☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Israel
|
Not applicable
|
||||||
(State or other jurisdiction of incorporation or organization)
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(I.R.S. employer identification no.)
|
||||||
3 Hatnufa Street, Floor 6, Yokneam Ilit, Israel
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2069203
|
||||||
(Address of principal executive offices)
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(Zip Code)
|
||||||
Securities registered pursuant to Section 12(b) of the Act
|
Title of each class
|
|
Name of exchange on which
registered
|
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Trading symbol
|
Ordinary shares, par value NIS 0.25
|
|
Nasdaq Capital Market
|
|
RWLK
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Large accelerated filer ☐
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Accelerated filer ☐
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Non-accelerated filer ☒
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Smaller reporting company ☒
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(Do not check if a smaller reporting company)
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Emerging growth company ☐
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Page No.
|
||
2
|
||
3 |
||
3 |
||
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3 |
|
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5 |
|
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6 |
|
|
7 |
|
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8 |
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26 |
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41 |
||
41 |
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42 |
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42 |
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42 |
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47 |
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47 |
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47 |
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48 |
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49 |
||
50 |
March 31,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$
|
16,602
|
$
|
16,253
|
||||
Trade receivable, net
|
726
|
794
|
||||||
Prepaid expenses and other current assets
|
1,294
|
903
|
||||||
Inventories
|
3,340
|
3,123
|
||||||
Total current assets
|
21,962
|
21,073
|
||||||
LONG-TERM ASSETS
|
||||||||
Restricted cash and other long term assets
|
1,049
|
1,061
|
||||||
Operating lease right-of-use assets
|
1,721
|
1,737
|
||||||
Property and equipment, net
|
485
|
501
|
||||||
Total long-term assets
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3,255
|
3,299
|
||||||
Total assets
|
$
|
25,217
|
$
|
24,372
|
March 31,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long term loan
|
$
|
5,699
|
$
|
5,438
|
||||
Current maturities of operating leases
|
658
|
637
|
||||||
Trade payables
|
2,789
|
2,698
|
||||||
Employees and payroll accruals
|
527
|
670
|
||||||
Deferred revenues
|
283
|
323
|
||||||
Other current liabilities
|
395
|
402
|
||||||
Total current liabilities
|
10,351
|
10,168
|
||||||
LONG-TERM LIABILITIES
|
||||||||
Long term loan, net of current maturities
|
—
|
1,527
|
||||||
Deferred revenues
|
497
|
521
|
||||||
Non-current operating leases
|
1,235
|
1,315
|
||||||
Other long-term liabilities
|
51
|
61
|
||||||
Total long-term liabilities
|
1,783
|
3,424
|
||||||
Total liabilities
|
12,134
|
13,592
|
||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
Shareholders’ equity:
|
||||||||
Share capital
|
||||||||
Ordinary share of NIS 0.25 par value-Authorized: 60,000,000 shares at March 31, 2020 and December 31, 2019; Issued and outstanding: 12,930,155 and 7,319,560 shares at March 31, 2020 and
December 31, 2019, respectively
|
903
|
504
|
||||||
Additional paid-in capital
|
184,489
|
178,745
|
||||||
Accumulated deficit
|
(172,309
|
)
|
(168,469
|
) |
||||
Total shareholders’ equity
|
13,083
|
10,780
|
||||||
Total liabilities and shareholders’ equity
|
$
|
25,217
|
$
|
24,372
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Revenues
|
$
|
760
|
$
|
1,581
|
||||
Cost of revenues
|
387
|
655
|
||||||
Gross profit
|
373
|
926
|
||||||
Operating expenses:
|
||||||||
Research and development, net
|
985
|
1,414
|
||||||
Sales and marketing
|
1,681
|
1,587
|
||||||
General and administrative
|
1,309
|
1,500
|
||||||
Total operating expenses
|
3,975
|
4,501
|
||||||
Operating loss
|
(3,602
|
)
|
(3,575
|
)
|
||||
Financial expenses, net
|
246
|
418
|
||||||
Loss before income taxes
|
(3,848
|
) |
(3,993
|
) | ||||
Taxes on income (tax benefit)
|
(8
|
) |
7
|
|||||
Net loss
|
$
|
(3,840
|
)
|
$
|
(4,000
|
) | ||
Net loss per ordinary share, basic and diluted
|
$
|
(0.37
|
) |
$
|
(1.25
|
)
|
||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
10,374,116
|
3,211,386
|
Ordinary Share
|
Additional | Total | ||||||||||||||||||
Number | Amount | paid-in capital |
Accumulated deficit |
shareholders’ equity (deficiency) |
||||||||||||||||
Balance as of December 31, 2018 (1)
|
2,813,087
|
193
|
154,670
|
(152,918
|
)
|
1,945
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
319
|
—
|
319
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
|
2,206
|
*
|
)
|
—
|
—
|
—
|
||||||||||||||
Issuance of ordinary shares in “best efforts” offering, net of issuance expenses in the amount of $686 (2)
|
760,000
|
52
|
3,632
|
—
|
3,684
|
|||||||||||||||
Exercise of pre-funded warrants and warrants (2)
|
119,881
|
8
|
99
|
—
|
107
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
(4,000
|
)
|
(4,000
|
)
|
|||||||||||||
Balance as of March 31, 2019
|
3,695,174
|
253
|
158,720
|
(156,918
|
)
|
2,055
|
||||||||||||||
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 vesting of 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 (2)
|
4,053,172
|
290
|
3,720
|
—
|
4,010
|
|||||||||||||||
Exercise of pre-funded warrants (2)
|
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
|
*)
|
Represents an amount lower than $1.
