Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 01, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
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 | |
Trading Symbol | PLX | |
Entity Common Stock, Shares Outstanding | 133,355,039 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 34,533 | $ 63,281 |
Accounts receivable - Trade | 3,005 | 693 |
Other assets | 4,081 | 2,321 |
Inventories | 7,059 | 5,245 |
Assets of discontinued operation | 213 | 327 |
Total current assets | 48,891 | 71,867 |
FUNDS IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT | 1,951 | 1,677 |
PROPERTY AND EQUIPMENT, NET | 8,158 | 8,703 |
Total assets | 59,000 | 82,247 |
Accounts payable and accruals: | ||
Trade | 7,852 | 4,007 |
Other | 9,339 | 7,496 |
Convertible notes | 53,872 | |
Deferred revenues | 1,925 | 837 |
Total current liabilities | 19,116 | 66,212 |
LONG TERM LIABILITIES: | ||
Convertible notes | 53,580 | 19,343 |
Liability for employee rights upon retirement | 2,671 | 2,348 |
Promissory note | 4,301 | 4,301 |
Total long term liabilities | 60,552 | 25,992 |
Total liabilities | 79,668 | 92,204 |
COMMITMENTS | ||
CAPITAL DEFICIENCY | ||
Total shareholders’ equity (capital deficiency) | (20,668) | (9,957) |
Total liabilities net of capital deficiency | $ 59,000 | $ 82,247 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | ||
REVENUES | $ 6,358 | $ 1,769 | $ 9,247 | $ 2,448 | |
COST OF REVENUES | (5,523) | (1,675) | (7,611) | (2,198) | |
GROSS PROFIT | 835 | 94 | 1,636 | 250 | |
RESEARCH AND DEVELOPMENT EXPENSES | [1] | (9,304) | (10,013) | (15,271) | (17,347) |
Less - grants | 478 | 2,194 | 1,816 | 3,503 | |
RESEARCH AND DEVELOPMENT EXPENSES, NET | (8,826) | (7,819) | (13,455) | (13,844) | |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | [1] | (2,814) | (2,206) | (5,351) | (4,201) |
OPERATING LOSS | (10,805) | (9,931) | (17,170) | (17,795) | |
FINANCIAL EXPENSES | (3,045) | (901) | (5,132) | (1,805) | |
FINANCIAL INCOME | 40 | 96 | 1,665 | 338 | |
(LOSS) INCOME FROM CHANGE IN FAIR VALUE OF CONVERTIBLE NOTES EMBEDDED DERIVATIVE | 14,260 | (38,061) | 0 | ||
FINANCIAL (EXPENSES) INCOME, NET | 11,255 | (805) | (41,528) | (1,467) | |
(LOSS) INCOME FROM CONTINUING OPERATIONS | 450 | (10,736) | (58,698) | (19,262) | |
LOSS FROM DISCONTINUED OPERATIONS | 0 | (117) | 0 | (189) | |
NET (LOSS) INCOME FOR THE PERIOD | $ 450 | $ (10,853) | $ (58,698) | $ (19,451) | |
NET (LOSS) EARNINGS PER SHARE OF COMMON STOCK - BASIC | |||||
(Loss) earnings from continuing operations | $ 0 | $ (0.11) | $ (0.47) | $ (0.20) | |
Earnings from discontinued operations | 0 | 0 | 0 | 0 | |
Net (loss) earnings per share of common stock | 0 | (0.11) | (0.47) | (0.20) | |
NET (LOSS) EARNINGS PER SHARE OF COMMON STOCK - DILUTED | |||||
Loss from continuing operations | (0.06) | (0.11) | (0.47) | (0.20) | |
Earnings from discontinued operations | 0 | 0 | 0 | 0 | |
Net loss per share of common stock | $ (0.06) | $ (0.11) | $ (0.47) | $ (0.20) | |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING (LOSS) INCOME PER SHARE - BASIC | 127,523,706 | 99,758,511 | 126,000,782 | 99,737,348 | |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING (LOSS) INCOME PER SHARE - DILUTED | 192,598,389 | 99,758,511 | 126,000,782 | 99,737,348 | |
[1] | Includes share-based compensation |
CONDENSED CONSOLIDATED STATEME4
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Research and Development Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 55 | $ 128 | $ 120 | $ 366 |
General and Administrative Expense [Member] | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation | $ 43 | $ 99 | $ 96 | $ 236 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | |
Balance at Dec. 31, 2015 | $ 10,873 | $ 100 | $ 194,064 | $ (183,291) | |
Balance (in shares) at Dec. 31, 2015 | [1] | 99,800,397 | |||
Share-based compensation related to stock options | 534 | 534 | |||
Share-based compensation related to restricted stock award | 68 | 68 | |||
Share-based compensation related to restricted stock award (in shares) | [1] | 7,843 | |||
Net loss from continuing operations | (19,262) | (19,262) | |||
Net loss from discontinued operations | (189) | (189) | |||
Balance at Jun. 30, 2016 | (7,976) | $ 100 | 194,666 | (202,742) | |
Balance (in shares) at Jun. 30, 2016 | [1] | 99,808,240 | |||
Balance at Dec. 31, 2016 | (9,957) | $ 124 | 202,575 | (212,656) | |
Balance (in shares) at Dec. 31, 2016 | [1] | 124,134,085 | |||
