Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 01, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | PLX | |
Entity Registrant Name | PROTALIX BIOTHERAPEUTICS, INC. | |
Entity Central Index Key | 1,006,281 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 99,800,397 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 34,248 | $ 54,767 |
Accounts receivable - Trade | 4,573 | 1,884 |
Other assets | 2,716 | 2,202 |
Inventories | 6,339 | 6,667 |
Total current assets | 47,876 | 65,520 |
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,569 | 1,555 |
PROPERTY AND EQUIPMENT, NET | 9,957 | 11,282 |
DEFERRED CHARGES | 90 | 113 |
Total assets | 59,492 | 78,470 |
Accounts payable and accruals: | ||
Trade | 4,057 | 3,951 |
Other | 11,946 | 15,496 |
Deferred revenues | 6,850 | 6,763 |
Total current liabilities | 22,853 | 26,210 |
LONG TERM LIABILITIES: | ||
Convertible notes | 67,774 | 67,464 |
Deferred revenues | 35,127 | 37,232 |
Liability in connection with collaboration operation | 912 | |
Liability for employee rights upon retirement | 2,249 | 2,253 |
Total long term liabilities | 105,150 | 107,861 |
Total liabilities | $ 128,003 | $ 134,071 |
COMMITMENTS | ||
CAPITAL DEFICIENCY | $ (68,511) | $ (55,601) |
Total liabilities net of capital deficiency | $ 59,492 | $ 78,470 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ||||
REVENUES | $ 4,301 | $ 2,396 | $ 12,475 | $ 11,517 |
COMPANY'S SHARE IN COLLABORATION AGREEMENT | 1,545 | 1,311 | 3,084 | 2,259 |
COST OF REVENUES | (2,346) | (1,798) | (6,785) | (7,476) |
GROSS PROFIT | 3,500 | 1,909 | 8,774 | 6,300 |
RESEARCH AND DEVELOPMENT EXPENSES (1) | (5,260) | (8,052) | (18,493) | (23,280) |
Less - grants and reimbursements | 1,207 | 1,947 | 3,856 | 6,146 |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (4,053) | (6,105) | (14,637) | (17,134) |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (2) | (2,254) | (2,012) | (6,259) | (7,289) |
OPERATING LOSS | (2,807) | (6,208) | (12,122) | (18,123) |
FINANCIAL EXPENSES | (1,030) | (1,851) | (2,805) | (3,490) |
FINANCIAL INCOME | 17 | 49 | 64 | 139 |
FINANCIAL EXPENSES - NET | (1,013) | (1,802) | (2,741) | (3,351) |
NET LOSS FOR THE PERIOD | $ (3,820) | $ (8,010) | $ (14,863) | $ (21,474) |
NET LOSS PER SHARE OF COMMON STOCK | ||||
NET LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED: | $ (0.04) | $ (0.09) | $ (0.16) | $ (0.23) |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC AND DILUTED: | ||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE - BASIC AND DILUTED: | 93,943,772 | 92,971,572 | 93,599,414 | 92,828,851 |
CONDENSED CONSOLIDATED STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Research and Development Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 258 | $ 173 | $ 667 | $ 764 |
General and Administrative Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 188 | $ (67) | $ 752 | $ (81) |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | ||
Balance | $ (55,601) | $ (26,946) | |||
Share-based compensation related to stock options | 947 | 161 | |||
Share-based compensation related to restricted stock award, net of forfeitures | 472 | 522 | |||
Exercise of options granted to employees (includes net exercise) | 534 | 43 | |||
Net loss for the period | $ (3,820) | $ (8,010) | (14,863) | (21,474) | |
Balance | (68,511) | (47,694) | (68,511) | (47,694) | |
Common Stock [Member] | |||||
Balance | $ 94 | $ 94 | |||
Balance, shares | 93,603,819 | 93,551,098 | |||
Share-based compensation related to stock options | |||||
Share-based compensation related to restricted stock award, net of forfeitures | |||||
Share-based compensation related to restricted stock award, net of forfeitures, shares | (2,501) | (1,834) | |||
Exercise of options granted to employees (includes net exercise) | [1] | ||||
Exercise of options granted to employees (includes net exercise), shares | 550,000 | 113,800 | |||
Net loss for the period | |||||
Balance | $ 94 | $ 94 | $ 94 | $ 94 | |
Balance, shares | 94,151,318 | 93,663,064 | 94,151,318 | 93,663,064 | |
Additional Paid-in Capital [Member] | |||||
Balance | $ 185,633 | $ 184,345 | |||
Share-based compensation related to stock options | 947 | 161 | |||
Share-based compensation related to restricted stock award, net of forfeitures | 472 | 522 | |||
Exercise of options granted to employees (includes net exercise) | $ 534 | $ 43 | |||
Net loss for the period | |||||
Balance | $ 187,586 | $ 185,071 | $ 187,586 | $ 185,071 | |
Accumulated Deficit [Member] | |||||
Balance | $ (241,328) | $ (211,385) | |||
Share-based compensation related to stock options | |||||
Share-based compensation related to restricted stock award, net of forfeitures | |||||
Exercise of options granted to employees (includes net exercise) | |||||
Net loss for the period | $ (14,863) | $ (21,474) | |||
Balance | $ (256,191) | $ (232,859) | $ (256,191) | $ (232,859) | |
[1] | Represents amount less than thousand |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY (Parenthetical) - $ / shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based compensation related to restricted stock award, forfeitures, shares | 2,501 | 1,834 |
Common stock, par value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (14,863) | $ (21,474) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Share based compensation | 1,419 | 683 |
