SOURCE: InSpireMD

InspireMD

November 10, 2015 07:00 ET

InspireMD Reports Financial Results for the Third Quarter Ended September 30, 2015

BOSTON, MA--(Marketwired - Nov 10, 2015) - 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 third quarter ended September 30, 2015.

In its third full quarter of a strategic transition into the carotid and neuro interventional markets utilizing its proprietary MicroNet™ technology, key activities included the announced strategic distributor agreement with global interventional therapies company Penumbra, Inc., strengthened intellectual property coverage, including the issuance of two US patents, and expanded regulatory footprint with CGuard approvals for both Argentina and Colombia. In addition, InspireMD's development program for its neurovascular flow diverter platform remains on track for pre-clinical results in December 2015 and CE Mark submission in 2H 2016. Broad collaboration discussions advanced steadily facilitated by an external financial and strategic advisor engaged to assist in the review of various strategic alternatives.

Alan Milinazzo, CEO of InspireMD, commented, "With 2015 being a transition year for InspireMD, we continue to execute on our strategic plan with clear focus and a sense of urgency. We highlight progress made in recent months and look forward to sustainable growth in 2016. Feedback from the CGuard™ launch remains positive, aided by both the CARENET and PARADIGM clinical data sets that have received prominent attention at major clinical meetings this year. Recent approvals in Colombia and Argentina also allow us to bring this important technology to key markets around the world as we balance investments in the business with disciplined cash management."

Mr. Milinazzo continued, "We are pleased to note that our development efforts in the high value neurovascular field are tracking to expectations while we actively advance discussions across indications that leverage our MicroNet™ technology. Finally, to ensure that we maximize InspireMD shareholder value, we have engaged TM Asante Healthcare Partners as an outside strategic advisor to further our business development activities."

Recent Operating Highlights:

COMMERCIAL

  • Announced full European market launch of CGuard™ in late September at CIRSE 2015 by Penumbra Inc., a global market leader in the interventional neuroradiology and peripheral vascular markets.

  • Reported sequential revenue increase of 85% for CGuard™.

  • On track for full Penumbra commercial launch of CGuard™ in Q4 of 2015.

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Received regulatory approvals to commercialize CGuard™ in Colombia and Argentina.

  • Received two US patent issuances.

  • Advanced next generation neurovascular flow diverter program with pre-clinical data on-track for December 2015 and CE Mark submission in 2H 2016.

  • Reported positive results from the investigator led PARADIGM trial in an all comers patient population.

  • Awarded 2015 Frost & Sullivan European Innovation Award for Product Development.

  • Advanced broad collaboration discussions across indications -- cardiovascular, carotid, and neurovascular -- that leverage the MicroNet™ technology, with facilitation from a recently engaged financial and strategic advisor.

FINANCIAL

  • Announced one-for-ten reverse stock split effective October 1, 2015.

  • Comprehensive cash management, with steady, measured declines in monthly cash use.

  • Continued implementation of cost containment activities while supporting key development programs.

Quarter Ended September 30, 2015 Financial Results

Revenue for the third quarter ended September 30, 2015 increased $0.3 million to $0.6 million compared to $0.3 million during the same period in 2014. The increase was predominately driven by sales of $0.3 million of our new product CGuard™ EPS, our carotid product, which was launched in October 2014. Sales of CGuard™ EPS during the three months ended September 30, 2015 were predominately driven by initial sales to our new strategic distribution partner, Penumbra, Inc.

The company's gross profit for the quarter ended September 30, 2015 was $0.1 million compared to a gross loss of $0.1 million for the same period in 2014. The improvement of 217.1% was largely attributable to the increase in product revenues and a decrease of write-offs of inventory of MGuard™ Prime EPS. These improvements in gross profit, however, were partially offset by an increase in labor and material costs attributable to higher revenues.

Total operating expenses for the quarter ended September 30, 2015 were $3.5 million, a decrease of 45.3% compared to $6.4 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 September 30, 2015 was $3.4 million, a decrease of 47.4% compared to a loss of $6.5 million for the same period in 2014.

