Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 01, 2017 | Jun. 30, 2016 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Protalix BioTherapeutics, Inc. | ||
Entity Central Index Key | 1,006,281 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 61.7 | ||
Trading Symbol | PLX | ||
Entity Common Stock, Shares Outstanding | 124,134,085 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 63,281 | $ 76,374 |
Accounts receivable - Trade | 693 | |
Other assets | 2,321 | 1,667 |
Inventories | 5,245 | 5,767 |
Assets of discontinued operation | 327 | 2,073 |
Total current assets | 71,867 | 85,881 |
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,677 | 1,628 |
PROPERTY AND EQUIPMENT, NET | 8,703 | 9,744 |
Total assets | 82,247 | 97,253 |
Accounts payable and accruals: | ||
Trade | 4,007 | 3,629 |
Other | 7,496 | 5,534 |
Convertible notes | 53,872 | |
Deferred revenues | 837 | 504 |
Liabilities of discontinued operation | 1,568 | |
Total current liabilities | 66,212 | 11,235 |
LONG TERM LIABILITIES: | ||
Convertible notes | 19,343 | 67,796 |
Deferred revenues | 744 | |
Liability for employee rights upon retirement | 2,348 | 2,304 |
Promissory note | 4,301 | 4,301 |
Total long term liabilities | 25,992 | 75,145 |
Total liabilities | 92,204 | 86,380 |
COMMITMENTS (Note 6) | ||
SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY): | ||
Common Stock, $0.001 par value: Authorized - as of December 31, 2015 and 2016, 150,000,000 and 250,000,000 shares; issued and outstanding, respectively - as of December 31, 2015 and 2016, 99,800,397 shares and 124,134,085 shares, respectively | 124 | 100 |
Additional paid-in capital | 202,575 | 194,064 |
Accumulated deficit | (212,656) | (183,291) |
Total shareholders’ equity (capital deficiency) | (9,957) | 10,873 |
Total liabilities and shareholders’ equity (net of capital deficiency) | $ 82,247 | $ 97,253 |
CONSOLIDATED BALANCE SHEETS _Pa
CONSOLIDATED BALANCE SHEETS [Parenthetical] - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Common Stock, Par or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 250,000,000 | 150,000,000 |
Common Stock, issued | 124,134,085 | 99,800,397 |
Common Stock, outstanding | 124,134,085 | 99,800,397 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
REVENUES | $ 9,199 | $ 4,364 | $ 3,523 |
COST OF REVENUES | (8,398) | (730) | (630) |
GROSS PROFIT | 801 | 3,634 | 2,893 |
RESEARCH AND DEVELOPMENT EXPENSES | (30,412) | (24,889) | (27,352) |
Less - grants | 5,804 | 4,864 | 5,128 |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (24,608) | (20,025) | (22,224) |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (9,356) | (7,279) | (9,228) |
OPERATING LOSS | (33,163) | (23,670) | (28,559) |
FINANCIAL EXPENSES | (10,665) | (3,735) | (4,935) |
FINANCIAL INCOME | 589 | 123 | 196 |
GAIN ON EXTINGUISHMENT OF CONVERTIBLE NOTES | 14,063 | ||
FINANCIAL INCOME (EXPENSES) - NET | 3,987 | (3,612) | (4,739) |
LOSS FROM CONTINUING OPERATIONS | (29,176) | (27,282) | (33,298) |
(LOSS) INCOME FROM DISCONTINUED OPERATIONS | (189) | 85,319 | 3,355 |
NET INCOME (LOSS) FOR THE YEAR | $ (29,365) | $ 58,037 | $ (29,943) |
Net Income (loss) per share of common stock - basic and diluted | |||
Loss from continuing operations (in dollars per share) | $ (0.29) | $ (0.29) | $ (0.36) |
Income from discontinued operations (in dollars per share) | 0 | 0.90 | 0.04 |
Net (loss) income per share of common stock (in dollars per share) | $ (0.29) | $ 0.61 | $ (0.32) |
Weighted average number of shares of common stock used in computing loss per share of common stock, basic and diluted | 101,387,704 | 94,922,390 | 92,891,846 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | |
Balance at Dec. 31, 2013 | $ (26,946) | $ 93 | $ 184,346 | $ (211,385) | |
Balance (in shares) at Dec. 31, 2013 | 93,551,098 | ||||
Share-based compensation related to stock options | 467 | 467 | |||
Share-based compensation related to restricted stock award, net of forfeitures | 775 | 775 | |||
Share-based compensation related to restricted stock award, net of forfeitures (in shares) | (81,209) | ||||
Exercise of options granted to employees | 46 | $ 1 | 45 | ||
Exercise of options granted to employees (in shares) | 133,930 | ||||
Net loss from continuing operations | (33,298) | (33,298) | |||
Net income (loss) from discontinued operations | 3,355 | 3,355 | |||
Balance at Dec. 31, 2014 | (55,601) | $ 94 | 185,633 | (241,328) | |
Balance (in shares) at Dec. 31, 2014 | 93,603,819 | ||||
Issuance of common stock | 6,101 | $ 6 | 6,095 | ||
Issuance of common stock (in shares) | 5,649,079 | ||||
Share-based compensation related to stock options | 1,273 | 1,273 | |||
Share-based compensation related to restricted stock award, net of forfeitures | 529 | 529 | |||
Share-based compensation related to restricted stock award, net of forfeitures (in shares) | (2,501) | ||||
Exercise of options granted to employees | 534 | [1] | 534 | ||
Exercise of options granted to employees (in shares) | 550,000 | ||||
Net loss from continuing operations | (27,282) | (27,282) | |||
Net income (loss) from discontinued operations | 85,319 | 85,319 | |||
Balance at Dec. 31, 2015 | 10,873 | $ 100 | 194,064 | (183,291) | |
Balance (in shares) at Dec. 31, 2015 | 99,800,397 | ||||
Issuance of common stock | 6,848 | $ 24 | 6,824 | ||
Issuance of common stock (in shares) | 23,846,735 | ||||
Equity component of convertible notes | 685 | 685 | |||
Share-based compensation related to stock options | 920 | 920 | |||
Share-based compensation related to restricted stock award, net of forfeitures | 68 | [1] | 68 | ||
Share-based compensation related to restricted stock award, net of forfeitures (in shares) | 7,843 | ||||
Exercise of options granted to employees | 14 | [1] | 14 | ||
Exercise of options granted to employees (in shares) | 479,110 | ||||
Net loss from continuing operations | (29,176) | (29,176) | |||
Net income (loss) from discontinued operations | (189) | (189) | |||
Balance at Dec. 31, 2016 | $ (9,957) | $ 124 | $ 202,575 | $ (212,656) | |
Balance (in shares) at Dec. 31, 2016 | 124,134,085 | ||||
[1] | Represents an amount of less than $1. |
CONSOLIDATED STATEMENTS OF CHA6
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY [Parenthetical] - shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Restricted Stock [Member] | ||
Share-based compensation related to restricted stock award, forfeitures, (in shares) | 2,501 | 185,709 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income (loss) | $ (29,365) | $ 58,037 | $ (29,943) |
Income (loss) from discontinued operations | (189) | 85,319 | 3,355 |
Loss from continuing operations | (29,176) | (27,282) | (33,298) |
Adjustments required to reconcile net income (loss) to net cash used in operating activities: | |||
Share based compensation | 988 | 1,802 | 1,242 |
Depreciation | 1,983 | 2,370 | 3,140 |
Financial expenses, net | 13 | 124 | 1,446 |
Changes in accrued liability for employee rights upon retirement | 10 | 59 | 140 |
Loss (gain) on amounts funded in respect of employee rights upon retirement | 7 | 18 | (22) |
Gain on sale of fixed assets | (7) | (2) | (3) |
Gain on extinguishment of convertible notes | (14,063) | ||
Change in fair value of convertible notes embedded derivative | 6,473 | ||
Amortization of debt issuance costs and debt discount | 568 | 445 | 444 |
Changes in operating assets and liabilities: | |||
Increase (decrease) in deferred revenues (including non-current potion) | (411) | 362 | 886 |
Decrease (increase) in accounts receivable and other assets | (1,133) | 523 | (1,006) |
Decrease (increase) in inventories | 522 | (2,316) | (3,451) |
Increase (decrease) in accounts payable and accruals (including long term ) | 2,139 | (1,873) | 1,367 |
Net cash used in continuing operations | (32,087) | (25,770) | (29,115) |
Net cash provided by (used in) discontinued operations | (11) | 1,486 | (166) |
Net cash used in operating activities | (32,098) | (24,284) | (29,281) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of property and equipment | (849) | (464) | (785) |
Proceeds from sale of property and equipment | 20 | 3 | 11 |
Decrease (increase) in restricted deposit | (106) | 45 | (90) |
Amounts funded in respect of employee rights upon retirement, net | (32) | (96) | (137) |
Net cash used in continuing operations | (967) | (512) | (1,001) |
Net cash provided by discontinued operations | 39,899 | ||
Net cash provided by (used in) investing activities | (967) | 39,387 | (1,001) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Net proceeds from issuance of convertible notes | 19,681 | ||
Issuance of shares, net of issuance cost | 6,101 | ||
Exercise of options | 14 | 534 | 46 |
Net cash provided by financing activities | 19,695 | 6,635 | 46 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 277 | (131) | (1,395) |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (13,093) | 21,607 | (31,631) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 76,374 | 54,767 | 86,398 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR | 63,281 | 76,374 | 54,767 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | |||
Purchase of property and equipment | 595 | 489 | 120 |
Issuance of promissory note | 0 | 4,301 | |
Issuance of common stock, net of issuance cost | 6,848 | ||
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | |||
Interest paid | $ 3,659 | $ 3,105 | $ 3,079 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2016 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”), and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® TM TM The Company’s product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder; (2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation; and (3) OPRX-106, the Company’s oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as a natural capsule for the expressed protein. Obtaining marketing approval with respect to any product candidate in any country is directly 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. Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer Inc. (“Pfizer”), as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the “Amended Pfizer Agreement”) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 60 40 100 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 for taliglucerase alfa. Fiocruz’s purchases of Uplyso 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 low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 In December 2016, the Company received a letter from Fiocruz regarding an order from the Brazilian Ministry of Health (the “Brazilian Ministry”) to purchase alfataliglicerase to treat Gaucher patients in Brazil. The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $ 24.3 4.0 The Company is required to pay a fee equal to 5 Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing. Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Functional currency The dollar is the currency of the primary economic environment in which the operations of the Company and its Subsidiaries are conducted. Most of the Company’s revenues are derived in dollars. Most of the Company’s expenses and capital expenditures are incurred in dollars, and the major source of the Company’s financing has been provided in dollars. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items (stated below) reflected in the statements of operations, the following exchange rates are used: (i) for transactions exchange rates at the transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) historical exchange rates. Currency transaction gains and losses are recorded as financial income or expenses, as appropriate. Cash equivalents The Company considers all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents. Inventories Inventories are valued at the lower of cost or market. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis. Cost of finished products is determined as follows: the value of the raw and packaging materials component is determined primarily using the “moving average” basis; the value of the labor and overhead component is determined on an average basis over the production period. Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions. g. Property and equipment 1. Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2. Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 Leasehold improvements are amortized by the straight-line method over the expected lease term, which is shorter than the estimated useful life of the improvements. Impairment in value of long-lived assets The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected future cash flows of definite life assets (undiscounted and without interest charges) is less than the carrying amount of such assets, the Company recognizes an impairment loss, and writes down the assets to their estimated fair values. i. Income taxes 1. Deferred income taxes Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of the differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. The Company used tax rates of 39%, 24% and 23%. 2. Uncertainty in income taxes Tax benefits recognized in the financial statements are those that the Company’s management deems at least more likely than not to be sustained, based on technical merits. The amount of benefits recorded for these tax benefits is measured as the largest benefit the Company’s management deems more likely than not to be sustained. j. Revenue Recognition Revenues from supply agreements and from selling products The Company recognizes revenues from supply agreements and from selling products upon delivery, when the sales price is fixed or determinable and collectability is reasonably assured. Research and development costs Research and development costs are expensed as incurred and consist primarily of personnel, subcontractors and consultants (mainly in connection with clinical trials), facilities, equipment and supplies for research and development activities. Grants received by the Israeli Subsidiary from the National Authority for Technological Innovation (“NATI”), which has replaced many of the functions of the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor (the “OCS”), are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company or the Subsidiaries will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. In connection with purchases of assets, amounts assigned to intangible assets to be used in a particular research and development project that have no alternative future use are charged to research and development costs at the purchase date. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are consumed or the related services are performed. Concentration of credit risks and trade receivable Financial instruments that potentially subject the Company to concentration of credit risk consist principally of bank deposits. The Company deposits these instruments with highly rated financial institutions, mainly in Israeli banks, and, as a matter of policy, limits the amounts of credit exposure to any one financial institution. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these instruments. The Company’s trade receivables represent amounts to be received from Pfizer and Brazil. The Company does not require Pfizer or Brazil to post collateral with respect to receivables. Share-based compensation The Company accounts for employee’s share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation cost for an award with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach. When stock options are granted as consideration for services provided by consultants and other non-employees, the grant is accounted for based on the fair value of the stock options issued. Options granted are measured on a final basis at the end of the related service period and is recognized over the related service period using the straight-line method. Net 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, par value $ 0.001 The calculation of diluted LPS does not include 18,850,724 19,778,424 23,532,492 Convertible notes All outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (ASC) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The Company accounts for the 2013 Notes (as defined in note 8a) as a liability, on an aggregated basis, in their entirety. The 2016 Notes (as defined in note 8b) partially are accounted for as liability and equity components of the instrument and partially as a debt host contract with an embedded derivative resulting from the conversion feature. The debt discount and debt issuance costs regarding the issuance of the 2013 Notes are deferred and amortized over the 2013 Notes period (5 years). Issuance costs regarding the issuance of the 2016 Notes were allocated to the liability, equity component, derivative and shares based on their relative fair values. Issuance costs that were allocated to the liability are amortized using the effective interest rate, other than issuance costs that were allocated to the derivative which were expensed immediately. Recently adopted standards In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718)” (“ASU 2016-09”) which simplifies certain aspects of the accounting for share-based payments, including accounting for income taxes, classification of awards as either equity or liabilities, classification on the statement of cash flows as well as allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur. ASU 2016-09 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Early adoption is permitted in any annual or interim period for which financial statements have not yet been issued, and all amendments in the ASU that apply must be adopted in the same period. The Company adopted this standard in the fourth quarter of 2016. The implementation of this ASU did not have a material impact on the consolidated financial statements Recently issued accounting pronouncements In May 2014, the FASB issued guidance on revenues from contracts with customers that will supersede most current revenue recognition guidance, including industry-specific guidance. The underlying principle is to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled to in exchange for those goods or services. The guidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions require capitalization of certain contracts costs, consideration of the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount timing and uncertainty of revenues and cash flows arising from an entity’s contracts with customers. The guidance is effective for the interim and annual periods beginning on or after December 15, 2017 (early adoption is permitted for the interim and annual periods beginning on or after December 15, 2016). The guidance permits the use of either a retrospective or modified retrospective transition method. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. In January 2016, the FASB issued ASU, No. 2016-01, Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities . In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires lessees to recognize leases on their balance sheets, and leaves lessor accounting largely unchanged. The amendments in this ASU are effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years. Early application is permitted for all entities. ASU 2016-02 requires a modified retrospective approach for all leases existing at, or entered into after, the date of initial application, with an option to elect to use certain transition relief. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flow - Classification of Certain Cash Receipts and Cash Payments (Topic 230)” (“ASU 2016-15”) which addresses specific cash flow issues with the objective of reducing the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. ASU 2016-15 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The Company is currently evaluating the impact of this new pronouncement on its consolidated statements of cash flows. In November 2016, the FASB issued ASU 2016-18, “Statement of cash flows (Topic 230): Restricted cash,” which addresses the treatment of restricted cash in the statements of cash flows. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance will be effective the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements. |
AGREEMENTS WITH PFIZER
AGREEMENTS WITH PFIZER | 12 Months Ended |
Dec. 31, 2016 | |
AGREEMENTS WITH PFIZER [Abstract] | |
AGREEMENTS WITH PFIZER | NOTE 2 - AGREEMENTS WITH PFIZER 1. On November 30, 2009, Protalix Ltd. and Pfizer entered into the Pfizer Agreement pursuant to which Pfizer was granted an exclusive, worldwide license to develop and commercialize taliglucerase alfa, except in Israel. Under the terms and conditions of the Pfizer Agreement, Protalix Ltd. retained the right to commercialize taliglucerase alfa in Israel. In June 2013, Pfizer returned the commercialization rights in Brazil to Protalix Ltd. Under the Pfizer Agreement and prior to its amendment in October 2015, Pfizer made an upfront payment to Protalix Ltd. of $ 60.0 5.0 25.0 40 4.3 The Company recognized revenue from milestone payments received pursuant to the Pfizer Agreement in accordance with guidance regarding arrangements with multiple deliverables. As the first Pfizer Agreement required the Company’s continued involvement with respect to the proposed commercialization of taliglucerase alfa, the non-refundable, up-front license payment the Company received from Pfizer was deferred and was recognized over the related performance period. The Company estimated the performance period of 14 The Company first determined that the initial, non-refundable upfront license fee payment of $60.0 million together with the first $ 5.0 4.6 25.0 2. In October 2015 the Company entered into the following agreements: Amended Pfizer Agreement - Pursuant to the amendment, the Company granted Pfizer an exclusive license in the entire world, including Israel but excluding Brazil. Pfizer acquired all the information, knowledge and permission to manufacture and sell Elelyso. Protalix also agreed to provide Pfizer with: a. Manufacturing and supply of the drug substance for its incorporation into the licensed product in consideration of an agreed price per unit. b. Assistance in arranging for the manufacture of the drug substance by Pfizer or by alternative supplier chosen by Pfizer in consideration of an agreed hourly rate plus reimbursement of expenses. Stock Purchase Agreement - the Company issued 5,649,079 Promissory note as of the date of the amendment, the Company owed Pfizer $ 4.3 The three contracts presented above are considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $ 46.0 6.1 39.9 The Amended Pfizer Agreement resulted in a discontinued operation as defined under ASU 2014-08 because it represented a strategic shift for the Company that has a major effect on the entity’s operations and financial results. Revenues from the Pfizer Agreements as well as revenues from sales of Elelyso in Israel are presented as discontinued operations, see note 12. In connection with the payments received under the Pfizer Agreement and the Amended Pfizer Agreement, Protalix Ltd. paid to other third parties certain royalties. See note 6a. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2016 | |
PROPERTY AND EQUIPMENT [Abstract] | |
PROPERTY AND EQUIPMENT | NOTE 3 - PROPERTY AND EQUIPMENT a. December 31, (U.S. dollars in thousands) 2015 2016 Laboratory equipment $ 15,493 $ 16,265 Furniture and computer equipment 2,244 2,342 Leasehold improvements 15,635 15,678 Equipment under construction 175 19 $ 33,547 $ 34,304 Less accumulated depreciation and amortization (23,803) (25,601) $ 9,744 $ 8,703 b. Depreciation in respect of property and equipment totaled approximately $ 3.1 2.4 2 |
INVENTORIES
INVENTORIES | 12 Months Ended |
Dec. 31, 2016 | |
INVENTORIES [Abstract] | |
INVENTORIES | NOTE 4 - INVENTORIES December 31, (U.S. dollars in thousands) 2015 2016 Raw materials $ 1,180 $ 2,591 Work in progress 395 Finished goods 4,587 2,259 Total inventory $ 5,767 $ 5,245 1.3 67,000 |
LIABILITY FOR EMPLOYEE RIGHTS U