|
(1)
|
Reflects our one-for-twenty-five reverse share split that became effective on April 1, 2019. See Note 7a to the condensed consolidated financial statements
|
(2)
|
See Note 7f to the condensed consolidated financial statements
|
|
Three Months Ended
March 31, |
|||||||
|
2020
|
2019
|
||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(3,840
|
)
|
$
|
(4,000
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
75
|
94
|
||||||
Share-based compensation to employees and non-employees
|
199
|
319
|
||||||
Deferred taxes
|
(4
|
)
|
(36
|
)
|
||||
Changes in assets and liabilities:
|
||||||||
Trade receivables, net
|
68
|
(334
|
)
|
|||||
Prepaid expenses, operating lease right-of-use assets and other assets
|
(448
|
)
|
(240
|
)
|
||||
Inventories
|
(267
|
)
|
(238
|
)
|
||||
Trade payables
|
79
|
238
|
||||||
Employees and payroll accruals
|
(143
|
)
|
(56
|
)
|
||||
Deferred revenues and advances from customers
|
(64
|
)
|
(25
|
)
|
||||
Other liabilities
|
4
|
25
|
||||||
Net cash used in operating activities
|
(4,341
|
)
|
(4,253
|
)
|
||||
|
||||||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(9
|
)
|
—
|
|||||
Net cash used in investing activities
|
(9
|
)
|
—
|
|||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Repayment of long term loan
|
(1,266
|
)
|
(401
|
)
|
||||
Issuance of ordinary shares in a “best efforts” offering, net of issuance expenses paid in the amount of $496 (1)
|
—
|
3,874
|
||||||
Issuance of ordinary shares in a “best efforts” offerings, net of issuance expenses paid in the amount of $ 1,044 (1)
|
4,022
|
—
|
||||||
Exercise of pre-funded warrants and warrants (1)
|
1,934
|
107
|
||||||
Net cash provided by financing activities
|
4,690
|
3,580
|
||||||
|
||||||||
Increase (decrease) in cash, cash equivalents, and restricted cash
|
340
|
(673
|
)
|
|||||
Cash, cash equivalents, and restricted cash at beginning of period
|
16,992
|
10,347
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
$
|
17,332
|
$
|
9,674
|
||||
Supplemental disclosures of non-cash flow information
|
||||||||
Classification of inventory to property and equipment, net
|
$
|
50
|
$
|
—
|
||||
“Best efforts” offering issuance cost not yet paid (1)
|
$
|
12
|
$
|
189
|
||||
Initial recognition of operating lease right-of-use assets
|
$
|
—
|
$
|
2,099
|
||||
Initial recognition of operating lease liabilities
|
$
|
—
|
$
|
(2,249
|
)
|
|||
Supplemental cash flow information:
|
||||||||
Cash and cash equivalents
|
$
|
16,602
|
$
|
8,862
|
||||
Restricted cash included in other long term assets
|
730
|
812
|
||||||
Total Cash, cash equivalents, and restricted cash
|
$
|
17,332
|
$
|
9,674
|
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 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 already had a negative impact on the Company's
sales and results of operations, and the Company expects that it will continue to negatively affect its sales and results of operations but 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 our estimates and judgments, and any such differences may be material to our financial statements.
