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InspireMD Reports Financial Results For Period Ended

Key Takeaway: InspireMD Reports Financial Results For Period Ended March 31, 2013 33% over prior year - milestones achieved - BOSTON and TEL AVIV, MAY 8, 2013 - InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader in embolic protection stents, today announced financi

Full Press Release Details

InspireMD Reports Financial Results
For Period Ended March 31, 2013
33% over prior year -
milestones achieved -
BOSTON and TEL AVIV, MAY 8, 2013
- InspireMD, Inc. ("InspireMD" or the "Company") (NYSE MKT: NSPR), a leader in embolic protection stents,
today announced financial results for the three month period ended March 31, 2013, the third quarter of its 2013 fiscal year.
Revenue for the period increased by 33%
over the March 31, 2012 quarter, reflecting the impact of several new marketing initiatives leveraging positive validation from
the MASTER I trial of the Company's MGuard Embolic Protection Stent (EPS ) published in the November 6, 2012
edition of the peer-reviewed Journal of American College of Cardiology (JACC), Vol. 60, No. 19. Authors of the study concluded
that, "among patients with acute STEMI (ST Segment Elevation Myocardial Infarction) undergoing
emergent PCI enrolled in the present multicenter, randomized, controlled trial, the MGuard Embolic Protection Stent (EPS) compared
to standard metallic stents resulted in superior rates of epicardial coronary flow and complete STR, with trends present toward
reduced microvascular obstruction, infarct size and mortality."
Alan Milinazzo, President and CEO of InspireMD,
said, "Since joining the Company on January 3rd, we have made significant progress in key strategic areas of the
business. In addition to a solid increase in quarterly revenues, we obtained the CE Mark for our carotid stent and we strengthened
our board and executive management team. Momentum continued in April as we re-capitalized the Company, uplisted to the NYSE MKT
and received regulatory approval to begin enrolling patients in our MASTER II clinical trial. These achievements represent a very
good start to 2013 and we expect to continue to deliver strong results on multiple fronts throughout the year."
Financial Highlights for the Quarter
Ended March 31, 2013
-Revenue for the quarter ended March
31, 2013 totaled $1.5 million, an increase of 33% over the $1.1 million recorded in the same period in 2012. The increase was the
result of improved selling activities in key European countries.
-Gross profit for the March 31, 2013
period increased 49% to $840,000, compared to $564,000 for the March 31, 2012 period. The increase was due to higher revenue and
gross margins, which increased from 50% to 55% due to a higher average selling price and lower cost per unit sold.
-Total operating expenses for the
March 31, 2013 period were $4.1 million, compared to $3.7 million in the March 31, 2012 period, an increase of $400,000. With enrollment
for the MASTER I trial completed, as well as a timing gap between the pre-clinical phase and the start of the recruitment phase
of the FDA trial, R&D expenses for the March 31, 2013 period decreased by approximately $500,000, or 33%, compared to the March
31, 2012 period. This decrease was offset by an 81% increase in sales and marketing expenses as we expanded our sales activities
worldwide, and a 23% increase in G&A expenses due mainly to an increase in share-based compensation and salary expenses.
-The loss from operations for the
March 31, 2013 period was $3.2 million, compared to $3.1 million for the March 31, 2012 period.
-The net loss for the period ended
March 31, 2013 totaled $4.9 million, or $0.27 per basic and diluted share, compared to a net loss of $3.1 million, or $0.18 per
basic and diluted share in the period ended March 31, 2012. The increased net loss for the quarter just ended resulted primarily
from a roughly $400,000 increase in operating expenses, and $1.7 million in financial expenses related to debenture amortization
costs and anti-dilution rights expenses. The weighted average number of shares of common stock used in computing net loss per share
(basic and diluted) was 18.2 million for the quarter ended March 31, 2013, and 17 million for the quarter ended March 31, 2012.
-At March 31, 2013, cash and cash
equivalents was approximately $2.5 million, compared to $10.3 million at June 30, 2012. On April 16, 2013, the Company completed
an underwritten public stock offering, providing net proceeds of approximately $22.6 million.
Key Activities; March 31, 2013 Period
Alan Milinazzo, a 15-year veteran of the
interventional cardiology industry, joined InspireMD on January 3rd as President, Chief Executive Officer and a member
