Full Press Release Details
InspireMD Reports Financial Results
for the First Quarter Ended March 31, 2016
BOSTON, MA - May 10, 2016
- InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" or the "Company"), a leader in embolic prevention
systems (EPS), neurovascular devices and thrombus management technologies, today announced its financial and operating results
for the first quarter ended March 31, 2016.
During the first quarter, InspireMD announced
initiatives to support ongoing commercial operations and development programs. Key activities include announced:
Sol Barer, Chairman of the Board of InspireMD,
commented, "In line with our focused execution of our strategy, a key priority is our ongoing management transition plan
with attention on our European commercial and development activities. These efforts were aided by our recent capital raise and
addition to the board. We look for timely and continuous updates as we execute on our plans."
Dr. Barer continued, "We remain
pleased with consistent, positive feedback with our CGuardTM commercial activities, noting progress with our early
efforts to drive market traction. We look forward to continued clinical presentations of CGuardTM patient evaluations
at relevant medical industry conferences, including the investigator-led PARADIGM-101 at the Late-Breaking Clinical Trial session
at EuroPCR on May 17th."
Recent Operating Highlights:
REGULATORY / CLINICAL / PRODUCT DEVELOPMENT
Quarter Ended March 31, 2016 Financial
Revenue for the first quarter ended March
31, 2016 increased $0.1 million to $0.6 million compared to $0.5 million during the same period in 2015. The increase was predominantly
driven by sales of $0.3 million of CGuard EPS, our carotid product. This increase, however, was partially offset 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.
The Company's gross profit for the quarter
ended March 31, 2016 was $66,000 compared to a gross loss of $37,000 for the same period in 2015. This increase in gross profit
was largely attributable to the increase in product revenues and a decrease of write-offs of MGuard Prime EPS inventory
offset by expenses related to the underutilization of our manufacturing resources.
Total operating expenses for the quarter
ended March 31, 2016 were $2.5 million, a decrease of 49.5% compared to $4.9 million for the same period in 2015. This decrease
was primarily due to a reduction of compensation related expenses, restructuring and impairment costs and other savings associated
with our ongoing cost reduction plan.
The loss from operations for the quarter
ended March 31, 2016 was $2.4 million, a decrease of 51.2% compared to a loss of $4.9 million for the same period in 2015.
Financial expenses for the quarter ended
March 31, 2016 were $0.2 million, a decrease of 27.8% compared to the same period in 2015. This decrease was primarily due to
a reduction in interest expense of our outstanding loan.
The net loss for the quarter ended March
31, 2016 totaled $2.6 million, or $0.32 per basic and diluted share, compared to a net loss of $5.2 million, or $1.04 per basic
and diluted share, in the same period in 2015.
net loss for the quarter ended March 31, 2016 was $1.9 million, or $0.23 per basic and diluted share, a decrease of 51.6% compared
to a non-GAAP net loss of $3.8 million, or $0.77 per basic and diluted share, for the same period in 2015. The non-GAAP
net loss for the quarter ended March 31, 2016 primarily excludes $0.7 million of share-based compensation. The
non-GAAP net loss for the quarter ended March 31, 2015 primarily excludes $1.0 million of share-based compensation and $0.3 million
of expense related to an impairment of a royalties buyout asset.
Cash and Cash Equivalents
As of March 31, 2016, cash and cash equivalents
were $2.0 million, compared to $3.3 million as of December 31, 2015.
No Conference Call Scheduled
The Company is not hosting a conference
call to discuss first quarter March 31, 2016 results. Additional updates will be provided as they become available.
PARADIGM is an investigator-initiated
Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic
and increased-risk asymptomatic carotid artery stenosis, using CGuard Mesh-covered embolic prevention stent
system. At EuroPCR 2015, Dr. Musialek summarized the results of his PARADIGM evaluation of 71 CGuardTM procedures in
unselected all-comer patients: 1) stent system success and procedure success rate of 100%; 2) periprocedural complications of
0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist
and non-invasive cardiologist evaluation.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MGuard with 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.
InspireMD 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.
Forward-looking Statements
This 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.
Chief Financial Officer
Email: craigs@inspiremd.com
Phone: (212) 554-5482
| CONSOLIDATED STATEMENTS OF OPERATIONS (1) |
| (U.S. dollars in thousands, except per share data) |
| Three months ended | ||||||||
| March 31, | ||||||||
| 2016 | 2015 | |||||||
| Revenues | $ | 563 | $ | 477 | ||||
| Cost of revenues | 497 | 514 | ||||||
| Gross Profit (Loss) | 66 | (37 | ) | |||||
| Operating Expenses: | ||||||||
| Research and development | 478 | 1,352 | ||||||
| Selling and marketing | 386 | 1,017 | ||||||
| General and administrative | 1,589 | 1,970 | ||||||
| Restructuring and impairment | - | 514 | ||||||
| Total operating expenses | 2,453 | 4,853 | ||||||
| Loss from operations | (2,387 | ) | (4,890 | ) | ||||
| Financial expenses | 221 | 306 | ||||||
| Loss before tax expenses | (2,608 | ) | (5,196 | ) | ||||
| Tax expenses | 1 | 16 | ||||||
| Net Loss | $ | (2,609 | ) | $ | (5,212 | ) | ||
| Net loss per share - basic and diluted | $ | (0.32 | ) | $ | (1.04 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 8,042,082 | 4,991,519 |
| RECONCILIATION OF NON-GAAP NET LOSS (2) |
| (U.S. dollars in thousands, except per share data) |
| Three months ended | ||||||||
| March 31, | ||||||||
| 2016 | 2015 | |||||||
| GAAP Net Loss | $ | (2,609 | ) | $ | (5,212 | ) | ||
| Non-GAAP Adjustments: | ||||||||
| Share-based compensation expenses | 741 | 1,029 | ||||||
| Impairment of royalties buyout | - | 316 | ||||||
| Royalties buyout amortization | 12 | 36 | ||||||
| Total Non-GAAP Adjustments | 934 | 1,381 | ||||||
| Non-GAAP Net Loss | $ | (1,856 | ) | $ | (3,831 | ) | ||
| Non-GAAP net loss per share - basic and diluted | $ | (0.23 | ) | $ | (0.77 | ) | ||
| Weighted average number of shares of common stock used in computing net loss per share - basic and diluted | 8,042,082 | 4,991,519 |
| CONSOLIDATED BALANCE SHEETS (3) |
| (U.S. dollars in thousands) |
| ASSETS | March 31, | December 31, | ||||||
| 2016 | 2015 | |||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 1,999 | $ | 3,257 | ||||
| Accounts receivable: | ||||||||
| Trade, net | 546 | 405 | ||||||
| Other | 204 | 142 | ||||||
| Prepaid expenses | 62 | 75 | ||||||
| Inventory | 511 | 753 | ||||||
| Total current assets | 3,322 | 4,632 | ||||||
| Non-current assets: | ||||||||
| Property, plant and equipment, net | 436 | 472 | ||||||
| Funds in respect of employee rights upon retirement | 411 | 502 | ||||||
| Royalties buyout | 75 | 87 | ||||||
| Total non-current assets | 922 | 1,061 | ||||||
| Total assets | $ | 4,244 | $ | 5,693 |