Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Mar. 01, 2014 | Jun. 28, 2013 |
Document And Entity Information [Abstract] | ' | ' | ' |
Document Type | '10-K | ' | ' |
Amendment Flag | 'false | ' | ' |
Document Period End Date | 31-Dec-13 | ' | ' |
Document Fiscal Year Focus | '2013 | ' | ' |
Document Fiscal Period Focus | 'FY | ' | ' |
Trading Symbol | 'PLX | ' | ' |
Entity Registrant Name | 'PROTALIX BIOTHERAPEUTICS, INC. | ' | ' |
Entity Central Index Key | '0001006281 | ' | ' |
Current Fiscal Year End Date | '--12-31 | ' | ' |
Entity Filer Category | 'Accelerated Filer | ' | ' |
Entity Voluntary Filers | 'No | ' | ' |
Entity Current Reporting Status | 'Yes | ' | ' |
Entity Well Known Seasoned Issuer | 'No | ' | ' |
Entity Common Stock, Shares Outstanding | ' | 93,580,464 | ' |
Entity Public Float | ' | ' | $286,000 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
CURRENT ASSETS: | ' | ' |
Cash and cash equivalents | $86,398 | $52,035 |
Accounts receivable- Trade | 2,091 | 1,410 |
Other assets | 1,457 | 3,686 |
Inventories | 7,957 | 4,039 |
Total current assets | 97,903 | 61,170 |
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,578 | 1,247 |
PROPERTY AND EQUIPMENT, NET | 13,711 | 16,310 |
DEFERRED CHARGES | 141 | ' |
Total assets | 113,333 | 78,727 |
Accounts payable and accruals: | ' | ' |
Trade | 5,254 | 5,267 |
Other | 12,073 | 11,051 |
Deferred revenues | 9,369 | 9,437 |
Total current liabilities | 26,696 | 25,755 |
LONG TERM LIABILITIES: | ' | ' |
Convertible notes | 67,048 | ' |
Deferred revenues | 41,796 | 48,888 |
Liability in connection with collaboration operation | 2,371 | 5,425 |
Liability for employee rights upon retirement | 2,368 | 2,016 |
Total long term liabilities | 113,583 | 56,329 |
Total liabilities | 140,279 | 82,084 |
COMMITMENTS (Note 6) | ' | ' |
CAPITAL DEFICIENCY: | ' | ' |
Common Stock, $0.001 par value: Authorized - as of December 31, 2012 and 2013, 150,000,000 shares; issued and outstanding - as of December 31, 2012 and 2013, 93,489,809 and 93,551,098 shares, respectively | 93 | 93 |
Additional paid-in capital | 184,346 | 180,145 |
Accumulated deficit | -211,385 | -183,595 |
Total capital deficiency | -26,946 | -3,357 |
Total liabilities net of capital deficiency | $113,333 | $78,727 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
CONSOLIDATED BALANCE SHEETS [Abstract] | ' | ' |
Common stock, par value per share | $0.00 | $0.00 |
Common Stock, Authorized | 150,000,000 | 150,000,000 |
Common Stock, issued | 93,551,098 | 93,489,809 |
Common Stock, outstanding | 93,551,098 | 93,489,809 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ' | ' | ' |
REVENUES (see Note 11(c)) | $10,479 | $34,870 | $8,386 |
COMPANY'S SHARE IN COLLABORATION AGREEMENT | 1,034 | -446 | -5,418 |
COST OF REVENUES | -5,428 | -8,144 | -1,525 |
GROSS PROFIT | 6,085 | 26,280 | 1,443 |
RESEARCH AND DEVELOPMENT EXPENSES | -33,313 | -36,665 | -37,818 |
Less - grants and reimbursements | 8,497 | 7,976 | 6,775 |
RESEARCH AND DEVELOPMENT EXPENSES, NET | -24,816 | -28,689 | -31,043 |
GENERAL AND ADMINISTRATIVE EXPENSES | -8,385 | -9,763 | -6,931 |
OPERATING LOSS | -27,116 | -12,172 | -36,531 |
FINANCIAL INCOME (EXPENSES) - NET | -674 | 554 | 2 |
NET LOSS FOR THE YEAR | ($27,790) | ($11,618) | ($36,529) |
NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED: | ($0.30) | ($0.13) | ($0.43) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE OF COMMON STOCK, BASIC AND DILUTED: | 92,368,138 | 90,845,901 | 84,645,364 |
CONSOLIDATED_STATEMENT_OF_CHAN
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Balance | ($3,357) | ($26,077) | ($11,323) |
Common stock issued for cash (net of issuance costs) | ' | 25,388 | 20,590 |
Share-based compensation | 1,013 | 4,612 | 886 |
Share-based compensation related to restricted stock award, net of forfeitures | 3,076 | 3,139 | ' |
Exercise of options granted to employees and non-employees | 112 | 1,199 | 299 |
Net Loss | -27,790 | -11,618 | -36,529 |
Balance | -26,946 | -3,357 | -26,077 |
Common Stock [Member] | ' | ' | ' |
Balance, shares | 93,489,809 | 85,630,157 | 81,248,472 |
Balance | 93 | 86 | 81 |
Common stock issued for cash (net of issuance costs) (in shares) | ' | 5,175,000 | 4,000,000 |
Common stock issued for cash (net of issuance costs) | ' | 5 | 4 |
Share-based compensation | ' | ' | ' |
Share-based compensation related to restricted stock award, net of forfeitures | ' | 1 | ' |
Share-based compensation related to restricted stock award, net of forfeitures (shares) | -17,834 | 1,496,792 | ' |
Exercise of options granted to employees and non-employees | ' | 1 | 1 |
Exercise of options granted to employees and non-employees, shares | 79,123 | 1,187,860 | 381,685 |
Net Loss | ' | ' | ' |
Balance | 93 | 93 | 86 |
Balance, shares | 93,551,098 | 93,489,809 | 85,630,157 |
Additional Paid-in Capital [Member] | ' | ' | ' |
Balance | 180,145 | 145,814 | 124,044 |
Common stock issued for cash (net of issuance costs) | ' | 25,383 | 20,586 |
Share-based compensation | 1,013 | 4,612 | 886 |
Share-based compensation related to restricted stock award, net of forfeitures | 3,076 | 3,138 | ' |
Exercise of options granted to employees and non-employees | 112 | 1,198 | 298 |
Net Loss | ' | ' | ' |
Balance | 184,346 | 180,145 | 145,814 |
Accumulated Deficit [Member] | ' | ' | ' |
Balance | -183,595 | -171,977 | -135,448 |
Common stock issued for cash (net of issuance costs) | ' | ' | ' |
Share-based compensation | ' | ' | ' |
Share-based compensation related to restricted stock award, net of forfeitures | ' | ' | ' |
Exercise of options granted to employees and non-employees | ' | ' | ' |
Net Loss | -27,790 | -11,618 | -36,529 |
Balance | ($211,385) | ($183,595) | ($171,977) |
CONSOLIDATED_STATEMENT_OF_CHAN1
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY (Parenthetical) (USD $) | 12 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2012 | Dec. 31, 2011 |
CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY [Abstract] | ' | ' |
Common stock issued for cash, issuance costs | $1,780 | $1,410 |
Restricted stock awards forfeited, share | 3,208 | ' |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' | ' |
Net loss | ($27,790) | ($11,618) | ($36,529) |
Adjustments required to reconcile net loss to net cash provided by (used in) operating activities: | ' | ' | ' |
Share based compensation | 4,089 | 7,751 | 886 |
Depreciation and write down of fixed assets | 3,539 | 3,692 | 3,631 |
Financial expenses (income), net (mainly exchange differences) | -264 | -171 | 350 |
Changes in accrued liability for employee rights upon retirement | 200 | 276 | 155 |
Gain on amounts funded in respect of employee rights upon retirement | -58 | -36 | -14 |
Loss on sale of fixed assets | ' | ' | 8 |
Amortization of debt issuance costs and debt discount | 127 | ' | ' |
Changes in operating assets and liabilities: | ' | ' | ' |
Increase (decrease) in deferred revenues (including non-current portion) | -7,160 | 1,281 | -3,005 |
Decrease in accounts receivable and other assets | 1,904 | 243 | 3,891 |
Decrease (increase) in inventories | -3,918 | -3,760 | 910 |
Increase (decrease) in accounts payable and accruals (including long term) | -1,322 | 2,977 | 6,147 |
Net cash provided by (used in) operating activities | -30,653 | 635 | -23,570 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' | ' |
Purchase of property and equipment | -1,890 | -2,068 | -5,705 |
Proceeds from sale of property and equipment | ' | ' | 2 |
Investment in restricted deposit | -42 | -80 | ' |
Amounts funded in respect of employee rights upon retirement, net | -170 | -138 | -165 |
Net cash used in investing activities | -2,102 | -2,286 | -5,868 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' | ' |
Net proceeds from issuance of convertible notes | 66,780 | ' | ' |
Issuance of shares, net of issuance cost | ' | 25,328 | 20,650 |
Exercise of options | 112 | 1,230 | 277 |
Net cash provided by financing activities | 66,892 | 26,558 | 20,927 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 226 | 127 | -388 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 34,363 | 25,034 | -8,899 |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR | 52,035 | 27,001 | 35,900 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR | 86,398 | 52,035 | 27,001 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ' | ' | ' |
Purchase of property and equipment | 186 | 1,136 | 1,473 |
Issuance cost not yet paid | ' | ' | 60 |
Exercise of options granted to employees | ' | ' | $31 |
SIGNIFICANT_ACCOUNTING_POLICIE
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended | ||
Dec. 31, 2013 | |||
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ' | ||
SIGNIFICANT ACCOUNTING POLICIES | ' | ||
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES | |||
a. | General | ||
Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the "Company"), and its wholly-owned subsidiary, Protalix Ltd., are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company's proprietary ProCellEx® protein expression system ("ProCellEx"). In September 2009, Protalix Ltd. formed another wholly-owned subsidiary under the laws of the Netherlands, Protalix B.V., in connection with the European Medicines Agency ("EMA") application process in the European Union. The Company's two subsidiaries are referred to collectively herein as the "Subsidiaries." | |||
On May 1, 2012, the U.S. Food and Drug Administration ("FDA") approved taliglucerase alfa for injection, the Company's first approved drug product, as an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase (GCD) that the Company developed using ProCellEx. Taliglucerase alfa was also approved by the Israeli Ministry of Health (the "Israeli MOH") in September 2012, by the Brazilian Ministry of Health (the "Brazilian MOH") in March 2013 and by the applicable regulatory authorities of certain other countries. Taliglucerase alfa is the first plant cell-based recombinant therapeutic protein approved by the FDA or any other major regulatory authority. | |||
Taliglucerase alfa is being marketed in the United States under the brand name ELELYSO™ by Pfizer Inc. ("Pfizer"), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer (the "Pfizer Agreement"). The Company, through Protalix Ltd., markets ELELYSO in Israel and in Brazil under the brand name UPLYSO. | |||
Protalix Ltd. granted Pfizer an exclusive, worldwide license to develop and commercialize taliglucerase alfa under the Pfizer Agreement, but retained those rights in Israel and, since 2014, in Brazil (see below). The Company has agreed to a specific allocation between Protalix Ltd. and Pfizer regarding the responsibilities for the continued development efforts for taliglucerase alfa. To date, the Company has received an upfront payment of $60.0 million in connection with the execution of the Pfizer Agreement and shortly thereafter an additional $5.0 million clinical development-related milestone payment. The Company received during 2012 an additional $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States, which was considered to be a substantive milestone for purposes of revenue recognition, and, accordingly, was recorded as revenue during the period in which the milestone was achieved. The agreement provides that the Company share with Pfizer the net profits or loss related to the development and commercialization of taliglucerase alfa on a 40% and 60% basis, respectively, except with respect to the profits or losses related to commercialization efforts in Israel and Brazil, where the Company retained exclusive marketing rights. In calculating the net profits or losses under the agreement, there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold. | |||
In December 2012, Protalix Ltd. entered into a Clinical Development Agreement with Pfizer under which Protalix Ltd. will continue to manage, administer and sponsor current, ongoing clinical trials relating to taliglucerase alfa. According to the terms of the agreement, Protalix Ltd. was eligible to receive a payment of $8.3 million upon the achievement of certain near-term clinical development goals. The goals were achieved, and the payment made, in December 2012. The Company evaluated the terms of the agreement and the nature of the payment made by Pfizer and concluded that the amount received represents an upfront funding of the anticipated costs of the Company's ongoing clinical trials relating to taliglucerase alfa. Accordingly, the amount was deferred upon receipt and is recognized as a reduction of research and development expenses over the ongoing clinical trial period. | |||
On June 18, 2013, Protalix Ltd. entered into a Supply and Technology Transfer Agreement (the "Brazil Agreement") with Fundação Oswaldo Cruz ("Fiocruz"), an arm of the Brazilian MOH, for taliglucerase alfa. The brand name for taliglucerase alfa in Brazil is UPLYSOTM. The first term of the technology transfer is seven years and the agreement may be extended for an additional five-year term, as needed, to complete the technology transfer. The technology transfer is designed to be effected in four stages and is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high quality, and cost effective supply of taliglucerase alfa. Under the agreement, Fiocruz has committed to purchase at least approximately $40 million worth of taliglucerase alfa during the first two years of the agreement. In subsequent years, Fiocruz is required to purchase at least approximately $40 million worth of taliglucerase alfa per year. Additionally, Protalix Ltd. is not required to complete the final stage of the technology transfer until Fiocruz purchases at least approximately $280 million worth of taliglucerase alfa. The Brazil agreement became effective in 2014. | |||
