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 (CAD), today announced
financial and operating results as of and for the second quarter
ended June 30, 2021.
Second Quarter 2021 and recent highlights
- Revenue of $1,038,000, an increase
of 231.6% compared to the same period in 2020
- Initiated U.S. enrollment in the
“C-Guardians” IDE clinical trial. Eleven (11) patients treated and
enrolled in the first 2 weeks at Ballad Health Systems (Kingsport,
TN) by Principal Investigator Dr. Christopher Metzger
- Transferred the listing of the
company’s common stock and warrants to the Nasdaq Capital Market
for access to broader and more fundamental investor base
- Appointed seasoned marketing
executive Kathryn Arnold to the company’s Board of Directors
- Appointed acclaimed interventional
cardiologist Kenneth Rosenfield, M.D. as Chair of the company’s
newly formed Medical Advisory Board (MAB)
Marvin Slosman, InspireMD CEO, commented, “We are pleased with
our second quarter results that showed strong procedural recovery
and market demand of CGuard EPS. Our ultimate goal is to change the
standard of care in the treatment of carotid artery disease away
from surgical endarterectomy to the minimally invasive use of
CGuard EPS Carotid Stent System.
“Our commercial efforts in driving global expansion, through
expanding use of CGuard EPS in our 33 served markets, combined with
growing our footprint into the U.S. and Asia, has created awareness
of the clinical advantages of CGuard EPS. Initiating our U.S. Food
and Drug Administration (FDA) C-Guardians IDE trial this quarter
marked a milestone for the company in establishing awareness and
experience with CGuard EPS among U.S. physicians treating carotid
artery disease. To date, Interventional Cardiologist Chris Metzger,
M.D., our principal investigator, and system chair of clinical
research at Ballad Health System (Kingsport, TN) has already
enrolled 11 patients in the trial in the first two weeks.
“During the second quarter, we successfully transferred the
listing of our shares and warrants to the Nasdaq Capital Market,
which we believe will help broaden our shareholder base and
increase interest by institutional and fundamental investors to
create additional long-term shareholder value.
“Additionally, we appointed seasoned MedTech marketing executive
Kathryn Arnold to our Board of Directors. Ms. Arnold brings more
than two decades of strategy and commercialization experience in
the medical device industry. Her knowledge and leadership will be
invaluable in helping the company shape our strategic planning and
expanding our commercial and business development.
“We also formed a Medical Advisory Board composed of global Key
Opinion Leaders (KOL’s) who treat carotid artery disease to provide
the company guidance and direction on clinical strategy, product
pipeline, and technology advancements. To lead this Board, we have
appointed acclaimed interventional cardiologist, Kenneth
Rosenfield, M.D. as Chair. Dr. Rosenfield is the Section Head for
Vascular Medicine and Intervention and chairs the Acute Myocardial
Infarction (STEMI) Committee for the Cardiac Catheterization
Laboratory at Massachusetts General Hospital.
“We continue to advance our global growth plans in our Asian
markets. In China we are progressing with our distributor partners
to initiate our regulatory trial toward market approval, and we
continue our commercial expansion efforts into the markets of
Japan, Taiwan and South Korea.
“We are making significant progress advancing our product
pipeline with new innovation and offerings. CGuard Prime, our next
generation trans-femoral delivery system is scheduled for
regulatory submission in early 2022 with commercial launch in the
second half 2022. Additionally, we are making great progress on a
new embolic protection device (EPD) and delivery system, expanding
our toolset and offerings to the vascular surgical community,”
concluded Mr. Slosman.
Financial Results for the Second Quarter ended June 30,
2021
For the three months ended June 30, 2021, revenue increased by
$725,000, or 231.6%, to $1,038,000, from $313,000 during the three
months ended June 30, 2020. This increase was predominantly driven
by a 276.0% increase in sales volume of CGuard EPS from $271,000
during the three months ended June 30, 2020, to $1,019,000 during
the three months ended June 30, 2021. This sales increase was
mainly due to the fact that in the three months ended June 30,
2021, procedures with CGuard EPS, which are generally scheduled for
non-emergency cases, began to return to normal levels as compared
to the three months ended June 30, 2020, when procedures with
CGuard EPS were mostly postponed as hospitals shifted resources to
patients affected by COVID-19. This increase in sales of CGuard EPS
was partially offset by a decrease of 54.8% in sales of MGuard
Prime EPS from $42,000 during the three months ended June 30, 2020,
to $19,000 during the three months ended June 30, 2021, largely
driven by the predominant industry preferences favoring
drug-eluting stents rather than bare metal stents such as MGuard
Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”)
patients.
For the three months ended June 30, 2021, gross
profit (revenue less cost of revenues) increased by $382,000, to
$262,000, from a gross loss of $120,000 during the three months
ended June 30, 2020. This increase in gross profit resulted from a
$237,000 increase in revenues less the related material and labor
costs (as described above), a decrease in write-offs of $144,000,
which were driven mainly by changes related to components supply
issues and a decrease of $1,000 in miscellaneous expenses during
the three months ended June 30, 2021. Gross margin (gross profits
as a percentage of revenue) increased to 25.2% during the three
months ended June 30, 2021 from (38.3)% during the three months
ended June 30, 2020, driven mainly by the decrease in write-offs
mentioned above.
Total operating expenses for the quarter ended
June 30, 2021 were $3,702,000, an increase of 59.2% compared to
$2,326,000 for the same period in 2020. This increase was primarily
due to increases of $705,000 in salary expenses and related accrual
expenses mainly driven by temporary salary reductions during the
three months ended June 30, 2020, that were implemented in response
to the COVID-19 effect on revenues as well as additional resources
mainly in our product development and sales infrastructure,
$437,000 in expenses related to the commencement of the C-Guardians
FDA study, $315,000 in share-based compensation-related expenses
due to the expense recognition of grants made after June 30, 2020,
$297,000 in development expenses associated with CGuard EPS
accessory solutions, and $108,000 of Directors’ and Officers’
Liability Insurance expense due to increased premiums caused by
recent trends in the overall insurance industry. This increase was
partially offset by a decrease of $400,000 relating to a settlement
agreement with an underwriter of our prior offerings which occurred
in the three months ended June 30, 2020 and a reduction of $86,000
of miscellaneous expense.
For the three months ended June 30, 2021,
financial expenses were $67,000, compared to $34,000 during the
three months ended June 30, 2020. Net loss for the second quarter
of 2021 totaled $3,507,000, or $0.46 per basic and diluted share,
compared to a net loss of $2,480,000, or $2.93 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
7,704,707 in Q2 2021 and 845,451 in Q2 2020, both adjusted to
reflect the 1:15 reverse split effected by us on April 26,
2021.
Financial Results for the Six Months
ended June 30, 2021
For the six months ended June 30, 2021, revenue
increased by $697,000, or 51.7%, to $2,044,000, from $1,347,000
during the six months ended June 30, 2020. This increase was
predominantly driven by a 60.0% increase in sales volume of CGuard
EPS from $1,242,000 during the six months ended June 30, 2020, to
$1,987,000 during the six months ended June 30, 2021. This sales
increase was mainly due to the fact that in the six months ended
June 30, 2021, procedures with CGuard EPS, which are generally
scheduled for non-emergency procedures began to return to normal
levels as compared to the six months ended June 30, 2020, when
procedures with CGuard EPS were postponed as hospitals shifted
resources to patients affected by COVID-19 beginning in February
2020. This increase in sales of CGuard EPS was partially offset by
a decrease of 45.7% in sales of MGuard Prime EPS from $105,000
during the six months ended June 30, 2020, to $57,000 during the
six months ended June 30, 2021, largely driven by the predominant
industry preferences favoring drug-eluting stents rather than bare
metal stents such as MGuard Prime EPS in STEMI patients.
For the six months ended June 30, 2021, gross
profit (revenue less cost of revenues) increased by $193,000, to
$368,000, compared to a $175,000 for the same period in 2020. This
increase in gross profit resulted from a $257,000 increase in
revenues less the related material and labor costs (as described
above). This increase was partially offset by an increase of
$64,000 in miscellaneous expenses. Gross margin (gross profits as a
percentage of revenue) increased to 18.0% during the six months
ended June 30, 2021 from 13.0% during the six months ended June 30,
2020, driven by the reasons mentioned above.
Total operating expenses for the six months
ended June 30, 2021 were $7,122,000, an increase of 53.4% compared
to $4,642,000 for the same period in 2020. This increase was
primarily due to increases of $1,136,000 in salary expenses and
related accrual expenses mainly driven by temporary salary
reductions during the six months ended June 30, 2020, that were
implemented in response to the COVID-19 effect on revenues as well
as additional resources mainly in our product development and sales
infrastructure, $563,000 in share-based compensation-related
expenses due to the expense recognition of grants made after June
30, 2020, $521,000 in development expenses associated with CGuard
EPS accessory solutions, $483,000 in expenses related to the
commencement of the C-Guardians FDA study, $226,000 of Directors’
and Officers’ Liability Insurance expense due to increased premiums
caused by recent trends in the overall insurance industry. This
increase was partially offset by a decrease of $400,000 relating to
a settlement agreement with an underwriter of our prior offerings
which occurred in the three months ended June 30, 2020 and a
reduction of $49,000 of miscellaneous expense.
For the six months ended June 30, 2021,
financial income was $4,000, compared to $9,000 during the six
months ended June 30, 2020. Net loss for the six months ended June
2021 totaled $6,750,000, or $0.98 per basic and diluted share,
compared to a net loss of $4,458,000, or $7.73 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
6,918,090 for the six months ended June 2021 and 576,827 for the
six months ended June 2020, both adjusted to reflect the 1:15
reverse split effected by us on April 26, 2021.
As of June 30, 2021, cash and cash equivalents were $41.4
million compared to $12.6 million as of December 31, 2020.
Conference Call and Webcast Details
Management will host a conference call at 8:30AM ET today,
August 10, 2021, to review financial results and provide an update
on corporate developments. Following management’s formal
remarks, there will be a question-and-answer session.
Please 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: 1-844-854-4417 (domestic), or
1-412-317-5739 (international). All callers should dial in
approximately 10 minutes prior to the scheduled start time and ask
to be joined into the InspireMD call. The conference call will also
be available through a live webcast found here:
https://services.choruscall.com/mediaframe/webcast.html?webcastid=a2t5MXpf.
Additionally, it will be broadcast live through the Company’s
website via the following link:
https://www.inspiremd.com/en/investors/investor-relations/.
A webcast replay of the call will be available approximately one
hour after the end of the call through November 10, 2021, at the
above links. A telephonic replay of the call will be available
through August 24, 2021, and may be accessed by calling
1-877-344-7529 (domestic) or 1-412-317-0088 (international) and
using access code 10158721.
About InspireMD, Inc.InspireMD
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.
Forward-looking Statements
This 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. For example, the company
is using forward-looking statements when it discusses its future
plans with respect to its CGuard EPS stent, its belief that its
efforts has created potential future momentum for its CGuard EPS
stent, the potential benefits of its listing on Nasdaq, the intends
regulatory submission and commercial launch of its CGuard Prime and
the belief that it has sufficient cash reserves and liquidity to
fund its planned operations. 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 (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 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. 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.
Investor Contacts:Craig ShoreChief Financial
OfficerInspireMD, Inc.888-776-6804craigs@inspiremd.com
CORE IRinvestor-relations@inspiremd.com
CONSOLIDATED STATEMENTS OF OPERATIONS
(1) |
|
(U.S. dollars in thousands, except per share data) |
|
|
|
|
Six months ended |
|
|
Three months ended |
|
|
June 30, |
|
June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
1,038 |
|
|
$ |
313 |
|
|
$ |
2,044 |
|
|
$ |
1,347 |
|
|
Cost
of revenues |
|
776 |
|
|
|
433 |
|
|
|
1,676 |
|
|
|
1,172 |
|
|
|
|
|
|
|
|
|
|
|
Gross Profit |
|
262 |
|
|
|
(120 |
) |
|
|
368 |
|
|
|
175 |
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
1,290 |
|
|
|
444 |
|
|
|
2,129 |
|
|
|
967 |
|
|
Selling and marketing |
|
636 |
|
|
|
377 |
|
|
|
1,344 |
|
|
|
1,001 |
|
|
General and administrative |
|
1,776 |
|
|
|
1,505 |
|
|
|
3,649 |
|
|
|
2,674 |
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
3,702 |
|
|
|
2,326 |
|
|
|
7,122 |
|
|
|
4,642 |
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
(3,440 |
) |
|
|
(2,446 |
) |
|
|
(6,754 |
) |
|
|
(4,467 |
) |
|
|
|
|
|
|
|
|
|
|
Financial income (expenses) |
|
(67 |
) |
|
|
(34 |
) |
|
|
4 |
|
|
|
9 |
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
$ |
(3,507 |
) |
|
$ |
(2,480 |
) |
|
$ |
(6,750 |
) |
|
$ |
(4,458 |
) |
|
|
|
|
|
|
|
|
|
|
Net
loss per share – basic and diluted |
$ |
(0.46 |
) |
|
$ |
(2.93 |
) |
|
$ |
(0.98 |
) |
|
$ |
(7.73 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares ofcommon stock used in computing
netloss per share – basic and diluted |
|
7,704,707 |
|
|
|
845,451 |
|
|
|
6,918,090 |
|
|
|
576,827 |
|
|
CONSOLIDATED BALANCE SHEETS
(2) |
(U.S. dollars in thousands) |
ASSETS |
June 30, |
|
December 31, |
2021 |
|
2020 |
|
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
41,419 |
|
$ |
12,645 |
Accounts receivable: |
|
|
|
Trade, net |
|
962 |
|
|
476 |
Other |
|
136 |
|
|
146 |
Prepaid expenses |
|
63 |
|
|
334 |
Inventory |
|
1,342 |
|
|
1,415 |
Receivable for sale of Shares |
|
- |
|
|
323 |
|
|
|
|
Total current assets |
|
43,922 |
|
|
15,339 |
|
|
|
|
|
|
|
|
Non-current assets: |
|
Property, plant and equipment, net |
|
443 |
|
|
448 |
Operating lease right of use
assets |
|
1,251 |
|
|
1,265 |
Funds
in respect of employee rights upon retirement |
|
759 |
|
|
725 |
|
|
|
|
Total non-current assets |
|
2,453 |
|
|
2,438 |
|
|
|
|
Total assets |
$ |
46,375 |
|
$ |
17,777 |
LIABILITIES AND EQUITY |
June 30, |
|
December 31, |
2021 |
|
2020 |
|
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accruals: |
|
|
|
Trade |
$ |
739 |
|
|
$ |
236 |
|
Other |
|
2,940 |
|
|
|
3,469 |
|
|
|
|
|
Total current liabilities |
|
3,679 |
|
|
|
3,705 |
|
|
|
|
|
Long-term liabilities: |
|
|
|
Operating lease liabilities |
|
904 |
|
|
|
999 |
|
Liability for employees rights upon retirement |
|
962 |
|
|
|
910 |
|
Total long-term liabilities |
|
1,866 |
|
|
|
1,909 |
|
|
|
|
|
Total liabilities |
|
5,545 |
|
|
|
5,614 |
|
|
|
|
|
Equity: |
|
|
|
Common stock, par value $0.0001 per share; 150,000,000shares
authorized at June 30, 2021 and December 31, 2020;7,914,339 and
3,284,322 shares issued and outstanding atJune 30, 2021 and
December 31, 2020, respectively |
|
1 |
|
|
* |
|
Preferred B shares, par value
$0.0001 per share; 500,000 shares authorized at June 30, 2021 and
December 31,2020; 0 and 17,303 shares issued and outstanding at
June 30,2021 and December 31, 2020 |
|
- |
|
|
* |
|
Preferred C shares, par value
$0.0001 per share; 1,172,000 shares authorized at June 30, 2021 and
December 31,2020; 1,718 and 2,343 shares issued and outstanding at
June 30,2021 and December 31, 2020, respectively |
|
* |
|
|
* |
|
Additional paid-in capital |
|
215,755 |
|
|
|
180,339 |
|
Accumulated deficit |
|
(174,926 |
) |
|
|
(168,176 |
) |
|
|
|
|
Total equity |
|
40,830 |
|
|
|
12,163 |
|
|
|
|
|
Total liabilities and equity |
$ |
46,375 |
|
|
$ |
17,777 |
|
|
|
|
|
(1) All 2021 financial information is derived from the Company’s
2021 unaudited financial statements, as disclosed in the Company’s
Quarterly Report on Form 10-Q, filed with the Securities and
Exchange Commission; all 2020 financial information is derived from
the Company’s 2020 unaudited financial statements, as disclosed in
the Company’s Quarterly Report on Form 10-Q, filed with the
Securities and Exchange Commission.
(2) All June 30, 2021 financial information is derived from the
Company’s 2021 unaudited financial statements, as disclosed in the
Company’s Quarterly Report on Form 10-Q, filed with the Securities
and Exchange Commission. All December 31, 2020 financial
information is derived from the Company’s 2020 audited financial
statements as disclosed in the Company’s Annual Report on Form
10-K, for the twelve months ended December 31, 2020 filed with the
Securities and Exchange Commission.
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