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ReWalk Robotics Reports Fourth Quarter and Year-End 2016 Financial Results

LFWD

— 2016 Full year revenue grows 57% to $5.9 million —
— Year-over-year unit placements up 63%; favorable insurance reimbursement decisions up 122% —

YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Feb. 17, 2017 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (Nasdaq:RWLK) (“ReWalk” or “the Company”) today announced its financial results for the three- and twelve-month periods ended December 31, 2016.

Highlights of and subsequent to the fourth quarter include:

  • Total revenue for the fourth quarter 2016 was $1.6 million; total revenue for the full year 2016 grew 57% to $5.9 million compared to 2015;
  • 39 units were placed during the fourth quarter 2016; 119 units were placed in 2016, up 63% over 2015;
  • In 2016, a total of 51 favorable insurance coverage decisions resulted in reimbursement for ReWalk devices: 13 from the U.S. Department of Veterans Affairs and 38 favorable case by case decisions from payors in the U.S. and Germany;
  • The 522 post-market clinical study initiated at Stanford University was expanded to two additional sites and the scope was broadened to include utilization patterns and quality of life measures; and
  • Net proceeds of $34 million were secured during 2016 through a combination of debt and equity to fund the Company’s strategic market development and reimbursement activities.

“As ReWalk strives to create and lead this new industry, we believe we made solid progress in 2016 to advance our goals. More ReWalk devices are being used at home and in the community than ever before and through our efforts with the U.S. Department of Veterans Affairs, all qualified veterans now have a path to a ReWalk system.  Additionally, we are optimistic that our advanced discussions with large national coverage providers in the U.S. and Germany will result in broad coverage policies this year, expanding access to potentially thousands of new users over time,” stated Larry Jasinski, Chief Executive Officer.

“We are also focused on opportunities to treat additional indications and have focused our R&D efforts on our collaboration with Harvard’s Wyss Institute to develop a soft exo-suit designed to meet the needs of stroke victims. As we prepare for our first clinical trial of the soft exo-suit this year, we are excited by the potential of the technology to serve as a new standard of care in treating stroke patients in the rehabilitation setting,” added Jasinski.

“In 2017, we intend to focus on supporting sales growth, securing broad reimbursement coverage, and advancing our product developments efforts,” concluded Jasinski.

Fourth Quarter 2016 Financial Results

Total revenue was $1.6 million for the fourth quarter of 2016, compared to $1.3 million in the fourth quarter of 2015, and up sequentially from $1.4 million in the third quarter of 2016.  39 ReWalk systems were placed during the fourth quarter of 2016, compared to 25 ReWalk systems placed in the prior year period, and 23 placed in the third quarter of 2016.

Total operating expenses in the fourth quarter of 2016 were $7.9 million compared to $7.5 million in the prior year period.

Net loss was $8.5 million for the fourth quarter of 2016 compared to a net loss of $7.5 million in the fourth quarter of 2015. Non-GAAP net loss for the fourth quarter was $7.2 million compared with a non-GAAP net loss of $6.7 million in the fourth quarter of 2015.*

*A reconciliation of net loss to non-GAAP net loss is included at the end of this press release.

Year-End 2016 Financial Results

Total revenue was $5.9 million for the year ended December 31, 2016, compared to $3.7 million in 2015. In 2016, 119 ReWalk systems were placed compared to 73 ReWalk systems placed during 2015.

Full year 2016 operating expenses were $31.2 million compared to $25.4 million in 2015. In 2017, ReWalk is implementing initiatives to reduce operating expenses including staff reductions, savings from projects completed at the end of 2016 and other corporate spend. 

Net loss for the year ended December 31, 2016 was $32.5 million compared to a net loss of $25.4 million for the full year 2015. Non-GAAP net loss was $27.7 million for the year compared with a non-GAAP net loss of $22.6 million last year.*

*A reconciliation of net loss to non-GAAP net loss is included at the end of this press release.

Liquidity

As of December 31, 2016, ReWalk had $23.7 million in cash on its balance sheet. In 2016, ReWalk generated approximately $34 million from debt and equity financing activities.

Conference Call

ReWalk management will host its fourth quarter 2016 and year end conference call as follows:

Date   Friday, February 17, 2017
Time   8:30 AM EST
Telephone U.S:   (844) 423-9889
  International:   (716) 247-5804
  Israel:   18 09 31 53 62
Access code   66049360
Webcast (live, listen-only and archive)   www.rewalk.com under the “Investors” section.