To facilitate the arrangement with Fiocruz, Pfizer amended its exclusive license and supply agreement with Protalix Ltd. The amendment provides for the transfer of the commercialization and other rights to taliglucerase alfa in Brazil back to Protalix Ltd. As consideration for the transfer of the commercialization and supply rights, Protalix Ltd. agreed to pay Pfizer a maximum amount of approximately $12.5 million from its net profits (as defined in the license and supply agreement) per year. Pfizer has also agreed to perform certain transitional services in Brazil on Protalix Ltd.'s behalf in connection with the supply of taliglucerase alfa to Fiocruz. | |||
Protalix Ltd. is required to pay a fee equal to 5% of the net proceeds generated in Brazil to its agent for services provided in assisting Protalix Ltd. complete the Brazil Agreement pursuant to an agency agreement between Protalix Ltd. and the agent. The agency agreement will remain in effect with respect to the Brazil Agreement until the termination thereof. | |||
In addition to the approvals from the FDA, the Israeli MOH and the Brazilian MOH, marketing approval has been granted to UPLYSO in Mexico, Chile and Uruguay. In addition, the Company is cooperating with Pfizer in its efforts to obtain marketing approval for taliglucerase alfa in additional countries and jurisdictions. Currently, marketing authorization applications have been filed in a number of countries. | |||
Currently, patients are being treated with taliglucerase alfa on a commercial basis in the United States, Brazil and Israel. In addition, patients are being treated globally through the Company's clinical trials and related studies, compassionate use programs and other programs. On July 13, 2010, the Company announced that the French regulatory authority had granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. | |||
An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists. This ATU allows Gaucher patients in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union. Payment for taliglucerase alfa has been secured through government allocations to hospitals. In addition, taliglucerase alfa is currently being provided to Gaucher patients under special access agreements or named patient provisions in other countries. | |||
In addition to taliglucerase alfa, the Company is working on the development of certain other products using ProCellEx. | |||
In addition to the approval of taliglucerase alfa for marketing in the United States, Israel, Brazil, Mexico and other countries, successful completion of the Company's development programs and its transition to normal operations is dependent upon obtaining the foreign regulatory approvals required to sell its products internationally. A substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all, and the Company expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. | |||
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. | |||
b. | 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 assets and 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. | |||
d. | 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 carried to financial income or expenses, as appropriate. | |||
e. | 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. | |||
f. | 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 that are capitalized is determined as follows: the value of the raw and packaging materials component is determined primarily on a using the "moving average" basis; the value of the labor and overhead component is determined on an average basis over the production period. | |||
Prior to the FDA's approval of taliglucerase alfa, manufacturing costs related to taliglucerase alfa were not capitalized; rather, such costs were expensed as research and development expenses. Effective as of the FDA approval of taliglucerase alfa on May 1, 2012, the Company capitalizes manufacturing costs associated with taliglucerase alfa. | |||
If actual market prices for finished products prove less favorable than those projected by management, inventory write-downs may be required. 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 | 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 | 15-Oct | ||
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. | |||
h. | 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 guidance prohibits the recognition of deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result from changes in exchange rates or indexing for tax purposes. Consequently, the above mentioned differences with respect to Protalix Ltd. were not reflected in the computation of deferred tax assets and liabilities. | |||
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 | ||
The Company recognizes revenue when the earnings process is complete, which is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or services has occurred, the sales price is fixed or determinable and collectability is reasonably assured. | |||
1 | Revenues from the license and supply agreement with Pfizer | ||
The Company recognizes revenue from milestone payments received pursuant to the Pfizer Agreement in accordance with guidance regarding revenue recognition and accounting for revenue arrangements with multiple deliverables. As the arrangement with Pfizer requires 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 recognized over the related performance period. The Company estimated the performance period of 14 years (commencing upon the date of the Company's receipt of the up-front license payment payable by Pfizer under the Pfizer Agreement) based on the date the last relevant patent expires. See Note 2. The Company adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Each milestone payment that is considered to be substantive for purposes of revenue recognition is recorded as revenue during the period during which the milestone is achieved. | |||
2 | Revenues from selling products | ||
The Company recognizes revenues from selling products upon delivery, when the sales price is fixed or determinable and collectability is reasonably assured. | |||
3 | Company's share in the collaboration agreement | ||
Under the terms and conditions of the Pfizer Agreement, the Company is entitled to 40% of the profits or loss from sales of taliglucerase alfa, and related expenses incurred, except with respect to sales in Israel and Brazil (since 2014), where the Company retained exclusive marketing rights. Since Pfizer bears most of the risks and rewards relating to the agreement, the Company's share in the profits and loss in the agreement is recognized on a net basis. The Company recognizes its share of net profit or loss from the Pfizer Agreement based on reports it receives from Pfizer summarizing the results of the collaborative activities under the agreement for the applicable period. Under the terms of the Pfizer Agreement, for its subsidiaries operating outside the United States, financial information is included based on the fiscal year ending November 30, while financial information for the U.S. entity is included based on the fiscal year ending December 31. | |||
k. | 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 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 Subsidiary 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. | |||
Reimbursements received from Pfizer are recognized when the reimbursements become receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the reimbursements and there is reasonable assurance the reimbursements will be received. The reimbursements are 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. | |||
l. | 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 receivable represents amounts to be received from Pfizer and the Company's customers in Israel. The Company does not require Pfizer or any of its Israeli customers to post collateral with respect to receivables. The Company performs periodic credit evaluations of Pfizer's financial condition and believes there is no significant risk with respect to Pfizer's payment of the receivables. As all Israeli customers are government entities, the Company believes there is no significant risk with respect to its receivables from such entities. | |||
m. | 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, net of estimated forfeitures. The Company estimates forfeitures based on historical experience and anticipated future conditions. | |||
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 is 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. | |||
n. | Net loss per share | ||
Basic and diluted loss per share ("LPS") are computed by dividing net loss by the weighted average number of shares of the Company's Common Stock, par value $0.001 per share (the "Common Stock") outstanding for each period. | |||
Diluted LPS does not include 7,469,088, 7,280,469 and 10,675,304 shares of Common Stock underlying outstanding options , restricted shares of Common Stock and shares issuable upon conversion of the convertible notes (issued in September 2013) for the fiscal years ended December 31, 2011, 2012 and 2013, respectively, because the effect would be anti-dilutive. | |||
o. | Convertible notes | ||
The convertible notes are accounted for using the guidance provided set forth in FASB Accounting Standards Codification (ASC) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. The Company accounts for the convertible notes as a liability, on an aggregated basis, in their entirely. |
LICENSE_AND_SUPPLY_AGREEMENT
LICENSE AND SUPPLY AGREEMENT | 12 Months Ended |
Dec. 31, 2013 | |
LICENSE AND SUPPLY AGREEMENT [Abstract] | ' |
LICENSE AND SUPPLY AGREEMENT | ' |
NOTE 2 - LICENSE AND SUPPLY AGREEMENT | |
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. As mentioned in note 1, in June 2013, Pfizer returned the commercialization rights in Brazil to Protalix Ltd. Under the Pfizer Agreement, Pfizer made an upfront payment to Protalix Ltd. of $60.0 million in connection with the execution of the agreement and shortly thereafter paid Protalix Ltd. an additional $5.0 million upon the Company's filing of a proposed pediatric investigation plan to the Pediatric Committee of the EMA. Protalix Ltd. received a $25.0 million milestone payment in connection with the approval of taliglucerase alfa by the FDA in May 2012. Protalix Ltd. is entitled to 40% of the results (profits or losses) earned on Pfizer's sales of taliglucerase alfa. Such result (profit or loss) will be calculated while, in addition to other adjustments, taking into account Protalix Ltd.'s cost of goods sold and Pfizer's commercial expenses, with certain expenses capped or borne solely by one party ("Collaboration Operation"). Of the losses incurred by the Collaboration Operation through December 31, 2011, 40% will be deducted from the cash payments to be paid to the Company as its share in the profits from future years, if any. This deduction will be limited to a certain percentage of any quarterly profit. As of December 31, 2013 and 2012, the Company accrued a liability in respect of these losses equal to approximately $8.0 million and $8.5 million, respectively. | |
The Company has determined that the initial, non-refundable upfront license fee payment of $60.0 million together with the first $5.0 million payment will be recognized on a straight line basis as revenue over the estimated relationship period (approximately $4.6 million per year). The Company has estimated that the relationship period for its arrangement with Pfizer will be approximately 14 years (commencing upon the Company's receipt of the up-front license payment) based on the Company's last material patent relating to taliglucerase alfa to expire. The $25.0 million milestone payment received during 2012 in connection with the FDA's approval of taliglucerase alfa in the United States was considered to be a substantive milestone for purposes of revenue recognition and, accordingly, was recorded as revenue during the period in which the milestone was achieved. | |
The Company's deliverables under this collaboration include an exclusive license to taliglucerase alfa as an enzyme replacement therapy for the treatment of Gaucher disease, certain research and development services as required under the Pfizer Agreement for taliglucerase alfa and manufacturing of taliglucerase alfa. | |
According to the terms and conditions of the Pfizer Agreement, the Company retained manufacturing rights and sells its products to Pfizer. In addition, Pfizer is required to reimburse the Company for certain costs it incurs in connection with certain development expenses for taliglucerase alfa. In connection with the payments received under the Pfizer Agreement, Protalix Ltd. is obligated to pay certain royalties. See Note 6a. |
PROPERTY_AND_EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
PROPERTY AND EQUIPMENT [Abstract] | ' | ||||||||
PROPERTY AND EQUIPMENT | ' | ||||||||
NOTE 3 - PROPERTY AND EQUIPMENT | |||||||||
a. | Composition of property and equipment grouped by major classifications is as follows: | ||||||||
December 31, | |||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||
Laboratory equipment | $ | 14,502 | $ | 14,858 | |||||
Furniture and computer equipment | 1,818 | 2,074 | |||||||
Leasehold improvements | 14,447 | 15,070 | |||||||
Equipment under construction | 329 | 28 | |||||||
$ | 31,096 | $ | 32,030 | ||||||
Less - accumulated depreciation and amortization | (14,786 | ) | (18,319 | ) | |||||
$ | 16,310 | $ | 13,711 | ||||||
