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
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
Non-accelerated filer ☒
|
Smaller reporting company ☒
|
Emerging growth company ☐
|
|
Page No.
|
|
2
|
||
3
|
||
3
|
||
|
3
|
|
|
5
|
|
|
6
|
|
|
7
|
|
|
8
|
|
24
|
||
37
|
||
37
|
||
37
|
||
37
|
||
38
|
||
39
|
||
39
|
||
39
|
||
39
|
||
40
|
||
41
|
March 31,
|
December 31,
|
|||||||
2021
|
2020
|
|||||||
(unaudited) | ||||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$
|
67,411
|
$
|
20,350
|
||||
Trade receivable, net
|
498
|
684
|
||||||
Prepaid expenses and other current assets
|
517
|
672
|
||||||
Inventories
|
3,493
|
3,542
|
||||||
Total current assets
|
71,919
|
25,248
|
||||||
LONG-TERM ASSETS
|
||||||||
Restricted cash and other long-term assets
|
1,021
|
1,033
|
||||||
Operating lease right-of-use assets
|
1,229
|
1,349
|
||||||
Property and equipment, net
|
392
|
437
|
||||||
Total long-term assets
|
2,642
|
2,819
|
||||||
Total assets
|
$
|
74,561
|
$
|
28,067
|
|
March 31,
|
December 31,
|
||||||
|
2021
|
2020
|
||||||
(unaudited) | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of operating leases
|
633
|
660
|
||||||
Trade payables
|
1,981
|
2,268
|
||||||
Employees and payroll accruals
|
577
|
867
|
||||||
Deferred revenues
|
388
|
441
|
||||||
Other current liabilities
|
443
|
432
|
||||||
Total current liabilities
|
4,022
|
4,668
|
||||||
|
||||||||
LONG-TERM LIABILITIES
|
||||||||
Deferred revenues
|
706
|
667
|
||||||
Non-current operating leases
|
782
|
923
|
||||||
Other long-term liabilities
|
32
|
35
|
||||||
Total long-term liabilities
|
1,520
|
1,625
|
||||||
|
||||||||
Total liabilities
|
5,542
|
6,293
|
||||||
|
||||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
Shareholders’ equity:
|
||||||||
|
||||||||
Share capital
|
||||||||
Ordinary share of NIS 0.25 par value-Authorized: 60,000,000 shares at March 31, 2021 and December 31, 2020; Issued and outstanding: 46,092,577 and 25,332,225 shares at March 31, 2021 and December 31, 2020,
respectively
|
3,385
|
1,827
|
||||||
Additional paid-in capital
|
250,141
|
201,392
|
||||||
Accumulated deficit
|
(184,507
|
)
|
(181,445
|
)
|
||||
Total shareholders’ equity
|
69,019
|
21,774
|
||||||
Total liabilities and shareholders’ equity
|
$
|
74,561
|
$
|
28,067
|
Three Months Ended
March 31,
|
||||||||
2021
|
2020
|
|||||||
Revenues
|
$
|
1,316
|
$
|
760
|
||||
Cost of revenues
|
609
|
387
|
||||||
Gross profit
|
707
|
373
|
||||||
Operating expenses:
|
||||||||
Research and development, net
|
795
|
985
|
||||||
Sales and marketing
|
1,671
|
1,681
|
||||||
General and administrative
|
1,262
|
1,309
|
||||||
Total operating expenses
|
3,728
|
3,975
|
||||||
Operating loss
|
(3,021
|
)
|
(3,602
|
)
|
||||
Financial expenses (income), net
|
(4
|
)
|
246
|
|||||
Loss before income taxes
|
(3,017
|
) |
(3,848
|
) |
||||
Taxes on income (tax benefit)
|
45
|
(8
|
) |
|||||
Net loss
|
$
|
(3,062
|
)
|
$
|
(3,840
|
) |
||
Net loss per ordinary share, basic and diluted
|
$
|
(0.08
|
) |
$
|
(0.37
|
)
|
||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
36,187,789
|
10,374,116
|
|
Ordinary Share
|
Additional
paid-in
capital |
Total
shareholders’
equity (deficiency) |
|||||||||||||||||
|
Number
|
Amount
|
Accumulated
deficit |
|||||||||||||||||
Balance as of December 31, 2019
|
7,319,560
|
504
|
178,745
|
(168,469
|
)
|
10,780
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
199
|
—
|
199
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and restricted stock units (“RSUs”) by employees and non-employees
|
10,595
|
*
|
)
|
—
|
—
|
—
|
||||||||||||||
Issuance of ordinary shares in “best efforts” offering, net of issuance expenses in the amount of $1,056 (1)
|
4,053,172
|
290
|
3,720
|
—
|
4,010
|
|||||||||||||||
Exercise of pre-funded warrants (1)
|
1,546,828
|
109
|
1,825
|
—
|
1,934
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
(3,840
|
)
|
(3,840
|
)
|
|||||||||||||
Balance as of March 31, 2020
|
12,930,155
|
903
|
184,489
|
(172,309
|
)
|
13,083
|
||||||||||||||
|
||||||||||||||||||||
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
|
*) |
Represents an amount lower than $1.
