ReWalk Robotics Ltd. - 1607962 - 2022
0001607962 false --12-31 2022 Q1 IL See Note 7.e. to the condensed consolidated financial statements. See Note 7.c. to the condensed consolidated financial statements. See Note 7.c. to the condensed consolidated financial statements. See Note 7.c. to the condensed consolidated financial statements. Long-lived assets are comprised of property and equipment, net, and operating lease right-of-use assets. Balance presented net of unrecognized revenues that were not yet collected. During the three months ended March 31, 2022, $123 thousand of the December 31, 2021 deferred revenues balance was recognized as revenues. Less than 10% See Note 7.e. to the condensed consolidated financial statements. Calculation of weighted average remaining contractual term does not include the RSUs that were granted, which have an indefinite contractual term. Represents warrants for ordinary shares issuable upon an exercise price of $7.500 per share, which were granted on December 31, 2015 to Kreos Capital V (Expert) Fund Limited (“Kreos”) in connection with a loan made by Kreos to the Company and are currently exercisable (in whole or in part) until the earlier of (i) December 30, 2025 or (ii) immediately prior to the consummation of a merger, consolidation, or reorganization of the Company with or into, or the sale or license of all or substantially all the assets or shares of the Company to, any other entity or person, other than a wholly owned subsidiary of the Company, excluding any transaction in which the Company’s shareholders prior to the transaction will hold more than 50% of the voting and economic rights of the surviving entity after the transaction. None of these warrants had been exercised as of December 31, 2021. Represents common warrants that were issued as part of the $8.0 million drawdown under the Loan Agreement which occurred on December 28, 2016. See footnote 1 for exercisability terms. Represents common warrants that were issued as part of the Company’s follow-on public offering in November 2018. Represents common warrants that were issued to the underwriters as compensation for their role in the Company’s follow-on public offering in November 2018. Represents warrants that were issued to the exclusive placement agent as compensation for its role in the Company’s follow-on public offering in February 2019. Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s registered direct offering of ordinary shares in April 2019. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s April 2019 registered direct offering. Represents warrants that were issued to certain institutional investors in a warrant exercise agreement on June 5, 2019, and June 6, 2019, respectively. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 warrant exercise agreement and concurrent private placement of warrants. Represents warrants that were issued to certain institutional investors in a warrant exercise agreement in June 2019. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 registered direct offering and concurrent private placement of warrants. Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s best efforts offering of ordinary shares in February 2020. During the year ended December 31, 2021, 3,740,100 warrants were exercised for total consideration of $4,675,125. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2020 best efforts offering. During the year ended December 31, 2021, 230,160 warrants were exercised for total consideration of $359,625. Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in July 2020. During the year ended December 31, 2021, 2,020,441 warrants were exercised for total consideration of $3,555,976. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering. Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in December 2020. During the year ended December 31, 2021, 3,598,072 warrants were exercised for total consideration of $4,821,416. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s December 2020 private placement. During the year ended December 31, 2021, 225,981 warrants were exercised for total consideration of $405,003. Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in February 2021. Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2021 private placement. Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in September 2021. 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2022

or

  TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from______to______

Commission File Number: 001-36612

 

ReWalk Robotics Ltd.

(Exact name of registrant as specified in charter)

Israel

 

Not applicable

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

3 Hatnufa Street, Floor 6, Yokneam Ilit, Israel

 

2069203

(Address of principal executive offices)

 

(Zip Code)

+972.4.959.0123

Registrant's telephone number, including area code

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

 

Trading Symbol

 

Name of each exchange on which registered

Ordinary shares, par value NIS 0.25

 

RWLK

 

Nasdaq Capital Market

  
Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒   No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒   No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐

   

Accelerated filer ☐

 

Non-accelerated filer

   

Smaller reporting company

 
     

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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐  No 

As of May 13, 2022, the registrant had outstanding 62,509,872 ordinary shares, par value NIS 0.25 per share.


REWALK ROBOTICS LTD.

FORM 10-Q

FOR THE QUARTER ENDED MARCH 31, 2022

TABLE OF CONTENTS

 

Page No.

GENERAL AND WHERE YOU CAN FIND MORE INFORMATION

2

PART I

FINANCIAL INFORMATION

3

ITEM 1.

FINANCIAL STATEMENTS (unaudited)

3

 

CONDENSED CONSOLIDATED BALANCE SHEETS - MARCH 31, 2022 AND DECEMBER 31, 2021

3

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - THREE MONTHS ENDED MARCH 31, 2022 AND 2021

5

 

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - MARCH 31, 2022 AND 2021

6

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - THREE MONTHS ENDED MARCH 31, 2022 AND 2021

7

 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

8

ITEM 2.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

24

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

33

ITEM 4.

CONTROLS AND PROCEDURES

33

PART II

OTHER INFORMATION

34

ITEM 1.

LEGAL PROCEEDINGS

34

ITEM 1A.

RISK FACTORS

34

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

36

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

36

ITEM 4.

MINE SAFETY DISCLOSURES

36

ITEM 5.

OTHER INFORMATION

36

ITEM 6.

EXHIBITS

37

SIGNATURES

38

 


 
Introduction and Where You Can Find Other Information
 
As used in this quarterly report on Form 10-Q (this “quarterly report”), the terms “ReWalk,” the “Company,” “RRL,” “we,” “us” and “our” refer to ReWalk Robotics Ltd. and its subsidiaries, unless the context clearly indicates otherwise. Our website is www.rewalk.com. Information contained in, or that can be accessed through, our website does not constitute a part of this quarterly report on Form 10-Q and is not incorporated by reference herein. We have included our website address in this quarterly report solely for informational purposes. Information that we furnish to or file with the Securities and Exchange Commission (the “SEC”), including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to, or exhibits included in, these reports are available for download, free of charge, on our website as soon as reasonably practicable after such materials are filed with or furnished to the SEC. Our SEC filings, including exhibits filed or furnished therewith, are also available on the SEC’s website at http://www.sec.gov.
 
Special Note Regarding Forward-Looking Statements
 
In addition to historical information, this quarterly report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements may include projections regarding our future performance and, in some cases, can be identified by words like “anticipate,” “assume,” “believe,” “could,” “seek,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “should,” “will,” “would” or similar expressions that convey uncertainty of future events or outcomes and the negatives of those terms. These statements may be found in this section of this quarterly report titled “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this quarterly report. These statements include, but are not limited to, statements regarding:
 
our expectations regarding future growth, including our ability to increase sales in our existing geographic markets and expand to new markets;
our ability to maintain and grow our reputation and the market acceptance of our products;
our ability to achieve reimbursement from third-party payors or advance Centers for Medicare & Medicaid Services (“CMS”) coverage for our products;
our ability to maintain compliance with the continued requirements of the Nasdaq Capital Market and the risk that our ordinary shares will be delisted if we do not comply with such requirements;
the adverse effect that the COVID-19 pandemic has had and continues to have on our business and results of operations;
our ability to have sufficient funds to meet certain future capital requirements, which could impair our efforts to develop and commercialize existing and new products;
our limited operating history and our ability to leverage our sales, marketing and training infrastructure;
our ability to grow our business through acquisitions of businesses, products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, which could have a material adverse effect on our business, financial condition, and operating results;
our expectations as to our clinical research program and clinical results;
our ability to obtain certain components of our products from third-party suppliers and our continued access to our product manufacturers;
our ability to improve our products and develop new products;
our compliance with medical device reporting regulations to report adverse events involving our products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on our ability to market and sell our products;
our ability to gain and maintain regulatory approvals and to comply with any post-marketing requests
 
the risk of a cybersecurity attack or breach of our information technology systems significantly disrupting our business operations;
our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;
the impact of substantial sales of our shares by certain shareholders on the market price of our ordinary shares;
our ability to use effectively the proceeds of our offerings of securities;
the risk of substantial dilution resulting from the periodic issuances of our ordinary shares;
the impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company;
market and other conditions; and
other factors discussed in the “Risk Factors” section of our 2021 annual report on Form 10-K and in our subsequent reports filed with the SEC.
 
The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The statements are based on our beliefs, assumptions, and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance, or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the statements. In particular, you should consider the risks provided under “Part I, Item 1A. Risk Factors” of our 2021 annual report on Form 10-K, and in other reports subsequently filed by us with, or furnished to, the SEC.
 
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur.
 
Any forward-looking statement in this quarterly report speaks only as of the date hereof. Except as required by law, we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future developments or otherwise.
 