of the board. Mr. Milinazzo was instrumental in the launch of ENDEAVOR, Medtronic, Inc.'s
first drug eluting stent platform which has since generated more than $1 billion in revenue. He previously spent 12 years in executive
positions at Boston Scientific Corporation, another major stent producer, serving as Vice President of Marketing at its $200 million
SCIMED European unit, responsible for product launches, clinical programs and regulatory strategies. Most recently he served as
President and Chief Executive Officer of Nasdaq-listed Orthofix International N.V., a position he was promoted to in 2006 after
being hired a year earlier as Chief Operating Officer. During his tenure at Orthofix, he transformed it into a category leader
in novel spine and orthopedic stem cell therapy. Total company revenue grew from $300 million to $580 million and profits nearly
Since joining InspireMD, he has been instrumental
in completing a $25 million equity raise, and in leading the creation of new sales, marketing and corporate strategies; goals and
programs intended to position the Company for near and long-term growth as a leader in the worldwide stent market.
-The Company continues to strengthen
its commercial activities with an expanded sales and marketing organization and new distributor relationships, in order to leverage
the MASTER I trial's initial outcomes, MGuard EPS product line expansions and new regulatory approvals.
-Michael Berman, a former Group President
and Executive Committee member of Boston Scientific, joined InspireMD's board of directors in February. Since leaving Boston
Scientific, he co-founded or was a founding director of seven medical technology companies, three of which sold for more than $350
million, plus $100 million in contingent payments.
-The Company received CE Mark approval
for its self-expanding Nitinol carotid EPS, further validating the MGuard MicroNet technology and strengthening its distributor
and partnership strategy in the near term.
-On April 16, the Company completed
an underwritten public offering of 12.5 million common shares, raising net proceeds of approximately $22.6 million. A portion of
the proceeds were used in connection with the retirement of the Company's outstanding debentures and the Company intends
to use the balance of the proceeds to support the worldwide commercialization of the MGuard EPS, to pursue FDA approval in the
U.S. of the MGuard EPS and for general corporate purposes. Concurrent with this funding, the Company's shares commenced trading
-On April 19, Gwen K. Bame joined
the Company as Vice President of Corporate Development, a new position created to strengthen the Company's focus on executing
strategic programs and partnerships designed to meet the Company's ambitious global growth objectives. Ms. Bame, who previously
held executive positions with Boston Scientific and Covidien, is expected to identify and negotiate in/out licensing agreements,
analyze strategic partnerships and structure joint ventures worldwide.
-On April 23, the Company announced
it received approval with conditions from the FDA to commence a pivotal trial in support of its IDE application. An approval with
conditions indicates the FDA concurs with the overall trial design and, while minor details are being finalized, it allows the
Company to initiate enrollment in the randomized MASTER II IDE trial of patients suffering from ST Elevation Myocardial Infraction
(STEMI). The principal investigators for the 1,114-patient trial, which will be conducted at 70 sites in the U.S. and Europe, will
be Gregg Stone, MD, of the Cardiovascular Research Foundation in New York and Jose P.S. Henriques, MD, of the Academic Medical
Center Amsterdam in The Netherlands.
InspireMD will host a symposium with key opinion leaders to
review six month follow up data from the Company's multi-center MASTER trial of the MGuard Embolic Protection Stent. The
meeting will take place at the EuroPCR meeting in Paris, France on Thursday, May 23rd at 12:00pm Paris time.
About Stenting and MGuard EPS
Standard stents were not engineered for
heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion
in a heart attack patient.
In acute heart attack patients, the plaque
or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal)
in a significant portion of heart attack patients.
The MGuard EPS is integrated with a precisely
engineered micro net mesh that prevents the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage
While offering superior performance relative
to standard stents in STEMI patients with regard to ST segment resolution, the MGuard EPS requires no change in current physician
Last updated: May 8, 2013