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2016 | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT [Abstract] | |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | NOTE 5 - LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT The Israeli Subsidiary is required to make a severance payment upon dismissal of an employee or upon termination of employment in certain circumstances. The severance pay liability to the employees (based upon length of service and the latest monthly salary - one month’s salary for each year employed) is recorded on the Company’s balance sheets under “Liability for employee rights upon retirement.” The liability is recorded as if it were payable at each balance sheet date on an undiscounted basis. The liability is funded in part from the purchase of insurance policies or by the establishment of pension funds with dedicated deposits in the funds. The amounts used to fund these liabilities are included in the Company’s balance sheets under “Funds in respect of employee rights upon retirement.” These policies are the Company’s assets. However, under labor agreements and subject to certain limitations, any policy may be transferred to the ownership of the individual employee for whose benefit the funds were deposited. In the years ended December 31, 2014, 2015 and 2016, the Company deposited approximately $ 195,000 168,000 164,000 In accordance with the current employment agreements with certain employees, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s rights upon retirement. The Company is fully relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected in the Company’s balance sheets, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies (the “Contribution Plans”). The amounts of severance pay expenses were approximately $ 1.0 800,000 842,000 779,000 675,000 675,000 22,000 The Company expects to contribute approximately $ 869,000 708,000 During the five-year period following December 31, 2016, the Company expects to pay future benefits to two employees upon each such employee’s normal retirement age. The Company anticipates that the benefits payable will be approximately $ 209,000 |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2016 | |
COMMITMENTS [Abstract] | |
COMMITMENTS | NOTE 6 - COMMITMENTS a. Royalty Commitments 1. The Company is obligated to pay royalties to NATI on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from NATI or its predecessor, the OCS. At the time the grants were received, successful development of the related projects was not assured. In the case of failure of a project that was partly financed as described above, the Company is not obligated to pay any such royalties or repay funding received from NATI or the OCS. Under the terms of the applicable funding arrangements, royalties of 3 6 300 Royalty expenses to NATI or the OCS are included in the statement of operations as a component of the cost of revenues both in continuing and discontinued operations and were approximately $ 951,000 2.2 288,000 At December 31, 2015 and 2016, the maximum total royalty amount payable by the Company under these funding arrangements is approximately $33.3 million and $ 38.5 100 2. The Company is a party to certain research and license agreements. Under the agreements, the Company is obligated to pay royalties at varying rates from its future revenues. The aggregate royalties payable under all of the agreements is equal to a varying range of percentages of net sales of licensed products. Royalty expenses under the agreements are included in the statement of operations as a component of the cost of revenues both in continuing and discontinued operations and were approximately $ 104,000 51,000 286,000 Under each agreement, the Company is also obligated to pay milestone, licensing and other payments to the counterparties of the agreement. The payments under the agreements are for varying amounts and are subject to varying conditions. If all of the contingencies with respect to milestone payments under the research and license agreements are met, the aggregate milestone payments total payable would be approximately $ 8.4 300,000 None of the agreements has a fixed termination date. Subject to earlier termination for other reasons, each agreement terminates after a certain number of years following the first commercial sale of any licensed product under the agreement or after a certain number of years without the initiation of commercial sales of any product under the agreement. b. Subcontracting Agreements The Company has entered into sub-contracting agreements with several clinical providers and consultants in Israel, the United States and certain other countries in connection with its primary product development process. As of December 31, 2016, total commitments under said agreements were approximately $ 12.5 c. Lease Agreements The Company is a party to a number of lease agreements for its facilities, the latest of which has been extended until 2021. The Company has the option to extend certain of such agreements on two additional occasions for additional five-year periods each, for a total of 10 additional years. Under the leases, the aggregate monthly rental payments are approximately $ 61,000 288,000 735,000 722,000 680,000 680,000 543,000 1.0 d. Vehicle Lease and Maintenance Agreements The Company entered into several three-year lease and maintenance agreements for vehicles which are regularly amended as new vehicles are leased. The current monthly lease fees aggregate approximately $ 51,000 563,000 $ 289,000 84,000 |
SHARE CAPITAL
SHARE CAPITAL | 12 Months Ended |
Dec. 31, 2016 | |
SHARE CAPITAL [Abstract] | |
SHARE CAPITAL | NOTE 7 - SHARE CAPITAL a. Rights of the Company’s Common Stock The Company’s Common Stock is listed on the NYSE MKT and on the Tel Aviv Stock Exchange. Each share of Common Stock is entitled to one vote. The holders of shares of Common Stock are also entitled to receive dividends whenever funds are legally available, when and if declared by the Board of Directors. Since its inception, the Company has not declared any dividends. b. Stock based compensation On December 14, 2006, the Board of Directors adopted the Protalix BioTherapeutics, Inc. 2006 Stock Incentive Plan, as amended (the “Plan”). The Plan has since been amended to, among other things, increase the number of shares of common stock available under the plan to 13,841,655 As of December 31, 2016, 2,391,481 For purposes of determining the fair value of the options and restricted stock granted to employees and non-employees, the Company’s management uses the fair value of the Common Stock. From January 1, 2014 through December 31, 2016, the Company granted options and shares of restricted stock to certain employees and non-employees as follows: 1. Options and restricted stock granted to employees: a) Fair value at grant (U.S. Year of No. of options Exercise dollars in Expiration grant granted price Vesting period thousands) period 2014 900,000 $ 2.37 4 years $ 1,007 10 years 2015 1,909,000 $ 1.72 4 years $ 1,900 10 years 2,809,000 Set forth below are grants made by the Company to employees (including related parties) during the three-year period ended December 31, 2016 (such grants appear in the table above): On September 28, 2014, the Company’s Board of Directors approved, subject to certain terms and conditions, the grant of a 10 900,000 2.37 16 1.0 0 62 1.86 On March 23, 2015, the Company’s compensation committee approved the grant of a 10 1,909,000 1.72 25 1.9 0 61.7 1.6 b) The total unrecognized compensation cost of employee stock options and restricted stock at December 31, 2016 is approximately $ 509,000 0.8 The total cash received from employees as a result of employee stock option exercises for the years ended December 31, 2014, 2015 and 2016 was approximately $ 46,000 534,000 14,000 During 2016, the Company issued 479,110 shares of Common Stock in connection with the exercise of 553,125 options granted to a certain employee of the Company. The Company received cash proceeds equal to approximately $14,000 in connection with such exercises. 2. Options granted to consultants, directors, and other service providers: On July 24, 2014, the Company’s Board of Directors approved, subject to certain terms and conditions, the grant of a 10 150,000 3.37 193,000 0 62 1.9 No cash was received from consultants as a result of consultant stock option exercises for the years ended December 31, 2014, 2015 and 2016. During 2015 and 2016, no shares of Common Stock were issued in connection with the exercise of options by consultants of the Company. 3. A summary of share option plans, and related information, under all of the Company’s equity incentive plans for the years ended December 31, 2014, 2015 and 2016 are as follows: a. Year ended December 31, 2014 2015 2016 Weighted Weighted Weighted Number average Number average Number average of exercise of exercise of exercise options price options price options price Outstanding at beginning 5,153,898 $ 3.951 5,870,309 $ 3.770 6,952,293 $ 3.363 Changes during the year: Granted 900,000 2.370 1,909,000 1.72 Forfeited and Expired 44,201 6.833 277,016 5.395 1,514,957 3.748 Exercised (*) 139,388 0.446 550,000 0.972 553,125 0.067 Outstanding at end of year 5,870,309 $ 3.770 6,952,293 $ 3.363 4,884,211 $ 3.617 Exercisable at end of year 4,905,559 $ 3.933 4,477,043 $ 4.182 3,498,492 $ 4.296 (*) The total intrinsic value of options exercised during the years ended December 31, 2014, 2015 and 2016, was approximately 447,000 675,000 213,000 , respectively. b. Year ended December 31, 2014 2015 2016 Number of Restricted Shares Outstanding at beginning of year 970,208 386,124 127,874 Changes during the year: Vested 398,375 255,749 127,874 Forfeited 185,709 2,501 Outstanding at end of year 386,124 127,874 - c. Year ended December 31, 2014 2015 2016 Number Number Number of Weighted of Weighted of Weighted options/ average options/ average options/ average restricted exercise restricted exercise restricted exercise stock price stock price stock price Outstanding at beginning of Year 912,425 $ 7.259 1,208,592 $ 6.136 637,209 $ 11.638 Changes during the year: Granted 296,167 2.678 Expired 466,883 0.001 429,209 15.748 Vested restricted stock 104,500 Outstanding at end of year 1,208,592 6.136 637,209 11.638 208,000 3.156 Exercisable at end of year 912,425 $ 7.259 549,709 $ 12.954 170,500 $ 3.109 d. December 31, 2016 Options outstanding Options exercisable Number of Weighted Weighted options average average outstanding remaining Number of remaining Exercise at end of contractual options contractual prices year life exercisable life $ 0.001 8,000 0.86 8,000 0.86 $ 1.720 1,784,279 8.22 792,310 8.22 $ 2.350 40,000 1.81 40,000 1.81 $ 2.370 900,000 7.74 506,250 7.74 $ 2.650 212,682 2.15 212,682 2.15 $ 3.020 50,000 1.10 50,000 1.10 $ 3.370 150,000 7.56 112,500 7.56 $ 5.000 1,009,250 1.10 1,009,250 1.10 $ 6.900 710,000 3.15 710,000 3.15 $ 7.550 160,000 3.65 160,000 3.65 $ 9.660 68,000 3.83 68,000 3.83 5,092,211 3,668,992 e. Year ended December 31, (U.S. dollars in thousands) 2014 2015 2016 Research and development expenses $ 936 $ 904 $ 571 Marketing, general and administrative expenses 306 898 417 $ 1,242 $ 1,802 $ 988 c. Private and 144A Offerings 1. On October 12, 2015, the Company completed a private offering of 5,649,079 2. On December 7, 2016, the Company exchanged with certain existing noteholders $ 54.052 4.50 40.186 23,846,735 |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 12 Months Ended |
Dec. 31, 2016 | |
CONVERTIBLE NOTES [Abstract] | |