Depreciation | 1,811 | 2,418 |
Financial expenses, net (mainly exchange differences) | 102 | 869 |
Changes in accrued liability for employee rights upon retirement | 16 | 149 |
Loss (Gain) on amounts funded in respect of employee rights upon retirement | 28 | (25) |
Amortization of debt issuance costs and debt discount | 333 | 332 |
Changes in operating assets and liabilities: | ||
Decrease in deferred revenues (including non-current portion) | (2,018) | (6,172) |
Increase in accounts receivable and other assets | (3,187) | (578) |
Decrease in inventories | 328 | 1,127 |
Decrease in accounts payable and accruals (including long term ) | (4,396) | (1,736) |
Net cash used in operating activities | (20,427) | (24,407) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | $ (460) | (617) |
Investment in restricted deposit | (93) | |
Amounts funded in respect of employee rights upon retirement, net | $ (56) | (122) |
Net cash used in investing activities | (516) | (832) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Exercise of options | 534 | 43 |
Net cash provided by financing activities | 534 | 43 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | (110) | (885) |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (20,519) | (26,081) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 54,767 | 86,398 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 34,248 | 60,317 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
Purchase of property and equipment | 146 | 122 |
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | ||
Interest paid | $ 3,105 | $ 3,079 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 9 Months Ended |
Sep. 30, 2015 | |
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). Using the ProCellEx system, the Company is developing a pipeline of proprietary recombinant therapeutic proteins. The Company's initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. The Company's strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. To date, the Company has successfully developed a treatment for Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets, and the Company has number of product candidates in varying stages of the clinical development process. 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 for sale the Company's first commercial product, taliglucerase alfa for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Subsequently, taliglucerase alfa was approved for marketing by the regulatory authorities of other countries. Taliglucerase alfa is being marketed under the name Uplyso TM TM Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer Inc. (Pfizer), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd., the Company's wholly-owned subsidiary, and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the Amended Pfizer Agreement) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to Elelyso in Brazil. Under the initial Pfizer Agreement, Pfizer and the Company shared revenues and expenses for the development and commercialization of Elelyso on a 60 40 100 12.5 For further details please see Note 5. On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the Brazil Agreement) with Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health for taliglucerase alfa. The agreement became effective in January 2014. The technology transfer is designed to be completed in four 280 Fiocruz's purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 The Company will pay a fee equal to 5 of the net proceeds generated in Brazil to an agent for services provided in assisting the Company complete the Brazil Agreement pursuant to an agreement between the agent and the Company. The agreement will remain in effect with respect to the Brazil Agreement until the termination thereof. In addition to taliglucerase alfa, the Company is developing an innovative product pipeline using its ProCellEx protein expression system. The Company's product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans. (2) PRX-106, the Company's oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as a natural capsule for the expressed protein. (3) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation. (4) PRX-112, an orally administered glucocerebrosidase enzyme for the treatment of Gaucher patients utilizing oral delivery of the recombinant GCD enzyme produced and encapsulated within carrot cells. 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. Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months no b. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2014, filed by the Company with the U.S. Securities and Exchange Commission (the Commission) c. 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 18,781,572 19,797,190 18,661,182 19,820,485 |
INVENTORIES
INVENTORIES | 9 Months Ended |
Sep. 30, 2015 | |
INVENTORIES [Abstract] | |
INVENTORIES | NOTE 2 - INVENTORIES Inventory at September 30, 2015 and December 31, 2014 consisted of the following: September 30, December 31, 2015 2014 ( U.S. dollars in thousands) Raw materials $ 1,502 $ 1,616 Work in progress 132 Finished goods 4,837 4,919 Total inventory $ 6,339 $ 6,667 During the nine months ended September 30, 2015, the Company recorded approximately $ 1.6 |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 9 Months Ended |