Financial expenses for the quarter ended September 30, 2015 was $0.2 million, a decrease of 27.2% 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 September 30, 2015 totaled $3.6 million, or $0.48 per basic and diluted share, compared to a net loss of $6.8 million, or $1.96 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the quarter ended September 30, 2015 was $2.8 million, or $0.36 per basic and diluted share, a decrease of 51.6% compared to a non-GAAP net loss of $5.7 million, or $1.65 per basic and diluted share, for the same period in 2014. The non-GAAP net loss for the quarter ended September 30, 2015 primarily excludes $0.6 million of share-based compensation and $0.3 million of expense related to the impairment of the value of our royalties buyout option associated with MGuard™ Prime EPS. The non-GAAP net loss for the quarter ended September 30, 2014 primarily excludes $1.1 million of share-based compensation.

Nine Months Ended September 30, 2015 Financial Results

Revenue for the nine months ended September 30, 2015 decreased $0.1 million to $1.8 million compared to $1.9 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 launched in October 2014. The sales of CGuard™ EPS during the nine months ended September 30, 2015 included initial sales to our new strategic distribution partner, Penumbra, Inc. which commenced during the third quarter.

The company's gross loss for the nine months ended September 30, 2015 was $0.2 million, a decrease of 141.0% compared to a gross profit of $0.4 million for the same period in 2014. The decrease was largely attributable to an increase in labor and material costs attributable to higher costs for CGuard™ EPS and write-offs of inventory due to the trend of increased usage of DES stents in STEMI patients, longer shelf life requirements and the transition to the rapid exchange delivery system for CGuard from the over the wire platform.

Total operating expenses for the nine months ended September 30, 2015 were $11.7 million, a decrease of 40.4% compared to $19.6 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard's MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plan.

The loss from operations for the nine months ended September 30, 2015 was $11.9 million, a decrease of 38.3% compared to a loss of $19.3 million for the same period in 2014.

Financial expenses for the nine months ended September 30, 2015 decreased 18.6% to $0.9 million from $1.1 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 nine months ended September 30, 2015 totaled $12.7 million, or $1.89 per basic and diluted share, compared to a net loss of $20.3 million, or $5.93 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the nine months ended September 30, 2015 was $9.5 million, or $1.40 per basic and diluted share, a decrease of 44.7% compared to a non-GAAP net loss of $17.1 million, or $5.00 per basic and diluted share, for the same period in 2014. The non-GAAP net loss for the nine months ended September 30, 2015 primarily excludes $2.6 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 nine months ended September 30, 2014 primarily excludes $3.2 million of share-based compensation.

Cash and Cash Equivalents

As of September 30, 2015, cash and cash equivalents were $6.5 million, compared to $6.3 million as of December 31, 2014.

Quarterly Conference Call Details

The company has scheduled a conference call to discuss third quarter 2015 financial results for today at 8:30 AM Eastern. To participate in the conference call, please dial (888) 243-4451 (United States) or (412) 542-4135 (International) and request the InspireMD call. A live webcast of the call will also be available on the Investor Relations section of the Company's website at http://www.inspiremd.com/en/investors/investor-relations/. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company's website at http://www.inspiremd.com/en/investors/investor-relations/ for a limited time. A dial-in replay of the call will also be available to those interested until November 24, 2015. To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International) and enter code: 10075630.

About InspireMD, Inc.

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.

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.

   
CONSOLIDATED STATEMENTS OF OPERATIONS (1)  
(U.S. dollars in thousands, except per share data)  
   
  Three months ended
September 30,
    Nine months ended
September 30,
 
 
  2015     2014     2015     2014  
                               
                               
Revenues $ 632     $ 273     $ 1,794     $ 1,948  
Cost of revenues   543       349       1,954       1,558  
                               
Gross Profit (Loss)   89       (76 )     (160 )     390  
                               
Operating Expenses:                              
Research and development   781       2,460       2,880       7,485  
Selling and marketing   588       1,806       2,600       5,030  
General and administrative   1,713       2,139       5,270       7,126  
Restructuring and impairment expenses   418       -       964       -  
                               
Total operating expenses   3,500       6,405       11,714       19,641  
                               
Loss from operations   (3,411 )     (6,481 )     (11,874 )     (19,251 )
                               
Financial expenses   228       313       856       1,051  
                               
Loss before tax expenses   (3,639 )     (6,794 )     (12,730 )     (20,302 )
                               