CONVERTIBLE NOTES | NOTE 8 - CONVERTIBLE NOTES a. 4.5% Convertible Notes ("2013 Notes") On September 18, 2013, the Company completed a private placement of $ 69.0 9.0 4.50 54.052 14.948 The net proceeds from the offering of the 2013 Notes were $ 66.8 Holders may convert their 2013 Notes at any time prior to the close of business on the business day immediately preceding September 15, 2018. The initial conversion rate for the 2013 Notes is 173.6593 5.76 Redemption of the 2013 Notes was prohibited prior to September 19, 2016, and no sinking fund is provided for the 2013 Notes. On or after September 19, 2016, the Company may redeem for cash all or part of the 2013 Notes (except for the notes that the Company is then required to repurchase in connection with a fundamental change) if the last reported sale price of the Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading-day period ending on the trading day immediately preceding the date on which the Company provides the notice of redemption. Year ended December 31, (U.S. Dollars in thousands) 2014 2015 2016 Contractual interest expense $ 3,105 $ 3,105 $ 2,943 Amortization of debt issuance costs and debt discount 444 444 421 Total $ 3,549 $ 3,549 $ 3,364 b. 7.5% Convertible Notes ("2016 Notes") On December 1, 2016, the Company entered into a note purchase agreement with institutional investors, which hold part of the 2013 Notes (the “Purchasers”), relating to the sale by the Company of $ 22.5 54.052 40.186 23,846,735 In connection with the completion of the exchange and the private placement, the Company entered into an indenture (the “2016 Indenture”) with The Bank of New York Mellon Trust Company, N.A., as trustee, governing the 2016 Notes. The 2016 Notes accrue interest at a rate of 7.50 The net proceeds from the private placement were $ 19.7 Holders may convert their 2016 Notes at any time. The initial conversion rate for the 2016 Notes is 1,176.4706 shares of the Common Stock for each $1,000 principal amount of 2016 Notes (equivalent to an initial conversion price of approximately $ 0.85 a) any or all of the 2016 Notes if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days exceeds 150% of the conversion price on each applicable trading day, or b) all of the 2016 Notes then outstanding if the aggregate principal amount of the 2016 Notes then outstanding is less than 15% of the aggregate principal amount of the notes issued. The 2016 Notes are guaranteed by the Restricted Subsidiaries (as defined in the 2016 Indenture) and are secured by a first-priority security interest in all of the present and after-acquired assets of the Company and each of the Restricted Subsidiaries (the “Collateral”), including, but not limited to, (i) 100% of the capital stock of the Guarantors (as defined in the 2016 Indenture) and each Restricted Subsidiary of the Company that is held by the Company or any Restricted Subsidiary, (ii) intellectual property, including all copyrights, copyright licenses, patents, patent licenses, software, trademarks, trademark licenses and trade secrets and other proprietary information, including, but not limited to, domain names, (iii) all cash, deposit accounts, securities accounts, commodities accounts and contract rights, (iv) all real property and leased property, subject to applicable minimum thresholds, as set forth in the 2016 Indenture, and (v) all other tangible and intangibles of the Company and the Guarantors. In connection with the grant of such liens, the Company entered into certain agreements with both Wilmington Savings Fund Society, FSB, as collateral agent in the United States, and with Altshuler Shaham Trusts Ltd., as security trustee in Israel. The 2016 Indenture restricts the ability of the Company, the Subsidiaries and any future subsidiaries to make certain investments, including transfers of the Company’s assets that constitute collateral securing the 2016 Notes, in its existing and future foreign subsidiaries, subject to certain exceptions. Upon (i) the occurrence of a fundamental change (as defined in the 2016 Indenture) or (ii) if the Company calls the 2016 Notes for redemption as described below (either event, a “make-whole fundamental change”) and a holder elects to convert its 2016 Notes in connection with such make-whole fundamental change, the Company will, in certain circumstances, increase the conversion rate by a number of additional shares (the “Additional Shares”). In no event will the conversion rate exceed the maximum conversion rate, which is 1,787.3100 shares per $1,000 principal amount of 2016 Notes, which amount is inclusive of repayment of the principal of the 2016 Notes. If a fundamental change occurs at any time, holders will have the right, at their option, to require the Company to purchase for cash any or all of the 2016 Notes, or any portion of the principal amount thereof, that is equal to $1,000 or an integral multiple of $ 1,000 For accounting purposes, since the terms of the 2013 Notes and the 2016 Notes are substantially different, the Exchange Agreement was considered as an extinguishment, which in essence means recording a gain due to the 2013 Notes that were exchanged for the 2016 Notes recorded at fair value as of the closing date. The gain on extinguishment of $ 14.063 As the settlement upon conversion is subject to compliance with the listing standards of NYSE MKT, until the Company’s stockholders’ approval will be obtained, the Company is prohibited by these rules from issuing shares in excess of 20 With respect to the remainder of the 2016 Notes, for which the conversion feature qualifies for equity classification (since upon conversion the Company at its election may settle the 2016 Notes by paying cash, shares of Common Stock or a combination of cash and shares of Common Stock) separate liability (debt) and equity (conversion option) components of such 2016 Notes were recorded. The Company measured the liability according to amortized cost using the effective interest method. (U.S. Dollars in thousands) December 7, December 31, Stock price (USD) 0.3 0.445 Expected term 4.94 4.88 Risk free rate 1.86 % 1.95 % Volatility 54.12 % 56.08 % Yield 13.98 % (U.S. Dollars in thousands) Year Ended Contractual interest expense $ 313 Debt discount amortization 147 Gain on extinguishment (14,063) Change in fair value of convertible note embedded derivative 6,473 Total $ (7,130) |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 12 Months Ended |
Dec. 31, 2016 | |
FAIR VALUE MEASUREMENT [Abstract] | |
FAIR VALUE MEASUREMENT | NOTE 9 - FAIR VALUE MEASUREMENT The Company discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value. The fair value of the convertible notes derivative is based on level 3 measurement. The fair value of the remaining $ 14.9 62.7 10 64 As for the parameters used in the valuation of the fair value see note 8b. |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2016 | |
TAXES ON INCOME [Abstract] | |
TAXES ON INCOME | NOTE 10 - TAXES ON INCOME a. The Company Protalix BioTherapeutics, Inc. is taxed according to U.S. tax laws. The Company’s income is taxed in the United States at the rate of up to 39 b. Protalix Ltd. The Israeli Subsidiary is taxed according to Israeli tax laws: 1. Tax rates The income of the Israeli Subsidiary, other than income from “Approved Enterprises,” is taxed in Israel at the regular corporate tax rates which were 26.5 25 In January 2016, the Law for the Amendment of the Income Tax Ordinance (No.216) was published, enacting a reduction of corporate tax rate beginning in 2016 and thereafter, from 26.5 25 In December 2016, the Economic Efficiency Law (Legislative Amendments for Implementing the Economic Policy for the 2017 and 2018 Budget Year), 2016 was published, introducing a gradual reduction in corporate tax rate from 25 23 24 23 Capital gain is subject to capital gain tax according to the corporate tax rate for the year during which the assets are sold. 2. The Law for the Encouragement of Capital Investments, 1959 (the “Encouragement of Capital Investments Law”) Under the Encouragement of Capital Investments Law, including Amendment No. 60 to the Encouragement of Capital Investments Law as published in April 2005, by virtue of the “Approved Enterprise” or “Benefited Enterprise” status the Israeli Subsidiary is entitled to various tax benefits as follows: a. Reduced tax rates Income derived from the Approved Enterprise during a 10-year period commencing upon the year in which the enterprise first realizes taxable income is tax exempt, provided that the maximum period to which it is restricted by the Encouragement of Capital Investments Law has not elapsed. The Israeli Subsidiary has an “Approved Enterprise” plan since 2004 and “Benefited Enterprise” plan since 2009. The period of benefits in respect of the main enterprise of the Company has not yet commenced. The period during which the Company is entitled to benefits in connection with the Benefited Enterprise expires in 2021. If the Israeli Subsidiary subsequently pays a dividend out of income derived from the “Approved Enterprise” or “Benefited Enterprise” during the tax exemption period, it will be subject to a tax on the gross amount distributed (including the company tax on these amounts), at the rate which would have been applicable had such income not been exempted. b. Accelerated depreciation The Israeli Subsidiary is entitled to claim accelerated depreciation, as provided by Israeli law, in the first five years of operation of each asset, in respect of buildings, machinery and equipment used by the Approved Enterprise and the Benefited Enterprise. c. Conditions for entitlement to the benefits The Israeli Subsidiary’s entitlement to the benefits described above is subject to its fulfilling the conditions stipulated by the law, rules and regulations published thereunder, and the instruments of approval for the specific investment in an approved enterprise. Failure by the Israeli Subsidiary to comply with these conditions may result in the cancellation of the benefits, in whole or in part, and the Subsidiary may be required to refund the amount of the benefits with interest. The Israeli Subsidiary received a final implementation approval with respect to its “Approved Enterprise” from the Investment Center. d. Amendment of the Law for the Encouragement of Capital Investments, 1959 The Encouragement of Capital Investments Law was amended as part of the Economic Policy Law for the years 2011-2012, which was passed by the Israeli Knesset on December 29, 2010 (the “Capital Investments Law Amendment”). The Capital Investments Law Amendment sets alternative benefit tracks to those currently in effect under the provisions of the Encouragement of Capital Investments Law. The Company elected not to have the Capital Investments Law Amendment apply to the Company. c. Tax losses carried forward to future years As of December 31, 2016, the Company had aggregate net operating loss (“NOL”) carry-forwards equal to approximately $ 153 1. The Company The NOL carry-forward of the Company equal to approximately $ 20 million (as of December 31, 2015, approximately $ 19 2. Protalix Ltd. At December 31, 2016, the Israeli Subsidiary had approximately $ 133 million (as of December 31, 2015, approximately $ 102 d. Deferred income taxes: December 31, (U.S. dollars in thousands) 2015 2016 In respect of: Timing Differences $ 3,588 $ 3,520 Net operating loss carry forwards 33,451 38,515 Valuation allowance (37,039) (42,035) - - Deferred taxes are computed using the tax rates expected to be in effect when those differences reverse. e. Reconciliation of the theoretical tax expense to actual tax expense The main reconciling item between the statutory tax rate of the Company and the effective rate is the provision for a full valuation allowance in respect of tax benefits from carry forward tax losses due to the uncertainty of the realization of such tax benefits (see above). f. Tax assessments In accordance with the Income Tax Ordinance, as of December 31, 2016, all of Protalix Ltd.’s tax assessments through tax year 2012 are considered final. Jurisdiction: Years: Israel 2013-2016 United States (*) 2013-2016 (*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
SUPPLEMENTARY FINANCIAL STATEME
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended |
Dec. 31, 2016 | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION [Abstract] | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | NOTE 11 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION December 31, (U.S. dollars in thousands) 2015 2016 a. Other assets: Institutions $ 216 $ 333 State of Israel (see note 6a) 621 1,046 Restricted deposit 371 477 Prepaid expenses 408 416 Sundry 51 49 $ 1,667 $ 2,321 December 31, (U.S. dollars in thousands) 2015 2016 b. Accounts payable and accruals other: Payroll and related expenses 1,125 1,190 Interest payable 914 511 Provision for vacation 1,406 1,399 Accrued expenses 1,571 3,575 Royalties payable 29 226 Property and equipment suppliers 489 595 $ 5,534 $ 7,496 |
DISCONTINUED OPERATIONS
DISCONTINUED OPERATIONS | 12 Months Ended |
Dec. 31, 2016 | |
Discontinued Operations and Disposal Groups [Abstract] | |
DISCONTINUED OPERATIONS | NOTE 12 - DISCONTINUED OPERATIONS As mentioned in note 2, the Company accounted for the termination of the Pfizer Agreement and the sale of the license as a discontinued operation, in accordance with ASU No. 2014-08. December 31, (U.S. dollars in thousands) 2015 2016 CURRENT ASSETS: Accounts receivable - Trade $ 1,993 $ 327 Inventories 80 Total current assets of discontinued operation 2,073 327 CURRENT LIABILITIES: Other Accounts payable and accruals $ 1,568 Total current liabilities of discontinued operation 1,568 The following summarizes financial information related to the Company’s discontinued operations, in the Company’s consolidated statements of operations: Year ended December 31, 2014 2015 2016 (U.S. dollars in thousands) REVENUES $ 10,128 $ 48,674 $ 209 COMPANY’S SHARE IN COLLABORATION AGREEMENT 1,509 5,048 COST OF REVENUES (8,423) (7,697) (373) GROSS PROFIT (LOSS) 3,214 46,025 (164) RESEARCH AND DEVELOPMENT EXPENSES (2,409) (586) Less reimbursements 2,983 545 RESEARCH AND DEVELOPMENT EXPENSES, NET 574 (41) SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (433) (564) (25) NET INCOME (LOSS) FOR THE YEAR FROM DISCONTINUED OPERATIONS $ 3,355 $ 45,420 $ (189) GAIN ON THE DISPOSAL 39,899 NET INCOME (LOSS) $ 3,355 $ 85,319 $ (189) |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2016 | |