|
d. |
The Company has an accumulated deficit in the total amount of approximately $172.3 million as of March 31, 2020 and negative cash flow from operations of $4.3 million, and further losses are anticipated in
the development of its business. Those factors raise substantial doubt about the Company’s ability to continue as a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary
financing to meet its obligations and repay its liabilities arising from normal business operations when they become due.
|
The condensed consolidated financial statements for the three months ended March 31, 2020 do not include any adjustments to reflect the possible future effects on the recoverability and classification of
assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
|
a. |
Revenue Recognition
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Units placed
|
$
|
633
|
$
|
1,474
|
||||
Spare parts and warranties
|
127
|
107
|
||||||
Total Revenues
|
$
|
760
|
$
|
1,581
|
March 31,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
Trade receivable, net (1)
|
$
|
726
|
$
|
794
|
||||
Deferred revenues (1) (2)
|
$
|
780
|
$
|
844
|
(1) |
Balance presented net of unrecognized revenues that were not yet collected.
|
(2) |
$159 thousand of December 31, 2019 deferred revenues balance were recognized as revenues during the three months ended March 31, 2020.
|
b. |
New Accounting Pronouncements
|
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments and subsequent amendments
to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05, which amends the current approach to estimate credit losses on certain financial assets, including trade and other receivables. Generally, this amendment
requires entities to establish a valuation allowance for the expected lifetime losses of these certain financial assets. Upon the initial recognition of such assets, which will be based on, among other things, historical
information, current conditions, and reasonable supportable forecasts. Subsequent changes in the valuation allowance are recorded in current earnings and reversal of previous losses are permitted. Currently, U.S. GAAP requires
entities to write down credit losses only when losses are probable and loss reversals are not permitted. Originally, ASU 2016-13 was effective for fiscal years, and for interim periods within those fiscal years, beginning
after December 15, 2019, with early adoption permitted. An entity should apply the standard by recording a cumulative effect adjustment to retained earnings upon adoption. In November 2019, FASB issued ASU No.
2019-10, Financial Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842). This ASU defers the effective date of ASU 2016-13 for public companies that are considered smaller
reporting companies as defined by the SEC to fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company is planning to adopt this standard in the first quarter of fiscal
2023. The adoption of this standard is not expected to result in a material impact to the Company’s financial statements.
|
c. |
Concentrations of Credit Risks:
|
March 31,
|
December 31,
|
|||||||
|
2020
|
2019
|
||||||
Customer A
|
23
|
%
|
*
|
)
|
||||
Customer B
|
15
|
%
|
13
|
%
|
||||
Customer C
|
14
|
%
|
12
|
%
|
||||
Customer D
|
13
|
%
|
*
|
)
|
||||
Customer E
|
12
|
%
|
*
|
)
|
||||
Customer F
|
*
|
)
|
14
|
%
|
||||
Customer G
|
*
|
)
|
13
|
%
|
||||
Customer H
|
*
|
)
|
12
|
%
|
||||
Customer I
|
*
|
)
|
12
|
%
|
||||
Customer J
|
*
|
)
|
12
|
%
|
d. |
Warranty provision
|
US Dollars
in thousands |
||||
Balance at December 31, 2019
|
$
|
227
|
||
Provision
|
24
|
|||
Usage
|
(51
|
)
|
||
Balance at March 31, 2020
|
$
|
200
|
March 31,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
Finished products
|
$
|
2,548
|
$
|
2,394
|
||||
Raw materials
|
792
|
729
|
||||||
$
|
3,340
|
$
|
3,123
|
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 2019 and 2023. A portion of our facilities leases is generally subject to annual changes in the Consumer Price Index
(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 2019 and 2022. A subset of our 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 $41 thousand as of March 31,
2020.
|
2020
|
$
|
708
|
||
2021
|
693
|
|||
2022
|
624
|
|||
2023
|
306
|
|||
Total lease payments
|
2,331
|
|||
Less: imputed interest
|
(438
|
)
|
||
Present value of future lease payments
|
1,893
|
|||
Less: current maturities of operating leases
|
(658
|
)
|
||
Non-current operating leases
|
$
|
1,235
|
||
Weighted-average remaining lease term (in years)
|
3.36
|
|||
Weighted-average discount rate
|
12.6
|
%
|
Lease expense under the Company’s operating leases was $183 and $178 for the three months ended March 31, 2020 and 2019, respectively.
|
c. |
Royalties:
|
d. |
Liens:
|
e. |
Legal Claims:
|
a.
