed for PRX-102, due to the novel coronavirus disease (“COVID-19”), the FDA reviewed records under Section 704(a)(4) of the U.S. Federal Food, Drug, and Cosmetic Act (the “FFDCA”) in lieu of a pre-licensing inspection. In the CRL, the FDA stated that it will communicate remaining issues to the facility in order to seek prompt resolution of any pending items. In addition to the foregoing, in the CRL, the FDA noted that Fabrazyme ® The Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The planned data package for the BLA resubmission, given the changed regulatory landscape in the United States, will include the final two-year analyses of the BALANCE In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates: (1) alidornase alfa, or PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, which has successfully completed a phase II efficacy and safety study; the Company is continuing to evaluate potential strategic marketing partnerships and collaboration programs with biotechnology and pharmaceutical companies for this product candidate for various respiratory indications; (2) PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat severe gout; and (3) PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases. Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”) which was amended on May 2, 2022. Pursuant to the terms of the Sales Agreement, the Company may sell from time to time through the Agent shares of its common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the Sales Agreement, the Company terminated the ATM Equity Offering SM On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States. Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs, capped at $10.0 million per year, and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa, subject to a maximum of $7.5 million per year, and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the full amount of development costs to which it is entitled under the Chiesi Agreements. Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply. On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. In accordance with the term sheet, Chiesi made a $10.0 million payment to the Company in the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company also agreed to negotiate certain manufacturing related matters. Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) under the initial Exclusive License and Supply Agreement (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 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 adopted during the earlier stages of the pandemic in its offices and facilities in an effort to promote social distancing resulted in minor delays in the performance of administrative activities outside of the clinical programs. 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 short-term bank deposits as of June 30, 2022 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued. In addition, under the terms of the Company’s , the Company is required to maintain a minimum cash balance of at least $7.5 million. |
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, 2021, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2021 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, 2021. |
Loss per share | c. Loss per share Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of Common Stock attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 32,960,732 and 32,982,043 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the outstanding 2024 Notes and the exercise of outstanding warrants for the three and six months ended June 30, 2022, respectively, and 25,874,641 and 26,322,164 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the Company’s then outstanding 7.50% Senior Secured Convertible Notes due 2021 (the “2021 Notes”) and the exercise of outstanding warrants for the three and six months ended June 30, 2021, respectively, because their effect would be anti-dilutive. |
Revenue recognition | d. Revenue recognition The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer. 1. Revenues from selling products The Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery). 2. Revenue from Chiesi Agreements The Company has identified two performance obligations in Chiesi agreements as follows: (1) the license and research and development services and (2) the contingent performance obligation regarding future manufacturing. The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug. The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services. The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue. Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation. Revenue from additional research and development services ordered by Chiesi is recognized over time using the cost-to-cost method. 3. Revenue from R&D services Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service. |
INVENTORIES (Tables)
