Full Press Release Details
Announces Third Quarter 2020 Financial Results
quarter 2020 revenue returns to pre-COVID-19 levels
to host investor conference call today, November 9, 2020 at 8:30 a.m. ET
Aviv, Israel- November 9, 2020 - InspireMD, Inc. (NYSE American: NSPR)("Inspire" or the "Company"),
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 third quarter ended September 30, 2020.
Quarter 2020 and recent highlights:
| The U.S. Food and Drug Administration (FDA) granted InspireMD approval of its Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard EPS. The company has begun to plan its pivotal study and has retained Dr. Christine Brennan, recognized expert in carotid artery disease, as a consultant during the planning process. | ||
| InspireMD added Dr. Gary Roubin to its Board of Directors. One of the most recognized interventional cardiologists in the world, Dr. Roubin's pioneering work in carotid stenting and embolic protection devices brings knowledge and experience that will be invaluable. During his tenure as Chief of Interventional Cardiology at The University of Alabama at Birmingham and later as Department Chairman and Chief of Service of the Lenox Hill Hospital Cardiac and Vascular program in New York, he helped bring both programs to international standing in peripheral, neurovascular, and cardiac interventions. Dr. Roubin's vast clinical experience has enabled him to recognize and advance technical innovations that improve patient outcomes. He played a pivotal role in the success of Mednova Inc., which was acquired by Abbott Vascular, resulting in the introduction and marketing in the U.S. of the top selling carotid embolic protection system (NAV6) and stent system (XACT). | ||
| The Company appointed Andrea Tommasoli as senior vice president of global sales and marketing. Andrea's leadership of our global sales and marketing effort is an investment in our customer and commercial focus and provides the essential leadership needed to elevate our growth and acceleration to standard of care with CGuard EPS. Andrea's experience in leading commercial teams, in particular, indirect channel partners, globally adds immediate value to our geographic expansion and higher performance in served markets. | ||
| InspireMD appointed Patrick Jamnik as vice president of business development and strategic initiatives. Patrick will oversee the Company's business development activities and play a key role in advancing our short and long-term strategic goals. |
Slosman, InspireMD's Chief Executive Officer commented, "Our third quarter financial results return us to our pre-COVID
revenue levels, and while we remain cautiously optimistic about the fourth quarter, new restrictions instituted to combat the
spread of COVID-19 may provide additional uncertainly in our markets. Nevertheless, our strategic pathway to growth for CGuard
EPS is robust, rooted in broadening market share in endovascular carotid artery stent procedures in our served markets, while
encouraging practitioners to make the shift from carotid endarterectomy to carotid stenting and launching our products in new
countries. We view carotid artery disease as the next significant vascular condition to shift toward an endovascular standard
of care, much the same way cerebral aneurysms, coronary artery disease, thoracic/abdominal aortic aneurysms, and peripheral artery
disease already have. Therefore, making the case for the value of expanded application of carotid stenting to the vascular surgeon
and INR (interventional neuroradiology) communities remains a top priority.
of our key goals is the initiation of our pivotal study in the United States, and we are buoyed by the addition of Dr. Gary Roubin
to our Board of Directors and Dr. Christine Brennan as a strategic advisor, both of whom will be instrumental in the development
and implementation of the trial. While it is important to continue to grow revenues in the markets we currently serve, we believe
our investments in the world's largest markets, including the United States, China and Japan, will pave a pathway to global
adoption of CGuard EPS.
to meet the needs of each physician specialty, our strategy includes developing a new advanced tool set of adjunctive delivery
system options including periprocedural embolic protection, specifically targeted for the vascular surgical community, all intended
to drive adoption of CGuard EPS. These advances represent additional significant revenue pathways for InspireMD, and we are excited
to broaden our portfolio and build on our growth and market adoption," concluded Mr. Slosman.
Results for the Third Quarter and Nine Months ended September 30, 2020
the three months ended September 30, 2020, revenue increased by $41,000, or 4.4%, to $980,000, from $939,000 during the three
months ended September 30, 2019. This increase was predominantly driven by a 69.0% increase in sales volume of MGuard EPS from
$87,000 during the three months ended September 30, 2019, to $147,000 during the three months ended September 30, 2020. This increase
was mainly due to the timing of shipments to one of the distributors for a tender recently won. This increase was offset, in part,
by a 2.2% decrease in sales volume of CGuard Prime EPS from $852,000 during the three months ended September 30, 2019, to $833,000
during the three months ended September 30, 2020, largely driven by procedures with CGuard EPS, which are generally scheduled
or non-emergency procedures, only beginning to return to normal levels towards the end of the quarter as hospitals began to re-shift
resources to non-COVID-19 patients.