|
Reverse share split:
|
b.
|
Share option plans:
|
Three Months Ended March 31,
|
||||
2019
|
||||
Expected volatility
|
57.5
|
%
|
||
Risk-free rate
|
2.22
|
%
|
||
Dividend yield
|
—
|
%
|
||
Expected term (in years)
|
6.11
|
|||
Share price
|
$
|
5.37
|
Number
|
Average
exercise
price
|
Average
remaining
contractual
life (in years)
|
Aggregate
intrinsic
value (in
thousands)
|
|||||||||||||
Options outstanding at the beginning of the period
|
74,713
|
$
|
41.60
|
6.34
|
$
|
135
|
||||||||||
Granted
|
—
|
—
|
||||||||||||||
Exercised
|
—
|
—
|
||||||||||||||
Forfeited
|
(320
|
)
|
26.875
|
|||||||||||||
Options outstanding at the end of the period
|
74,393
|
$
|
41.67
|
5.98
|
$
|
21
|
||||||||||
Options exercisable at the end of the period
|
49,609
|
$
|
51.87
|
4.81
|
$
|
—
|
Number of shares underlying outstanding RSUs
|
Weighted average grant date fair value
|
|||||||
Unvested RSUs at the beginning of the period
|
62,378
|
$
|
44.61
|
|||||
Granted
|
-
|
-
|
||||||
Vested
|
(10,595
|
)
|
7.06
|
|||||
Forfeited
|
(3,805
|
)
|
10.25
|
|||||
Unvested RSUs at the end of the period
|
47,978
|
$
|
55.80
|
Range of exercise price
|
Options and RSUs outstanding as of March 31, 2020
|
Weighted
average
remaining
contractual
life (years) (1)
|
Options outstanding and exercisable as of March 31, 2020
|
Weighted
average
remaining
contractual
life (years) (1)
|
||||
RSUs only
|
47,978
|
—
|
—
|
—
|
||||
$5.37
|
12,425
|
8.99
|
3,106
|
8.99
|
||||
$20.42 - $33.75
|
36,531
|
5.97
|
23,377
|
4.79
|
||||
$37.14 - $38.75
|
10,194
|
3.71
|
10,194
|
3.71
|
||||
$50 - $52.50
|
11,395
|
5.34
|
9,084
|
4.87
|
||||
$182.5 - $524
|
3,848
|
4.32
|
3,848
|
4.32
|
||||
122,371
|
5.98
|
49,609
|
4.81
|
(1) |
Calculation of weighted average remaining contractual term does not include the RSUs that were granted, which have an indefinite contractual term.
|
c.
|
Share-based awards to non-employee consultants:
|
d.
|
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
|
$
|
7.5
|
4,771
|
See footnote (1)
|
||||||||
November 1, 2016 (2)
|
97,496
|
$
|
118.75
|
97,496
|
November 1, 2021
|
||||||||
December 28, 2016 (3)
|
1,908
|
$
|
7.5
|
1,908
|
See footnote (1)
|
||||||||
November 20, 2018 (4)
|
126,839
|
$
|
7.5
|
126,839
|
November 20, 2023
|
||||||||
November 20, 2018 (5)
|
106,680
|
$
|
9.375
|
106,680
|
November 15, 2023
|
||||||||
February 25, 2019 (6)
|
45,600
|
$
|
7.1875
|
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)
|
5,600,000
|
$
|
1.25
|
5,600,000
|
February 10, 2025
|
||||||||
February 10, 2020 (14)
|
336,000
|
$
|
1.5625
|
336,000
|
February 10, 2025
|
||||||||
8,795,978
|
8,795,978
|
(1) |
Represents warrants for ordinary shares issuable upon an exercise price of $7.5 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 our 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, 2020.
|
(2) |
Represents warrants issued as part of our follow-on offering in November 2016. At any time, the 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 $8.0 million drawdown under the Loan Agreement which occurred on December 28, 2016. See footnote 1 for exercisability terms.
|
(4) |
Represents common warrants that were issued as part of our follow-on offering in November 2018.
|
(5) |
Represents common warrants that were issued to the underwriters as compensation for their role in our follow-on offering in November 2018.
|
(6) |
Represents warrants that were issued to the exclusive placement agent and its designees as compensation for their role in our 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 purchasers in a private placement in the Company’s registered direct offering of ordinary shares 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.
|
(14) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2020 best efforts offering`
|
e.
