ReWalk Robotics Ltd. - 1607962 - 2022
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly
period ended March
31, 2022
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition
period from______to______
Commission File
Number: 001-36612
ReWalk
Robotics Ltd.
(Exact name of
registrant as specified in charter)
Israel
Not
applicable
(State or other
jurisdiction of
incorporation or
organization)
(I.R.S. Employer
Identification
No.)
3
Hatnufa Street , Floor
6 , Yokneam Ilit ,
Israel
2069203
(Address of principal
executive offices)
(Zip Code)
+ 972 . 4.959.0123
Registrant's telephone
number, including area code
Not
Applicable
(Former name,
former address and former fiscal year, if changed since last report)
Securities registered
pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol
Name
of each exchange on which registered
Ordinary
shares, par value NIS 0.25
RWLK
Nasdaq
Capital Market
Indicate by a check mark whether
the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check
mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required
to submit such files).
Yes
☒ No ☐
Indicate by
check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company
or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated
filer ☐
Accelerated filer ☐
Non-accelerated
filer ☒
Smaller reporting
company ☒
Emerging growth company
☐
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any
new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check
mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No ☒
As of May 13, 2022,
the registrant had outstanding 62,509,872
ordinary shares, par value NIS 0.25 per share.
REWALK
ROBOTICS LTD.
FORM
10-Q
FOR
THE QUARTER ENDED MARCH 31, 2022
TABLE
OF CONTENTS
Page
No.
GENERAL
AND WHERE YOU CAN FIND MORE INFORMATION
2
PART
I
FINANCIAL
INFORMATION
3
ITEM
1.
FINANCIAL
STATEMENTS (unaudited)
3
CONDENSED
CONSOLIDATED BALANCE SHEETS - MARCH 31, 2022 AND DECEMBER 31, 2021
3
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS - THREE MONTHS ENDED MARCH 31, 2022 AND 2021
5
CONDENSED
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - MARCH 31, 2022 AND 2021
6
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS - THREE MONTHS ENDED MARCH 31, 2022 AND 2021
7
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
8
ITEM
2.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
24
ITEM
3.
QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
33
ITEM
4.
CONTROLS
AND PROCEDURES
33
PART
II
OTHER
INFORMATION
34
ITEM
1.
LEGAL
PROCEEDINGS
34
ITEM
1A.
RISK
FACTORS
34
ITEM
2.
UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
36
ITEM
3.
DEFAULTS
UPON SENIOR SECURITIES
36
ITEM
4.
MINE
SAFETY DISCLOSURES
36
ITEM
5.
OTHER
INFORMATION
36
ITEM
6.
EXHIBITS
37
SIGNATURES
38
Introduction and Where You Can Find Other Information
As
used in this quarterly report on Form 10-Q (this “quarterly report”), the terms “ReWalk,” the “Company,”
“RRL,” “we,” “us” and “our” refer to ReWalk Robotics Ltd. and its subsidiaries, unless
the context clearly indicates otherwise. Our website is www.rewalk.com. Information contained in, or that can be accessed through, our
website does not constitute a part of this quarterly report on Form 10-Q and is not incorporated by reference herein. We have included
our website address in this quarterly report solely for informational purposes. Information that we furnish to or file with the Securities
and Exchange Commission (the “SEC”), including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports
on Form 8-K and any amendments to, or exhibits included in, these reports are available for download, free of charge, on our website as
soon as reasonably practicable after such materials are filed with or furnished to the SEC. Our SEC filings, including exhibits filed
or furnished therewith, are also available on the SEC’s website at http://www.sec.gov.
Special
Note Regarding Forward-Looking Statements
In
addition to historical information, this quarterly report contains forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, that are
based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements
include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive
position, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking
statements may include projections regarding our future performance and, in some cases, can be identified by words like “anticipate,”
“assume,” “believe,” “could,” “seek,” “estimate,” “expect,” “intend,”
“may,” “plan,” “potential,” “predict,” “project,” “future,” “should,”
“will,” “would” or similar expressions that convey uncertainty of future events or outcomes and the negatives
of those terms. These statements may be found in this section of this quarterly report titled “Part I, Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this quarterly report. These statements
include, but are not limited to, statements regarding:
•
our
expectations regarding future growth, including our ability to increase sales in our existing geographic markets and expand to new markets;
•
our
ability to maintain and grow our reputation and the market acceptance of our products ;
•
our
ability to achieve reimbursement from third-party payors or advance Centers for Medicare & Medicaid Services (“CMS”) coverage
for our products;
•
our
ability to maintain compliance with the continued requirements of the Nasdaq Capital Market and the risk that our ordinary shares will
be delisted if we do not comply with such requirements;
•
the
adverse effect that the COVID-19 pandemic has had and continues to have on our business and results of operations;
•
our
ability to have sufficient funds to meet certain future capital requirements, which could impair our efforts to develop and commercialize
existing and new products;
•
our
limited operating history and our ability to leverage our sales, marketing and training infrastructure;
•
our
ability to grow our business through acquisitions of businesses, products or technologies, and the failure to manage acquisitions, or
the failure to integrate them with our existing business, which could have a material adverse effect on our business, financial condition,
and operating results;
•
our
expectations as to our clinical research program and clinical results;
•
our
ability to obtain certain components of our products from third-party suppliers and our continued access to our product manufacturers;
•
our
ability to improve our products and develop new products;
•
our
compliance with medical device reporting regulations to report adverse events involving our products, which could result in voluntary
corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on our ability to
market and sell our products;
•
our
ability to gain and maintain regulatory approvals and to comply with any post-marketing requests
•
the
risk of a cybersecurity attack or breach of our information technology systems significantly disrupting our business operations;
•
our
ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others;
•
the
impact of substantial sales of our shares by certain shareholders on the market price of our ordinary shares;
•
our
ability to use effectively the proceeds of our offerings of securities;
•
the
risk of substantial dilution resulting from the periodic issuances of our ordinary shares;
•
the
impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company;
•
market
and other conditions; and
•
other
factors discussed in the “Risk Factors ” section of our 2021 annual report on
Form 10-K and in our subsequent reports filed with the SEC.
The
preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The statements are based on our beliefs,
assumptions, and expectations of future performance, taking into account the information currently available to us. These statements are
only predictions based upon our current expectations and projections about future events. There are important factors that could cause
our actual results, levels of activity, performance, or achievements to differ materially from the results, levels of activity, performance
or achievements expressed or implied by the statements. In particular, you should consider the risks provided under “Part I, Item
1A. Risk Factors” of our 2021 annual report on Form 10-K, and in other reports subsequently filed by us with, or furnished to, the
SEC.
You
should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in
the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and
circumstances reflected in the forward-looking statements will be achieved or will occur.
Any
forward-looking statement in this quarterly report speaks only as of the date hereof. Except as required by law, we undertake no obligation
to update publicly any forward-looking statements, whether as a result of new information, future developments or otherwise.
2
PART
I - FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share data)
March
31,
December
31,
2022
2021
(unaudited)
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
82,632
$
88,337
Trade receivable,
net
564
585
Prepaid expenses
and other current assets
1,378
610
Inventories
3,232
2,989
Total current assets
87,806
92,521
LONG-TERM ASSETS
Restricted cash and
other long-term assets
1,062
1,064
Operating lease right-of-use
assets
823
881
Property and equipment,
net
307
284
Total long-term assets
2,192
2,229
Total assets
$
89,998
$
94,750
The accompanying
notes are an integral part of these condensed consolidated financial statements.
3
REWALK ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share and per share data)
March
31,
December
31,
2022
2021
(unaudited)
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Current maturities
of operating leases
$
638
$
641
Trade payables
1,465
1,384
Employees and payroll
accruals
677
1,142
Deferred revenues
323
316
Other current liabilities
517
555
Total current liabilities
3,620
4,038
LONG-TERM LIABILITIES
Deferred revenues
825
866
Non-current operating
leases
330
418
Other long-term liabilities
37
45
Total long-term liabilities
1,192
1,329
Total liabilities
4,812
5,367
COMMITMENTS AND CONTINGENT
LIABILITIES
Shareholders’
equity:
Share
capital
O rdinary
share of NIS 0.25
par value-Authorized: 120,000,000
shares at March 31, 2022
and
December 31, 2021; Issued and outstanding: 62,508,517
and 62,480,163
shares at
March
31, 2022 and December 31, 2021, respectively
4,663
4,661
Additional paid-in
capital
279,054
278,903
Accumulated deficit
( 198,531
)
( 194,181
)
Total shareholders’
equity
85,186
89,383
Total liabilities
and shareholders’ equity
$
89,998
$
94,750
The accompanying
notes are an integral part of these condensed consolidated financial statements.