RELATED PARTY TRANSACTIONS [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 13 - RELATED PARTY TRANSACTIONS Year ended December 31, (U.S. dollars in thousands) 2014 2015 2016 Compensation (including share based compensation) to the non-executive directors (includes the interim Chairman of the Board through 2014 and the Chairman of the Board for part of 2014) $ 560 $ 631 $ 560 |
SIGNIFICANT ACCOUNTING POLICI21
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
General | General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”), and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® TM TM The Company’s product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder; (2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation; and (3) OPRX-106, the Company’s oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as a natural capsule for the expressed protein. Obtaining marketing approval with respect to any product candidate in any country is directly 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. Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer Inc. (“Pfizer”), as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the “Amended Pfizer Agreement”) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 60 40 100 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 for taliglucerase alfa. Fiocruz’s purchases of Uplyso 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 low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 In December 2016, the Company received a letter from Fiocruz regarding an order from the Brazilian Ministry of Health (the “Brazilian Ministry”) to purchase alfataliglicerase to treat Gaucher patients in Brazil. The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $ 24.3 4.0 The Company is required to pay a fee equal to 5 Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing. |
Basis of presentation | Basis of presentation The Company’s financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”). |
Use of estimates in the preparation of financial statements | c. Use of estimates in the preparation of financial statements The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. |
Functional currency | Functional currency The dollar is the currency of the primary economic environment in which the operations of the Company and its Subsidiaries are conducted. Most of the Company’s revenues are derived in dollars. Most of the Company’s expenses and capital expenditures are incurred in dollars, and the major source of the Company’s financing has been provided in dollars. Transactions and balances originally denominated in dollars are presented at their original amounts. Balances in non-dollar currencies are translated into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-dollar transactions and other items (stated below) reflected in the statements of operations, the following exchange rates are used: (i) for transactions exchange rates at the transaction dates or average rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation and amortization, etc.) historical exchange rates. Currency transaction gains and losses are recorded as financial income or expenses, as appropriate. |
Cash equivalents | Cash equivalents The Company considers all short-term, highly liquid investments, which include short-term bank deposits with original maturities of three months or less from the date of purchase, that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents. |
Inventories | Inventories Inventories are valued at the lower of cost or market. Cost of raw and packaging materials and purchased products is determined using the “moving average” basis. Cost of finished products is determined as follows: the value of the raw and packaging materials component is determined primarily using the “moving average” basis; the value of the labor and overhead component is determined on an average basis over the production period. Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions. |
Property and equipment | g. Property and equipment 1. Property and equipment are stated at cost, net of accumulated depreciation and amortization. 2. Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 Leasehold improvements are amortized by the straight-line method over the expected lease term, which is shorter than the estimated useful life of the improvements. |
Impairment in value of long-lived assets | Impairment in value of long-lived assets The Company tests long-lived assets for impairment if an indication of impairment exists. If the sum of expected future cash flows of definite life assets (undiscounted and without interest charges) is less than the carrying amount of such assets, the Company recognizes an impairment loss, and writes down the assets to their estimated fair values. |
Income taxes | i. Income taxes 1. Deferred income taxes Deferred taxes are determined utilizing the assets and liabilities method based on the estimated future tax effects of the differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has provided a full valuation allowance with respect to its deferred tax assets. The Company used tax rates of 39%, 24% and 23%. 2. Uncertainty in income taxes Tax benefits recognized in the financial statements are those that the Company’s management deems at least more likely than not to be sustained, based on technical merits. The amount of benefits recorded for these tax benefits is measured as the largest benefit the Company’s management deems more likely than not to be sustained. |
Revenue Recognition | j. Revenue Recognition Revenues from supply agreements and from selling products The Company recognizes revenues from supply agreements and from selling products upon delivery, when the sales price is fixed or determinable and collectability is reasonably assured. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred and consist primarily of personnel, subcontractors and consultants (mainly in connection with clinical trials), facilities, equipment and supplies for research and development activities. Grants received by the Israeli Subsidiary from the National Authority for Technological Innovation (“NATI”), which has replaced many of the functions of the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor (the “OCS”), are recognized when the grant becomes receivable, provided there is reasonable assurance that the Company or the Subsidiaries will comply with the conditions attached to the grant and there is reasonable assurance the grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred. In connection with purchases of assets, amounts assigned to intangible assets to be used in a particular research and development project that have no alternative future use are charged to research and development costs at the purchase date. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are consumed or the related services are performed. |
Concentration of credit risks and trade receivable | Concentration of credit risks and trade receivable Financial instruments that potentially subject the Company to concentration of credit risk consist principally of bank deposits. The Company deposits these instruments with highly rated financial institutions, mainly in Israeli banks, and, as a matter of policy, limits the amounts of credit exposure to any one financial institution. The Company has not experienced any credit losses in these accounts and does not believe it is exposed to any significant credit risk on these instruments. The Company’s trade receivables represent amounts to be received from Pfizer and Brazil. The Company does not require Pfizer or Brazil to post collateral with respect to receivables. |
Share-based compensation | Share-based compensation The Company accounts for employee’s share-based payment awards classified as equity awards using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period. The Company elected to recognize compensation cost for an award with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach. When stock options are granted as consideration for services provided by consultants and other non-employees, the grant is accounted for based on the fair value of the stock options issued. Options granted are measured on a final basis at the end of the related service period and is recognized over the related service period using the straight-line method. |
Net earnings (loss) per share | Net 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, par value $ 0.001 The calculation of diluted LPS does not include 18,850,724 19,778,424 23,532,492 |
Convertible notes | Convertible notes All outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (ASC) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The Company accounts for the 2013 Notes (as defined in note 8a) as a liability, on an aggregated basis, in their entirety. The 2016 Notes (as defined in note 8b) partially are accounted for as liability and equity components of the instrument and partially as a debt host contract with an embedded derivative resulting from the conversion feature. The debt discount and debt issuance costs regarding the issuance of the 2013 Notes are deferred and amortized over the 2013 Notes period (5 years). Issuance costs regarding the issuance of the 2016 Notes were allocated to the liability, equity component, derivative and shares based on their relative fair values. Issuance costs that were allocated to the liability are amortized using the effective interest rate, other than issuance costs that were allocated to the derivative which were expensed immediately. |
Recently adopted standards | Recently adopted standards In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718)” (“ASU 2016-09”) which simplifies certain aspects of the accounting for share-based payments, including accounting for income taxes, classification of awards as either equity or liabilities, classification on the statement of cash flows as well as allowing an entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures as they occur. ASU 2016-09 is effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. Early adoption is permitted in any annual or interim period for which financial statements have not yet been issued, and all amendments in the ASU that apply must be adopted in the same period. The Company adopted this standard in the fourth quarter of 2016. The implementation of this ASU did not have a material impact on the consolidated financial statements |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In May 2014, the FASB issued guidance on revenues from contracts with customers that will supersede most current revenue recognition guidance, including industry-specific guidance. The underlying principle is to recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled to in exchange for those goods or services. The guidance provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions require capitalization of certain contracts costs, consideration of the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount timing and uncertainty of revenues and cash flows arising from an entity’s contracts with customers. The guidance is effective for the interim and annual periods beginning on or after December 15, 2017 (early adoption is permitted for the interim and annual periods beginning on or after December 15, 2016). The guidance permits the use of either a retrospective or modified retrospective transition method. The Company is currently evaluating the impact of the guidance on its consolidated financial statements. In January 2016, the FASB issued ASU, No. 2016-01, Financial Instruments-Overall: Recognition and Measurement of Financial Assets and Financial Liabilities . In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing guidance for lease accounting, Leases (Topic 840). ASU 2016-02 requires lessees to recognize leases on their balance sheets, and leaves lessor accounting largely unchanged. The amendments in this ASU are effective for fiscal years beginning after December 15, 2018 and interim periods within those fiscal years. Early application is permitted for all entities. ASU 2016-02 requires a modified retrospective approach for all leases existing at, or entered into after, the date of initial application, with an option to elect to use certain transition relief. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flow - Classification of Certain Cash Receipts and Cash Payments (Topic 230)” (“ASU 2016-15”) which addresses specific cash flow issues with the objective of reducing the existing diversity in practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. ASU 2016-15 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. The Company is currently evaluating the impact of this new pronouncement on its consolidated statements of cash flows. In November 2016, the FASB issued ASU 2016-18, “Statement of cash flows (Topic 230): Restricted cash,” which addresses the treatment of restricted cash in the statements of cash flows. Amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance will be effective the fiscal year beginning on January 1, 2018, including interim periods within that year (early adoption is permitted). The Company is currently evaluating the potential effect of the guidance on its consolidated financial statements. |
