Full Press Release Details
Announces Fourth Quarter and Year-End 2019 Financial Results
CGuard EPS year-over-year revenue growth of 31%
to host investor conference call today, March 10, at 8:30am ET
Aviv, Israel- March 10, 2020 - 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 (CAD), today announced
financial and operating results for the fourth quarter and year ended December 31, 2019.
Quarter 2019 and recent highlights:
| Announced the appointment of leading medical devices executive Marvin Slosman as Chief Executive Officer | |
| Generated revenue of $1,013,000, representing growth of 23% over the fourth quarter 2018, driven by continued strong growth in sales of CGuard EPS | |
| Generated CGuard EPS revenue of $921,000, up 31% over the fourth quarter 2018 | |
| Chosen for the third consecutive year to demonstrate a successful live clinical case transmission featuring CGuard EPS at the Leipzig Interventional Course (LINC) 2020 that showcased CGuard's ease-of-use and exceptional patient safety features | |
| Presented updated data at the 2019 VEITH Symposium and LINC 2020 from the IRONGUARD 2 study, a physician initiated prospective multi-center and multi-specialty registry that enrolled more than 700 patients, which suggested that the use of the CGuard EPS in routine clinical practice is associated with no major periprocedural and 30-day neurologic complications | |
| Began exploring the potential broadening of the company's product portfolio with procedural protection devices based on its reverse flow technology | |
| Beginning to engage with French health authorities to gain reimbursement in France | |
| Advanced productive discussions with FDA and addressed requests related to the company's pending IDE application |
assumed the role of Chief Executive Officer of InspireMD because I believe the combination of the substantial amount of published
data confirming the safety and efficacy of CGuard, along with real world performance demonstrating the unique patient safety features
of the device and a growing appreciation of CAS, or carotid artery stenting, as a first line treatment for CAD, position CGuard
EPS and MicroNet to change the standard of care in this disease," said Marvin Slosman, Chief Executive Officer. "The
strong revenue growth that we reported in the fourth quarter was again driven by growing demand for CGuard in our key European
markets, and my discussions with our physician and distribution partners in the field confirm that we are realizing this success
by educating practitioners and creating awareness for the value of our platform."
are also executing on another of the pillars of our commercial focus which is compilation of multiple clinical registries designed
to capture relevant data to support additional indications for the CGuard EPS platform, which we believe are numerous and significant."
at key industry conferences such as VEITH and LINC, along with our strong relationships with key opinion leaders in the field,
are absolutely crucial to our long-term growth, and we are pleased to continue to play a significant role at these events, which
attract leading vascular surgeons and interventionalists from around the world. We believe these presentations serve as the foundation
of a multifaceted commercial growth strategy that we continue to drive in CE mark territories and Asia."
parallel with these efforts, we continue to work vigorously to address FDA's information and testing requests in support
of our pending IDE application, and the initiation of clinical testing in the all-important US market which is among our highest
corporate priorities."
the three months ended December 31, 2019, revenue increased by 23.2%, to $1,013,000, from $822,000 during the three months ended
December 31, 2018. This increase was predominantly driven by a 31.4% increase in sales volume of CGuard EPS from $701,000 during
the three months ended December 31, 2018, to $921,000 during the three months ended December 31, 2019, mainly due to our continued
focus on expanding existing markets. This increase in sales of CGuard EPS was partially offset by a 24.0% decrease in sales of
MGuard Prime EPS, largely driven by the general shift in preference to drug-eluting stents rather than bare metal stents, such
as MGuard Prime EPS, in ST-Elevation Myocardial Infarction ("STEMI") patients. The company's gross profit for
the quarter ended December 31, 2019 was $259,000, compared to a gross profit of $227,000 for the same period in 2018. This increase
in gross profit was primarily driven by a higher volume of sales of CGuard EPS less the related material and labor costs, offset
by an increase in write-offs predominantly driven by a non-recurring component supply issue of CGuard EPS. Gross margin decreased
to 25.6% in the fourth quarter of 2019 from 27.6% for the same period in 2018.
