Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | 1-May-14 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
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 Common Stock, Shares Outstanding | ' | 93,606,460 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
CURRENT ASSETS: | ' | ' |
Cash and cash equivalents | $77,690 | $86,398 |
Accounts receivable- Trade | 1,735 | 2,091 |
Other assets | 2,609 | 1,457 |
Inventories | 6,527 | 7,957 |
Total current assets | 88,561 | 97,903 |
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,622 | 1,578 |
PROPERTY AND EQUIPMENT, NET | 13,098 | 13,711 |
DEFERRED CHARGES | 135 | 141 |
Total assets | 103,416 | 113,333 |
Accounts payable and accruals: | ' | ' |
Trade | 4,639 | 5,254 |
Other | 14,533 | 12,073 |
Deferred revenues | 7,609 | 9,369 |
Total current liabilities | 26,781 | 26,696 |
LONG TERM LIABILITIES: | ' | ' |
Convertible notes | 67,151 | 67,048 |
Deferred revenues | 40,655 | 41,796 |
Liability in connection with collaboration operation | ' | 2,371 |
Liability for employee rights upon retirement | 2,407 | 2,368 |
Total long term liabilities | 110,213 | 113,583 |
Total liabilities | 136,994 | 140,279 |
COMMITMENTS | ' | ' |
CAPITAL DEFICIENCY | -33,578 | -26,946 |
Total liabilities net of capital deficiency | $103,416 | $113,333 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS [Abstract] | ' | ' |
REVENUES | $6,696 | $3,568 |
COMPANY'S SHARE IN COLLABORATION AGREEMENT | 687 | 400 |
COST OF REVENUES | -4,073 | -971 |
GROSS PROFIT | 3,310 | 2,997 |
RESEARCH AND DEVELOPMENT EXPENSES | -8,152 | -7,754 |
Less - grants and reimbursements | 2,085 | 2,431 |
RESEARCH AND DEVELOPMENT EXPENSES, NET | -6,067 | -5,323 |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | -3,711 | -2,103 |
OPERATING LOSS | -6,468 | -4,429 |
FINANCIAL EXPENSES | -915 | -14 |
FINANCIAL INCOME | 38 | 122 |
FINANCIAL INCOME (EXPENSES) - NET | -877 | 108 |
NET LOSS FOR THE PERIOD | ($7,345) | ($4,321) |
LOSS PER SHARE OF COMMON STOCK: | ' | ' |
BASIC AND DILUTED | $0.08 | $0.05 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING LOSS PER SHARE: | ' | ' |
BASIC AND DILUTED | 92,686,638 | 92,184,220 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Research and Development Expense [Member] | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Share-based compensation | $428 | $870 |
General and Administrative Expense [Member] | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Share-based compensation | $242 | $497 |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY (USD $) | 3 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | |
Beginning Balance | ($26,946) | ($3,357) | |
Share-based compensation related to stock options | 162 | 347 | |
Share-based compensation related to restricted stock award, net of forfeitures | 508 | 1,020 | |
Exercise of options granted to employees | 43 | 28 | |
Net loss for the period | -7,345 | -4,321 | |
Ending Balance | -33,578 | -6,283 | |
Common Stock [Member] | ' | ' | |
Beginning Balance | 94 | 93 | |
Beginning Balance (in shares) | 93,551,098 | 93,489,809 | |
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 (in shares) | ' | ' | |
Exercise of options granted to employees | ' | [1] | 1 |
Exercise of options granted to employees (in shares) | 55,362 | 12,421 | |
Net loss for the period | ' | ' | |
Ending Balance | 94 | 94 | |
Ending Balance (in shares) | 93,606,460 | 93,502,230 | |
Additional paid-in Capital [Member] | ' | ' | |
Beginning Balance | 184,345 | 180,145 | |
Share-based compensation related to stock options | 162 | 347 | |
Share-based compensation related to restricted stock award, net of forfeitures | 508 | 1,020 | |
Exercise of options granted to employees | 43 | 27 | |
Net loss for the period | ' | ' | |
Ending Balance | 185,058 | 181,539 | |
Accumulated Deficit [Member] | ' | ' | |
Beginning Balance | -211,385 | -183,595 | |
Share-based compensation related to stock options | ' | ' | |
Share-based compensation related to restricted stock award, net of forfeitures | ' | ' | |
Exercise of options granted to employees | ' | ' | |
Net loss for the period | -7,345 | -4,321 | |