Share-based compensation related to stock options | 216 | 216 | |||
Convertible notes conversions | 4,137 | $ 5 | 4,132 | ||
Convertible notes conversions (in shares) | [1] | 4,948,821 | |||
Net loss from continuing operations | (58,698) | (58,698) | |||
Net loss from discontinued operations | 0 | ||||
Balance at Jun. 30, 2017 | $ (20,668) | $ 129 | $ 250,557 | $ (271,354) | |
Balance (in shares) at Jun. 30, 2017 | [1] | 129,082,906 | |||
[1] | Common Stock, $0.001 par value; Authorized as of June 30, 2017 - 250,000,000 shares and as of June 30, 2016 - 150,000,000 shares. |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (CAPITAL DEFICIENCY) [Parenthetical] - $ / shares | Jun. 30, 2017 | Jun. 30, 2016 |
Common stock, par value per share | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 250,000,000 | 150,000,000 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (58,698) | $ (19,451) |
Loss from discontinued operations | 0 | (189) |
Loss from continuing operations | (58,698) | (19,262) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Share based compensation | 216 | 602 |
Depreciation | 986 | 1,006 |
Financial (income) expenses, net (mainly exchange differences) | 56 | (167) |
Changes in accrued liability for employee rights upon retirement | 89 | 107 |
Gain on amounts funded in respect of employee rights upon retirement | (19) | (3) |
Gain on conversion of convertible notes | (739) | 0 |
Change in fair value of convertible notes embedded derivative | 38,061 | 0 |
Amortization of debt issuance costs and debt discount | 1,141 | 221 |
Issuance of shares for interest payment in connection with conversions of convertible notes | 634 | 0 |
Changes in operating assets and liabilities: | ||
(Decrease) increase in deferred revenues (including non-current portion) | 1,088 | (127) |
Increase in accounts receivable and other assets | (3,538) | (4,952) |
Increase in inventories | (1,814) | (300) |
Increase in accounts payable and accruals (including long term) | 5,378 | 1,273 |
Net cash used in continuing operations | (17,159) | (21,602) |
Net cash provided by discontinued operations | 114 | 285 |
Net cash used in operating activities | (17,045) | (21,317) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (543) | (575) |
Increase in restricted deposit | (343) | |
Amounts funded in respect of employee rights upon retirement, net | (83) | (84) |
Net cash used in investing activities | (969) | (659) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net payment for conversion of convertible notes | (10,961) | 0 |
Net cash used in financing activities | (10,961) | 0 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 227 | 228 |
NET DECREASE IN CASH AND CASH EQUIVALENTS | (28,748) | (21,748) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 63,281 | 76,374 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD | 34,533 | 54,626 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | ||
Purchase of property and equipment | 493 | 656 |
Convertible notes conversions | 3,503 | |
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS | ||
Interest paid | $ 2,330 | $ 1,553 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2017 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 SIGNIFICANT ACCOUNTING POLICIES General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”), and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® TM TM The Company’s product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder; (2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation; and (3) OPRX-106, the Company’s oral antiTNF product candidate which is being developed as an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein. Obtaining marketing approval with respect to any product candidate in any country is directly dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the “Amended Pfizer Agreement”) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 60 40 100 On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fiocruz, an arm of the Brazilian MoH, for taliglucerase alfa. Fiocruz’s purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 In December 2016, the Company received a letter from Fiocruz regarding an order from the Brazilian MoH to purchase alfataliglicerase to treat Gaucher patients in Brazil. The Brazilian MoH’s order consists of a number of shipments during 2017 for a total of approximately $ 24.3 Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing. Basis