INVENTORIES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
INVENTORIES | |
Schedule of Inventory | Inventories at June 30, 2022 and December 31, 2021 consisted of the following: June 30, December 31, ( U.S. dollars in thousands) 2022 2021 Raw materials $ 3,304 $ 3,166 Work in progress 3,296 3,262 Finished goods 9,907 11,526 Total inventory $ 16,507 $ 17,954 |
FAIR VALUE MEASUREMENT (Tables)
FAIR VALUE MEASUREMENT (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
2024 Notes | |
Schedule of Fair Value Assumptions | 2024 Notes Stock price (USD) 1.09 Expected term 2.18 Risk free rate 2.94 % Volatility 75.34 % Yield 13.85 % |
REVENUES (Tables)
REVENUES (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
REVENUES | |
Schedule of Company's Disaggregation of Revenues | Three Months Ended June 30, Six Months Ended June 30, ( U.S. dollars in thousands) 2022 2021 2022 2021 Pfizer $ 3,382 $ 2,237 $ 6,738 $ 6,748 Brazil $ - $ 988 $ 5,454 $ 988 Chiesi $ - $ 18 $ 218 $ 18 Total revenues from selling goods $ 3,382 $ 3,243 $ 12,410 $ 7,754 Revenues from license and R&D services $ 5,371 $ 3,184 $ 12,428 $ 9,993 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Additional Information) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jul. 02, 2021 USD ($) $ / shares shares | May 13, 2021 USD ($) | Jul. 23, 2018 USD ($) | Oct. 19, 2017 USD ($) | Oct. 31, 2015 | Jun. 30, 2022 USD ($) agreement $ / shares shares | Jun. 30, 2021 $ / shares shares | Jun. 30, 2022 USD ($) agreement $ / shares shares | Jun. 30, 2021 USD ($) $ / shares shares | |
Significant Accounting Policies [Line Items] | |||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | |||||
Stock issuance proceeds | $ 2,641 | $ 8,575 | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 32,960,732 | 25,874,641 | 32,982,043 | 26,322,164 | |||||
2021 Notes | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Interest rate (as a percent) | 7.50% | 7.50% | |||||||
2024 Notes | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Interest rate (as a percent) | 7.50% | 7.50% | |||||||
Maintain of Minimum Cash Balance | $ 7,500 | $ 7,500 | |||||||
Amended Pfizer Agreement | Protalix Bio Therapeutics Incorporation | Brazil | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Collaborative Arrangement Revenues Expenses Sharing Percentage | 100% | ||||||||
Chiesi US Agreement and Chiesi Ex-US Agreement | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Non-refundable Payment Receivable | $ 25,000 | $ 25,000 | |||||||
Chiesi Agreements | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Performance obligation number | agreement | 2 | 2 | |||||||
Chiesi US Agreement | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Additional Amounts Payable To Cover Development Costs | 20,000 | ||||||||
Maximum entitlement of development costs to cover per year | 7,500 | ||||||||
Additional amount payable for achievement of regulatory and commercial milestones | $ 760,000 | ||||||||
Chiesi US Agreement | Minimum | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Payment On Net Sales Percentage | 15% | ||||||||
Chiesi US Agreement | Maximum | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Payment On Net Sales Percentage | 40% | ||||||||
Chiesi Ex-US Agreement | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Additional Amounts Payable To Cover Development Costs | 25,000 | ||||||||
Maximum entitlement of development costs to cover per year | 10,000 | ||||||||
Additional amount payable for achievement of regulatory and commercial milestones | $ 320,000 | ||||||||
Change in amount receivable for achievement of regulatory and commercial milestones | $ 25,000 | ||||||||
Agreement Amendment Payment Receivable | $ 10,000 | ||||||||
Chiesi Ex-US Agreement | Minimum | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Payment On Net Sales Percentage | 15% | ||||||||
Chiesi Ex-US Agreement | Maximum | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Payment On Net Sales Percentage | 35% | ||||||||
ATM Shares | |||||||||
Significant Accounting Policies [Line Items] | |||||||||
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ / shares | $ 0.001 | ||||||||
Sale of stock, maximum offering price | $ 20,000 | $ 17,200 | |||||||
Number of shares issued (in shares) | shares | 3,296,123 | ||||||||
Stock issuance proceeds | $ 13,800 |
INVENTORIES (Schedule of Invent
INVENTORIES (Schedule of Inventory) (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
INVENTORIES | ||
Raw materials | $ 3,304 | $ 3,166 |
Work in progress | 3,296 | 3,262 |
Finished goods | 9,907 | 11,526 |
Total inventory | $ 16,507 | $ 17,954 |
FAIR VALUE MEASUREMENT (Schedul
FAIR VALUE MEASUREMENT (Schedule of Fair Value Assumptions) (Details) - 2024 Notes - Level 3 | Jun. 30, 2022 Y $ / shares |
Share Price. | |
Debt Instrument, Measurement Input | $ / shares | 1.09 |
Expected term | |
Debt Instrument, Measurement Input | Y | 2.18 |
