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)
|
Title of each class
|
Trading symbol
|
Name of 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.
|
|
ii
|
||
1
|
||
1
|
||
|
1-2
|
|
|
3
|
|
|
4-5
|
|
|
6
|
|
|
7-26
|
|
27-42
|
||
43 | ||
43
|
||
44 | ||
44 | ||
44-51 | ||
52
|
||
52
|
||
52
|
||
52
|
||
53
|
||
54
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$
|
18,050
|
$
|
16,253
|
||||
Trade receivable, net
|
715
|
794
|
||||||
Prepaid expenses and other current assets
|
833
|
903
|
||||||
Inventories
|
3,707
|
3,123
|
||||||
Total current assets
|
23,305
|
21,073
|
||||||
|
||||||||
LONG-TERM ASSETS
|
||||||||
|
||||||||
Restricted cash and other long-term assets
|
1,034
|
1,061
|
||||||
Operating lease right-of-use assets
|
1,421
|
1,737
|
||||||
Property and equipment, net
|
474
|
501
|
||||||
Total long-term assets
|
2,929
|
3,299
|
||||||
Total assets
|
$
|
26,234
|
$
|
24,372
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of long-term loans
|
$
|
3,280
|
$
|
5,438
|
||||
Current maturities of operating leases
|
622
|
637
|
||||||
Trade payables
|
2,107
|
2,698
|
||||||
Employees and payroll accruals
|
687
|
670
|
||||||
Deferred revenues
|
445
|
323
|
||||||
Other current liabilities
|
504
|
402
|
||||||
Total current liabilities
|
7,645
|
10,168
|
||||||
|
||||||||
LONG-TERM LIABILITIES
|
||||||||
Long-term loan, net of current maturities
|
154
|
1,527
|
||||||
Deferred revenues
|
626
|
521
|
||||||
Non-current operating leases
|
985
|
1,315
|
||||||
Other long-term liabilities
|
35
|
61
|
||||||
Total long-term liabilities
|
1,800
|
3,424
|
||||||
|
||||||||
Total liabilities
|
9,445
|
13,592
|
||||||
|
||||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
Shareholders’ equity:
|
||||||||
|
||||||||
Share capital
|
||||||||
Ordinary share of NIS 0.25 par value-Authorized: 60,000,000 shares at September 30,
2020 and December 31, 2019; Issued and outstanding: 19,158,963 and 7,319,560
shares at September 30, 2020 and December 31, 2019, respectively
|
1,352
|
504
|
||||||
Additional paid-in capital
|
193,937
|
178,745
|
||||||
Accumulated deficit
|
(178,500
|
)
|
(168,469
|
)
|
||||
Total shareholders’ equity
|
16,789
|
10,780
|
||||||
Total liabilities and shareholders’ equity
|
$
|
26,234
|
$
|
24,372
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Revenues
|
$
|
747
|
$
|
1,234
|
$
|
3,175
|
$
|
3,692
|
||||||||
Cost of revenues
|
355
|
585
|
1,388
|
1,682
|
||||||||||||
|
||||||||||||||||
Gross profit
|
392
|
649
|
1,787
|
2,010
|
||||||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, net
|
756
|
1,018
|
2,695
|
4,292
|
||||||||||||
Sales and marketing
|
1,507
|
1,453
|
4,541
|
4,571
|
||||||||||||
General and administrative
|
1,198
|
1,209
|
3,774
|
3,988
|
||||||||||||
|
||||||||||||||||
Total operating expenses
|
3,461
|
3,680
|
11,010
|
12,851
|
||||||||||||
|
||||||||||||||||
Operating loss
|
(3,069
|
)
|
(3,031
|
)
|
(9,223
|
)
|
(10,841
|
)
|
||||||||
Financial expenses, net
|
242
|
360
|
723
|
1,131
|
||||||||||||
|
||||||||||||||||
Loss before income taxes
|
(3,311
|
)
|
(3,391
|
)
|
(9,946
|
)
|
(11,972
|
)
|
||||||||
Taxes on income (tax benefit)
|
25
|
(2
|
)
|
85
|
4
|
|||||||||||
|
||||||||||||||||
Net loss
|
$
|
(3,336
|
)
|
$
|
(3,389
|
)
|
$
|
(10,031
|
)
|
$
|
(11,976
|
)
|
||||
|
||||||||||||||||
Net loss per ordinary share, basic and diluted
|
$
|
(0.18
|
)
|
$
|
(0.46
|
)
|
$
|
(0.71
|
)
|
$
|
(2.27
|
)
|
||||
|
||||||||||||||||
Weighted average number of shares used in computing
net loss per ordinary share, basic and diluted
|
18,881,694
|
7,290,791
|
14,132,375
|
5,284,451
|
|
Ordinary Share
|
Additional
paid-in
capital
|
Accumulated
deficit
|
Total
shareholders’ equity |
||||||||||||||||
|
Number
|
Amount
|
||||||||||||||||||
Balance as of June 30, 2019
|
7,289,110
|
503
|
178,270
|
(161,505
|
)
|
17,268
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
236
|
—
|
236
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
|
10,962
|
*
|
)
|
—
|
—
|
—
|
||||||||||||||
Net loss
|
—
|
—
|
—
|
(3,389
|
)
|
(3,389
|
)
|
|||||||||||||
Balance as of September 30, 2019
|
7,300,072
|
503
|
178,506
|
(164,894
|
)
|
14,115
|
||||||||||||||
|
||||||||||||||||||||
Balance as of June 30, 2020
|
14,190,685
|
993
|
186,070
|
(175,164
|
)
|
11,899
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
232
|
—
|
232
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
|
20,000
|
2
|
(2
|
)
|
—
|
—
|
||||||||||||||
Issuance of ordinary shares in a “registered direct" offering, net of issuance expenses in the amount of $ 1,019 (1)
|
4,938,278
|
357
|
7,624
|
—
|
7,981
|
|||||||||||||||
Exercise of warrants (1)(2)
|
10,000
|
—
|
13
|
—
|
13
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
(3,336
|
)
|
(3,336
|
)
|
|||||||||||||
Balance as of September 30, 2020
|
19,158,963
|
1,352
|
193,937
|
(178,500
|
)
|
16,789
|
*)
|
Represents an amount lower than $1.
