Full Press Release Details
InspireMD Reports Financial Results for
the Third Quarter Ended September 30, 2015
BOSTON, MA - November 10,
2015 - InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"),
a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced its financial
and operating results for the third quarter ended September 30, 2015.
In its third full quarter of a strategic
transition into the carotid and neuro interventional markets utilizing its proprietary MicroNetTM technology, key activities
included the announced strategic distributor agreement with global interventional therapies company Penumbra, Inc., strengthened
intellectual property coverage, including the issuance of two US patents, and expanded regulatory footprint with CGuard approvals
for both Argentina and Colombia. In addition, InspireMD's development program for its neurovascular flow diverter platform
remains on track for pre-clinical results in December 2015 and CE Mark submission in 2H 2016. Broad collaboration discussions advanced
steadily facilitated by an external financial and strategic advisor engaged to assist in the review of various strategic alternatives.
Alan Milinazzo, CEO of InspireMD, commented,
"With 2015 being a transition year for InspireMD, we continue to execute on our strategic plan with clear focus and a sense
of urgency. We highlight progress made in recent months and look forward to sustainable growth in 2016. Feedback from the CGuardTM
launch remains positive, aided by both the CARENET and PARADIGM clinical data sets that have received prominent attention at major
clinical meetings this year. Recent approvals in Colombia and Argentina also allow us to bring this important technology to key
markets around the world as we balance investments in the business with disciplined cash management."
Mr. Milinazzo continued, "We are
pleased to note that our development efforts in the high value neurovascular field are tracking to expectations while we actively
advance discussions across indications that leverage our MicroNetTM technology. Finally, to ensure that we maximize
InspireMD shareholder value, we have engaged TM Asante Healthcare Partners as an outside strategic advisor to further our business
development activities."
Recent Operating Highlights:
REGULATORY / CLINICAL / PRODUCT DEVELOPMENT
Quarter Ended September 30, 2015 Financial
Revenue for the third quarter ended September
30, 2015 increased $0.3 million to $0.6 million compared to $0.3 million during the same period in 2014. The increase was predominately
driven by sales of $0.3 million of our new product CGuard EPS, our carotid product, which was launched in October 2014.
Sales of CGuard EPS during the three months ended September 30, 2015 were predominately driven by initial sales to our new
strategic distribution partner, Penumbra, Inc.
The company's gross profit for the quarter
ended September 30, 2015 was $0.1 million compared to a gross loss of $0.1 million for the same period in 2014. The improvement
of 217.1% was largely attributable to the increase in product revenues and a decrease of write-offs of inventory of MGuard
Prime EPS. These improvements in gross profit, however, were partially offset by an increase in labor and material costs attributable
Total operating expenses for the quarter
ended September 30, 2015 were $3.5 million, a decrease of 45.3% compared to $6.4 million for the same period in 2014. This decrease
was primarily due to a reduction of expenses related to MGuard Prime EPS's MASTER II trial, which was suspended in
October 2014, a decrease in compensation related expenses and other savings associated with our cost reduction plan.
The loss from operations for the quarter
ended September 30, 2015 was $3.4 million, a decrease of 47.4% compared to a loss of $6.5 million for the same period in 2014.
Financial expenses for the quarter ended
September 30, 2015 was $0.2 million, a decrease of 27.2% compared to the same period in 2014. This decrease was primarily due to
a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.
The net loss for the quarter ended September
30, 2015 totaled $3.6 million, or $0.48 per basic and diluted share, compared to a net loss of $6.8 million, or $1.96 per basic
and diluted share, in the same period in 2014.
net loss for the quarter ended September 30, 2015 was $2.8 million, or $0.36 per basic and diluted share, a decrease of 51.6% compared
to a non-GAAP net loss of $5.7 million, or $1.65 per basic and diluted share, for the same period in 2014. The non-GAAP net
loss for the quarter ended September 30, 2015 primarily excludes $0.6 million of share-based compensation and
$0.3 million of expense related to the impairment of the value of our royalties buyout option associated with MGuard Prime
EPS. The non-GAAP net loss for the quarter ended September 30, 2014 primarily excludes $1.1 million of share-based compensation.
Nine Months Ended September 30, 2015
Revenue for the nine months ended September
30, 2015 decreased $0.1 million to $1.8 million compared to $1.9 million during the same period in 2014. The 2015 period included
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 offset by sales of our new product CGuard EPS, which was launched in October 2014.
The sales of CGuard EPS during the nine months ended September 30, 2015 included initial sales to our new strategic distribution
partner, Penumbra, Inc. which commenced during the third quarter.
The company's gross loss for the nine months
ended September 30, 2015 was $0.2 million, a decrease of 141.0% compared to a gross profit of $0.4 million for the same period
in 2014. The decrease was largely attributable to an increase in labor and material costs attributable to higher costs for CGuard
EPS and write-offs of inventory due to the trend of increased usage of DES stents in STEMI patients, longer shelf life requirements
and the transition to the rapid exchange delivery system for CGuard from the over the wire platform.
Total operating expenses for the nine months
ended September 30, 2015 were $11.7 million, a decrease of 40.4% compared to $19.6 million for the same period in 2014. This decrease
was primarily due to a reduction of expenses related to MGuard's MASTER II trial, a decrease in compensation related expenses and
other savings associated with our cost reduction plan.
The loss from operations for the nine months
ended September 30, 2015 was $11.9 million, a decrease of 38.3% compared to a loss of $19.3 million for the same period in 2014.
Financial expenses for the nine months
ended September 30, 2015 decreased 18.6% to $0.9 million from $1.1 million during the same period in 2014. This decrease was primarily
due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.
The net loss for the nine months ended
September 30, 2015 totaled $12.7 million, or $1.89 per basic and diluted share, compared to a net loss of $20.3 million, or $5.93
per basic and diluted share, in the same period in 2014.
Non-GAAP net loss for the nine months ended
September 30, 2015 was $9.5 million, or $1.40 per basic and diluted share, a decrease of 44.7% compared to a non-GAAP net loss
of $17.1 million, or $5.00 per basic and diluted share, for the same period in 2014. The non-GAAP net loss for the nine months
ended September 30, 2015 primarily excludes $2.6 million of share-based compensation and $0.6 million of expense related to an
impairment of a royalties buyout asset. The non-GAAP net loss for the nine months ended September 30, 2014 primarily excludes $3.2
million of share-based compensation.
Cash and Cash Equivalents
As of September 30, 2015, cash and cash
equivalents were $6.5 million, compared to $6.3 million as of December 31, 2014.
Quarterly Conference Call Details
company has scheduled a conference call to discuss third quarter 2015 financial results for today at 8:30 AM Eastern. To participate
in the conference call, please dial (888) 243-4451 (United States) or (412)
542-4135 (International) and request the InspireMD call. A live webcast
of the call will also be available on the Investor Relations section of the Company's website at http://www.inspiremd.com/en/investors/investor-relations/.
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 two hours after completion of the live event and will be accessible on the Investor Relations section of the Company's
website at http://www.inspiremd.com/en/investors/investor-relations/ for a limited time. A dial-in replay of the call will also
be available to those interested until November 24, 2015. To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088
(International) and enter code: 10075630.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MGuard with MicroNetTM technology to make its products the industry standard for embolic protection and to provide