|
Share-based compensation expense for employees and non-employees:
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Cost of revenues
|
$
|
2
|
$
|
4
|
||||
Research and development, net
|
42
|
61
|
||||||
Sales and marketing
|
29
|
72
|
||||||
General and administrative
|
126
|
182
|
||||||
Total
|
$
|
199
|
$
|
319
|
f.
|
Equity raise:
|
1.
|
Follow-on offerings:
|
2.
|
Investment agreement:
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Foreign currency transactions and other
|
$
|
(73
|
)
|
$
|
3
|
|||
Financial expenses related to loan agreement with Kreos
|
310
|
404
|
||||||
Bank commissions
|
9
|
11
|
||||||
$
|
246
|
$
|
418
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Revenues based on customer’s location :
|
||||||||
Israel
|
$
|
—
|
$
|
—
|
||||
United States
|
216
|
497
|
||||||
Europe
|
542
|
1,079
|
||||||
Asia-Pacific
|
2
|
5
|
||||||
Total revenues
|
$
|
760
|
$
|
1,581
|
March 31,
|
December 31,
|
|||||||
2020
|
2019
|
|||||||
Long-lived assets by geographic region (*):
|
||||||||
Israel
|
$
|
175
|
$
|
179
|
||||
United States
|
232
|
244
|
||||||
Germany
|
78
|
78
|
||||||
$
|
485
|
$
|
501
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Major customer data as a percentage of total revenues:
|
||||||||
Customer A
|
22.4
|
%
|
*
|
)
|
||||
Customer B
|
14.1 |
% | * | ) | ||||
Customer C
|
12.9
|
%
|
*
|
)
|
||||
Customer D
|
12.3
|
%
|
*
|
)
|
||||
Customer E
|
11.3
|
%
|
*
|
)
|
||||
Customer F
|
*
|
)
|
12.9
|
%
|
• |
On April 21, 2020, RRI entered into an unsecured note (the “Note”) evidencing an unsecured loan in the amount of $392 thousand under the Paycheck Protection Program (the “PPP”) as part of the Coronavirus
Aid, Relief, and Economic Security Act (the “CARES Act”) enacted on March 27, 2020. The Note provides for an interest rate of 1.00% per year, and matures two years after the date of initial disbursement. Beginning on the seventh month
following the date of initial disbursement, RRI is required to make 18 monthly payments of principal and interest. The Note may be used for payroll costs, costs related to certain group health care benefits and insurance premiums, rent
payments, utility payments, mortgage interest payments and interest payments on any other debt obligation that were incurred before February 15, 2020. Under the terms of the CARES Act, PPP loan recipients can apply for and be granted
forgiveness for all or a portion of loan granted under the PPP, with such forgiveness to be determined, subject to limitations, based on the use of the loan proceeds for payment of payroll costs and any payments of mortgage interest,
rent, and utilities. The terms of any forgiveness may also be subject to further requirements in any regulations and guidelines the Small Business Administration may adopt. While the Company currently believes that its use of the Note
proceeds will meet the conditions for forgiveness under the PPP, no assurance is provided that the Company will obtain forgiveness of the Note in whole or in part.
|
• |
On April 30, 2020, the Company and Harvard amended the Collaboration Agreement with certain adjustments to the quarterly installments and extending the term an additional three quarters until February 2023.
For further details on the Collaboration Agreement, see note 6 above.
|
• |
our management’s conclusion, and our independent registered public accounting firm’s statement in its opinion relating to our consolidated financial statements for the fiscal year ended December 31, 2019, that there is a substantial
doubt as to our ability to continue as a going concern;
|
• |
the current coronavirus (COVID-19) pandemic has adversely affected and may continue to affect adversely 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 ability to establish a pathway to commercialize our products in China;
|
• |
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 expectations regarding future growth, including our ability to increase sales in our existing geographic markets and expand to new markets;
|
• |
our ability to obtain certain components of our products from third-party suppliers and our continued access to our product manufacturers;
|
• |
our ability to repay our secured indebtedness;
|
• |
our ability to improve our products and develop new products;
|
• |
the outcome of ongoing shareholder class action litigation relating to our initial public offering (“IPO”);
|
• |
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;
|
• |
our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual
property rights of others;
|
• |
the risk of a cybersecurity attack or breach of our IT systems significantly disrupting our business operations;
|
• |
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; and
|
• |
the impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company.
|
• |
Total revenue for the first quarter of 2020 was $0.8 million, compared to $1.6 million in the prior year quarter.
