UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 10, 2020

ReWalk Robotics Ltd.

(Exact name of registrant as specified in its charter)

Israel
 
001-36612
 
Not applicable
(State or Other Jurisdiction
of Incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
     
3 Hatnufa St., Floor 6, Yokneam Ilit, Israel
 
2069203
(Address of principal executive offices)
 
(Zip Code)

Registrant’s telephone number, including area code: +972.4.959.0123

Not applicable
(Former name or former address, if changed since last report)
 
Securities registered pursuant to
Section 12(b) of the Exchange Act
 
Trading symbol
 
Name of exchange on which
registered
Ordinary shares, par value NIS 0.25
 
RWLK
 
Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

Item 2.02 Results of Operations and Financial Condition.
 
On November 10, 2020, ReWalk Robotics Ltd. (the “Company,” “we” or “us”) issued a press release announcing its financial results for the third quarter ended September 30, 2020. A copy of the press release is being furnished herewith as Exhibit 99.1. As set forth in the press release, the Company hosted a conference call to discuss its financial results for the third quarter ended September 30, 2020 on November 10, 2020 at 8:30 a.m. E.D.T. The archived webcast will be available at https://edge.media-server.com/mmc/p/ou3s2suj and/or through the Company’s website at www.rewalk.com under the “Investors” section for 30 days after the completion of the call.
 
The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “1934 Act”), nor shall it be deemed “incorporated by reference” into any filing under the Securities Act of 1933, as amended, or the 1934 Act, except as may be expressly set forth by specific reference in such filing.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits
*
Furnished herewith


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
ReWalk Robotics Ltd.
 
Dated: November 10, 2020
By:
/s/ Ori Gon
 
 
Name:
Ori Gon
 
 
Title:
Chief Financial Officer
 



Exhibit 99.1


ReWalk Robotics Reports Third Quarter 2020 Financial Results
 
MARLBOROUGH, Mass. BERLIN, Germany and YOKNEAM ILIT, Israel, November 10, 2020 - ReWalk Robotics Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”) today announced its financial results for the three and nine months ended September 30, 2020.
 
Highlights of and subsequent to the third quarter of 2020 include:
 

Total revenue for the third quarter of 2020 was $0.7 million, compared to $1.2 million in the prior year quarter;
 

Received Medicare Provider certification from the Centers for Medicare & Medicaid Services ("CMS");
 

Completed additional contract with a German payor; and
 

Raised total of approximately $9.0 million in gross proceeds from a registered direct offering of ordinary shares and a concurrent private placement of unregistered warrants to purchase ordinary shares (as previously referenced in ReWalk’s Second Quarter 2020 Financial Results).

Our most important measurements in the quarter were the achievements with CMS certification and the additional German insurance contract as they are the strategic drivers of growth for our company” said Larry Jasinski, Chief Executive Officer. “The revenue for the quarter was impacted by the limited market access to train and process insurance submissions due to the current environment. We anticipate that our results will remain choppy until COVID-19 restrictions lessen.”
 
Third Quarter 2020 Financial Results
 
Total revenue was $0.7 million for the third quarter of 2020, compared to $1.2 million during the prior year quarter. The decrease was mainly due to a lower number of units sold in Germany and the U.S.
 
Gross margin remained generally flat with 52% during the third quarter of 2020 compared to 53% during the third quarter of 2019.
 
Total operating expenses in the third quarter of 2020 were $3.5 million, compared to $3.7 million in the prior year quarter. The decrease was mainly due to lower R&D spend as we completed the development of our ReStore® device.
 
Net loss was $3.3 million for the third quarter of 2020, compared to a net loss of $3.4 million in the prior year quarter.
 
Non-GAAP net loss was $3.0 million for the third of 2020 compared to $3.1 million during the prior year quarter. Reconciliation of net loss to non-GAAP net loss is included at the end of this press release.
 
Liquidity
 
As of September 30, 2020, ReWalk had $18.1 million in cash on its balance sheet and $3.4 million in short- and long-term debt.
 

Conference Call
 
ReWalk management will host its third quarter 2020 conference call as follows:

Date
Tuesday, November 10, 2020
Time
8:30 AM EST
Telephone
U.S:
(844) 423-9889
 
International:
(716) 247-5804
 
Israel:
18 09 31 53 62
 
Germany:
08 00 18 15 287
Access code
7496152
Webcast (live, listen-only and archive)
www.rewalk.com under the “Investors” section.