|
(1)
|
See Note 7.e. to the condensed consolidated financial statements.
|
(2)
|
See Note 7.c. to the condensed consolidated financial statements.
|
|
Three Months Ended
March 31, |
|||||||
|
2021
|
2020
|
||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(3,062
|
)
|
$
|
(3,840
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
70
|
75
|
||||||
Share-based compensation to employees and non-employees
|
168
|
199
|
||||||
Deferred taxes
|
—
|
(4
|
)
|
|||||
Changes in assets and liabilities:
|
||||||||
Trade receivables, net
|
186
|
68
|
||||||
Prepaid expenses, operating lease right-of-use assets and other assets
|
264
|
(448
|
)
|
|||||
Inventories
|
49
|
(267
|
)
|
|||||
Trade payables
|
(384
|
)
|
79
|
|||||
Employees and payroll accruals
|
(290
|
)
|
(143
|
)
|
||||
Deferred revenues
|
(14
|
)
|
(64
|
)
|
||||
Operating lease liabilities and other liabilities
|
(160
|
)
|
4
|
|||||
Net cash used in operating activities
|
(3,173
|
)
|
(4,341
|
)
|
||||
|
||||||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(9
|
)
|
(9
|
)
|
||||
Net cash used in investing activities
|
(9
|
)
|
(9
|
)
|
||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Repayment of long term loan
|
—
|
(1,266
|
)
|
|||||
Issuance of ordinary shares in a “best efforts” offerings, net of issuance expenses paid in the amount of $ 1,044 (1)
|
—
|
4,022
|
||||||
Issuance of ordinary shares in a private placement, net of issuance expenses paid in the amount of $ 3,582 (1)
|
36,418
|
—
|
||||||
Exercise of pre-funded warrants and warrants (1)(2)
|
13,818
|
1,934
|
||||||
Net cash provided by financing activities
|
50,236
|
4,690
|
||||||
|
||||||||
Increase in cash, cash equivalents, and restricted cash
|
47,054
|
340
|
||||||
Cash, cash equivalents, and restricted cash at beginning of period
|
21,054
|
16,992
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
$
|
68,108
|
$
|
17,332
|
||||
Supplemental disclosures of non-cash flow information
|
||||||||
“Best efforts” offering issuance cost not yet paid (1)
|
$
|
—
|
$
|
12
|
||||
Classification of inventory to property and equipment, net
|
$
|
—
|
$
|
50
|
||||
Expenses related to offerings not yet paid (1)
|
$
|
97
|
$
|
—
|
||||
Classification of other current assets to property and equipment, net
|
$
|
16
|
$
|
—
|
||||
Supplemental cash flow information:
|
||||||||
Cash and cash equivalents
|
$
|
67,411
|
$
|
16,602
|
||||
Restricted cash included in other long-term assets
|
697
|
730
|
||||||
Total Cash, cash equivalents, and restricted cash
|
$
|
68,108
|
$
|
17,332
|
(1)
|
See Note 7.e. to the condensed consolidated financial statements.