of presentation The 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, 2016, filed by the Company with the Commission. The comparative balance sheet at December 31, 2016 has been derived from the audited financial statements at that date. Net (loss) earnings per share Basic (loss) earnings per share (“LPS”) are computed by dividing net loss (income) by the weighted average number of shares of the Company’s common stock 0.001 Diluted loss per share is calculated by dividing the net income by the weighted-average number of shares of common stock outstanding during each period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive shares had been issued. Potentially dilutive shares include additional shares issuable upon the assumed conversion of the convertible notes (issued in September 2013 and December 2016). Six Months Ended Three Months Ended June 30, 2017 June 30, 2016 June 30, 2017 June 30, 2016 Net loss (income) for the period $ (58,698 ) $ (19,451 ) $ 450 $ (10,853 ) Financial income, net of convertible notes - - $ (11,847 ) - Loss used for the computation of diluted loss per share $ (58,698 ) $ (19,451 ) $ (11,397 ) $ (10,853 ) Weighted average shares of common stock outstanding for basic calculation 126,000,782 99,737,348 127,523,706 99,758,511 Weighted average dilutive effect of shares issuable upon conversion of convertible notes - - 65,066,683 - Weighted average dilutive effect of stock options - - 8,000 - Weighted average shares of common stock outstanding for diluted calculation 126,000,782 99,737,348 192,598,389 99,758,511 Diluted LPS is calculated in continuing operations. The calculation of diluted LPS does not include 19,617,149 74,087,411 19,586,488 because the effect would be anti-dilutive. The calculation of diluted LPS does not include 5,059,186 |
INVENTORIES
INVENTORIES | 6 Months Ended |
Jun. 30, 2017 | |
INVENTORIES [Abstract] | |
INVENTORIES | NOTE 2 INVENTORIES June 30, December 31, 2017 2016 (U.S. dollars in thousands) Raw materials $ 3,130 $ 2,591 Work in progress 444 395 Finished goods 3,485 2,259 Total inventory $ 7,059 $ 5,245 |
FAIR VALUE MEASUREMENT
FAIR VALUE MEASUREMENT | 6 Months Ended |
Jun. 30, 2017 | |
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 derivative is based on Level 3 measurement. As of June 30, 2017, the fair value of the remaining $ 14.9 51.9 11.5 75.1 |
DISCONTINUED OPERATIONS
DISCONTINUED OPERATIONS | 6 Months Ended |
Jun. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
DISCONTINUED OPERATIONS | NOTE 4 DISCONTINUED OPERATIONS June 30, 2017 December 31, 2016 (U.S. dollars in thousands) CURRENT ASSETS: Accounts receivable - Trade $ 213 $ 327 Total current assets of discontinued operations $ 213 $ 327 The following summarizes financial information related to the Company’s discontinued operations in the Company’s consolidated statements of operations for the six months ended June 30, 2017 and June 30, 2016: Six months ended June 30, 2017 2016 (U.S. dollars in thousands) REVENUES $ 209 COST OF REVENUES (373) GROSS PROFIT (164) SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (25) NET (LOSS) FOR THE PERIOD FROM DISCONTINUED $ (189) |
CONVERTIBLE NOTES
CONVERTIBLE NOTES | 6 Months Ended |
Jun. 30, 2017 | |
CONVERTIBLE NOTES [Abstract] | |
CONVERTIBLE NOTES | NOTE 5 CONVERTIBLE NOTES All of the Company’s outstanding convertible notes are accounted for using the guidance set forth in the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (ASC) 815 requiring that the Company determine whether the embedded conversion option must be separated and accounted for separately. ASC 470-20 regarding debt with conversion and other options requires the issuer of a convertible debt instrument that may be settled in cash upon conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer’s nonconvertible debt borrowing rate. The Company accounts for the 4.5% convertible notes as liability, on an aggregated basis, in their entirety. The conversion feature for the Company’s 7.5% convertible notes is accounted for as a derivative which is bifurcated from the debt host contract and is measured at fair value through the statement of operations. On April 12, 2017, the Company received approval from its stockholders to issue shares of the Company’s Common Stock in excess of 19.9% of the Company’s outstanding shares of Common Stock immediately prior to the closing of the issuance of the