4
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In
thousands, except share and per share data)
Three
Months Ended
March
31,
2022
2021
Revenues
$
876
$
1,316
Cost
of revenues
611
609
Gross
profit
265
707
Operating
expenses:
Research
and development
907
795
Sales
and marketing
2,184
1,671
General
and administrative
1,462
1,262
Total
operating expenses
4,553
3,728
Operating
loss
( 4,288
)
( 3,021
)
Financial
expenses (income), net
24
( 4
)
Loss
before income taxes
( 4,312
)
( 3,017
)
Taxes
on income
38
45
Net
loss
$
( 4,350
)
$
( 3,062
)
Net
loss per ordinary share, basic and diluted
$
( 0.07
)
$
( 0.08
)
Weighted
average number of shares used in computing net loss per ordinary share, basic and diluted
62,493,496
36,187,789
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)
(In
thousands, except share data)
Ordinary
Share
Additional
paid-in
Accumulated
Total
shareholders’
Number
Amount
capital
deficit
equity
Balance as of December
31, 2020
25,332,225
1,827
201,392
( 181,445
)
21,774
Share-based compensation to employees
and non-employees
-
-
168
-
168
Issuance of ordinary shares upon
vesting of RSUs by employees and non-employees
24,096
2
( 2
)
-
-
Issuance
of ordinary shares in a private placement, net of issuance expenses in the amount of $ 3,679
(1)
10,921,502
832
35,489
-
36,321
Exercises of warrants (2)
9,814,754
724
13,094
-
13,818
Net loss
-
-
-
( 3,062
)
( 3,062
)
Balance as of March
31, 2021
46,092,577
3,385
250,141
( 184,507
)
69,019
Balance as of December
31, 2021
62,480,163
4,661
278,903
( 194,181
)
89,383
Share-based
compensation to employees and non-employees
-
-
153
-
153
Issuance of ordinary shares upon
vesting of RSUs by employees and non-employees
28,354
2
( 2
)
-
-
Net loss
-
-
-
( 4,350
)
( 4,350
)
Balance as of March
31, 2022
62,508,517
4,663
279,054
( 198,531
)
85,186
(1)
See Note 7.e. to
the condensed consolidated financial statements.
(2)
See Note 7.c. to the condensed consolidated
financial statements.
The accompanying
notes are an integral part of these condensed consolidated financial statements.
6
REWALK ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In
thousands)
Three
Months Ended
March
31,
2022
2021
Cash
flows used in operating activities:
Net loss
$
( 4,350
)
$
( 3,062
)
Adjustments to reconcile
net loss to net cash used in operating activities:
Depreciation
53
70
Share-based
compensation to employees and non-employees
153
168
Deferred
taxes
1
-
Changes
in assets and liabilities:
Trade
receivables, net
21
186
Prepaid
expenses, operating lease right-of-use assets and other assets
( 706
)
264
Inventories
( 325
)
49
Trade
payables
81
( 384
)
Employees
and payroll accruals
( 465
)
( 290
)
Deferred
revenues
( 34
)
( 14
)
Operating
lease liabilities and other liabilities
( 137
)
( 160
)
Net cash used in
operating activities
( 5,708
)
( 3,173
)
Cash
flows used in investing activities:
Purchase of property
and equipment
( 3
)
( 9
)
Net cash used in
investing activities
( 3
)
( 9
)
Cash
flows from financing activities:
Issuance
of ordinary shares in a private placement, net of issuance expenses paid in the amount of $ 3,582
(1)
-
36,418
Exercise of warrants
(1)
-
13,818
Net cash provided
by financing activities
-
50,236
Increase (decrease)
in cash, cash equivalents, and restricted cash
( 5,711
)
47,054
Cash, cash equivalents,
and restricted cash at beginning of period
89,050
21,054
Cash, cash equivalents,
and restricted cash at end of period
$
83,339
$
68,108
Supplemental
disclosures of non-cash flow information
Expenses related
to offerings not yet paid (1)
$
-
$
97
Classification of inventory to property
and equipment, net
$
51
$
-
Classification of inventory to other
current assets
$
54
$
-
Classification of other current assets
to property and equipment, net
$
22
$
16
Supplemental
cash flow information:
Cash and cash equivalents
$
82,632
$
67,411
Restricted cash included
in other long-term assets
707
697
Total Cash, cash
equivalents, and restricted cash
$
83,339
$
68,108
(1)
See Note 7.e. to
the condensed consolidated financial statements.
(2)
See Note 7.c. to the condensed consolidated
financial statements.
The accompanying
notes are an integral part of these consolidated financial statements.
7
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
1: GENERAL
a. ReWalk
Robotics Ltd. (“RRL”, and together with its subsidiaries, the “Company”) was incorporated under the laws of the
State of Israel on June 20, 2001 and commenced operations on the same date.
b. RRL
has two wholly-owned subsidiaries: (i) ReWalk Robotics Inc. (“RRI”) incorporated under the laws of Delaware on February 15,
2012 and (ii) ReWalk Robotics GMBH. (“RRG”) incorporated under the laws of Germany on January 14, 2013.
The
Company is designing, developing, and commercializing robotic exoskeletons that allow individuals with mobility impairments or other medical
conditions the ability to stand and walk once again. The Company has developed and is continuing to commercialize the ReWalk, an exoskeleton
designed for individuals with paraplegia that uses its patented tilt-sensor technology and an on-board computer and motion sensors to
drive motorized legs that power movement. The ReWalk system consists of a light wearable brace support suit which integrates motors at
the joints, rechargeable batteries, an array of sensors and a computer-based control system to power knee and hip movement. Additionally,
the Company developed and, in June 2019, started to commercialize the ReStore following receipt of European Union CE mark and United States
Food and Drug Administration (“FDA”) clearance. The ReStore is a powered, lightweight soft exo-suit intended for use in the
rehabilitation of individuals with lower limb disability due to stroke. The Company markets and sells its products directly to institutions
and individuals and through third-party distributors. The Company sells its products directly primarily in Germany and the United States,
and primarily through distributors in other markets. In its direct markets, the Company has established relationships with rehabilitation
centers and the spinal cord injury community, and in its indirect markets, the Company’s distributors maintain these relationships.
RRI markets and sells products mainly in the United States. RRG markets and sells the Company’s products mainly in Germany and Europe.
During
the second quarter of 2020, the Company finalized two separate agreements to distribute additional product lines in the U.S. market. The
Company is the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and has distribution rights
for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the U.S. Department of Veterans Affairs (“VA”)
hospitals. These new products have improved the Company’s product offering to clinics as well as patients within the VA as they
both have similar clinician and patient profiles.
c. The
worldwide spread of COVID-19 has resulted in a global economic slowdown and is expected to continue to disrupt general business operations
until the disease is contained. This has had a negative impact on the Company’s sales and results of operations since the start
of the pandemic, and the Company expects that it will continue to negatively affect its sales and results of operations; however, the
Company is currently unable to predict the scale and duration of that impact. As of the date of issuance of these financial statements,
the Company is not aware of any specific event or circumstance that would require an update of its accounting estimates or judgments or
revision of the carrying value of its assets or liabilities. This determination may change as new events occur and additional information
is obtained. Actual results could differ from management’s estimates and judgments, and any such differences may be material to
the Company’s financial statements.
d. As
of March 31, 2022, the Company incurred a consolidated net loss of $ 4.4
million and has an accumulated deficit in the total amount of $ 198.5
million. The Company’s cash and cash equivalent as of March 31, 2022 totaled $ 82.6
million and the Company’s negative operating cash flow for the three months ended March 31, 2022 was $ 5.7
million. The Company has sufficient funds to support its operations for more than 12 months following the issuance date of its condensed
consolidated unaudited financial statements for the three months ended March 31, 2022. The Company expects to incur future net losses
and its transition to profitability is dependent upon, among other things, the successful development and commercialization of its products
and product candidates, and the achievement of a level of revenues adequate to support its cost structure. Until the Company achieves
profitability or generates positive cash flows, it will continue to need to raise additional cash. the Company intends to fund future
operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding
warrants or a combination of the foregoing. In addition, the Company may seek additional capital through arrangements with strategic partners
or from other sources and will continue to address its cost structure. Notwithstanding, there can be no assurance that the Company will
be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.
8
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2: UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted
accounting principles and standards of the Public Company Accounting Oversight Board for interim financial information. Accordingly, they
do not include all the information and footnotes required by generally accepted accounting principles in the United States for complete
financial statements. In management’s opinion, the accompanying financial statements reflect all adjustments of a normal recurring
nature that are necessary for a fair presentation of the results for the interim periods presented. The Company’s interim period
results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.
These
financial statements and accompanying notes should be read in conjunction with the 2021 consolidated financial statements and notes thereto
included in the Company’s Annual Report on Form 10-K for its fiscal year ended December 31, 2021 filed with the SEC on February
24, 2022, as amended on May 2, 2022 (the “2021 Form 10-K”). There have been no changes in the significant accounting policies
from those that were disclosed in the audited consolidated financial statements for the fiscal year ended December 31, 2021 included in
the 2021 Form 10-K, unless otherwise stated.
9
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
3: SIGNIFICANT ACCOUNTING POLICIES
a. Revenue
Recognition
The
Company generates revenues from sales of products. The Company sells its products directly to end customers and through distributors.
The Company sells its products to private individuals (who finance the purchases by themselves, through fundraising or reimbursement coverage
from insurance companies), rehabilitation facilities and distributors.
Disaggregation
of Revenues (in thousands)
Three
Months Ended
March
31,
2022
2021
Units
placed
$
778
$
1,142
Spare
parts and warranties
98
174
Total
Revenues
$
876
$
1,316
Units
placed
The
Company currently offers five products: (1) ReWalk Personal; (2) ReWalk Rehabilitation; (3) ReStore; (4) MyoCycle; and (5) MediTouch.