2

 
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS

REWALK ROBOTICS LTD. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

   

March 31,

   

December 31,

 
   

2022

   

2021

 
   

(unaudited)

       

ASSETS

           

 

           

CURRENT ASSETS

           

 

           

Cash and cash equivalents

 

$

82,632

   

$

88,337

 

Trade receivable, net

   

564

     

585

 

Prepaid expenses and other current assets

   

1,378

     

610

 

Inventories

   

3,232

     

2,989

 

Total current assets

   

87,806

     

92,521

 

 

               

LONG-TERM ASSETS

               

 

               

Restricted cash and other long-term assets

   

1,062

     

1,064

 

Operating lease right-of-use assets

   

823

     

881

 

Property and equipment, net

   

307

     

284

 

Total long-term assets

   

2,192

     

2,229

 

Total assets

 

$

89,998

   

$

94,750

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


REWALK ROBOTICS LTD. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

   

March 31,

   

December 31,

 
   

2022

   

2021

 
   

(unaudited)

       

LIABILITIES AND SHAREHOLDERS’ EQUITY

           

CURRENT LIABILITIES

           

Current maturities of operating leases

 

$

638

   

$

641

 

Trade payables

   

1,465

     

1,384

 

Employees and payroll accruals

   

677

     

1,142

 

Deferred revenues

   

323

     

316

 

Other current liabilities

   

517

     

555

 

Total current liabilities

   

3,620

     

4,038

 

 

               

LONG-TERM LIABILITIES

               

Deferred revenues

   

825

     

866

 

Non-current operating leases

   

330

     

418

 

Other long-term liabilities

   

37

     

45

 

Total long-term liabilities

   

1,192

     

1,329

 

 

               

Total liabilities

   

4,812

     

5,367

 

 

               

COMMITMENTS AND CONTINGENT LIABILITIES

               

Shareholders’ equity:

               

 

               

Share capital

               

Ordinary share of NIS 0.25 par value-Authorized: 120,000,000 shares at March 31, 2022

and December 31, 2021; Issued and outstanding: 62,508,517 and 62,480,163 shares at

March 31, 2022 and December 31, 2021, respectively

   

4,663

     

4,661

 

Additional paid-in capital

   

279,054

     

278,903

 

Accumulated deficit

   

(198,531

)

   

(194,181

)

Total shareholders’ equity

   

85,186

     

89,383

 

Total liabilities and shareholders’ equity

 

$

89,998

   

$

94,750

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


REWALK ROBOTICS LTD. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share data)

   

Three Months Ended

 
   

March 31,

 
   

2022

   

2021

 

Revenues

 

$

876

   

$

1,316

 

Cost of revenues

   

611

     

609

 

 

               

Gross profit

   

265

     

707

 

 

               

Operating expenses:

               

Research and development

   

907

     

795

 

Sales and marketing

   

2,184

     

1,671

 

General and administrative

   

1,462

     

1,262

 

 

               

Total operating expenses

   

4,553

     

3,728

 

 

               

Operating loss

   

(4,288

)

   

(3,021

)

Financial expenses (income), net

   

24

     

(4

)

 

               

Loss before income taxes

   

(4,312

)

   

(3,017

)

Taxes on income 

   

38

 

   

45

 

 

               

Net loss

 

$

(4,350

)

 

$

(3,062

)

 

               

Net loss per ordinary share, basic and diluted

 

$

(0.07

)

 

$

(0.08

)

 

               

Weighted average number of shares used in computing net loss per ordinary share, basic and diluted

   

62,493,496

     

36,187,789

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


REWALK ROBOTICS LTD. AND SUBSIDIARIES

CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

(In thousands, except share data)

   

Ordinary Share

   

Additional

paid-in

   

Accumulated

   

Total

shareholders’

 
   

Number

   

Amount

   

capital

   

deficit

   

equity

 

Balance as of December 31, 2020

   

25,332,225

     

1,827

     

201,392

     

(181,445

)

   

21,774

 

Share-based compensation to employees and non-employees

   

-

     

-

     

168

     

-

     

168

 

Issuance of ordinary shares upon vesting of RSUs by employees and      non-employees

   

24,096

     

2

     

(2

)

   

-

     

-

 

Issuance of ordinary shares in a private placement, net of issuance expenses in the amount of $3,679 (1)

   

10,921,502

     

832

     

35,489

     

-

     

36,321

 

Exercises of warrants (2)

   

9,814,754

     

724

     

13,094

     

-

     

13,818

 

Net loss

   

-

     

-

     

-

     

(3,062

)

   

(3,062

)

Balance as of March 31, 2021

   

46,092,577

     

3,385

     

250,141

     

(184,507

)

   

69,019

 

 

                                       

Balance as of December 31, 2021

   

62,480,163

     

4,661

     

278,903

     

(194,181

)

   

89,383

 

Share-based compensation to employees and non-employees

   

-

     

-

     

153

     

-

     

153

 

Issuance of ordinary shares upon vesting of RSUs by employees and     non-employees

   

28,354

     

2

     

(2

)

   

-

     

-

 

Net loss

   

-

     

-

     

-

     

(4,350

)

   

(4,350

)

Balance as of March 31, 2022

   

62,508,517

     

4,663

     

279,054

     

(198,531

)

   

85,186

 
 
 

(1)

See Note 7.e. to the condensed consolidated financial statements.

 

(2)

See Note 7.c. to the condensed consolidated financial statements.

The accompanying notes are an integral part of these condensed consolidated financial statements.

6


REWALK ROBOTICS LTD. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

   

Three Months Ended

 
   

March 31,

 
   

2022

   

2021

 

Cash flows used in operating activities:

           

Net loss

 

$

(4,350

)

 

$

(3,062

)

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation

   

53

     

70

 

Share-based compensation to employees and non-employees

   

153

     

168

 

Deferred taxes

   

1

 

   

-

 

Changes in assets and liabilities:

               

Trade receivables, net

   

21

 

   

186

 

Prepaid expenses, operating lease right-of-use assets and other assets

   

(706

)    

264

 

Inventories

   

(325

)    

49

 

Trade payables

   

81

 

   

(384

)

Employees and payroll accruals

   

(465

)    

(290

)

Deferred revenues 

   

(34

)    

(14

)

Operating lease liabilities and other liabilities

   

(137

)

   

(160

)

Net cash used in operating activities

   

(5,708

)

   

(3,173

)

 

               

Cash flows used in investing activities:

               

Purchase of property and equipment

   

(3

)

   

(9

)

Net cash used in investing activities

   

(3

)

   

(9

)

 

               

Cash flows from financing activities:

               

Issuance of ordinary shares in a private placement, net of issuance expenses paid in the amount of $3,582 (1)

   

-

     

36,418

 

Exercise of warrants  (1)

   

-

     

13,818

 

Net cash provided by financing activities

   

-

     

50,236

 

 

               

Increase (decrease) in cash, cash equivalents, and restricted cash

   

(5,711

)    

47,054

 

Cash, cash equivalents, and restricted cash at beginning of period

   

89,050

     

21,054

 

Cash, cash equivalents, and restricted cash at end of period

 

$

83,339

   

$

68,108

 

Supplemental disclosures of non-cash flow information

               

Expenses related to offerings not yet paid (1)

 

$

-

   

$

97

 

Classification of inventory to property and equipment, net

 

$

51

   

$

-

 

Classification of inventory to other current assets

 

$

54

   

$

-

 

Classification of other current assets to property and equipment, net

 

$

22

   

$

16

 

Supplemental cash flow information:

               

Cash and cash equivalents

 

$

82,632

   

$

67,411

 

Restricted cash included in other long-term assets

   

707

     

697

 

Total Cash, cash equivalents, and restricted cash

 

$

83,339

   

$

68,108

 
 
 

(1)

See Note 7.e. to the condensed consolidated financial statements.

 

(2)

See Note 7.c. to the condensed consolidated financial statements.

The accompanying notes are an integral part of these consolidated financial statements.

7


REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 1:GENERAL

a.ReWalk Robotics Ltd. (“RRL”, and together with its subsidiaries, the “Company”) was incorporated under the laws of the State of Israel on June 20, 2001 and commenced operations on the same date.

b.RRL has two wholly-owned subsidiaries: (i) ReWalk Robotics Inc. (“RRI”) incorporated under the laws of Delaware on February 15, 2012 and (ii) ReWalk Robotics GMBH. (“RRG”) incorporated under the laws of Germany on January 14, 2013.

The Company is designing, developing, and commercializing robotic exoskeletons that allow individuals with mobility impairments or other medical conditions the ability to stand and walk once again. The Company has developed and is continuing to commercialize the ReWalk, an exoskeleton designed for individuals with paraplegia that uses its patented tilt-sensor technology and an on-board computer and motion sensors to drive motorized legs that power movement. The ReWalk system consists of a light wearable brace support suit which integrates motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system to power knee and hip movement. Additionally, the Company developed and, in June 2019, started to commercialize the ReStore following receipt of European Union CE mark and United States Food and Drug Administration (“FDA”) clearance. The ReStore is a powered, lightweight soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke. The Company markets and sells its products directly to institutions and individuals and through third-party distributors. The Company sells its products directly primarily in Germany and the United States, and primarily through distributors in other markets. In its direct markets, the Company has established relationships with rehabilitation centers and the spinal cord injury community, and in its indirect markets, the Company’s distributors maintain these relationships. RRI markets and sells products mainly in the United States. RRG markets and sells the Company’s products mainly in Germany and Europe.

During the second quarter of 2020, the Company finalized two separate agreements to distribute additional product lines in the U.S. market. The Company is the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and has distribution rights for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the U.S. Department of Veterans Affairs (“VA”) hospitals. These new products have improved the Company’s product offering to clinics as well as patients within the VA as they both have similar clinician and patient profiles.

c.The worldwide spread of COVID-19 has resulted in a global economic slowdown and is expected to continue to disrupt general business operations until the disease is contained. This has had a negative impact on the Company’s sales and results of operations since the start of the pandemic, and the Company expects that it will continue to negatively affect its sales and results of operations; however, the Company is currently unable to predict the scale and duration of that impact. As of the date of issuance of these financial statements, the Company is not aware of any specific event or circumstance that would require an update of its accounting estimates or judgments or revision of the carrying value of its assets or liabilities. This determination may change as new events occur and additional information is obtained. Actual results could differ from management’s estimates and judgments, and any such differences may be material to the Company’s financial statements.

d.As of March 31, 2022, the Company incurred a consolidated net loss of $4.4 million and has an accumulated deficit in the total amount of $198.5 million. The Company’s cash and cash equivalent as of March 31, 2022 totaled $82.6 million and the Company’s negative operating cash flow for the three months ended March 31, 2022 was $5.7 million. The Company has sufficient funds to support its operations for more than 12 months following the issuance date of its condensed consolidated unaudited financial statements for the three months ended March 31, 2022. The Company expects to incur future net losses and its transition to profitability is dependent upon, among other things, the successful development and commercialization of its products and product candidates, and the achievement of a level of revenues adequate to support its cost structure. Until the Company achieves profitability or generates positive cash flows, it will continue to need to raise additional cash. the Company intends to fund future operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing. In addition, the Company may seek additional capital through arrangements with strategic partners or from other sources and will continue to address its cost structure. Notwithstanding, there can be no assurance that the Company will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.

