TEL AVIV, Israel, September 12, 2012 /PRNewswire/ --
InspireMD, Inc. (OTC BB NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary embolic protection stent platform technology for use in patients with Acute Myocardial Infarctions, today announced financial results for the six months ended June 30, 2012.
As previously announced, the Company changed its fiscal year end to June 30. As a result, the six months ended June 30, 2012 represent a transition period, with the next fiscal year covering the period from July 1, 2012 through June 30, 2013
"Several key milestones were achieved during the six months ended June 30, 2012," said Ofir Paz, Co-founder and CEO of InspireMD. We completed enrollment in the nine-country, 433-patient MASTER trial ahead of schedule, raised $11 million with a convertible debt offering and strengthened senior management.
"Subsequently, on August 20, we received notice that the MASTER trial comparing the MGuard™ embolic prevention stent to commercially-approved bare metal or drug-eluting stents in heart attack patients undergoing primary percutaneous coronary intervention (PCI) demonstrated a positive outcome," he added. "This is a significant milestone for InspireMD. We are eagerly awaiting presentation of the study's findings at the Transcatheter Cardiovascular Therapeutics (TCT) meeting next month in Miami."
The MASTER (MGuard for Acute ST Elevation Reperfusion) trial is the first company-sponsored randomized clinical study of the MGuard™ embolic protection stent.
In eleven prior single arm studies and a 40-patient physician-sponsored randomized trial, the MGuard™ embolic protection stent showed effectiveness in restoring blood flow and reducing major adverse events following heart attack stenting.
About 3.2 million stenting procedures are expected to be performed worldwide this year, of which 850,000, or about 26 percent, will be for patients having heart attacks. Of the $5.9 billion global stent market, stents for heart attacks account for $1.7 billion, or nearly 30 percent, of the total.
Transition Period Financial Highlights
For the six-month transition period ended June 30, 2012, compared to the corresponding six month time period of 2011:
- Total revenues were $2.1 million, compared with approximately $2.7 million during the same period in 2011.
- The decrease in revenue year over year was mainly attributable to a first time shipment of approximately $1.2 million to the Company's distributor in India during the first three months of 2011. This was a large shipment used to launch MGuard[TM] in India -- no such single large sale occurred during the transition period in 2012.
- Shipments to other countries (excluding India) increased by approximately $0.7 million, or 56.5%, compared to the same period in 2011.
- Gross profit was $0.7 million, a decrease of 41.5% or approximately $0.5 million, from the same period in 2011.
- The gross margin decrease was driven by a reserve set forth for slow moving inventory in the amount of approximately $0.4 million. Approximately 89.7% of the decreased in gross margin is attributable to this reserve.
- Total operating expenses were $7.9 million compared to $4.5 million in the same period of 2011. This increase was mainly driven by increased share-based compensation of $1.3 million, additional R&D expenditures relating to the MASTER trial, the planned FDA trial and the carotid stent development expenses of $1.2 million, increased salary and related expenses of approximately $0.4 million due to operational expansion and other expenses of $0.5 million.
- Loss from operations was $7.2 million, compared to a loss from operations of $3.3 million in the same period in 2011.
- The net loss was $7.1 million, or $0.10 per weighted average share, compared to a net loss of $4.1 million in the same period of 2011.
- The Company ended the transition period with cash and cash equivalents of approximately $10.3 million, compared to $8.1 million in the same period in 2011.
June 30, 2012 Transition Period and Subsequent Achievements
--Enrollment in the 433-patient randomized MASTER trial, which is comparing the MGuard™ embolic prevention stent to conventional stents in heart attack patients in nine countries, was completed in May, one month ahead of schedule.
--On August 20, 2012, the Company announced that the MASTER trial demonstrated a positive outcome. Detailed results will be presented at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) meeting in Miami, FL (October 22-26, 2012).