ReWalk
Personal and ReWalk Rehabilitation are units for spinal cord injuries (“SCI Products”). SCI Products are currently designed
for everyday use by paraplegic individuals at home and in their communities, and are custom fitted for each user, as well as for use by
paraplegia patients in the clinical rehabilitation environment, where they provide individuals access to valuable exercise and therapy.
ReStore
is a powered, lightweight soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke
in the clinical rehabilitation environment.
The
MyoCycle device uses Functional Electrical Stimulation (“FES”) technology to facilitate therapeutic exercise for persons with
muscle weakness or paralysis caused by disorders like spinal cord injury, multiple sclerosis, and stroke.
The
MediTouch Tutor movement biofeedback product line includes the Arm, Hand, 3D and Leg Tutor devices. These devices are used by physical
and occupational therapists to evaluate functional tasks during rehabilitation of neurologic disorders and can also be used by patients
remotely at home.
Pursuant
to two separate distribution agreements entered into during the second quarter of 2020, the Company now markets both the MediTouch and
MyoCyle products (together the “Distributed Products”) in the United States for use at home or in a clinic.
Units
placed includes revenue from sales of SCI Products, ReStore and the Distributed Products.
For
units placed, the Company recognizes revenues when it transfers control and title has passed to the customer. Each unit placed is
considered an independent, unbundled performance obligation. The Company generally does not grant a right of return for its products besides
isolated cases where the Company assesses the likelihood of such event to occur based on the Company’s historical experience and
estimates. The Company also offers a rent-to-purchase model in which the Company recognizes revenue ratably according to the agreed rental
monthly fee.
10
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Spare
parts and warranties
Spare
parts are sold to private individuals, rehabilitation facilities and distributors. Revenue is recognized when the Company satisfies a
performance obligation by transferring control over promised goods or services to the customer. Each part sold is considered an independent,
unbundled performance obligation.
Warranties
are classified as either assurance type or service type warranty. A warranty is considered an assurance type warranty if it provides the
consumer with assurance that the product will function as intended for a limited period of time.
In
the beginning of 2018, the Company updated its service policy for SCI Products to include a five- year warranty compared to a period of
two years that were included in the past for parts and services. The first two years are considered as assurance type warranty and the
additional period is considered an extended service arrangement, which is a service type warranty. An assurance type warranty is not accounted
for as separate performance obligations under the revenue model. A service type warranty is either sold with a unit or separately for
units for which the warranty has expired. Revenue is then recognized ratably over the life of the warranty.
The
ReStore device is offered with a two-year warranty which is considered as assurance type warranty.
T he
Distributed Products are sold with an assurance-type warranty that is covered by the vendor ranging from one
year to ten
years depending on the specific product and part.
Contract
balances (in thousands)
March
31,
December
31,
2022
2021
Trade
receivable, net (1)
$
564
$
585
Deferred
revenues (1) (2)
$
1,148
$
1,182
(1)
Balance
presented net of unrecognized revenues that were not yet collected.
(2)
During
the three months ended March 31, 2022, $ 123
thousand of the December 31, 2021 deferred revenues balance was recognized as revenues.
Deferred
revenue is comprised mainly of unearned revenue related to service type warranty but also includes other offerings for which the Company
has been paid in advance and earns revenue when the Company transfers control of the product or service.
The
Company’s unfilled performance obligations as of March 31, 2022 and the estimated revenue expected to be recognized in the future
related to the service type warranty amounts to $1,18 million, which is fulfilled over one to five years.
11
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
b. Concentrations
of Credit Risks:
Concentration
of credit risk with respect to trade receivable is primarily limited to a customer to which the Company makes substantial sales.
The below table reflects the concentration of credit risk for the Company’s current customers as of the quarter ended March 31,
2022, to which substantial sales were made:
March
31,
December
31,
2022
2021
Customer
A
21
%
*
)
Customer
B
20
%
*
)
Customer
C
15
%
*
)
Customer
D
15
%
*
)
Customer
E
10
%
*
)
Customer
F
*
)
20
%
Customer
G
*
)
18
%
Customer
H
*
)
16
%
Customer
I
*
)
12
%
Customer
J
*
)
10
%
*) Less
than 10%
T he
Company’s trade receivables are geographically diversified and derived primarily from sales to customers in various countries, mainly
in the United States and Europe. Concentration of credit risk with respect to trade receivables is limited by credit limits, ongoing credit
evaluation and account monitoring procedures. The Company performs ongoing credit evaluations of its distributors based upon a specific
review of all significant outstanding invoices. The Company writes off receivables when they are deemed uncollectible and having exhausted
all collection efforts. As of March 31, 2022 and December 31, 2021 trade receivables are presented net of allowance for doubtful accounts
in the amount of $ 27
thousand and $ 42
thousand, respectively, and net of sales return reserve of $ 52
thousand and $ 43
thousand, respectively.
c. Warranty
provision
T he
Company provided a two-year standard warranty for its products. In the beginning of 2018, our service policy for new devices sold includes
five-year
warranty. The Company determined that the first two
years of warranty is an assurance-type warranty and records a provision for the estimated cost to repair or replace products
under warranty at the time of sale. Factors that affect the Company’s warranty reserve include the number of units sold, historical
and anticipated rates of warranty repairs and the cost per repair.
US
Dollars in thousands
Balance
at December 31, 2021
$
112
Provision
67
Usage
( 72
)
Balance
at March 31, 2022
$
107
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
d. Basic
and diluted net loss per ordinary share
Basic
net loss per ordinary share is computed based on the weighted average number of ordinary shares outstanding during each year.
For
the three months ended March 31, 2022, the total number of ordinary shares related to the outstanding warrants aggregated to 19,420,894 ,
which were excluded from the calculations of diluted loss per ordinary share since it would have an anti-dilutive effect.
e. New
Accounting Pronouncements
Recently
Implemented Accounting Pronouncement
i.
Accounting
for Convertible Instruments and Contracts in an Entity’s Own Equity
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2020-06, Accounting for Convertible Instruments
and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the accounting for certain financial instruments
with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. Among
other changes, ASU 2020-06 removes from U.S. GAAP the liability and equity separation model for convertible instruments with a cash conversion
feature and a beneficial conversion feature, and as a result, after adoption, entities will no longer separately present in equity an
embedded conversion feature for such debt. Similarly, the embedded conversion feature will no longer be amortized into income as interest
expense over the life of the instrument. Instead, entities will account for a convertible debt instrument wholly as debt unless (1) a
convertible instrument contains features that require bifurcation as a derivative under ASC Topic 815, Derivatives and Hedging, or (2)
a convertible debt instrument was issued at a substantial premium. Additionally, ASU 2020-06 requires the application of the if-converted
method to calculate the impact of convertible instruments on diluted earnings per share (“EPS”). ASU 2020-06 is effective
for fiscal years beginning after December 15, 2021, with early adoption permitted for fiscal years beginning after December 15, 2020 and
can be adopted on either a fully retrospective or modified retrospective basis. The adoption of this standard did not have a material
impact on the Company’s consolidated financial statements.
Recent
Accounting Pronouncements Not Yet Adopted
i.
Financial
Instruments
In
June 2016, FASB issued ASU 2016-13, Financial Instruments - –Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments. ASU 2016-13 amends the impairment model to utilize an expected loss methodology in place of the currently used incurred loss
methodology, which will result in the more timely recognition of losses. Topic 326 will be effective for the Company beginning on January
1, 2023. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
13
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4: INVENTORIES
The
components of inventories are as follows (in thousands):
March
31,
December
31,
2022
2021
Finished products
$
2,695
$
2,284
Raw materials
537
705
$
3,232
$
2,989
In the
three months ended March 31, 2022 and 2021, the Company wrote off inventory in the amount of $ 2
and $ 38
thousand, respectively. The write off inventory were recorded in cost of revenues.
NOTE
5: COMMITMENTS AND CONTINGENT LIABILITIES
a. Purchase
commitments:
T he
Company has contractual obligations to purchase goods from its contract manufacturer as well as raw materials from different vendors.
Purchase obligations do not include contracts that may be canceled without penalty. As of March 31, 2022, non-cancelable outstanding obligations
amounted to approximately $ 1.5
million.
b. Operating
lease commitment:
(i) T he
Company operates from leased facilities in Israel, the United States and Germany. These
leases expire between 2022 and 2023. A portion of the Company’s facilities leases is generally subject to annual
changes in the Consumer Price Index (the “CPI”). The changes to the CPI are treated as variable lease payments and recognized
in the period in which the obligation for those payments was incurred.
(ii)
RRL
and RRG lease cars for their employees under cancelable operating lease agreements expiring at various dates in between 2022 and 2025.
A subset of the Company’s cars leases is considered variable. The variable lease payments for such cars leases are based on actual
mileage incurred at the stated contractual rate. RRL and RRG have an option to be released from these agreements, which may result in
penalties in a maximum amount of approximately $ 23
thousand as of March 31, 2022.