|
(1)
|
See Note 8f to the condensed consolidated financial statements.
|
(2)
|
See Note 8d to the condensed consolidated financial statements.
|
|
Ordinary Share
|
Additional
paid-in |
Accumulated
|
Total
shareholders’ equity |
||||||||||||||||
|
Number
|
Amount
|
capital
|
deficit
|
||||||||||||||||
Balance as of December 31, 2018
|
2,813,087
|
193
|
154,670
|
(152,918
|
)
|
1,945
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
869
|
—
|
869
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
|
27,985
|
1
|
—
|
—
|
1
|
|||||||||||||||
Issuance of ordinary shares in a “best efforts” offering, net of issuance expenses in the amount of $686 (1)
|
760,000
|
52
|
3,632
|
—
|
3,684
|
|||||||||||||||
Exercise of pre-funded warrants and warrants (1) (2)
|
584,087
|
40
|
1,461
|
—
|
1,501
|
|||||||||||||||
Issuance of ordinary shares in a “Registered Direct” offerings, net of issuance expenses in the amount of $1,125 (1)
|
1,650,248
|
115
|
8,010
|
—
|
8,125
|
|||||||||||||||
Issuance of ordinary shares in a “Warrant exercise” agreement, net of issuance expenses in the amount of $1,019 (1)
|
1,464,665
|
102
|
9,864
|
—
|
9,966
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
(11,976
|
)
|
(11,976
|
)
|
|||||||||||||
Balance as of September 30, 2019
|
7,300,072
|
503
|
178,506
|
(164,894
|
)
|
14,115
|
||||||||||||||
|
||||||||||||||||||||
Balance as of December 31, 2019
|
7,319,560
|
504
|
178,745
|
(168,469
|
)
|
10,780
|
||||||||||||||
Share-based compensation to employees and non-employees
|
—
|
—
|
544
|
—
|
544
|
|||||||||||||||
Issuance of ordinary shares upon exercise of options to purchase ordinary shares and RSUs by employees and non-employees
|
44,625
|
2
|
(2
|
)
|
—
|
—
|
||||||||||||||
Issuance of ordinary shares in a “best effort” offering, net of issuance expenses in the amount of $1,056 (1)
|
4,053,172
|
290
|
3,720
|
—
|
4,010
|
|||||||||||||||
Issuance of ordinary shares in a “registered direct" offering, net of issuance expenses in the amount of $ 1,019 (1)
|
4,938,278
|
357
|
7,624
|
—
|
7,981
|
|||||||||||||||
Exercise of pre-funded warrants and warrants (1) (2)
|
2,803,328
|
199
|
3,306
|
—
|
3,505
|
|||||||||||||||
Net loss
|
—
|
—
|
—
|
(10,031
|
)
|
(10,031
|
)
|
|||||||||||||
Balance as of September 30, 2020
|
19,158,963
|
1,352
|
193,937
|
(178,500
|
)
|
16,789
|
*)
|
Represents an amount lower than $1.
|
(1)
|
See Note 8f to the condensed consolidated financial statements.
|
(2)
|
See Note 8d to the condensed consolidated financial statements.
|
|
Nine Months Ended
September 30, |
|||||||
|
2020
|
2019
|
||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(10,031
|
)
|
$
|
(11,976
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
215
|
242
|
||||||
Share-based compensation to employees and non-employees
|
544
|
869
|
||||||
Deferred taxes
|
(68
|
)
|
(67
|
)
|
||||
Financial expenses related to long-term loans
|
59
|
—
|
||||||
Changes in assets and liabilities:
|
||||||||
Trade receivables, net
|
79
|
186
|
||||||
Prepaid expenses, operating lease right-of-use assets and other assets
|
33
|
(397
|
)
|
|||||
Inventories
|
(634
|
)
|
(828
|
)
|
||||
Trade payables
|
(633
|
)
|
625
|
|||||
Employees and payroll accruals
|
17
|
(56
|
)
|
|||||
Deferred revenues and advances from customers
|
227
|
180
|
||||||
Operating lease liabilities and other liabilities
|
61
|
(3
|
)
|
|||||
Net cash used in operating activities
|
(10,131
|
)
|
(11,225
|
) |
||||
|
||||||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(73
|
)
|
(8
|
)
|
||||
Net cash used in investing activities
|
(73
|
)
|
(8
|
)
|
||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Repayment of long-term loan
|
(3,982
|
)
|
(1,261
|
)
|
||||
Proceeds from issuance of long-term debt
|
392
|
—
|
||||||
Issuance of ordinary shares in a “best efforts” offering, net of issuance expenses in the amount of $ 686 (1)
|
—
|
3,684
|
||||||
Issuance of ordinary shares in a “registered direct” offerings, net of issuance expenses in the amount of $1,035 (1)
|
—
|
8,215
|
||||||
Issuance of ordinary shares in a “warrant exercise” agreement, net of issuance expenses in the amount of $ 1,019 (1)
|
—
|
9,966
|
||||||
Issuance of ordinary shares in a “best efforts” offerings, net of issuance expenses paid in the amount of $ 1,056 (1)
|
4,010
|
—
|
||||||
Issuance of ordinary shares in a “registered direct” offerings, net of issuance expenses in the amount of $977 (1)
|
8,023
|
—
|
||||||
Exercise of pre-funded warrants and warrants (1) (2)
|
3,505
|
1,429
|
||||||
Net cash provided by financing activities
|
11,948
|
22,033
|
||||||
|
||||||||
Increase in cash, cash equivalents, and restricted cash
|
1,744
|
10,800
|
||||||
Cash, cash equivalents, and restricted cash at beginning of period
|
16,992
|
10,347
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
$
|
18,736
|
$
|
21,147
|
||||
Supplemental disclosures of non-cash flow information
|
||||||||
“Registered direct” offerings issuance cost not yet paid (1)
|
$
|
42
|
$ |
—
|
||||
Classification of other current assets to property and equipment, net
|
$
|
65
|
$
|
90 | ||||
Classification of inventory to property and equipment, net
|
$
|
50
|
$
|
88
|
||||
Cashless exercise of pre-funded warrants (1) (2)
|
$
|
—
|
$
|
72
|
||||
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
|
$
|
18,050
|
$
|
20,410
|
||||
Restricted cash included in other long-term assets
|
686
|
737
|
||||||
Total Cash, cash equivalents, and restricted cash
|
$
|
18,736
|
$
|
21,147
|
(1)
|
See Note 8f to the condensed consolidated financial statements.