|
(2)
|
See Note 7.c. to the condensed consolidated financial statements.
|
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.
|
c. |
The worldwide spread of the novel coronavirus (“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 during 2020, and the Company expects that it will continue to negatively affect its sales and results of operations as long as the pandemic impacts our direct markets in Germany and the United
States and disturbs our ability to trial new ReWalk Personal 6.0 patients and access clinics to demonstrate our rehab products. The Company is currently unable to predict the scale and duration of that impact due to the considerable
uncertainty that still surrounds the length of time that the areas in which we operate will continue to be impacted by the measures designed to reduce and contain the spread of the virus taken on international, national and local levels. 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 to the Company’s 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 our estimates and judgments, and any such differences may be material to our financial
statements.
|
d. |
As of March 31, 2021, the Company incurred a consolidated net loss of $3.1 million and has an accumulated deficit in the total amount of $184.5 million. The Company’s
cash and cash equivalent as of March 31, 2021 totaled $67.4 million and the Company’s negative operating cash flow for the three months ended March 31, 2021 was $3.2 million. The Company has sufficient funds to support its operations for more
than 12 months following the issuance date of our condensed consolidated unaudited financial statements for the three months ended March 31, 2021. The Company expects 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.
|
a. |
Revenue Recognition
|
|
Three Months Ended March 31,
|
|||||||
|
2021
|
2020
|
||||||
Units placed
|
$
|
1,142
|
$
|
633
|
||||
Spare parts and warranties
|
174
|
127
|
||||||
Total Revenues
|
$
|
1,316
|
$
|
760
|
|
March 31,
|
December 31,
|
||||||
|
2021
|
2020
|
||||||
Trade receivable, net (1)
|
$
|
498
|
$
|
684
|
||||
Deferred revenues (1) (2)
|
$
|
1,094
|
$
|
1,108
|
(1) |
Balance presented net of unrecognized revenues that were not yet collected.
|
(2) |
During the three months ended March 31, 2021, $191 thousand of the December 31, 2020 deferred revenues balance was recognized as revenues.
|
b. |
New Accounting Pronouncements
|
i.
|
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity
|
ii.
|
Financial Instruments
|
c. |
Concentrations of Credit Risks:
|
|
March 31,
|
December 31,
|
||||||
|
2021
|
2020
|
||||||
Customer A
|
24
|
%
|
*
|
)
|
||||
Customer B
|
23
|
%
|
*
|
)
|
||||
Customer C
|
18
|
%
|
*
|
)
|
||||
Customer D
|
18
|
%
|
11
|
%
|
||||
Customer E
|
13
|
%
|
12
|
%
|
||||
Customer F
|
*
|
)
|
15
|
%
|
||||
Customer G
|
*
|
)
|
15
|
%
|
||||
Customer H
|
*
|
)
|
15
|
%
|
||||
Customer I
|
*
|
)
|
14
|
%
|
d. |
Warranty provision
The Company provided a two-year standard warranty for its products. As of 2018, our service policy for new devices sold includes five-year warranties. 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, 2020
|
$
|
140
|
||
Provision
|
52
|
|||
Usage
|
(68
|
)
|
||
Balance at March 31, 2021
|
$
|
124
|
e. |
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.
The total number of ordinary shares related to the outstanding warrants aggregated to 10,550,625, was excluded from the
calculations of diluted loss per ordinary share since it would have an anti-dilutive effect.
|
|
March 31,
|
December 31,
|
||||||
|
2021
|
2020
|
||||||
Finished products
|
$
|
2,777
|
$
|
2,764
|
||||
Raw materials
|
716
|
778
|
||||||
|
$
|
3,493
|
$
|
3,542
|
a. |
Purchase commitments:
|
b. |
Operating lease commitment:
|
(i) |
The Company operates from leased facilities in Israel, the United States and Germany. These leases expire between 2021 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 2021 and 2023. 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,
2021.