b. | Depreciation and amortization in respect of property and equipment totaled approximately $3.6 million, $3.7 million and $3.5 million for the years ended December 31, 2011, 2012 and 2013, respectively, out of which the Company recorded a total write down of approximately $10,000, $0 and $0, respectively. | ||||||||
INVENTORIES
INVENTORIES | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
INVENTORIES [Abstract] | ' | ||||||||
INVENTORIES | ' | ||||||||
NOTE 4 - INVENTORIES | |||||||||
a. | Inventories at December 31, 2012 and 2013 consisted of the following: | ||||||||
December 31, | |||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||
Raw materials | $ | 2,118 | $ | 2,342 | |||||
Work in progress | 192 | 92 | |||||||
Finished goods | 1,729 | 5,523 | |||||||
Total inventory | $ | 4,039 | $ | 7,957 | |||||
b. | During the year ended December 31, 2012 and 2013, the Company recorded approximately $684,000 and $1.6 million, respectively, for write-down of inventory under cost of revenues. |
LIABILITY_FOR_EMPLOYEE_RIGHTS_
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT | 12 Months Ended |
Dec. 31, 2013 | |
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, 2011, 2012 and 2013, the Company deposited approximately $181,000, $177,000 and $194,000, respectively, with insurance companies in connection with its severance payment obligations. | |
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 $816,000, $1.0 million and $1.0 million for the years ended December 31, 2011, 2012 and 2013, respectively, of which approximately $641,000, $670,000 and $801,000 in the years ended December 31, 2011, 2012 and 2013, respectively, were in respect of a Contribution Plan. Gain on amounts funded in respect of employee rights upon retirement totaled approximately $14,000, $36,000 and $58,000 for the years ended December 31, 2011, 2012 and 2013, respectively. | |
The Company expects to contribute approximately $1.1 million in the year ending December 31, 2014 to insurance companies in connection with its severance liabilities for its operations for that year, approximately $847,000 of which will be contributed to one or more Contribution Plans. | |
During the five-year period following December 31, 2013, the Company expects to pay future benefits to three employees upon each such employee's normal retirement age. The Company anticipates that the benefits payable will be immaterial. |
COMMITMENTS
COMMITMENTS | 12 Months Ended | ||
Dec. 31, 2013 | |||
COMMITMENTS [Abstract] | ' | ||
COMMITMENTS | ' | ||
NOTE 6 - COMMITMENTS | |||
a. | Royalty commitments | ||
1 | The Company is obligated to pay royalties to the OCS on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from 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 the OCS. | |||
Under the terms of the funding arrangements with the OCS, royalties of 3% to 6% are payable on the sale of products developed from projects funded by the OCS, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received (dollar linked), plus, commencing upon January 1, 2001, interest at annual rate based on LIBOR. In addition, if the Company receives approval to manufacture products developed with government grants outside the State of Israel, it will be required to pay an increased total amount of royalties (possibly up to 300% of the grant amounts plus interest), depending on the manufacturing volume that is performed outside the State of Israel, and, possibly, an increased royalty rate. | |||
Royalty expenses to the OCS are included in the statement of operations as a component of the cost of revenues and were approximately $158,000, $1.5 million and $392,000 during the years ended December 31, 2011, 2012 and 2013, respectively. | |||
At December 31, 2013, the maximum royalty amount payable by the Company under these funding arrangements is approximately $26.7 million (without interest, assuming 100% of the funds are payable). | |||
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 and were approximately $19,000, $674,000 and $80,000 during the years ended December 31, 2011, 2012 and 2013, respectively. | ||
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 payable would be approximately $0.3 million and would be payable, if at all, as the Company's projects progress over the course of a number of years. No milestone payments were made during 2011, 2012 and 2013. | |||
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 and with expenditure of the Company's manufacturing facilities. As of December 31, 2013, total commitments under said agreements were approximately $1.1 million. | |||
c. | Lease Agreements | ||
The Company is a party to a number of lease agreements for its facilities, the latest of which expires in 2016. The Company has the option to extend certain of such agreements on three occasions for additional five-year periods, for a total of 15 additional years. Under the leases, the aggregate monthly rental payments are approximately $86,000. As of December 31, 2013, the Company provided bank guarantees of approximately $344,000, in the aggregate, to secure the fulfillment of its obligations under the lease agreements. The future minimum lease payments required in each of the next three years under the operating leases for such premises are approximately as follows: 2014 - $1,041,000, 2015 - $1,050,000, 2016 - $865,000. Lease expenses totaled $994,000, $971,000 and $1,133,000 for the years ended December 31, 2011, 2012 and 2013, respectively. | |||
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 $53,000. The expected lease payments for the years ending December 31, 2014, 2015 and 2016 are approximately $618,000, $415,000 and $94,000, respectively. |
SHARE_CAPITAL
SHARE CAPITAL | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||||||
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, since September 6, 2010, 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 (the "Plan"). The Plan was amended on June 17, 2012 to increase the number of shares of common stock available under the plan from 9,741,655 shares to 11,341,655 shares. The grant of options to Israeli employees under the Plan is subject to the terms stipulated by Sections 102 and 102A of the Israeli Income Tax Ordinance. Each option grant is subject to the track chosen by the Company, either Section 102 or Section 102A of the Israeli Income Tax Ordinance, and pursuant to the terms thereof, the Company is not allowed to claim, as an expense for tax purposes, the amounts credited to employees as a benefit, including amounts recorded as salary benefits in the Company's accounts, in respect of options granted to employees under the Plan, with the exception of the work-income benefit component, if any, determined on the grant date. For Israeli non-employees, the share option plan is subject to Section 3(i) of the Israeli Income Tax Ordinance. | |||||||||||||||||||||||||
As of December 31, 2013, 215,378 shares of Common Stock remain available for grant under the Plan. | |||||||||||||||||||||||||
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, 2011 through December 31, 2013, 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) | Below is a table summarizing all of the options and restricted stock grants to employees for each year of the three-year period ended December 31, 2013: | ||||||||||||||||||||||||
Year of | No. of options | Exercise | Vesting period | Fair value | Expiration | ||||||||||||||||||||
grant | or restricted | price range | at grant | period | |||||||||||||||||||||
stock granted | (U.S. | ||||||||||||||||||||||||
dollars in | |||||||||||||||||||||||||
thousands) | |||||||||||||||||||||||||
2012 | 400,000 | n/a | 3 years | $ | 2,288 | n/a | |||||||||||||||||||
2012 | 1,100,000 | n/a | 4 years | $ | 6,292 | n/a | |||||||||||||||||||
1,500,000 | |||||||||||||||||||||||||
Set forth below are grants made by the Company to employees (including related parties) during the three-year period ended December 31, 2013 (such grants appear in the table above): | |||||||||||||||||||||||||
On July 16, 2012, the Company's Board of Directors approved the grant of 1,500,000 shares of restricted Common Stock to its officers and certain other employees. Of such restricted stock, 1,100,000 of the shares were issued to the Company's named executive officers and vest in 16 equal, quarterly increments over a four-year period, commencing upon the date of grant, and are subject to a 24-month lock-up period, commencing upon the applicable vesting dates. Immediately and automatically in the event of a Change in Control, as such term is defined in the Plan, as amended, all of the shares of restricted Common Stock issued to the named executive officers shall vest, and the lock-up periods shall terminate, subject to certain exceptions. The remaining 400,000 shares of restricted Common Stock were issued to other employees of the Company and vest in 12 equal, quarterly increments over a three-year period, commencing upon the date of grant. | |||||||||||||||||||||||||
b) | The fair value of restricted stock granted during the year ended December 31, 2012 was $8.6 million based on the Company's share price on the NYSE MKT on the grant date. | ||||||||||||||||||||||||
The total unrecognized compensation cost of employee stock options and restricted stock at December 31, 2013 is approximately $2.7 million (net of forfeiture rate). The unrecognized compensation cost of employee stock options is expected to be recognized over a weighted average period of 0.8 years. | |||||||||||||||||||||||||
The total cash received from employees as a result of employee stock option exercises for the years ended December 31, 2011, 2012 and 2013 was approximately $277,000, $1.2 million and $112,000, respectively. The Company did not realize any tax benefit in connection with these exercises. | |||||||||||||||||||||||||
During 2013, the Company issued 79,123 shares of Common Stock in connection with the exercise of 79,123 options by certain employees of the Company. The Company received cash proceeds equal to approximately $112,000 in connection with such exercises. | |||||||||||||||||||||||||
2 | Options granted to consultants, directors, and other service providers: | ||||||||||||||||||||||||
As of December 31, 2013, the Company has recognized and recorded all compensation costs related to outstanding options for consultants, directors and other services providers. | |||||||||||||||||||||||||
No cash was received from consultants as a result of consultant stock option exercises for the years ended December 31, 2011 and December 31, 2013, approximately $39,000 was received during the year ended December 31, 2012. The Company did not realize any tax benefits in connection with these exercises. | |||||||||||||||||||||||||
During 2013, 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, 2011, 2012 and 2013 are as follows: | ||||||||||||||||||||||||
a. | Options granted to employees: | ||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2011 | 2012 | 2013 | |||||||||||||||||||||||
Weighted | Weighted | Weighted | |||||||||||||||||||||||
Number | average | Number | average | Number | average | ||||||||||||||||||||
of | exercise | of | exercise | of | exercise | ||||||||||||||||||||
options | price | options | price | options | price | ||||||||||||||||||||
Outstanding at beginning of year | 6,367,979 | $ | 3.576 | 6,141,030 | $ | 3.563 | 5,253,579 | $ | 3.923 | ||||||||||||||||
Changes during the year: | |||||||||||||||||||||||||
Forfeited and Expired | 44,856 | 6.207 | 25,858 | 4.372 | 20,558 | 6.603 | |||||||||||||||||||
Exercised (*) | 182,093 | 1.652 | 861,593 | 1.346 | 79,123 | 1.418 | |||||||||||||||||||
Outstanding at end of year | 6,141,030 | $ | 3.563 | 5,253,579 | $ | 3.923 | 5,153,898 | $ | 3.951 | ||||||||||||||||
Exercisable at end of year | 4,647,834 | $ | 2.581 | 4,258,441 | $ | 3.201 | 4,614,148 | $ | 3.591 | ||||||||||||||||
(*) | The total intrinsic value of options exercised during the years ended December 31, 2011, 2012 and 2013, was approximately $1.3 million, $4.8 million and $306,000, respectively. | ||||||||||||||||||||||||
b. | Restricted stock granted to employees: | ||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2012 | 2013 | ||||||||||||||||||||||||
Number of Restricted Shares | |||||||||||||||||||||||||
Outstanding at beginning of year | - | 1,394,708 | |||||||||||||||||||||||
Changes during the year: | |||||||||||||||||||||||||
Granted | 1,500,000 | ||||||||||||||||||||||||
Vested | 102,084 | 406,666 | |||||||||||||||||||||||
Forfeited | 3,208 | 17,834 | |||||||||||||||||||||||
Outstanding at end of year | 1,394,708 | 970,208 | |||||||||||||||||||||||
c. | Options granted to consultants, directors, and other service providers: | ||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2011 | 2012 | 2013 | |||||||||||||||||||||||
Weighted | Weighted | Weighted | |||||||||||||||||||||||
Number | average | Number | average | Number | average | ||||||||||||||||||||
of | exercise | of | exercise | of | exercise | ||||||||||||||||||||
options | price | options | price | options | price | ||||||||||||||||||||
Outstanding at beginning of year | 1,438,692 | $ | 4.697 | 1,238,692 | $ | 5.385 | 912,425 | $ | 7.259 | ||||||||||||||||
Changes during the year-Exercised (*) | 200,000 | 0.001 | 326,267 | 0.12 | |||||||||||||||||||||
Outstanding at end of year | 1,238,692 | $ | 5.385 | 912,425 | $ | 7.259 | 912,425 | $ | 7.259 | ||||||||||||||||
Exercisable at end of year | 1,235,567 | $ | 5.385 | 912,425 | $ | 7.259 | 912,425 | $ | 7.259 | ||||||||||||||||
