Full Press Release Details
Reports Fourth Quarter and Year-End 2021 Financial Results
CGuard Revenue Generated 87.5% growth over Q4'20 and 55.9% Year-over-Year -
Published CGuard Clinical trial results in Journals of the American College of Cardiology -
Established Reimbursement Approval for CGuard from the French National Authority -
CGuard Included as Carotid Stent Treatment Option in National Institute of Neurological
Disorders and Stroke (NINDS) Sponsored CREST-2
Approval of IDE Supplement Application -
to Host Investor Conference Call Today, March 8, at 8:30am ET
Aviv, Israel- March 8, 2022 - InspireMD, Inc. (Nasdaq: 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 fourth quarter and year ended December 31, 2021.
Quarter 2021 and Recent Highlights:
| CGuard revenues for the fourth quarter 2021 were $1,291,000 an 87.5% increase over the same period in 2020 and for the 12-month period ended December 31, 2021, CGuard revenues totaled $4,309,000 representing a year over year increase of 55.9%. | ||
| Appointed Katherine Arnold, to the Board of Directors and Dr. Adnan Siddiqui to the Scientific Advisory Board; each provide leadership and guidance to their respective boards with vast industry specific experience in the medical device market. | ||
| Accelerated enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial despite surging Omicron infection rates, staffing limitations and resource constraints at hospitals and healthcare systems across the United States. Under the leadership of Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee the trial has 12 sites actively enrolling or recruiting patients. | ||
| Gained approval and reimbursement coverage for CGuard EPS in France from the French National Authority for Health (HAS) and instituted a direct sales structure for commercial expansion, building on European market growth. | ||
| Published a randomized study (SIBERIA) in Journals of the American College of Cardiology (JACC), comparing InspireMD CGuard EPS to the Abbott Acculink , demonstrating CGuards's 4.5-fold superiority in clinical outcomes versus this first-generation open cell Abbott stent. |
Slosman, CEO of InspireMD, commented: "InspireMD continues its quest to change the standard of care for the prevention of stroke
caused by carotid artery disease, through measurable progress advancing our goals of execution and growth. 2021 CGuard EPS revenue results
reflected a significant rebound to the prior year with a 55.9% increase year over year, reflecting our sustained focus on commercial
growth in our current 40 served markets along with continued work towards gaining approvals in both China and the United States. We advanced
our pipeline of innovation with two new stent delivery accessories planned in 2022, to facilitate greater utilization of CGuard EPS as
a first line stent solution for carotid artery disease management.
2021, we initiated and accelerated enrollment in our ongoing C-Guardians IDE pivotal study of CGuard EPS (C-Guardian) in
the United States, with the leadership and advisory support of renowned interventional cardiologist Gary Roubin, M.D., Ph.D., who serves
on our Board of Directors, Dr. Chris Metzger, principal investigator, and lead enroller to date as well as Christina Brennan, M.D., supporting
trial execution. We secured 12 of the leading interventional sites in the United States to contribute to expanding enrollment. The results
to date, along with enthusiasm and feedback of the interventional community to participate and gain experience with CGuard, are an important
step in maintaining our post approval commercial momentum," Marvin Slosman added.
terms of our global strategy, in 2021 we continued to expand our market presence, obtaining registration and reimbursement in France
along with the establishment of a direct sales presence to serve this key European market. We are currently applying for and exploring
regulatory and reimbursement approvals in important new markets such as Japan and Taiwan to bolster our global footprint and advance
our strategic plan for Asia.
cash position remains sound, having raised an aggregate of approximately $51 million in 2020 and 2021, providing sufficient capital to
continue our growth initiatives and business development plans. Our company focus and foundation is built on the superiority of our CGuard
stent system, through the unique MicroNet mesh platform, providing sustained cerebral protection. InspireMD is committed to become an
industry leader by addressing the broadest physician base of vascular specialist. We believe that expanding our leadership in transfemoral
delivery of CGuard into our rapid advancing trans carotid artery revascularization (TCAR) accessory device platform will enable
broader adoption of trans carotid procedural preference, thus enabling greater conversion of surgeries to stenting," added
enter 2022 with tremendous momentum, anticipating growth of CGuard, continuing pipeline development and advancing the growing body of
evidence demonstrating CGuards's superiority in clinical performance amongst all other stent options and surgery," said Marvin
Slosman, CEO of InspireMD.
Results for the Fourth Quarter ended December 31, 2021
the fourth quarter of 2021, revenue increased by $1,222,000, or 773.8%, to $1,380,000, from $158,000 during the fourth quarter of 2020.
Excluding the $580,000 negative impact on revenue from our settlement of litigation with a former distributor from 2014 in the fourth
quarter of 2020, total revenue increased by $642,000, or 87.0%, to $1,380,000, from $738,000 during the fourth quarter of 2020. This
increase was predominately driven by an increase in revenue of CGuard EPS by $603,000, or 87.5%, to $1,291,000 for the fourth quarter
of 2021, from $689,000 during the fourth quarter of 2020. This increase is mainly due to growth in market share in major markets, expansion
into new markets and due to the fact that in the fourth quarter of 2021, procedures with CGuard EPS, which are generally scheduled for
non-emergency procedures began to return to normal levels as compared to the fourth quarter of 2020, when procedures with CGuard EPS
were postponed as hospitals shifted resources to patients affected by COVID-19 beginning in February 2020.
the fourth quarter of 2021, gross profit increased $684,000, to $294,000, compared to a gross loss of $390,000 for the fourth quarter
of 2020. This increase in gross profit resulted from the impact of the $580,000 settlement with our former distributor in 2014 which
was recorded in the three months ended December 31, 2020 (as mentioned above), as well as $207,000 increase in revenues less the related
material and labor costs. Gross margin increased to 21.3% during the fourth quarter of 2021 from a negative 246.8% during the fourth
quarter of 2020, driven by the reasons mentioned above.
the fourth quarter of 2021, total operating expenses were $4,225,000, an increase of $897,000, or 27.0% compared to $3,328,000 for the
fourth quarter of 2020. This increase was primarily due to increases in expenses related to the commencement of the C-Guardians U.S.
Food and Drug Administration (FDA) study, share-based compensation-related expenses due to the recognition of grants made since August
31, 2020 and sales and marketing expenses associated with expansion of existing and new markets.
the fourth quarter of 2021, financial expenses decreased by 7.6%, or $10,000, to $121,000, from $131,000 during the fourth quarter of
2020. Net loss for the fourth quarter of 2021 totaled $4,097,000, or $0.53 per basic and diluted share, compared to a net loss of $3,853,000,
or $1.52 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per
share calculation were 7,796,027 in the fourth quarter of 2021 and 2,533,936 in the fourth quarter of 2020, both adjusted to reflect
the 1:15 reverse split effected by us on April 26, 2021.
Results for the full year ended December 31, 2021
revenue for the year ended December 31, 2021 were $4,495,000, an increase of 80.9% compared to $2,485,000 for the year ended 2020.
profit for the year ended December 31, 2021 was $754,000, or 16.8 % of revenue, as compared to $83,000, or 3.3 % of revenue for the year
operating expenses for the year ended December 31, 2021 were $15,470,000, an increase of 47.9%, compared to $10,463,000 for the year
loss for the year ended December 31, 2021, was $14,918,000, or $2.03 per basic and diluted share, as compared to a net loss of $10,544,000,
or $6.97 per basic and diluted share, for the year ended 2020. The average amount of shares outstanding used for the earnings per share
calculation were 7,346,022 for the full year 2021, and 1,512,439 for the same period in 2020, both adjusted to reflect the 1:15 reverse
split effected by us on April 26, 2021.
of December 30, 2021, cash, cash equivalents and short-term bank deposits were $34.0 million compared to $12.6 million as of December
Call and Webcast Details
will host a conference call at 8:30AM ET today, March 8, 2022, to review financial results and provide an update on corporate developments.
Following management's formal remarks, there will be a question-and-answer session.
March 8, 2022 at 8:30 a.m. ET
| Domestic: | 877-407-4018 | ||
| International: | 201-689-8471 | ||
| Conference ID: | 13727214 | ||
| Webcast: | Webcast Link |
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. InspireMD's common stock is quoted on the Nasdaq under
the ticker symbol NSPR, and certain warrants are quoted on the Nasdaq under the symbol NSPRZ.
more information, please visit www.inspiremd.com.
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",
"scheduled" 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. For example, the company is using forward looking statements when it discusses its plans to apply for regulatory and reimbursement
approvals in new jurisdictions, its belief that it has sufficient capital to continue its growth initiatives and business development
plans and that it anticipates momentum in 2022, the belief that expanding its leadership in transfemoral delivery of CGuard into its
rapid advancing TCAR accessory device platform, will enable broader adoption of trans carotid procedural preference, thus enabling greater
conversion of surgeries to stenting and its anticipation for continuing pipeline development and advancing the growing body of evidence
demonstrating CGuards's superiority in clinical performance amongst all other stent options and surgery. 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