SIGNIFICANT ACCOUNTING POLICI22
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Schedule of Useful Life | The Company’s assets are depreciated by the straight-line method on the basis of their estimated useful lives as follows: Years Laboratory equipment 5 Furniture 10-15 Computer equipment 3 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
PROPERTY AND EQUIPMENT [Abstract] | |
Schedule of Property and Equipment | Composition of property and equipment grouped by major classifications is as follows: December 31, (U.S. dollars in thousands) 2015 2016 Laboratory equipment $ 15,493 $ 16,265 Furniture and computer equipment 2,244 2,342 Leasehold improvements 15,635 15,678 Equipment under construction 175 19 $ 33,547 $ 34,304 Less accumulated depreciation and amortization (23,803) (25,601) $ 9,744 $ 8,703 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
INVENTORIES [Abstract] | |
Schedule of Inventory | Inventories at December 31, 2015 and 2016 consisted of the following: December 31, (U.S. dollars in thousands) 2015 2016 Raw materials $ 1,180 $ 2,591 Work in progress 395 Finished goods 4,587 2,259 Total inventory $ 5,767 $ 5,245 |
SHARE CAPITAL (Tables)
SHARE CAPITAL (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SHARE CAPITAL [Abstract] | |
Schedule of Options and Restricted Stocks Granted | Below is a table summarizing all of the options and restricted stock grants to employees for each year of the two-year period ended December 31, 2015: Fair value at grant (U.S. Year of No. of options Exercise dollars in Expiration grant granted price Vesting period thousands) period 2014 900,000 $ 2.37 4 years $ 1,007 10 years 2015 1,909,000 $ 1.72 4 years $ 1,900 10 years 2,809,000 |
Summary of Stock Option Activity - Options Granted to Employees | Options granted to employees: Year ended December 31, 2014 2015 2016 Weighted Weighted Weighted Number average Number average Number average of exercise of exercise of exercise options price options price options price Outstanding at beginning 5,153,898 $ 3.951 5,870,309 $ 3.770 6,952,293 $ 3.363 Changes during the year: Granted 900,000 2.370 1,909,000 1.72 Forfeited and Expired 44,201 6.833 277,016 5.395 1,514,957 3.748 Exercised (*) 139,388 0.446 550,000 0.972 553,125 0.067 Outstanding at end of year 5,870,309 $ 3.770 6,952,293 $ 3.363 4,884,211 $ 3.617 Exercisable at end of year 4,905,559 $ 3.933 4,477,043 $ 4.182 3,498,492 $ 4.296 (*) The total intrinsic value of options exercised during the years ended December 31, 2014, 2015 and 2016, was approximately 447,000 675,000 213,000 , respectively. |
Summary of Restricted Stock Activity - Options Granted to Employees | Restricted stock granted to employees: Year ended December 31, 2014 2015 2016 Number of Restricted Shares Outstanding at beginning of year 970,208 386,124 127,874 Changes during the year: Vested 398,375 255,749 127,874 Forfeited 185,709 2,501 Outstanding at end of year 386,124 127,874 - |
Schedule of Options Granted to Service Providers | Options and restricted stocks granted to consultants, directors, and other service providers: Year ended December 31, 2014 2015 2016 Number Number Number of Weighted of Weighted of Weighted options/ average options/ average options/ average restricted exercise restricted exercise restricted exercise stock price stock price stock price Outstanding at beginning of Year 912,425 $ 7.259 1,208,592 $ 6.136 637,209 $ 11.638 Changes during the year: Granted 296,167 2.678 Expired 466,883 0.001 429,209 15.748 Vested restricted stock 104,500 Outstanding at end of year 1,208,592 6.136 637,209 11.638 208,000 3.156 Exercisable at end of year 912,425 $ 7.259 549,709 $ 12.954 170,500 $ 3.109 |
Schedule of Information about Share Options Outstanding | The following tables summarize information concerning outstanding and exercisable options and restricted stock as of December 31, 2016: December 31, 2016 Options outstanding Options exercisable Number of Weighted Weighted options average average outstanding remaining Number of remaining Exercise at end of contractual options contractual prices year life exercisable life $ 0.001 8,000 0.86 8,000 0.86 $ 1.720 1,784,279 8.22 792,310 8.22 $ 2.350 40,000 1.81 40,000 1.81 $ 2.370 900,000 7.74 506,250 7.74 $ 2.650 212,682 2.15 212,682 2.15 $ 3.020 50,000 1.10 50,000 1.10 $ 3.370 150,000 7.56 112,500 7.56 $ 5.000 1,009,250 1.10 1,009,250 1.10 $ 6.900 710,000 3.15 710,000 3.15 $ 7.550 160,000 3.65 160,000 3.65 $ 9.660 68,000 3.83 68,000 3.83 5,092,211 3,668,992 |
Schedule of Stock-Based Compensation Expense in Statement of Operations | The following table illustrates the effect of share-based compensation on the statement of operations: Year ended December 31, (U.S. dollars in thousands) 2014 2015 2016 Research and development expenses $ 936 $ 904 $ 571 Marketing, general and administrative expenses 306 898 417 $ 1,242 $ 1,802 $ 988 |
CONVERTIBLE NOTES (Tables)
CONVERTIBLE NOTES (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
CONVERTIBLE NOTES [Abstract] | |
Schedule of Interest Expense Recognized | The following table sets forth total interest expense recognized for the years ended December 31, 2014, 2015 and 2016 related to the 2013 Notes: Year ended December 31, (U.S. Dollars in thousands) 2014 2015 2016 Contractual interest expense $ 3,105 $ 3,105 $ 2,943 Amortization of debt issuance costs and debt discount 444 444 421 Total $ 3,549 $ 3,549 $ 3,364 |
Fair Value Measurements, Recurring and Nonrecurring | The Company prepared a valuation of the fair value of the 2016 Notes (a Level 3 valuation). The value of the 2016 Notes was estimated by implementing the binomial model. The liability component was valued based on the Income Approach. The following parameters were used: (U.S. Dollars in thousands) December 7, December 31, Stock price (USD) 0.3 0.445 Expected term 4.94 4.88 Risk free rate 1.86 % 1.95 % Volatility 54.12 % 56.08 % Yield 13.98 % |
Schedule of Debt | The following table sets forth total interest expense recognized for the year ended December 31, 2016 related to the 2016 Notes: (U.S. Dollars in thousands) Year Ended Contractual interest expense $ 313 Debt discount amortization 147 Gain on extinguishment (14,063) Change in fair value of convertible note embedded derivative 6,473 Total $ (7,130) |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
TAXES ON INCOME [Abstract] | |
Schedule of Deferred Tax Assets | The components of the Company’s net deferred tax assets at December 31, 2015 and 2016 were as follows: December 31, (U.S. dollars in thousands) 2015 2016 In respect of: Timing Differences $ 3,588 $ 3,520 Net operating loss carry forwards 33,451 38,515 Valuation allowance (37,039) (42,035) - - |
Schedule of Open Tax Years | A summary of open tax years by major jurisdiction is presented below: Jurisdiction: Years: Israel 2013-2016 United States (*) 2013-2016 (*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
SUPPLEMENTARY FINANCIAL STATE28
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION [Abstract] | |
Supplemental Information, Balance Sheets | Balance sheets: December 31, (U.S. dollars in thousands) 2015 2016 a. Other assets: Institutions $ 216 $ 333 State of Israel (see note 6a) 621 1,046 Restricted deposit 371 477 Prepaid expenses 408 416 Sundry 51 49 $ 1,667 $ 2,321 December 31, (U.S. dollars in thousands) 2015 2016 b. Accounts payable and accruals other: Payroll and related expenses 1,125 1,190 Interest payable 914 511 Provision for vacation 1,406 1,399 Accrued expenses 1,571 3,575 Royalties payable 29 226 Property and equipment suppliers 489 595 $ 5,534 $ 7,496 |
DISCONTINUED OPERATIONS (Tables
DISCONTINUED OPERATIONS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Discontinued Operations | The following assets and liabilities associated with the Company’s discontinued operations, have been segregated and classified as assets and liabilities of discontinued operations, as appropriate, in the consolidated balance sheets as of December 31, 2015 and 2016, respectively: December 31, (U.S. dollars in thousands) 2015 2016 CURRENT ASSETS: Accounts receivable - Trade $ 1,993 $ 327 Inventories 80 Total current assets of discontinued operation 2,073 327 CURRENT LIABILITIES: Other Accounts payable and accruals $ 1,568 Total current liabilities of discontinued operation 1,568 The following summarizes financial information related to the Company’s discontinued operations, in the Company’s consolidated statements of operations: Year ended December 31, 2014 2015 2016 (U.S. dollars in thousands) REVENUES $ 10,128 $ 48,674 $ 209 COMPANY’S SHARE IN COLLABORATION AGREEMENT 1,509 5,048 COST OF REVENUES (8,423) (7,697) (373) GROSS PROFIT (LOSS) 3,214 46,025 (164) RESEARCH AND DEVELOPMENT EXPENSES (2,409) (586) Less reimbursements 2,983 545 RESEARCH AND DEVELOPMENT EXPENSES, NET 574 (41) SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (433) (564) (25) NET INCOME (LOSS) FOR THE YEAR FROM DISCONTINUED OPERATIONS $ 3,355 $ 45,420 $ (189) GAIN ON THE DISPOSAL 39,899 NET INCOME (LOSS) $ 3,355 $ 85,319 $ (189) |
RELATED PARTY TRANSACTIONS (Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
RELATED PARTY TRANSACTIONS [Abstract] | |
Schedule of Related Party Transactions | Year ended December 31, (U.S. dollars in thousands) 2014 2015 2016 Compensation (including share based compensation) to the non-executive directors (includes the interim Chairman of the Board through 2014 and the Chairman of the Board for part of 2014) $ 560 $ 631 $ 560 |
SIGNIFICANT ACCOUNTING POLICI31
SIGNIFICANT ACCOUNTING POLICIES (Useful Lives of Property and Equipment) (Details) | 12 Months Ended |
Dec. 31, 2016 | |
Laboratory Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 5 years |
Furniture [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 10 years |
Furniture [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 15 years |
Computer Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, useful life | 3 years |
SIGNIFICANT ACCOUNTING POLICI32
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Significant Accounting Policies [Line Items] | ||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 23,532,492 | 19,778,424 | 18,850,724 | |
Revenues, Total | $ 9,199 | $ 4,364 | $ 3,523 | |
Tax Rate Assumption Related To Deferred Tax Difference Reversal | The Company used tax rates of 39%, 24% and 23%. | |||
Brazil [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Percentage of Adult Gaucher Patients Treated with Uplyso | 10.00% | |||
Brazil Agreement [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Revenues, Total | $ 4,000 | |||
Supply Commitment In Year 2017 | $ 24,300 | |||
Brazil Agreement [Member] | Subsidiaries [Member] | Fiocruz [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Agent Fee, Percentage Of Net Proceeds | 5.00% | |||
Pfizer Agreement [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Proceeds From Exchange For Rights To Royalties | $ 36,000 | |||