 

8


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2:UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles and standards of the Public Company Accounting Oversight Board for interim financial information. Accordingly, they do not include all the information and footnotes required by generally accepted accounting principles in the United States for complete financial statements. In management’s opinion, the accompanying financial statements reflect all adjustments of a normal recurring nature that are necessary for a fair presentation of the results for the interim periods presented. The Company’s interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.
 
These financial statements and accompanying notes should be read in conjunction with the 2021 consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for its fiscal year ended December 31, 2021 filed with the SEC on February 24, 2022, as amended on May 2, 2022 (the “2021 Form 10-K”). There have been no changes in the significant accounting policies from those that were disclosed in the audited consolidated financial statements for the fiscal year ended December 31, 2021 included in the 2021 Form 10-K, unless otherwise stated.

 

9


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 3:SIGNIFICANT ACCOUNTING POLICIES

a.Revenue Recognition

The Company generates revenues from sales of products. The Company sells its products directly to end customers and through distributors. The Company sells its products to private individuals (who finance the purchases by themselves, through fundraising or reimbursement coverage from insurance companies), rehabilitation facilities and distributors.

Disaggregation of Revenues (in thousands)

   

Three Months Ended

March 31,

 
   

2022

   

2021

 

Units placed

 

$

778

   

$

1,142

 

Spare parts and warranties

   

98

     

174

 

Total Revenues

 

$

876

   

$

1,316

 

Units placed

The Company currently offers five products: (1) ReWalk Personal; (2) ReWalk Rehabilitation; (3) ReStore; (4) MyoCycle; and (5) MediTouch.

ReWalk Personal and ReWalk Rehabilitation are units for spinal cord injuries (“SCI Products”). SCI Products are currently designed for everyday use by paraplegic individuals at home and in their communities, and are custom fitted for each user, as well as for use by paraplegia patients in the clinical rehabilitation environment, where they provide individuals access to valuable exercise and therapy.

ReStore is a powered, lightweight soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke in the clinical rehabilitation environment.

The MyoCycle device uses Functional Electrical Stimulation (“FES”) technology to facilitate therapeutic exercise for persons with muscle weakness or paralysis caused by disorders like spinal cord injury, multiple sclerosis, and stroke.

The MediTouch Tutor movement biofeedback product line includes the Arm, Hand, 3D and Leg Tutor devices. These devices are used by physical and occupational therapists to evaluate functional tasks during rehabilitation of neurologic disorders and can also be used by patients remotely at home.

Pursuant to two separate distribution agreements entered into during the second quarter of 2020, the Company now markets both the MediTouch and MyoCyle products (together the “Distributed Products”) in the United States for use at home or in a clinic.

Units placed includes revenue from sales of SCI Products, ReStore and the Distributed Products.

For units placed, the Company recognizes revenues when it transfers control and title has passed to the customer. Each unit placed is considered an independent, unbundled performance obligation. The Company generally does not grant a right of return for its products besides isolated cases where the Company assesses the likelihood of such event to occur based on the Company’s historical experience and estimates. The Company also offers a rent-to-purchase model in which the Company recognizes revenue ratably according to the agreed rental monthly fee.
 

10


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Spare parts and warranties

Spare parts are sold to private individuals, rehabilitation facilities and distributors. Revenue is recognized when the Company satisfies a performance obligation by transferring control over promised goods or services to the customer. Each part sold is considered an independent, unbundled performance obligation.

Warranties are classified as either assurance type or service type warranty. A warranty is considered an assurance type warranty if it provides the consumer with assurance that the product will function as intended for a limited period of time.

In the beginning of 2018, the Company updated its service policy for SCI Products to include a five- year warranty compared to a period of two years that were included in the past for parts and services. The first two years are considered as assurance type warranty and the additional period is considered an extended service arrangement, which is a service type warranty. An assurance type warranty is not accounted for as separate performance obligations under the revenue model. A service type warranty is either sold with a unit or separately for units for which the warranty has expired. Revenue is then recognized ratably over the life of the warranty.

The ReStore device is offered with a two-year warranty which is considered as assurance type warranty.

The Distributed Products are sold with an assurance-type warranty that is covered by the vendor ranging from one year to ten years depending on the specific product and part.

Contract balances (in thousands)

   

March 31,

   

December 31,

 
   

2022

   

2021

 

Trade receivable, net (1)

 

$

564

   

$

585

 

Deferred revenues (1) (2)

 

$

1,148

   

$

1,182

 

(1)

Balance presented net of unrecognized revenues that were not yet collected.

(2)

During the three months ended March 31, 2022, $123 thousand of the December 31, 2021 deferred revenues balance was recognized as revenues.

Deferred revenue is comprised mainly of unearned revenue related to service type warranty but also includes other offerings for which the Company has been paid in advance and earns revenue when the Company transfers control of the product or service.

The Company’s unfilled performance obligations as of March 31, 2022 and the estimated revenue expected to be recognized in the future related to the service type warranty amounts to $1,18 million, which is fulfilled over one to five years.

 

11


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

b.Concentrations of Credit Risks:

Concentration of credit risk with respect to trade receivable is primarily limited to a customer to which the Company makes substantial sales. The below table reflects the concentration of credit risk for the Company’s current customers as of the quarter ended March 31, 2022, to which substantial sales were made:

   

March 31,

   

December 31,

 
   

2022

   

2021

 

Customer A

   

21

%

   

*

)

Customer B

   

20

%

   

*

)

Customer C

   

15

%

   

*

)

Customer D

   

15

%

   

*

)

Customer E

   

10

%

   

*

)

Customer F

   

*

)

   

20

%

Customer G

   

*

)

   

18

%

Customer H

   

*

)

   

16

%

Customer I

    * )     12 %

Customer J

    * )     10 %

*) Less than 10%

The Company’s trade receivables are geographically diversified and derived primarily from sales to customers in various countries, mainly in the United States and Europe. Concentration of credit risk with respect to trade receivables is limited by credit limits, ongoing credit evaluation and account monitoring procedures. The Company performs ongoing credit evaluations of its distributors based upon a specific review of all significant outstanding invoices. The Company writes off receivables when they are deemed uncollectible and having exhausted all collection efforts. As of March 31, 2022 and December 31, 2021 trade receivables are presented net of allowance for doubtful accounts in the amount of $27 thousand and $42 thousand, respectively, and net of sales return reserve of $52 thousand and $43 thousand, respectively.

c.Warranty provision

The Company provided a two-year standard warranty for its products. In the beginning of 2018, our service policy for new devices sold includes five-year warranty. The Company determined that the first two years of warranty is an assurance-type warranty and records a provision for the estimated cost to repair or replace products under warranty at the time of sale. Factors that affect the Company’s warranty reserve include the number of units sold, historical and anticipated rates of warranty repairs and the cost per repair.

   

US Dollars in thousands

 

Balance at December 31, 2021

 

$

112

 

Provision

   

67

 

Usage

   

(72

)

Balance at March 31, 2022

 

$

107

 

 

12


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

d.Basic and diluted net loss per ordinary share

Basic net loss per ordinary share is computed based on the weighted average number of ordinary shares outstanding during each year.


For the three months ended March 31, 2022, the total number of ordinary shares related to the outstanding warrants aggregated to 19,420,894, which were excluded from the calculations of diluted loss per ordinary share since it would have an anti-dilutive effect.

e.New Accounting Pronouncements

Recently Implemented Accounting Pronouncement

 
  i.
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity

In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity.  Among other changes, ASU 2020-06 removes from U.S. GAAP the liability and equity separation model for convertible instruments with a cash conversion feature and a beneficial conversion feature, and as a result, after adoption, entities will no longer separately present in equity an embedded conversion feature for such debt. Similarly, the embedded conversion feature will no longer be amortized into income as interest expense over the life of the instrument. Instead, entities will account for a convertible debt instrument wholly as debt unless (1) a convertible instrument contains features that require bifurcation as a derivative under ASC Topic 815, Derivatives and Hedging, or (2) a convertible debt instrument was issued at a substantial premium. Additionally, ASU 2020-06 requires the application of the if-converted method to calculate the impact of convertible instruments on diluted earnings per share (“EPS”). ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, with early adoption permitted for fiscal years beginning after December 15, 2020 and can be adopted on either a fully retrospective or modified retrospective basis. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

Recent Accounting Pronouncements Not Yet Adopted

  i.
Financial Instruments 

In June 2016, FASB issued ASU 2016-13, Financial Instruments - –Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss methodology, which will result in the more timely recognition of losses. Topic 326 will be effective for the Company beginning on January 1, 2023. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.

13


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 4:INVENTORIES

The components of inventories are as follows (in thousands):

   

March 31,

   

December 31,

 
   

2022

   

2021

 

Finished products

 

$

2,695

   

$

2,284

 

Raw materials

   

537

     

705

 
   

$

3,232

   

$

2,989

 

In the three months ended March 31, 2022 and 2021, the Company wrote off inventory in the amount of $2 and $38 thousand, respectively. The write off inventory were recorded in cost of revenues.