--Positive results were reported from the first randomized trial of the MGuard™ embolic protection stent, a 40-patient physician-sponsored study in Chile. The MICAMI trial showed a significant improvement in microvascular reperfusion for MGuard™ vs. bare metal stents.
--Dr. James Barry, a former senior executive at Boston Scientific, joined the Company's Board of Directors, and Robert Ratini was appointed Vice President of Sales and Marketing, with responsibilities for global marketing strategies for the MGuard stent technology.
--The Company closed a private placement of senior secured convertible debentures that resulted in $11 million of net proceeds. The debentures were issued with a 6% original issuance discount, bear interest of 8 percent per annum (up to a maximum aggregate of 12% for the term of the debentures) and are convertible at any time into common stock at $1.75 per share.
--Three-year data from the extended follow-up of the 60-patient prospective MAGICAL trial was presented, showing statistically significant improvement in acute outcomes in heart attack patients when compared with traditional bare metal stents. Ninety percent of the patients achieved TIMI grade 3 flow, 73.3 percent achieved myocardial blush grade 3, and 61.4 percent achieved complete ST segment resolution.
CONSOLIDATED STATEMENTS OF OPERATIONS (1) (U.S. dollars in thousands, except per share data) Six months ended June 30, 2012 2011 Revenues $2,071 $2,726 Cost of Revenues 1,377 1,539 Gross Profit 694 1,187 Operating Expenses: Research and development 2,607 1,093 Selling and marketing 1,246 1,045 General and administrative 3,999 2,391 Total operating expenses 7,852 4,529 Loss from Operations -7,158 -3,342 Financial (income),expenses net -109 787 Loss before tax expenses -7,049 -4,129 Tax Expenses 32 20 Net Loss ($7,081) ($4,149) Net loss per share - basic and diluted ($0.10) ($0.07) Weighted average number of shares of common stock used in computing net loss per share - basic and diluted 68,176,882 57,312,945 CONSOLIDATED BALANCE SHEETS (2) (U.S. dollars in thousands) June 30, December 31, ASSETS 2012 2011 Current Assets: Cash and cash equivalents $10,284 $5,094 Restricted cash 37 91 Accounts receivable: Trade 1,824 2,284 Other 264 118 Prepaid expenses 93 72 Inventory: On hand 1,744 2,061 On consignment 63 110 Total current assets 14,309 9,830 Property, plant and equipment, net of accumulated depreciation and amortization 462 420 Other non-current assets: Funds in respect of employees rights upon retirement 282 215 Deferred debt issuance costs 961 Total other non-current assets 1,243 215 Total assets $16,014 $10,465 June 30, December 31, LIABILITIES AND EQUITY 2012 2011 Current liabilities: Current maturities of long-term loans $- $94 Accounts payable and accruals: Trade 441 814 Other 2,925 2,217 Advanced payment from customers 174 316 Deferred revenues 10 Total current liabilities 3,550 3,441 Long-term liabilities: Liability for employees rights upon retirement 354 270 Convertible loans 5,018 Contingently redeemable warrants 1,706 Total long-term liabilities 7,078 270 Commitments and contingent liabilities - Total liabilities 10,628 3,711 Equity: Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 68,178,946 shares issued and outstanding at March 31, 2012 and December 31, 2011. 7 7 Additional paid-in capital 49,101 43,388 Accumulated deficit -43,722 -36,641 Total equity 5,386 6,754 Total liabilities and equity $16,014 $10,465 (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 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 audited financial statements, as disclosed in the Company's Annual Report on Form 10-K, filed with the Securities and Exchange Commission.
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 listed on the OTC BB under the ticker symbol "NSPR".
About MGuard™ Coronary Stent
MGuard™ 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™ is designed to provide outstanding and lifelong embolic protection, without affecting deliverability. MGuard™ is CE Mark approved.
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, including the Company's Annual Report on Form 10-K, 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.
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SOURCE InspireMD, Inc