Sep. 30, 2015 | |
FAIR VALUE MEASUREMENT [Abstract] | |
FAIR VALUE MEASUREMENT | NOTE 3 FAIR VALUE MEASUREMENT The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date. The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value. The fair value of the convertible notes as of September 30, 2015 is approximately $ 45.5 |
STOCK TRANSACTIONS
STOCK TRANSACTIONS | 9 Months Ended |
Sep. 30, 2015 | |
STOCK TRANSACTIONS [Abstract] | |
STOCK TRANSACTIONS | NOTE 4 STOCK TRANSACTIONS On March 23, 2015, the Company's compensation committee approved the grant of a 10 1,909,000 1.72 four 25 12 three 1.9 0 61.7 1.6 six |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 9 Months Ended |
Sep. 30, 2015 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 5 SUBSEQUENT EVENTS On October 12, 2015, the Company entered into the Amended Pfizer Agreement which amends and restates, in its entirety, the Pfizer Agreement. See Note 1. Pursuant to the Amended Pfizer Agreement, the Company sold its share in the collaboration with Pfizer on the commercialization of Elelyso to Pfizer in exchange for a cash payment equal to $ 36.0 4.2 On October 12, 2015, the Company also entered into a Stock Purchase Agreement with Pfizer, pursuant to which the Company issued 5,649,079 10.0 180 90 |
SIGNIFICANT ACCOUNTING POLICI13
SIGNIFICANT ACCOUNTING POLICIES (Policy) | 9 Months Ended |
Sep. 30, 2015 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
General | 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). Using the ProCellEx system, the Company is developing a pipeline of proprietary recombinant therapeutic proteins. The Company's initial commercial focus has been on complex therapeutic proteins, including proteins for the treatment of genetic disorders, such as Gaucher disease and Fabry disease. The Company's strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications. To date, the Company has successfully developed a treatment for Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets, and the Company has number of product candidates in varying stages of the clinical development process. 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 for sale the Company's first commercial product, taliglucerase alfa for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adult patients with a confirmed diagnosis of type 1 Gaucher disease. Subsequently, taliglucerase alfa was approved for marketing by the regulatory authorities of other countries. Taliglucerase alfa is being marketed under the name Uplyso TM TM Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer Inc. (Pfizer), the Company's commercialization partner, as provided in the exclusive license and supply agreement by and between Protalix Ltd., the Company's wholly-owned subsidiary, and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the Amended Pfizer Agreement) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to Elelyso in Brazil. Under the initial Pfizer Agreement, Pfizer and the Company shared revenues and expenses for the development and commercialization of Elelyso on a 60 40 100 12.5 For further details please see Note 5. On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the Brazil Agreement) with Fundação Oswaldo Cruz (Fiocruz), an arm of the Brazilian Ministry of Health for taliglucerase alfa. The agreement became effective in January 2014. The technology transfer is designed to be completed in four 280 Fiocruz's purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 The Company will pay a fee equal to 5 of the net proceeds generated in Brazil to an agent for services provided in assisting the Company complete the Brazil Agreement pursuant to an agreement between the agent and the Company. The agreement will remain in effect with respect to the Brazil Agreement until the termination thereof. In addition to taliglucerase alfa, the Company is developing an innovative product pipeline using its ProCellEx protein expression system. The Company's product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans. (2) PRX-106, the Company's oral antiTNF product candidate which is being developed as an orally-delivered anti inflammatory treatment using plant cells as a natural capsule for the expressed protein. (3) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation. (4) PRX-112, an orally administered glucocerebrosidase enzyme for the treatment of Gaucher patients utilizing oral delivery of the recombinant GCD enzyme produced and encapsulated within carrot cells. 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. Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months no |
Basis of Presentation | b. Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2014, filed by the Company with the U.S. Securities and Exchange Commission (the Commission) |
Net loss per share | c. 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 18,781,572 19,797,190 18,661,182 19,820,485 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
INVENTORIES [Abstract] | |
Schedule of Inventory | September 30, December 31, 2015 2014 ( U.S. dollars in thousands) Raw materials $ 1,502 $ 1,616 Work in progress 132 Finished goods 4,837 4,919 Total inventory $ 6,339 $ 6,667 |
SIGNIFICANT ACCOUNTING POLICI15
SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Oct. 31, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Jun. 18, 2013 | |
Significant Accounting Policies [Line Items] | ||||||
Common stock, par value per share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||
Options to purchase common stock not included in diluted LPS because the effect would be anti-dilutive | 19,820,485 | 18,661,182 | 19,797,190 | 18,781,572 | ||
Brazil Agreement [Member] | Protalix Ltd. [Member] | Fiocruz [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Supply commitment for entitled rights to be received | $ 280 | |||||
Percentage of adult Gaucher patients in Brazil currently treated with Uplyso | 10.00% | |||||
Agent fee, percentage of net proceeds | 5.00% | |||||
Pfizer Agreement [Member] | Pfizer Incorporation [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Agreement, future revenues and expenses sharing percentage | 60.00% | 60.00% | ||||
Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Agreement, future revenues and expenses sharing percentage | 40.00% | 40.00% | ||||
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Proceeds from sale of share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso | $ 36 | |||||
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Pfizer Incorporation [Member] | Excluding Brazil [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Agreement, future revenues and expenses sharing percentage | 100.00% | |||||
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
License and supply agreement potential future payment, elimination amount | $ 12.5 | |||||
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | BRAZIL | ||||||
Significant Accounting Policies [Line Items] | ||||||
Agreement, future revenues and expenses sharing percentage | 100.00% |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Dec. 31, 2014 | |
INVENTORIES [Abstract] | ||
Raw materials | $ 1,502 | $ 1,616 |
Work in process | 132 | |
Finished goods | 4,837 | 4,919 |
Total inventory | 6,339 | $ 6,667 |
Inventory write-down | $ 1,600 |
FAIR VALUE MEASUREMENT (Details
FAIR VALUE MEASUREMENT (Details) $ in Millions | Sep. 30, 2015USD ($) |
FAIR VALUE MEASUREMENT [Abstract] | |
Fair value convertible notes | $ 45.5 |
STOCK TRANSACTIONS (Details)
STOCK TRANSACTIONS (Details) - 2006 Employee Stock Incentive Plan [Member] - Option to purchase shares of common stock [Member] $ / shares in Units, $ in Millions | 1 Months Ended |
Mar. 23, 2015USD ($)item$ / sharesshares | |
Class of Stock [Line Items] | |
Option granted (in shares) | shares | 1,909,000 |
Term of option | 10 years |
Exercise price (in dollars per share) | $ / shares | $ 1.72 |
Vesting period | 4 years |
Fair value of option on the date of grant | $ 1.9 |
Dividend yield | 0.00% |
Expected volatility | 61.70% |
Risk free interest rate | 1.60% |
Expected life in years | 6 years |
Vest on the first anniversary of the grant date [Member] | |
Class of Stock [Line Items] | |
Percentage of options vested | 25.00% |
Vest over the subsequent quarterly period | |
Class of Stock [Line Items] | |
Number of installments for vesting of stock | item | 12 |
Vesting period | 3 years |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - USD ($) $ in Millions | 1 Months Ended | |
Oct. 31, 2015 | Sep. 30, 2015 | |
Pfizer Agreement [Member] | Pfizer Incorporation [Member] | ||
Subsequent Event [Line Items] | ||
Agreement, future revenues and expenses sharing percentage | 60.00% | |
Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||
Subsequent Event [Line Items] | ||
Agreement, future revenues and expenses sharing percentage | 40.00% | |
Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Common stock issued | 5,649,079 | |
Common stock issued, value | $ 10 | |
Subsequent Event [Member] | Directors and Executive Officers [Member] | ||
Subsequent Event [Line Items] | ||
Lock-up period with respect to the purchased shares of common stock | 90 days | |
Subsequent Event [Member] | Pfizer Incorporation [Member] | ||
Subsequent Event [Line Items] | ||
Lock-up period with respect to the purchased shares of common stock | 180 days | |
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | ||
Subsequent Event [Line Items] | ||
Proceeds from sale of share in the collaboration created under the initial Pfizer Agreement for the commercialization of Elelyso | $ 36 | |
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Pfizer Incorporation [Member] | Excluding Brazil [Member] | ||
Subsequent Event [Line Items] | ||
Agreement, future revenues and expenses sharing percentage | 100.00% | |
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||
Subsequent Event [Line Items] | ||
License and supply agreement potential future payment, elimination amount | $ 12.5 | |
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | BRAZIL | ||
Subsequent Event [Line Items] | ||
Agreement, future revenues and expenses sharing percentage | 100.00% | |
Subsequent Event [Member] | Amended Pfizer Agreement [Member] | October 2015 Promissory Note To Pfizer [Member] | ||
Subsequent Event [Line Items] | ||
Promissory note, amount | $ 4.2 | |
Maturity date | Oct. 31, 2020 |