A telephone replay will be available shortly after the completion of the call for two weeks at (855) 859-2056 (U.S.) or (404) 537-3406 (International). The passcode for the replay is 66049360.

About ReWalk Robotics Ltd.

ReWalk Robotics Ltd. develops, manufactures and markets wearable robotic exoskeletons for individuals with spinal cord injury. Our mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies. Founded in 2001, ReWalk has headquarters in the U.S., Israel and Germany. For more information on the ReWalk systems, please visit http://www.rewalk.com.

ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel.

Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. Such forward-looking statements may include projections regarding ReWalk’s future performance and, in some cases, may be identified by words like “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “will,” “should,” “would,” “seek” and similar terms or phrases. The forward-looking statements contained in this press release are based on management’s current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk’s control. Important factors that could cause ReWalk’s actual results to differ materially from those indicated in the forward-looking statements include, among others: ReWalk’s expectations regarding future growth, including its ability to increase sales in its existing geographic markets and to expand to new markets; the conclusion of ReWalk’s management, and the opinion of ReWalk’s auditors in their report on the Company’s consolidated financial statements for the fiscal year ended December 31, 2016, that there are substantial doubts as to ReWalk’s ability to continue as a going concern; ReWalk’s ability to maintain and grow its reputation and to achieve and maintain market acceptance of its products; ReWalk’s ability to achieve reimbursement from third-party payors for its products; ReWalk’s ability to repay its secured indebtedness; ReWalk’s expectations as to its clinical research program and clinical results; ReWalk’s expectations as to the results of, and the Food and Drug Administration’s potential regulatory actions with respect to, ReWalk’s mandatory post-market 522 surveillance study; the outcome of ongoing shareholder class action litigation relating to ReWalk’s initial public offering; ReWalk’s ability to improve its products and develop new products; ReWalk’s ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; ReWalk’s ability to gain and maintain regulatory approvals; ReWalk’s ability to use effectively the proceeds of its 2016 follow-on offering; ReWalk’s ability to secure capital from its at-the-market equity distribution program based on the price range of its ordinary shares and conditions in the financial markets; ReWalk’s ability to maintain relationships with existing customers and develop relationships with new customers; ReWalk’s ability to regain compliance with NASDAQ continued listing requirements; and other factors discussed under the heading “Risk Factors” in ReWalk’s Annual Report on Form 10-K for the year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission and other documents subsequently filed with or furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this press release speaks only as of the date hereof. Factors or events that could cause ReWalk’s actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), ReWalk believes that the use of non-GAAP accounting measures, including non-GAAP net loss, is helpful to its investors. These measures, which the Company refers to as non-GAAP financial measures, are not prepared in accordance with GAAP.

For the three and twelve months ended December 31, 2016 and 2015, non-GAAP net loss is calculated as GAAP net loss excluding (i) non-cash share-based compensation expense, (ii) depreciation and (iii) non-cash financial expenses.

Because of varying available valuation methodologies, subjective assumptions, and the variety of equity instruments that can impact a company’s non-cash expenses, ReWalk believes that providing non-GAAP financial measures that exclude non-cash share-based compensation expense, depreciation and non-cash financial (income) expenses allows for more meaningful comparisons between operating results from period to period. Each of the Company’s non-GAAP financial measures is an important tool for financial and operational decision-making and for the Company’s evaluation of its operating results over different periods of time. The non-GAAP financial data are not measures of the Company’s financial performance under U.S. GAAP, and should not be considered as alternatives to operating loss or net loss or any other performance measures derived in accordance with GAAP. Non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in ReWalk’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. In addition, there are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with GAAP, may be different from non-GAAP financial measures used by other companies and exclude expenses that may have a material impact on the Company’s reported financial results. Further, share-based compensation expense has been, and will continue to be for the foreseeable future, a significant recurring expense in the Company’s business and an important part of the compensation provided to its employees. The presentation of non-GAAP financial information is not meant to be considered in isolation or as a substitute for the directly comparable financial measures prepared in accordance with GAAP. ReWalk urges investors to review the reconciliation of the Company’s non-GAAP financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate the Company’s business.

