Full Press Release Details
Reports Financial Results for the Second Quarter Ended
- Company to Host Conference Call Today at
MA - August 9, 2016 - InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) ("InspireMD" or the "Company"),
a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced financial
and operating results for the second quarter ended June 30, 2016, and provided a business update.
continue to see steady traction in sales of our CGUARD Embolic Prevention System, and are encouraged by the solid growth
in second quarter sales for this product versus the same quarter last year. Notably, sales in Italy, one of the first countries
in which we launched CGuard, grew more than 190% this quarter compared to the same quarter last year, and 20% compared to the
first quarter of 2016," said James Barry, PhD, Chief Executive Officer of InspireMD. "In addition, our Micronet technology
continues to gain recognition among industry experts, as evidenced by the selection of the investigator-initiated PARADIGM study
for presentation in the late-breaking clinical trial session at the EuroPCR 2016 Conference, highlighting the clinical efficacy
of routine use of the CGuard system, including use in high risk patients."
closing of our $14.6 million financing and recent debt restructuring provide us with the financial flexibility to advance the
commercialization of CGuard EPS and MGuard Prime EPS in key markets," Dr. Barry continued. "We also
continue to advance our robust product pipeline with the goal of utilizing our proprietary Micronet technology for other
indications, including the development of our NGuard Flow Diverter for an anticipated 2017 CE Mark submission."
| Sales growth of CGuard TM increased by 112% in the second quarter of 2016 versus same quarter last year. | |
| Continued strong sales growth of CGuard TM in Italy, which grew 194% compared to the second quarter of 2015, and 20% compared to the first quarter of 2016. |
/ CLINICAL / PRODUCT DEVELOPMENT
| Closing of a $14.6 million public offering of approximately 442,424 shares of Series B Convertible preferred stock and warrants to purchase up to 44,242,400 shares of common stock. | |
| Restructuring of an outstanding loan with Hercules Capital, including four principal payment deferrals which began May 1st, 2016. |
Quarter 2016 Financial Results
for the second quarter ended June 30, 2016 was $0.5 million compared to $0.7 million during the same period in 2015. The decrease
was primarily the result of an expected decline in sales of MGuard Prime EPS associated with the trend of doctors increasingly
using drug eluting stents rather than bare metal stents in STEMI patients. This decrease was partially offset by an increase in
sales of $0.2 million of CGuard EPS, the Company's carotid product.
Company's gross profit for the quarter ended June 30, 2016 was $62,000 compared to a gross loss of $0.2 million for the
same period in 2015. The increase in gross profit was largely attributable to a decrease of write-offs of MGuard Prime
EPS inventory and a decrease in labor and material costs attributable to lower revenues, offset by a decrease in product revenues.
operating expenses for the quarter ended June 30, 2016 were $1.9 million, a decrease of 44.6% compared to $3.4 million for the
same period in 2015. This decrease was primarily due to a reduction of compensation related expenses and other savings associated
with our ongoing cost reduction plan.
loss from operations for the quarter ended June 30, 2016 was $1.8 million, a decrease of 49.6% compared to a loss of $3.6 million
for the same period in 2015.
expenses for the quarter ended June 30, 2016 were $0.2 million, a decrease of 44.1% compared to the same period in 2015. This
decrease was primarily due to a reduction in interest expense of our outstanding loan.
net loss for the quarter ended June 30, 2016 totaled $2.0 million, or $0.19 per basic and diluted share, compared to a net loss
of $3.9 million, or $0.51 per basic and diluted share, in the same period in 2015.
net loss for the quarter ended June 30, 2016 was $1.7 million, or $0.16 per basic and diluted share, a decrease of 41.6% compared
to a non-GAAP net loss of $2.9 million, or $0.38 per basic and diluted share, for the same period in 2015. The non-GAAP net loss
for the quarter ended June 30, 2016 primarily excludes $0.3 million of share-based compensation. The non-GAAP net loss for the
quarter ended June 30, 2015 primarily excludes $1.0 million of share-based compensation.
Months Ended June 30, 2016 Financial Results
for the six months ended June 30, 2016 was $1.1 million compared to $1.2 million during the same period in 2015. The decrease
was predominantly driven by an expected decline in sales of MGuard Prime EPS associated with the trend of doctors increasingly
using drug eluting stents rather than bare metal stents in STEMI patients.
Company's gross profit for the six months ended June 30, 2016 was $0.1 million compared to a gross loss of $0.3 million
for the same period in 2015. This increase in gross profit was largely attributable to a decrease of write-offs of MGuard
Prime EPS inventory, offset by expenses related to the underutilization of our manufacturing resources.
operating expenses for the six months ended June 30, 2016 were $4.3 million, a decrease of 47.5% compared to $8.2 million for
the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, restructuring and impairment
costs and other savings associated with our ongoing cost reduction plan.
loss from operations for the six months ended June 30, 2016 was $4.2 million, a decrease of 50.5% compared to a loss of $8.5 million
for the same period in 2015.
expenses for the six months ended June 30, 2016 were $0.4 million, a decrease of 36.1% compared to the same period in 2015. This
decrease was primarily due to a reduction in interest expense of our outstanding loan.
net loss for the six months ended June 30, 2016 totaled $4.6 million, or $0.49 per basic and diluted share, compared to a net
loss of $9.1 million, or $1.44 per basic and diluted share, in the same period in 2015.
net loss for the six months ended June 30, 2016 was $3.5 million, or $0.38 per basic and diluted share, a decrease of 47.3% compared
to a non-GAAP net loss of $6.7 million, or $1.07 per basic and diluted share, for the same period in 2015. The non-GAAP net loss
for the six months ended June 30, 2016 primarily excludes $1.0 million of share-based compensation. The non-GAAP net loss for
the six months ended June 30, 2015 primarily excludes $2.0 million of share-based compensation and $0.3 million of expense related
to an impairment of a royalties buyout asset.
and Cash Equivalents
of June 30, 2016, cash and cash equivalents were $0.9 million, compared to $3.3 million as of December 31, 2015. This amount does
not include the net proceeds from the Company's public offering which closed on July 7, 2016. The aggregate net proceeds
to InspireMD from the financing were $13.0 million.
company has scheduled a conference call to discuss second quarter 2016 financial results for today at 4:30 PM Eastern. To participate
in the conference call, please dial 866-652-5200 (United States) or 412-317-6060 (International) and request the InspireMD call.
A live webcast will be available in the Investor Relations section of the Company's website or by clicking here.
Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.
archive of the webcast will be available approximately two hours following the call and will be accessible in the Investor Relations
section of the Company's website or by clicking here. A dial-in replay of the call will also be available to those
interested until August 23, 2016.
seeks to utilize its proprietary MicroNetTM 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.
intends to pursue applications of this MicroNet technology in coronary, carotid (CGuardTM), neurovascular, and peripheral
artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants
are quoted on the NYSE MKT under the ticker symbol NSPR.WS.
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,