|
(2)
|
See Note 8d to the condensed consolidated financial statements.
|
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.
|
|
c.
|
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. There are currently two types of ReWalk products: ReWalk Personal and ReWalk Rehabilitation. ReWalk Personal is designed for everyday use by individuals at home and in their communities and is custom-fitted for each
user. ReWalk Rehabilitation is designed for the clinical rehabilitation environment where it provides individuals access to valuable exercise and therapy. 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”). 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 in Germany and the United States and through third-party 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 sell the Company’s products mainly in Germany and Europe.
The company added two new product lines through distribution agreements and started commercializing them during the third quarter.
|
|
d.
|
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 during 2020, 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.
|
|
e.
|
The Company has an accumulated deficit in the total amount of approximately $179 million as of September 30, 2020 and negative cash flow from operations of $10 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 Company intends to finance operating costs over the next twelve months with existing cash on hand, continued close examination of its operating spend and
potential reduction in specific areas, and future issuances of equity and debt securities, or through a combination of the foregoing. However, the Company will need to seek additional sources of financing if the Company requires more
funds than anticipated during the next 12 months or in later periods.
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the
realization of assets and liabilities and commitments in the normal course of business.
The condensed consolidated financial statements for the three and nine months ended September 30, 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.
|
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 the opinion of management, the accompanying financial statements include all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company’s (i) consolidated
financial position as of September 30, 2020, (ii) consolidated results of operations for the three and nine months ended September 30, 2020, (iii) consolidated statements of changes in shareholders’ equity as of September 30, 2020
and (iv) consolidated cash flows for the nine months ended September 30, 2020. The results for the three and nine months periods ended September 30, 2020, as applicable, are not necessarily indicative of the results that may be
expected for the year ending December 31, 2020.
|
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.
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Units placed
|
$
|
522
|
$
|
1,104
|
$
|
2,583
|
$
|
3,350
|
||||||||
Spare parts and warranties
|
225
|
130
|
592
|
342
|
||||||||||||
Total Revenues
|
$
|
747
|
$
|
1,234
|
$
|
3,175
|
$
|
3,692
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
Trade receivable, net (1)
|
$
|
715
|
$
|
794
|
||||
Deferred revenues (1) (2)
|
$
|
1,071
|
$
|
844
|
(1)
|
Balance presented net of unrecognized revenues that were not yet collected.
|
(2)
|
$345 thousand of December 31, 2019 deferred revenues balance were recognized as revenues during the nine months ended
September 30, 2020.
|
|
b.
|
New Accounting Pronouncements
Recent Accounting Pronouncements Not Yet Adopted
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.
|
|
In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which
simplifies the guidance on the issuer’s accounting for convertible debt instruments by removing the separation models for (1) convertible debt with a cash conversion feature and (2) convertible instruments with a beneficial
conversion feature. As a result, entities will not separately present in equity an embedded conversion feature in such debt. Instead, they will account for a convertible debt instrument wholly as debt, unless certain other
conditions are met. The elimination of these models will reduce reported interest expense and increase reported net income for entities that have issued a convertible instrument that was within the scope of those models before the
adoption of ASU 2020-06. ASU 2020-06 also requires that the effect of potential share settlement be included in the diluted EPS calculation when an instrument may be settled in cash or share. This amendment removes current guidance
that allows an entity to rebut this presumption if it has a history or policy of cash settlement. Furthermore, ASU 2020-06 requires the application of the if-converted method for calculating diluted earnings per share, the treasury
stock method will be no longer available. In addition, ASU 2020-06 clarifies that an average market price should be used to calculate the diluted EPS denominator in cases in which the exercise prices may change on the basis of an
entity’s share price or changes in the entity’s share price may affect the number of shares that may be used to settle a financial instrument and that an entity should use the weighted-average share count from each quarter when
calculating the year-to-date weighted-average share. The provisions of ASU 2020-06 are applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years beginning after
December 15, 2020. The Company is currently evaluating the impact of ASU 2020-06 on its consolidated financial statements.
|
|
c.
|
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.