The archived webcast will be available via the following URL https://edge.media-server.com/mmc/p/ou3s2sujor through the 'Investors—Webcasts & Presentations' section on www.rewalk.com.
 
About ReWalk Robotics Ltd.
 
ReWalk Robotics Ltd. develops, manufactures, and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke.  ReWalk’s 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 www.rewalk.com.
 
ReWalk® is a registered trademark of ReWalk Robotics Ltd. in Israel and the United States.
 
ReStore® is a registered trademark of ReWalk Robotics Ltd. in Europe and an allowed trademark in the United States.
 

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 other statements that are not statements of historical fact 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 management's conclusion, and its independent registered public accounting firm's statement in its opinion relating to its consolidated financial statements for the fiscal year ended December 31, 2019, that there is a substantial doubt as to the Company's ability to continue as a going concern; the current COVID-19 pandemic has adversely affected and may continue to affect adversely  business and results of operations; ReWalk's ability to have sufficient funds to meet certain future capital requirements, which could impair the Company's efforts to develop and commercialize existing and new products; ReWalk's ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market and the risk that its ordinary shares will be delisted if it cannot do so; ReWalk's ability to establish a pathway to commercialize its products in China; ReWalk's ability to maintain and grow its reputation and the market acceptance of its products; ReWalk's ability to achieve reimbursement from third-party payors for its products; ReWalk's limited operating history and its ability to leverage its sales, marketing and training infrastructure; ReWalk's expectations as to its clinical research program and clinical results; ReWalk's expectations regarding future growth, including its ability to increase sales in its existing geographic markets and expand to new markets; ReWalk's ability to obtain certain components of its products from third-party suppliers and its continued access to its product manufacturers; ReWalk's ability to repay its secured indebtedness; ReWalk's ability to improve its products and develop new products; ReWalk's compliance with medical device reporting regulations to report adverse events involving the Company's products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on ReWalk's ability to market and sell its products; ReWalk's ability to gain and maintain regulatory approvals; ReWalk's expectations as to the results of, and the Food and Drug Administration's potential regulatory developments with respect to its mandatory 522 postmarket surveillance study; ReWalk's ability to maintain adequate protection of its intellectual property and to avoid violation of the intellectual property rights of others; the risk of a cybersecurity attack or breach of the Company's IT systems significantly disrupting its business operations; the impact of substantial sales of the Company's shares by certain shareholders on the market price of the Company's ordinary shares; ReWalk's ability to use effectively the proceeds of its offerings of securities; the risk of substantial dilution resulting from the periodic issuances of ReWalk's ordinary shares; the impact of the market price of the Company's ordinary shares on the determination of whether it is a passive foreign investment company; and other factors discussed under the heading "Risk Factors" in ReWalk's annual report on Form 10-K for the year ended December 31, 2019 filed with the SEC and other documents subsequently filed with or furnished to the SEC. 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 nine months ended September 30, 2020 and 2019, 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.
 
Investor Contact:
Ori Gon
Chief Financial Officer 
ReWalk Robotics Ltd.
T: +972-4-9590123 
E: investorrelations@rewalk.com


ReWalk Robotics Ltd. And subsidiaries
Condensed Consolidated Statements of Operations
(unaudited)
(In thousands, except share and per share data)

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
September 30,
 
   
2020
   
2019
   
2020
   
2019
 
                         
Revenue
 
$
747
   
$
1,234
   
$
3,175
   
$
3,692
 
Cost of revenues
   
355
     
585
     
1,388
     
1,682
 
                                 
Gross profit
   
392
     
649
     
1,787
     
2,010
 
                                 
Operating expenses:
                               
Research and development, net
   
756
     
1,018
     
2,695
     
4,292
 
Sales and marketing
   
1,507
     
1,453
     
4,541
     
4,571
 
General and administrative
   
1,198
     
1,209
     
3,774
     
3,988
 
Total operating expenses
   
3,461
     
3,680
     
11,010
     
12,851
 
Operating loss
   
(3,069
)
   
(3,031
)
   
(9,223
)
   
(10,841
)
Financial expenses, net
   
242
     
360
     
723
     
1,131
 
Loss before income taxes
   
(3,311
)
   
(3,391
)
   
(9,946
)
   
(11,972
)
Taxes on income (tax benefit)
   
