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InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update - Record fourth quarter 2023 CGuard EPS revenue of $1.76 million increased 71.6% over fourth quarter 2022 - - Announced p

Key Takeaway: InspireMD reported strong financial results for Q4 2023, achieving a record revenue of $1.76 million, which represents a 71.6% increase compared to the same period in 2022. The company also announced positive 30-day data from its C-GUARDIANS clinical trial and new leadership appointments for its upcoming studies. Despite the revenue growth, InspireMD recorded a net loss of $19.9 million for the year, highlighting ongoing financial challenges. The increase in operating expenses and the need for future capital raising could pose risks to the company's objectives.

Market Sentiment Analysis

POSITIVE FACTORS

  • Record fourth quarter 2023 CGuard EPS revenue of $1.76 million, a 71.6% increase from Q4 2022.
  • Strong growth in stent sales with over 3,100 units sold, up more than 74% year-over-year.
  • Positive results from C-GUARDIANS clinical trial, showing best-in-class outcomes for carotid interventions.

CONCERNS & RISKS

  • Despite increased revenue, the company reports a substantial net loss of $19.9 million for 2023.
  • Operating expenses rose by 15.7% for the year, indicating potential issues with cost management.

Full Press Release Details

Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
Record fourth quarter 2023 CGuard EPS revenue of $1.76 million increased 71.6% over fourth quarter 2022 -
Announced positive 30-day data from the Company's ongoing U.S. Investigational Device Exemption (IDE) clinical trial, C-GUARDIANS,
designed to support U.S. approval of CGuard Prime -
Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company's C-GUARDIANS II clinical trial
of its SwitchGuard NPS for Transcarotid Artery Revascularization (TCAR), as well as Dr. William Gray, as advisor to the company
to host investor conference call today, March 6, at 8:30am ET
Aviv, Israel and Miami, FL - March 6, 2024 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic
Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating
results for the fourth quarter and full-year ended December 31, 2023.
Quarter 2023 and Recent Developments:
Slosman, CEO of InspireMD, commented: "We delivered another strong quarter of sales growth in our approved CE Mark territories
while at the same time advancing our U.S. clinical trial and product development pipeline. Our total revenue of $1.76 million represents
a record quarter and an increase of nearly 72% over the comparable period in 2022. Notably, we sold over 3,100 stents, up more than 74%
year-over-year and bringing our real-world experience to more than 48,000 stents sold to date. The receipt of formal recertification
of our CE Mark under the EU's new Medical Device Regulation (MDR) regulatory framework just a few weeks ago allows us to now leverage
the new product development pathway and the latest regulatory certification provided under MDR.
during the quarter, we were extremely pleased to report 30-day follow-up data from our C-GUARDIANS clinical trial at VIVA23 and the VEITH
Symposium, which are among the most important annual gatherings of specialists who treat vascular disease. The data showed that stenting
with CGuard in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95% from procedure
through 30 days, which compares favorably to both surgery and alternative stenting options and represents best in class results to date
of any pivotal trial of carotid intervention. We remain on track to report 12-month follow-up data mid-year, followed by the submission
of our Premarket Approval (PMA) application.
we made progress advancing our new product pipeline by announcing the lead PIs for our upcoming C-GUARDIANS II clinical trial of our
SwitchGuard NPS for use with CGuard Prime in TCAR procedures. We also announced an agreement with Jacobs Institute to conduct an early
feasibility study of CGuard Prime to treat patients with acute ischemic stroke and tandem lesions.
believe InspireMD is uniquely positioned with a best-in-class implant and solutions to support both CAS and TCAR procedures, with line-of-sight
to significant clinical and regulatory catalysts this year and next," Mr. Slosman concluded.
Results for the Fourth Quarter Ended December 31, 2023
