Full Press Release Details
Reports Financial Results for the Third Quarter Ended September 30, 2016
Company to Host Conference Call Today at 4:30pm ET -
MA - November 14, 2016 - InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) ("InspireMD" or the "Company"),
a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced financial
and operating results for the third quarter and nine months ended September 30, 2016, and provided a business update.
have been very active these last few months building a foundation for commercial, corporate, and regulatory success, and executing
our strategy for realizing the value of our lead product, the CGuard Embolic Prevention System. There continues to be a
growing body of data on CGuard, including recent data published in the Journal of Endovascular Therapy and long term follow-up
data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium. These clinical data continue
to showcase the benefits of this innovative device, including long-term reduction of post-procedural embolization, resulting in
less complications for patients," said James Barry, PhD, Chief Executive Officer of InspireMD. "These important data
will help to support our marketing efforts as we look to expand our sales into new geographies and to grow sales in existing areas.
Reinforced by the key addition of Agustin Gago as the Company's new Chief Commercial Officer and plans for an IDE submission
in the United States in 2017, InspireMD is poised for growth on several fronts in the coming quarters."
| Closing of a $14.6 million public offering of approximately 442,424 shares of Series B Convertible preferred stock and warrants to purchase up to 1,769,696 shares of common stock (post reverse split) | ||
| Regained compliance with the NYSE MKT listing standards | ||
| Completed 1-to-25 reverse stock split |
/ CLINICAL / PRODUCT DEVELOPMENT
| Received regulatory approval to commercialize the CGuard Embolic Prevention System for the treatment of carotid artery disease in Russia. | ||
| 12-month follow up data from PARADIGM-101, an investigator-initiated clinical trail of CGuard , were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium in Washington, D.C. The study found device and procedure success were each 99.1%, with vessel narrowing reduced from 83 9% to only 6.7 5%, and 0% peri-procedural death/major stroke/myocardial infarction (MI), along with a normal healing profile at 12 months. | ||
| An independent study titled "Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent," was published in the Journal of Endovascular Therapy . The study found 100% success in implanting the CGuard EPS, no peri- or post-procedural complications, no deaths or major adverse events, and all vessels treated with the CGuard system remained patent (open) at six months. |
| In September, InspireMD appointed Thomas Kester to its Board of Directors and as Chairman of the Company's Audit Committee. Mr. Kester has 40 years of public accounting experience as well as board member experience of publicly traded companies. | ||
| In October, Agustin Gago was appointed as Executive Vice President and Chief Commercial Officer of InspireMD. Mr. Gago brings over 25 years of industry experience, including senior management positions leading international commercial sales and marketing organizations. |
Commercial AND REGULATORY MILESTONES
| Commercial launch of CGuard EPS in Brazil in the first half of 2017. | ||
| Commercial launch of CGuard EPS in India in the second half of 2017. | ||
| 2017 Investigational Device Exemption (IDE) submission to the FDA. |
Quarter 2016 Financial Results
for the third quarter ended September 30, 2016 was $469,000 compared to $632,000 during the same period in 2015. The decrease
was primarily the result of an expected decline in sales of MGuard Prime EPS associated with the trend of doctors increasingly
using drug eluting stents rather than bare metal stents in STEMI patients. There was no material change in the sales of CGuard
EPS, the Company's carotid product.
Company's gross profit for the quarter ended September 30, 2016 was $31,000 compared to $89,000 for the same period in 2015.
The decrease in gross profit was largely attributable to a decrease in product revenues and an increase in expenses related to
the underutilization of our manufacturing resources, offset by a decrease in labor and material costs attributable to lower revenues.
operating expenses for the quarter ended September 30, 2016 were $1,801,000, a decrease of 48.5% compared to $3,500,000 for the
same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, consultant fees and other
savings associated with our ongoing cost reduction plan.
loss from operations for the quarter ended September 30, 2016 was $1,770,000, a decrease of 48.1% compared to a loss of $3,411,000
for the same period in 2015.
the quarter ended September 30, 2016, there was no material change in financial expenses compared to the same period in 2015.
net loss for the quarter ended September 30, 2016 totaled $2.0 million, or $0.86 per basic and diluted share, compared to a net
loss of $3.6 million, or $11.93 per basic and diluted share, in the same period in 2015.
Months Ended September 30, 2016 Financial Results
for the nine months ended September 30, 2016 was $1,572,000 compared to $1,794,000 during the same period in 2015. The decrease
was predominantly driven by an expected decline in sales of MGuard Prime EPS associated with the trend of doctors increasingly
using drug eluting stents rather than bare metal stents in STEMI patients. This decrease was partially offset by an increase in
sales of $415,000 of CGuard EPS.