NOTE 5:COMMITMENTS AND CONTINGENT LIABILITIES

a.Purchase commitments:

The Company has contractual obligations to purchase goods from its contract manufacturer as well as raw materials from different vendors. Purchase obligations do not include contracts that may be canceled without penalty. As of March 31, 2022, non-cancelable outstanding obligations amounted to approximately $1.5 million.

b.Operating lease commitment:

(i)The Company operates from leased facilities in Israel, the United States and Germany. These leases expire between 2022 and 2023. A portion of the Company’s facilities leases is generally subject to annual changes in the Consumer Price Index (the “CPI”). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred.

(ii)    RRL and RRG lease cars for their employees under cancelable operating lease agreements expiring at various dates in between 2022 and 2025. A subset of the Company’s cars leases is considered variable. The variable lease payments for such cars leases are based on actual mileage incurred at the stated contractual rate. RRL and RRG have an option to be released from these agreements, which may result in penalties in a maximum amount of approximately $23 thousand as of March 31, 2022.

The Company's future lease payments for its facilities and cars, which are presented as current maturities of operating leases and non-current operating leases liabilities on the Company's condensed consolidated balance sheets as of March 31, 2022 are as follows (in thousands):

2022

 

$

520

 

2023

   

523

 
2024     32  

2025

   

4

 

Total lease payments

   

1,079

 

Less: imputed interest

   

(111

)

Present value of future lease payments

   

968

 

Less: current maturities of operating leases

   

(638

)

Non-current operating leases

 

$

330

 

Weighted-average remaining lease term (in years)

   

1.62

 

Weighted-average discount rate

   

12.5

%

14


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

Lease expense under the Company’s operating leases was $179 thousand and $186 thousand for the three months ended March 31, 2022 and 2021, respectively.

c.Royalties:

 
The Company's research and development efforts are financed, in part, through funding from the Israel Innovation Authority (the "IIA")
and the Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”). Since the Company's inception through March 31, 2022, the Company received funding from the IIA and BIRD in the total amount of $1.97 million and $500 thousand, respectively. Out of the $1.97 million in funding from the IIA, a total amount of $1.57 million were royalty-bearing grants (as of March 31, 2022, the Company paid royalties to the IIA in the total amount of $105 thousand), while a total amount of $400 thousand was received in consideration of 209 convertible preferred A shares, which converted after the Company's initial public offering in September 2014 into ordinary shares in a conversion ratio of 1 to 1. The Company is obligated to pay royalties to the IIA, amounting to 3% of the sales of the products and other related revenues generated from such projects, up to 100% of the grants received.
 
The royalty payment obligations also bear interest at the LIBOR rate. The obligation to pay these royalties is contingent on actual sales of the applicable products and in the absence of such sales, no payment is required.

Additionally, the Exclusive License Agreement between the Company and Harvard University’s Wyss Institute for Biologically Inspired Engineering ("Harvard") requires the Company to pay Harvard royalties on net sales. See note 6 below for more information about the Collaboration Agreement and the License Agreement.

Royalties expenses in cost of revenues were $3 and $0 thousand for the three months ended March 31, 2022 and 2021, respectively. 

As of March 31, 2022, the contingent liability to the IIA amounted to $1.6 million. The Israeli Research and Development Law provides that know-how developed under an approved research and development program may not be transferred to third parties without the approval of the IIA. Such approval is not required for the sale or export of any products resulting from such research or development. The IIA, under special circumstances, may approve the transfer of IIA-funded know-how outside Israel, in the following cases:

(a) the grant recipient pays to the IIA a portion of the sale price paid in consideration for such IIA-funded know-how or in consideration for the sale of the grant recipient itself, as the case may be, which portion will not exceed six times the amount of the grants received plus interest (or three times the amount of the grant received plus interest, in the event that the recipient of the know-how has committed to retain the research and development activities of the grant recipient in Israel after the transfer); (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded know-how; (c) such transfer of IIA-funded know-how arises in connection with certain types of cooperation in research and development activities; or (d) If such transfer of know-how arises in connection with a liquidation by reason of insolvency or receivership of the grant recipient.

d.Liens:

As part of the Company’s other long-term assets and restricted cash, an amount of $707 thousand has been pledged as security in respect of a guarantee granted to a third party. Such deposit cannot be pledged to others or withdrawn without the consent of such third party.

 

15


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

e.Legal Claims:

Occasionally, the Company is involved in various claims such as product liability claims, lawsuits, regulatory examinations, investigations, and other legal matters arising, for the most part, in the ordinary course of business. The outcome of any pending or threatened litigation and other legal matters is inherently uncertain, and it is possible that resolution of any such matters could result in losses material to the Company’s consolidated results of operations, liquidity, or financial condition. Except as otherwise disclosed herein, the Company is not currently party to any material litigation.

NOTE 6:RESEARCH COLLABORATION AGREEMENT AND LICENSE AGREEMENT
 

On May 16, 2016, the Company entered into a Research Collaboration Agreement (“Collaboration Agreement”) and an Exclusive License Agreement (“License Agreement”) with Harvard. The Research Collaboration Agreement was amended on May 1, 2017, and April 1, 2018 (as amended, the “Collaboration Agreement”), and the Exclusive License Agreement was amended on April 1, 2018 (as amended, the “License Agreement”), to extend the term of the Collaboration Agreement by one year to May 16, 2022 and reallocate the Company’s quarterly installment payments to Harvard through such date, and to make certain technical changes. On April 30, 2020, the Company and Harvard amended the Collaboration Agreement, which included certain adjustments to the quarterly installments and extended the term an additional three quarters until February 2023. On October 14, 2021, the Company and Harvard further amended the Collaboration Agreement, to make certain adjustments to the quarterly installments and technical changes and establish that the term of the Collaboration Agreement would conclude on March 31, 2022. As of March 31, 2022, the Collaboration Agreement has expired.
 
Under the License Agreement, Harvard has granted the Company an exclusive, worldwide royalty-bearing license under certain patents of Harvard relating to lightweight “soft suit” exoskeleton system technologies for lower limb disabilities, a royalty-free license under certain related know-how and the option to obtain a license under certain inventions conceived under the joint research collaboration.

The License Agreement required the Company to pay Harvard an upfront fee, reimbursements for expenses that Harvard incurred in connection with the licensed patents, royalties on net sales and several milestone payments contingent upon the achievement of certain product development and commercialization milestones. The Harvard License Agreement will continue in full force and effect until the expiration of the last-to-expire valid claim of the licensed patents. As of March 31, 2022, the Company achieved three of the milestones which represent all development milestones under the License Agreement. The Company continues to evaluate the likelihood that the other milestones will be achieved on a quarterly basis.

The Company has recorded expenses in the amount of $10 thousand and $159 thousand as research and development expenses related to the License Agreement and to the Collaboration Agreement for the three months ended March 31, 2022, and 2021, respectively. No withholding tax was deducted from the Company’s payments to Harvard in respect of the Collaboration Agreement and the License Agreement since this is not taxable income in Israel in accordance with Section 170 of the Israel Income Tax Ordinance 1961-5721.

16


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 7:SHAREHOLDERS’ EQUITY

a.Share option plans:

As of March 31, 2022, and December 31, 2021, the Company had reserved 379,763 and 233,957ordinary shares, respectively, for issuance to the Company’s and its affiliates’ respective employees, directors, officers, and consultants pursuant to equity awards granted under the Company's 2014 Incentive Compensation Plan (the “2014 Plan”).

Options to purchase ordinary shares generally vest over four years, with certain options to non-employee directors vesting quarterly over one year. Any option that is forfeited or canceled before expiration becomes available for future grants under the 2014 Plan.

There were no options granted during the three months ended March 31, 2022 and 2021.

The fair value of RSUs granted is determined based on the price of the Company's ordinary shares on the date of grant.

A summary of employee share options activity during the three months ended March 31, 2022 is as follows:

   

Number

   

Average

exercise

price

   

Average

remaining

contractual

life (in years)

   

Aggregate

intrinsic

value

(in thousands)

 

Options outstanding at the beginning of the period

   

61,832

   

$

38.34

     

4.55

   

$

-

 

Granted

   

-

     

-

     

-

     

-

 

Exercised

   

-

     

-

     

-

     

-

 

Forfeited

   

(165

)

   

15.09

     

-

     

-

 

Options outstanding at the end of the period

   

61,667

   

$

38.37

     

3.71

   

$

-

 

 

                               

Options exercisable at the end of the period

   

57,732

   

$

40.32

     

3.50

   

$

-

 
 
The aggregate intrinsic value in the table above represents the total intrinsic value that would have been received by the option holders had all option holders that hold options with positive intrinsic value exercised their options on the last date of the exercise period. No options were exercised during the three months ended March 31, 2022 and 2021.

 

17


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

A summary of employees and non-employees RSUs activity during the three months ended March 31, 2022 is as follows:

   

Number of shares

underlying

outstanding RSUs

   

Weighted average

grant date fair value

 

Unvested RSUs at the beginning of the period

   

1,356,284

   

$

1.61

 

Granted

   

55,000

     

1.12

 

Vested

   

(28,354

)

   

2.04

 

Forfeited

   

(200,641

)

   

1.53

 

Unvested RSUs at the end of the period

   

1,182,289

   

$

1.59

 

The weighted average grant date fair value of RSUs granted during the three months ended March 31, 2022, and 2021 was $1.12 and $1.32, respectively. 