(*) The total intrinsic value of options exercised during the years ended December 31, 2011 and 2012, was approximately $1.9 million, and $2.3 million, respectively. | |||||||||||||||||||||||||
d. | The following tables summarize information concerning outstanding and exercisable options and restricted stock as of December 31, 2013: | ||||||||||||||||||||||||
31-Dec-13 | |||||||||||||||||||||||||
Options and restricted stock | Options exercisable | ||||||||||||||||||||||||
outstanding | |||||||||||||||||||||||||
Exercise | Number of | Weighted | Number of | Weighted | |||||||||||||||||||||
prices | options and | average | options | average | |||||||||||||||||||||
restricted stock | remaining | exercisable | remaining | ||||||||||||||||||||||
outstanding | contractual | contractual | |||||||||||||||||||||||
at end of | life | life | |||||||||||||||||||||||
year | |||||||||||||||||||||||||
n/a | 970,208 | n/a | n/a | n/a | |||||||||||||||||||||
(Restricted | |||||||||||||||||||||||||
Stock) | |||||||||||||||||||||||||
$ | 0.001 | 719,207 | 1.54 | 719,207 | 1.54 | ||||||||||||||||||||
$ | 0.12 | 409,765 | 2.42 | 409,765 | 2.42 | ||||||||||||||||||||
$ | 0.399 | 22,587 | 0.92 | 22,587 | 0.92 | ||||||||||||||||||||
$ | 0.972 | 996,353 | 2.44 | 996,353 | 2.44 | ||||||||||||||||||||
$ | 2.35 | 40,000 | 4.82 | 40,000 | 4.82 | ||||||||||||||||||||
$ | 2.65 | 361,119 | 5.15 | 361,119 | 5.15 | ||||||||||||||||||||
$ | 3.02 | 50,000 | 4.1 | 50,000 | 4.1 | ||||||||||||||||||||
$ | 5 | 1,708,000 | 4.1 | 1,708,000 | 4.1 | ||||||||||||||||||||
$ | 6.81 | 150,000 | 6.1 | 150,000 | 6.1 | ||||||||||||||||||||
$ | 6.9 | 993,750 | 6.15 | 501,000 | 6.15 | ||||||||||||||||||||
$ | 7.55 | 160,000 | 6.66 | 130,000 | 6.66 | ||||||||||||||||||||
$ | 9.66 | 68,000 | 6.83 | 51,000 | 6.83 | ||||||||||||||||||||
$ | 16.7 | 387,542 | 2.99 | 387,542 | 2.99 | ||||||||||||||||||||
7,036,531 | 5,526,573 | ||||||||||||||||||||||||
The aggregate intrinsic value of the total outstanding options and restricted stock and of total vested and exercisable options as of December 31, 2013 is approximately $11.7 million and $7.9 million, respectively. | |||||||||||||||||||||||||
e. | The following table illustrates the effect of share-based compensation on the statement of operations: | ||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
(U.S. dollars in thousands) | 2011 | 2012 | 2013 | ||||||||||||||||||||||
Cost of revenues | $ | 220 | |||||||||||||||||||||||
Research and development expenses | $ | 422 | 4,756 | $ | 2,655 | ||||||||||||||||||||
General and administrative expenses | 464 | 2,775 | 1,434 | ||||||||||||||||||||||
$ | 886 | $ | 7,751 | $ | 4,089 | ||||||||||||||||||||
c. | Public and 144A Offerings | ||||||||||||||||||||||||
1 | On March 23, 2011, the Company issued and sold 4,000,000 shares of Common Stock in an underwritten public offering at a price to the public of $5.50 per share. The net proceeds to the Company were approximately $20.6 million (net of underwriting commissions and issuance costs of $1.4 million) | ||||||||||||||||||||||||
2 | On February 22, 2012, the Company issued and sold 5,175,000 shares of Common Stock in an underwritten public offering at a price to the public of $5.25 per share. The net proceeds to the Company were approximately $25.4 million (net of underwriting commissions and issuance costs of $1.8 million). | ||||||||||||||||||||||||
3 | On September 18, 2013, the Company completed a private offering of 4.50% convertible notes due 2018. The net proceeds from the offering, including net proceeds from the exercise in full by the initial purchaser of its option to purchase an additional $9.0 million in aggregate principal amount of the Notes, were $66.8 million (net of the initial purchaser's discount and commission and offering expenses payable by the Company). See also Note 8. |
CONVERTIBLE_NOTE
CONVERTIBLE NOTE | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
CONVERTIBLE NOTES [Abstract] | ' | ||||
CONVERTIBLE NOTES | ' | ||||
NOTE 8 - CONVERTIBLE NOTES | |||||
On September 18, 2013, the Company completed a private placement of $69.0 million in aggregate principal amount of Notes, including $9.0 million aggregate principal amount of Notes related to the initial purchaser's over-allotment option, which was exercised in full. In connection with the completion of the offering, the Company entered into an indenture (the "Indenture") with The Bank of New York Mellon Trust Company, N.A., as trustee, governing the Notes. The Notes accrue interest at a rate of 4.50% per year, payable semiannually in arrears on March 15 and September 15 of each year, beginning on March 15, 2014. The Notes mature on September 15, 2018. | |||||
The net proceeds from the offering, including net proceeds from the exercise in full by the initial purchaser of its option to purchase an additional $9.0 million in aggregate principal amount of the Notes, were $66.8 million, after deducting the initial purchaser's discount and commission and offering expenses payable by the Company. The debt discount and debt issuance costs are deferred and amortized over the convertible notes period (5 years). | |||||
Holders may convert their 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 Notes is 173.6593 shares of the Common Stock for each $1,000 principal amount of Notes (equivalent to an initial conversion price of approximately $5.76 per share of the Common Stock. Upon conversion, the Company will deliver a number of shares of Common Stock, per $1,000 principal amount of Notes, equal to the conversion rate. The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. | |||||
Prior to September 19, 2016, the Company may not redeem the Notes, and no sinking fund is provided for the Notes. On or after September 19, 2016, the Company may redeem for cash all or part of the Notes (except for the notes that the Company is then required to repurchase in connection with a fundamental change, as defined below) 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. The redemption price will equal the sum of (i) 100% of the principal amount of the Notes being redeemed, plus (ii) accrued and unpaid interest, including additional interest, if any, to, but excluding, the redemption date, plus (iii) the sum of the present values of each of the remaining scheduled payments of interest that would have been made on the Notes being redeemed had such Notes remained outstanding from the redemption date to the maturity date. | |||||
The following table sets forth total interest expense recognized for the year ended December 31, 2013 related to the Notes (in thousands): | |||||
December 31, 2013 | |||||
Contractual interest expense | 888 | ||||
Amortization of debt issuance costs and debt discount | 127 | ||||
Total | 1,015 | ||||
FAIR_VALUE_MEASUREMENT
FAIR VALUE MEASUREMENT | 12 Months Ended |
Dec. 31, 2013 | |
FAIR VALUE MEASUREMENT [Abstract] | ' |
FAIR VALUE MEASUREMENT | ' |
NOTE 9 - FAIR VALUE MEASUREMENT | |
The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. | |
The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: | |
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. | |
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. | |
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. | |
In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. | |
The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value. | |
The fair value of the convertible notes as of December 31, 2013 is approximately $72 million based on level 2 measurement. |
TAXES_ON_INCOME
TAXES ON INCOME | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
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, or will be, 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 | Measurement of results for tax purposes | ||||||||
Since 2008, the Company has measured the results of the Israeli Subsidiary for tax purposes in nominal terms in NIS. Pursuant to the Israel Income Tax Law (Adjustments for Inflation), 1985, the Subsidiary's results for tax purposes have been measured through 2007 on a real basis, based on changes in the Israel consumer price index. | |||||||||
2 | Tax rates | ||||||||
The income of the Israeli Subsidiary, other than income from "Approved Enterprises," is taxed in Israel at the regular rate. See 3 below. | |||||||||
On July 14, 2009 the Economic Efficiency Law (Legislation Amendments for the Implementation of the Economic Plan for the years 2009 and 2010), 2009 (the "2009 Amendment"), was passed in the Knesset; this law determined, inter alia, a further gradual reduction of the corporate tax rate as from 2011, as follows: 2011 - 24%, 2012 - 23%, 2013 - 22%, 2014 - 21%, 2015 - 20%, 2016 and thereafter - 18%. | |||||||||
On December 6, 2011, the "Tax Burden Distribution Law" was officially published, discontinuing a previously approved gradual decrease in corporate tax provided in the 2009 Amendment, and setting the corporate tax rate in Israel for 2012 and thereafter to 25%. | |||||||||
On August 5, 2013, the Law for Change of National Priorities (Legislative Amendments for Achieving the Budgetary Goals for 2013-2014), 2013 was published in Reshumot (the Israeli government official gazette), enacting, among other things, the raising the corporate tax rate beginning in 2014 and thereafter to 26.5% (instead of 25%). | |||||||||
Capital gain is subject to capital gain tax according to corporate tax rate in the year of selling the assets. | |||||||||
3 | 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 amount distributed, including any company tax on these amounts, at the rate which would have been applicable had such income not been exempted. | |||||||||
In addition to the corporate taxes in Israel, the Company might be subject to a withholding tax on the U.S. revenue source portion of the payments made to the Company for its share of Pfizer's net profits under the Pfizer Agreement. The withholding tax rate is currently 15%. | |||||||||
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. If there is any failure by the Israeli Subsidiary to comply with these conditions, the benefits may be cancelled and the Subsidiary may be required to refund the amount of the benefits, in whole or in part, 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 benefits granted to the Benefited Enterprises will be unlimited in time, unlike the benefits granted to special Benefited enterprises, which will be limited for a 10-year period. The benefits shall be granted to companies that will qualify under criteria set in the law; for the most part, those criteria are similar to the criteria that were set in the Encouragement of Capital Investments Law prior to its amendment. | |||||||||
Under the transitional provisions of the Encouragement of Capital Investments Law, the Company is entitled to take advantage of the tax benefits available under the Encouragement of Capital Investments Law prior to its amendment until the end of the benefits period, as defined in the Encouragement of Capital Investments Law. The Company will be allowed to set the "year of election" no later than tax year 2012, provided that the minimum qualifying investment was made not later than the end of 2010. On each year during the benefits period, the Company will be able to elect that the Capital Investments Amendment apply to the Company, thereby making the tax rates described above available to the Company. An election to have the Capital Investments Amendment apply is irrecoverable. The Company elected not to have the Capital Investments Amendment apply to the Company. | |||||||||
4 | The Law for the Encouragement of Industry (Taxation), 1969: | ||||||||
The Israeli Subsidiary is an "industrial company," as defined under the Law for the Encouragement of Industry (Taxation), 1969 (the "Law for the Encouragement of Industry"). As such, the Israeli Subsidiary is entitled to claim depreciation at increased rates for equipment used in industrial activity, as stipulated by regulations published under Law for the Encouragement of Industry, and has done so. | |||||||||
Under the provisions of the Income Tax Regulations "Accelerated Depreciation in respect of Equipment acquired during the Defined Period" (Temporary Orders), industrial companies whose operations are mostly "eligible operations" are entitled to claim accelerated depreciation at a rate of 50% on machinery and equipment acquired from June 1, 2008 to May 31, 2009. | |||||||||
c. | Tax losses carried forward to future years | ||||||||
As of December 31, 2013, the Company had aggregate net operating loss (NOL) carry-forwards equal to approximately $112.7 million that are available to reduce future taxable income as follows: | |||||||||
1 | The Company | ||||||||
The NOL carry-forward of the Company equal to approximately $15.3 million may be restricted under Section 382 of the Internal Revenue Code ("IRC"). IRC Section 382 applies whenever a corporation with NOL experiences an ownership change. As a result of IRC Section 382, the taxable income for any post change year that may be offset by a pre-change NOL may not exceed the general IRC Section 382 limitation, which is the fair market value of the pre-change entity multiplied by the IRC long-term tax exempt rate. | |||||||||
2 | Protalix Ltd. | ||||||||
At December 31, 2013, the Israeli Subsidiary had approximately $97.4 million of NOL carry-forwards that are available to reduce future taxable income with no limited period of use. | |||||||||
d. | Deferred income taxes: | ||||||||
The components of the Company's net deferred tax assets at December 31, 2012 and 2013 were as follows: | |||||||||
December 31, | |||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||