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
Customer A
|
15
|
%
|
*
|
)
|
||||
Customer B
|
13
|
%
|
*
|
)
|
||||
Customer C
|
13
|
%
|
*
|
)
|
||||
Customer D
|
13
|
%
|
*
|
)
|
||||
Customer E
|
12
|
%
|
*
|
)
|
||||
Customer F
|
11
|
%
|
12
|
%
|
||||
Customer G
|
*
|
)
|
14
|
%
|
||||
Customer H
|
*
|
)
|
13
|
%
|
||||
Customer I
|
*
|
)
|
13
|
%
|
||||
Customer J
|
*
|
)
|
12
|
%
|
||||
Customer K
|
*
|
)
|
12
|
%
|
||||
Customer L
|
*
|
)
|
12
|
%
|
|
*)
|
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 September 30, 2020 and December 31, 2019, trade receivables are
presented net of allowance for doubtful accounts in the amount of $31 thousand and $31 thousand, respectively, and net of sales return reserve $0 as of September 30, 2020 and $86 thousand as of December 31, 2019.
|
|
d.
|
Warranty provision
The Company provided a two-year standard warranty for its products. In the beginning of 2018, we updated our service policy for new devices
sold to include 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, 2019
|
$
|
227
|
||
Provision
|
60
|
|||
Usage
|
(133
|
)
|
||
Balance at September 30, 2020
|
$
|
154
|
NOTE 4:-
|
INVENTORIES
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
Finished products
|
$
|
2,954
|
$
|
2,394
|
||||
Raw materials
|
753
|
729
|
||||||
|
$
|
3,707
|
$
|
3,123
|
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 September 30, 2020, non-cancelable outstanding obligations to the Company’s contract manufacturer and raw material vendors amounted to
approximately $0.9 million.
|
|
b.
|
Operating lease commitment:
|
|
(i)
|
The Company operates from leased facilities in Israel, the United States and Germany. These leases expire between 2020 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 2020 and 2023. 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 $23 thousand as of September 30, 2020.
|
2020
|
$
|
167
|
||
2021
|
668
|
|||
2022
|
637
|
|||
2023
|
461
|
|||
Total lease payments
|
1,933
|
|||
Less: imputed interest
|
(326
|
)
|
||
Present value of future lease payments
|
1,607
|
|||
Less: current maturities of operating leases
|
(622
|
)
|
||
Non-current operating leases
|
$
|
985
|
||
Weighted-average remaining lease term (in years)
|
2.93
|
|||
Weighted-average discount rate
|
12.6
|
%
|
|
c.
|
Royalties:
The Company’s research and development efforts are financed, in part, through funding from the IIA and BIRD. Since the Company’s inception
through September 30, 2020, 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 September 30, 2020, the Company paid royalties to the IIA in the total amount of $92 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 License Agreement requires the Company to pay Harvard royalties on net sales, See note 7 below for more information about
the Collaboration Agreement and the License Agreement.
Royalties expenses in cost of revenue were $2 and $8 thousand for the three months ended September 30, 2020 and 2019, respectively. For the
nine months ended September 30, 2020 and 2019, the royalties expenses were $5 thousand and $13 thousand, respectively.
As of September 30, 2020, 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 discussed in Note 6 to the Company’s audited consolidated financial statements in its annual report on Form 10-K for the fiscal year ended
December 31, 2019 (the “2019 Form 10-K”), the Company is party to a loan agreement, as amended (the “Loan Agreement”), with Kreos Capital V (Expert Fund) Limited (“Kreos”), pursuant to which Kreos extended a $20 million line of credit
to the Company. In connection with the Loan Agreement, the Company granted Kreos a first priority security interest over all of its assets, including intellectual property and equity interests in its subsidiaries, subject to certain
permitted security interests
The Company’s other long-term assets in the amount of $686 thousand have been pledged to third parties as a security in respect to lease agreements. Such deposit
cannot be pledged to others or withdrawn without the consent of such third party.
|
|
e.
|
Legal Claims:
Occasionally the Company is involved in various claims, lawsuits, regulatory examinations, investigations and other legal matters arising,
for the most part, in the ordinary course of business. The outcome of litigation and other legal matters is inherently uncertain. In making a determination regarding accruals, using available information, the Company evaluates the
likelihood of an unfavorable outcome in legal or regulatory proceedings to which the Company is a party and records a loss contingency when it is probable a liability has been incurred and the amount of the loss can be reasonably
estimated. Where the Company determines an unfavorable outcome is not probable or reasonably estimable, the Company does not accrue for any potential litigation loss. These subjective determinations are based on the status of such legal
or regulatory proceedings, the merits of the company's defenses and consultation with legal counsel. Actual outcomes of these legal and regulatory proceedings may materially differ from the Company’s current estimates. It is possible
that resolution of one or more of the legal matters currently pending or threatened could result in losses material to the Company’s consolidated results of operations, liquidity or financial condition.
As previously disclosed, between September 2016 and January 2017, eight putative class actions on behalf of alleged shareholders that purchased or acquired the Company ordinary shares pursuant and/or
traceable to its registration statement on Form F-1 (File No. 333-197344) used in connection with the initial public offering, or the Company’s IPO, were commenced in the following courts: (i) the Superior Court of the State of
California, County of San Mateo; (ii) the Superior Court of the Commonwealth of Massachusetts, Suffolk County; (iii) the United States District Court for the Northern District of California; and (iv) the United States District Court
for the District of Massachusetts. As of March 31, 2020, all complaints have been dismissed, with one dismissal affirmed on appeal. The actions involved or involve claims under various sections of the Securities Act of 1933, or the
Securities Act, against the Company, certain of its current and former directors and officers, the underwriters of the Company’s IPO and certain other defendants.
