2018 CGuardTM EPS annual sales increased 55% compared to 2017
On-Track to Submit U.S. IDE in Mid-2019
Company to Host Investor Conference Call at 8:00am ET
Tel Aviv, Israel— February 19, 2019 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced results for the fourth quarter ending December 31, 2018.
Fourth Quarter 2018 and recent highlights:
“During the fourth quarter and subsequent period, we continued to build upon the mounting evidence demonstrating the numerous clinical advantages of CGuard™ EPS versus conventional carotid stents, with numerous presentations prominently featuring CGuard at two international vascular medicine conferences,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “These presentations complement our internal sales efforts and help drive awareness among cardiologists and vascular surgeons as to the use of CGuard as a safer treatment of carotid artery disease. Receiving regulatory approval in South Africa came as a direct result of treating physicians learning of CGuard at a medical conference and working proactively with local regulators and distributors to get access to the product for use in their own practices. We are gratified by this ‘pull-through’ demand that we are seeing and believe it speaks to physicians’ desire to offer safer, more durable and less-invasive treatment alternatives to their patients. We are awaiting reimbursement approval in South Africa, which we expect to receive shortly, and look forward to receiving such approval.”
Overall revenue for the fourth quarter ended December 31, 2018 was $822,000 compared to $833,000 during the same period in 2017. CGuard EPS sales increased by 16% or $95,000 compared to the sales made in the fourth quarter ended December 31, 2017, primarily due to our continued focus on expanding in existing markets such as Russia and Germany, expanding into new geographies such as India and our transition from our prior exclusive distribution partner for most of Europe to local distributors. Total sales for the fourth quarter ended December 31, 2018 compared to the fourth quarter ended December 31, 2017 declined due to a decrease in MGuard Prime™ EPS sales, driven largely by doctors predominantly using drug-eluting coronary stents rather than bare metal stents such as MGuard Prime EPS in patients with coronary artery disease. The Company’s gross profit for the quarter ended December 31, 2018 was $227,000 compared to $210,000 for the same period in 2017. Gross margin increased to 27.6% in the three months ended December 31, 2018 from 25.2% in the same period in 2017.
Total operating expenses for the quarter ended December 31, 2018 were $2,433,000, an increase of 46.6%, compared to $1,660,000 for the same period in 2017. This increase was primarily due to an increase in salary expenses, primarily due to a salary related accrual adjustment which reduced our salary expenses in 2017, and an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2018. Financial expenses for the quarter ended December 31, 2018 were $7,000 compared to $24,000 for the same period in 2017. Net loss for the quarter ended December 31, 2018 totaled $2,213,000, or $0.05 per basic and diluted share, compared to a net loss of $1,500,000, or $7.38 per basic and diluted share, for the same period in 2017.
Revenue for the twelve months ended December 31, 2018 was $3,601,000 compared to $2,761,000 for the same period in 2017. The increase was primarily due to an increase in sales of CGuard™ EPS as a result of our transition from our prior exclusive distribution partner for most of Europe to local distributors, continued focus on expanding existing markets such as Germany, Russia, Spain and Italy, and expansion into new geographies such as India. The Company’s gross profit for the twelve months ended December 31, 2018 was $995,000 compared to $585,000 for the same period in 2017. Gross margin increased to 27.6% in the twelve months ended December 31, 2018 from 21.2% in the same period in 2017, driven mainly by higher volume of sales and more efficient utilization of fixed manufacturing resources.
Total operating expenses for the twelve months ended December 31, 2018 were $8,606,000, a decrease of 2.4% compared to $8,817,000 for the same period in 2017. This decrease was primarily due to a decrease in share-based compensation expenses and a decrease in salary expenses, primarily due to a salary related accrual in 2017. These decreases were partially offset by an increase in in quality assurance and regulatory expenses related to annual audit activities which included validation reviews required every two years and an increase in clinical expenses associated with CGuard™ EPS that we cited earlier. Financial income for the twelve months ended December 31, 2018 was $371,000 compared to $179,000 of financial expenses for the same period in 2017, largely due to non-cash income associated with preferred stock. Net loss for the twelve months ended December 31, 2018 totaled $7,240,000, or $0.33 per basic and diluted share, compared to a net loss of $8,438,000, or $34.98 per basic and diluted share, for the same period in 2017.
As of December 31, 2018, cash and cash equivalents were $9,384,000, compared to $3,710,000 as of December 31, 2017.
Conference Call and Webcast Details
The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=133118
A webcast will also be archived on the Company’s website and a telephone replay of the call will be available approximately one hour following the call for approximately two weeks, and can be accessed by dialing 844-512-2921 for U.S. callers or +1 412-317-6671 for international callers and entering conference ID: 13687159.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for Carotid Stenting by providing outstanding acute results and durable stroke free long-term outcomes.
InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.
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.
Chief Financial Officer
LifeSci Advisors, LLC