BOSTON, MA--(Marketwired - Mar 31, 2016) - InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2015, which was filed on March 28, 2016 with the Securities and Exchange Commission, the audited financial statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm. See further discussion in Note 1 to the Company's consolidated financial statements included in the Company's Annual Report on Form 10-K.
This announcement is made pursuant to NYSE MKT Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company's consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2015.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR.
Forward-looking Statements
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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CONSOLIDATED STATEMENTS OF OPERATIONS (1) |
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(U.S. dollars in thousands, except per share data) |
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Three months ended |
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Twelve months ended |
December 31, |
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December 31, |
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2015 |
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2014 |
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2015 |
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2014 |
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Revenues |
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$ |
516 | |
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$ |
870 |
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$ |
2,310 |
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$ |
2,818 |
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Cost of revenues |
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652 |
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476 |
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2,606 |
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2,034 |
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Gross Profit (Loss) |
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(136 |
) |
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394 |
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(296 |
) |
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784 |
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Operating Expenses: |
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Research and development |
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762 |
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1,525 |
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3,642 |
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8,744 |
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Selling and marketing |
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578 |
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1,583 |
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3,178 | |
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6,613 |
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General and administrative |
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1,117 |
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1,733 |
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6,387 |
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9,125 |
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Restructuring and impairment |
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18 |
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- |
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982 |
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- |
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Total operating expenses |
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2,475 |
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4,841 |
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14,189 |
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24,482 |
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Loss from operations |
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(2,611 |
) |
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(4,447 |
) |
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(14,485 |
) |
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(23,698 |
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Financial expenses |
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| 240 |
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334 |
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1,096 |
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1,385 |
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Loss before tax expenses |
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(2,851 |
) |
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(4,781 |
) |
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(15,581 |
) |
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(25,083 |
) |
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Tax expenses (Income) |
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3 |
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9 |
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4 |
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12 |
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Net Loss |
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$ |
(2,854 |
) |
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$ |
(4,790 |
) |
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$ |
(15,585 |
) |
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$ |
(25,095 |
) |
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| |
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Net loss per share - basic and diluted |
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$ |
(0.37 |
) |
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$ |
(1.19 |
) |
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$ |
(2.23 |
) |
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$ |
(7.09 |
) |
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Weighted average number of shares of common stock used in computing net loss per share - basic and diluted |
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7,638,988 |
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4,015,295 |
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6,976,378 |
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3,539,364 |
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RECONCILIATION OF NON-GAAP NET LOSS (2) |
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(U.S. dollars in thousands, except per share data) |
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Three months ended |
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Twelve months ended |
December 31, |
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December 31, |
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2015 |
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2014 |
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2015 |
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2014 |
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GAAP Net Loss |
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$ |
(2,854 |
) |
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$ |
(4,790 |
) |
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$ |
(15,585 |
) |
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$ |
(25,095 |
) |
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Non-GAAP Adjustments: |
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Share-based compensation expenses |
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507 |
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987 |
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3,107 |
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4,138 |
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Impairment of royalties buyout |
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- |
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- |
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576 |
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- |
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Royalties buyout expenses and amortization |
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9 |
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40 |
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89 |
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100 | |
Non-cash financial expenses (income)(3) |
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- |
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- |
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- |
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(47 |
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Total Non-GAAP Adjustments |
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516 |
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1,027 |
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3,772 |
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4,191 |
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Non-GAAP Net Loss |
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$ |
(2,338 |
) |
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$ |
(3,763 |
) |
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$ |
(11,813 |
) |
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$ |
(20,904 |
) |
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Non-GAAP net loss per share - basic and diluted |
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$ |
(0.31 |
) |
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$ |
(0.94 |
) |
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$ |
(1.69 |
) |
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$ |
(5.91 |
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Weighted average number of shares of common stock used in computing net loss per share - basic and diluted |
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7,638,988 |
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4,015,295 |
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6,976,378 |
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3,539,364 |
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CONSOLIDATED BALANCE SHEETS (4) |
(U.S. dollars in thousands) |
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ASSETS |
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December 31, |
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December 31, |
2015 |
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2014 |
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Current Assets: |
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Cash and cash equivalents |
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$ |
3,257 |
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$ |
6,300 |
Accounts receivable: |
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Trade, net |
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405 |
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635 |
Other |
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|
142 |
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359 |
Prepaid expenses |
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|
75 |
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|
150 |
Inventory |
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|
753 |
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1,924 |
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Total current assets |
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4,632 | |
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9,368 |
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Non-current assets: |
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Property, plant and equipment, net |
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472 |
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622 |
Deferred issuance costs |
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85 |
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153 |
Funds in respect of employee rights upon retirement |
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502 |
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498 |
Long term prepaid expenses |
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66 |
Royalties buyout |
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87 |
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752 |
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Total non-current assets |
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1,146 |
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2,091 |
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Total assets |
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$ |
5,778 |
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$ |
11,459 |
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LIABILITIES (NET OF CAPITAL DEFICIENCY) |
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December 31, |
|
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December 31, |
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2015 |
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2014 |
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Current liabilities: |
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Accounts payable and accruals: |
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Trade |
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$ |
512 |
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$ |
909 |
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Other |
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2,006 |
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|
3,576 |
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Advanced payment from customers |
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|
167 |
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|
179 |
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Current maturity of loan |
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4,234 |
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3,809 |
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Total current liabilities |
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6,919 |
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8,473 |
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Long-term liabilities: |
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Liability for employees rights upon retirement |
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|
706 |
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|
687 |
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Long -term loan |
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1,099 |
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5,086 |
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Total long-term liabilities |
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1,805 |
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| |
5,773 |
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Total liabilities |
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8,724 |
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14,246 |
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Equity: |
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Common stock, par value $0.0001 per share; 50,000,000 shares authorized; 7,676,074 and 4,136,890 shares issued and outstanding at December 31, 2015 and 2014, respectively |
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1 |
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Additional paid-in capital |
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120,049 |
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|
104,624 |
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Accumulated deficit |
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(122,996 |
) |
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(107,411 |
) |
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Total capital deficiency |
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(2,946 |
) |
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(2,787 |
) |
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Total liabilities net of capital deficiency |
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$ |
5,778 |
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$ |
11,459 |
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(1) All financial information for the twelve months ended December 31, 2015 is derived from the Company's 2015 audited financial statements and all financial information for the twelve months ended December 31, 2014 is derived from the Company's 2014 audited financial statements, as disclosed in the Company's Annual Report on Form 10-K, for the twelve months ended December 31, 2015 filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2015 and 2014 is derived from the Company's unaudited, internal financial statements. |
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(2) Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we are providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance. |
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(3) Non-cash financial income relates to the issuance of shares as a result of the anti-dilution rights of our March 2011 investors. |
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(4) All December 31, 2015 financial information is derived from the Company's 2015 audited financial statements and all December 31, 2014 financial information is derived from the Company's 2014 audited financial statements, as disclosed in the Company's Annual Report on Form 10-K, for the twelve months ended December 31, 2015 filed with the Securities and Exchange Commission. |
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