Full Press Release Details
Announces Third Quarter 2019 Financial Results
revenue driven by record orders of CGuard EPS
to host investor conference call today, November 12, at 8:30am ET
Aviv, Israel- November 12, 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 financial
and operating results for the third quarter ended September 30, 2019.
Quarter 2019 and recent highlights:
| Generated revenue of $939,000, up 22.1% over the third quarter 2018, driven largely by record orders of CGuard EPS | ||
| CGuard EPS revenue of $852,000, up 41.1% over the third quarter 2018 | ||
| Announced the receipt of two new U.S. patents (No. 10,406,006 and No. 10,406,008) covering the company's proprietary single fiber mesh technology, known as MicroNet TM | ||
| Raised gross proceeds of $5 million through an underwritten public offering | ||
| Continued to engage the FDA in productive discussions and is working methodically to provide the additional information and testing requested by the FDA for the company's IDE application |
were pleased with our third quarter financial and operating results, typically a seasonally soft quarter, which were highlighted
by record orders of CGuard ," said James Barry, PhD, Chief Executive Officer of InspireMD. "We believe our educational
and outreach programs such as our Centers of Excellence and presentations at highly regarded medical meetings such as Joint Congress
of the World Heart Federation and the European Society of Cardiology are gaining traction among interventional cardiologists and,
more importantly, vascular surgeons who perform a majority of carotid procedures. This quarter's results also show the maturity
of our distribution network in our key territories. Looking forward, we continue to work with the FDA to address outstanding questions
regarding our IDE application, and we remain committed to initiating U.S. clinical trials to bring this game-changing technology
to the USA. I believe the third quarter was an inflection for our company, and we are working tirelessly to sustain this momentum."
the three months ended September 30, 2019, revenue increased by $170,000, or 22.1%, to $939,000, from $769,000 during the three
months ended September 30, 2018. This increase was predominantly driven by a 41.1% increase in sales volume of CGuard EPS from
$604,000 during the three months ended September 30, 2018, to $852,000 during the three months ended September 30, 2019, mainly
due to our continued focus on expanding existing markets such as Italy and Russia. This increase in sales of CGuard EPS was partially
offset by a 47.3% decrease in sales of MGuard Prime EPS from $165,000 during the three months ended September 30, 2018, to $87,000
during the three months ended September 30, 2019, largely driven by the move to drug-eluting stents rather than bare metal stents,
such as MGuard Prime EPS, in ST-Elevation Myocardial Infarction ("STEMI") patients.
company's gross profit for the quarter ended September 30, 2019 was $128,000, compared to a gross profit of $198,000 for
the same period in 2018. Gross margin decreased to 13.6% in the third quarter of 2019 from 25.7% for the same period in 2018.
This decrease in gross profit resulted from a $65,000 increase in write-offs predominantly driven by a non-recurring component
supply issue and a $11,000 decrease associated with the higher sales volume of CGuard EPS (as mentioned above), sold at a lower
average selling price for the three months ended September 30, 2019, compared to the average selling price of CGuard EPS for the
three months ended September 30, 2018. These decreases in gross profit were partially offset by a decrease of $6,000 in miscellaneous
operating expenses for the quarter ended September 30, 2019 were $2,125,000, a decrease of 2.4% compared to $2,177,000 for the
same period in 2018. This decrease was primarily due to a non-recurring marketing consulting expense associated with CGuard
expenses for the quarter ended September 30, 2019 were $73,000 compared to financial expenses of $32,000 for the same period in
2018. This increase in financial expenses of $41,000 was predominately due to changes in exchange rates. Net loss for the third
quarter of 2019 totaled $2,070,000 or $1.26 per basic and diluted share, compared to a net loss of $2,011,000, or $2.47 per basic
and diluted share, for the same period in 2018.
