BOSTON, MA -- (Marketwired) -- 03/31/16 -- 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.
CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data)
Three months ended Twelve months ended
December 31, December 31,
-------------------------- --------------------------
2015 2014 2015 2014
------------ ------------ ------------ ------------
Revenues $ 516 $ 870 $ 2,310 $ 2,818
Cost of revenues 652 476 2,606 2,034
------------ ------------ ------------ ------------
Gross Profit (Loss) (136) 394 (296) 784
------------ ------------ ------------ ------------
Operating Expenses:
Research and
development 762 1,525 3,642 8,744
Selling and
marketing 578 1,583 3,178 6,613
General and
administrative 1,117 1,733 6,387 9,125
Restructuring and
impairment 18 - 982 -
------------ ------------ ------------ ------------
Total operating
expenses 2,475 4,841 14,189 24,482
------------ ------------ ------------ ------------
Loss from operations (2,611) (4,447) (14,485) (23,698)
Financial expenses 240 334 1,096 1,385
------------ ------------ ------------ ------------
Loss before tax
expenses (2,851) (4,781) (15,581) (25,083)
Tax expenses
(Income) 3 9 4 12
------------ ------------ ------------ ------------
Net Loss $ (2,854) $ (4,790) $ (15,585) $ (25,095)
============ ============ ============ ============
Net loss per share -
basic and diluted $ (0.37) $ (1.19) $ (2.23) $ (7.09)
============ ============ ============ ============
Weighted average
number of shares of
common stock used
in computing net
loss per share -
basic and diluted 7,638,988 4,015,295 6,976,378 3,539,364
============ ============ ============ ============
RECONCILIATION OF NON-GAAP NET LOSS (2)
(U.S. dollars in thousands, except per share data)
Three months ended Twelve months ended
December 31, December 31,
-------------------------- --------------------------
2015 2014 2015 2014
------------ ------------ ------------ ------------
GAAP Net Loss $ (2,854) $ (4,790) $ (15,585) $ (25,095)
------------ ------------ ------------ ------------
Non-GAAP
Adjustments:
Share-based
compensation
expenses 507 987 3,107 4,138
Impairment of
royalties buyout - - 576 -
Royalties buyout
expenses and
amortization 9 40 89 100
Non-cash financial
expenses
(income)(3) - - - (47)
Total Non-GAAP
Adjustments 516 1,027 3,772 4,191
------------ ------------ ------------ ------------
Non-GAAP Net Loss $ (2,338) $ (3,763) $ (11,813) $ (20,904)
============ ============ ============ ============
Non-GAAP net loss
per share - basic
and diluted $ (0.31) $ (0.94) $ (1.69) $ (5.91)
Weighted average
number of shares of
common stock used
in computing net
loss per share -
basic and diluted 7,638,988 4,015,295 6,976,378 3,539,364
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CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)
ASSETS December 31, December 31,
2015 2014
------------- -------------
Current Assets:
Cash and cash equivalents $ 3,257 $ 6,300
Accounts receivable:
Trade, net 405 635
Other 142 359
Prepaid expenses 75 150
Inventory 753 1,924
------------- -------------
Total current assets 4,632 9,368
------------- -------------
Non-current assets:
Property, plant and equipment, net 472 622
Deferred issuance costs 85 153
Funds in respect of employee rights upon
retirement 502 498
Long term prepaid expenses 66
Royalties buyout 87 752
------------- -------------
Total non-current assets 1,146 2,091
------------- -------------
Total assets $ 5,778 $ 11,459
============= =============
LIABILITIES (NET OF CAPITAL DEFICIENCY) December 31, December 31,
2015 2014
------------- -------------
Current liabilities:
Accounts payable and accruals:
Trade $ 512 $ 909
Other 2,006 3,576
Advanced payment from customers 167 179
Current maturity of loan 4,234 3,809
------------- -------------
Total current liabilities 6,919 8,473
------------- -------------
Long-term liabilities:
Liability for employees rights upon retirement 706 687
Long -term loan 1,099 5,086
------------- -------------
Total long-term liabilities 1,805 5,773
------------- -------------
Total liabilities 8,724 14,246
------------- -------------
Equity:
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 1
Additional paid-in capital 120,049 104,624
Accumulated deficit (122,996) (107,411)
------------- -------------
Total capital deficiency (2,946) (2,787)
------------- -------------
Total liabilities net of capital deficiency $ 5,778 $ 11,459
============= =============
(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.
(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.
(3) Non-cash financial income relates to the issuance of shares as a result
of the anti-dilution rights of our March 2011 investors.
(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.
Investor Contacts:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: (Skype) 1-888-776-6804 FREE
Email: craigs@inspiremd.com
PCG Advisory
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482