|
• |
Amended our research collaboration agreement with Harvard to focus on tele-health solutions and extend the term through March 2023.
|
• |
Entering upper and lower extremity products, offering hand, leg, arm and balance systems with MediTouch.
|
• |
Adding functional electrical stimulation cycle for home and rehab therapy with Myolyn.
|
• |
DGUV accepted a binding offer to provide qualified SCI patients ReWalk Personal 6.0.
|
• |
Finalized national agreement for the supply of ReWalk Personal 6.0 to qualified patients with multiple German SHIs - Techniker Krankenkasse ("TK") and Deutsche Angestellten-Krankenkasse – Gesundheit ("DAK-Gesundheit") and a third SHI
group of payors.
|
• |
CMS code hearing for ReWalk Personal scheduled for June 1, 2020.
|
• |
Regained compliance with Nasdaq $1 bid price listing requirement.
|
Three Months Ended March 31,
|
||||||||
Statements of Operations Data:
|
2020
|
2019
|
||||||
Revenues
|
$
|
760
|
$
|
1,581
|
||||
Cost of revenues
|
387
|
655
|
||||||
Gross profit
|
373
|
926
|
||||||
Operating expenses:
|
||||||||
Research and development, net
|
985
|
1,414
|
||||||
Sales and marketing
|
1,681
|
1,587
|
||||||
General and administrative
|
1,309
|
1,500
|
||||||
Total operating expenses
|
3,975
|
4,501
|
||||||
Operating loss
|
(3,602
|
)
|
(3,575
|
)
|
||||
Financial expenses, net
|
246
|
418
|
||||||
Loss before income taxes
|
(3,848
|
)
|
(3,993
|
) | ||||
Income taxes (tax benefit)
|
(8
|
)
|
7
|
|||||
Net loss
|
$
|
(3,840
|
)
|
$
|
(4,000
|
) | ||
Net loss per ordinary share, basic and diluted
|
$
|
(0.37
|
)
|
$
|
(1.25
|
) | ||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
10,374,116
|
3,211,386
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
(in thousands, except unit amounts)
|
||||||||
Personal unit revenues
|
$
|
714
|
$
|
1,546
|
||||
Rehabilitation unit revenues
|
46
|
35
|
||||||
Revenues
|
$
|
760
|
$
|
1,581
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Gross profit
|
$
|
373
|
$
|
926
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Research and development expenses, net
|
$
|
985
|
$
|
1,414
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Sales and marketing expenses
|
$
|
1,681
|
$
|
1,587
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
General and administrative
|
$
|
1,309
|
$
|
1,500
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Financial expenses, net
|
$
|
246
|
$
|
418
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Income taxes (tax benefit)
|
$
|
(8
|
)
|
$
|
7
|
Three Months Ended March 31,
|
||||||||
2020
|
2019
|
|||||||
Net cash used in operating activities
|
$
|
(4,341
|
)
|
$
|
(4,253
|
) | ||
Net cash used in investing activities
|
(9
|
)
|
—
|
|||||
Net cash provided by financing activities
|
4,690
|
3,580
|
||||||
Net cash flow
|
$
|
340
|
$
|
(673
|
) |
Payments due by period (in dollars, in thousands)
|
||||||||||||||||||||
Contractual obligations
|
Total
|
Less than 1 year
|
1-3 years
|
3-5 years
|
More than 5 years
|
|||||||||||||||
Purchase obligations (1)
|
$
|
1,163
|
$
|
1,163
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Collaboration Agreement and License Agreement obligations (2)
|
2,461
|
973
|
1,488
|
—
|
—
|
|||||||||||||||
Operating lease obligations (3)
|
2,331
|
708
|
1,317
|
306
|
—
|
|||||||||||||||
Long-term debt obligations (4)
|
6,300
|
6,300
|
—
|
—
|
—
|
|||||||||||||||
Total
|
$
|
12,255
|
$
|
9,144
|
$
|
2,805
|
$
|
306
|
$
|
—
|
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 U.S. Securities and Exchange Commission permitting the confidential treatment of select information.
|
ReWalk Robotics Ltd.
|
||
Date: May 28, 2020
|
By:
|
/s/ Larry Jasinski
|
Larry Jasinski
|
||
Chief Executive Officer
|
||
Date: May 28, 2020
|
By:
|
/s/ Ori Gon
|
Ori Gon
|
||
Chief Financial Officer
|
||
(Principal Financial and 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.
|