the nine months ended September 30, 2019, revenue decreased by $71,000, or 2.6%, to $2,708,000, from $2,779,000 during the nine
months ended September 30, 2018. This decrease was predominantly driven by a 28.8% decrease in sales volume of MGuard Prime EPS
from $511,000 during the nine months ended September 30, 2018, to $364,000 during the nine months ended September 30, 2019, largely
driven by the move to drug-eluting stents rather than bare metal stents, such as MGuard Prime EPS, in STEMI patients. This decrease
was offset by a 3.4% increase in sales volume of CGuard EPS from $2,268,000 during the nine months ended September 30, 2018, to
$2,344,000 during the nine months ended September 30, 2019. This increase was primarily due to our continued focus on expanding
existing markets such as Poland, Switzerland, India, Italy and Spain and expansion into new geographies such as Australia and
South Africa. The overall increase was offset across the board due to shipment delays in the three months ended March 31, 2019
associated with us changing sterilization companies and sales decreases in certain of our markets. The transition to our new sterilization
is now complete and we do not currently anticipate any future disruptions in fulfilling new orders and sales decreases in certain
Company's gross profit for the nine months ended September 30, 2019 was $497,000 compared to a gross profit of $768,000
for the same period in 2018. Gross margin decreased to 18.4% in the nine months ended September 30, 2019 from 27.6% in the same
period in 2018. This decrease in gross profit resulted from a $106,000 increase in write-offs predominantly driven by a non-recurring
component supply issue, a $92,000 decrease in revenues (as mentioned above), less the related material and labor costs, $69,000
of expenses related to upgrades made to our production facilities and $46,000 of expenses pertaining to annual and new employee
training of the production workers, offset by a decrease of $42,000 in miscellaneous expenses.
operating expenses for the nine months ended September 30, 2019 were $7,807,000, an increase of 26.5% compared to $6,173,000 for
the same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard EPS,
mainly related to IDE efforts in 2019 and due to a settlement payment made to a former service provider pursuant to a settlement
expenses for the nine months ended September 30, 2019, were $173,000 an increase of $551,000, or 145.8%, versus a gain of $378,000
for the nine months ended September 30, 2018. The increase in financial expenses primarily resulted from the $438,000 of financial
income related to the revaluation of the embedded derivative of the Series C Preferred Stock recorded during the nine months ended
September 30, 2018, which did not occur during the nine months ended in September 30, 2019, and an increase of $117,000 in financial
expenses related to changes in exchange rates. These increases in financial expenses were partially offset by a decrease of $4,000
in miscellaneous expenses during the nine months ended September 30, 2019. Net loss for the nine months ended September 30, 2019
totaled $7,483,000, or $5.79 per basic and diluted share, compared to a net loss of $5,027,000, or $16.24 per basic and diluted
share, for the same period in 2018.
of September 30, 2019, cash and cash equivalents were $7,154,000, compared to $9,384,000 at December 31, 2018.
Call and Webcast Details
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=135364.
The webcast will be archived on the Company's website.
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.
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.
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.
STATEMENTS OF OPERATIONS (1)
dollars in thousands, except per share data)
| Three months ended | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues | $ | 939 | $ | 769 | $ | 2,708 | $ | 2,779 | ||||||||
| Cost of revenues | 811 | 571 | 2,211 | 2,011 | ||||||||||||
| Gross Profit | 128 | 198 | 497 | 768 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 442 | 416 | 2,432 | 898 | ||||||||||||
| Selling and marketing | 537 | 605 | 1,791 | 1,677 | ||||||||||||
| General and administrative | 1,146 | 1,156 | 3,584 | 3,598 | ||||||||||||
| Total operating expenses | 2,125 | 2,177 | 7,807 | 6,173 | ||||||||||||
| Loss from operations | (1,997 | ) | (1,979 | ) | (7,310 | ) | (5,405 | ) | ||||||||
| Financial income (expenses) | (73 | ) | (32 | ) | (173 | ) | 378 | |||||||||
| Loss before tax expenses | (2,070 | ) | (2,011 | ) | (7,483 | ) | (5,027 | ) | ||||||||
| Tax expenses (Income) | - | - | - | - | ||||||||||||
| Net Loss | $ | (2,070 | ) | $ | (2,011 | ) | $ | (7,483 | ) | $ | (5,027 | ) | ||||
| Net loss per share - basic and diluted | $ | (1.26 | ) | $ | (2.47 | ) | $ | (5.79 | ) | $ | (16.24 | ) | ||||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 1,648,302 | 815,283 | 1,293,321 | 334,581 |
dollars in thousands)