|
2021
|
$
|
513
|
||
2022
|
662
|
|||
2023
|
481
|
|||
Total lease payments
|
1,656
|
|||
Less: imputed interest
|
(241
|
)
|
||
Present value of future lease payments
|
1,415
|
|||
Less: current maturities of operating leases
|
(633
|
)
|
||
Non-current operating leases
|
$
|
782
|
||
Weighted-average remaining lease term (in years)
|
2.47
|
|||
Weighted-average discount rate
|
12.6
|
%
|
c. |
Royalties:
|
d. |
Liens:
|
e. |
Legal Claims:
|
|
Number
|
Average
exercise
price
|
Average
remaining
contractual
life (in years)
|
Aggregate
intrinsic
value (in
thousands)
|
||||||||||||
Options outstanding at the beginning of the period
|
69,606
|
$
|
37.90
|
5.59
|
$
|
—
|
||||||||||
Granted
|
—
|
—
|
—
|
—
|
||||||||||||
Exercised
|
—
|
—
|
—
|
—
|
||||||||||||
Forfeited
|
(1,860
|
)
|
26.83
|
—
|
—
|
|||||||||||
Options outstanding at the end of the period
|
67,746
|
$
|
38.20
|
5.04
|
$
|
—
|
||||||||||
|
||||||||||||||||
Options exercisable at the end of the period
|
54,779
|
$
|
43.17
|
4.47
|
$
|
—
|
|
Number of shares underlying outstanding RSUs
|
Weighted average grant date fair value
|
||||||
Unvested RSUs at the beginning of the period
|
1,251,311
|
$
|
3.20
|
|||||
Granted
|
13,000
|
1.32
|
||||||
Vested
|
(24,096
|
)
|
1.60
|
|||||
Forfeited
|
(75,764
|
)
|
1.60
|
|||||
Unvested RSUs at the end of the period
|
1,164,451
|
$
|
3.90
|
Range of exercise price
|
|
Options and RSUs outstanding as of March 31, 2021
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
|
Options outstanding and exercisable as of March 31, 2021
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
RSUs only
|
|
1,164,451
|
|
—
|
|
—
|
|
—
|
$5.37
|
|
12,425
|
|
7.99
|
|
6,212
|
|
7.99
|
$20.42 - $33.75
|
|
34,620
|
|
4.71
|
|
28,235
|
|
4.18
|
$37.14 - $38.75
|
|
9,992
|
|
2.54
|
|
9,992
|
|
2.54
|
$50 - $52.50
|
|
8,043
|
|
5.21
|
|
7,674
|
|
5.16
|
$182.5 - $524
|
|
2,666
|
|
4.45
|
|
2,666
|
|
4.45
|
|
|
1,232,197
|
|
5.04
|
|
54,779
|
|
4.47
|
(1) |
Calculation of weighted average remaining contractual term does not include the RSUs that were granted, which have an indefinite contractual term.
|
|
c.