Company’s 7.5% convertible notes to settle conversion requests and pay interest on the Company’s issued 7.5% convertible notes. As a result, the Company reclassified the embedded derivative to equity. During the six months ended June 30, 2017 such measurement of the derivative resulted in a non-cash charge to the Company’s statement of operations of $ 38,061 thousand. The debt discount and debt issuance costs regarding the issuance of the Company’s outstanding 4.5% convertible notes due 2018 are deferred and amortized over the applicable convertible period ( 5 Issuance costs regarding the issuance of the Company’s 7.5 During the six months ended June 30, 2017, note holders converted approximately $ 10.8 4,948,821 11 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | NOTE 6 SUBSEQUENT EVENTS On July 24, 2017, the Company entered into a note purchase agreement with certain institutional investors relating to the private issuance and sale by the Company of $ 10 7.5 Concurrently with the consummation of the purchase described above, the Company entered into a privately negotiated exchange agreement with certain of its existing note holders holding the Company’s 4.5% convertible note due 2018 to exchange $ 9 4.5 8.55 4.5 Interest payments on both the 4.5% senior convertible notes due 2022 and 7.5% convertible notes due 2021 are payable on a semiannual basis, and the initial conversion rate for the both sets of notes is approximately 1,176 1,000 0.85 |
SIGNIFICANT ACCOUNTING POLICI14
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
General | General Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”), and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx ® TM TM The Company’s product pipeline currently includes, among other candidates: (1) PRX-102, or alpha-GAL-A, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder; (2) PRX-110, a proprietary plant cell recombinant human Deoxyribonuclease 1, or DNase, under development for the treatment of cystic fibrosis, to be administered by inhalation; and (3) OPRX-106, the Company’s oral antiTNF product candidate which is being developed as an orally-delivered anti-inflammatory treatment using plant cells as a natural capsule for the expressed protein. Obtaining marketing approval with respect to any product candidate in any country is directly dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities. Since its approval by the FDA, taliglucerase alfa has been marketed mainly in the United States by Pfizer as provided in the exclusive license and supply agreement by and between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, the Company entered into an Amended and Restated Exclusive License and Supply Agreement (the “Amended Pfizer Agreement”) which amends and restates the Pfizer Agreement in its entirety. Pursuant to the Amended Pfizer Agreement, the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso in exchange for a cash payment equal to $ 36.0 60 40 100 On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fiocruz, an arm of the Brazilian MoH, for taliglucerase alfa. Fiocruz’s purchases of Uplyso to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the low purchase amounts, the Company is, at this time, continuing to supply Uplyso to Fiocruz under the Brazil Agreement, and patients continue to be treated with Uplyso in Brazil. Approximately 10 In December 2016, the Company received a letter from Fiocruz regarding an order from the Brazilian MoH to purchase alfataliglicerase to treat Gaucher patients in Brazil. The Brazilian MoH’s order consists of a number of shipments during 2017 for a total of approximately $ 24.3 Based on its current cash resources and commitments, the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures for at least 12 months, although no assurance can be given that it will not need additional funds prior to such time. If there are unexpected increases in general and administrative expenses or research and development expenses, the Company may need to seek additional financing. |
Basis of presentation | Basis of presentation The 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, 2016, filed by the Company with the Commission. The comparative balance sheet at December 31, 2016 has been derived from the audited financial statements at that date. |