As of March 31, 2022, there were $1.5 million of total unrecognized compensation costs related to non-vested share-based compensation arrangements granted under the Company's 2014 Plan. This cost is expected to be recognized over a period of approximately 2.7 years.

The number of options and RSUs outstanding as of March 31, 2022 is set forth below, with options separated by range of exercise price.

Range of exercise price

 

Options and RSUs outstanding as of

March 31, 2022

   

Weighted

average

remaining

contractual

life (years) (1)

   

Options outstanding and exercisable as of

March 31, 2022

   

Weighted

average

remaining

contractual

life (years) (1)

 

RSUs only

   

1,182,289

     

-

     

-

     

-

 

$5.37

   

12,425

     

6.99

     

9,318

     

6.99

 

$20.42 - $33.75

   

30,990

     

2.65

     

30,162

     

2.55

 

$37.14 - $38.75

   

8,946

     

1.73

     

8,946

     

1.73

 

$50 - $52.50

   

6,731

     

5.22

     

6,731

     

5.22

 

$182.5 - $524

   

2,575

     

3.60

     

2,575

     

3.60

 
     

1,243,956

     

3.71

     

57,732

     

3.50

 
   

(1)

Calculation of weighted average remaining contractual term does not include the RSUs that were granted, which have an indefinite contractual term.

b.Share-based awards to non-employee consultants:

As of March 31, 2022, there are no outstanding options or RSUs held by non-employee consultants.

18


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

c.Warrants to purchase ordinary shares:

The following table summarizes information about warrants outstanding and exercisable that were classified as equity as of March 31, 2022:

Issuance date

 

Warrants

outstanding

   

Exercise price

per warrant

   

Warrants

outstanding and

exercisable

   

Contractual

term

 
   

(number)

         

(number)

       

December 31, 2015 (1)

   

4,771

   

$

7.500

     

4,771

     

See footnote (1)

 

December 28, 2016 (2)

   

1,908

   

$

7.500

     

1,908

     

See footnote (1)

 

November 20, 2018 (3)

   

126,839

   

$

7.500

     

126,839

     

November 20, 2023

 

November 20, 2018 (4)

   

106,680

   

$

9.375

     

106,680

     

November 15, 2023

 

February 25, 2019 (5)

   

45,600

   

$

7.187

     

45,600

     

February 21, 2024

 

April 5, 2019 (6)

   

408,457

   

$

5.140

     

408,457

     

October 7, 2024

 

April 5, 2019 (7)

   

49,015

   

$

6.503

     

49,015

     

April 3, 2024

 

June 5, 2019, and June 6, 2019 (8)

   

1,464,665

   

$

7.500

     

1,464,665

     

June 5, 2024

 

June 5, 2019 (9)

   

87,880

   

$

9.375

     

87,880

     

June 5, 2024

 

June 12, 2019 (10)

   

416,667

   

$

6.000

     

416,667

     

December 12, 2024

 

June 10, 2019 (11)

   

50,000

   

$

7.500

     

50,000

     

June 10, 2024

 

February 10, 2020 (12)

   

28,400

   

$

1.250

     

28,400

     

February 10, 2025

 

February 10, 2020 (13)

   

105,840

   

$

1.563

     

105,840

     

February 10, 2025

 

July 6, 2020 (14)

   

448,698

   

$

1.760

     

448,698

     

January 2, 2026

 

July 6, 2020 (15)

   

296,297

   

$

2.278

     

296,297

     

January 2, 2026

 

December 8, 2020 (16)

   

586,760

   

$

1.340

     

586,760

     

June 8, 2026

 

December 8, 2020 (17)

   

108,806

   

$

1.792

     

108,806

     

June 8, 2026

 

February 26, 2021 (18)

   

5,460,751

   

$

3.600

     

5,460,751

     

August 26, 2026

 

February 26, 2021 (19)

   

655,290

   

$

4.578

     

655,290

     

August 26, 2026

 

September 29, 2021 (20)

   

8,006,759

   

$

2.000

     

8,006,759

     

March 29, 2027

 

September 29, 2021 (21)

   

960,811

   

$

2.544

     

960,811

     

September 27, 2026

 
     

19,420,894

             

19,420,894

         
   

(1)

Represents warrants for ordinary shares issuable upon an exercise price of $7.50 per share, which were granted on December 31, 2015 to Kreos Capital V (Expert) Fund Limited (“Kreos”) in connection with a loan made by Kreos to the Company and are currently exercisable (in whole or in part) until the earlier of (i) December 30, 2025 or (ii) immediately prior to the consummation of a merger, consolidation, or reorganization of the Company with or into, or the sale or license of all or substantially all the assets or shares of the Company to, any other entity or person, other than a wholly owned subsidiary of the Company, excluding any transaction in which the Company’s shareholders prior to the transaction will hold more than 50% of the voting and economic rights of the surviving entity after the transaction. None of these warrants had been exercised as of March 31, 2022. 

19


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(2)

Represents common warrants that were issued as part of the $8.0 million drawdown under the Loan Agreement which occurred on December 28, 2016. See footnote 1 for exercisability terms.

   

(3)

Represents common warrants that were issued as part of the Company’s follow-on public offering in November 2018. 

 

 

(4)

Represents common warrants that were issued to the underwriters as compensation for their role in the Company’s follow-on public offering in November 2018. 

 

 

(5)

Represents warrants that were issued to the exclusive placement agent as compensation for its role in the Company’s follow-on public offering in February 2019. 

 

 

(6)

Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s registered direct offering of ordinary shares in April 2019. 

 

 

(7)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s April 2019 registered direct offering. 

 

 

(8)

Represents warrants that were issued to certain institutional investors in a warrant exercise agreement on June 5, 2019, and June 6, 2019, respectively. 

 

 

(9)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 warrant exercise agreement and concurrent private placement of warrants. 

 

 

(10)

Represents warrants that were issued to certain institutional investors in a warrant exercise agreement in June 2019. 

 

 

(11)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 registered direct offering and concurrent private placement of warrants. 

 

 

(12)

Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s best efforts offering of ordinary shares in February 2020. During the year ended December 31, 2021, 3,740,100 warrants were exercised for total consideration of $4,675,125

 

 

(13)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2020 best efforts offering. During the year ended December 31, 2021, 230,160 warrants were exercised for total consideration of $359,625

 

 

(14)

Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in July 2020. During the year ended December 31, 2021, 2,020,441 warrants were exercised for total consideration of $3,555,976

 

 

(15)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering. 

 

20


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

(16)

Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in December 2020. During the year ended December 31, 2021, 3,598,072 warrants were exercised for total consideration of $4,821,416

 

 

(17)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s December 2020 private placement. During the year ended December 31, 2021, 225,981 warrants were exercised for total consideration of $405,003.

(18)

Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in February 2021. 

 

 

(19)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s private placement offering in February 2021 (the “February 2021 Offering”).

 

 

(20)

Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in September 2021. 

 

 

(21)

Represents warrants that were issued to the placement agent as compensation for its role in the Company’s September 2021 registered direct offering. 

d.Share-based compensation expense for employees and non-employees:

The Company recognized non-cash share-based compensation expense for both employees and non-employees in the condensed consolidated statements of operations as follows (in thousands):

   

Three Months Ended

March 31,

 
   

2022

   

2021

 

Cost of revenues

 

$

3

   

$

2

 

Research and development, net

   

16

 

   

(2

)

Sales and marketing

   

51

     

45

 

General and administrative

   

83

     

123

 

Total

 

$

153

   

$

168

 

e.Equity raise:

   Follow-on offerings and warrants exercise:

On February 19, 2021, the Company entered into a purchase agreement with certain institutional and other accredited investors for the issuance and sale of 10,921,502 ordinary shares, par value NIS 0.25 per share at $3.6625 per ordinary share and warrants to purchase up to an aggregate of 5,460,751 ordinary shares with an exercise price of $3.6 per share, exercisable from February 19, 2021 until August 26, 2026.  Additionally, the Company issued warrants to purchase up to 655,290 ordinary shares, with an exercise price of $4.578125 per share, exercisable from February 19, 2021 until August 26, 2026, to certain representatives of H.C. Wainwright & Co., LLC (“H.C. Wainwright”) as compensation for its role as the placement agent in our February 2021 Offering.

On September 27, 2021, the Company signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary shares, par value NIS 0.25 per share, pre-funded warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary warrants to purchase up to an aggregate of 8,006,759 ordinary shares at an exercise price of $2.00 per share. The Pre-Funded Warrants have an exercise price of $0.001 per Ordinary Share and are immediately exercisable and can be exercised at any time after their original issuance until such pre-funded warrants are exercised in full. Each ordinary share was sold at an offering price of $2.035 and each pre-funded warrant was sold at an offering price of $2.034 (equal to the purchase price per ordinary share minus the exercise price of the pre-funded warrant). The offering of the ordinary shares, the pre-funded warrants and the ordinary shares that are issuable from time to time upon exercise of the pre-funded warrants was made pursuant to the Company’s shelf registration statement on Form S-3 initially filed with the Securities and Exchange Commission (“SEC”) on May 9, 2019, and declared effective by the SEC on May 23, 2019, and the ordinary warrants were issued in a concurrent private placement. The ordinary warrants are exercisable at any time and from time to time, in whole or in part, following the date of issuance and ending five and one-half years from the date of issuance. All of the pre-funded warrants were exercised in full on September 27, 2021, and the offering closed on September 29, 2021. Additionally, the Company issued warrants to purchase up to 960,811 ordinary shares, with an exercise price of $2.5438 per share, exercisable from September 27, 2021, until September 27, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in our September 2021 registered direct offering.