operating expenses for the quarter ended December 31, 2019 were $2,765,000, an increase of 13.6% compared to $2,433,000 for the
same period in 2018. This increase was primarily due to payments related to the separation agreement of $684,000 the company entered
into with its former chief executive officer, offset by a reduction of miscellaneous expenses of approximately $352,000 throughout
expenses for the quarter ended December 31, 2019 were $27,000 compared to financial expenses of $7,000 for the same period in
2018. This increase in financial expenses of $20,000 was predominately due to changes in exchange rates. Net loss for the fourth
quarter of 2019 totaled $2,557,000, or $0.57 per basic and diluted share, compared to a net loss of $2,213,000, or $2.64 per basic
and diluted share, for the same period in 2018.
the twelve months ended December 31, 2019, revenue increased by $120,000, or 3.3%, to $3,721,000, from $3,601,000 during the twelve
months ended December 31, 2018. This increase was predominantly driven by a 10.0% increase in sales volume of CGuard EPS from
$2,970,000 during the twelve months ended December 31, 2018, to $3,265,000 during the twelve months ended December 31, 2019, as
a result of our continued focus on expanding existing markets such as Poland, Switzerland, Italy, and Spain and expansion into
new geographies such as Australia and South Africa. This increase was offset by a 27.7% decrease in sales volume of MGuard Prime
EPS from $631,000 during the twelve months ended December 31, 2018, to $456,000 during the twelve months ended December 31, 2019.
In addition, the overall increase mentioned above was offset across the board by shipment delays in the three months ended March
31, 2019 associated with the company's decision to switch its third-party sterilizer. The transition to the new sterilization
company was completed in early April 2019, and the company does not currently anticipate any future disruptions in fulfilling
Company's gross profit for the twelve months ended December 31, 2019 was $756,000 compared to a gross profit of $995,000
for the same period in 2018. This decrease in gross profit resulted from a $142,000 increase in write-offs predominantly driven
by a non-recurring component supply issue of CGuard EPS and slow moving MGuard Prime EPS, $69,000 of expenses related to upgrades
made to our production facilities and $48,000 of expenses pertaining to annual and new employee training of production workers,
and offset by a reduction of $20,000 in miscellaneous expenses. Gross margin decreased to 20.3% in the twelve months ended December
31, 2019 from 27.6% in the same period in 2018.
operating expenses for the twelve months ended December 31, 2019 were $10,572,000, an increase of 22.8% compared to $8,606,000
for the same period in 2018. This increase was primarily due to an increase of $804,000 in clinical expenses associated with CGuard
EPS, mainly related to IDE efforts in 2019, payments related to the separation agreement of $684,000 the company entered into
with its former chief executive officer and a settlement payment of $354,000 made to a former service provider.
expenses for the twelve months ended December 31, 2019, were $200,000 as compared to financial income of $371,000 for the twelve
months ended December 31, 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 Convertible Preferred Stock recorded during the twelve months ended
December 31, 2018, which did not occur during the twelve months ended in December 31, 2019, and an increase of $144,000 in financial
expenses related to changes in exchange rates. These increases in financial expenses were partially offset by a decrease of $11,000
in miscellaneous expenses during the twelve months ended December 31, 2019. Net loss for the twelve months ended December 31,
2019 totaled $10,040,000, or $4.80 per basic and diluted share, compared to a net loss of $7,240,000, or $16.67 per basic and
diluted share, for the same period in 2018.
of December 31, 2019, cash and cash equivalents were $5,514,000, compared to $9,384,000 at December 31, 2018. Based on the Company's
current business plan, the Company believes its cash and cash equivalents as of December 31, 2019, will be sufficient to meet
its operating requirements until the end of May 2020. As disclosed in the Company's Annual Report on Form 10-K for the year
ended December 31, 2019, which was filed on March 9, 2020, with the Securities and Exchange Commission, the audited financial
statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting
firm. See further discussion in Note 1b to the Company's consolidated financial statements included in the Company's
Annual Report on Form 10-K. This announcement is made pursuant to NYSE American Company Guide Section 610(b), which requires public
announcement of the receipt of an audit opinion containing a going concern paragraph.
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 13699019. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=138070.
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, including the transition to the new European Medical Devices Regulation, (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