|
Warrants to purchase ordinary shares:
|
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)
|
||||||||
November 1, 2016 (2)
|
97,496
|
$
|
118.750
|
97,496
|
November 1, 2021
|
||||||||
December 28, 2016 (3)
|
1,908
|
$
|
7.500
|
1,908
|
See footnote (1)
|
||||||||
November 20, 2018 (4)
|
126,839
|
$
|
7.500
|
126,839
|
November 20, 2023
|
||||||||
November 20, 2018 (5)
|
106,680
|
$
|
9.375
|
106,680
|
November 15, 2023
|
||||||||
February 25, 2019 (6)
|
45,600
|
$
|
7.187
|
45,600
|
February 21, 2024
|
||||||||
April 5, 2019 (7)
|
408,457
|
$
|
5.140
|
408,457
|
October 7, 2024
|
||||||||
April 5, 2019 (8)
|
49,015
|
$
|
6.503
|
49,015
|
April 3, 2024
|
||||||||
June 5, 2019 and June 6, 2019 (9)
|
1,464,665
|
$
|
7.500
|
1,464,665
|
June 5, 2024
|
||||||||
June 5, 2019 (10)
|
87,880
|
$
|
9.375
|
87,880
|
June 5, 2024
|
||||||||
June 12, 2019 (11)
|
416,667
|
$
|
6.000
|
416,667
|
December 12, 2024
|
||||||||
June 10, 2019 (12)
|
50,000
|
$
|
7.500
|
50,000
|
June 10, 2024
|
||||||||
February 10, 2020 (13)
|
28,400
|
$
|
1.250
|
28,400
|
February 10, 2025
|
||||||||
February 10, 2020 (14)
|
105,840
|
$
|
1.5625
|
105,840
|
February 10, 2025
|
||||||||
July 6, 2020 (15)
|
448,698
|
$
|
1.76
|
448,698
|
July 2, 2025
|
||||||||
July 6, 2020 (16)
|
296,297
|
$
|
2.2781
|
296,297
|
July 2, 2025
|
||||||||
December 3, 2020 (17)
|
586,760
|
$
|
1.34
|
586,760
|
June 8, 2026
|
||||||||
December 3, 2020 (18)
|
108,806
|
$
|
1.7922
|
108,806
|
June 8, 2026
|
||||||||
February 26, 2021 (19)
|
5,460,751
|
$
|
3.6
|
5,460,751
|
August 26, 2026
|
||||||||
February 26, 2021 (20)
|
655,290
|
$
|
4.5781
|
655,290
|
August 26, 2026
|
||||||||
|
10,550,820
|
10,550,820
|
|
(1) |
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, or Kreos, in connection with a loan made by Kreos to us 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 us with or into, or the sale or license of all or
substantially all the assets or shares of us to, any other entity or person, other than a wholly-owned subsidiary of us, 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, 2021.
|
(2) |
Represents warrants issued as part of the Company’s follow-on offering in November 2016. At any time, the Company’s board of directors may reduce the exercise price of the warrants to any amount and for any period of time it deems
appropriate.
|
(3) |
Represents common warrants that were issued as part of the $8.000 million December 28, 2016 drawdown under the Loan Agreement between the Company and Kreos, pursuant to which Kreos extended a line of credit to us in the amount of $20
million, with interest payable monthly in arrears on any amounts drawn down at a rate of 10.75% per year from the applicable drawdown date through December 29, 2020, the date on which all principal was repaid. See footnote 1 for
exercisability terms of the common warrants.
|
(4) |
Represents common warrants that were issued as part of the Company’s follow-on offering in November 2018.
|
(5) |
Represents common warrants that were issued to the underwriters as compensation for their role in the Company’s follow-on offering in November 2018.
|
(6) |
Represents warrants that were issued to the exclusive placement agent as compensation for its role in the Company’s follow-on offering in February 2019.
|
(7) |
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.
|
(8) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s April 2019 registered direct offering.
|
(9) |
Represents warrants that were issued to certain institutional investors in a warrant exercise agreement on June 5, 2019 and June 6, 2019, respectively.
|
(10) |
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.
|
(11) |
Represents warrants that were issued to certain institutional investors in a warrant exercise agreement in June 2019.
|
(12) |
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.
|
(13) |
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 three months ended March 31, 2021 3,740,100 warrants
were exercised for total consideration of $4,675,125.
|
(14) |
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 three months ended March 31, 2021 230,160 warrants were exercised for total
consideration of $359,625.
|
(15) |
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 three months ended March 31, 2021 2,020,441 warrants were
exercised for total consideration of $3,555,976.
|
(16) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering.
|
(17) |
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 three months ended March 31, 2021 3,598,072 warrants were
exercised for total consideration of $4,821,416.
|
(18) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s December 2020 private placement. During the three months ended March 31, 2021 225,981 warrants were exercised for total consideration
of $405,003.
|
(19) |
Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in February 2021.
|
(20) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2021 private placement.