As of March 31, 2022, a total of 9,814,754 previously issued warrants with exercise prices ranging from $1.25 to $1.79 have been exercised for total gross proceeds of approximately $13.8 million.

21


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 8:FINANCIAL EXPENSES (INCOME), NET

The components of financial expenses (income), net were as follows (in thousands):

   

Three Months Ended

March 31,

 
   

2022

   

2021

 

Foreign currency transactions and other

 

$

15

   

$

(14

)

Bank commissions

   

9

     

10

 
   

$

24

   

$

(4

)

22


REWALK ROBOTICS LTD. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 9:GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER AND PRODUCT DATA

Summary information about geographic areas:

ASC 280, “Segment Reporting” establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company manages its business on the basis of one reportable segment and derives revenues from selling systems and services (see Note 1 for a brief description of the Company’s business). The following is a summary of revenues within geographic areas (in thousands):

   

Three Months Ended

March 31,

 
   

2022

   

2021

 

Revenues based on customer’s location:

               

United States

 

$

220

   

$

476

 

Europe

   

647

     

837

 

Asia-Pacific

   

8

     

2

 

Africa

   

1

     

1

 

Total revenues

 

$

876

   

$

1,316

 
   

March 31,

   

December 31,

 
   

2022

   

2021

 

Long-lived assets by geographic region (*):

               

Israel

 

$

611

   

$

629

 

United States

   

453

     

493

 

Germany

   

66

     

43

 
   

$

1,130

   

$

1,165

 

(*)

Long-lived assets are comprised of property and equipment, net, and operating lease right-of-use assets.

         
      Three Months Ended
March 31,
 
     

2022

     

2021

 

Major customer data as a percentage of total revenues:

               

Customer A

    18 %     * )

Customer B

    14 %     -  

Customer C

    13 %     -  

Customer D

    11 %     -  

Customer E

    10 %     * )

Customer F

    10 %     -  

Customer G

    * )     15 %

Customer H

    -       10 %

Customer I

    -       10 %

 

*)

Less than 10%.


23

  
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
The following discussion and analysis of our financial condition and results of operation should be read in conjunction with the unaudited condensed consolidated financial statements and the related notes included elsewhere in this quarterly report and with our audited consolidated financial statements included in our Form 10-K for the year ended December 31, 2021 as filed with the SEC on February 24, 2022 and amended on May 2, 2022 (the “2021 Form 10-K”). In addition to historical condensed financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. For a discussion of factors that could cause or contribute to these differences, see “Special Note Regarding Forward-Looking Statements” above.
 
Overview
 
We are an innovative medical device company that is designing, developing, and commercializing robotic exoskeletons that allow individuals with mobility impairments or other medical conditions the ability to stand and walk once again. We have developed and are continuing to commercialize our ReWalk Personal and ReWalk Rehabilitation devices for individuals with spinal cord injury (“SCI Products”), which are exoskeletons designed for individuals with paraplegia that use our patented tilt-sensor technology and an on-board computer and motion sensors to drive motorized legs that power movement.
 
We have also developed and began commercializing our ReStore device in June 2019. ReStore is a powered, lightweight soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke. During the second quarter of 2020 we have finalized and moved to implement two separate agreements to distribute additional product lines in the U.S. market. The Company will be the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and will also have distribution rights for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the U.S. Department of Veterans Affairs (“VA”) hospitals and other personal sales. These new products will improve our product offering to clinics as well as patients within the VA as they both have similar clinician and patient profile.
 
Our principal markets are the United States and Europe. In Europe, we have a direct sales operation in Germany and the United Kingdom and work with distribution partners in certain other major countries. We have offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, where we operate our business from.
 
We have in the past generated and expect to generate in the future revenues from a combination of third-party payors, self-payors, including private and government employers, and institutions. While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States for electronic exoskeleton technologies such as the ReWalk Personal, we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics. In December 2015, the U.S. Department of Veterans Affairs, or the VA, issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States. The VA policy is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury. As of December 31, 2021, we had placed 25 units as part of the VA policy.
 
According to a 2017 report published by the Centers for Medicare and Medicaid Services, or CMS, approximately 55% of the spinal cord injury population which are at least five years post their injury date are covered by CMS. In July 2020, a code was issued for ReWalk Personal 6.0 (effective October 1, 2020), which might later be followed by coverage policy of CMS.
 
Additionally, to date, several private insurers in the United States and Europe have provided reimbursement for ReWalk in certain cases. In Germany, we continue to make progress toward achieving ReWalk coverage from the various government, private and worker’s compensation payors. In September 2017, each of German insurer BARMER GEK (“Barmer”) and national social accident insurance provider Deutsche Gesetzliche Unfallversicherung (“DGUV”), indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria. In February 2018, the head office of German statutory health insurance, or SHI, Spitzenverband (“GKV”) confirmed their decision to list the ReWalk Personal 6.0 exoskeleton system in the German Medical Device Directory. This decision means that ReWalk will be listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis. During the year 2020 we announced several new agreements with German SHIs such as TK and DAK Gesundheit and others as well as the first German Private Health Insurer (“PHI”) that have chosen to enter into an agreement that outlines the process of obtaining a device for eligible insured patient. We are currently working with several additional SHIs and PHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal 6.0 device for their beneficiaries within their system.
 
During the second quarter of 2020 we finalized and moved to implement two separate agreements to distribute additional product lines in the U.S. market. The Company will be the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and will also have distribution rights for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the VA hospitals. These new products will improve our product offering to clinics as well as patients within the VA as they both have similar clinician and patient profile. We have incurred net losses and negative cash flow from operations since inception and anticipate this to continue in the near term. We will continue to evaluate spending while continuing to focus resources on activities to commercialize the Restore device for stroke patients, achieving additional commercial reimbursement coverage decisions for our ReWalk Personal device, continued research and development activities related mainly to our product line maintenance as well as our soft exo-suit design and activities related to our FDA 522 postmarket study.
24

 
 First Quarter 2022 and Subsequent Period Business Highlights
 
 

Total revenue for the first quarter of 2022 was $0.9 million, compared to $1.3 million in the first quarter of 2021;

 
 

Placed on June 8th CMS agenda of the Biannual Healthcare Common Procedure Coding System (HCPCS) meeting that includes benefit category determination for the first time under the new DEMPOS rules.  This is based on previous interactions with CMS to determine ReWalk’s benefit category and payment status;

 
 

ReWalk has increased resources and presence in VA Polytrauma/TBI Care Systems as well as a process to expand training through the VA’s designated Community Based Outpatient Clinic network;

 
 

Strong cash position with $82.6 million as of March 31, 2022;

 
 

The Company’s operating expenses were $4.6 million in the first quarter of 2022, compared to $3.7 million in the first quarter of 2021;

 
 

In April 2022, the Company joined the Human Robot Interaction Consortium, part of the Israel Innovation Authority MAGNET incentive program, where it will collaborate with several universities to develop advanced technologies aimed at improving the human-exoskeleton interaction.

 
Evolving COVID-19 Pandemic
 
The impact of the COVID-19 pandemic has resulted in, and will likely continue to result in, significant disruptions to the global economy and the capital markets, as well as our business. A significant number of our global suppliers, vendors, distributors and manufacturing facilities are located in regions that have been affected by the pandemic. Those operations have been materially adversely affected by restrictive government and private enterprise measures implemented in response to the pandemic, which in turn, has negatively impacted our operations. Despite the distribution of COVID-19 vaccines, new and occasionally more virulent variants of the virus that causes COVID-19, including the Delta and Omicron variants, have emerged, and there is significant uncertainty as to how the countries in which we do business will continue to respond to such outbreaks, including whether there will be future partial or total shutdowns, which would adversely affect our business.
 
The COVID-19 pandemic has affected our ability to engage with our SCI Products, ReStore and Distributed Products existing customers, conduct trials of candidates, deliver ordered units or repair existing systems and provide training of our products to new patients who have largely remained at home due to local movement restrictions and to rehabilitation centers, which have temporarily shifted priorities and responses to pandemic-related medical equipment. In addition, staffing shortages within the healthcare system itself has resulted in a diminished demand for our SCI Products as the attention of healthcare workers and potential patients has turned elsewhere. As a result, our sales and results of operations have been adversely impacted. We believe that these adverse impacts may continue as long as the pandemic continues to impact our key markets, which are Germany and the United States, especially as long as our ability to conduct trials of product candidates is limited or if our existing customers can’t train with our SCI Products and as long as capital budgets for rehabilitation devices such as the ReStore remain reduced or on-hold. Additionally, some clinics, such as VA clinics, and many other healthcare facilities, are enforcing in-clinic restrictions that affect our ability to demonstrate our devices to patients or start training for qualified potential customers. We continue to monitor our sales pipeline on a day-to-day basis in order to assess the effect of these limitations as some have short term effects and others affect our future pipeline development. While our sole manufacturer, Sanmina Corporation, has not shut down its facilities during the COVID-19 pandemic, supply chain delays, component shortages have had a limited impact on our manufacturing and are also leading to price increases of specific parts. Other adverse impacts on our production capacity as a result of government directives or health protocols can occur. Moreover, the current limitations on our sales activities has made it difficult to effectively forecast our future requirements for systems. For more information, see “Part I, Item 1A. Risk Factors.” of our 2021 Form 10-K in addition to the “Risk Factors” section included below.
 