Net (loss) earnings per share | Net (loss) earnings per share Basic (loss) earnings per share (“LPS”) are computed by dividing net loss (income) by the weighted average number of shares of the Company’s common stock 0.001 Diluted loss per share is calculated by dividing the net income by the weighted-average number of shares of common stock outstanding during each period increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive shares had been issued. Potentially dilutive shares include additional shares issuable upon the assumed conversion of the convertible notes (issued in September 2013 and December 2016). Six Months Ended Three Months Ended June 30, 2017 June 30, 2016 June 30, 2017 June 30, 2016 Net loss (income) for the period $ (58,698 ) $ (19,451 ) $ 450 $ (10,853 ) Financial income, net of convertible notes - - $ (11,847 ) - Loss used for the computation of diluted loss per share $ (58,698 ) $ (19,451 ) $ (11,397 ) $ (10,853 ) Weighted average shares of common stock outstanding for basic calculation 126,000,782 99,737,348 127,523,706 99,758,511 Weighted average dilutive effect of shares issuable upon conversion of convertible notes - - 65,066,683 - Weighted average dilutive effect of stock options - - 8,000 - Weighted average shares of common stock outstanding for diluted calculation 126,000,782 99,737,348 192,598,389 99,758,511 Diluted LPS is calculated in continuing operations. The calculation of diluted LPS does not include 19,617,149 74,087,411 19,586,488 because the effect would be anti-dilutive. The calculation of diluted LPS does not include 5,059,186 |
SIGNIFICANT ACCOUNTING POLICI15
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |
Schedule of Net (loss) earnings per share | The loss and weighted average number of shares outstanding used to calculate (loss) earnings per share were as follows: Six Months Ended Three Months Ended June 30, 2017 June 30, 2016 June 30, 2017 June 30, 2016 Net loss (income) for the period $ (58,698 ) $ (19,451 ) $ 450 $ (10,853 ) Financial income, net of convertible notes - - $ (11,847 ) - Loss used for the computation of diluted loss per share $ (58,698 ) $ (19,451 ) $ (11,397 ) $ (10,853 ) Weighted average shares of common stock outstanding for basic calculation 126,000,782 99,737,348 127,523,706 99,758,511 Weighted average dilutive effect of shares issuable upon conversion of convertible notes - - 65,066,683 - Weighted average dilutive effect of stock options - - 8,000 - Weighted average shares of common stock outstanding for diluted calculation 126,000,782 99,737,348 192,598,389 99,758,511 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
INVENTORIES [Abstract] | |
Schedule of Inventory | Inventory at June 30, 2017 and December 31, 2016 consisted of the following: June 30, December 31, 2017 2016 (U.S. dollars in thousands) Raw materials $ 3,130 $ 2,591 Work in progress 444 395 Finished goods 3,485 2,259 Total inventory $ 7,059 $ 5,245 |
DISCONTINUED OPERATIONS (Tables
DISCONTINUED OPERATIONS (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Schedule of Discontinued Operations | June 30, 2017 December 31, 2016 (U.S. dollars in thousands) CURRENT ASSETS: Accounts receivable - Trade $ 213 $ 327 Total current assets of discontinued operations $ 213 $ 327 The following summarizes financial information related to the Company’s discontinued operations in the Company’s consolidated statements of operations for the six months ended June 30, 2017 and June 30, 2016: Six months ended June 30, 2017 2016 (U.S. dollars in thousands) REVENUES $ 209 COST OF REVENUES (373) GROSS PROFIT (164) SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (25) NET (LOSS) FOR THE PERIOD FROM DISCONTINUED $ (189) |
SIGNIFICANT ACCOUNTING POLICI18
SIGNIFICANT ACCOUNTING POLICIES (Net (loss) earnings per share) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Net loss (income) for the period | $ 450 | $ (10,853) | $ (58,698) | $ (19,451) |
Financial income, net of convertible notes | (11,847) | 0 | 0 | 0 |
Loss used for the computation of diluted loss per share | $ (11,397) | $ (10,853) | $ (58,698) | $ (19,451) |
Weighted average shares of common stock outstanding for basic calculation | 127,523,706 | 99,758,511 | 126,000,782 | 99,737,348 |
Weighted average dilutive effect of shares issuable upon conversion of convertible notes | 65,066,683 | 0 | 0 | 0 |
Weighted average dilutive effect of stock options | 8,000 | 0 | 0 | 0 |
Weighted average shares of common stock outstanding for diluted calculation | 192,598,389 | 99,758,511 | 126,000,782 | 99,737,348 |