Ending Balance | ($218,730) | ($187,916) | |
[1] | Represents an amount less than $1. |
CONDENSED_CONSOLIDATED_STATEME3
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY (Parenthetical) (USD $) | Mar. 31, 2014 | Mar. 31, 2013 |
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN CAPITAL DEFICIENCY [Abstract] | ' | ' |
Common Stock, par value | $0.00 | $0.00 |
Common Stock, Authorized | 150,000,000 | 150,000,000 |
CONDENSED_CONSOLIDATED_STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' |
Net loss | ($7,345) | ($4,321) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ' | ' |
Share based compensation | 670 | 1,367 |
Depreciation and write down of fixed assets | 828 | 926 |
Financial expenses (income), net (mainly exchange differences) | 14 | -78 |
Changes in accrued liability for employee rights upon retirement | 50 | 60 |
Gain on amounts funded in respect of employee rights upon retirement | -1 | -19 |
Amortization of debt issuance costs and debt discount | 109 | ' |
Changes in operating assets and liabilities: | ' | ' |
Decrease in deferred revenues (including non-current portion) | -2,901 | -2,740 |
Increase in accounts receivable and other assets | -744 | -42 |
Decrease (increase) in inventories | 1,430 | -1,734 |
Decrease in accounts payable and accruals (including long term ) | -450 | -3,005 |
Net cash used in operating activities | -8,340 | -9,586 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' |
Purchase of property and equipment | -263 | -642 |
Investment in restricted deposit | -57 | ' |
Amounts funded in respect of employee rights upon retirement, net | -50 | -47 |
Net cash used in investing activities | -370 | -689 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' |
Exercise of options | 31 | ' |
Net cash provided by financing activities | 31 | ' |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | -29 | 110 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | -8,708 | -10,165 |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 86,398 | 52,035 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 77,690 | 41,870 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ' | ' |
Purchase of property and equipment | 138 | 815 |
Exercise of options granted to employees | $12 | $28 |
SIGNIFICANT_ACCOUNTING_POLICIE
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended | ||
Mar. 31, 2014 | |||
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. 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. | |||
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 during the first quarter of 2014. | |||
During the three months ended March 31, 2014, the Company recorded revenues of approximately $3.5 million from the sale of products to Fiocruz. | |||
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, Chile 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 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, 2013, filed by the Company with the Securities and Exchange Commission. The comparative balance sheet at December 31, 2013 has been derived from the audited financial statements at that date. | |||
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 per share (the "Common Stock") outstanding for each period. | |||
Diluted LPS does not include 7,471,571 and 18,913,153 shares of Common Stock underlying outstanding options and restricted shares of Common Stock and shares issuable upon conversion of the convertible notes (issued in September 2013) for the three months ended March 31, 2013 and 2014, respectively, because the effect would be anti-dilutive. |
INVENTORIES
INVENTORIES | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
INVENTORIES [Abstract] | ' | ||||||||
INVENTORIES | ' | ||||||||
NOTE 2 - INVENTORIES | |||||||||
Inventory at March 31, 2014 and December 31, 2013 consisted of the following: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(U.S. dollars in thousands) | |||||||||
Raw materials | $ | 2,076 | $ | 2,342 | |||||
Work in progress | 170 | 92 | |||||||
Finished goods | 4,281 | 5,523 | |||||||
Total inventory | $ | 6,527 | $ | 7,957 | |||||
During the three months ended March 31, 2014, the Company recorded approximately $1.1 million for write-down of inventory under cost of revenues. |