The four actions commenced in the Superior Court of the State of California, County of San Mateo were dismissed in January 2017 for lack of
personal jurisdiction, and the action commenced in the United States District Court for the Northern District of California was voluntarily dismissed in March 2017. Additionally, the two actions commenced in the Superior Court of the
Commonwealth of Massachusetts, Suffolk County, or the Superior Court, were consolidated in December 2017, and voluntarily dismissed with prejudice in November 2018, after the District Court for the District of Massachusetts partially
dismissed the related claims in that court and the parties in the Superior Court entered a stipulation of dismissal with prejudice.
The action commenced in the United States District Court for the District of Massachusetts (the “District Court”), alleging violations of Sections 11 and 15 of the Securities Act and Sections 10(b) and
20(a) of the Exchange Act, was partially dismissed on August 23, 2018. In particular, the District Court granted the motion to dismiss the claims under Sections 11 and 15 of the Securities Act, finding that the plaintiff failed to
plead a false or misleading statement in the IPO registration statement. The District Court did not address the claims under Sections 10(b) and 20(a) of the Exchange Act because, as a result of the dismissal of the claims under the
Securities Act, the lead plaintiff lacked standing to pursue those claims. Because the action in the District Court was styled as a class action, the District Court permitted the plaintiff to file a supplemental memorandum concerning
standing or a motion to appoint a substitute or supplemental plaintiff. On September 10, 2018, the plaintiff sought leave to amend his complaint to add a new plaintiff that purportedly has standing to pursue Exchange Act claims, and
the Company opposed the motion to amend on September 24, 2018. On May 16, 2019, the court denied the plaintiff’s motion to amend and the complaint was dismissed. Thereafter, the plaintiff timely appealed to the United States Court of
Appeals for the First Circuit (the “First Circuit”). The appeal was fully briefed in January 2020 and the court held oral arguments on March 2, 2020. On August 25, the First Circuit affirmed the dismissal and the denial of the
plaintiff’s motion to amend. The plaintiff’s deadline to file a petition for certiorari for appeal of the case to the Supreme Court of the United States is November 24, 2020.
Based on information currently available and the current stage of the litigation, the Company is unable to reasonably estimate a possible loss or range of possible losses, if any, with regard to the
remaining lawsuit in the District Court; therefore, no litigation reserve has been recorded in the Company’s condensed consolidated balance sheets as of September 30, 2020.The Company will continue to evaluate information as it
becomes known and will record an estimate for losses at the time or times if and when it is probable that a loss will be incurred and the amount of the loss is reasonably estimable.
|
NOTE 6:-
|
PAYCHECK PROTECTION PROGRAM LOAN
|
Period
|
Amount
|
|||
Remainder of 2020
|
$
|
43
|
||
2021
|
263
|
|||
2022
|
88
|
|||
Total principal payments
|
$
|
394
|
||
|
||||
Current portion
|
$
|
240
|
||
Long-term portion
|
154
|
|||
Note payable, net
|
$
|
394
|
NOTE 7:-
|
RESEARCH COLLABORATION AGREEMENT AND LICENSE AGREEMENT
|
NOTE 8:-
|
SHAREHOLDERS’ EQUITY
|
|
a.
|
Reverse share split:
On March 27, 2019, the Company’s shareholders approved (i) a reverse share split within a range of 1:8 to 1:32, to be effective at the ratio
and on a date to be determined by the Board of Directors, and (ii) amendments to the Company’s Articles of Association authorizing an increase in the Company’s authorized share capital (and corresponding authorized number of ordinary
shares, proportionally adjusting such number for the reverse share split) by up to NIS 17.5 million. Following the shareholder approval, an authorized committee of the Board of Directors of the Company approved a one-for-twenty-five
reverse share split of the Company’s ordinary shares, and the Company filed the Third Amended and Restated Articles of Association of the Company with the Registrar of Companies of the State of Israel to effect the reverse share split
and to increase the Company’s authorized share capital after the effect of the reverse share split. The reverse share split became effective on April 1, 2019. Additionally, effective at the same time, the total number of ordinary shares
the Company is authorized to issue changed from 250,000,000 shares to 60,000,000 shares, the par value per share of the ordinary shares changed to NIS 0.25 and the authorized share capital of the Company changed from NIS 2,500,000 to
NIS 15,000,000. All share and per share data included in these condensed consolidated financial statements, for periods before the three months ended June 30, 2019, give retroactive effect to the reverse stock split.
Upon the effectiveness of the reverse share split, every twenty-five shares were automatically combined and converted into one ordinary
share. Appropriate adjustments were also made to all outstanding derivative securities of the Company, including all outstanding equity awards and warrants.
No fractional shares were issued in connection with the reverse share split. Instead, all fractional shares (including shares underlying
outstanding equity awards and warrants) were rounded down to the nearest whole number.
|
|
b.
|
Share option plans:
As of September 30, 2020, and December 31, 2019, the Company had reserved 623,408 and 12,409 ordinary 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.