Tax expenses (Income)   2       (19 )     1       3  
                               
Net Loss $ (3,641 )   $ (6,775 )   $ (12,731 )   $ (20,305 )
                               
Net loss per share - basic and diluted $ (0.48 )   $ (1.96 )   $ (1.89 )   $ (5.93 )
                               
Weighted average number of shares of common stock used in computing net loss per share - basic and diluted   7,630,985       3,458,152       6,753,011       3,425,162  
                               
                               
                               
RECONCILIATION OF NON-GAAP NET LOSS (2)  
(U.S. dollars in thousands, except per share data)  
   
  Three months ended
September 30,
    Nine months ended
September 30,
 
 
  2015     2014     2015     2014  
                               
                               
GAAP Net Loss $ (3,641 )   $ (6,775 )   $ (12,731 )   $ (20,305 )
                               
Non-GAAP Adjustments:                              
Share-based compensation expenses   601       1,052       2,600       3,151  
Impairment of royalties buyout   260       -       576       -  
Royalties buyout expenses and amortization   22       20       80       60  
Non-cash financial expenses (income)(3)   -       -       -       (47 )
                               
Total Non-GAAP Adjustments   883       1,072       3,256       3,164  
                               
Non-GAAP Net Loss $ (2,758 )   $ (5,703 )   $ (9,475 )   $ (17,141 )
                               
Non-GAAP net loss per share - basic and diluted $ (0.36 )   $ (1.65 )   $ (1.40 )   $ (5.00 )
                               
Weighted average number of shares of common stock used in computing net loss per share - basic and diluted   7,630,985       3,458,152       6,753,011       3,425,162  
                               
                               
                               
CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)
 
ASSETS September 30,
2015
  December 31,
2014
           
Current Assets:          
Cash and cash equivalents $ 6,509   $ 6,300
Accounts receivable:          
Trade, net   664     635
Other   199     359
Prepaid expenses   108     150
Inventory   1,081     1,924
           
Total current assets   8,561     9,368
           
           
Non-current assets:
Property, plant and equipment, net   516     622
Deferred issuance costs   102     153
Funds in respect of employee rights upon retirement   466     498
Long term prepaid expenses   20     66
Royalties buyout   96     752
           
Total non-current assets   1,200     2,091
           
Total assets $ 9,761   $ 11,459
           
           
           
LIABILITIES (NET OF CAPITAL DEFICIENCY) September 30,     December 31,  
2015     2014  
               
Current liabilities:              
Accounts payable and accruals:              
Trade $ 834     $ 909  
Other   2,403       3,576  
Advanced payment from customers   170       179  
Current maturity of loan   4,123       3,809  
               
Total current liabilities   7,530       8,473  
               
               
Long-term liabilities:              
Liability for employees rights upon retirement   658       687  
Long -term loan   2,147       5,086  
               
Total long-term liabilities   2,805       5,773  
               
               
Total liabilities   10,335       14,246  
               
Equity:              
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 7,632,752 and 4,136,889 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively   7       4  
Additional paid-in capital   119,561       104,620  
Accumulated deficit   (120,142 )     (107,411 )
               
Total capital deficiency   (574 )     (2,787 )
               
Total liabilities net of capital deficiency $ 9,761     $ 11,459  
               
(1) All 2015 financial information is derived from the Company's 2015 unaudited financial statements, as disclosed in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2014 financial information is derived from the Company's 2014 unaudited financial statements, as disclosed in the Company's Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.  
   
(2) Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we are providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results "through the eyes" of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.  
               
(3) Non-cash financial income relates to the issuance of shares as a result of the anti-dilution rights of our March 2011 investors.  
               
(4) All September 30, 2015 financial information is derived from the Company's 2015 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, 2014 financial information is derived from the Company's 2014 audited financial statements as disclosed in the Company's Annual Report on Form 10-K, for the twelve months ended December 31, 2014 filed with the Securities and Exchange Commission.  
   

Contact Information

  • Investor Contacts:
    InspireMD, Inc.
    Craig Shore
    Chief Financial Officer
    Phone: 1-888-776-6804 FREE
    Email: craigs@inspiremd.com

    PCG Advisory
    Vivian Cervantes
    Investor Relations
    Phone: (212) 554-5482