|
|
Three Months Ended March 31,
|
|||||||
|
2021
|
2020
|
||||||
Cost of revenues
|
$
|
2
|
$
|
2
|
||||
Research and development, net
|
(2
|
)
|
42
|
|||||
Sales and marketing
|
45
|
29
|
||||||
General and administrative
|
123
|
126
|
||||||
Total
|
$
|
168
|
$
|
199
|
|
Three Months Ended March 31,
|
|||||||
|
2021
|
2020
|
||||||
Foreign currency transactions and other
|
$
|
(14
|
)
|
$
|
(73
|
)
|
||
Financial expenses related to loan agreement with Kreos
|
—
|
310
|
||||||
Bank commissions
|
10
|
9
|
||||||
|
$
|
(4
|
)
|
$
|
246
|
|
Three Months Ended March 31,
|
|||||||
|
2021
|
2020
|
||||||
Revenues based on customer’s location :
|
||||||||
Israel
|
—
|
—
|
||||||
United States
|
$
|
476
|
$
|
216
|
||||
Europe
|
837
|
542
|
||||||
Asia-Pacific
|
2
|
2
|
||||||
Africa
|
1
|
—
|
||||||
Total revenues
|
$
|
1,316
|
$
|
760
|
|
March 31,
|
December 31,
|
||||||
|
2021
|
2020
|
||||||
Long-lived assets by geographic region (*):
|
||||||||
Israel
|
$
|
145
|
$
|
145
|
||||
United States
|
217
|
249
|
||||||
Germany
|
30
|
43
|
||||||
|
$
|
392
|
$
|
437
|
|
Three Months Ended March 31,
|
|||||||
|
2021
|
2020
|
||||||
Major customer data as a percentage of total revenues:
|
||||||||
Customer A
|
15
|
%
|
*
|
)
|
||||
Customer B
|
10
|
%
|
—
|
|||||
Customer C
|
10
|
%
|
—
|
|||||
Customer D
|
—
|
22
|
%
|
|||||
Customer E
|
—
|
14
|
%
|
|||||
Customer F
|
—
|
13
|
%
|
|||||
Customer G
|
—
|
12
|
%
|
|||||
Customer H
|
—
|
11
|
%
|
•
|
the adverse effect that the COVID-19 pandemic has had and may continue 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 ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market and the risk that our ordinary shares will be delisted if we cannot do so;
|
•
|
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 for our products;
|
•
|
our limited operating history and our ability to leverage our sales, marketing and training infrastructure;
|
•
|
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 ReWalk’s ability to market and sell its products;
|
•
|
our ability to gain and maintain regulatory approvals;
|
•
|
our expectations as to the results of the FDA, potential regulatory developments with respect to our mandatory 522 postmarket surveillance study;
|
•
|
the risk of a cybersecurity attack or breach of our IT 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;
|
•
|
our ability to establish a pathway to commercialize our products in China;
|
•
|
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 “Part I. Item 1A. Risk Factors.”
|
• |
The Company’s total revenue in the first quarter of 2021 was $1.3 million, compared to $0.8 million in the prior year’s first quarter;
|
• |
The Company’s gross margin was 54% in Q1 of 2021, compared to 49% in Q1 of 2020;
|
• |
The Company’s operating expenses were $3.7 million in Q1 of 2021, compared to $4 million in Q1 2020;
|
• |
The Company entered into a contract with BKK Mobile Oil health insurance to supply ReWalk’s Personal 6.0 System to eligible persons in Germany; and
|
• |
The Company has a strong balance sheet with $67.4 million in cash as of March 31, 2021.