25
     
(2
)
   
85
     
4
 
                                 
Net loss
 
$
(3,336
)
 
$
(3,389
)
 
$
(10,031
)
 
$
(11,976
)
                                 
Net loss per ordinary share, basic and diluted
 
$
(0.18
)
 
$
(0.46
)
 
$
(0.71
)
 
$
(2.27
)
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
   
18,881,694
     
7,290,791
     
14,132,375
     
5,284,451
 
                                 
Reconciliation of GAAP to Non-GAAP net loss
                               
Net loss
 
$
(3,336
)
 
$
(3,389
)
 
$
(10,031
)
 
$
(11,976
)
Non-cash share based compensation expense
   
232
     
236
     
544
     
869
 
Depreciation of property and equipment, net
   
64
     
69
     
215
     
242
 
Non-cash financial expenses
   
59
     
-
     
59
     
-
 
Non-GAAP net loss
 
$
(2,981
)
 
$
(3,084
)
 
$
(9,213
)
 
$
(10,865
)


ReWalk Robotics Ltd. And subsidiaries
Condensed Consolidated Balance Sheets
(unaudited)
(In thousands, except share and per share data)

   
September 30,
   
December 31,
 
   
2020
   
2019
 
Assets
           
             
Current assets
           
Cash and cash equivalents
 
$
18,050
   
$
16,253
 
Trade receivable, net
   
715
     
794
 
Prepaid expenses and other current assets
   
833
     
903
 
Inventories
   
3,707
     
3,123
 
Total current assets
   
23,305
     
21,073
 
                 
Restricted cash and other long term assets
   
1,034
     
1,061
 
Operating lease right-of-use assets
   
1,421
     
1,737
 
Property and equipment, net
   
474
     
501
 
Total assets
 
$
26,234
   
$
24,372
 
                 
Liabilities and equity
               
                 
Current liabilities
               
Current maturities of long term loans
 
$
3,280
   
$
5,438
 
Current maturities of operating leases
   
622
     
637
 
Trade payables
   
2,107
     
2,698
 
Other current liabilities
   
1,636
     
1,395
 
Total current liabilities
   
7,645
     
10,168
 
                 
Long term loan, net of current maturities
   
154
     
1,527
 
Noncurrent operating leases
   
985
     
1,315
 
Other long-term liabilities
   
661
     
582
 
                 
Shareholders’ equity
   
16,789
     
10,780
 
Total liabilities and equity
 
$
26,234
   
$
24,372
 


ReWalk Robotics Ltd. And subsidiaries
Condensed Consolidated Statements of Cash Flows
(unaudited)
(In thousands)

   
Nine Months Ended
 
   
September 30,
 
   
2020
   
2019
 
             
Net cash used in operating activities
 
$
(10,131
)
 
$
(11,225
)
                 
Net cash used in investing activities
   
(73
)
   
(8
)
                 
Net cash provided by financing activities
   
11,948
     
22,033
 
                 
Increase in cash, cash equivalents, and restricted cash
   
1,744
     
10,800
 
Cash, cash equivalents, and restricted cash at beginning of period
   
16,992
     
10,347
 
                 
Cash, cash equivalents, and restricted cash at end of period
 
$
18,736
   
$
21,147
 

ReWalk Robotics Ltd. And subsidiaries
(unaudited)
(In thousands, except units placed)

   
Three Months Ended
   
Nine Months Ended
 
   
September 30,
   
September 30,
 
   
2020
   
2019
   
2020
   
2019
 
   
(Unaudited)
   
(Unaudited)
 
Revenue:
                       
Israel
 
$
-
   
$
-
   
$
-
   
$
2
 
United States
   
325
     
569
     
1,172
     
1,492
 
Europe
   
413
     
665
     
1,990
     
2,162
 
Asia Pacific
   
2
     
-
     
6
     
36
 
Latin America
   
6
     
-
     
6
     
-
 
Africa
   
1
     
-
     
1
     
-
 
Total Revenue
 
$
747
   
$
1,234
   
$
3,175
   
$
3,692
 
                                 
Revenue:
                               
Personal units revenue
 
$
698
   
$
1,127
   
$
3,079
   
$
3,524
 
Rehabilitation units revenue
   
49
     
107
     
96
     
168
 
Total Revenue
 
$
747
   
$
1,234
   
$
3,175
   
$
3,692