Full Press Release Details
InspireMD Reports Financial Results for
the First Quarter Ended March 31, 2014
BOSTON, MA - May 7, 2014 - InspireMD, Inc.
(NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic protection systems ("EPS"),
today announced financial and operating results for the quarter ended March 31, 2014.
"As expected, overall revenue for
the quarter was relatively flat at $1.5 million compared to the same period last year. Importantly, countries with direct sales
reps reported an increase in revenue compared to the prior quarter and the majority of these territories outperformed the prior
year period, which is an encouraging early indicator that our strategy is working in these key markets," stated Alan Milinazzo,
Chief Executive Officer of InspireMD. "We also announced positive clinical results from the iMOS Prime Registry for the MGuard
Prime EPS, which reported complete ST-resolution in approximately 75% of cases, and a 2.2% MACE rate at 30 days, including zero
cases of mortality. This study enrolled 97 acute STEMI patients undergoing PCI from two sites in the Netherlands over the course
of approximately 15 months."
Mr. Milinazzo concluded, "Finally,
our recent decision to initiate a Voluntary Field Action has been communicated to all of our customers and we are in the process
of working through the regulatory approval processes which would allow us to begin shipping modified MGuard Primes back into the
marketplace and to restart enrollment in our MASTER II trial. This action underscores the Company's strong commitment to
quality and we feel confident the modified product will be well received once commercial and clinical activities resume."
Operational Overview
The Company continues to move forward with
the CARENET (CARotid Embolic protection using microNET) study, which is a multi-specialty
trial to evaluate the safety and efficacy of the CGuard EPS. The CGuard uses the Company's proprietary MicroNet technology
and is designed for the treatment of carotid lesions in order to protect patients from plaque debris, blood clots and reduce the
risk of stroke. Enrollment in the CARENET trial started ahead of schedule and the Company is on track to release initial results
of the trial in the third quarter of 2014.
InspireMD is in the process of conducting
pre-clinical studies for the viability of combining its proprietary MicroNet(TM) technology with several already CE Marked or FDA
approved drug eluting coronary stents. These tests are evaluating the safety and efficacy of the stent when it is combined with
the Company's MicroNet technology. This is an important phase in the development of the Company's next generation embolic
protection system and management is carefully evaluating opportunities in this area on an ongoing basis. The Company is currently
in negotiations with several stent manufacturers regarding next steps in the development of a combined product.
The Company recently became aware of reports
of stent dislodgements occurring in the MGuard Prime EPS, leading to the precautionary measure of initiating a VFA. Although there
were no reports of patients being harmed, management believed that proactively addressing the issue was important to uphold the
Company's standards of quality and safety. The Company believes that it has identified the root cause of these dislodgements
and, upon approval from the European regulatory agency, intends to modify all existing units of the MGuard Prime EPS in order to
improve stent retention and performance. InspireMD has notified its clinical and commercial partners worldwide of the VFA for the
MGuard Prime EPS and intends to modify all units in the field once regulatory approval is received.
As previously announced, the Company has
temporarily suspended enrollment in its MASTER II FDA trial pending a review by the FDA of the manufacturing improvements to the
MGuard Prime EPS. This is likely to delay enrollment in the trial for approximately 3 to 6 months. The Company intends to focus
on site activation activities during this review period in order to accelerate enrollment once the study resumes.
Quarter Ended March 31, 2014 Financial
Revenue for the quarter ended March 31,
2014 was relatively flat at $1.5 million compared to $1.5 million during the same period in 2013. The 2014 period included a decline
in sales volume associated with the move away from sales distributors as we transition towards direct sales channels, which was
mostly offset by new customer sales in the Middle East.
Gross profit for the quarter ended March
31, 2014 totaled $0.9 million, an increase of 2.0% or $17,000, compared to $0.8 million for same period in 2013. Gross margin for
the three months ended March 31, 2014 was 57.8%, an increase from 55.5% in the three months ended December 31, 2013. This increase
in gross profit was attributable to a decrease in cost of revenues that was partially offset by a write-off of slow moving inventory
of $52,000. If the non-recurring effects of the write-off of slow moving inventory in the three months ended March 31, 2014, are
removed, gross margin for the three months ended March 31, 2014 would have been 61.3%.
Total operating expenses for the quarter
ended March 31, 2014 were $6.4 million, an increase of 57.8% compared to $4.1 million for the same period in 2013. This was primarily
due to increased research and development expenses attributable to the MASTER II trial and expenditures in sales and marketing
as the Company increased its efforts to support the new sales strategies in key European countries.
The loss from operations for the quarter
ended March 31, 2014 was $5.5 million, an increase of 72.4% compared to a loss of $3.2 million for the same period in 2013.
Financial expenses for the three months
ended March 31, 2014 decreased 75.6%, or $1.3 million, to $0.4 million from $1.7 million during the same period in 2013. The decrease
in financial expenses resulted primarily from a decrease of $1.3 million of anti-dilution rights expense associated with the April
2013 fund raising of $25 million.
The net loss for the quarter ended March
31, 2014 totaled $6.0 million, or $0.18 per basic and diluted share, compared to a net loss of $4.9 million, or $0.27 per basic
and diluted share, in the same period in 2013.
Non-GAAP net loss for the quarter ended
March 31, 2014 was $4.9 million, or $0.15 per basic and diluted share, an increase of 132.1% compared to a non-GAAP net loss of
$2.1 million, or $0.12 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the quarter ended March
31, 2014 primarily excludes $1.0 million of share-based compensation. The non-GAAP net loss for quarter ended December 31, 2013
primarily excludes $1.5 million in non-cash financial expenses and $1.3 million in share-based compensation expenses. See "Use
of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Net Loss" below.
Cash and Cash Equivalents
As of March 31, 2014, cash and cash equivalents
were $13.7 million, compared to $17.5 million as of December 31, 2013.
Investor Conference Call
The Company will host a conference call
at 4:30 p.m. ET on Wednesday, May 7th to review its financial results and business outlook. Participants should call
(877) 407-0784 (United States) or (201) 689-8560 (International) and request the InspireMD call or provide confirmation code: 13581583.
A live webcast of the call will also be available on the Investor Relations section of the Company's website at www.inspire-md.com/site_en/for-investors.
Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.
An archive of the webcast will be available
approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company's
website at www.inspire-md.com/site_en/for-investors for a limited time. A dial-in replay of the call will also be available to
those interested until May 21st. To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International)
and enter code: 13581583.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MGuard(TM) with MicroNet(TM)
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(TM)) and peripheral artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the
Use of Non-GAAP Financial Measures
To supplement the Company's consolidated
financial statements presented on a GAAP basis, the Company discloses a non-GAAP measure as non-GAAP net loss because management
uses this supplemental non-GAAP financial measure to evaluate performance period over period, to analyze the underlying trends
in its business, and to establish operational goals and forecasts that are used in allocating resources. In addition, the Company
believes many investors use this non-GAAP measure to monitor the Company's performance. This non-GAAP measure should not
be considered as an alternative to GAAP measures as an indicator of the Company's operating performance.
Non-GAAP net loss is defined by the Company