|
Three Months Ended
March 31,
|
||||||||
2021
|
2020
|
|||||||
Revenues
|
$
|
1,316
|
$
|
760
|
||||
Cost of revenues
|
609
|
387
|
||||||
Gross profit
|
707
|
373
|
||||||
Operating expenses:
|
||||||||
Research and development, net
|
795
|
985
|
||||||
Sales and marketing
|
1,671
|
1,681
|
||||||
General and administrative
|
1,262
|
1,309
|
||||||
Total operating expenses
|
3,728
|
3,975
|
||||||
Operating loss
|
(3,021
|
)
|
(3,602
|
)
|
||||
Financial expenses (income), net
|
(4
|
)
|
246
|
|||||
Loss before income taxes
|
(3,017
|
) |
(3,848
|
) |
||||
Taxes on income (tax benefit)
|
45
|
(8
|
) |
|||||
Net loss
|
$
|
(3,062
|
)
|
$
|
(3,840
|
) |
||
Net loss per ordinary share, basic and diluted
|
$
|
(0.08
|
) |
$
|
(0.37
|
)
|
||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
36,187,789
|
10,374,116
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
|
(in thousands, except unit amounts)
|
|||||||
Personal unit revenues
|
$
|
1,308
|
$
|
714
|
||||
Rehabilitation unit revenues
|
8
|
46
|
||||||
|
||||||||
Revenues
|
$
|
1,316
|
$
|
760
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Gross profit
|
$
|
707
|
$
|
373
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Research and development expenses, net
|
$
|
795
|
$
|
985
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Sales and marketing expenses
|
$
|
1,671
|
$
|
1,681
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
General and administrative
|
$
|
1,262
|
$
|
1,309
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Financial expenses (income), net
|
$
|
(4
|
)
|
$
|
246
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Income taxes (tax benefit)
|
$
|
45
|
$
|
(8
|
)
|
|
Three Months Ended
March 31,
|
|||||||
|
2021
|
2020
|
||||||
Net cash used in operating activities
|
$
|
(3,173
|
)
|
$
|
(4,341
|
)
|
||
Net cash used in investing activities
|
(9
|
)
|
(9
|
)
|
||||
Net cash provided by financing activities
|
50,236
|
4,690
|
||||||
Net cash flow
|
$
|
47,054
|
$
|
340
|
|
Payments due by period (in dollars, in thousands)
|
|||||||||||
Contractual obligations
|
Total
|
Less than
1 year |
1-3 years
|
|||||||||
|
||||||||||||
Purchase obligations (1)
|
$
|
1,150
|
$
|
1,150
|
$
|
—
|
||||||
Collaboration Agreement and License Agreement obligations (2)
|
2,144
|
1,344
|
800
|
|||||||||
Operating lease obligations (3)
|
1,656
|
681
|
975
|
|||||||||
Total
|
$
|
4,950
|
$
|
3,175
|
$
|
1,775
|
(1)
|
The Company depends on one contract manufacturer, Sanmina, 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. Additionally, we have purchase obligations to our raw material vendors related to the ReStore production, which began in the second quarter of 2019 following regulatory clearance.
|
(2)
|
Our Collaboration Agreement with Harvard was originally signed for a period of six years and, as of March 31, 2021, has a remaining term of approximately 1.91 years. Under the Collaboration
Agreement, we are 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 of 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. These product development milestones have been met as of March 31, 2021. There are commercialization milestones which 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.
|
|
Exhibit
Number
|
|
Description
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
*
|
Furnished herewith.
|
|
|
^
|
Portions of this exhibit (indicated by asterisks) have been omitted under rules of the SEC permitting the confidential treatment of select information.
|
#
|
The schedules to this exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K.
|
|
ReWalk Robotics Ltd.
|
|
|
|
|
Date: May 11, 2021
|
By:
|
/s/ Larry Jasinski
|
|
|
Larry Jasinski
|
|
|
Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
Date: May 11, 2021
|
By:
|
/s/ Ori Gon
|
|
|
Ori Gon
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Principal Accounting Officer)
|
|
/s/ Larry Jasinski
|
|
|
Larry Jasinski
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
ReWalk Robotics Ltd.
|
|
|
/s/ Ori Gon
|
|
|
Ori Gon
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
|
|
ReWalk Robotics Ltd.
|
|
• |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
• |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ Larry Jasinski
|
|
|
Larry Jasinski
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
ReWalk Robotics Ltd.
|
|
• |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
• |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company
|
|
/s/ Ori Gon
|
|
|
Ori Gon
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial Officer)
|
|
|
ReWalk Robotics Ltd.
|
|