Company's gross profit for the nine months ended September 30, 2016 was $158,000 compared to a gross loss of $160,000 for
the same period in 2015. This increase in gross profit was largely attributable to a decrease of write-offs of MGuard Prime
EPS inventory and a decrease in labor and material costs attributable to lower revenues, offset by expenses related to the underutilization
of our manufacturing resources and a decrease in product revenues.
operating expenses for the nine months ended September 30, 2016 were $6,116,000, a decrease of 47.8% compared to $11,714,000 million
for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, restructuring and
impairment costs, clinical and development expenses and other savings associated with our ongoing cost reduction plan.
loss from operations for the nine months ended September 30, 2016 was $5,958,000, a decrease of 49.8% compared to a loss of $11,874,000
for the same period in 2015.
expenses for the nine months ended September 30, 2016 were $638,000, a decrease of 25.5% compared to the same period in 2015.
This decrease was primarily due to a reduction in interest expense of our outstanding loan.
net loss for the nine months ended September 30, 2016 totaled $6,597,000, or $6.37 per basic and diluted share, compared to a
net loss of $12,731,000, or $47.13 per basic and diluted share, in the same period in 2015.
and Cash Equivalents
of September 30, 2016, cash and cash equivalents were $10,468,000, compared to $3,257,000 as of December 31, 2015.
company has scheduled a conference call to discuss third quarter 2016 financial results for today at 4:30 pm Eastern Time. To
participate in the conference call, please dial 866-652-5200 (United States) or 412-317-6060 (International) and request the InspireMD
call. A live webcast will be available in the Investor Relations section of the Company's website or by clicking here.
Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.
archive of the webcast will be available approximately two hours following the call and will be accessible in the Investor Relations
section of the Company's website or by clicking here. A dial-in replay of the call will also be available to those
interested until November 28, 2016. To access the replay, dial 877-344-7529 (United States) or 412-317-0088 (International) and
enter code 10095759.
seeks to utilize its proprietary MicroNetTM technology to make its products the industry standard for embolic protection
and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization,
no reflow and major adverse cardiac events.
intends to pursue applications of this MicroNet technology in coronary, carotid (CGuardTM), neurovascular, and peripheral
artery procedures. InspireMD's common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants
are quoted on the NYSE MKT under the ticker symbol NSPR.WS.
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 | Nine months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues | $ | 469 | $ | 632 | $ | 1,572 | $ | 1,794 | ||||||||
| Cost of revenues | 438 | 543 | 1,414 | 1,954 | ||||||||||||
| Gross Profit (Loss) | 31 | 89 | 158 | (160 | ) | |||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 289 | 781 | 1,068 | 2,880 | ||||||||||||
| Selling and marketing | 329 | 588 | 1,116 | 2,600 | ||||||||||||
| General and administrative | 1,183 | 1,713 | 3,932 | 5,270 | ||||||||||||
| Restructuring and impairment | - | 418 | - | 964 | ||||||||||||
| Total operating expenses | 1,801 | 3,500 | 6,116 | 11,714 | ||||||||||||
| Loss from operations | (1,770 | ) | (3,411 | ) | (5,958 | ) | (11,874 | ) | ||||||||
| Financial expenses | 237 | 228 | 638 | 856 | ||||||||||||
| Loss before tax expenses | (2,007 | ) | (3,639 | ) | (6,596 | ) | (12,730 | ) | ||||||||
| Tax expenses (Income) | - | 2 | 1 | 1 | ||||||||||||
| Net Loss | $ | (2,007 | ) | $ | (3,641 | ) | $ | (6,597 | ) | $ | (12,731 | ) | ||||
| Net loss per share - basic and diluted | $ | (0.86 | ) | $ | (11.93 | ) | $ | (6.37 | ) | $ | (47.13 | ) | ||||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 2,341,807 | 305,240 | 1,034,943 | 270,120 |
dollars in thousands)
| ASSETS | September 30, 2016 | December 31, 2015 | ||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 10,468 | $ | 3,257 | ||||
| Accounts receivable: | ||||||||
| Trade, net | 542 | 405 | ||||||
| Other | 139 | 142 | ||||||
| Prepaid expenses | 107 | 75 | ||||||
| Inventory | 365 | 753 | ||||||
| Total current assets | 11,621 | 4,632 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 379 | 472 | ||||||
| Funds in respect of employee rights upon retirement | 407 | 502 | ||||||
| Royalties buyout | 50 | 87 | ||||||
| Total non-current assets | 836 | 1,061 | ||||||
| Total assets | $ | 12,457 | $ | 5,693 |