The
Company's future lease payments for its facilities and cars, which are presented as current maturities of operating leases and non-current
operating leases liabilities on the Company's condensed consolidated balance sheets as of March 31, 2022 are as follows (in thousands):
2022
$
520
2023
523
2024
32
2025
4
Total
lease payments
1,079
Less:
imputed interest
( 111
)
Present
value of future lease payments
968
Less:
current maturities of operating leases
( 638
)
Non-current
operating leases
$
330
Weighted-average
remaining lease term (in years)
1.62
Weighted-average
discount rate
12.5
%
14
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
L ease
expense under the Company’s operating leases was $ 179
thousand and $ 186
thousand for the three months ended March 31, 2022 and 2021, respectively.
c. Royalties:
The
Company's research and development efforts are financed, in part, through funding from the Israel Innovation Authority (the "IIA") and
the Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”). Since
the Company's inception through March 31, 2022, the Company received funding from the IIA and BIRD in the total amount of $ 1.97
million and $500 thousand, respectively. Out of the $1.97 million in funding from the IIA, a total amount of $ 1.57
million were royalty-bearing grants (as of March 31, 2022, the Company paid royalties to the IIA in the total amount of $ 105
thousand), while a total amount of $ 400
thousand was received in consideration of 209
convertible preferred A shares, which converted after the Company's initial public offering in September 2014 into ordinary
shares in a conversion ratio of 1 to 1. The Company is obligated to pay royalties to the IIA, amounting to 3 %
of the sales of the products and other related revenues generated from such projects, up to 100 %
of the grants received.
The
royalty payment obligations also bear interest at the LIBOR rate. The obligation to pay these royalties is contingent on actual sales
of the applicable products and in the absence of such sales, no payment is required.
Additionally,
the Exclusive License Agreement between the Company and Harvard University’s Wyss Institute for Biologically Inspired Engineering
("Harvard") requires the Company to pay Harvard royalties on net sales. See note 6 below for more information about the Collaboration
Agreement and the License Agreement.
R oyalties expenses
in cost of revenues were $ 3
and $ 0
thousand for the three months ended March 31, 2022 and 2021, respectively.
A s
of March 31, 2022, the contingent liability to the IIA amounted to $ 1.6
million. The Israeli Research and Development Law provides that know-how developed under an approved research and development program
may not be transferred to third parties without the approval of the IIA. Such approval is not required for the sale or export of any products
resulting from such research or development. The IIA, under special circumstances, may approve the transfer of IIA-funded know-how outside
Israel, in the following cases:
(a)
the grant recipient pays to the IIA a portion of the sale price paid in consideration for such IIA-funded know-how or in consideration
for the sale of the grant recipient itself, as the case may be, which portion will not exceed six times the amount of the grants received
plus interest (or three times the amount of the grant received plus interest, in the event that the recipient of the know-how has committed
to retain the research and development activities of the grant recipient in Israel after the transfer); (b) the grant recipient receives
know-how from a third party in exchange for its IIA-funded know-how; (c) such transfer of IIA-funded know-how arises in connection with
certain types of cooperation in research and development activities; or (d) If such transfer of know-how arises in connection with a liquidation
by reason of insolvency or receivership of the grant recipient.
d. Liens:
A s
part of the Company’s other long-term assets and restricted cash, an amount of $ 707
thousand has been pledged as security in respect of a guarantee granted to a third party. Such deposit cannot be pledged to others or
withdrawn without the consent of such third party.
15
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
e. Legal
Claims:
Occasionally,
the Company is involved in various claims such as product liability claims, lawsuits, regulatory examinations, investigations, and other
legal matters arising, for the most part, in the ordinary course of business. The outcome of any pending or threatened litigation and
other legal matters is inherently uncertain, and it is possible that resolution of any such matters could result in losses material to
the Company’s consolidated results of operations, liquidity, or financial condition. Except as otherwise disclosed herein, the Company
is not currently party to any material litigation.
NOTE
6: RESEARCH COLLABORATION AGREEMENT AND LICENSE AGREEMENT
On
May 16, 2016, the Company entered into a Research Collaboration Agreement (“Collaboration Agreement”) and an Exclusive License
Agreement (“License Agreement”) with Harvard. The Research Collaboration Agreement was amended on May 1, 2017, and April 1,
2018 (as amended, the “Collaboration Agreement”), and the Exclusive License Agreement was amended on April 1, 2018 (as amended,
the “License Agreement”), to extend the term of the Collaboration Agreement by one year to May
16, 2022 and reallocate the Company’s quarterly installment payments to Harvard through such date, and to make certain
technical changes. On April 30, 2020, the Company and Harvard amended the Collaboration Agreement, which included certain adjustments
to the quarterly installments and extended the term an additional three quarters until February 2023. On October 14, 2021, the Company
and Harvard further amended the Collaboration Agreement, to make certain adjustments to the quarterly installments and technical changes
and establish that the term of the Collaboration Agreement would conclude on March 31, 2022. As of March 31, 2022, the Collaboration Agreement
has expired.
Under
the License Agreement, Harvard has granted the Company an exclusive, worldwide royalty-bearing license under certain patents of Harvard
relating to lightweight “soft suit” exoskeleton system technologies for lower limb disabilities, a royalty-free license under
certain related know-how and the option to obtain a license under certain inventions conceived under the joint research collaboration.
T he
License Agreement required the Company to pay Harvard an upfront fee, reimbursements for expenses that Harvard incurred in connection
with the licensed patents, royalties on net sales and several milestone payments contingent upon the achievement of certain product development
and commercialization milestones. The Harvard License Agreement will continue in full force and effect until the expiration of the last-to-expire
valid claim of the licensed patents. As of March 31, 2022, the Company achieved three of the milestones which represent all development
milestones under the License Agreement. The Company continues to evaluate the likelihood that the other milestones will be achieved on
a quarterly basis.
T he
Company has recorded expenses in the amount of $ 10
thousand and $ 159
thousand as research and development expenses related to the License Agreement and to the Collaboration Agreement for the three months
ended March 31, 2022, and 2021, respectively. No withholding tax was deducted from the Company’s payments to Harvard in respect
of the Collaboration Agreement and the License Agreement since this is not taxable income in Israel in accordance with Section 170 of
the Israel Income Tax Ordinance 1961-5721.
16
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
7: SHAREHOLDERS’ EQUITY
a. Share
option plans:
A s
of March 31, 2022, and December 31, 2021, the Company had reserved 379,763
and 233,957 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.
There
were no options granted during the three months ended March 31, 2022 and 2021.
The
fair value of RSUs granted is determined based on the price of the Company's ordinary shares on the date of grant.
A
summary of employee share options activity during the three months ended March 31, 2022 is as follows:
Number
Average
exercise
price
Average
remaining
contractual
life
(in years)
Aggregate
intrinsic
value
(in
thousands)
Options outstanding
at the beginning of the period
61,832
$
38.34
4.55
$
-
Granted
-
-
-
-
Exercised
-
-
-
-
Forfeited
( 165
)
15.09
-
-
Options outstanding
at the end of the period
61,667
$
38.37
3.71
$
-
Options exercisable
at the end of the period
57,732
$
40.32
3.50
$
-
The
aggregate intrinsic value in the table above represents the total intrinsic value that would have been received by the option holders
had all option holders that hold options with positive intrinsic value exercised their options on the last date of the exercise period.
No options were exercised during the three months ended March 31, 2022 and 2021.
17
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
A
summary of employees and non-employees RSUs activity during the three months ended March 31, 2022 is as follows:
Number
of shares
underlying
outstanding
RSUs
Weighted
average
grant
date fair value
Unvested RSUs at
the beginning of the period
1,356,284
$
1.61
Granted
55,000
1.12
Vested
( 28,354
)
2.04
Forfeited
( 200,641
)
1.53
Unvested RSUs at
the end of the period
1,182,289
$
1.59
T he
weighted average grant date fair value of RSUs granted during the three months ended March 31, 2022, and 2021 was $ 1.12
and $ 1.32 ,
respectively.
A s
of March 31, 2022, there were $ 1.5
million of total unrecognized compensation costs related to non-vested share-based compensation arrangements granted under the Company's
2014 Plan. This cost is expected to be recognized over a period of approximately 2.7
years.
The
number of options and RSUs outstanding as of March 31, 2022 is set forth below, with options separated by range of exercise price.
Range
of exercise price
Options
and RSUs outstanding as of
March
31, 2022
Weighted
average
remaining
contractual
life
(years) (1)
Options
outstanding and exercisable as of
March
31, 2022
Weighted
average
remaining
contractual
life
(years) (1)
RSUs only
1,182,289
-
-
-
$ 5.37
12,425
6.99
9,318
6.99
$ 20.42
- $ 33.75
30,990
2.65
30,162
2.55
$ 37.14
- $ 38.75
8,946
1.73
8,946
1.73
$ 50
- $ 52.50
6,731
5.22
6,731
5.22
$ 182.5
- $ 524
2,575
3.60
2,575
3.60
1,243,956
3.71
57,732
3.50
(1)
Calculation of weighted average remaining
contractual term does not include the RSUs that were granted, which have an indefinite contractual term.
b. Share-based
awards to non-employee consultants:
As
of March 31, 2022, there are no outstanding options or RSUs held by non-employee consultants.
18
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
c. Warrants
to purchase ordinary shares:
The
following table summarizes information about warrants outstanding and exercisable that were classified as equity as of March 31, 2022:
Issuance
date
Warrants
outstanding
Exercise
price
per
warrant
Warrants
outstanding
and
exercisable
Contractual
term
(number)
(number)
December 31, 2015
(1)
4,771
$
7.500
4,771
See footnote (1)
December 28, 2016
(2)
1,908
$
7.500
1,908
See footnote (1)
November 20, 2018
(3)
126,839
$
7.500
126,839
November
20, 2023
November 20, 2018
(4)
106,680
$
9.375
106,680
November
15, 2023
February 25, 2019
(5)
45,600
$
7.187
45,600
February
21, 2024
April 5, 2019 (6)
408,457
$
5.140
408,457
October
7, 2024
April 5, 2019 (7)
49,015
$
6.503
49,015
April
3, 2024
June 5, 2019, and
June 6, 2019 (8)
1,464,665
$
7.500
1,464,665
June
5, 2024
June 5, 2019 (9)
87,880
$
9.375
87,880
June
5, 2024
June 12, 2019 (10)
416,667
$
6.000
416,667
December
12, 2024
June 10, 2019 (11)
50,000
$
7.500
50,000
June
10, 2024
February 10, 2020
(12)
28,400
$
1.250
28,400
February
10, 2025
February 10, 2020
(13)
105,840
$
1.563
105,840
February
10, 2025
July 6, 2020 (14)
448,698
$
1.760
448,698
January
2, 2026
July 6, 2020 (15)
296,297
$
2.278
296,297
January
2, 2026
December 8, 2020
(16)
586,760
$
1.340
586,760
June
8, 2026
December 8, 2020
(17)
108,806
$
1.792
108,806
June
8, 2026
February 26, 2021
(18)
5,460,751
$
3.600
5,460,751
August
26, 2026
February 26, 2021
(19)
655,290
$
4.578
655,290
August
26, 2026
September 29, 2021
(20)
8,006,759
$
2.000
8,006,759
March
29, 2027
September 29, 2021
(21)
960,811
$
2.544
960,811
September
27, 2026
19,420,894
19,420,894
(1)
Represents warrants
for ordinary shares issuable upon an exercise price of $ 7.50
per share, which were granted on December
31, 2015 to Kreos Capital V (Expert) Fund Limited (“Kreos”) in connection with a loan made by Kreos to the
Company and are currently
exercisable (in whole or in part) until the earlier of (i) December 30, 2025 or (ii) immediately prior to the consummation of a merger,
consolidation, or reorganization of the Company with or into, or the sale or license of all or substantially all the assets or shares
of the Company to, any other entity or person, other than a wholly owned subsidiary of the Company, excluding any transaction in which
the Company’s shareholders prior to the transaction will hold more than 50% of the voting and economic rights of the surviving entity
after the transaction. None of these warrants had been exercised as of March 31, 2022.
19
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(2)
Represents common
warrants that were issued as part of the $ 8 .0
million drawdown under the Loan Agreement which occurred on December 28, 2016. See footnote 1 for exercisability terms.
(3)
Represents common
warrants that were issued as part of the Company’s follow-on public offering in November 2018.
(4)
Represents common
warrants that were issued to the underwriters as compensation for their role in the Company’s follow-on public offering in November
2018.
(5)
Represents warrants
that were issued to the exclusive placement agent as compensation for its role in the Company’s follow-on public offering in February
2019.
(6)
Represents warrants
that were issued to certain institutional purchasers in a private placement in the Company’s registered direct offering of ordinary
shares in April 2019.
(7)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s April 2019 registered direct offering.
(8)
Represents warrants
that were issued to certain institutional investors in a warrant exercise agreement on June 5, 2019, and June 6, 2019, respectively.
(9)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s June 2019 warrant exercise agreement and concurrent
private placement of warrants.
(10)
Represents warrants that were issued
to certain institutional investors in a warrant exercise agreement in June 2019.
(11)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s June 2019 registered direct offering and concurrent
private placement of warrants.
(12)
Represents warrants
that were issued to certain institutional purchasers in a private placement in the Company’s best efforts offering of ordinary shares
in February 2020. During the year ended December 31, 2021, 3,740,100
warrants were exercised for total consideration of $ 4,675,125 .
(13)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s February 2020 best efforts offering. During
the year ended December 31, 2021, 230,160
warrants were exercised for total consideration of $ 359,625 .
(14)
Represents warrants
that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in July
2020. During the year ended December 31, 2021, 2,020,441
warrants were exercised for total consideration of $ 3,555,976 .
(15)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering.
20
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ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(16)
Represents warrants
that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in December
2020. During the year ended December 31, 2021, 3,598,072
warrants were exercised for total consideration of $ 4,821,416 .
(17)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s December 2020 private placement. During the
year ended December 31, 2021, 225,981
warrants were exercised for total consideration of $405,003.
(18)
Represents warrants
that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in February
2021.
(19)
Represents warrants
that were issued to the placement agent as compensation for its role in the Company’s private placement offering in February 2021
(the “February 2021 Offering”).
(20)
Represents warrants
that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in September
2021.
(21)
Represents warrants that were issued
to the placement agent as compensation for its role in the Company’s September 2021 registered direct offering.
d. Share-based
compensation expense for employees and non-employees:
The
Company recognized non-cash share-based compensation expense for both employees and non-employees in the condensed consolidated statements
of operations as follows (in thousands):
Three
Months Ended
March
31,
2022
2021
Cost of revenues
$
3
$
2
Research and development,
net
16
( 2
)
Sales and marketing
51
45
General and administrative
83
123
Total
$
153
$
168
e. Equity
raise:
Follow-on offerings and warrants exercise:
On
February 19, 2021, the Company entered into a purchase agreement with certain institutional and other accredited investors for
the issuance and sale of 10,921,502
ordinary shares, par value NIS 0.25
per share at $ 3.6625
per ordinary share and warrants to purchase up to an aggregate of 5,460,751
ordinary shares with an exercise price of $ 3.6
per share, exercisable
from February 19, 2021 until August 26, 2026. Additionally, the Company issued warrants to purchase up to 655,290
ordinary shares, with an exercise price of $ 4.578125
per share, exercisable from February 19, 2021 until August 26, 2026, to certain representatives of H.C. Wainwright & Co., LLC (“H.C.
Wainwright”) as compensation for its role as the placement agent in our February 2021 Offering.
On September
27, 2021, the
Company signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary shares, par
value NIS 0.25 per share, pre-funded warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary warrants to purchase
up to an aggregate of 8,006,759 ordinary shares at an exercise price of $2.00 per share. The Pre-Funded Warrants have an exercise price
of $0.001 per Ordinary Share and are immediately exercisable and can be exercised at any time after their original issuance until such
pre-funded warrants are exercised in full. Each ordinary share was sold at an offering price of $2.035 and each pre-funded warrant was
sold at an offering price of $2.034 (equal to the purchase price per ordinary share minus the exercise price of the pre-funded warrant).
The offering of the ordinary shares, the pre-funded warrants and the ordinary shares that are issuable from time to time upon exercise
of the pre-funded warrants was made pursuant to the Company’s shelf registration statement on Form S-3 initially filed with the
Securities and Exchange Commission (“SEC”) on May 9, 2019, and declared effective by the SEC on May 23, 2019, and the ordinary
warrants were issued in a concurrent private placement. The ordinary warrants are exercisable at any time and from time to time, in whole
or in part, following the date of issuance and ending five and one-half years from the date of issuance. All of the pre-funded warrants
were exercised in full on September 27, 2021, and the offering closed on September 29, 2021. Additionally, the Company issued warrants
to purchase up to 960,811 ordinary shares, with an exercise price of $2.5438 per share, exercisable from September 27, 2021, until September
27, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in our September 2021 registered
direct offering.
A s
of March 31, 2022, a total of 9,814,754
previously issued warrants with exercise prices ranging from $ 1.25
to $ 1.79 have
been exercised for total gross proceeds of approximately $ 13.8
million.
21
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
8: FINANCIAL EXPENSES (INCOME), NET
The
components of financial expenses (income), net were as follows (in thousands):
Three
Months Ended
March
31,
2022
2021
Foreign currency
transactions and other
$
15
$
( 14
)
Bank commissions
9
10
$
24
$
( 4
)
22
REWALK
ROBOTICS LTD. AND SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
9: GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER AND PRODUCT DATA
Summary
information about geographic areas:
A SC
280, “Segment Reporting” establishes standards for reporting information about operating segments. Operating segments are
defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief
operating decision maker in deciding how to allocate resources and in assessing performance. The Company manages its business on the basis
of one
reportable segment and derives revenues from selling systems and services (see Note 1 for a brief description of the Company’s business).
The following is a summary of revenues within geographic areas (in thousands):
Three
Months Ended
March
31,
2022
2021
Revenues based on
customer’s location:
United
States
$
220
$
476
Europe
647
837
Asia-Pacific
8
2
Africa
1
1
Total revenues
$
876
$
1,316
March
31,
December
31,
2022
2021
Long-lived assets
by geographic region (*):
Israel
$
611
$
629
United
States
453
493
Germany
66
43
$
1,130
$
1,165
(*)
Long-lived assets are comprised of
property and equipment, net, and operating lease right-of-use assets.
Three
Months Ended
March 31,
2022
2021
Major
customer data as a percentage of total revenues:
Customer
A
18
%
*
)
Customer
B
14
%
-
Customer
C
13
%
-
Customer
D
11
%
-
Customer
E
10
%
*
)
Customer
F
10
%
-
Customer
G
*
)
15
%
Customer
H
-
10
%
Customer
I
-
10
%
*)
Less
than 10 %.
23
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of operation should be read in conjunction with the unaudited
condensed consolidated financial statements and the related notes included elsewhere in this quarterly report and with our audited consolidated
financial statements included in our Form 10-K for the year ended December 31, 2021 as filed with the SEC on February 24, 2022 and amended
on May 2, 2022 (the “2021 Form 10-K”). In addition to historical condensed financial information, the following discussion
contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those
discussed in the forward-looking statements. For a discussion of factors that could cause or contribute to these differences, see “Special
Note Regarding Forward-Looking Statements” above.
Overview
We
are an innovative medical device company that is designing, developing, and commercializing robotic exoskeletons that allow individuals
with mobility impairments or other medical conditions the ability to stand and walk once again. We have developed and are continuing to
commercialize our ReWalk Personal and ReWalk Rehabilitation devices for individuals with spinal cord injury (“SCI Products”),
which are exoskeletons designed for individuals with paraplegia that use our patented tilt-sensor technology and an on-board computer
and motion sensors to drive motorized legs that power movement.
We
have also developed and began commercializing our ReStore device in June 2019. ReStore is a powered, lightweight soft exo-suit intended
for use in the rehabilitation of individuals with lower limb disability due to stroke. During the second quarter of 2020 we have finalized
and moved to implement two separate agreements to distribute additional product lines in the U.S. market. The Company will be the exclusive
distributor of the MediTouch Tutor movement biofeedback systems in the United States and will also have distribution rights for the MYOLYN
MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the U.S. Department of Veterans Affairs (“VA”)
hospitals and other personal sales. These new products will improve our product offering to clinics as well as patients within the VA
as they both have similar clinician and patient profile.
Our
principal markets are the United States and Europe. In Europe, we have a direct sales operation in Germany and the United Kingdom and
work with distribution partners in certain other major countries. We have offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam,
Israel, where we operate our business from.
We
have in the past generated and expect to generate in the future revenues from a combination of third-party payors, self-payors, including
private and government employers, and institutions. While a broad uniform policy of coverage and reimbursement by third-party commercial
payors currently does not exist in the United States for electronic exoskeleton technologies such as the ReWalk Personal, we are pursuing
various paths of reimbursement and support fundraising efforts by institutions and clinics. In December 2015, the U.S. Department of Veterans
Affairs, or the VA, issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all
qualifying veterans across the United States. The VA policy is the first national coverage policy in the United States for qualifying
individuals who have suffered spinal cord injury. As of December 31, 2021, we had placed 25 units as part of the VA policy.
According
to a 2017 report published by the Centers for Medicare and Medicaid Services, or CMS, approximately 55% of the spinal cord injury population
which are at least five years post their injury date are covered by CMS. In July 2020, a code was issued for ReWalk Personal 6.0 (effective
October 1, 2020), which might later be followed by coverage policy of CMS.
Additionally,
to date, several private insurers in the United States and Europe have provided reimbursement for ReWalk in certain cases. In Germany,
we continue to make progress toward achieving ReWalk coverage from the various government, private and worker’s compensation payors.
In September 2017, each of German insurer BARMER GEK (“Barmer”) and national social accident insurance provider Deutsche Gesetzliche
Unfallversicherung (“DGUV”), indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria.
In February 2018, the head office of German statutory health insurance, or SHI, Spitzenverband (“GKV”) confirmed their decision
to list the ReWalk Personal 6.0 exoskeleton system in the German Medical Device Directory. This decision means that ReWalk will be listed
among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis. During
the year 2020 we announced several new agreements with German SHIs such as TK and DAK Gesundheit and others as well as the first German
Private Health Insurer (“PHI”) that have chosen to enter into an agreement that outlines the process of obtaining a device
for eligible insured patient. We are currently working with several additional SHIs and PHIs on securing a formal operating contract that
will establish the process of obtaining a ReWalk Personal 6.0 device for their beneficiaries within their system.
During
the second quarter of 2020 we finalized and moved to implement two separate agreements to distribute additional product lines in the U.S.
market. The Company will be the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and will
also have distribution rights for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through the VA hospitals.
These new products will improve our product offering to clinics as well as patients within the VA as they both have similar clinician
and patient profile. We have incurred net losses and negative cash flow from operations since inception and anticipate this to continue
in the near term. We will continue to evaluate spending while continuing to focus resources on activities to commercialize the Restore
device for stroke patients, achieving additional commercial reimbursement coverage decisions for our ReWalk Personal device, continued
research and development activities related mainly to our product line maintenance as well as our soft exo-suit design and activities
related to our FDA 522 postmarket study.
24
First
Quarter 2022 and Subsequent Period Business Highlights
•
Total revenue for the first quarter
of 2022 was $0.9 million, compared to $1.3 million in the first quarter of 2021;
•
Placed on June 8th CMS agenda of
the Biannual Healthcare Common Procedure Coding System (HCPCS) meeting that includes benefit category determination for the first time
under the new DEMPOS rules. This is based on previous interactions with CMS to determine ReWalk’s benefit category and payment
status;
•
ReWalk has increased resources and
presence in VA Polytrauma/TBI Care Systems as well as a process to expand training through the VA’s designated Community Based Outpatient
Clinic network;
•
Strong cash position with $82.6 million
as of March 31, 2022;
•
The Company’s operating expenses
were $4.6 million in the first quarter of 2022, compared to $3.7 million in the first quarter of 2021;
•
In April 2022, the Company joined
the Human Robot Interaction Consortium, part of the Israel Innovation Authority MAGNET incentive program, where it will collaborate with
several universities to develop advanced technologies aimed at improving the human-exoskeleton interaction.
Evolving
COVID-19 Pandemic
The
impact of the COVID-19 pandemic has resulted in, and will likely continue to result in, significant disruptions to the global economy
and the capital markets, as well as our business. A significant number of our global suppliers, vendors, distributors and manufacturing
facilities are located in regions that have been affected by the pandemic. Those operations have been materially adversely affected by
restrictive government and private enterprise measures implemented in response to the pandemic, which in turn, has negatively impacted
our operations. Despite the distribution of COVID-19 vaccines, new and occasionally more virulent variants of the virus that causes COVID-19,
including the Delta and Omicron variants, have emerged, and there is significant uncertainty as to how the countries in which we do business
will continue to respond to such outbreaks, including whether there will be future partial or total shutdowns, which would adversely affect
our business.
The
COVID-19 pandemic has affected our ability to engage with our SCI Products, ReStore and Distributed Products existing customers, conduct
trials of candidates, deliver ordered units or repair existing systems and provide training of our products to new patients who have largely
remained at home due to local movement restrictions and to rehabilitation centers, which have temporarily shifted priorities and responses
to pandemic-related medical equipment. In addition, staffing shortages within the healthcare system itself has resulted in a diminished
demand for our SCI Products as the attention of healthcare workers and potential patients has turned elsewhere. As a result, our sales
and results of operations have been adversely impacted. We believe that these adverse impacts may continue as long as the pandemic continues
to impact our key markets, which are Germany and the United States, especially as long as our ability to conduct trials of product candidates
is limited or if our existing customers can’t train with our SCI Products and as long as capital budgets for rehabilitation devices
such as the ReStore remain reduced or on-hold. Additionally, some clinics, such as VA clinics, and many other healthcare facilities, are
enforcing in-clinic restrictions that affect our ability to demonstrate our devices to patients or start training for qualified potential
customers. We continue to monitor our sales pipeline on a day-to-day basis in order to assess the effect of these limitations as some
have short term effects and others affect our future pipeline development. While our sole manufacturer, Sanmina Corporation, has not shut
down its facilities during the COVID-19 pandemic, supply chain delays, component shortages have had a limited impact on our manufacturing
and are also leading to price increases of specific parts. Other adverse impacts on our production capacity as a result of government
directives or health protocols can occur. Moreover, the current limitations on our sales activities has made it difficult to effectively
forecast our future requirements for systems. For more information, see “Part I, Item 1A. Risk Factors.” of
our 2021 Form 10-K in addition to the “Risk Factors” section included below.
In
addition, our future results of operations and liquidity could be adversely impacted by delays in payments of outstanding receivable amounts
beyond normal payment terms, supply chain disruptions and operational challenges faced by our customers. The occurrence of new outbreaks
of COVID-19 could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries,
resulting in an economic downturn or a global recession that could cause significant volatility or decline in the trading price of our
securities, affect our ability to execute strategic business activities such as business combination, affect demand for our products and
likely impact our operating results. These may further limit or restrict our ability to access capital on favorable terms, or at all,
lead to consolidation that negatively impacts our business, weaken demand, increase competition, cause us to reduce our capital spend
further, or otherwise disrupt our business.
25
During
the pandemic, we have implemented remote working procedures in the United States, Germany and Israel and are establishing in-office measures
to contain the spread of COVID-19 according to local regulations. With the vaccination of most of our employees, we gradually returned
to work from our offices during 2021 but are currently facing another disruption with the spread of the Omicron variant. Despite this
current situation and the challenges it imposes, we have developed several methods to continue to engage with our current and prospective
customers with some success through video conferencing, virtual training events, and online education demos to offer our support and showcase
the value of our products.
Results
of Operations for the Three Months Ended March 31, 2022 and March 31, 2021
Our
operating results for the three months ended March 31, 2022, as compared to the same period in 2021, are presented below. The results
set forth below are not necessarily indicative of the results to be expected in future periods.
Three
Months Ended March 31,
2022
2021
Revenues
$
876
$
1,316
Cost
of revenues
611
609
Gross
profit
265
707
Operating
expenses:
Research
and development
907
795
Sales
and marketing
2,184
1,671
General
and administrative
1,462
1,262
Total
operating expenses
4,553
3,728
Operating
loss
(4,288
)
(3,021
)
Financial
expenses (income), net
24
(4
)
Loss
before income taxes
(4,312
)
(3,017
)
Taxes
on income
38
45
Net
loss
$
(4,350
)
$
(3,062
)
Net
loss per ordinary share, basic and diluted
$
(0.07
)
$
(0.08
)
Weighted
average number of shares used in computing net loss per ordinary share, basic and diluted
62,493,496
36,187,789
26
Three
Months Ended March 31, 2022 Compared to Three Months Ended March 31, 2021
Revenues
Our
revenues for the three months ended March 31, 2022 and 2021 were as follows:
Three
Months Ended March 31,
2022
2021
(in
thousands, except unit amounts)
Personal
unit revenues
$
770
$
1,308
Rehabilitation
unit revenues
106
8
Revenues
$
876
$
1,316
Personal
unit revenues consist of ReWalk Personal 6.0 and Distributed Products sale, rental, service and warranty revenue for home use.
Rehabilitation
unit revenues consist of ReStore, Distributed Products and SCI Products sale, rental, service and warranty revenue to clinics, hospitals
for treating patients with relevant medical conditions or medical academic centers.
Revenues
decreased by $440 thousand, or 33%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021. The decrease
is due to lower number of ReWalk Personal 6.0 units sold in the United States and Germany.
In
the future, we expect our growth to be driven by sales of our ReWalk Personal device to third-party payors as we continue to focus our
resources on broader commercial coverage policies with third-party payors as well as sales of the ReStore and other products to rehabilitation
clinics and for personal use.
Gross
Profit
Our
gross profit for the three months ended March 31, 2022 and 2021 was as follows (in thousands):
Three
Months Ended March 31,
2022
2021
Gross
profit
$
265
$
707
Gross
profit was 30% of revenue for the three months ended March 31, 2022 compared to 54% for the three months ended March 31, 2021. The decrease
in gross profit for the three months ended March 31, 2022 was mainly driven by the lower volume of units sold and a decrease in our average
selling price due to a change in sales mix.
We
expect our gross profit to improve, assuming we increase our sales volumes, which could also decrease the product manufacturing costs.
Improvements may be partially offset by the lower margins we currently expect from ReStore and our Distributed Products as well as due
to an increase in the cost of product parts, especially as long as COVID-19 pandemic is affecting the market.
27
Research
and Development Expenses
Our
research and development expenses, net, for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
Three
Months Ended March 31,
2022
2021
Research
and development expenses
$
907
$
795
Research
and development expenses, increased by $112 thousand, or 14%, for the three months ended March 31, 2022 compared to the three months ended
March 31, 2021. The increase is attributable to increased consulting and subcontractors expenses.
We
intend to focus our research and development expenses mainly on our current products maintenance and improvement as well as developing
our “soft suit” exoskeleton for additional indications affecting the ability to walk or a home use design such as the ReBoot
design.
Sales
and Marketing Expenses
Our
sales and marketing expenses for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
Three
Months Ended March 31,
2022
2021
Sales
and marketing expenses
$
2,184
$
1,671
Sales
and marketing expenses increased by $513 thousand, or 31%, for the three months ended March 31, 2022 compared to the three months ended
March 31, 2021. The increase was driven by higher employee and employee related expenses, travel and tradeshows activities.
In
the near term our sales and marketing expenses are expected to be driven by our efforts to expand our reimbursement coverage of our ReWalk
Personal device and to expand our current product commercialization.
General
and Administrative Expenses
Our
general and administrative expenses for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
Three
Months Ended March 31,
2022
2021
General
and administrative
$
1,462
$
1,262
General
and administrative expenses increased by $200 thousand, or 16%, for the three months ended March 31, 2022 compared to the three months
ended March 31, 2021. The increase was driven by increased personnel and personnel related expenses as well as professional services expenses.
28
Financial
Expenses (Income), Net
Our
financial expenses (income), net, for the three months ended March 31, 2022 and 2021 were as follows (in thousands):
Three
Months Ended March 31,
2022
2021
Financial
expenses (income), net
$
24
$
(4
)
Financial
expenses (income), net, increased by $28 thousand for the three months ended March 31, 2022 compared to the three months ended March 31,
2021. This increase was primarily due to exchange rate fluctuations.
Income
Taxes
Our
income tax for the three months ended March 31, 2022 and 2021 was as follows (in thousands):
Three
Months Ended March 31,
2022
2021
Income
taxes
$
38
$
45
Income
taxes decreased by $7 thousand, or 16%, for the three months ended March 31, 2022 compared to the three months ended March 31, 2021 mainly
due to higher deferred income tax resulting from a decrease in deferred revenues.
Critical
Accounting Policies and Estimates
Our
condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our condensed financial statements
requires us to make estimates, judgments and assumptions that can affect the reported amounts of assets and liabilities, disclosure of
contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. We base our estimates, judgments and assumptions on historical experience and other factors that we believe to be reasonable
under the circumstances. Materially different results can occur as circumstances change and additional information becomes known. Besides
the estimates identified above that are considered critical, we make many other accounting estimates in preparing our condensed financial
statements and related disclosures. See Note 2 to our audited consolidated financial statements included in our 2021 Form 10-K for a description
of the significant accounting policies that we used to prepare our consolidated financial statements.
There
have been no material changes to our critical accounting policies or our critical judgments from the information provided in “Part
II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies”
of our 2021 Form 10-K, except for the updates provided in Note 3 of our unaudited condensed
consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of this quarterly report .
Recent
Accounting Pronouncements
See
Note 3 to our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of
this quarterly report for information regarding new accounting pronouncements.
29
Liquidity
and Capital Resources
Sources
of Liquidity and Outlook
Since
inception, we have funded our operations primarily through the sale of certain of our equity securities and convertible notes to investors
in private placements, the sale of our ordinary shares in public offerings and the incurrence of bank debt.
As
of March 31, 2022, we incurred a consolidated net loss of $4.4 million and have an accumulated deficit in the total amount of $198.5 million.
Our cash and cash equivalent as of March 31, 2022, totaled $82.6 million and our negative operating cash flow for the three months ended
March 31, 2022, was $5.7 million. We have sufficient funds to support our operation for more than 12 months following the issuance date
of our condensed consolidated unaudited financial statements for the three months ended March 31, 2022.
We
expect to incur future net losses and our transition to profitability is dependent upon, among other things, the successful development
and commercialization of our products and product candidates, the achievement of a level of revenues adequate to support our cost structure.
Until we achieve profitability or generate positive cash flows, we will continue to need to raise additional cash. We intend to fund future
operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding
warrants or a combination of the foregoing. In addition, we may seek additional capital through arrangements with strategic partners or
from other sources and we will continue to address our cost structure. Notwithstanding, there can be no assurance that we will be able
to raise additional funds or achieve or sustain profitability or positive cash flows from operations.
Our
anticipated primary uses of cash are (i) sales, marketing and reimbursement expenses related to market development activities of our ReStore
and Personal 6.0 devices, broadening third-party payor and CMS coverage for our ReWalk Personal device and commercializing our new product
lines added through distribution agreements; (ii) research and development of our lightweight exo-suit technology for potential home personal
health utilization for multiple indications and future generation designs for our spinal cord injury device; (iii) routine product updates;
(iv) general corporate purposes, including working capital needs; and (v) potential acquisitions of business. Our future cash requirements
will depend on many factors, including our rate of revenue growth, the expansion of our sales and marketing activities, the timing and
extent of our spending on research and development efforts and international expansion. If our current estimates of revenue, expenses
or capital or liquidity requirements change or are inaccurate, we may seek to sell additional equity or debt securities, arrange for additional
bank debt financing, or refinance our indebtedness. There can be no assurance that we will be able to raise such funds on acceptable terms.