the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022. This increase
was predominantly driven by the CE Mark recertification which occurred subsequent to the end of the fourth quarter 2022.
profit for the fourth quarter of 2023 increased by $307,000, or 155.1%, to $505,000, compared to a gross profit of $198,000 for the fourth
quarter of 2022. This increase resulted from higher revenue and a decrease in miscellaneous expenses. Gross margin (gross profits as
a percentage of revenue) increased to 28.7% during the three months ended December 31, 2023, from 19.3% during the three months ended
operating expenses for the fourth quarter of 2023 were $6,313,000, an increase of $1,179,000, or 23.0% compared to $5,134,000 for the
fourth quarter of 2022. This increase was primarily due to increases in expenses related to the salaries and share-based compensation
offset by a reduction in clinical trial expenses as we near completion of the C-GUARDIANS trial.
financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter
of 2022. This increase was primarily due to a $349,000 increase in interest income from investment in marketable securities, money market
funds and short-term bank deposits.
loss for the fourth quarter of 2023 totaled $5,405,000, or $0.16 per basic and diluted share, compared to a net loss of $4,845,000, or
$0.60 per basic and diluted share, for the same period in 2022.
of December 31, 2023, cash, cash equivalents, short-term bank deposits and marketable securities were $39.0 million compared to $17.8
million as of December 31, 2022.
Results for the full year ended Dec 31, 2023
the twelve months ended December 31, 2023, total revenue increased by $1,034,000, or 20.0%, to $6,205,000, from $5,171,000 during the
twelve months ended December 31, 2022. This increase was driven by a 21.1% increase in sales of CGuard EPS, to $6,205,000 during the
twelve months ended December 31, 2023, from $5,123,000 during the twelve months ended December 31, 2022. This sales increase was mainly
due to growth in existing and new markets.
profit for the twelve months ended December 31, 2023, increased by $690,000, or 61.8%, to $1,807,000, compared to a gross profit of $1,117,000
for the twelve months ended December 31, 2022. This increase in gross profit resulted from higher revenue and a decrease in write-off
and miscellaneous expenses. Gross margin increased to 29.1% during the twelve months ended December 31, 2023, from 21.6% during the twelve
months ended December 31, 2022.
operating expenses for the twelve months ended December 31, 2023 were $22,950,000, an increase of $3,120,000, or 15.7% compared to $19,830,000
for the twelve months ended December 31, 2022. This increase was primarily due to increases in expenses related to salaries and share-based
compensation offset by a reduction in clinical and product development expenses.
financial income for the twelve months ended December 2023, was $1,292,000, an increase of $1,042,000 or 417% compared to $250,000 for
the twelve months ended December 31, 2022. This increase was primarily due to a $1,152,000 increase in interest income from investment
in marketable securities, money market funds and short-term bank deposits.
loss for the twelve months ended December 31, 2023 totaled $19,916,000, or $0.82 per basic and diluted share, compared to a net loss
of $18,491,000, or $2.35 per basic and diluted share, for the twelve months ended December 31, 2022.
Call and Webcast Details
will host a conference call at 8:30AM ET today, March 6th, 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 6th at 8:30 a.m. ET
Domestic: 1-877-407-4018
International: 1-201-689-8471
Conference ID: 13744173
Webcast: Webcast Link - Click 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
statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's

Frequently Asked Questions

What was InspireMD's Q4 2023 revenue?

InspireMD reported a record revenue of $1.76 million for Q4 2023.

Who are the principal investigators for C-GUARDIANS II?

Dr. Patrick Geraghty and Dr. Patrick Muck are the lead investigators for C-GUARDIANS II.

How much did CGuard EPS sales grow in 2023?

CGuard EPS sales increased by 21.1%, reaching $6.2 million in 2023.

What was the gross margin for Q4 2023?

The gross margin for Q4 2023 was 28.7%, up from 19.3% in Q4 2022.

When is the investor conference call scheduled?

The investor conference call is scheduled for March 6, 2024, at 8:30 AM ET.

Last updated: Mar 6, 2024