Full Press Release Details
Reports Third Quarter 2023 Financial Results and Provides
Presented positive 30-day follow-up results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial demonstrating
an overall major adverse events rate (DSMI) of 0.95% from procedure through 30 days at the Vascular InterVentional Advances Annual
Announced support for CMS' final decision expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly
expanding the U.S. CAS addressable market -
Generated Q3 2023 CGuard EPS revenue of $1.56 million, an increase of nearly 9% over Q3 2022 -
to host investor conference call today, November 6th, at 8:30am ET
Aviv, Israel, and Miami, FL - November 6, 2023 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic
Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial results and
business updates for the third quarter ended September 30, 2023.
Quarter 2023 and Recent Developments:
| Announced presentation of positive 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial of CGuard EPS at the Vascular InterVentional Advances Annual Meeting (VIVA23). The results demonstrated that patients with obstructive carotid artery disease and at high risk for carotid endarterectomy (CEA) had an overall major adverse events rate (including cumulative death, stroke and myocardial infarction) of 0.95% from procedure through 30 days follow up when treated with carotid artery stenting (CAS) using the CGuard EPS. | ||
| Implemented senior leadership additions and changes designed to support the Company's commercial growth initiatives, including the hiring of Patrick Verta, MD, as Executive Vice President of Clinical and Medical Affairs and Cheryl Tal as Vice President of Quality Assurance and Regulatory Affairs. In addition, Shane Gleason, former General Manager of North America and Vice President of Global Marketing, has been promoted to Chief Commercial Officer. | ||
| Announced support for the Centers for Medicare and Medicaid Services' (CMS) final National Coverage Determination expanding coverage for CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market. | ||
| Generated CGuard revenue for the third quarter 2023 of $1,556,072, an 8.8 % increase over the same period in 2022. | ||
| Sold 2,734 CGuard EPS stent systems in the third quarter of 2023, as compared to 2,624 in the third quarter of 2022, an increase of 4.2 %. |
Slosman, CEO of InspireMD, commented: "During the third quarter, we continued to grow revenue in our served markets outside
the U.S., generating nearly 9% year-over-year revenue growth, while continuing our post-enrollment work toward a potential approval and
launch of CGuard EPS in the U.S. in the first half of 2025.
previously announced, we were pleased to have presented very compelling 30-day safety data from C-GUARDIANS at VIVA23, one of the most
important gatherings of endovascular specialists in the world. The results are consistent with eight previously completed clinical studies
demonstrating extremely low rates of complications - death, stroke or myocardial infarction - as compared to historical data
on competing first generation stents as well as conventional surgery (carotid endarterectomy, or CEA). The data emerging from C-GUARDIANS
adds to the vast and growing body of evidence demonstrating the outstanding short- and long-term patient outcomes facilitated by CGuard
EPS, which remains the cornerstone of our business.
to the end of the quarter, CMS issued its final National Coverage Determination (NCD), expanding coverage of CAS to include both asymptomatic
and standard risk patients, significantly expanding the U.S. CAS addressable market. As we are focused on developing products for both
CAS and TCAR approaches, we view this as very positive for our company, and a change that we believe will accelerate the ongoing shift
toward an endovascular stent first' approach for all carotid interventions from the current more invasive surgery standard
am extremely pleased by our continued execution against our 2023 objectives and the transformational tailwind provided by the CMS coverage
determination that will catalyze a stent-first approach to the treatment of carotid disease, a market we have invested to transform."
Results for the Third Quarter ended September 30, 2023
the three months ended September 30, 2023, revenue increased by $125,000, or 8.7%, to $1,556,000, from $1,431,000 during the three months
ended September 30, 2022. This increase was predominantly primarily driven by an increase in commercial sales of $166,000 of CGuard EPS
to existing geographies, offset by a $41,000 decrease in the United States as the enrollment of all patients in the C-Guardians IDE clinical
trial was completed in June 2023 and accordingly there were no further enrollments in the three months ended September 30, 2023.
the three months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by $72,000, or 19.7%, to $438,000,
from $366,000 during the three months ended September 30, 2022. This increase in gross profit resulted from a $85,000 increase in revenues
less the associated related material and labor offset by $13,000 in miscellaneous expenses. Gross margin (gross profits as a percentage
of revenue) increased to 28.1% during the three months ended September 30, 2023, from 25.6% during the three months ended September 30,
2022, driven by the factors mentioned above.
operating expenses for the third quarter of 2023 were $6,077,000, an increase of $1,101,000 or 22.1% compared to $4,976,000 for the third
quarter of 2022. This increase was primarily due to an increase in compensation expenses.
financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter
of 2022. This increase was primarily due to a $412,000 increase in interest income from investment in marketable securities, money market
funds and short-term bank deposits.
loss for the third quarter of 2023 totaled $5,178,000 or $0.15 per basic and diluted share, compared to a net loss of $4,529,000, or
$0.58 per basic and diluted share, for the same period in 2022.
of September 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $43.0 million compared to $17.8 million
as of December 31, 2022.
Results for the Nine Months ended September 30, 2023
the nine months ended September 30, 2023, revenue increased by $299,000, or 7.2%, to $4,444,000, from $4,145,000 during the nine months
ended September 30, 2022. This increase was predominantly driven by a $347,000 increase in sales volume of CGuard EPS from $4,097,000
during the nine months ended September 30, 2022, to $4,444,000 during the nine months ended September 30, 2023.
the nine months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by 41.7%, or $383,000, to $1,302,000,
compared to a $919,000 for the same period in 2022. This increase in gross profit resulted from a $246,000 increase in revenues less
the associated related material and labor costs and a decrease in write-offs of $199,000. This increase was partially offset by an increase
of $62,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.3% during the nine months
ended September 30, 2023, from 22.2% during the nine months ended September 30, 2022, driven by the reasons mentioned above.
operating expenses for the nine months ended September 30, 2023, were $16,637,000, an increase of $1,941,000, or 13.2% compared to $14,696,000
for the nine months ended September 30, 2022. This increase was primarily due to an increase in compensation and other general and administrative
financial income for the nine months ended September 2023, was $824,000, an increase of $693,000 or 529% compared to $131,000 for the
nine months ended September 30, 2022. This increase was primarily due to a $689,000 increase in interest income from investment in marketable
securities, money market funds and short-term bank deposits.
loss for the nine months ended September 30, 2023 totaled $14,511,000, or $0.69 per basic and diluted share, compared to a net loss of
$13,646,000, or $1.75 per basic and diluted share, for the nine months ended September 30, 2022.
Call and Webcast Details
will host a conference call today, Monday, November 6th, at 8:30 AM ET, to review financial results and provide an update
on corporate developments. Following management's formal remarks, there will be a question-and-answer session.
November 6th, at 8:30 a.m. ET
| Domestic: | 1-877-407-4018 | |
| International: | 1-201-689-8471 | |
| Conference ID: | 13741842 | |
| Call me | Link here | |
| Webcast: | Link here |
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.
routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
press release contains "forward-looking statements." Forward-looking statements include, but are not limited to, statements
regarding InspireMD or its management team's expectations, hopes, beliefs, intentions or strategies regarding the future. 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. Such risks and uncertainties include, without limitation, risks and
uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments
and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; our need to raise additional
capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute
out stockholders' ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals
for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance
with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for
our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our
ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected
from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to
other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological,
research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development
and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product
liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental
and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering
our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel
and other foreign jurisdictions; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture
our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions
and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking