Full Press Release Details
Announces Strong Second Quarter 2021 Financial Results
rebound, strong procedural recovery
to host investor conference call today, August 10, 2021, at
Aviv, Israel- August 10, 2021 - 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.
Quarter 2021 and recent highlights
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.
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
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
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.
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
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
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.
Results for the Second Quarter ended June 30, 2021
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.
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.
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.
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
Results for the Six Months ended June 30, 2021
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.
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.
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.
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.
of June 30, 2021, cash and cash equivalents were $41.4 million compared to $12.6 million as of December 31, 2020.
Call and Webcast Details
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.
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.
conference call will also be available through a live webcast found here: https://services.choruscall.com/mediaframe/webcast.html?webcastid=a2t5MXpf.
it will be broadcast live through the Company's website via the following link: https://www.inspiremd.com/en/investors/investor-relations/.
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)