|By PR Newswire||
|November 2, 2012 07:15 PM EDT||
TEL AVIV, Israel, November 2, 2012 /PRNewswire/ --
InspireMD, Inc. ("InspireMD" or the "Company") (OTC: NSPR) announced financial results for the period ended September 30, 2012, the first quarter of its 2013 fiscal year.
As previously indicated, revenue declined from the same period in 2011 due mainly to stocking and selling disruptions caused by a realignment of the Company's distributors in advance of the presentation of the MASTER trial of its MGuard™ Embolic Protective Stent (EPS) at the 24th Annual Transcathter Therapeutics (TCT) scientific meeting in Miami on October 24.
The positive results, presented at the TCT's Late Breaking Clinical Trials Session by Study Chairman Gregg W. Stone, MD, showed that the novel MGuard EPS provided a statistically and clinically significant acute advantage and, as a result, may hold the potential to lower the incidence of adverse sequela and prolong survival of heart attack victims.
MGuard EPS is CE Mark approved. It is not approved for sale in the U.S. by the Food and Drug Administration (FDA) at this time. The Company plans to initiate a FDA approval study on or before March 31, 2013.
Key financial highlights 1Q ended September 30, 2012 include:
--Revenue for the period ended September 30, 2012 totaled $509,000, compared to $1,986,000 in the same period in 2011, a decrease of $1,477,000, or 74.4 percent, due largely to anticipated disruptions in stocking and sales activities in the periods leading up to the TCT.
--Gross profit for the Sept. 30 2012 period was $279,000, compared to $1,185,000 for the Sept. 30, 2011 period, a decline of 76.5 percent.
--Total operating expenses for the Sept. 30, 2012 period were $3,560,000, compared to $3,335,000 in the Sept. 30, 2011 period. A $274,000 decrease in G&A in the Sept. 30, 2012 period was offset by a $399,000 increase in R&D (mainly to support the MASTER trial), and a slight increase in sales and marketing expense.
--The loss from operations for the Sept. 30, 2012 period was ($3,281,000), compared to ($2,150,000) for the Sept. 30, 2011 period.
--$4,225,000 in financial and tax expenses for the Sept. 30, 2012 period brought the final net loss to ($7,506,000), or ($0.11) per basic and diluted share. Financial and tax expenses for the Sept. 30, 2011 period were $133,000, bringing final net loss for the period to ($2,283,000), or ($0.04) per basic and diluted share.
--At September 30, 2012, cash and cash equivalents stood at approximately $8.3 million, compared to $10.3 million at June 30, 2012.
--The MASTER trial of MGuard EPS, presented on Oct. 24 at TCT, met its primary endpoint (proportion of patients with ST segment resolution of ≥ 70%, measured at 60 to 90 minutes post procedure), showing the MGuard EPS was significantly superior to the control arm of bare metal and drug eluting stents in the treatment of heart attack patients.
--During the past month, the Company instituted changes which it believes will strengthen relationships with its best distribution partners, and it is in the process of appointing new distributors in certain territories.
--Direct sales channels are being established in key European countries where end user average selling prices and the lack of strong distributors are limiting factors.
--Five experienced sales and marketing executives joined the Company last month to help bolster sales of MGuard EPS following the MASTER trial through third party distribution and direct sales channels.
About Stenting and MGuard EPS
Standard stents weren't engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.
In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.
The MGuard EPS is integrated with a precisely engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.
While offering superior performance relative to standard stents in STEMI patients, the MGuard EPS requires no change in current physician practice - an important factor in promoting acceptance and general use in time-critical emergency settings.
About InspireMD, Inc.
InspireMD is a medical device company focusing on the development and commercialization of its proprietary stent system technology, MGuard™. InspireMD intends to pursue applications of this technology in coronary, carotid and peripheral artery procedures. InspireMD's common stock is quoted on the OTC under the ticker symbol NSPR.
About MGuard™ Embolic Protection Coronary Stent
MGuard™ EPS combines a coronary stent merged with an embolic protection specifically designed for acute MI patients. The embolic protection is comprised of an ultra-thin polymer micron net that is integrated with the stent. The MGuard EPS is designedto provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard EPS is CE Mark approved. MGuard™ is not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.
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, multi-national companies, (v) product liability claims, (vi) our limited manufacturing capabilities and reliance on subcontractors for assistance, (vii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (viii) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (ix) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (x) our reliance on single suppliers for certain product components, (xi) 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 (xii) 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 Transition Report on From 10-K/T 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 September 30, 2012 2011 Revenues $509 $1,986 Cost of Revenues 230 801 Gross Profit 279 1,185 Operating Expenses: Research and development 946 547 Selling and marketing 402 302 General and administrative 2,212 2,486 Total operating expenses 3,560 3,335 Loss from Operations -3,281 -2,150 Financial (income),expenses net 4,218 108 Loss before tax expenses -7,499 -2,258 Tax Expenses 7 25 Net Loss ($7,506) ($2,283) Net loss per share - basic and diluted ($0.11) ($0.04) Weighted average number of shares of common stock used in computing net loss per share - basic and diluted 68,296,940 64,300,685
CONSOLIDATED BALANCE SHEETS [(2)] (U.S. dollars in thousands) June 30, June 30, ASSETS 2012 2012 Current Assets: Cash and cash equivalents $8,297 $10,284 Restricted cash 37 37 Accounts receivable: Trade 1,078 1,824 Other 408 264 Prepaid expenses 56 93 Inventory: On hand 2,076 1,744 On consignment 22 63 Total current assets 11,974 14,309 Property, plant and equipment, net of accumulated depreciation and amortization 463 462 Other non-current assets: Funds in respect of employees rights upon retirement 304 282 Deferred debt issuance costs 874 961 Total other non-current assets 1,178 1,243 Total assets $13,615 $16,014
September 30, June 30, LIABILITIES AND EQUITY 2012 2012 Current liabilities: Accounts payable and accruals: Trade $556 $441 Other 2,628 2,925 Advanced payment from customers 169 174 Deferred revenues 10 10 Total current liabilities 3,363 3,550 Long-term liabilities: Liability for employees rights upon retirement 394 354 Convertible loans 5,635 5,018 Contingently redeemable warrants 4,979 1,706 Total long-term liabilities 11,008 7,078 Total liabilities 14,371 10,628 Equity: Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 68,596,903 and 68,160,161 shares issued and outstanding at September 30, 2012 and June 30, 2012. 7 7 Additional paid-in capital 50,464 49,101 Accumulated deficit -51,227 -43,722 Total equity (capital deficiency) -756 5,386 Total liabilities and equity (capital deficiency) $13,615 $16,014 (1) All 2012 financial information is derived from the Company's 2012 unaudited financial statements and all 2011 financial information is derived from the Company's 2011 unaudited financial statements, as disclosed in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. (2) All September 30, 2012 financial information is derived from the Company's 2012 unaudited financial statements and all June 30, 2012 financial information is derived from the Company's 2012 audited financial statements, as disclosed in the Company's Transition Report on Form 10-KT, filed with the Securities and Exchange Commission.
For additional information:
SOURCE InspireMD, Inc.
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