In respect of: | |||||||||
Research and development expenses | $ | 6,003 | 5,257 | ||||||
Property and equipment | (647 | ) | (491 | ) | |||||
Provision for vacation | 363 | 417 | |||||||
Severance pay obligation | 192 | 209 | |||||||
Deferred revenues | 10,449 | 9,867 | |||||||
Net operating loss carry forwards | 15,176 | 23,167 | |||||||
Valuation allowance | (31,536 | ) | (38,426 | ) | |||||
- | - | ||||||||
Deferred taxes are computed using the tax rates expected to be in effect when those differences reverse. The Company used tax rates of 39%, 25%, 26.5% and 0%. | |||||||||
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 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, 2013, all of Protalix Ltd.'s tax assessments through tax year 2009 are considered final. | |||||||||
A summary of open tax years by major jurisdiction is presented below: | |||||||||
Jurisdiction: | Years: | ||||||||
Israel | 2010-2013 | ||||||||
United States (*) | 2009-2013 | ||||||||
Netherlands | 2009-2013 | ||||||||
(*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. |
SUPPLEMENTARY_FINANCIAL_STATEM
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION [Abstract] | ' | ||||||||||||
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | ' | ||||||||||||
NOTE 11 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION | |||||||||||||
Balance sheets: | |||||||||||||
December 31, | |||||||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||||||
a. Other assets: | |||||||||||||
Deferred costs* | $ | 89 | |||||||||||
Institutions | 542 | $ | 356 | ||||||||||
State of Israel (see Note 6a) | 2,400 | 366 | |||||||||||
Restricted deposit | 298 | 362 | |||||||||||
Prepaid expenses | 251 | 286 | |||||||||||
Sundry | 106 | 87 | |||||||||||
$ | 3,686 | $ | 1,457 | ||||||||||
* Manufacturing costs of inventory, paid by Pfizer, but not delivered. | |||||||||||||
(U.S. dollars in thousands) | |||||||||||||
b. Accounts payable and accruals - other: | |||||||||||||
Payroll and related expenses | $ | 1,748 | $ | 1,557 | |||||||||
Interest payable | - | 888 | |||||||||||
Provision for vacation | 1,453 | 1,572 | |||||||||||
Accrued expenses | 2,032 | 1,785 | |||||||||||
Royalties payable | 1,560 | 419 | |||||||||||
Liability in connection with collaboration operation - current portion | 3,122 | 5,666 | |||||||||||
Property and equipment suppliers | 1,136 | 186 | |||||||||||
$ | 11,051 | $ | 12,073 | ||||||||||
Statements of operations: | |||||||||||||
Year ended December 31, | |||||||||||||
2011 | 2012 | 2013 | |||||||||||
(U.S. dollars in thousands) | |||||||||||||
c. Revenues: | |||||||||||||
Deferred revenues from the license and supply agreement with Pfizer | $ | 4,563 | $ | 4,563 | $ | 4,563 | |||||||
Milestone payment (see Note 2) | 25,000 | ||||||||||||
Revenues from selling products | 3,823 | 5,307 | 5,916 | ||||||||||
$ | 8,386 | $ | 34,870 | $ | 10,479 | ||||||||
RELATED_PARTY_TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
RELATED PARTY TRANSACTIONS [Abstract] | ' | ||||||||||||
RELATED PARTY TRANSACTIONS | ' | ||||||||||||
NOTE 12 - RELATED PARTY TRANSACTIONS | |||||||||||||
Year ended December 31, | |||||||||||||
(U.S. dollars in thousands) | 2011 | 2012 | 2013 | ||||||||||
Compensation to the non-executive directors (includes the interim Chairman of the Board) | $ | 215 | $ | 375 | $ | 509 | |||||||
SIGNIFICANT_ACCOUNTING_POLICIE1
SIGNIFICANT ACCOUNTING POLICIES (Policy) | 12 Months Ended | ||
Dec. 31, 2013 | |||
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ' | ||
General | ' | ||
General | |||
Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the "Company"), and its wholly-owned subsidiary, Protalix Ltd., are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company's proprietary ProCellEx® protein expression system ("ProCellEx"). In September 2009, Protalix Ltd. formed another wholly-owned subsidiary under the laws of the Netherlands, Protalix B.V., in connection with the European Medicines Agency ("EMA") application process in the European Union. The Company's two subsidiaries are referred to collectively herein as the "Subsidiaries." | |||
On May 1, 2012, the U.S. Food and Drug Administration ("FDA") approved taliglucerase alfa for injection, the Company's first approved drug product, as an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Taliglucerase alfa is a proprietary, recombinant form of glucocerebrosidase (GCD) that the Company developed using ProCellEx. Taliglucerase alfa was also approved by the Israeli Ministry of Health (the "Israeli MOH") in September 2012, by the Brazilian Ministry of Health (the "Brazilian MOH") in March 2013 and by the applicable regulatory authorities of certain other countries. Taliglucerase alfa is the first plant cell-based recombinant therapeutic protein approved by the FDA or any other major regulatory authority. | |||
Taliglucerase alfa is being marketed in the United States under the brand name ELELYSO™ by Pfizer Inc. ("Pfizer"), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer (the "Pfizer Agreement"). The Company, through Protalix Ltd., markets ELELYSO in Israel and in Brazil under the brand name UPLYSO. | |||
Protalix Ltd. granted Pfizer an exclusive, worldwide license to develop and commercialize taliglucerase alfa under the Pfizer Agreement, but retained those rights in Israel and, since 2014, in Brazil (see below). The Company has agreed to a specific allocation between Protalix Ltd. and Pfizer regarding the responsibilities for the continued development efforts for taliglucerase alfa. To date, the Company has received an upfront payment of $60.0 million in connection with the execution of the Pfizer Agreement and shortly thereafter an additional $5.0 million clinical development-related milestone payment. The Company received during 2012 an additional $25.0 million milestone payment in connection with the FDA's approval of taliglucerase alfa in the United States, which was considered to be a substantive milestone for purposes of revenue recognition, and, accordingly, was recorded as revenue during the period in which the milestone was achieved. The agreement provides that the Company share with Pfizer the net profits or loss related to the development and commercialization of taliglucerase alfa on a 40% and 60% basis, respectively, except with respect to the profits or losses related to commercialization efforts in Israel and Brazil, where the Company retained exclusive marketing rights. In calculating the net profits or losses under the agreement, there are certain agreed upon limits on the amounts that may be deducted from gross sales for certain expenses and costs of goods sold. | |||
In December 2012, Protalix Ltd. entered into a Clinical Development Agreement with Pfizer under which Protalix Ltd. will continue to manage, administer and sponsor current, ongoing clinical trials relating to taliglucerase alfa. According to the terms of the agreement, Protalix Ltd. was eligible to receive a payment of $8.3 million upon the achievement of certain near-term clinical development goals. The goals were achieved, and the payment made, in December 2012. The Company evaluated the terms of the agreement and the nature of the payment made by Pfizer and concluded that the amount received represents an upfront funding of the anticipated costs of the Company's ongoing clinical trials relating to taliglucerase alfa. Accordingly, the amount was deferred upon receipt and is recognized as a reduction of research and development expenses over the ongoing clinical trial period. | |||
On June 18, 2013, Protalix Ltd. entered into a Supply and Technology Transfer Agreement (the "Brazil Agreement") with Fundação Oswaldo Cruz ("Fiocruz"), an arm of the Brazilian MOH, for taliglucerase alfa. The brand name for taliglucerase alfa in Brazil is UPLYSOTM. The first term of the technology transfer is seven years and the agreement may be extended for an additional five-year term, as needed, to complete the technology transfer. The technology transfer is designed to be effected in four stages and is intended to transfer to Fiocruz the capacity and skills required for the Brazilian government to construct its own manufacturing facility, at its sole expense, and to produce a sustainable, high quality, and cost effective supply of taliglucerase alfa. Under the agreement, Fiocruz has committed to purchase at least approximately $40 million worth of taliglucerase alfa during the first two years of the agreement. In subsequent years, Fiocruz is required to purchase at least approximately $40 million worth of taliglucerase alfa per year. Additionally, Protalix Ltd. is not required to complete the final stage of the technology transfer until Fiocruz purchases at least approximately $280 million worth of taliglucerase alfa. The Brazil agreement became effective in 2014. | |||
To facilitate the arrangement with Fiocruz, Pfizer amended its exclusive license and supply agreement with Protalix Ltd. The amendment provides for the transfer of the commercialization and other rights to taliglucerase alfa in Brazil back to Protalix Ltd. As consideration for the transfer of the commercialization and supply rights, Protalix Ltd. agreed to pay Pfizer a maximum amount of approximately $12.5 million from its net profits (as defined in the license and supply agreement) per year. Pfizer has also agreed to perform certain transitional services in Brazil on Protalix Ltd.'s behalf in connection with the supply of taliglucerase alfa to Fiocruz. | |||
Protalix Ltd. is required to pay a fee equal to 5% of the net proceeds generated in Brazil to its agent for services provided in assisting Protalix Ltd. complete the Brazil Agreement pursuant to an agency agreement between Protalix Ltd. and the agent. The agency agreement will remain in effect with respect to the Brazil Agreement until the termination thereof. | |||
In addition to the approvals from the FDA, the Israeli MOH and the Brazilian MOH, marketing approval has been granted to UPLYSO in Mexico, Chile and Uruguay. In addition, the Company is cooperating with Pfizer in its efforts to obtain marketing approval for taliglucerase alfa in additional countries and jurisdictions. Currently, marketing authorization applications have been filed in a number of countries. | |||
Currently, patients are being treated with taliglucerase alfa on a commercial basis in the United States, Brazil and Israel. In addition, patients are being treated globally through the Company's clinical trials and related studies, compassionate use programs and other programs. On July 13, 2010, the Company announced that the French regulatory authority had granted an Autorisation Temporaire d'Utilisation (ATU), or Temporary Authorization for Use, for taliglucerase alfa for the treatment of Gaucher disease. | |||
An ATU is the regulatory mechanism used by the French Health Products and Safety Agency to make non-approved drugs available to patients in France when a genuine public health need exists. This ATU allows Gaucher patients in France to receive treatment with taliglucerase alfa before marketing authorization for the product is granted in the European Union. Payment for taliglucerase alfa has been secured through government allocations to hospitals. In addition, taliglucerase alfa is currently being provided to Gaucher patients under special access agreements or named patient provisions in other countries. | |||
In addition to taliglucerase alfa, the Company is working on the development of certain other products using ProCellEx. | |||
In addition to the approval of taliglucerase alfa for marketing in the United States, Israel, Brazil, Mexico and other countries, successful completion of the Company's development programs and its transition to normal operations is dependent upon obtaining the foreign regulatory approvals required to sell its products internationally. A substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all, and the Company expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. | |||
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. | |||
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 | ' | ||
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 assets and 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 carried to 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 that are capitalized is determined as follows: the value of the raw and packaging materials component is determined primarily on a using the "moving average" basis; the value of the labor and overhead component is determined on an average basis over the production period. | |||
Prior to the FDA's approval of taliglucerase alfa, manufacturing costs related to taliglucerase alfa were not capitalized; rather, such costs were expensed as research and development expenses. Effective as of the FDA approval of taliglucerase alfa on May 1, 2012, the Company capitalizes manufacturing costs associated with taliglucerase alfa. | |||
If actual market prices for finished products prove less favorable than those projected by management, inventory write-downs may be required. Inventory is written down for estimated obsolescence based upon management assumptions about future demand and market conditions. | |||
Property and equipment | ' | ||
Property and equipment | |||
1 | Property and equipment are stated at cost, net of accumulated depreciation and amortization. | ||
2 | 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 | 15-Oct | ||
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 | ' | ||