SIGNIFICANT ACCOUNTING POLICI19
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Oct. 31, 2015 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2017 | |
Significant Accounting Policies [Line Items] | ||||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 5,059,186 | 19,586,488 | 74,087,411 | 19,617,149 | ||
Brazil [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Percentage of Adult Gaucher Patients Treated with Uplyso | 10.00% | |||||
Brazil Agreement [Member] | Scenario, Forecast [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Supply Commitment In Year 2017 | $ 24.3 | |||||
Pfizer Agreement [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Proceeds From Exchange For Rights To Royalties | $ 36 | |||||
Pfizer Agreement [Member] | Pfizer Incorporation [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Collaborative Arrangement Revenues and Expenses Sharing Percentage | 60.00% | |||||
Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Collaborative Arrangement Revenues and Expenses Sharing Percentage | 40.00% | |||||
Amended Pfizer Agreement [Member] | Protalix Bio Therapeutics Incorporation [Member] | Brazil [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Collaborative Arrangement Revenues and Expenses Sharing Percentage | 100.00% |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Raw materials | $ 3,130 | $ 2,591 |
Work in progress | 444 | 395 |
Finished goods | 3,485 | 2,259 |
Total inventory | $ 7,059 | $ 5,245 |
FAIR VALUE MEASUREMENT (Narrati
FAIR VALUE MEASUREMENT (Narrative) (Details) $ in Millions | Jun. 30, 2017USD ($) |
Four Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | $ 14.9 |
Seven Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | 51.9 |
Fair Value, Inputs, Level 3 [Member] | Four Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | 11.5 |
Fair Value, Inputs, Level 3 [Member] | Seven Point Five Percentage Convertible Notes [Member] | |
Convertible Debt, Fair Value Disclosures | $ 75.1 |
DISCONTINUED OPERATIONS (Balanc
DISCONTINUED OPERATIONS (Balance Sheets) (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
CURRENT ASSETS: | ||
Accounts receivable - Trade | $ 213 | $ 327 |
Total current assets of discontinued operations | $ 213 | $ 327 |
DISCONTINUED OPERATIONS (Operat
DISCONTINUED OPERATIONS (Operations) (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
REVENUES | $ 209 | |
COST OF REVENUES | (373) | |
GROSS PROFIT | (164) | |
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (25) | |
NET (LOSS) FOR THE PERIOD FROM DISCONTINUED OPERATIONS | $ (189) |
CONVERTIBLE NOTES (Narrative) (
CONVERTIBLE NOTES (Narrative) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | |
Repayments of Convertible Debt | $ 10,961 | $ 0 | |
Embedded Derivative, Gain (Loss) on Embedded Derivative, Net | $ 14,260 | $ (38,061) | $ 0 |
Seven Point Five Percentage Convertible Notes [Member] | |||
Debt Conversion, Converted Instrument, Shares Issued | 4,948,821 | ||
Debt Instrument, Interest Rate, Stated Percentage | 7.50% | 7.50% | |
Repayments of Convertible Debt | $ 11,000 | ||
Debt Conversion, Original Debt, Amount | $ 10,800 | ||
Four Point Five Percentage Convertible Notes [Member] | |||
Debt Instrument, Convertible, Conversion Period | 5 years |
SUBSEQUENT EVENTS (Narrative) (
SUBSEQUENT EVENTS (Narrative) (Details) - USD ($) | Jul. 24, 2017 | Jun. 30, 2017 |
Seven Point Five Percentage Convertible Notes [Member] | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 7.50% | |
Subsequent Event [Member] | Convertible Notes Payable [Member] | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Face Amount | $ 1,000 | |
Debt Instrument, Convertible, Conversion Price | $ 0.85 | |
Shares Issuable Upon Conversion | 1,176 | |
Subsequent Event [Member] | Seven Point Five Percentage Convertible Notes [Member] | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Face Amount | $ 10,000,000 | |
Debt Instrument, Interest Rate, Stated Percentage | 7.50% | |
Subsequent Event [Member] | Four Point Five Percentage Convertible Notes [Member] | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Face Amount | $ 9,000,000 | |
Debt Instrument, Interest Rate, Stated Percentage | 4.50% | |
Subsequent Event [Member] | Four Point Five Percentage Senior Convertible Notes [Member] | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Face Amount | $ 8,550,000 | |
Debt Instrument, Interest Rate, Stated Percentage | 4.50% |