In addition, our future results of operations and liquidity could be adversely impacted by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and operational challenges faced by our customers. The occurrence of new outbreaks of COVID-19 could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn or a global recession that could cause significant volatility or decline in the trading price of our securities, affect our ability to execute strategic business activities such as business combination, affect demand for our products and likely impact our operating results. These may further limit or restrict our ability to access capital on favorable terms, or at all, lead to consolidation that negatively impacts our business, weaken demand, increase competition, cause us to reduce our capital spend further, or otherwise disrupt our business.
25

 
During the pandemic, we have implemented remote working procedures in the United States, Germany and Israel and are establishing in-office measures to contain the spread of COVID-19 according to local regulations. With the vaccination of most of our employees, we gradually returned to work from our offices during 2021 but are currently facing another disruption with the spread of the Omicron variant. Despite this current situation and the challenges it imposes, we have developed several methods to continue to engage with our current and prospective customers with some success through video conferencing, virtual training events, and online education demos to offer our support and showcase the value of our products.
 
Results of Operations for the Three Months Ended March 31, 2022 and March 31, 2021
 
Our operating results for the three months ended March 31, 2022, as compared to the same period in 2021, are presented below. The results set forth below are not necessarily indicative of the results to be expected in future periods.
 
   
Three Months Ended March 31,
 
   
2022
   
2021
 
Revenues
 
$
876
   
$
1,316
 
Cost of revenues
   
611
     
609
 
                 
Gross profit
   
265
     
707
 
                 
Operating expenses:
               
Research and development
   
907
     
795
 
Sales and marketing
   
2,184
     
1,671
 
General and administrative
   
1,462
     
1,262
 
                 
Total operating expenses
   
4,553
     
3,728
 
                 
Operating loss
   
(4,288
)
   
(3,021
)
Financial expenses (income), net
   
24
     
(4
)
                 
Loss before income taxes
   
(4,312
)    
(3,017
)
Taxes on income
   
38
     
45
 
                 
Net loss
 
$
(4,350
)
 
$
(3,062
)
                 
Net loss per ordinary share, basic and diluted
 
$
(0.07
)  
$
(0.08
)
                 
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
   
62,493,496
     
36,187,789
 
 
26

Three Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021
 
Revenues
 
Our revenues for the three months ended March 31, 2022 and 2021 were as follows:
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
 
 
(in thousands, except unit amounts)
 
Personal unit revenues
 
$
770
   
$
1,308
 
Rehabilitation unit revenues
   
106
     
8
 
 
               
Revenues
 
$
876
   
$
1,316
 
 
Personal unit revenues consist of ReWalk Personal 6.0 and Distributed Products sale, rental, service and warranty revenue for home use.
 
Rehabilitation unit revenues consist of ReStore, Distributed Products and SCI Products sale, rental, service and warranty revenue to clinics, hospitals for treating patients with relevant medical conditions or medical academic centers.
 
Revenues decreased by $440 thousand, or 33%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. The decrease is due to lower number of ReWalk Personal 6.0 units sold in the United States and Germany.
 
In the future, we expect our growth to be driven by sales of our ReWalk Personal device to third-party payors as we continue to focus our resources on broader commercial coverage policies with third-party payors as well as sales of the ReStore and other products to rehabilitation clinics and for personal use.
 
Gross Profit
 
Our gross profit for the three months ended March 31, 2022 and 2021 was as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Gross profit
 
$
265
   
$
707
 
 
Gross profit was 30% of revenue for the three months ended March 31, 2022 compared to 54% for the three months ended March 31, 2021. The decrease in gross profit for the three months ended March 31, 2022 was mainly driven by the lower volume of units sold and a decrease in our average selling price due to a change in sales mix.
 
We expect our gross profit to improve, assuming we increase our sales volumes, which could also decrease the product manufacturing costs. Improvements may be partially offset by the lower margins we currently expect from ReStore and our Distributed Products as well as due to an increase in the cost of product parts, especially as long as COVID-19 pandemic is affecting the market.
27

 
Research and Development Expenses
 
Our research and development expenses, net, for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Research and development expenses
 
$
907
   
$
795
 
 
Research and development expenses, increased by $112 thousand, or 14%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. The increase is attributable to increased consulting and subcontractors expenses.
 
We intend to focus our research and development expenses mainly on our current products maintenance and improvement as well as developing our “soft suit” exoskeleton for additional indications affecting the ability to walk or a home use design such as the ReBoot design.
 
Sales and Marketing Expenses
 
Our sales and marketing expenses for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Sales and marketing expenses
 
$
2,184
   
$
1,671
 
 
Sales and marketing expenses increased by $513 thousand, or 31%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. The increase was driven by higher employee and employee related expenses, travel and tradeshows activities.
 
In the near term our sales and marketing expenses are expected to be driven by our efforts to expand our reimbursement coverage of our ReWalk Personal device and to expand our current product commercialization.
 
General and Administrative Expenses
 
Our general and administrative expenses for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
General and administrative
 
$
1,462
   
$
1,262
 
 
General and administrative expenses increased by $200 thousand, or 16%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. The increase was driven by increased personnel and personnel related expenses as well as professional services expenses.
 
28

 
Financial Expenses (Income), Net
 
Our financial expenses (income), net, for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Financial expenses (income), net
 
$
24
   
$
(4
)
 
Financial expenses (income), net, increased by $28 thousand for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. This increase was primarily due to exchange rate fluctuations.
 
Income Taxes
 
Our income tax for the three months ended March 31, 2022 and 2021 was as follows (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Income taxes
 
$
38
   
$
45
 
 
Income taxes decreased by $7 thousand, or 16%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 mainly due to higher deferred income tax resulting from a decrease in deferred revenues.
 
Critical Accounting Policies and Estimates
 
Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our condensed financial statements requires us to make estimates, judgments and assumptions that can affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We base our estimates, judgments and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known. Besides the estimates identified above that are considered critical, we make many other accounting estimates in preparing our condensed financial statements and related disclosures. See Note 2 to our audited consolidated financial statements included in our 2021 Form 10-K for a description of the significant accounting policies that we used to prepare our consolidated financial statements.
 
There have been no material changes to our critical accounting policies or our critical judgments from the information provided in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies” of our 2021 Form 10-K, except for the updates provided in Note 3 of our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of this quarterly report.
 
Recent Accounting Pronouncements
 
See Note 3 to our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of this quarterly report for information regarding new accounting pronouncements.
 
29

 
Liquidity and Capital Resources
 
Sources of Liquidity and Outlook
 
Since inception, we have funded our operations primarily through the sale of certain of our equity securities and convertible notes to investors in private placements, the sale of our ordinary shares in public offerings and the incurrence of bank debt.
 
As of March 31, 2022, we incurred a consolidated net loss of $4.4 million and have an accumulated deficit in the total amount of $198.5 million. Our cash and cash equivalent as of March 31, 2022, totaled $82.6 million and our negative operating cash flow for the three months ended March 31, 2022, was $5.7 million. We have sufficient funds to support our operation for more than 12 months following the issuance date of our condensed consolidated unaudited financial statements for the three months ended March 31, 2022.
 
We expect to incur future net losses and our transition to profitability is dependent upon, among other things, the successful development and commercialization of our products and product candidates, the achievement of a level of revenues adequate to support our cost structure. Until we achieve profitability or generate positive cash flows, we will continue to need to raise additional cash. We intend to fund future operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing. In addition, we may seek additional capital through arrangements with strategic partners or from other sources and we will continue to address our cost structure. Notwithstanding, there can be no assurance that we will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.
 
Our anticipated primary uses of cash are (i) sales, marketing and reimbursement expenses related to market development activities of our ReStore and Personal 6.0 devices, broadening third-party payor and CMS coverage for our ReWalk Personal device and commercializing our new product lines added through distribution agreements; (ii) research and development of our lightweight exo-suit technology for potential home personal health utilization for multiple indications and future generation designs for our spinal cord injury device; (iii) routine product updates; (iv) general corporate purposes, including working capital needs; and (v) potential acquisitions of business. Our future cash requirements will depend on many factors, including our rate of revenue growth, the expansion of our sales and marketing activities, the timing and extent of our spending on research and development efforts and international expansion. If our current estimates of revenue, expenses or capital or liquidity requirements change or are inaccurate, we may seek to sell additional equity or debt securities, arrange for additional bank debt financing, or refinance our indebtedness. There can be no assurance that we will be able to raise such funds on acceptable terms.
 