Pfizer Agreement [Member] | Pfizer Incorporation [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Collaborative Arrangement Revenues and Expenses Sharing Percentage | 60.00% | |||
Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Collaborative Arrangement Revenues and Expenses Sharing Percentage | 40.00% | |||
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% |
AGREEMENTS WITH PFIZER (Narrati
AGREEMENTS WITH PFIZER (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Oct. 31, 2015 | Nov. 30, 2009 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2012 | Oct. 12, 2015 | |
Revenue Recognized Over Designated Period | $ 4.6 | |||||
Proceeds from Collaborators | $ 60 | |||||
Milestone Payment | $ 25 | |||||
Revenue Recognition, Multiple-deliverable Arrangements, Performance Period | 14 years | |||||
Protalix Bio Therapeutics Incorporation [Member] | ||||||
Collaborative Arrangement Profit Share Percentage | 40.00% | |||||
Collaboration Operation [Member] | ||||||
Accrued Liabilities | $ 4.3 | |||||
Pfizer [Member] | ||||||
Stock Issued During Period, Shares, New Issues | 5,649,079 | |||||
Debt Instrument, Face Amount | $ 4.3 | |||||
Fair Value, Net Asset (Liability), Total | 46 | |||||
Equity, Fair Value Disclosure, Total | 6.1 | |||||
Indefinite-lived Intangible Assets (Excluding Goodwill), Fair Value Disclosure | 39.9 | |||||
Upon Filing of Pediatric Investigation Plan to EMA [Member] | ||||||
Proceeds from Collaborators | $ 5 | $ 5 | ||||
Upon FDAApproval [Member] | ||||||
Milestone Payment | $ 25 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | $ 34,304 | $ 33,547 | |
Less - accumulated depreciation and amortization | (25,601) | (23,803) | |
Property, Plant and Equipment, Net | 8,703 | 9,744 | |
Depreciation | 1,983 | 2,370 | $ 3,140 |
Laboratory Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 16,265 | 15,493 | |
Furniture And Computer Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 2,342 | 2,244 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 15,678 | 15,635 | |
Equipment Under Construction [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | $ 19 | $ 175 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Raw materials | $ 2,591,000 | $ 1,180,000 |
Work in progress | 395,000 | 0 |
Finished goods | 2,259,000 | 4,587,000 |
Total inventory | 5,245,000 | 5,767,000 |
Inventory Write-down | $ 67,000 | $ 1,300,000 |
LIABILITY FOR EMPLOYEE RIGHTS36
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee severance obligation payments | $ 164,000 | $ 168,000 | $ 195,000 |
Contributions | 675,000 | 675,000 | 779,000 |
Expected severance liabilities payments for fiscal year end 2016 | 869,000 | ||
Expected contribution to one or more Contribution Plans | 708,000 | ||
Severance expense | 842,000 | 800,000 | 1,000,000 |
Net gain (loss) for the period | (7,000) | $ (18,000) | $ 22,000 |
Benefits Payable During Next Five Years | $ 209,000 |
COMMITMENTS (Narrative) (Detail
COMMITMENTS (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Commitments And Contingencies [Line Items] | |||
Subcontracting commitment amount | $ 12,500,000 | ||
Milestone Potential Payable | 8,400,000 | ||
Milestone Payment, Amount Paid | 300,000 | ||
OCS [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalty expense included in cost of revenue | 288,000 | $ 2,200,000 | $ 951,000 |
Research And License Agreements [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalty expense included in cost of revenue | 286,000 | 51,000 | 104,000 |
Lease Agreements [Member] | |||
Commitments And Contingencies [Line Items] | |||
Monthly rent/lease expense | 61,000 | ||
Future minimum lease payments, 2017 | 735,000 | ||
Future minimum lease payments, 2018 | 722,000 | ||
Future minimum lease payments, 2019 | 680,000 | ||
Future minimum lease payments, 2020 | 680,000 | ||
Cash deposited as bank guarantee | 288,000 | ||
Lease/rent expense | 1,000,000 | 1,000,000 | $ 1,000,000 |
Future minimum lease payments, 2021 | 543,000 | ||
Vehicle Lease And Maintenance Agreements [Member] | |||
Commitments And Contingencies [Line Items] | |||
Monthly rent/lease expense | 51,000 | ||
Future minimum lease payments, 2017 | 563,000 | ||
Future minimum lease payments, 2018 | 289,000 | ||
Future minimum lease payments, 2019 | $ 84,000 | ||
Minimum [Member] | OCS [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalties based on sale of products developed from funded projects, percentage | 3.00% | ||
Maximum [Member] | OCS [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalties based on sale of products developed from funded projects, percentage | 6.00% | ||
Accrued royalties | $ 38,500,000 | $ 33,300,000 | |
Percentage amount the aggregate amount of royalties that should not exceed grant received | 100.00% | 100.00% | |
Maximum [Member] | Products Manufactured Outside Of Israel [Member] | |||
Commitments And Contingencies [Line Items] | |||
Royalties based on sale of products developed from funded projects, percentage | 300.00% |
SHARE CAPITAL (Summary of Optio
SHARE CAPITAL (Summary of Option and Restricted Stock Granted to Employees) (Details) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of options or restricted stock granted | 2,809,000 |
2014 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 2.37 |
Vesting period | 4 years |
Fair value of at grant date | $ | $ 1,007 |
Expiration period | 10 years |
2014 [Member] | Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of options or restricted stock granted | 900,000 |
2015 [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ / shares | $ 1.72 |
Vesting period | 4 years |
Fair value of at grant date | $ | $ 1,900 |
Expiration period | 10 years |
2015 [Member] | Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of options or restricted stock granted | 1,909,000 |
SHARE CAPITAL (Options Granted
SHARE CAPITAL (Options Granted to Employees) (Details) - Options And Restricted Stock Granted To Employees [Member] - USD ($) | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Intrinsic value of options exercised | $ 213,000 | $ 675,000 | $ 447,000 | |
Number of options | ||||
Outstanding at beginning of year | 6,952,293 | 5,870,309 | 5,153,898 | |
Granted | 1,909,000 | 900,000 | ||
Forfeited and Expired | 1,514,957 | 277,016 | 44,201 | |
Exercised | [1] | 553,125 | 550,000 | 139,388 |
Outstanding at end of year | 4,884,211 | 6,952,293 | 5,870,309 | |
Exercisable at end of year | 3,498,492 | 4,477,043 | 4,905,559 | |
Weighted average exercise price | ||||
Outstanding at beginning of year | $ 3.363 | $ 3.770 | $ 3.951 | |
Granted | 1.72 | 2.370 | ||
Forfeited and Expired | 3.748 | 5.395 | 6.833 | |
Exercised | [1] | 0.067 | 0.972 | 0.446 |
Outstanding at end of year | 3.617 | 3.363 | 3.770 | |
Exercisable at end of year | $ 4.296 | $ 4.182 | $ 3.933 | |
[1] | The total intrinsic value of options exercised during the years ended December 31, 2014, 2015 and 2016, was approximately $447,000, $675,000 and $213,000, respectively. |
SHARE CAPITAL (Restricted Stock
SHARE CAPITAL (Restricted Stock Granted to Employees) (Details) - Employees [Member] - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Outstanding at beginning of year | 127,874 | 386,124 | 970,208 |
Vested | 127,874 | 255,749 | 398,375 |
Forfeited | 2,501 | 185,709 | |
Outstanding at end of year | 0 | 127,874 | 386,124 |
SHARE CAPITAL (Options and Rest
SHARE CAPITAL (Options and Restricted Stocks Granted to Consultants, Directors and Other Service Providers) (Details) - Options and Restricted Stocks Granted To Consultants Directors And Other Service Providers [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Number of options | |||
Outstanding at beginning of year | 637,209 | 1,208,592 | 912,425 |
Granted | 296,167 | ||
Expired | 429,209 | 466,883 | |
Vested restricted stock | 104,500 | ||
Outstanding at end of year | 208,000 | 637,209 | 1,208,592 |
Exercisable at end of year | 170,500 | 549,709 | 912,425 |
Weighted average exercise price | |||
Outstanding at beginning of year | $ 11.638 | $ 6.136 | $ 7.259 |
Granted | 2.678 | ||
Expired | 15.748 | 0.001 | |
Outstanding at end of year | 3.156 | 11.638 | 6.136 |
Exercisable at end of year | $ 3.109 | $ 12.954 | $ 7.259 |
SHARE CAPITAL (Summary of Outst
SHARE CAPITAL (Summary of Outstanding and Restricted Stocks) (Details) - Options and Restricted Stock [Member] | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number of options and restricted stock outstanding at end of year | 5,092,211 |
Number of options exercisable at end of year | 3,668,992 |
0.001 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 0.001 |
Number of options and restricted stock outstanding at end of year | 8,000 |
Weighted average remaining contractual life | 10 months 10 days |
Number of options exercisable at end of year | 8,000 |
Weighted average remaining contractual life, exercisable | 10 months 10 days |
1.720 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 1.720 |
Number of options and restricted stock outstanding at end of year | 1,784,279 |
Weighted average remaining contractual life | 8 years 2 months 19 days |
Number of options exercisable at end of year | 792,310 |
Weighted average remaining contractual life, exercisable | 8 years 2 months 19 days |
2.350 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 2.350 |
Number of options and restricted stock outstanding at end of year | 40,000 |
Weighted average remaining contractual life | 1 year 9 months 22 days |
Number of options exercisable at end of year | 40,000 |
Weighted average remaining contractual life, exercisable | 1 year 9 months 22 days |
2.370 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 2.370 |
Number of options and restricted stock outstanding at end of year | 900,000 |
Weighted average remaining contractual life | 7 years 8 months 26 days |
Number of options exercisable at end of year | 506,250 |
Weighted average remaining contractual life, exercisable | 7 years 8 months 26 days |
2.650 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 2.650 |
Number of options and restricted stock outstanding at end of year | 212,682 |
Weighted average remaining contractual life | 2 years 1 month 24 days |
Number of options exercisable at end of year | 212,682 |
Weighted average remaining contractual life, exercisable | 2 years 1 month 24 days |
3.020 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.020 |
Number of options and restricted stock outstanding at end of year | 50,000 |
Weighted average remaining contractual life | 1 year 1 month 6 days |
Number of options exercisable at end of year | 50,000 |
Weighted average remaining contractual life, exercisable | 1 year 1 month 6 days |
3.370 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 3.370 |
Number of options and restricted stock outstanding at end of year | 150,000 |
Weighted average remaining contractual life | 7 years 6 months 22 days |
Number of options exercisable at end of year | 112,500 |
Weighted average remaining contractual life, exercisable | 7 years 6 months 22 days |
5.000 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 5 |
Number of options and restricted stock outstanding at end of year | 1,009,250 |
Weighted average remaining contractual life | 1 year 1 month 6 days |
Number of options exercisable at end of year | 1,009,250 |
Weighted average remaining contractual life, exercisable | 1 year 1 month 6 days |
6.900 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 6.900 |
Number of options and restricted stock outstanding at end of year | 710,000 |
Weighted average remaining contractual life | 3 years 1 month 24 days |
Number of options exercisable at end of year | 710,000 |
Weighted average remaining contractual life, exercisable | 3 years 1 month 24 days |
7.550 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 7.550 |
Number of options and restricted stock outstanding at end of year | 160,000 |
Weighted average remaining contractual life | 3 years 7 months 24 days |
Number of options exercisable at end of year | 160,000 |
Weighted average remaining contractual life, exercisable | 3 years 7 months 24 days |
9.660 [Member] | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Exercise price | $ / shares | $ 9.660 |
Number of options and restricted stock outstanding at end of year | 68,000 |
Weighted average remaining contractual life | 3 years 9 months 29 days |