Risk free rate | |
Debt Instrument, Measurement Input | 2.94 |
Volatility | |
Debt Instrument, Measurement Input | 75.34 |
Yield | |
Debt Instrument, Measurement Input | 13.85 |
FAIR VALUE MEASUREMENT (Additio
FAIR VALUE MEASUREMENT (Additional Information) (Details) - Level 3 - 2024 Notes $ in Thousands | Jun. 30, 2022 USD ($) |
Debt Instrument Carrying Amount | $ 28,750 |
Debt Instrument Fair Value | $ 32,300 |
REVENUES (Details)
REVENUES (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenues | $ 8,753 | $ 6,427 | $ 24,838 | $ 17,747 |
Goods | ||||
Revenues | 3,382 | 3,243 | 12,410 | 7,754 |
Goods | Pfizer | ||||
Revenues | 3,382 | 2,237 | 6,738 | 6,748 |
Goods | Brazil | ||||
Revenues | 988 | 5,454 | 988 | |
Goods | Chiesi | ||||
Revenues | 18 | 218 | 18 | |
License and R&D Services | ||||
Revenues | $ 5,371 | $ 3,184 | $ 12,428 | $ 9,993 |
STOCK TRANSACTIONS (Details)
STOCK TRANSACTIONS (Details) | 2 Months Ended | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2022 USD ($) item $ / shares shares | Feb. 25, 2022 USD ($) shares | Aug. 31, 2022 USD ($) shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2021 USD ($) shares | Aug. 02, 2022 shares | Jun. 29, 2022 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 | 120,000,000 | 120,000,000 | ||||
Issuance of common stock under the Sales Agreement, net | $ | $ 2,641,000 | $ 2,641,000 | $ 8,575,000 | |||||
Subsequent Event | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common Stock, Shares Authorized | 144,000,000 | |||||||
Issuance of common stock under the Sales Agreement, net | $ | $ 1,152,650 | |||||||
Issuance of common stock under the Sales Agreement, net (in shares) | 1,040,457 | |||||||
ATM Shares | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Issuance of common stock under the Sales Agreement, net | $ | $ 2,800,000 | |||||||
Issuance of common stock under the Sales Agreement, net (in shares) | 2,395,823 | |||||||
2006 Employee Stock Incentive Plan | Option to purchase shares of common stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares authorized for issuance under share-based payment arrangement | 8,475,171 | 8,475,171 | 8,475,171 | 5,725,171 | ||||
2006 Employee Stock Incentive Plan | Chief Executive Officer | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of restricted stock granted (in shares) | 637,531 | |||||||
Value of restricted stock granted | $ | $ 523,000 | |||||||
2006 Employee Stock Incentive Plan | Chief Financial Officer | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of restricted stock granted (in shares) | 121,951 | |||||||
Value of restricted stock granted | $ | $ 100,000 | |||||||
2006 Employee Stock Incentive Plan | New director | Option to purchase shares of common stock | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Term of award | 10 years | |||||||
Granted (in shares) | 40,000 | |||||||
Exercise Price (in dollars per share) | $ / shares | $ 1.09 | $ 1.09 | $ 1.09 | |||||
Vesting Period | 4 years | |||||||
Number of equal quarterly increments | item | 16 | |||||||
Grant Date Fair Value | $ | $ 32,000 | $ 32,000 | $ 32,000 | |||||
Share price | $ / shares | $ 1.09 | $ 1.09 | $ 1.09 | |||||
Dividend Yield | 0% | |||||||
Expected Volatility Rate | 85.95% | |||||||
Risk Free Interest Rate | 3.025% | |||||||
Expected Term | 6 years |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) | 2 Months Ended | 3 Months Ended | 6 Months Ended | |||
Aug. 15, 2022 USD ($) | Aug. 01, 2022 USD ($) item $ / shares shares | Aug. 31, 2022 USD ($) shares | Jun. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | |
Subsequent Event [Line Items] | ||||||
Issuance of common stock under the Sales Agreement, net | $ 2,641,000 | $ 2,641,000 | $ 8,575,000 | |||
Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Issuance of common stock under the Sales Agreement, net | $ 1,152,650 | |||||
Issuance of common stock under the Sales Agreement, net (in shares) | shares | 1,040,457 | |||||
Subsequent Event | Option to purchase shares of common stock | Employee | 2006 Employee Stock Incentive Plan | ||||||
Subsequent Event [Line Items] | ||||||
Term of award | 10 years | |||||
Granted (in shares) | shares | 160,000 | |||||
Exercise Price (in dollars per share) | $ / shares | $ 1.06 | |||||
Vesting Period | 4 years | |||||
Number of equal quarterly increments | item | 16 | |||||
Grant Date Fair Value | $ 124,000 | |||||
Share price | $ / shares | $ 1.06 | |||||
Dividend Yield | 0% | |||||
Expected Volatility Rate | 85.95% | |||||
Risk Free Interest Rate | 2.65% | |||||
Expected Term | 6 years | |||||
Subsequent Event | Pfizer Agreement [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds From Sale Of Products | $ 1,100,000 | |||||
Subsequent Event | Chiesi Agreements | Alfataliglicerase | ||||||
Subsequent Event [Line Items] | ||||||
Proceeds from expense reimbursements | $ 1,100,000 |