Equity Raises
 
Beginning with the filing of our Form 10-K on February 17, 2017, we were subject to limitations under the applicable rules of Form S-3, which constrained our ability to secure capital pursuant to our ATM Offering Program (as defined below) or other public offerings pursuant to our effective Form S-3. These rules limit the size of primary securities offerings conducted by issuers with a public float of less than $75 million to no more than one-third of their public float in any 12-month period. At the time of filing our annual report for the year ended December 31, 2020, we were no longer subject to these limitations, because our public float had reached at least $75 million in the 60 days preceding the filing of that annual report. Likewise, because our public float was at least $75 million within the 60 days preceding the date of our 2021 Annual Report, we are not currently subject to these limitations. Our currently effective registration statement on Form S-3 expires on May 23, 2022. We have filed a new registration statement on Form S-3 to replace our expiring registration statement which has not yet been declared effective by the SEC. Assuming our new Form S-3 becomes effective and is available for our use during 2022, we will continue to not be subject to these limitations for the remainder of the 2022 fiscal year and until such time as we file our next annual report for the year ended December 31, 2022, at which time we will be required to re-test our status under these rules. If our public float subsequently drops below $75 million as of the filing of our next annual report on Form 10-K, or at the time we file a new Form S-3, we will become subject to these limitations again, until the date that our public float again reaches $75 million. These limitations do not apply to secondary offerings for the resale of our ordinary shares or other securities by selling shareholders or to the issuance of ordinary shares upon conversion by holders of convertible securities, such as warrants. We have registered up to $100 million of ordinary shares warrants and/or debt securities and certain other outstanding securities with registration rights on our new registration statement on Form S-3, which will be available for our use once the registration statement has been declared effective by the SEC.
30

 
Equity Offerings and Warrant Exercises
 
On February 19, 2021, we entered into a purchase agreement with certain institutional and other accredited investors for the issuance and sale of 10,921,502 ordinary shares, par value NIS 0.25 per share at $3.6625 per ordinary share and warrants to purchase up to an aggregate of 5,460,751 ordinary shares with an exercise price of $3.6 per share, exercisable from February 19, 2021, until August 26, 2026. Additionally, we issued warrants to purchase up to 655,290 ordinary shares, with an exercise price of $4.578125 per share, exercisable from February 19, 2021, until August 26, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in our February 2021 Offering.
 
On September 27, 2021, we signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary shares, pre-funded warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary warrants to purchase up to an aggregate of 8,006,759 ordinary shares at an exercise price of $2.00 per share. The pre-funded warrants have an exercise price of $0.001 per ordinary share and are immediately exercisable and can be exercised at any time after their original issuance until such pre-funded warrants are exercised in full. Each ordinary share was sold at an offering price of $2.035 and each pre-funded warrant was sold at an offering price of $2.034 (equal to the purchase price per ordinary share minus the exercise price of the pre-funded warrant). The offering of the ordinary shares, the pre-funded warrants and the ordinary shares that are issuable from time to time upon exercise of the pre-funded warrants was made pursuant to our shelf registration statement on Form S-3 initially filed with the SEC on May 9, 2019, and declared effective by the SEC on May 23, 2019, and the ordinary warrants were issued in a concurrent private placement. The ordinary warrants are exercisable at any time and from time to time, in whole or in part, following the date of issuance and ending five and one-half years from the date of issuance. All of the pre-funded warrants were exercised in full on September 27, 2021, and the offering closed on September 29, 2021. Additionally, we issued warrants to purchase up to 960,811 ordinary shares, with an exercise price of $2.5438 per share, exercisable from September 27, 2021, until September 27, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in our September 2021 private placement offering.
 
As of March 31, 2022, a total of 9,814,754 previously issued warrants with exercise prices ranging from $1.25 to $1.79 have been exercised for total gross proceeds of approximately $13.8 million.
 
ATM Offering Program
 
On May 10, 2016, we entered into our Equity Distribution Agreement with Piper Jaffray, as amended on May 9, 2019, pursuant to which we may offer and sell, from time to time, ordinary shares having an aggregate offering price of up to $25.0 million through Piper Jaffray acting as our agent (the “ATM Offering Program”). Subject to the terms and conditions of the Equity Distribution Agreement, Piper Jaffray will use its commercially reasonable efforts to sell on our behalf all of the ordinary shares requested to be sold by us, consistent with its normal trading and sales practices. Piper Jaffray may also act as principal in the sale of ordinary shares under the Equity Distribution Agreement. Such sales may be made under our Form S-3 in what may be deemed “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act, directly on or through the Nasdaq Capital Market, to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated transactions.
 
Piper Jaffray is entitled to compensation at a fixed commission rate of 3% of the gross sales price per share sold through it as agent under the Equity Distribution Agreement. Where Piper Jaffray acts as principal in the sale of ordinary shares under the Equity Distribution Agreement, such rate of compensation will not apply, but in no event will the total compensation of Piper Jaffray, when combined with the reimbursement of Piper Jaffray for the out-of-pocket fees and disbursements of its legal counsel, exceed 8.0% of the gross proceeds received from the sale of the ordinary shares.
 
We may instruct Piper Jaffray not to sell ordinary shares if the sales cannot be effected at or above the price designated by us in any instruction. We or Piper Jaffray may suspend an offering of ordinary shares under the ATM Offering Program upon proper notice and subject to other conditions, as further described in the Equity Distribution Agreement. Additionally, the ATM Offering Program will terminate on the earlier of (i) the sale of all ordinary shares subject to the Equity Distribution Agreement, (ii) the date that is three years after a new registration statement on Form S-3 goes effective, (iii) our becoming ineligible to use Form S-3 and (iv) termination of the Equity Distribution Agreement by the parties. The Equity Distribution Agreement may be terminated by Piper Jaffray or us at any time on the close of business on the date of receipt of written notice, and by Piper Jaffray at any time in certain circumstances, including any suspension or limitation on the trading of our ordinary shares on the Nasdaq Capital Market, as further described in the Equity Distribution Agreement. We temporarily suspended use of the ATM Offering Program on February 20, 2019 to facilitate our February 2019 “best efforts” public offering. As of September 30, 2020, we had sold 302,092 ordinary shares under the ATM Offering Program for net proceeds to us of $14.5 million (after commissions, fees, and expenses). Additionally, as of that date, we had paid Piper Jaffray compensation of $471 thousand and had incurred total expenses (including such commissions) of approximately $1.2 million in connection with the ATM Offering Program. No sales were made under the ATM Offering Program during the year ended December 31, 2021 or during the three months ended March 31, 2022.
31

 
We intend to continue using the at-the-market offering or similar continuous offering programs opportunistically to raise additional funds, although we are currently subject to restrictions on using the ATM Offering Program with Piper Jaffray. Under our September 2021 purchase agreement with certain investors, equity or debt securities convertible into, or exercisable or exchangeable for, ordinary shares at a conversion price, exercise price or exchange price which floats with the trading price of the ordinary shares or which may be adjusted after issuance upon the occurrence of certain events or (ii) enter into any agreement, including an equity line of credit, whereby the Company may issue securities at a future-determined price, other than an at–the-market facility with the placement agent, H.C. Wainwright & Co, LLC, beginning on March 29, 2022. Such limitations may inhibit our ability to access capital efficiently.
 
Cash Flows for the Three Months Ended March 31, 2022 and March 31, 2021 (in thousands):
 
 
 
Three Months Ended March 31,
 
 
 
2022
   
2021
 
Net cash used in operating activities
 
$
(5,708
)
 
$
(3,173
)
Net cash used in investing activities
   
(3
)
   
(9
)
Net cash provided by financing activities
   
-
     
50,236
 
Net cash flow
 
$
(5,711
)
 
$
47,054
 
 
Net Cash Used in Operating Activities
 
Net cash used in operating activities increased by $2.5 million or 80% primarily due to increased insurance prepaid expenses, increased inventory purchases, and higher business development costs.
 
Net Cash Provided by Financing Activities
 
Net cash provided by financing activities was $0 for the three months ended March 31, 2022 compared to $50.2 million for the three months ended March 31, 2021, was from the proceeds received through our February 2021 Offering and warrants exercises received during the first quarter of 2021.
 
Obligations and Contractual Commitments
 
Set forth below is a summary of our contractual obligations as of March 31, 2022.
32

 
 
 
Payments due by period (in dollars, in thousands)
 
Contractual obligations
 
Total
   
Less than
1 year
   
1-3 years
 
 
                 
Purchase obligations (1)
 
$
1,549
   
$
1,549
   
$
-
 
Collaboration Agreement and License Agreement obligations (2)
   

59

     

59

     
-
 
Operating lease obligations (3)
   
1,079
     
686
     
393
 
Total
 
$

2,687

   
$
2,294
   
$
393
 
 
(1)
The Company depends on one contract manufacturer, Sanmina Corporation, for both the ReStore products and the SCI Products. We place our manufacturing orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements
(2)
Our Collaboration Agreement with Harvard was originally for a term of five years, commencing in May 2016, and was subsequently amended in April 2018 to extend the term by one additional year. The Collaboration Agreement expired as of March 31, 2022. Under the Collaboration Agreement, we were required to pay in quarterly installments the funding of our joint research collaboration with Harvard, subject to a minimum funding commitment under applicable circumstances. Our License Agreement with Harvard consists of patent reimbursement expenses payments and a license upfront fee payment. There are also several milestone payments contingent upon the achievement of certain product development and commercialization milestones and royalty payments on net sales from certain patents licensed to Harvard. All product development milestones contemplated by the License Agreement have been met as of March 31, 2022; however, there are still outstanding commercialization milestones under the License Agreement that depend on us reaching certain sales amounts, some or all of which may not occur.
(3)
Our operating leases consist of leases for our facilities in the United States and Israel and motor vehicles.
 

We calculated the payments due under our operating lease obligation for our Israeli office that are to be paid in NIS at a rate of exchange of NIS 3.176: $1.00, and the payments due under our operating lease obligation for our German subsidiary that are to be paid in euros at a rate of exchange of €1.00: $1.109, both of which were the applicable exchange rates as of March 31, 2022.

 
Off-Balance Sheet Arrangements
 
We had no off-balance sheet arrangements or guarantees of third-party obligations as of March 31, 2022.
 
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
There have been no material changes to our market risk during the first quarter of 2022. For a discussion of our exposure to market risk, please see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our 2021 Form 10-K.
 
ITEM 4. CONTROLS AND PROCEDURES
 
Disclosure Controls and Procedures
 
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required financial disclosure.
 
As of the end of the period covered by this quarterly report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure