Full Press Release Details
Announces First Quarter 2019 Financial Results
to Submit U.S. IDE expected in Mid-2019
to Host Investor Conference Call at 8:00am ET
Aviv, Israel- May 14, 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 first
quarter ending March 31, 2019.
Quarter 2019 and recent highlights:
| Pre-clinical testing remains on track for U.S. IDE submission expected in mid 2019 | ||
| $5.8 million of cash as of March 31, 2019 | ||
| Subsequent to the end of the quarter, completed a follow-on offering of common stock that raised gross proceeds of approximately $2.5 million | ||
| Pro-forma cash and equivalents expected to be sufficient to achieve key milestones through year-end |
the issue that we encountered with our primary sterilization partner during the first quarter which led to a shortfall of product
available to ship to our distributors, we continued to execute on our multi-faceted growth plan," said James Barry, PhD,
Chief Executive Officer of InspireMD. "In addition to our more focused sales strategy opening more hospital centers in our
key European territories, our Centers of Excellence that we have established continue to yield very positive results by providing
interventional cardiologists and vascular surgeons with hands-on, real-world experience with the CGuard device and continues
to help us expand our user base across clinical specialities. We believe these efforts are creating a solid foundation from which
to drive future growth. Finally, our IDE submission remains on-track for submission expected in the coming months. The continuing
and growing body of evidence confirming the superiority of the CGuard procedure versus conventional open strut stents and
carotid endarterectomy surgery, continued through the first quarter as we reported earlier in the year from the data presented
at the LINCC meeting in January. We continue to believe CGuard is well positioned to become the new standard of care in
the treatment of carotid artery disease."
the three months ended March 31, 2019, revenue was $415,000, representing a decrease of 59% from the comparable period in 2018.
This decrease was predominantly driven by a 55% decrease in sales of CGuard EPS from $831,000 in the three months ended March
31, 2018, to $376,000 in the three months ended March 31, 2019, and a 78% decrease in sales of MGuard EPS from $176,000 in the
three months ended March 31, 2018, to $39,000 in the three months ended March 31, 2019. Both decreases were due to the Company's
third-party sterilizer's equipment failures that resulted in significant interruption in sterilized product supply for the
majority of the quarter. As a result, the Company was unable to fulfill a significant portion of the orders received during the
quarter resulting in a backlog of approximately $600,000. As of today, the third-party sterilizer issue has been resolved and
the majority of the $600,000 of the backlog recorded has been shipped.
Company's gross loss for the quarter ended March 31, 2019 was $73,000 compared to a gross profit of $293,000 for the same
period in 2018. Gross margin decreased to (17.6) % in the three months ended March 31, 2019 from 29.1% in the same period in 2018.
This decrease in gross margin resulted from a $249,000 decrease in revenues, less the related material and labor costs, resulting
from delays related to product sterilization interruption as discussed above and an increase of $118,000 in write-offs of inventory
due to the same issue.
operating expenses for the quarter ended March 31, 2019 were $3,057,000, an increase of 36 % compared to $2,246,000 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 quarter ended March 31, 2019 were $77,000 compared to $436,000 for the same period in 2018. This decrease of
$359,000 was predominately due to a non-cash expense associated with our preferred stock in the quarter ended March 31, 2018 that
we did not incur this quarter. Net loss for the quarter ended March 31, 2019 totaled $3,207,000, or $3.82 per basic and diluted
share, compared to a net loss of $2,389,000, or $54.00 per basic and diluted share, for the same period in 2018.
of March 31, 2019, cash and cash equivalents were $5,807,000, compared to $9,384,000 at December 31, 2018. Subsequent to the end
of the first quarter, the Company completed an offering of common stock that yielded gross proceeds of approximately $2.5 million.
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=133118
webcast will also be archived on the Company's website and a telephone replay of the call will be available approximately
one hour following the call for approximately two weeks and can be accessed by dialing 844-512-2921 for U.S. callers or +1 412-317-6671
for international callers and entering conference ID: 13687159.
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.
| Three months ended | ||||||||
| March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenues | $ | 415 | $ | 1,007 | ||||
| Cost of revenues | 488 | 714 | ||||||
| Gross Profit (Loss) | (73 | ) | 293 | |||||
| Operating Expenses: | ||||||||
| Research and development | 1,125 | 252 | ||||||
| Selling and marketing | 634 | 492 | ||||||
| General and administrative | 1,298 | 1,502 | ||||||
| Total operating expenses | 3,057 | 2,246 | ||||||
| Loss from operations | (3,130 | ) | (1,953 | ) | ||||
| Financial expenses | 77 | 436 | ||||||
| Loss before tax expenses | (3,207 | ) | (2,389 | ) | ||||
| Tax expenses (Income) | - | - | ||||||
| Net Loss | $ | (3,207 | ) | $ | (2,389 | ) | ||
| Net loss per share - basic and diluted | $ | (3.82 | ) | $ | (54.00 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 839,533 | 45,079 |
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| March 31, 2019 | December 31, 2018 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 5,807 | $ | 9,384 | ||||
| Accounts receivable: | ||||||||
| Trade, net | 464 | 716 | ||||||
| Other | 186 | 104 | ||||||
| Prepaid expenses | 66 | 81 | ||||||
| Inventory | 1,447 | 1,134 | ||||||
| Total current assets | 7,970 | 11,419 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 452 | 421 | ||||||
| Right of use | 1,104 | - | ||||||
| Deferred issuance costs | 49 | - | ||||||
| Funds in respect of employee rights upon retirement | 482 | 448 | ||||||
| Total non-current assets | 2,087 | 869 | ||||||
| Total assets | $ | 10,057 | $ | 12,288 |
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| LIABILITIES AND EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | $ | 872 | $ | 929 | ||||
| Other | 1,740 | 1,966 | ||||||
| Contract liability | 25 | 25 | ||||||
| Total current liabilities | 2,637 | 2,920 | ||||||
| Long-term liabilities: | ||||||||
| Leasing liability | 1,138 | - | ||||||
| Liability for employees rights upon retirement | 642 | 605 | ||||||
| Total long-term liabilities | 1,780 | 605 | ||||||
| Total liabilities | 4,417 | 3,525 | ||||||
| Equity: | ||||||||
| Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2019 and December 31, 2018; 871,872 and 768,615 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | - | - | ||||||
| Preferred B shares, par value $0.0001 per share; 500,000 shares authorized at March 31, 2019 and December 31, 2018; 17,303 shares issued and outstanding at March 31, 2019 and December 31, 2018. | - | - | ||||||
| Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2019 and December 31, 2018; 59,423 and 61,423 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively | - | - | ||||||
| Additional paid-in capital | 156,439 | 156,355 | ||||||
| Accumulated deficit | (150,799 | ) | (147,592 | ) | ||||
| Total equity | 5,640 | 8,763 | ||||||
| Total liabilities and equity | $ | 10,057 | $ | 12,288 |
All 2019 financial information is derived from the Company's 2019 unaudited financial statements, as disclosed in the Company's
Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2018 financial information is derived from
the Company's 2018 unaudited financial statements, as disclosed in the Company's Quarterly Report on Form 10-Q, filed
with the Securities and Exchange Commission.
All March 31, 2019 financial information is derived from the Company's 2019 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, 2018
financial information is derived from the Company's 2018 audited financial statements as disclosed in the Company's
Annual Report on Form 10-K, for the twelve months ended December 31, 2018 filed with the Securities and Exchange Commission.