(tables follow)


ReWalk Robotics Ltd.    
Condensed Consolidated Statements of Operations    
In thousands except per share data    
(unaudited)    
                       
    Three Months Ended     Twelve months ended    
    December 31,     December 31,    
    2016     2015       2016     2015      
                               
Revenue $ 1,591   $ 1,336     $ 5,869   $ 3,746      
Cost of revenues   1,723     1,302       5,133     3,532      
Gross profit (loss)   (132 )   34       736     214      
Operating expenses:                      
Research and development, net   2,291     1,687       9,028     5,937      
Sales and marketing   3,384     3,935       13,961     13,056      
General and administration   2,228     1,917       8,188     6,395      
Total operating expenses   7,903     7,539       31,177     25,388      
Operating loss   (8,035 )   (7,505 )     (30,441 )   (25,174 )    
Financial expenses, net   545     4       2,059     188      
Loss before income taxes   (8,580 )   (7,509 )     (32,500 )   (25,362 )    
Income taxes   (36 )   (2 )     3     53      
Net loss $ (8,544 ) $ (7,507 )   $ (32,503 ) $ (25,415 )    
Net loss per ordinary share, basic and diluted $ (0.56 ) $ (0.62 )   $ (2.47 ) $ (2.10 )    
Weighted average number of shares, basic and diluted   15,227,211     12,175,430       13,178,107     12,115,038      
                       
                       
Reconciliation of GAAP to Non-GAAP net loss                      
Net loss $ (8,544 ) $ (7,507 )   $ (32,503 ) $ (25,415 )    
Non-cash share-based compensation expense   940     661       3,398     2,345      
Depreciation   193     189       696     438      
Non-cash financial expenses   180           675          
Non-GAAP net loss $ (7,231 ) $ (6,657 )   $ (27,734 ) $ (22,632 )    
                       
                       
ReWalk Robotics Ltd.    
Condensed Consolidated Balance Sheets    
In thousands    
(unaudited)    
                       
    December 31,              
    2016     2015                
Assets                      
Current assets                      
Cash & cash equivalents $ 23,678   $ 17,869                
Trade receivable, net   1,254     2,146                
Prepaid expenses and other current assets   1,291     1,227                
Inventory   3,264     2,534                
Total current assets   29,487     23,776                
Other long-term assets   1,018     470                
Property and equipment, net   1,258     1,328                
Total assets $ 31,763   $ 25,574                
Liabilities and equity                      
Current liabilities                      
Current maturities of long term loan $ 7,495   $                
Trade payables   3,424     2,474                
Other current liabilities   1,479     1,869                
Total current liabilities   12,398     4,343                
                       
Long term loan, net of current maturities   10,518                    
Other long-term liabilities   587     311                
Shareholders' equity   8,260     20,920                
Total liabilities and shareholders’ equity $ 31,763   $ 25,574                
                       
                       
                       
ReWalk Robotics Ltd.    
Condensed Consolidated Statements of Cash Flows    
In thousands    
(unaudited)    
                       
    Twelve months ended          
    December 31,          
    2016     2015                
                       
Net cash used in operating activities $ (27,537 ) $ (25,180 )              
                       
Net cash provided by (used in) investing activities   (437 )   1,083                
                       
Net cash provided by financing activities   33,783     137                
                       
Increase (decrease) in cash and cash equivalents   5,809     (23,960 )              
                       
Cash and cash equivalents at beginning of period   17,869     41,829                
                       
Cash and cash equivalents at end of period $ 23,678   $ 17,869                
                       
                       
                       
ReWalk Robotics Ltd.  
Revenue and Units Placed by Region and Product  
In thousands except units  
(unaudited)  
                       
    Three Months Ended     Twelve months ended    
    December 31,     December 31,    
    2016     2015       2016     2015      
Revenue:                      
United States $ 765   $ 764     $ 3,741   $ 2,439      
Europe   236     461       1,144     820      
Asia Pacific   590     111       984     487      
Total Revenue $ 1,591   $ 1,336     $ 5,869   $ 3,746      
                       
Units Placed:                      
United States   12     16       63     44      
Europe   5     7       25     19      
Asia Pacific   22     2       31     10      
Total Units Placed   39     25       119     73      
                       
                       
Revenue:                      
Personal units revenue $ 1,268   $ 1,196     $ 5,197   $ 2,766      
Rehabilitation units revenue   323     140       672     980      
Total Revenue $ 1,591   $ 1,336     $ 5,869   $ 3,746      
                       
Units Placed:                      
Personal units placed   34     23       109     53      
Rehabilitation units placed   5     2       10     20      
Total Units Placed   39     25       119     73      
                       
Investor Contact: Lisa M. Wilson President In-Site Communications, Inc. T: 212-452-2793 E: lwilson@insitecony.com

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