Full Press Release Details
Announces Second Quarter 2019 Financial Results
Investigational Device Exemption (IDE) application submitted to FDA
to host investor conference call today, August 6, at 8:00am ET
Aviv, Israel- August 6, 2019 - 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, today announced results for the second
quarter ended June 30, 2019.
Quarter 2019 and recent highlights:
| Submitted U.S. IDE application which, if approved, will allow the company to commence U.S. clinical trials of CGuard | ||
| Successfully transitioned to a new sterilization partner and cleared all of the $592,000 sales backlog that existed entering the second quarter | ||
| Cash and equivalents expected to fund operations until the end of 2019 |
the headwinds that we faced in the first quarter of the year with the company's prior sterilization partner that limited
us to selling products that were predominantly in stock in our warehouse from 2018, we were pleased to see the entire $592,000
of product backlog shipped in the second quarter, as key accounts were once again able to obtain the products, and we returned
to normalizing product availability in all of our markets," said James Barry, PhD, Chief Executive Officer of InspireMD.
"Importantly, we submitted our IDE application as planned, and if approved, we would have the ability to begin U.S. clinical
trials. We believe CGuard represents a true paradigm shift in the treatment of carotid artery disease, and we continue
to execute on our multi-faceted growth plan with the goal of making this cutting-edge device technology platform available to
patients worldwide."
the three months ended June 30, 2019, revenue was $1,354,000, representing an increase of 35.0% from the comparable period in
2018. This increase was predominantly driven by a 34.0% increase in sales of CGuard EPS from $833,000 in the three months ended
June 30, 2018, to $1,116,000 in the three months ended June 30, 2019, and a 39.9% increase in sales of MGuard EPS from $170,000
in the three months ended June 30, 2018, to $238,000 in the three months ended June 30, 2019. Both increases were due to the shipments
during the three months ended June 30, 2019 of approximately $592,000 of backlog that accumulated in the three months ended March
31, 2019 that we were unable to previously ship. These increases, however, were partially offset by sales decreases in certain
markets during the three months ended June 30, 2019, resulting from new orders being delayed while the product backlog was being
Company's gross profit for the quarter ended June 30, 2019 was $442,000 compared to a gross profit of $277,000 for the same
period in 2018. Gross margin increased to 32.6% in the three months ended June 30, 2019 from 27.6% in the same period in 2018.
This increase in gross profit resulted from a $180,000 increase in revenues, less the related material and labor costs, as discussed
above, and a receipt of $135,000 compensation from the company's former third-party sterilizer for the delays related to
the product sterilization interruption during the first quarter of 2019. These increases were offset by $69,000 of expenses related
to upgrades made to the company's production facilities, $40,000 of expenses pertaining to annual and new employee training
of the production workers and an increase of $41,000 in miscellaneous expenses.
operating expenses for the quarter ended June 30, 2019 were $2,625,000, an increase of 50.0% compared to $1,750,000 for the same
period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard EPS, mainly
related to IDE efforts in 2019 and due to a salary related accrual reversal in the second quarter of 2018 that did not repeat
itself in the same period this year.
expenses for the quarter ended June 30, 2019 were $23,000 compared to financial income of $846,000 for the same period in 2018.
This decrease in financial income of $869,000 was predominately due to a non-cash income associated with the company's preferred
stock in the quarter ended June 30, 2018, which did not occur during this quarter. Net loss for the quarter ended June 30, 2019
totaled $2,206,000, or $1.59 per basic and diluted share, compared to a net loss of $627,000, or $7.66 per basic and diluted share,
for the same period in 2018.
the six months ended June 30, 2019, revenue was $1,769,000, representing a decrease of 12.0% from the comparable period in 2018.
This decrease was predominantly driven by a 10.3% decrease in sales of CGuard EPS from $1,664,000 in the six months ended June
30, 2018, to $1,492,000 in the six months ended June 30, 2019, and a 19.9% decrease in sales of MGuard EPS from $346,000 in the
six months ended June 30, 2018, to $277,000 in the six months ended June 30, 2019. Both decreases were primarily due to shipment
delays in the three months ended March 31, 2019 associated with us changing sterilization companies and sales decreases in certain
of the company's markets. The transition to the company's new sterilization is now complete and we do not currently
anticipate any future disruptions in fulfilling new orders.
Company's gross profit for the six months ended June 30, 2019 was $369,000 compared to a gross profit of $570,000 for the
same period in 2018. Gross margin decreased to 20.9 % in the six months ended June 30, 2019 from 28.4% in the same period in 2018.
This decrease in gross profit resulted from a $69,000 decrease in revenues (as mentioned above), less the related material and
labor costs, $69,000 of expenses related to upgrades made to the company's production facilities, $38,000 of expenses pertaining
to annual and new employee training of the production workers, and an increase of $25,000 in miscellaneous expenses.
operating expenses for the six months ended June 30, 2019 were $5,682,000, an increase of 42.2% compared to $3,996,000 for the
same period in 2018. This increase was primarily due to an increase in clinical expenses associated with CGuard EPS, mainly
related to IDE efforts in 2019 and due to a settlement payment made to a former service provider pursuant to a settlement agreement.
expenses for the six months ended June 30, 2019 were $100,000 compared to financial income of 410,000 for the same period in 2018.
This decrease in financial income of $510,000 was predominately due to a non-cash income associated with the company's preferred
stock in the six months ended June 30, 2018, which did not occur during the six months ended June 30, 2019. Net loss for the six
months ended June 30, 2019 totaled $5,413,000, or $4.86 per basic and diluted share, compared to a net loss of $3,016,000, or
$38.48 per basic and diluted share, for the same period in 2018.
of June 30, 2019, cash and cash equivalents were $4,823,000, compared to $9,384,000 at December 31, 2018.
Call and Webcast Details
conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international
callers, and referencing conference ID 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=135364.
The webcast will be archived on the Company's website.
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
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.
STATEMENTS OF OPERATIONS (1)
dollars in thousands, except per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues | $ | 1,354 | $ | 1,003 | $ | 1,769 | $ | 2,010 | ||||||||
| Cost of revenues | 912 | 726 | 1,400 | 1,440 | ||||||||||||
| Gross Profit | 442 | 277 | 369 | 570 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 865 | 230 | 1,990 | 482 | ||||||||||||
| Selling and marketing | 620 | 580 | 1,254 | 1,072 | ||||||||||||
| General and administrative | 1,140 | 940 | 2,438 | 2,442 | ||||||||||||
| Total operating expenses | 2,625 | 1,750 | 5,682 | 3,996 | ||||||||||||
| Loss from operations | (2,183 | ) | (1,473 | ) | (5,313 | ) | (3,426 | ) | ||||||||
| Financial expenses (income) | (23 | ) | 846 | (100 | ) | 410 | ||||||||||
| Loss before tax expenses | (2,206 | ) | (627 | ) | (5,413 | ) | (3,016 | ) | ||||||||
| Tax expenses (Income) | - | - | - | - | ||||||||||||
| Net Loss | $ | (2,206 | ) | $ | (627 | ) | $ | (5,413 | ) | $ | (3,016 | ) | ||||
| Net loss per share - basic and diluted | $ | (1.59 | ) | $ | (7.66 | ) | $ | (4.86 | ) | $ | (38.48 | ) | ||||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 1,383,238 | 134,907 | 1,112,888 | 90,234 |
dollars in thousands)
| June 30, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 4,823 | $ | 9,384 | ||||
| Accounts receivable: | ||||||||
| Trade, net | 861 | 716 | ||||||
| Other | 276 | 104 | ||||||
| Prepaid expenses | 44 | 81 | ||||||
| Inventory | 1,218 | 1,134 | ||||||
| Total current assets | 7,222 | 11,419 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 513 | 421 | ||||||
| Right of use | 1,042 | - | ||||||
| Funds in respect of employee rights upon retirement | 507 | 448 | ||||||
| Total non-current assets | 2,062 | 869 | ||||||
| Total assets | $ | 9,284 | $ | 12,288 |
| June 30, 2019 | December 31, 2018 | |||||||
| LIABILITIES AND EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 618 | $ | 929 | ||||
| Other | 1,307 | 1,966 | ||||||
| Contract liability | 20 | 25 | ||||||
| Total current liabilities | 1,945 | 2920 | ||||||
| Long-term liabilities: | ||||||||
| Leasing liability | 1,095 | - | ||||||
| Liability for employees rights upon retirement | 670 | 605 | ||||||
| Total long-term liabilities | 1,765 | 605 | ||||||
| Total liabilities | 3,710 | 3,525 | ||||||
| Equity: | ||||||||
| Common stock, par value $0.0001 per share; 150,000,000 shares authorized at June 30, 2019 and December 31, 2018; 1,397,133 and 768,615 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | - | - | ||||||
| Preferred B shares, par value $0.0001 per share; 500,000 shares authorized at June 30, 2019 and December 31, 2018; 17,303 shares issued and outstanding at June 30, 2019 and December 31, 2018. | - | - | ||||||
| Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at June 30, 2019 and December 31, 2018; 38,806 and 61,423 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | - | - | ||||||
| Additional paid-in capital | 158,579 | 156,355 | ||||||
| Accumulated deficit | (153,005 | ) | (147,592 | ) | ||||
| Total equity | 5,574 | 8,763 | ||||||
| Total liabilities, redeemable preferred shares and equity | $ | 9,284 | $ | 12,288 |
All 2019 financial information is derived from the Company's 2019 unaudited financial statements, as disclosed in the Company's