InspireMD Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2015
(firmenpresse) - BOSTON, MA -- (Marketwired) -- 03/28/16 -- (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 fourth quarter and year ended December 31, 2015.
In 2015, InspireMD advanced its strategic transition into the carotid and neuro interventional markets utilizing its proprietary MicroNet™ technology. Key activities include announced:
Consistent, positive clinical results, with therapeutic benefits sustained at 12 months from the CGuard™ trial, as well as the ongoing investigator-led study;
Expanded regulatory footprint, with CGuard™ approvals in Argentina and Columbia;
Strategic distribution agreement with global interventional therapies company Penumbra, Inc., a market leader in the interventional neuroradiology and peripheral vascular markets;
Initiated European commercial market launch activities of CGuard™ with Penumbra Inc;
Strengthened intellectual property coverage; and
Operational and financial realignment, with ongoing implementation of a comprehensive cash management program.
Sol Barer, Chairman of the Board of InspireMD, commented, "We close 2015 with continued focus and sense of urgency to execute on our strategic plan. While a challenging year, we note progress made. We look forward to completing additional initiatives that position us for sustainable growth, including our ongoing management transition plan with attention on our European commercial and development activities, which were aided by our recent capital raise. Gross proceeds from the March 16th, 2016 private placement and public offering were approximately $1.7 million."
Dr. Barer continued, "We are also pleased with consistent, positive feedback from the CGuard™ launch and are encouraged by its early market traction. In addition, our development efforts in the high value neurovascular field are progressing through positive development milestones.. We look forward to providing timely and continuous updates as we execute on our plans."
Initial European commercial launch of CGuard™ by Penumbra.
Continued focus on expanding European commercial activities in new geographies.
Announced positive 12 month follow up data from its CGuard™ (otid mbolic protection Study using micro) trial which demonstrated zero strokes or stroke-related deaths at 12 months.
Received a DEKRA medical device certification for the manufacture and commercialization of its CGuard™ delivery catheter. The certification also allows the Company to add-on facilities for additional manufacturing work flow.
Advanced next generation neurovascular flow diverter program with positive pre-clinical data results.
Received regulatory approvals to commercialize CGuard™ in Colombia and Argentina.
Comprehensive and active cash management program, including a March 16th, 2016 pricing of an underwritten public offering of 1,900,000 shares of its common stock and warrants to purchase up to 950,000 shares of common stock and a concurrent private placement of 1,033,051shares of its common stock and warrants to purchase up to 516,526 shares of common stock to certain of the Company''s directors.
Announced one-for-ten reverse stock split effective October 1st, 2015.
Continued implementation of cost containment activities while supporting key development programs.
Revenue for the fourth quarter ended December 31, 2015 decreased $0.4 million to $0.5 million compared to $0.9 million during the same period in 2014. The 2015 period included 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 offset by sales of our new product CGuard™ EPS, which was partially launched in October 2014.
The Company''s gross loss for the quarter ended December 31, 2015 was $0.1 million compared to a gross profit of $0.4 million for the same period in 2014. The decrease of 134.5% was largely attributable to the decrease in product revenues and an increase of write-offs and other related adjustments of MGuard™ Prime EPS inventory due to the trend of increased usage of drug eluting stents rather than bare metal stents in STEMI patients., however, were partially offset by a decrease in labor and material costs attributable to lower revenues.
Total operating expenses for the quarter ended December 31, 2015 were $2.5 million, a decrease of 48.9% compared to $4.8 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard™ Prime EPS''s MASTER II trial, which was suspended in October 2014, a decrease in compensation related expenses and other savings associated with our cost reduction plan.
The loss from operations for the quarter ended December 31, 2015 was $2.6 million, a decrease of 41.3% compared to a loss of $4.4 million for the same period in 2014.
Financial expenses for the quarter ended December 31, 2015 was $0.2 million, a decrease of 28.1% compared to the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.
The net loss for the quarter ended December 31, 2015 totaled $2.9 million, or $0.37 per basic and diluted share, compared to a net loss of $4.8 million, or $1.19 per basic and diluted share, in the same period in 2014.
Non-GAAP net loss for the quarter ended December 31, 2015 was $2.3 million, or $0.31 per basic and diluted share, a decrease of 37.9% compared to a non-GAAP net loss of $3.8 million, or $0.94 per basic and diluted share, for the same period in 2014. The non-GAAP net loss for the quarter ended Dec 31, 2015 primarily excludes $0.5 million of share-based compensation. The non-GAAP net loss for the quarter ended December 31, 2014 primarily excludes $1.0 million of share-based compensation.
Revenue for the twelve months ended December 31, 2015 decreased $0.5 million to $2.3 million compared to $2.8 million during the same period in 2014. The 2015 period included 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 offset by sales of our new product CGuard™ EPS, which was partially launched in October 2014.
The Company''s gross loss for the twelve months ended December 31, 2015 was $0.3 million, a decrease of 137.8% compared to a gross profit of $0.8 million for the same period in 2014. The decrease was largely attributable to the decrease in product revenues, an increase in labor and material costs attributable to higher costs for CGuard™ EPS, an increase of write-offs and other related adjustments of MGuard™ Prime EPS inventory due to the trend of increased usage of drug eluting stents rather than bare metal stents in STEMI patients. and longer shelf life requirements.
Total operating expenses for the twelve months ended December 31, 2015 were $14.2 million, a decrease of 42.0% compared to $24.5 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to the suspension of the MGuard MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plan offset by restructuring and impairment expenses.
The loss from operations for the twelve months ended December 31, 2015 was $14.5 million, a decrease of 38.9% compared to a loss of $23.7 million for the same period in 2014.
Financial expenses for the twelve months ended December 31, 2015 decreased 20.9% to $1.1 million from $1.4 million during the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.
The net loss for the twelve months ended December 31, 2015 totaled $15.6 million, or $2.23 per basic and diluted share, compared to a net loss of $25.1 million, or $7.09 per basic and diluted share, in the same period in 2014.
Non-GAAP net loss for the twelve months ended December 31, 2015 was $11.8 million, or $1.69 per basic and diluted share, a decrease of 43.5% compared to a non-GAAP net loss of $20.9 million, or $5.91 per basic and diluted share, for the same period in 2014. The non-GAAP net loss for the twelve months ended December 31, 2015 primarily excludes $3.1 million of share-based compensation and $0.6 million of expense related to an impairment of a royalties buyout asset. The non-GAAP net loss for the twelve months ended December 31, 2014 primarily excludes $4.1 million of share-based compensation.
As of December 31, 2015, cash and cash equivalents were $3.3 million, compared to $6.5 million as of September 30, 2015 and $6.3 million as of December 31, 2014.
The Company is not hosting a conference call to discuss fourth quarter and year end December 31, 2015 results. Additional updates will be provided as they become available.
InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™ 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 (CGuard™), neurovascular, and peripheral artery procedures. InspireMD''s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.
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 . The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email:
Vivian Cervantes
Investor Relations
Phone: (212) 554-5482
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 28.03.2016 - 06:26 Uhr
Sprache: Deutsch
News-ID 1424223
Anzahl Zeichen: 3024
contact information:
Contact person:
Town:
BOSTON, MA
Phone:
Kategorie:
Commercial & Investment Banking
Typ of Press Release:
type of sending:
Date of sending:
Anmerkungen:
Diese Pressemitteilung wurde bisher 186 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"InspireMD Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2015
"
steht unter der journalistisch-redaktionellen Verantwortung von
InspireMD, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