the three months ended September 30, 2020, gross profit increased by 132.8%, or $170,000, to $298,000, from $128,000 during the
three months ended September 30, 2019. This increase in gross profit resulted from a $94,000 increase in revenues (as described
above), less the related material and labor costs, a $56,000 decrease in write-offs, which were driven by a component supply issue
during the three months ended September 30, 2019 and which did not reoccur during the three months ended September 30, 2020, and
a decrease of $20,000 in miscellaneous expenses during the three months ended September 30, 2020. Gross margin increased to 30.4%
during the three months ended September 30, 2020 from 13.6% during the three months ended September 30, 2019, driven by the factors
operating expenses for the quarter ended September 30, 2020 were $2,493,000, an increase of 17.3% compared to $2,125,000 for the
same period in 2019. This increase was primarily due to increases of $127,000 in compensation expenses, $116,000 in development
expenses associated with CGuard EPS, mainly related to the new advanced delivery system, $92,000 of Directors' and Officers'
Liability Insurance expense due to recent economic changes in the insurance industry, $71,000 in regulatory expenses associated
with compliance to new European Union standards, $60,000 mainly due to the timing of our annual shareholders meeting, and $79,000
of miscellaneous expense. These increases were partially offset by a decrease in travel expenses of $177,000 in light of restrictions
imposed by governments worldwide in order to mitigate the spread of COVID-19.
the three months ended September 30, 2020, financial expenses decreased by 47.9%, or $35,000, to $38,000, from $73,000 during
the three months ended September 30, 2019. The decrease in financial expenses primarily resulted from changes in exchange rates.
loss for the third quarter of 2020 totaled $2,233,000, or $0.06 per basic and diluted share, compared to a net loss of $2,070,000,
or $1.26 per basic and diluted share, for the same period in 2019.
the nine months ended September 30, 2020, revenue decreased by $381,000, or 14.1%, to $2,327,000, from $2,708,000 during the nine
months ended September 30, 2019. This decrease was predominantly driven by a 11.5% decrease in sales volume of CGuard EPS from
$2,344,000 during the nine months ended September 30, 2019, to $2,075,000 during the nine months ended September 30, 2020, mainly
due to the postponement of procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, as hospitals
shifted resources to patients affected by COVID-19. In addition, there was a 30.8% decrease in sales volume of MGuard Prime EPS
from $364,000 during the nine months ended September 30, 2019, to $252,000 during the nine months ended September 30, 2020, mainly
due to the impact of COVID-19, as mentioned above.
the nine months ended September 30, 2020, gross profit decreased by 4.8%, or $24,000, to $473,000, compared to a $497,000 for
the same period in 2019. This decrease in gross profit resulted from a $119,000 decrease in revenues (as mentioned above), less
the related material and labor costs. This decrease was partially offset by a decrease of $69,000 in expenses related to upgrades
made to our production facilities during the nine months ended September 30, 2019 that did not reoccur during the nine months
ended September 30, 2020 and a decrease of $26,000 in miscellaneous expenses during the nine months ended September 30, 2020.
Gross margin increased to 20.3% during the nine months ended September 30, 2020 from 18.4% during the nine months ended September
30, 2019, driven by the factors mentioned above.
operating expenses for the nine months ended September 30, 2020 were $7,135,000, a decrease of 8.6% compared to $7,807,000 for
the same period in 2019. This decrease was primarily due to a decrease of $708,000 in clinical expenses associated with CGuard
EPS, mainly related to the IDE approval process, for which an approval from the FDA was received on September 8, 2020, $354,000
due to settlement expenses that were paid to a former service provider pursuant to a settlement agreement during the nine months
ended September 30, 2019, $316,000 in travel expenses in light of restrictions imposed by governments worldwide in order to mitigate
the spread of COVID-19, $150,000 in quality assurance and regulatory expenses related to the development of various projects and
$91,000 in promotional expenses, primarily related to having already built our social media infrastructure in 2019. These decreases
were partially offset by an increase in expenses of $400,000 due to the settlement agreement with the underwriter of our prior
offerings paid during the nine months ended September 30, 2020, $280,000 in development expenses related to CGuard EPS new advanced
delivery system, $130,000 in regulatory expenses required for new regulatory standards set by the European Union, and $115,000
in our Directors' and Officers' Liability Insurance expenses, partially due to recent changes in the insurance industry,
and $22,000 of miscellaneous expenses.
expenses for the nine months ended September 30, 2020 was $29,000 compared to $173,000 for the same period in 2019. The decrease
in financial expenses primarily resulted from changes in exchange rates.
loss for the nine months ended September 30, 2020 totaled $6,691,000, or $0.38 per basic and diluted share, compared to a net
loss of $7,483,000, or $5.79 per basic and diluted share, for the same period in 2019.
of September 30, 2020, cash and cash equivalents were $10,882,000 compared to $5,514,000 as of December 31, 2019.
Call and Webcast Details
will host a conference call at 8:30AM ET today, November 9, 2020, to review financial results and provide an update on corporate
developments. Following management's formal remarks, there will be a question and answer session. Participants are asked
to pre-register for the call through the following link: https://dpregister.com/sreg/10149730/dc9d128e76.
note that registered participants will receive their dial in number upon registration and will dial directly into the call without
delay. Those without internet access or unable to pre-register may dial in by calling: 1-866-777-2509 (domestic) or 1-412-317-5413
(international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into
conference call will also be available through a live webcast found here: https://services.choruscall.com/links/nspr201109.html
it will be broadcast live through the Company's website via the following link: https://www.inspiremd.com/en/investors/investor-relations/.
webcast replay of the call will be available approximately one hour after the end of the call through February 9, 2021 at the
above links. A telephonic replay of the call will be available through November 23, 2020 and may be accessed by calling 1-877-344-7529
(domestic) or 1-412-317-0088 (international) and using access code 10149730.
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,"