Full Press Release Details
Announces Second Quarter 2020 Financial Results
the second quarter the Company was granted approval to market its CGuard MicroNet stent in Brazil and completed an $11.5
million capital raise; reported outstanding results in studies treating patients with the CGuard MicroNET stent
to host investor conference call today, August 5, 2020 at 8:30am ET
Aviv, Israel- August 5, 2020 - InspireMD, Inc. (NYSE American: 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 for the second quarter ended June 30, 2020.
Quarter 2020 and recent highlights:
| Received approval from the Brazilian registration authority (ANVISA), to market the CGuard MicroNet - covered stent, effectively clearing it for sale and distribution in Brazil. SUPRI Artigos M dicos Hospitalares Ltda. will serve as distribution partner. | ||
| Completed an $11.5 million follow-on underwritten public offering, which included $1.5 million from the exercise by the underwriter of its full over-allotment option for the offering. | ||
| On June 25, 2020, the U.S. Food and Drug Administration (FDA) granted InspireMD conditional approval of its Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard EPS. We are in the process of addressing the Agency's remaining requests, specifically related to the stent-embolic protection device (EPD) compatibility performance testing that was previously conducted. | ||
| Published 12-month PARDIGM trial results in the journal, EuroIntervention , a prestigious peer-reviewed publication covering the latest advancements in vascular intervention. The paper, titled "Routine MicroNET" details the results of 101 unselected consecutive real-life patients treated with the CGuard MicroNET covered stent for carotid stenosis and the 12-month prevention of post-procedural neurologic events. The results indicate that 12 months following carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events. | ||
| Announced early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard compared to Acculink , evaluating 30-day silent brain infarcts in 100 patients who qualified for carotid revascularization with high risk for surgery. The results indicated that significantly fewer silent brain infarcts were associated with CGuard EPS versus Acculink at 30 days post-procedure. |
placed significant pressure on the operations of healthcare facilities worldwide, resulting in interruptions in elective procedure
volumes, including critical carotid artery treatments. However, we are encouraged by the gradual resumption of these crucial procedures
in a growing number of our key markets in Europe and other territories, and we look forward to this expansion taking hold in South
America as well. We are also buoyed by the scientific validation we continue to receive in both peer-reviewed publications and
opportunities to present at medical conferences where our CGuard MicroNet technology is being recognized as a valued advancement
in the carotid stent category," said Marvin Slosman, InspireMD's Chief Executive Officer. "Our expansion strategy
continues to progress, with our recent Brazilian approval for CGuard MicroNet introducing us to the largest
market for medical devices in Latin America and one of the top overall global markets for carotid artery disease. We believe this
approval will set the stage for continued expansion into other countries in South America.
are in the process of addressing the agencies remaining requests, specifically related to the stent-embolic protection device
(EPD) compatibility performance testing to gain full FDA approval of our Investigational Device Exemption (IDE) application to
initiate a pivotal study of CGuard EPS. We have already completed the testing of additional stents according to the FDA's
specifications, and have employed alternative visualization modalities that, we believe, will ultimately allow us to gain full
approval. Having an approved IDE is an extremely significant step towards enabling us to initiate a pivotal trial in the United
States, clearly one of the world's most important markets for carotid artery disease and other vascular treatments. We previously
indicated that the FDA has concurred with our clinical study design and data requirements to support the market approval of the
device. Accordingly, we believe that we are well positioned from a regulatory perspective in terms of our ability to initiate
addition, we believe the completion of our $11.5M financing will help ensure we are capable of advancing our commercial expansion
and research and development activities as a pillar of our growth objectives. Although the pandemic has put a spotlight on the
supply chain infrastructure challenges many in our field are facing, we stand at the ready to fulfill the needs of physicians
and their patients for these serious and lifesaving procedures," Mr. Slosman concluded.
Results for the Second Quarter and Six Months ended June 30, 2020
the three months ended June 30, 2020, revenue decreased by $1,041,000, or 76.9%, to $313,000, from $1,354,000 during the three
months ended June 30, 2019. This decrease was predominantly driven by a 75.7% decrease in sales volume of CGuard EPS from $1,116,000
during the three months ended June 30, 2019, to $271,000 during the three months ended June 30, 2020. This decrease was mainly
due to the fact that procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, were mostly postponed
as hospitals shifted resources to patients affected by COVID-19. The decrease was also due to the large shipments of CGuard EPS
that we made during the three months ended June 30, 2019 of backlog that accumulated in the three months ended March 31, 2019
that we were unable to ship previously due to our former third-party sterilizer equipment failures. Those large shipments did
not recur during the three months ended June 30, 2020. In addition, there was an 82.4% decrease in sales volume of MGuard Prime
EPS, from $238,000 during the three months ended June 30, 2019, to $42,000 during the three months ended June 30, 2020, mainly
due to similar reasons as mentioned above.