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 guidance prohibits the recognition of deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result from changes in exchange rates or indexing for tax purposes. Consequently, the above mentioned differences with respect to Protalix Ltd. were not reflected in the computation of deferred tax assets and liabilities. | |||
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 | ' | ||
Revenue Recognition | |||
The Company recognizes revenue when the earnings process is complete, which is when revenue is realized or realizable and earned, there is persuasive evidence a revenue arrangement exists, delivery of goods or services has occurred, the sales price is fixed or determinable and collectability is reasonably assured. | |||
1 | Revenues from the license and supply agreement with Pfizer | ||
The Company recognizes revenue from milestone payments received pursuant to the Pfizer Agreement in accordance with guidance regarding revenue recognition and accounting for revenue arrangements with multiple deliverables. As the arrangement with Pfizer requires 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 recognized over the related performance period. The Company estimated the performance period of 14 years (commencing upon the date of the Company's receipt of the up-front license payment payable by Pfizer under the Pfizer Agreement) based on the date the last relevant patent expires. See Note 2. The Company adjusts the performance periods, if appropriate, based on the applicable facts and circumstances. Each milestone payment that is considered to be substantive for purposes of revenue recognition is recorded as revenue during the period during which the milestone is achieved. | |||
2 | Revenues from selling products | ||
The Company recognizes revenues from selling products upon delivery, when the sales price is fixed or determinable and collectability is reasonably assured. | |||
3 | Company's share in the collaboration agreement | ||
Under the terms and conditions of the Pfizer Agreement, the Company is entitled to 40% of the profits or loss from sales of taliglucerase alfa, and related expenses incurred, except with respect to sales in Israel and Brazil (since 2014), where the Company retained exclusive marketing rights. Since Pfizer bears most of the risks and rewards relating to the agreement, the Company's share in the profits and loss in the agreement is recognized on a net basis. The Company recognizes its share of net profit or loss from the Pfizer Agreement based on reports it receives from Pfizer summarizing the results of the collaborative activities under the agreement for the applicable period. Under the terms of the Pfizer Agreement, for its subsidiaries operating outside the United States, financial information is included based on the fiscal year ending November 30, while financial information for the U.S. entity is included based on the fiscal year ending December 31. | |||
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 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 Subsidiary 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. | |||
Reimbursements received from Pfizer are recognized when the reimbursements become receivable, provided there is reasonable assurance that the Company will comply with the conditions attached to the reimbursements and there is reasonable assurance the reimbursements will be received. The reimbursements are 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 receivable represents amounts to be received from Pfizer and the Company's customers in Israel. The Company does not require Pfizer or any of its Israeli customers to post collateral with respect to receivables. The Company performs periodic credit evaluations of Pfizer's financial condition and believes there is no significant risk with respect to Pfizer's payment of the receivables. As all Israeli customers are government entities, the Company believes there is no significant risk with respect to its receivables from such entities. | |||
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, net of estimated forfeitures. The Company estimates forfeitures based on historical experience and anticipated future conditions. | |||
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 is 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 Loss per share | ' | ||
Net loss per share | |||
Basic and diluted loss per share ("LPS") are computed by dividing net loss by the weighted average number of shares of the Company's Common Stock, par value $0.001 per share (the "Common Stock") outstanding for each period. | |||
Diluted LPS does not include 7,469,088, 7,280,469 and 10,675,304 shares of Common Stock underlying outstanding options , restricted shares of Common Stock and shares issuable upon conversion of the convertible notes (issued in September 2013) for the fiscal years ended December 31, 2011, 2012 and 2013, respectively, because the effect would be anti-dilutive. | |||
Convertible notes | ' | ||
Convertible notes | |||
The convertible notes are accounted for using the guidance provided set forth in FASB Accounting Standards Codification (ASC) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. The Company accounts for the convertible notes as a liability, on an aggregated basis, in their entirely. |
SIGNIFICANT_ACCOUNTING_POLICIE2
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended | |||
Dec. 31, 2013 | ||||
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 | 15-Oct | |||
Computer equipment | 3 | |||
PROPERTY_AND_EQUIPMENT_Tables
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
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) | 2012 | 2013 | |||||||
Laboratory equipment | $ | 14,502 | $ | 14,858 | |||||
Furniture and computer equipment | 1,818 | 2,074 | |||||||
Leasehold improvements | 14,447 | 15,070 | |||||||
Equipment under construction | 329 | 28 | |||||||
$ | 31,096 | $ | 32,030 | ||||||
Less - accumulated depreciation and amortization | (14,786 | ) | (18,319 | ) | |||||
$ | 16,310 | $ | 13,711 | ||||||
INVENTORIES_Tables
INVENTORIES (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
INVENTORIES [Abstract] | ' | ||||||||
Schedule of Inventory | ' | ||||||||
Inventories at December 31, 2012 and 2013 consisted of the following: | |||||||||
December 31, | |||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||
Raw materials | $ | 2,118 | $ | 2,342 | |||||
Work in progress | 192 | 92 | |||||||
Finished goods | 1,729 | 5,523 | |||||||
Total inventory | $ | 4,039 | $ | 7,957 | |||||
SHARE_CAPITAL_Tables
SHARE CAPITAL (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2013 | |||||||||||||||||||||||||
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 three-year period ended December 31, 2013: | |||||||||||||||||||||||||
Year of | No. of options | Exercise | Vesting period | Fair value | Expiration | ||||||||||||||||||||
grant | or restricted | price range | at grant | period | |||||||||||||||||||||
stock granted | (U.S. | ||||||||||||||||||||||||
dollars in | |||||||||||||||||||||||||
thousands) | |||||||||||||||||||||||||
2012 | 400,000 | n/a | 3 years | $ | 2,288 | n/a | |||||||||||||||||||
2012 | 1,100,000 | n/a | 4 years | $ | 6,292 | n/a | |||||||||||||||||||
1,500,000 | |||||||||||||||||||||||||
Summary of Stock Option Activity - Options Granted to Employees | ' | ||||||||||||||||||||||||
Options granted to employees: | |||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2011 | 2012 | 2013 | |||||||||||||||||||||||
Weighted | Weighted | Weighted | |||||||||||||||||||||||
Number | average | Number | average | Number | average | ||||||||||||||||||||
of | exercise | of | exercise | of | exercise | ||||||||||||||||||||
options | price | options | price | options | price | ||||||||||||||||||||
Outstanding at beginning of year | 6,367,979 | $ | 3.576 | 6,141,030 | $ | 3.563 | 5,253,579 | $ | 3.923 | ||||||||||||||||
Changes during the year: | |||||||||||||||||||||||||
Forfeited and Expired | 44,856 | 6.207 | 25,858 | 4.372 | 20,558 | 6.603 | |||||||||||||||||||
Exercised (*) | 182,093 | 1.652 | 861,593 | 1.346 | 79,123 | 1.418 | |||||||||||||||||||
Outstanding at end of year | 6,141,030 | $ | 3.563 | 5,253,579 | $ | 3.923 | 5,153,898 | $ | 3.951 | ||||||||||||||||
Exercisable at end of year | 4,647,834 | $ | 2.581 | 4,258,441 | $ | 3.201 | 4,614,148 | $ | 3.591 | ||||||||||||||||
(*) | The total intrinsic value of options exercised during the years ended December 31, 2011, 2012 and 2013, was approximately $1.3 million, $4.8 million and $306,000, respectively. | ||||||||||||||||||||||||
Summary of Restricted Stock Activity - Options Granted to Employees | ' | ||||||||||||||||||||||||
Restricted stock granted to employees: | |||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2012 | 2013 | ||||||||||||||||||||||||
Number of Restricted Shares | |||||||||||||||||||||||||
Outstanding at beginning of year | - | 1,394,708 | |||||||||||||||||||||||
Changes during the year: | |||||||||||||||||||||||||
Granted | 1,500,000 | ||||||||||||||||||||||||
Vested | 102,084 | 406,666 | |||||||||||||||||||||||
Forfeited | 3,208 | 17,834 | |||||||||||||||||||||||
Outstanding at end of year | 1,394,708 | 970,208 | |||||||||||||||||||||||
Schedule of Options Granted to Service Providers | ' | ||||||||||||||||||||||||
Options granted to consultants, directors, and other service providers: | |||||||||||||||||||||||||
Year ended December 31, | |||||||||||||||||||||||||
2011 | 2012 | 2013 | |||||||||||||||||||||||
Weighted | Weighted | Weighted | |||||||||||||||||||||||
Number | average | Number | average | Number | average | ||||||||||||||||||||
of | exercise | of | exercise | of | exercise | ||||||||||||||||||||
options | price | options | price | options | price | ||||||||||||||||||||
Outstanding at beginning of year | 1,438,692 | $ | 4.697 | 1,238,692 | $ | 5.385 | 912,425 | $ | 7.259 | ||||||||||||||||
Changes during the year-Exercised (*) | 200,000 | 0.001 | 326,267 | 0.12 | |||||||||||||||||||||
Outstanding at end of year | 1,238,692 | $ | 5.385 | 912,425 | $ | 7.259 | 912,425 | $ | 7.259 | ||||||||||||||||
Exercisable at end of year | 1,235,567 | $ | 5.385 | 912,425 | $ | 7.259 | 912,425 | $ | 7.259 | ||||||||||||||||
(*) The total intrinsic value of options exercised during the years ended December 31, 2011 and 2012, was approximately $1.9 million, and $2.3 million, respectively. | |||||||||||||||||||||||||
Schedule of Information about Share Options Outstanding | ' | ||||||||||||||||||||||||
The following tables summarize information concerning outstanding and exercisable options and restricted stock as of December 31, 2013: | |||||||||||||||||||||||||
31-Dec-13 | |||||||||||||||||||||||||
Options and restricted stock | Options exercisable | ||||||||||||||||||||||||
outstanding | |||||||||||||||||||||||||
Exercise | Number of | Weighted | Number of | Weighted | |||||||||||||||||||||
prices | options and | average | options | average | |||||||||||||||||||||
restricted stock | remaining | exercisable | remaining | ||||||||||||||||||||||
outstanding | contractual | contractual | |||||||||||||||||||||||
at end of | life | life | |||||||||||||||||||||||
year | |||||||||||||||||||||||||
n/a | 970,208 | n/a | n/a | n/a | |||||||||||||||||||||
(Restricted | |||||||||||||||||||||||||
Stock) | |||||||||||||||||||||||||
$ | 0.001 | 719,207 | 1.54 | 719,207 | 1.54 | ||||||||||||||||||||
$ | 0.12 | 409,765 | 2.42 | 409,765 | 2.42 | ||||||||||||||||||||
$ | 0.399 | 22,587 | 0.92 | 22,587 | 0.92 | ||||||||||||||||||||
$ | 0.972 | 996,353 | 2.44 | 996,353 | 2.44 | ||||||||||||||||||||
$ | 2.35 | 40,000 | 4.82 | 40,000 | 4.82 | ||||||||||||||||||||
$ | 2.65 | 361,119 | 5.15 | 361,119 | 5.15 | ||||||||||||||||||||
$ | 3.02 | 50,000 | 4.1 | 50,000 | 4.1 | ||||||||||||||||||||
$ | 5 | 1,708,000 | 4.1 | 1,708,000 | 4.1 | ||||||||||||||||||||
$ | 6.81 | 150,000 | 6.1 | 150,000 | 6.1 | ||||||||||||||||||||
$ | 6.9 | 993,750 | 6.15 | 501,000 | 6.15 | ||||||||||||||||||||
$ | 7.55 | 160,000 | 6.66 | 130,000 | 6.66 | ||||||||||||||||||||
$ | 9.66 | 68,000 | 6.83 | 51,000 | 6.83 | ||||||||||||||||||||
$ | 16.7 | 387,542 | 2.99 | 387,542 | 2.99 | ||||||||||||||||||||
7,036,531 | 5,526,573 | ||||||||||||||||||||||||
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) | 2011 | 2012 | 2013 | ||||||||||||||||||||||
Cost of revenues | $ | 220 | |||||||||||||||||||||||
Research and development expenses | $ | 422 | 4,756 | $ | 2,655 | ||||||||||||||||||||
General and administrative expenses | 464 | 2,775 | 1,434 | ||||||||||||||||||||||
$ | 886 | $ | 7,751 | $ | 4,089 |
CONVERTIBLE_NOTES_Tables
CONVERTIBLE NOTES (Tables) | 12 Months Ended | ||||
Dec. 31, 2013 | |||||
CONVERTIBLE NOTES [Abstract] | ' | ||||
Schedule of Interest Expense Recognized | ' | ||||
The following table sets forth total interest expense recognized for the year ended December 31, 2013 related to the Notes (in thousands): | |||||
31-Dec-13 | |||||
Contractual interest expense | 888 | ||||
Amortization of debt issuance costs and debt discount | 127 | ||||
Total | 1,015 | ||||
TAXES_ON_INCOME_Tables
TAXES ON INCOME (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2013 | |||||||||
TAXES ON INCOME [Abstract] | ' | ||||||||
Schedule of Deferred Tax Assets | ' | ||||||||
The components of the Company's net deferred tax assets at December 31, 2012 and 2013 were as follows: | |||||||||
December 31, | |||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||
In respect of: | |||||||||
Research and development expenses | $ | 6,003 | 5,257 | ||||||
Property and equipment | (647 | ) | (491 | ) | |||||
Provision for vacation | 363 | 417 | |||||||