Number of options exercisable at end of year | 68,000 |
Weighted average remaining contractual life, exercisable | 3 years 9 months 29 days |
SHARE CAPITAL (Share Based Comp
SHARE CAPITAL (Share Based Compensation Expense Allocation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Allocated Share-based Compensation Expense | $ 988 | $ 1,802 | $ 1,242 |
Research and Development Expense [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Allocated Share-based Compensation Expense | 571 | 904 | 936 |
Marketing, General and administrative expenses [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Allocated Share-based Compensation Expense | $ 417 | $ 898 | $ 306 |
SHARE CAPITAL (Narrative) (Deta
SHARE CAPITAL (Narrative) (Details) | Dec. 07, 2016USD ($)shares | Oct. 12, 2015shares | Mar. 23, 2015USD ($)$ / sharesshares | Sep. 28, 2014USD ($)$ / sharesshares | Jul. 24, 2014USD ($)$ / sharesshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | Dec. 14, 2006shares | [1] |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common stock available for issuance | shares | 2,391,481 | 13,841,655 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Net of Forfeitures, Total | shares | 1,909,000 | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Total | $ 509,000 | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 9 months 18 days | |||||||||
Proceeds from Stock Options Exercised | $ 14,000 | $ 534,000 | $ 46,000 | |||||||
Debt Conversion, Converted Instrument, Shares Issued | shares | 23,846,735 | |||||||||
Four Point Five Percentage Convertible Notes [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.50% | |||||||||
Debt Conversion, Converted Instrument, Amount | $ 54,052,000 | $ 54,052,000 | ||||||||
Convertible Notes Due Two Thousand Twenty One [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Debt Conversion, Converted Instrument, Amount | $ 40,186,000 | |||||||||
Common Stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Common stock issued | shares | 5,649,079 | 23,846,735 | 5,649,079 | |||||||
Option to purchase shares of common stock [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award Grant Date Fair Value | $ 1,900,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 61.70% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.60% | |||||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price | $ / shares | $ 1.72 | |||||||||
Option to purchase shares of common stock [Member] | President and Chief Executive Officer [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of options or restricted stock granted | shares | 900,000 | |||||||||
Exercise price | $ / shares | $ 2.37 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award Grant Date Fair Value | $ 1,000,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 62.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.86% | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award Number Of Installments For Vesting Period | 16 | |||||||||
Option to purchase shares of common stock [Member] | Board of Directors Chairman [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Number of options or restricted stock granted | shares | 150,000 | |||||||||
Exercise price | $ / shares | $ 3.37 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award Grant Date Fair Value | $ 193,000 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 62.00% | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 1.90% | |||||||||
Option to purchase shares of common stock [Member] | Vest on the first anniversary of the grant date [Member] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 25.00% | |||||||||
[1] | The total intrinsic value of options exercised during the years ended December 31, 2014, 2015 and 2016, was approximately $447,000, $675,000 and $213,000, respectively. |
CONVERTIBLE NOTES (Schedule of
CONVERTIBLE NOTES (Schedule of Interest Expense Recognized) (Details) - 2013 Notes [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Contractual interest expense | $ 2,943 | $ 3,105 | $ 3,105 |
Amortization of debt issuance costs and debt discount | 421 | 444 | 444 |
Total | $ 3,364 | $ 3,549 | $ 3,549 |
CONVERTIBLE NOTES (Fair Value I
CONVERTIBLE NOTES (Fair Value Income Approach) (Details) - $ / shares | Dec. 07, 2016 | Dec. 31, 2016 |
Stock price (USD) | $ 0.3 | $ 0.445 |
Expected term | 4 years 11 months 8 days | 4 years 10 months 17 days |
Risk free rate | 1.86% | 1.95% |
Volatility | 54.12% | 56.08% |
Yield | 13.98% |
CONVERTIBLE NOTES (Schedule O47
CONVERTIBLE NOTES (Schedule Of Debt Interest Expenses) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($) | |
Gain on extinguishment | $ (14,063) |
Change in fair value of convertible note embedded derivative | (6,473) |
2016 Notes [Member] | |
Contractual interest expense | 313 |
Debt discount amortization | 147 |
Gain on extinguishment | (14,063) |
Change in fair value of convertible note embedded derivative | 6,473 |
Total | $ (7,130) |
CONVERTIBLE NOTES (Narrative) (
CONVERTIBLE NOTES (Narrative) (Details) - USD ($) | Dec. 07, 2016 | Dec. 31, 2016 | Sep. 19, 2016 | Sep. 18, 2013 | Dec. 31, 2016 | Dec. 31, 2014 |
Number of shares for basis conversion | 173.6593 | |||||
Net proceeds from issuance of convertible notes | $ 66,800,000 | $ 19,681,000 | ||||
Principal amount, related to the initial purchaser's over-allotment option | 9,000,000 | |||||
Gain (Loss) on Extinguishment of Debt | $ 14,063,000 | |||||
Percentage Of Excess Shares Outstanding | 20.00% | |||||
Debt Conversion, Converted Instrument, Shares Issued | 23,846,735 | |||||
Convertible Notes Payable [Member] | ||||||
Principal amount | $ 69,000,000 | |||||
Seven Point Five Percentage Convertible Notes [Member] | ||||||
Principal amount | $ 22,500,000 | $ 22,500,000 | ||||
Net proceeds from issuance of convertible notes | $ 19,700,000 | |||||
Maturity | Nov. 15, 2021 | |||||
Interest rate | 7.50% | 7.50% | ||||
Conversion price per share | $ 0.85 | $ 0.85 | ||||
Base value for conversion rate | $ 1,000 | |||||
Gain (Loss) on Extinguishment of Debt | $ 14,063,000 | |||||
Maximum Debt Instrument Convertible Conversion Share Number | $ 1,787.3100 | |||||
Debt Instrument, Redemption, Description | Prior to the maturity date, the Company may redeem in cash: a) any or all of the 2016 Notes if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days exceeds 150% of the conversion price on each applicable trading day, or b) all of the 2016 Notes then outstanding if the aggregate principal amount of the 2016 Notes then outstanding is less than 15% of the aggregate principal amount of the notes issued. | |||||
Four Point Five Percentage Convertible Notes [Member] | ||||||
Principal amount | $ 14,948,000 | $ 14,948,000 | ||||
Interest rate | 4.50% | |||||
Debt Conversion, Converted Instrument, Amount | $ 54,052,000 | $ 54,052,000 | ||||
Debt Instrument, Redemption, Description | On or after September 19, 2016, the Company may redeem for cash all or part of the 2013 Notes (except for the notes that the Company is then required to repurchase in connection with a fundamental change) if the last reported sale price of the Common Stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading-day period ending on the trading day immediately preceding the date on which the Company provides the notice of redemption. | |||||
Convertible Notes Due Two Thousand Twenty One [Member] | ||||||
Principal amount | 40,186,000 | |||||
Debt Conversion, Converted Instrument, Amount | $ 40,186,000 | |||||
Convertible Notes 2013 [Member] | ||||||
Interest rate | 4.50% | |||||
Conversion price per share | $ 5.76 |
FAIR VALUE MEASUREMENT (Narrati
FAIR VALUE MEASUREMENT (Narrative) (Details) - Fair Value, Inputs, Level 3 [Member] $ in Millions | Dec. 31, 2016USD ($) |
Four Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | $ 10 |
Four Point Five Percentage Convertible Notes [Member] | 2013 [Member] | |
Convertible Debt, Fair Value Disclosures | 14.9 |
Four Point Five Percentage Convertible Notes [Member] | 2016 [Member] | |
Convertible Debt, Fair Value Disclosures | 62.7 |
Seven Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | $ 64 |
TAXES ON INCOME (Deferred Incom
TAXES ON INCOME (Deferred Income Taxes) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
In respect of: | ||
Timing Differences | $ 3,520 | $ 3,588 |
Net operating loss carry forwards | 38,515 | 33,451 |
Valuation allowance | (42,035) | (37,039) |
Deferred Tax Assets, Net of Valuation Allowance, Total | $ 0 | $ 0 |
TAXES ON INCOME (Open Tax Years
TAXES ON INCOME (Open Tax Years) (Details) | 12 Months Ended | |
Dec. 31, 2016 | ||
ISRAEL [Member] | Minimum [Member] | ||
Income Tax Contingency [Line Items] | ||
Open tax year | 2,013 | |
ISRAEL [Member] | Maximum [Member] | ||
Income Tax Contingency [Line Items] | ||
Open tax year | 2,016 | |
UNITED STATES [Member] | Minimum [Member] | ||
Income Tax Contingency [Line Items] | ||
Open tax year | 2,013 | [1] |
UNITED STATES [Member] | Maximum [Member] | ||
Income Tax Contingency [Line Items] | ||
Open tax year | 2,016 | [1] |
[1] | Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Line Items] | |||||
Net operating loss carry forwards | $ 153 | ||||
Scenario, Forecast [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 23.00% | 24.00% | |||
Law for Amending the Israel Income Tax Ordinance - 2009, Tax year [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 26.50% | ||||
Law for Amending the Israel Income Tax Ordinance, Tax Thereafter [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 25.00% | ||||
Restricted Amount [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Net operating loss carry forwards | 20 | $ 19 | |||
Protalix Ltd. [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Net operating loss carry forwards | $ 133 | $ 102 | |||
Protalix Ltd. [Member] | Law for Amending the Israel Income Tax Ordinance, Tax Thereafter [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 25.00% | 26.50% | |||
Minimum [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 23.00% | 39.00% | |||
Maximum [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
Statutory income tax rate | 25.00% |
SUPPLEMENTARY FINANCIAL STATE53
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Other Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Other assets: | ||
Institutions | $ 333 | $ 216 |
State of Israel (see note 6a) | 1,046 | 621 |
Restricted deposit | 477 | 371 |
Prepaid expenses | 416 | 408 |
Sundry | 49 | 51 |
Other assets | $ 2,321 | $ 1,667 |
SUPPLEMENTARY FINANCIAL STATE54
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals, Other) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Accounts payable and accruals - other: | ||
Payroll and related expenses | $ 1,190 | $ 1,125 |
Interest payable | 511 | 914 |
Provision for vacation | 1,399 | 1,406 |
Accrued expenses | 3,575 | 1,571 |
Royalties payable | 226 | 29 |
Property and equipment suppliers | 595 | 489 |
Accounts Payable, Current | $ 7,496 | $ 5,534 |
DISCONTINUED OPERATIONS (Balanc
DISCONTINUED OPERATIONS (Balance Sheets) (Details) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
CURRENT ASSETS: | ||
Accounts receivable - Trade | $ 327 | $ 1,993 |
Inventories | 80 | |
Total current assets of discontinued operation | 327 | 2,073 |
CURRENT LIABILITIES: | ||
Other Accounts payable and accruals | 1,568 | |
Total current liabilities of discontinued operation | $ 1,568 |
DISCONTINUED OPERATIONS (Operat
DISCONTINUED OPERATIONS (Operations) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
REVENUES | $ 209 | $ 48,674 | $ 10,128 |
COMPANY’S SHARE IN COLLABORATION AGREEMENT | 5,048 | 1,509 | |
COST OF REVENUES | (373) | (7,697) | (8,423) |
GROSS PROFIT (LOSS) | (164) | 46,025 | 3,214 |
RESEARCH AND DEVELOPMENT EXPENSES | (586) | (2,409) | |
Less -reimbursements | 545 | 2,983 | |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (41) | 574 | |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (25) | (564) | (433) |
NET INCOME (LOSS) FOR THE YEAR FROM DISCONTINUED OPERATIONS | (189) | 45,420 | 3,355 |
GAIN ON THE DISPOSAL | 39,899 | ||
NET INCOME (LOSS) | $ (189) | $ 85,319 | $ 3,355 |
RELATED PARTY TRANSACTIONS (Com
RELATED PARTY TRANSACTIONS (Compensation) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Compensation To The non-executive Directors [Member] | |||
Related Party Transaction [Line Items] | |||
Related Party Transaction, Amounts of Transaction | $ 560 | $ 631 | $ 560 |