Full Press Release Details
Reports Second Quarter 2023 Financial Results and Provides
Completed transformational private placement for up to $113.6 million, including $42.2 million upfront -
Completed enrollment in the C-Guardians US IDE trial; on track to announce primary and secondary endpoints and, if successful, submit
PMA application in H2 2024 -
Generated Q2 2023 CGuard EPS revenue of $1.6 million, an increase of nearly 10% over Q2 2022 -
to host investor conference call today, August 8, at 8:30am ET
Aviv, Israel, and Miami, FL - August 8, 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 and operating
results for the second quarter ended June 30, 2023.
Quarter 2023 and Recent Developments:
Slosman, CEO of InspireMD, commented: "Our second quarter was marked by several transformational milestones for our business,
including the financing of up to $113.6 million that we announced in May. This capital allows us to advance our business towards multiple
value-creating milestones, including obtaining potential regulatory approval of and launching our CGuard stent system in the U.S., initiating
regulatory pathways for new advanced indications for CGuard, and developing new products, while at the same time continuing to grow our
business in approved markets outside of the United States.
also announced completion of enrollment in our C-Guardians IDE trial, which includes the first ever cases performed with our CGuard Prime
CAS stent delivery platform that we also plan to include in our regulatory submissions. Importantly, enrollment was completed efficiently
in under 24 months and gives us line of sight to results and, if successful, a PMA submission in the second half of next year. In parallel,
we continue to advance critical pre-commercial activities in the U.S. with the goal of launching CGuard Prime in the first half of 2025,
ongoing shift toward an endovascular standard of care with both CAS and TCAR, highlighted by the current CMS proposed decision memo to
expand reimbursement for CAS, further validates our strategic direction. We are striving to serve all physician specialties that treat
carotid disease, both CAS and TCAR, with our best-in-class CGuard EPS implant. We believe we are optimally positioned to make the CGuard
EPS stent system the standard of care, not only in the U.S. but globally," Mr. Slosman concluded.
Results for the Second Quarter ended June 30, 2023
the three months ended June 30, 2023, revenue increased by $118,000, or 7.7%, to $1,649,000, from $1,531,000 during the three months
ended June 30, 2022. This increase was predominantly driven by a 9.6% increase in sales of CGuard EPS from $1,505,000 during the three
months ended June 30, 2022, to $1,649,000 during the three months ended June 30, 2023.
the three months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by $60,000, or 14.0%, to $491,000, from
$431,000 during the three months ended June 30, 2022. This increase in gross profit resulted from a $90,000 increase in revenues (as
mentioned above), less the associated related material and labor offset by $30,000 in miscellaneous expenses. Gross margin (gross profits
as a percentage of revenue) increased to 29.8% during the three months ended June 30, 2023, from 28.1% during the three months ended
June 30, 2022, driven by the factors mentioned above.
operating expenses for the second quarter of 2023, were $5,806,000, an increase of $694,000 or 13.6% compared to $5,122,000 for the second
quarter of 2022. This increase was primarily due to an increase in compensation expenses.
loss for the second quarter of 2023 totaled $5,077,000 or $0.24 per basic and diluted share, compared to a net loss of $4,636,000, or
$0.59 per basic and diluted share, for the same period in 2022.
of June 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $47.0 million compared to $17.8 million as
of December 31, 2022. This includes the initial net funding of $37.5 million received upon closing of the transformational private placement
that was announced in May, after deducting transaction expenses.
Results for the Six Months ended June 30, 2023
the six months ended June 30, 2023, revenue increased by $174,000, or 6.4%, to $2,888,000, from $2,714,000 during the six months ended
June 30, 2022. This increase was predominantly driven by a 8.3% increase in sales volume of CGuard EPS from $2,666,000 during the six
months ended June 30, 2022, to $2,888,000 during the six months ended June 30, 2023.
the six months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by 56.2%, or $311,000, to $864,000, compared
to a $553,000 for the same period in 2022. This increase in gross profit resulted from a decrease in write-offs of $181,000 and a $161,000
increase in revenues (as mentioned above) less the associated related material and labor costs. This increase was partially offset by
an increase of $31,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.9% during the
six months ended June 30, 2023, from 20.4% during the six months ended June 30, 2022, driven by the reasons mentioned above.
operating expenses for the six months ended June 30, 2023, were $10,560,000, an increase of $840,000, or 8.6% compared to $9,720,000
for the six months ended June 30, 2022. This increase was primarily due to an increase in compensation and other general and administrative
loss for the six months ended June 30, 2023 totaled $9,333,000, or $0.64 per basic and diluted share, compared to a net loss of $9,117,000,
or $1.17 per basic and diluted share, for the six months ended June 30, 2022.
Call and Webcast Details
will host a conference call today, Tuesday, August 8, 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.
August 8th, at 8:30 a.m. ET
| Domestic: | 1-844-826-3035 | |||
| International: | 1-412-317-5195 | |||
| Conference ID: | 10180798 | |||
| 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
statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free
of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking
statements as a result of new information, future events or otherwise.
Padala, Managing Director
| CONSOLIDATED STATEMENTS OF OPERATIONS (1) | ||||||||||||||||
| (U.S. dollars in thousands, except per share data) | ||||||||||||||||
| Three months ended | Six months ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Revenues | $ | 1,649 | $ | 1,531 | $ | 2,888 | $ | 2,714 | ||||||||
| Cost of revenues | 1,158 | 1,100 | 2,024 | 2,161 | ||||||||||||
| Gross Profit | 491 | 431 | 864 | 553 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 1,993 | 2,056 | 3,836 | 3,736 | ||||||||||||
| Selling and marketing | 892 | 986 | 1,680 | 1,732 | ||||||||||||
| General and administrative | 2,921 | 2,070 | 5,044 | 4,252 | ||||||||||||
| Total operating expenses | 5,806 | 5,112 | 10,560 | 9,720 | ||||||||||||
| Loss from operations | (5,315 | ) | (4,681 | ) | (9,696 | ) | (9,167 | ) | ||||||||
| Financial income | 238 | 45 | 363 | 50 | ||||||||||||
| Net Loss | $ | (5,077 | ) | $ | (4,636 | ) | $ | (9,333 | ) | $ | (9,117 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.24 | ) | $ | (0.59 | ) | $ | (0.64 | ) | $ | (1.17 | ) | ||||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 21,074,187 | 7,807,795 | 14,619,622 | 7,806,030 |
| CONSOLIDATED BALANCE SHEETS (2) | ||||||||
| (U.S. dollars in thousands) | ||||||||
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 11,545 | $ | 4,632 | ||||
| Short-term bank deposits | 6,631 | 13,171 | ||||||
| Marketable securities | 28,817 | - | ||||||
| Accounts receivable: | ||||||||
| Trade, net | 1,470 | 1,034 | ||||||
| Other | 312 | 213 | ||||||
| Prepaid expenses | 56 | 655 | ||||||
| Inventory | 1,689 | 1,621 | ||||||
| Total current assets | 50,520 | 21,326 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 873 | 917 | ||||||
| Operating lease right of use assets | 1,388 | 1,554 | ||||||
| Funds in respect of employee rights upon retirement | 857 | 856 | ||||||
| Total non-current assets | 3,118 | 3,327 | ||||||
| Total assets | $ | 53,638 | $ | 24,653 |