Severance pay obligation | 192 | 209 | |||||||
Deferred revenues | 10,449 | 9,867 | |||||||
Net operating loss carry forwards | 15,176 | 23,167 | |||||||
Valuation allowance | (31,536 | ) | (38,426 | ) | |||||
- | - | ||||||||
Schedule of Open Tax Years | ' | ||||||||
A summary of open tax years by major jurisdiction is presented below: | |||||||||
Jurisdiction: | Years: | ||||||||
Israel | 2010-2013 | ||||||||
United States (*) | 2009-2013 | ||||||||
Netherlands | 2009-2013 | ||||||||
(*) Includes federal, state and local (or similar provincial jurisdictions) tax positions. | |||||||||
SUPPLEMENTARY_FINANCIAL_STATEM1
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION [Abstract] | ' | ||||||||||||
Supplemental Information, Balance Sheets | ' | ||||||||||||
Balance sheets: | |||||||||||||
December 31, | |||||||||||||
(U.S. dollars in thousands) | 2012 | 2013 | |||||||||||
a. Other assets: | |||||||||||||
Deferred costs* | $ | 89 | |||||||||||
Institutions | 542 | $ | 356 | ||||||||||
State of Israel (see Note 6a) | 2,400 | 366 | |||||||||||
Restricted deposit | 298 | 362 | |||||||||||
Prepaid expenses | 251 | 286 | |||||||||||
Sundry | 106 | 87 | |||||||||||
$ | 3,686 | $ | 1,457 | ||||||||||
* Manufacturing costs of inventory, paid by Pfizer, but not delivered. | |||||||||||||
(U.S. dollars in thousands) | |||||||||||||
b. Accounts payable and accruals - other: | |||||||||||||
Payroll and related expenses | $ | 1,748 | $ | 1,557 | |||||||||
Interest payable | - | 888 | |||||||||||
Provision for vacation | 1,453 | 1,572 | |||||||||||
Accrued expenses | 2,032 | 1,785 | |||||||||||
Royalties payable | 1,560 | 419 | |||||||||||
Liability in connection with collaboration operation - current portion | 3,122 | 5,666 | |||||||||||
Property and equipment suppliers | 1,136 | 186 | |||||||||||
$ | 11,051 | $ | 12,073 | ||||||||||
Supplemental Information, Income Statement | ' | ||||||||||||
Statements of operations: | |||||||||||||
Year ended December 31, | |||||||||||||
2011 | 2012 | 2013 | |||||||||||
(U.S. dollars in thousands) | |||||||||||||
c. Revenues: | |||||||||||||
Deferred revenues from the license and supply agreement with Pfizer | $ | 4,563 | $ | 4,563 | $ | 4,563 | |||||||
Milestone payment (see Note 2) | 25,000 | ||||||||||||
Revenues from selling products | 3,823 | 5,307 | 5,916 | ||||||||||
$ | 8,386 | $ | 34,870 | $ | 10,479 | ||||||||
RELATED_PARTY_TRANSACTIONS_Tab
RELATED PARTY TRANSACTIONS (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2013 | |||||||||||||
RELATED PARTY TRANSACTIONS [Abstract] | ' | ||||||||||||
Schedule of Related Party Transactions | ' | ||||||||||||
Year ended December 31, | |||||||||||||
(U.S. dollars in thousands) | 2011 | 2012 | 2013 | ||||||||||
Compensation to the non-executive directors (includes the interim Chairman of the Board) | $ | 215 | $ | 375 | $ | 509 | |||||||
SIGNIFICANT_ACCOUNTING_POLICIE3
SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2009 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Jun. 18, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2009 | Jun. 30, 2012 |
Protalix Ltd. [Member] | Protalix Ltd. [Member] | Protalix Bio Therapeutics Inc. [Member] | Pfizer Incorporation [Member] | Upon Filing of Pediatric Investigation Plan to EMA [Member] | Upon FDAApproval [Member] | |||||
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Subsidiaries | ' | 2 | ' | ' | ' | ' | ' | ' | ' | ' |
Pfizer Agreement, upfront payment received | $60,000 | ' | ' | ' | ' | ' | ' | ' | $5,000 | ' |
Milestone payment triggered | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25,000 |
Pfizer Agreement, future revenues and expense sharing percentage | ' | ' | ' | ' | ' | ' | 40.00% | 60.00% | ' | ' |
Common stock, par value per share | ' | $0.00 | $0.00 | ' | ' | ' | ' | ' | ' | ' |
Options to purchase common stock not included in diluted LPS because the effect would be anti-dilutive | ' | 10,675,304 | 7,280,469 | 7,469,088 | ' | ' | ' | ' | ' | ' |
Supply commitment for entitled rights to be received | ' | ' | ' | ' | 280,000 | ' | ' | ' | ' | ' |
License and supply agreement potential future payment | ' | ' | ' | ' | 12,500 | ' | ' | ' | ' | ' |
Supply commitment per year | ' | ' | ' | ' | 40,000 | ' | ' | ' | ' | ' |
Eligable payment receivable upon achievement | ' | ' | ' | ' | ' | $8,300 | ' | ' | ' | ' |
SIGNIFICANT_ACCOUNTING_POLICIE4
SIGNIFICANT ACCOUNTING POLICIES (Useful Lives of Property and Equipment) (Details) | 12 Months Ended |
Dec. 31, 2013 | |
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 |
LICENSE_AND_SUPPLY_AGREEMENT_D
LICENSE AND SUPPLY AGREEMENT (Details) (USD $) | 3 Months Ended | 12 Months Ended | 3 Months Ended | 6 Months Ended | ||||
In Thousands, unless otherwise specified | Dec. 31, 2009 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2013 | Dec. 31, 2009 | Jun. 30, 2012 |
Protalix Bio Therapeutics Inc. [Member] | Collaboration Operation [Member] | Collaboration Operation [Member] | Pfizer Incorporation [Member] | Upon Filing of Pediatric Investigation Plan to EMA [Member] | Upon FDAApproval [Member] | |||
Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Pfizer Agreement, upfront payment received | $60,000 | ' | ' | ' | ' | ' | $5,000 | ' |
Milestone payment triggered | ' | ' | ' | ' | ' | ' | ' | 25,000 |
Pfizer Agreement, future revenues and expense sharing percentage | ' | ' | 40.00% | ' | ' | 60.00% | ' | ' |
Accrued liabilities accrued related to the Collaboration Operation | ' | ' | ' | 8,000 | 8,500 | ' | ' | ' |
Revenue recognized over designated period of relationship | ' | $4,600 | ' | ' | ' | ' | ' | ' |
Revenue recognition period | ' | '14 years | ' | ' | ' | ' | ' | ' |
PROPERTY_AND_EQUIPMENT_Details
PROPERTY AND EQUIPMENT (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Property, Plant and Equipment [Line Items] | ' | ' | ' |
Property, Plant and Equipment, Gross | $32,030,000 | $31,096,000 | ' |
Less - accumulated depreciation and amortization | -18,319,000 | -14,786,000 | ' |
Property, Plant and Equipment, Net, Total | 13,711,000 | 16,310,000 | ' |
Depreciation and write down of fixed assets | 3,539,000 | 3,692,000 | 3,631,000 |
Impairment charges | 0 | 0 | 10,000 |
Laboratory Equipment [Member] | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' |
Property, Plant and Equipment, Gross | 14,858,000 | 14,502,000 | ' |
Furniture And Computer Equipment [Member] | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' |
Property, Plant and Equipment, Gross | 2,074,000 | 1,818,000 | ' |
Leasehold Improvements [Member] | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' |
Property, Plant and Equipment, Gross | 15,070,000 | 14,447,000 | ' |
Equipment Under Construction [Member] | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' |
Property, Plant and Equipment, Gross | $28,000 | $329,000 | ' |
INVENTORIES_Details
INVENTORIES (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
INVENTORIES [Abstract] | ' | ' |
Raw materials | $2,342 | $2,118 |
Work in process | 92 | 192 |
Finished goods | 5,523 | 1,729 |
Total inventory | 7,957 | 4,039 |
Inventory write-down | $1,600 | $684 |
LIABILITY_FOR_EMPLOYEE_RIGHTS_1
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
LIABILITY FOR EMPLOYEE RIGHTS UPON RETIREMENT [Abstract] | ' | ' | ' |
Employee severance obligation payments | $194 | $177 | $181 |
Severance expense | 1,000 | 1,000 | 816 |
Contributions | 801 | 670 | 641 |
Net (gain) or loss for the period | 58 | 36 | 14 |
Expected severance liabilities payments for fiscal year end 2014 | 1,100 | ' | ' |
Expected contribution to one or more Contribution Plans | $847 | ' | ' |
COMMITMENTS_Details
COMMITMENTS (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Commitments And Contingencies [Line Items] | ' | ' | ' |
Subcontracting commitment amount | $1,100 | ' | ' |
OCS [Member] | ' | ' | ' |
Commitments And Contingencies [Line Items] | ' | ' | ' |
Royalty expense included in cost of revenue | 392 | 1,500 | 158 |
Research And License Agreements [Member] | ' | ' | ' |
Commitments And Contingencies [Line Items] | ' | ' | ' |
Royalty expense included in cost of revenue | 80 | 674 | 19 |
Lease Agreements [Member] | ' | ' | ' |
Commitments And Contingencies [Line Items] | ' | ' | ' |
Monthly rent/lease expense | 86 | ' | ' |
Cash deposited as bank guarantee | 344 | ' | ' |
Lease/rent expense | 1,133 | 971 | 994 |
Future minimum lease payments, 2014 | 1,041 | ' | ' |
Future minimum lease payments, 2015 | 1,050 | ' | ' |
Future minimum lease payments, 2016 | 865 | ' | ' |
Vehicle Lease And Maintenance Agreements [Member] | ' | ' | ' |
Commitments And Contingencies [Line Items] | ' | ' | ' |
Monthly rent/lease expense | 53 | ' | ' |
Future minimum lease payments, 2014 | 618 | ' | ' |
Future minimum lease payments, 2015 | 415 | ' | ' |
Future minimum lease payments, 2016 | 94 | ' | ' |
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% | ' | ' |
Percentage amount the aggregate amount of royalties that should not exceed grant received | 100.00% | ' | ' |
Accrued royalties | $26,700 | ' | ' |
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_Narrative_Detail
SHARE CAPITAL (Narrative) (Details) (USD $) | 1 Months Ended | 12 Months Ended | 0 Months Ended | |||||||
In Thousands, except Share data, unless otherwise specified | Sep. 18, 2013 | Feb. 22, 2012 | Mar. 23, 2011 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 17, 2012 | Dec. 14, 2006 | Jul. 16, 2012 | Jul. 16, 2012 | Jul. 16, 2012 |
Restricted Stock [Member] | Restricted Stock [Member] | Restricted Stock [Member] | ||||||||
Officers And Certain Employees [Member] | Employees [Member] | Officers And Directors In Private Transaction [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering, common stock issued and sold | ' | 5,175,000 | 4,000,000 | 93,551,098 | 93,489,809 | ' | ' | ' | ' | ' |
Underwritten public offering, common stock price per share | ' | $5.25 | $5.50 | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering, net proceeds from issuance | ' | $25,400 | $20,600 | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering, commissions and issuance costs | ' | 1,800 | 1,400 | ' | ' | ' | ' | ' | ' | ' |
Shares of common stock approved for grant | ' | ' | ' | ' | ' | 11,341,655 | 9,741,655 | ' | ' | ' |
Common stock shares granted | ' | ' | ' | 1,500,000 | ' | ' | ' | ' | 400,000 | 1,100,000 |
Common stock available for issuance | ' | ' | ' | ' | ' | ' | ' | 1,500,000 | ' | ' |
Shares of common stock issued, lock up period | ' | ' | ' | ' | ' | ' | ' | '24 months | ' | ' |
Number of installments for vesting of stock | ' | ' | ' | ' | ' | ' | ' | 16 | 12 | ' |
Fair value of common stock at grant date | ' | ' | ' | ' | 8,600 | ' | ' | ' | ' | ' |
Proceeds from private placement | 66,800 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Debt additional principal amount | $9,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Interest rate | 4.50% | ' | ' | ' | ' | ' | ' | ' | ' | ' |
SHARE_CAPITAL_Summary_of_Optio
SHARE CAPITAL (Summary of Option and Restricted Stock Granted to Employees) (Details) (USD $) | 12 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Granted | 1,500,000 | ' |
Fair value of common stock at grant date | ' | $8,600 |
2012 [Member] | Employees [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Granted | 400,000 | ' |
Vesting period | '3 years | ' |
Fair value of common stock at grant date | 2,288 | ' |
2012 [Member] | Employees [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Granted | 1,100,000 | ' |
Vesting period | '4 years | ' |
Fair value of common stock at grant date | $6,292 | ' |
SHARE_CAPITAL_Fair_Value_Assum
SHARE CAPITAL (Fair Value Assumptions of Options Granted) (Details) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 |
SHARE CAPITAL [Abstract] | ' | ' |
Unrecognized share-based compensation expense | $2,700 | ' |
Unrecognized compensation cost, recognition period | '9 months 18 days | ' |
Fair value of common stock at grant date | ' | $8,600 |
SHARE_CAPITAL_Options_Granted_
SHARE CAPITAL (Options Granted to Employees) (Details) (USD $) | 12 Months Ended | |||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |||
Weighted average exercise price | ' | ' | ' | |||
Cash proceeds from exercise of options | $112 | $1,230 | $277 | |||
Options And Restricted Stock Granted To Employees [Member] | ' | ' | ' | |||
Number of options | ' | ' | ' | |||
Outstanding at beginning of year | 5,253,579 | 6,141,030 | 6,367,979 | |||
Forfeited and Expired | 20,558 | 25,858 | 44,856 | |||
Exercised | 79,123 | [1] | 861,593 | [1] | 182,093 | [1] |
Outstanding at end of year | 5,153,898 | 5,253,579 | 6,141,030 | |||
Exercisable at end of year | 4,614,148 | 4,258,441 | 4,647,834 | |||
Weighted average exercise price | ' | ' | ' | |||
Outstanding at beginning of year | $3.92 | $3.56 | $3.58 | |||
Forfeited and Expired | $6.60 | $4.37 | $6.21 | |||
Exercised | $1.42 | [1] | $1.35 | [1] | $1.65 | |
Outstanding at end of year | $3.95 | $3.92 | $3.56 | |||
Exercisable at end of year | $3.59 | $3.20 | $2.58 | |||
Intrinsic value of options exercised | 306 | 4,800 | 1,300 | |||
Cash proceeds from exercise of options | ' | $39 | ' | |||
[1] | The total intrinsic value of options exercised during the years ended December 31, 2011, 2012 and 2013, was approximately $1.3 million, $4.8 million and $306,000, respectively. |
SHARE_CAPITAL_Restricted_Stock
SHARE CAPITAL (Restricted Stock Granted to Employees) (Details) | 12 Months Ended | |
Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Forfeited | 17,834 | 3,208 |
Restricted Stock [Member] | Employees [Member] | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Outstanding at beginning of year | 1,394,708 | ' |
Granted | ' | 1,500,000 |
Vested | 102,084 | 406,666 |
Forfeited | 17,834 | 3,208 |
Outstanding at end of year | 970,208 | 1,394,708 |
SHARE_CAPITAL_Options_Granted_1
SHARE CAPITAL (Options Granted to Consultants, Directors and Other Service Providers) (Details) (Options Granted To Consultants Directors And Other Service Providers [Member], USD $) | 12 Months Ended | |||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |||
Options Granted To Consultants Directors And Other Service Providers [Member] | ' | ' | ' | |||
Number of options | ' | ' | ' | |||
Outstanding at beginning of year | 912,425 | 1,238,692 | 1,438,692 | |||
Exercised | ' | [1] | 326,267 | [1] | 200,000 | [1] |
Outstanding at end of year | 912,425 | 912,425 | 1,238,692 | |||
Exercisable at end of year | 912,425 | 912,425 | 1,235,567 | |||
Weighted average exercise price | ' | ' | ' | |||
Outstanding at beginning of year | $7.26 | $5.38 | $4.70 | |||
Exercised | ' | [1] | $0.12 | [1] | $0.00 | [1] |
Outstanding at end of year | $7.26 | $7.26 | $5.38 | |||
Exercisable at end of year | $7.26 | $7.26 | $5.38 | |||
Intrinsic value of options exercised | ' | $2,300 | $1,900 | |||
[1] | The total intrinsic value of options exercised during the years ended December 31, 2011 and 2012, was approximately $1.9 million, and $2.3 million, respectively. |
SHARE_CAPITAL_Summary_of_Outst
SHARE CAPITAL (Summary of Outstanding and Restricted Stocks) (Details) (USD $) | 12 Months Ended |
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2013 |
Restricted Stock [Member] | ' |
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 | 970,208 |
Number of options exercisable at end of year | ' |
Aggregate intrinsic value of the total vested and exercisable options | $7,900 |
Aggregate intrinsic value of total outstanding options and restricted stock | $11,700 |
Options And Restricted Stock [Member] | ' |
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 | 7,036,531 |
Number of options exercisable at end of year | 5,526,573 |
0.001 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $0.00 |
Number of Options and restricted stock outstanding at end of year | 719,207 |
Weighted average remaining contractual life | '1 year 6 months 15 days |
Number of options exercisable at end of year | 719,207 |
Weighted average remaining contractual life, exercisable | '1 year 6 months 15 days |
0.120 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $0.12 |
Number of Options and restricted stock outstanding at end of year | 409,765 |
Weighted average remaining contractual life | '2 years 5 months 1 day |
Number of options exercisable at end of year | 409,765 |
Weighted average remaining contractual life, exercisable | '2 years 5 months 1 day |
0.399 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $0.40 |
Number of Options and restricted stock outstanding at end of year | 22,587 |
Weighted average remaining contractual life | '11 months 1 day |
Number of options exercisable at end of year | 22,587 |
Weighted average remaining contractual life, exercisable | '11 months 1 day |
0.972 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $0.97 |
Number of Options and restricted stock outstanding at end of year | 996,353 |
Weighted average remaining contractual life | '2 years 5 months 9 days |
Number of options exercisable at end of year | 996,353 |
Weighted average remaining contractual life, exercisable | '2 years 5 months 9 days |
2.350 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $2.35 |
Number of Options and restricted stock outstanding at end of year | 40,000 |
Weighted average remaining contractual life | '4 years 9 months 26 days |
Number of options exercisable at end of year | 40,000 |
Weighted average remaining contractual life, exercisable | '4 years 9 months 26 days |
2.650 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $2.65 |
Number of Options and restricted stock outstanding at end of year | 361,119 |
Weighted average remaining contractual life | '5 years 1 month 24 days |
Number of options exercisable at end of year | 361,119 |
Weighted average remaining contractual life, exercisable | '5 years 1 month 24 days |
3.020 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $3.02 |
Number of Options and restricted stock outstanding at end of year | 50,000 |
Weighted average remaining contractual life | '4 years 1 month 6 days |
Number of options exercisable at end of year | 50,000 |
Weighted average remaining contractual life, exercisable | '4 years 1 month 6 days |
5.000 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $5 |
Number of Options and restricted stock outstanding at end of year | 1,708,000 |
Weighted average remaining contractual life | '4 years 1 month 6 days |
Number of options exercisable at end of year | 1,708,000 |
Weighted average remaining contractual life, exercisable | '4 years 1 month 6 days |
6.810 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $6.81 |
Number of Options and restricted stock outstanding at end of year | 150,000 |
Weighted average remaining contractual life | '6 years 1 month 6 days |
Number of options exercisable at end of year | 150,000 |
Weighted average remaining contractual life, exercisable | '6 years 1 month 6 days |
6.900 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $6.90 |
Number of Options and restricted stock outstanding at end of year | 993,750 |
Weighted average remaining contractual life | '6 years 1 month 24 days |
Number of options exercisable at end of year | 501,000 |
Weighted average remaining contractual life, exercisable | '6 years 1 month 24 days |
7.550 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $7.55 |
Number of Options and restricted stock outstanding at end of year | 160,000 |
Weighted average remaining contractual life | '6 years 7 months 28 days |
Number of options exercisable at end of year | 130,000 |
Weighted average remaining contractual life, exercisable | '6 years 7 months 28 days |
9.660 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $9.66 |
Number of Options and restricted stock outstanding at end of year | 68,000 |
Weighted average remaining contractual life | '6 years 9 months 29 days |
Number of options exercisable at end of year | 51,000 |
Weighted average remaining contractual life, exercisable | '6 years 9 months 29 days |
16.700 [Member] | Options And Restricted Stock [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Exercise price | $16.70 |
Number of Options and restricted stock outstanding at end of year | 387,542 |
Weighted average remaining contractual life | '2 years 11 months 27 days |
Number of options exercisable at end of year | 387,542 |
Weighted average remaining contractual life, exercisable | '2 years 11 months 27 days |
SHARE_CAPITAL_Share_Based_Comp
SHARE CAPITAL (Share Based Compensation Expense Allocation) (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated Share-based Compensation Expense | $4,089 | $7,751 | $886 |
Cost of Revenues [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated Share-based Compensation Expense | ' | 220 | ' |
Research and Development Expense [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated Share-based Compensation Expense | 2,655 | 4,756 | 422 |
General and Administrative Expense [Member] | ' | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' |
Allocated Share-based Compensation Expense | $1,434 | $2,775 | $464 |
CONVERTIBLE_NOTES_Narrative_De
CONVERTIBLE NOTES (Narrative) (Details) (USD $) | 1 Months Ended | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 18, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
CONVERTIBLE NOTES [Abstract] | ' | ' | ' | ' |
Principal amount | $69,000 | ' | ' | ' |
Debt additional principal amount | 9,000 | ' | ' | ' |
Interest rate | 4.50% | ' | ' | ' |
Base value for conversion rate | 1 | ' | ' | ' |
Number of shares for basis conversion | 173.6593 | ' | ' | ' |
Conversion price per share | $5.76 | ' | ' | ' |
Net proceeds from issuance of convertible notes | ' | $66,780 | ' | ' |
Maturity | 15-Sep-18 | ' | ' | ' |
CONVERTIBLE_NOTES_Schedule_of_
CONVERTIBLE NOTES (Schedule of Interest Expense Recognized) (Details) (USD $) | 12 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2013 |
CONVERTIBLE NOTES [Abstract] | ' |
Contractual interest expense | $888 |
Amortization of debt issuance costs | 127 |
Total | $1,015 |
FAIR_VALUE_MEASUREMENT_Details
FAIR VALUE MEASUREMENT (Details) (USD $) | Dec. 31, 2013 |
In Thousands, unless otherwise specified | |
FAIR VALUE MEASUREMENT [Abstract] | ' |
Fair value convertible notes | $72,000 |
TAXES_ON_INCOME_Narrative_Deta
TAXES ON INCOME (Narrative) (Details) (USD $) | 12 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2013 |
Income Tax Disclosure [Line Items] | ' |
Withholding tax on the U.S. revenue source portion of the payments made to the Company for its share of Pfizer's net profits | 15.00% |
Net operating loss carry forwards | 112,700 |
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 | 15,300 |
Protalix Ltd. [Member] | ' |
Income Tax Disclosure [Line Items] | ' |
Statutory income tax rate | 39.00% |
Additional gradual decrease in tax rate, 2011 | 24.00% |
Additional gradual decrease in tax rate, 2012 | 23.00% |
Additional gradual decrease in tax rate, 2013 | 22.00% |
Additional gradual decrease in tax rate, 2014 | 21.00% |
Additional gradual decrease in tax rate, 2015 | 20.00% |
Additional gradual decrease in tax rate, 2016 and thereafter | 18.00% |
Net operating loss carry forwards | 97,400 |
TAXES_ON_INCOME_Deferred_Incom
TAXES ON INCOME (Deferred Income Taxes) (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
TAXES ON INCOME [Abstract] | ' | ' |
Research and development expenses | $5,257 | $6,003 |
Property and equipment | -491 | -647 |
Provision for vacation | 417 | 363 |
Severance pay obligation | 209 | 192 |
Deferred revenues | 9,867 | 10,449 |
Net operating loss carry forwards | 23,167 | 15,176 |
Valuation allowance | -38,426 | -31,536 |
Deferred Tax Assets, Net of Valuation Allowance, Total | ' | ' |
TAXES_ON_INCOME_Open_Tax_Years
TAXES ON INCOME (Open Tax Years) (Details) | 12 Months Ended |
Dec. 31, 2013 | |
ISRAEL [Member] | Minimum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2010 |
ISRAEL [Member] | Maximum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2013 |
UNITED STATES [Member] | Minimum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2009 |
UNITED STATES [Member] | Maximum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2013 |
NETHERLANDS [Member] | Minimum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2009 |
NETHERLANDS [Member] | Maximum [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Open tax year | '2013 |
SUPPLEMENTARY_FINANCIAL_STATEM2
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Receivable, Other) (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 | ||
In Thousands, unless otherwise specified | ||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Prepaid expenses | $286 | $251 | ||
Other receivables | 1,457 | 3,686 | ||
Deferred Cost [Member] | ' | ' | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Other receivables | ' | [1] | 89 | [1] |
Institutions [Member] | ' | ' | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Other receivables | 356 | 542 | ||
State Of Israel [Member] | ' | ' | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Other receivables | 366 | 2,400 | ||
Restricted Deposit [Member] | ' | ' | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Other receivables | 362 | 298 | ||
Sundry [Member] | ' | ' | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ' | ' | ||
Other receivables | $87 | $106 | ||
[1] | Manufacturing costs of inventory, paid by Pfizer, but not delivered. |
SUPPLEMENTARY_FINANCIAL_STATEM3
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Accounts Payable and Accruals, Other) (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Accounts Payable And Accruals [Line Items] | ' | ' |
Payroll and related expenses | $1,557 | $1,748 |
Interest payable | 888 | ' |
Provision for vacation | 1,572 | 1,453 |
Accrued expenses | 1,785 | 2,032 |
Royalties payable | 419 | 1,560 |
Accounts payable and accruals, other | 12,073 | 11,051 |
Collaboration Operation Current Portion [Member] | ' | ' |
Accounts Payable And Accruals [Line Items] | ' | ' |
Accounts payable and accruals, other | 3,122 | 5,666 |
Property And Equipment Suppliers [Member] | ' | ' |
Accounts Payable And Accruals [Line Items] | ' | ' |
Accounts payable and accruals, other | $1,136 | $186 |
SUPPLEMENTARY_FINANCIAL_STATEM4
SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (Revenues) (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Supplemental Information Revenue [Line Items] | ' | ' | ' |
Revenues | $10,479 | $34,870 | $8,386 |
Deferred Revenue From License And Supply Agreement With Pzifer [Member] | ' | ' | ' |
Supplemental Information Revenue [Line Items] | ' | ' | ' |
Revenues | 4,563 | 4,563 | 4,563 |
Milestone Payments [Member] | ' | ' | ' |
Supplemental Information Revenue [Line Items] | ' | ' | ' |
Revenues | ' | 25,000 | ' |
Revenues from selling products [Member] | ' | ' | ' |
Supplemental Information Revenue [Line Items] | ' | ' | ' |
Revenues | $5,916 | $5,307 | $3,823 |
RELATED_PARTY_TRANSACTIONS_Det
RELATED PARTY TRANSACTIONS (Details) (Compensation To The Non -executiveDirectors [Member], USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
Compensation To The Non -executiveDirectors [Member] | ' | ' | ' |
Related Party Transaction [Line Items] | ' | ' | ' |
Related Party Transaction, Amounts of Transaction | $509 | $375 | $215 |