company recorded a gross loss for the quarter ended June 30, 2020 of $120,000, compared to a gross profit of $442,000 for the
same period in 2019. This decrease in gross profit resulted primarily from a $448,000 decrease in revenues (as described above),
less the related material and labor costs, and a decrease following a receipt of $135,000 compensation received in the quarter
ended June 30, 2019 from our former third-party sterilizer for the delays related to the product sterilization interruption during
the three months ended March 31, 2019, which did not reoccur in the three months ended June 30, 2020, offset by a $21,000 decrease
in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) decreased to (38.3)% during the three months
ended June 30, 2020 from 32.6% during the three months ended June 30, 2019, driven by the reasons mentioned above.
operating expenses for the quarter ended June 30, 2020 were $2,326,000, a decrease of 11.4% compared to $2,625,000 for the same
period in 2019. This decrease was primarily due to a reduction of $382,000 in clinical expenses associated with CGuard EPS, mainly
related to the IDE approval process, $235,000 in compensation related to temporary salary reductions due to the immediate impact
of COVID-19 on cash flow, and $82,000 of miscellaneous expense reductions offset by an increase of $400,000 due to a settlement
agreement with the underwriter of our prior offerings.
expenses for the quarter ended June 30, 2020 were $34,000 compared to $23,000 for the same period in 2019. Net loss for the second
quarter of 2020 totaled $2,480,000, or $0.20 per basic and diluted share, compared to a net loss of $2,206,000, or $1.59 per basic
and diluted share, for the same period in 2019.
the six months ended June 30, 2020, revenue decreased by $422,000, or 23.9%, to $1,347,000, from $1,769,000 during the six months
ended June 30, 2019. This decrease was predominantly driven by a 16.8% decrease in sales volume of CGuard EPS from $1,492,000
during the six months ended June 30, 2019, to $1,242,000 during the six months ended June 30, 2020, mainly due to the postponement
of procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, as hospitals shifted resources to patients
affected by COVID-19. In addition, there was a 62.1% decrease in sales volume of MGuard Prime EPS from $277,000 during the six
months ended June 30, 2019, to $105,000 during the six months ended June 30, 2020, mainly due to the impact of COVID-19, as mentioned
the six months ended June 30, 2020, gross profit decreased by $194,000, or 52.6%, to $175,000 from $369,000 for the same period
in 2019. This decrease in gross profit resulted primarily from a $225,000 decrease in revenues (as mentioned above), less the
related material and labor costs and a $61,000 increase in write-offs driven by a non-recurring component supply issue. This decrease
was partially offset by a decrease of $69,000 of expenses related to upgrades made to our production facilities during
the six months ended June 30, 2019, which did not reoccur during the six months ended in June 30, 2020 and a decrease of $23,000
in miscellaneous expenses during the six months ended June 30, 2020. Gross margin (gross profits as a percentage of revenue) decreased
to 13.0% during the six months ended June 30, 2020 from 20.9% during the six months ended June 30, 2019, driven by the reasons
operating expenses for the six months ended June 30, 2020 were $4,642,000, a decrease of 18.3% compared to $5,682,000 for the
same period in 2019. This decrease was primarily due to a reduction of $710,000 in clinical expenses associated with CGuard EPS,
mainly related to the IDE approval process, $354,000 due to settlement expenses that were paid to a former service provider pursuant
to a settlement agreement during the six months ended June 30, 2019, $235,000 in compensation expenses, primarily related to temporary
salary reductions due to the immediate impact of COVID-19 on cash flow, and $141,000 of miscellaneous expense reductions offset
by an increase of $400,000 due to a settlement agreement with the underwriter of our prior offerings.
income for the six months ended June 30, 2020 was $9,000 compared to $100,000 of financial expenses for the same period in 2019.
Net loss for the six months ended June 30, 2020 totaled $4,458,000, or $0.52 per basic and diluted share, compared to a net loss
of $5,413,000, or $4.86 per basic and diluted share, for the same period in 2019.
of June 30, 2020, cash and cash equivalents were $13,861,000 compared to $5,514,000 as of December 31, 2019.
Call and Webcast Details
will host a conference call at 8:30AM 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. Participants are asked to pre-register for the
call through the following link: http://dpregister.com/10146840. 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: 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in
approximately 10 minutes prior to the scheduled start time and ask for the InspireMD call. The conference call will also be available
through a live webcast, which can be accessed through the following link: https://services.choruscall.com/links/nspr200805.html
link is also available through the company's website at 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 4, 2020 at the
above links. A telephonic replay of the call will be available through August 19, 2020 and may be accessed by calling 1-877-344-7529
(domestic) or 1-412-317-0088 (international) and using access code 10146840.
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.
common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American
under the ticker symbol NSPR.WS and NSPR.WSB.
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"
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