FAIR_VALUE_MEASUREMENT
FAIR VALUE MEASUREMENT | 3 Months Ended |
Mar. 31, 2014 | |
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. |
STOCK_TRANSACTIONS
STOCK TRANSACTIONS | 3 Months Ended |
Mar. 31, 2014 | |
STOCK TRANSACTIONS [Abstract] | ' |
STOCK TRANSACTIONS | ' |
NOTE 4 - STOCK TRANSACTIONS | |
During the three months ended March 31, 2014, the Company issued a total of 55,362 shares of Common Stock in connection with the exercise of a total of 56,122 options by certain employees of the Company. The aggregate proceeds in connection with such exercises totaled approximately $43,000. | |
SIGNIFICANT_ACCOUNTING_POLICIE1
SIGNIFICANT ACCOUNTING POLICIES (Policy) | 3 Months Ended |
Mar. 31, 2014 | |
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. 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. | |
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 during the first quarter of 2014. | |
During the three months ended March 31, 2014, the Company recorded revenues of approximately $3.5 million from the sale of products to Fiocruz. | |
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, Chile 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 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, 2013, filed by the Company with the Securities and Exchange Commission. The comparative balance sheet at December 31, 2013 has been derived from the audited financial statements at that date. | |
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 7,471,571 and 18,913,153 shares of Common Stock underlying outstanding options and restricted shares of Common Stock and shares issuable upon conversion of the convertible notes (issued in September 2013) for the three months ended March 31, 2013 and 2014, respectively, because the effect would be anti-dilutive. | |
INVENTORIES_Tables
INVENTORIES (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
INVENTORIES [Abstract] | ' | ||||||||
Inventory | ' | ||||||||
Inventory at March 31, 2014 and December 31, 2013 consisted of the following: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
(U.S. dollars in thousands) | |||||||||
Raw materials | $ | 2,076 | $ | 2,342 | |||||
Work in progress | 170 | 92 | |||||||
Finished goods | 4,281 | 5,523 | |||||||
Total inventory | $ | 6,527 | $ | 7,957 | |||||
SIGNIFICANT_ACCOUNTING_POLICIE2
SIGNIFICANT ACCOUNTING POLICIES (Details) (USD $) | 3 Months Ended | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Dec. 31, 2009 | Mar. 31, 2014 | Mar. 31, 2014 | Jun. 18, 2013 | Dec. 31, 2009 | Jun. 30, 2012 |
Protalix Bio Therapeutics Incorporation [Member] | Pfizer Incorporation [Member] | Protalix Ltd. [Member] | Upon Filing of Pediatric Investigation Plan to EMA [Member] | Upon FDA Approval [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% | ' | ' | ' |
Supply commitment for entitled rights to be received | ' | ' | ' | ' | ' | 280,000 | ' | ' |
License and supply agreement potential future payment | ' | ' | ' | ' | ' | 12,500 | ' | ' |
Supply agreement maximum consideration payment | ' | ' | ' | ' | ' | 40,000 | ' | ' |
Revenue from sale of products | $3,500 | ' | ' | ' | ' | ' | ' | ' |
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 | 18,913,153 | 7,471,571 | ' | ' | ' | ' | ' | ' |
INVENTORIES_Schedule_of_Invent
INVENTORIES (Schedule of Inventory Components) (Details) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Dec. 31, 2013 |
INVENTORIES [Abstract] | ' | ' |
Raw materials | $2,076 | $2,342 |
Work in process | 170 | 92 |
Finished goods | 4,281 | 5,523 |
Total inventory | 6,527 | 7,957 |
Inventory write-down | $1,100 | ' |
STOCK_TRANSACTIONS_Details
STOCK TRANSACTIONS (Details) (USD $) | 3 Months Ended | |
In Thousands, except Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Class of Stock [Line Items] | ' | ' |
Cash proceeds from exercise of options | $31 | ' |
Certain Employee [Member] | ' | ' |
Class of Stock [Line Items] | ' | ' |
Exercise of options granted to employees (in shares) | 55,362 | ' |
Cash proceeds from exercise of options | $43 | ' |
Common stock issued in connection with exercise of options | 56,122 | ' |