The fair value for options granted during the nine months ended September 30, 2019 was estimated at the date of the grant using a Black-Scholes-Merton option
pricing model with the following assumptions:
|
|
Nine Months Ended
September 30, |
|||
|
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
|
$
|
41.6
|
6.34
|
$
|
135
|
||||||||||
Granted
|
—
|
—
|
||||||||||||||
Exercised
|
—
|
—
|
||||||||||||||
Forfeited
|
(1,713
|
)
|
133.74
|
|||||||||||||
Options outstanding at the end of the period
|
73,000
|
$
|
39.4
|
5.57
|
$
|
—
|
||||||||||
|
||||||||||||||||
Options exercisable at the end of the period
|
53,668
|
$
|
46.39
|
4.74
|
$
|
—
|
|
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
|
1,238,688
|
0.85
|
||||||
Vested
|
(44,625
|
)
|
8.86
|
|||||
Forfeited
|
(9,126
|
)
|
8.46
|
|||||
Unvested RSUs at the end of the period
|
1,247,315
|
$
|
2.78
|
Range of exercise price
|
|
Options and RSUs outstanding as of
September 30, 2020 |
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
|
|
Options
outstanding and exercisable as of September 30, 2020 |
|
|
Weighted
average
remaining
contractual
life (years) (1)
|
|
||||
RSUs only
|
|
|
1,247,315
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
$5.37
|
|
|
12,425
|
|
|
|
8.49
|
|
|
|
4,659
|
|
|
|
8.49
|
|
$20.42 - $33.75
|
|
|
36,299
|
|
|
|
5.51
|
|
|
|
26,120
|
|
|
|
4.70
|
|
$37.14 - $38.75
|
|
|
10,092
|
|
|
|
3.21
|
|
|
|
10,092
|
|
|
|
3.21
|
|
$50 - $52.5
|
|
|
11,228
|
|
|
|
4.91
|
|
|
|
9,841
|
|
|
|
4.67
|
|
$182.5 - $524.25
|
|
|
2,956
|
|
|
|
4.60
|
|
|
|
2,956
|
|
|
|
4.60
|
|
|
|
|
1,320,315
|
|
|
|
5.57
|
|
|
|
53,668
|
|
|
|
4.74
|
|
(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:
As of September 30, 2020, there are no outstanding options or RSUs held by non-employee consultants.
|
|
d.
|
Warrants to purchase ordinary shares:
The following table summarizes information about warrants outstanding and exercisable as of September 30, 2020:
|
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)
|
|
|
4,343,500
|
|
|
$
|
1.250
|
|
|
|
4,343,500
|
|
February 10, 2025
|
February 10, 2020 (14)
|
|
|
336,000
|
|
|
$
|
1.5625
|
|
|
|
336,000
|
|
February 10, 2025
|
July 6, 2020 (15)
|
2,469,139
|
$
|
1.76
|
2,469,139
|
July 2, 2025
|
||||||||
July 6, 2020 (16)
|
296,297
|
2.2781
|
296,297
|
July 2, 2025
|
|||||||||
|
|
|
10,304,914
|
|
|
|
|
|
|
|
10,304,914
|
|
|
(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 September 30, 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 as compensation for its role in our follow-on offering in February 2019.
|
(7)
|
Represents warrants that were issued to certain institutional purchasers in a private placement in our 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 our 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 our 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 our 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.
|
(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.
|
(16)
|
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering.
|
|
e.
|
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):
|
|
Nine Months Ended
September 30, |
|||||||
|
2020
|
2019
|
||||||
Cost of revenues
|
$
|
6
|
$
|
9
|
||||
Research and development, net
|
105
|
161
|
||||||
Sales and marketing
|
113
|
140
|
||||||
General and administrative
|
320
|
559
|
||||||
Total
|
$
|
544
|
$
|
869
|
|
f.
|
Equity raise:
|
|
1.
|
Follow-on offerings
In November 2018, the Company entered into an underwriting agreement with H.C. Wainwright & Co., LLC (“H.C. Wainwright”), in connection with the Company’s
follow-on public offering of 496,040 units, each consisting of one ordinary share and one common warrant to purchase one ordinary share with an exercise price of $7.5 per warrant. Each unit was sold to the public at a price of $7.50 per
unit. On November 18, 2018, H.C. Wainwright exercised in full its option to purchase 231,964 ordinary shares for $7.25 per share and/or common warrants to purchase up to an additional 231,964 ordinary shares for $0.25 per warrant.
Additionally, the Company issued and sold 1,050,372 pre-funded units at a price to the public of $7.25 per unit. Each unit containing one pre-funded warrant with an exercise price of $0.25 per share and
one warrant to purchase one ordinary share with an exercise price of $7.50 per warrant. The total gross proceeds received from the November 2018 follow-on public offering, before deducting commissions, discounts and expenses, were
$13.1 million (including proceeds from the exercise of 90,691 pre-funded warrants at the closing of the offering). As of December 31, 2018, additional pre-funded warrants to purchase an aggregate 562,466 ordinary shares had been
exercised, for additional proceeds of $140,617. During the nine month ended September 30, 2019 additional 288,000 pre-funded warrants and 296,087 warrants to purchase an aggregate 584,087 ordinary shares had been exercised, for
additional proceeds of $1.5 million. As compensation for their role in the offering, the Company also issued to the underwriters warrants to purchase up to 106,680 ordinary shares, which became immediately exercisable starting on
November 20, 2018 until November 15, 2023 at $9.375 per share.
In February 2019, the Company entered into an exclusive placement agent agreement with H.C. Wainwright, on a reasonable best-efforts basis in connection with a
public offering of 760,000 ordinary shares at a price of $5.75 per share.
The total gross proceeds received from the February 2019 follow-on public offering, before deducting commissions, discounts and expenses, were $4.37 million. The
Company also issued to H.C Wainwright and/or its designees warrants to purchase up to 45,600 ordinary shares, which are immediately exercisable starting on February 25, 2019 until February 21, 2024 at $7.1875 per share.
In April 2019, the Company entered into securities purchase agreements with certain institutional purchasers whereby the Company issued 816,914 ordinary shares at
$5.2025 per ordinary share and warrants to purchase up to 408,457 ordinary shares with an exercise price of $5.14 per share, exercisable from April 5, 2019 until October 7, 2024, in a private placement that took place concurrently with
the Company’s registered direct offering of ordinary shares in April 2019. Additionally the Company issued warrants to purchase up to 49,015 ordinary shares, with an exercise price of $6.503125 per share, exercisable from April 5, 2019
until April 3, 2024, to representatives of H.C. Wainwright as compensation for its role as the placement agent in our April 2019 registered direct offering and concurrent private placement of warrants.
|
|
3.
|
Investment agreement
In May 2018, the Company entered into a fee and release agreement with Canaccord Genuity LLC (“Canaccord Genuity”) requiring the Company to pay to Canaccord Genuity, in connection with a settlement, in
addition to certain cash amounts, (i) $125 thousand in ordinary shares of the Company after the closing of the first tranche on May 15, 2018 (the “First Tranche Closing”) of the Timwell transaction and (ii) $225 thousand in ordinary
shares of the Company after the closing of the Second Tranche of the Timwell transaction (or such lower amount if the Second Tranche Closing is less than $10.0 million). The price per share used for calculation of the number of
ordinary shares issued by the Company to Canaccord Genuity is based on the volume weighted average price of the Company’s ordinary shares as reported on the Nasdaq Capital Market for the five consecutive trading days prior to the date
of issuance. The Company is also obligated to pay $100 thousand in cash following the closing of the Third Tranche of $5.0 million (or such lower amount if the Third Tranche Closing is less than $5.0 million). Following the First
Tranche Closing, the Company issued 4,715 ordinary shares to Canaccord Genuity.
In late March 2020, Timwell notified the Company that it would not invest the second and third tranches under the Investment Agreement. In response, in early
April 2020, the Company’s Board of Directors also removed Timwell’s designee, who was appointed pursuant to the Investment Agreement, from the Board of Directors, due to this breach pursuant to the terms of the Investment Agreement. As
the Company continues to view China as a market with key opportunities for products designed for stroke patients, the Company continues to evaluate potential relationships with other groups to penetrate the Chinese market.
|
NOTE 9:-
|
FINANCIAL EXPENSES, NET
|
|
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
||||||||||
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
||||
Foreign currency transactions and other
|
|
$
|
(7
|
)
|
|
$
|
(10
|
)
|
|
$
|
(99
|
)
|
|
$
|
(50
|
)
|
Financial expenses related to loan agreement with Kreos
|
|
|
243
|
|
|
|
365
|
|
|
|
802
|
|
|
|
1,155
|
|
Bank commissions
|
|
|
6
|
|
|
|
5
|
|
|
|
20
|
|
|
|
26
|
|
|
|
$
|
242
|
|
|
$
|
360
|
|
|
$
|
723
|
|
|
$
|
1,131
|
|
NOTE 10:-
|
GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER AND PRODUCT DATA
|
|
|
Three Months Ended
September 30, |
|
|
Nine Months Ended
September 30, |
|
||||||||||
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
||||
Revenues based on customer’s location:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Israel
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
2
|
|
United States
|
|
|
325
|
|
|
|
569
|
|
|
|
1,172
|
|
|
|
1,492
|
|
Europe
|
|
|
413
|
|
|
|
665
|
|
|
|
1,990
|
|
|
|
2,162
|
|
Asia-Pacific
|
|
|
2
|
|
|
|
—
|
|
|
|
6
|
|
|
|
36
|
|
Latin America
|
|
|
6
|
|
|
|
—
|
|
|
|
6
|
|
|
|
—
|
|
Africa
|
|
|
1
|
|
|
|
—
|
|
|
|
1
|
|
|
|
—
|
|
Total revenues
|
|
$
|
747
|
|
|
$
|
1,234
|
|
|
$
|
3,175
|
|
|
$
|
3,692
|
|
|
September 30,
|
December 31,
|
||||||
|
2020
|
2019
|
||||||
Long-lived assets by geographic region (*):
|
||||||||
Israel
|
$
|
155
|
$
|
179
|
||||
United States
|
263
|
244
|
||||||
Germany
|
56
|
78
|
||||||
|
$
|
474
|
$
|
501
|
(*)
|
Long-lived assets are comprised of property and equipment, net.
|
|
|
Nine Months Ended
September 30, |
|
|||||
|
|
2020
|
|
|
2019
|
|
||
Major customer data as a percentage of total revenues:
|
|
|
|
|
|
|
||
Customer A
|
|
|
*
|
)
|
|
|
13.13
|
%
|
NOTE 11:-
|
SUBSEQUENT EVENTS
|
• |
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 litigation and other legal matters;
|
• 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 third quarter of 2020 was $0.7 million, compared to $1.2 million in the prior year quarter;
|
|
●
|
Received Medicare Provider certification from the Centers for Medicare & Medicaid Services ("CMS");
|
|
●
|
Completed additional contract with a German payor; and
|
|
●
|
Raised total of approximately $9.0 million in gross proceeds from a registered direct offering of ordinary shares and a
concurrent private placement of unregistered warrants to purchase ordinary shares (as previously referenced in ReWalk’s Second Quarter 2020 Financial Results).
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Revenues
|
$
|
747
|
$
|
1,234
|
$
|
3,175
|
$
|
3,692
|
||||||||
Cost of revenues
|
355
|
585
|
1,388
|
1,682
|
||||||||||||
|
||||||||||||||||
Gross profit
|
392
|
649
|
1,787
|
2,010
|
||||||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, net
|
756
|
1,018
|
2,695
|
4,292
|
||||||||||||
Sales and marketing
|
1,507
|
1,453
|
4,541
|
4,571
|
||||||||||||
General and administrative
|
1,198
|
1,209
|
3,774
|
3,988
|
||||||||||||
|
||||||||||||||||
Total operating expenses
|
3,461
|
3,680
|
11,010
|
12,851
|
||||||||||||
|
||||||||||||||||
Operating loss
|
(3,069
|
)
|
(3,031
|
)
|
(9,223
|
)
|
(10,841
|
)
|
||||||||
Financial expenses, net
|
242
|
360
|
723
|
1,131
|
||||||||||||
|
||||||||||||||||
Loss before income taxes
|
(3,311
|
)
|
(3,391
|
)
|
(9,946
|
)
|
(11,972
|
)
|
||||||||
Taxes on income (tax benefit)
|
25
|
(2
|
) |
85
|
4
|
|||||||||||
|
||||||||||||||||
Net loss
|
$
|
(3,336
|
)
|
$
|
(3,389
|
)
|
$
|
(10,031
|
)
|
$
|
(11,976
|
)
|
||||
|
||||||||||||||||
Net loss per ordinary share, basic and diluted
|
$
|
(0.18
|
)
|
$
|
(0.46
|
)
|
$
|
(0.71
|
)
|
$
|
(2.27
|
)
|
||||
|
||||||||||||||||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
18,881,694
|
7,290,291
|
14,132,375
|
5,284,451
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
|
(in thousands, except
unit amounts)
|
(in thousands, except
unit amounts)
|
||||||||||||||
Personal unit revenues
|
$
|
698
|
$
|
1,127
|
$
|
3,079
|
$
|
3,524
|
||||||||
Rehabilitation unit revenues
|
49
|
107
|
96
|
168
|
||||||||||||
Revenues
|
$
|
747
|
$
|
1,234
|
$
|
3,175
|
$
|
3,692
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Gross profit
|
$
|
392
|
$
|
649
|
$
|
1,787
|
$
|
2,010
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Research and development expenses, net
|
$
|
756
|
$
|
1,018
|
$
|
2,695
|
$
|
4,292
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Sales and marketing expenses
|
$
|
1,507
|
$
|
1,453
|
$
|
4,541
|
$
|
4,571
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
General and administrative expenses
|
$
|
1,198
|
$
|
1,209
|
$
|
3,774
|
$
|
3,988
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Financial expenses, net
|
$
|
242
|
$
|
360
|
$
|
723
|
$
|
1,131
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
Taxes on income (tax benefit)
|
$
|
25
|
$
|
(2
|
)
|
$
|
85
|
$
|
4
|
|
Nine Months Ended
September 30, |
|||||||
|
2020
|
2019
|
||||||
Net cash used in operating activities
|
$
|
(10,131
|
)
|
$
|
(11,225
|
)
|
||
Net cash used in investing activities
|
(73
|
)
|
(8
|
)
|
||||
Net cash provided by financing activities
|
11,948
|
22,033
|
||||||
Net cash flow
|
$
|
1,744
|
$
|
10,800
|
|
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)
|
$
|
871
|
$
|
871
|
$
|
—
|
$
|
—
|
$
|
—
|
||||||||||
Collaboration Agreement and License Agreement obligations (2)
|
2,364
|
1,164
|
1,200
|
—
|
—
|
|||||||||||||||
Operating lease obligations (3)
|
1,933
|
669
|
1,246
|
18
|
—
|
|||||||||||||||
Long-term debt obligations (4)
|
3,548
|
3,393
|
155
|
—
|
—
|
|||||||||||||||
Total
|
$
|
8,716
|
$
|
6,097
|
$
|
2,601
|
$
|
18
|
$
|
—
|
(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 was originally signed for a period of six years and as of September 30, 2020 has a remaining term of approx. 2.33 years, it requires us to pay in quarterly
installments for the funding of our joint research collaboration with Harvard, subject to a minimum funding commitment under applicable circumstances. Our License Agreement 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 September 30, 2020. There are commercialization milestones which depend on us reaching certain sales amounts some or all of which may not occur.
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(3)
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Our operating leases consist of leases for our facilities and motor vehicles.
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(4)
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Our long-term debt obligations consist of payments of principal and interest under our Loan Agreement with Kreos and the PPP Note. For more information, see “-Liquidity and Capital
Resources” above.
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Exhibit Number
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Description
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101.INS
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XBRL Instance Document
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101.SCH
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XBRL Taxonomy Extension Schema Document
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101.PRE
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XBRL Taxonomy Extension Presentation Linkbase Document
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101.CAL
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|
XBRL Taxonomy Extension Calculation Linkbase Document
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101.LAB
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|
XBRL Taxonomy Extension Label Linkbase Document
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101.DEF
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XBRL Taxonomy Extension Definition Linkbase Document
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*
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Furnished herewith.
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ReWalk Robotics Ltd.
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Date: November 10, 2020
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By:
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/s/ Larry Jasinski
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Larry Jasinski
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Chief Executive Officer
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Date: November 10, 2020
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By:
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/s/ Ori Gon
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Ori Gon
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Chief Financial Officer
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(Principal Financial and Accounting Officer)
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/s/ Larry Jasinski
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Larry Jasinski
|
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Chief Executive Officer
|
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(Principal Executive Officer)
|
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ReWalk Robotics Ltd.
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/s/ Ori Gon
|
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Ori Gon
|
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Chief Financial Officer
|
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(Principal Financial Officer)
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ReWalk Robotics Ltd.
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• |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
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• |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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/s/ Larry Jasinski
|
|
Larry Jasinski
|
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Chief Executive Officer
|
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(Principal Executive Officer)
|
|
ReWalk Robotics Ltd.
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• |
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
|
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Chief Financial Officer
|
|
(Principal Financial Officer)
|
|
ReWalk Robotics Ltd.
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