Equity
Raises
Beginning
with the filing of our Form 10-K on February 17, 2017, we were subject to limitations under the applicable rules of Form S-3, which constrained
our ability to secure capital pursuant to our ATM Offering Program (as defined below) or other public offerings pursuant to our effective
Form S-3. These rules limit the size of primary securities offerings conducted by issuers with a public float of less than $75 million
to no more than one-third of their public float in any 12-month period. At the time of filing our annual report for the year ended December
31, 2020, we were no longer subject to these limitations, because our public float had reached at least $75 million in the 60 days preceding
the filing of that annual report. Likewise, because our public float was at least $75 million within the 60 days preceding the date of
our 2021 Annual Report, we are not currently subject to these limitations. Our currently effective registration statement on Form S-3
expires on May 23, 2022. We have filed a new registration statement on Form S-3 to replace our expiring registration statement which has
not yet been declared effective by the SEC. Assuming our new Form S-3 becomes effective and is available for our use during 2022, we will
continue to not be subject to these limitations for the remainder of the 2022 fiscal year and until such time as we file our next annual
report for the year ended December 31, 2022, at which time we will be required to re-test our status under these rules. If our public
float subsequently drops below $75 million as of the filing of our next annual report on Form 10-K, or at the time we file a new Form
S-3, we will become subject to these limitations again, until the date that our public float again reaches $75 million. These limitations
do not apply to secondary offerings for the resale of our ordinary shares or other securities by selling shareholders or to the issuance
of ordinary shares upon conversion by holders of convertible securities, such as warrants. We have registered up to $100 million of ordinary
shares warrants and/or debt securities and certain other outstanding securities with registration rights on our new registration statement
on Form S-3, which will be available for our use once the registration statement has been declared effective by the SEC.
30
Equity
Offerings and Warrant Exercises
On
February 19, 2021, we entered into a purchase agreement with certain institutional and other accredited investors for the issuance and
sale of 10,921,502 ordinary shares, par value NIS 0.25 per share at $3.6625 per ordinary share and warrants to purchase up to an aggregate
of 5,460,751 ordinary shares with an exercise price of $3.6 per share, exercisable from February 19, 2021, until August 26, 2026. Additionally,
we issued warrants to purchase up to 655,290 ordinary shares, with an exercise price of $4.578125 per share, exercisable from February
19, 2021, until August 26, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in
our February 2021 Offering.
On
September 27, 2021, we signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary
shares, pre-funded warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary warrants to purchase up to an aggregate
of 8,006,759 ordinary shares at an exercise price of $2.00 per share. The pre-funded warrants have an exercise price of $0.001 per ordinary
share and are immediately exercisable and can be exercised at any time after their original issuance until such pre-funded warrants are
exercised in full. Each ordinary share was sold at an offering price of $2.035 and each pre-funded warrant was sold at an offering price
of $2.034 (equal to the purchase price per ordinary share minus the exercise price of the pre-funded warrant). The offering of the ordinary
shares, the pre-funded warrants and the ordinary shares that are issuable from time to time upon exercise of the pre-funded warrants was
made pursuant to our shelf registration statement on Form S-3 initially filed with the SEC on May 9, 2019, and declared effective by the
SEC on May 23, 2019, and the ordinary warrants were issued in a concurrent private placement. The ordinary warrants are exercisable at
any time and from time to time, in whole or in part, following the date of issuance and ending five and one-half years from the date of
issuance. All of the pre-funded warrants were exercised in full on September 27, 2021, and the offering closed on September 29, 2021.
Additionally, we issued warrants to purchase up to 960,811 ordinary shares, with an exercise price of $2.5438 per share, exercisable from
September 27, 2021, until September 27, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement
agent in our September 2021 private placement offering.
As
of March 31, 2022, a total of 9,814,754 previously issued warrants with exercise prices ranging from $1.25 to $1.79 have been exercised
for total gross proceeds of approximately $13.8 million.
ATM
Offering Program
On
May 10, 2016, we entered into our Equity Distribution Agreement with Piper Jaffray, as amended on May 9, 2019, pursuant to which we may
offer and sell, from time to time, ordinary shares having an aggregate offering price of up to $25.0 million through Piper Jaffray acting
as our agent (the “ATM Offering Program”). Subject to the terms and conditions of the Equity Distribution Agreement, Piper
Jaffray will use its commercially reasonable efforts to sell on our behalf all of the ordinary shares requested to be sold by us, consistent
with its normal trading and sales practices. Piper Jaffray may also act as principal in the sale of ordinary shares under the Equity Distribution
Agreement. Such sales may be made under our Form S-3 in what may be deemed “at-the-market” equity offerings as defined in
Rule 415 promulgated under the Securities Act, directly on or through the Nasdaq Capital Market, to or through a market maker other than
on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing
market prices, and/or any other method permitted by law, including in privately negotiated transactions.
Piper
Jaffray is entitled to compensation at a fixed commission rate of 3% of the gross sales price per share sold through it as agent under
the Equity Distribution Agreement. Where Piper Jaffray acts as principal in the sale of ordinary shares under the Equity Distribution
Agreement, such rate of compensation will not apply, but in no event will the total compensation of Piper Jaffray, when combined with
the reimbursement of Piper Jaffray for the out-of-pocket fees and disbursements of its legal counsel, exceed 8.0% of the gross proceeds
received from the sale of the ordinary shares.
We
may instruct Piper Jaffray not to sell ordinary shares if the sales cannot be effected at or above the price designated by us in any instruction.
We or Piper Jaffray may suspend an offering of ordinary shares under the ATM Offering Program upon proper notice and subject to other
conditions, as further described in the Equity Distribution Agreement. Additionally, the ATM Offering Program will terminate on the earlier
of (i) the sale of all ordinary shares subject to the Equity Distribution Agreement, (ii) the date that is three years after a new registration
statement on Form S-3 goes effective, (iii) our becoming ineligible to use Form S-3 and (iv) termination of the Equity Distribution Agreement
by the parties. The Equity Distribution Agreement may be terminated by Piper Jaffray or us at any time on the close of business on the
date of receipt of written notice, and by Piper Jaffray at any time in certain circumstances, including any suspension or limitation on
the trading of our ordinary shares on the Nasdaq Capital Market, as further described in the Equity Distribution Agreement. We temporarily
suspended use of the ATM Offering Program on February 20, 2019 to facilitate our February 2019 “best efforts” public offering.
As of September 30, 2020, we had sold 302,092 ordinary shares under the ATM Offering Program for net proceeds to us of $14.5 million (after
commissions, fees, and expenses). Additionally, as of that date, we had paid Piper Jaffray compensation of $471 thousand and had incurred
total expenses (including such commissions) of approximately $1.2 million in connection with the ATM Offering Program. No sales were made
under the ATM Offering Program during the year ended December 31, 2021 or during the three months ended March 31, 2022.
31
We
intend to continue using the at-the-market offering or similar continuous offering programs opportunistically to raise additional funds,
although we are currently subject to restrictions on using the ATM Offering Program with Piper Jaffray. Under our September 2021 purchase
agreement with certain investors, equity or debt securities convertible into, or exercisable or exchangeable for, ordinary shares at a
conversion price, exercise price or exchange price which floats with the trading price of the ordinary shares or which may be adjusted
after issuance upon the occurrence of certain events or (ii) enter into any agreement, including an equity line of credit, whereby the
Company may issue securities at a future-determined price, other than an at–the-market facility with the placement agent, H.C. Wainwright
& Co, LLC, beginning on March 29, 2022. Such limitations may inhibit our ability to access capital efficiently.
Cash
Flows for the Three Months Ended March 31, 2022 and March 31, 2021 (in thousands):
Three
Months Ended March 31,
2022
2021
Net
cash used in operating activities
$
(5,708
)
$
(3,173
)
Net
cash used in investing activities
(3
)
(9
)
Net
cash provided by financing activities
-
50,236
Net
cash flow
$
(5,711
)
$
47,054
Net
Cash Used in Operating Activities
Net
cash used in operating activities increased by $2.5 million or 80% primarily due to increased insurance prepaid expenses, increased inventory
purchases, and higher business development costs.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities was $0 for the three months ended March 31, 2022 compared to $50.2 million for the three months
ended March 31, 2021, was from the proceeds received through our February 2021 Offering and warrants exercises received during the first
quarter of 2021.
Obligations
and Contractual Commitments
Set
forth below is a summary of our contractual obligations as of March 31, 2022.
32
Payments
due by period (in dollars, in thousands)
Contractual
obligations
Total
Less
than
1 year
1-3
years
Purchase
obligations (1)
$
1,549
$
1,549
$
-
Collaboration
Agreement and License Agreement obligations (2)
59
59
-
Operating
lease obligations (3)
1,079
686
393
Total
$
2,687
$
2,294
$
393
(1)
The
Company depends on one contract manufacturer, Sanmina Corporation, for both the ReStore products and the SCI Products. We place our manufacturing
orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements
(2)
Our
Collaboration Agreement with Harvard was originally for a term of five years, commencing in May 2016, and was subsequently amended in
April 2018 to extend the term by one additional year. The Collaboration Agreement expired as of March 31, 2022. Under the Collaboration
Agreement, we were required to pay in quarterly installments the funding of our joint research collaboration with Harvard, subject to
a minimum funding commitment under applicable circumstances. Our License Agreement with Harvard consists of patent reimbursement expenses
payments and a license upfront fee payment. There are also several milestone payments contingent upon the achievement of certain product
development and commercialization milestones and royalty payments on net sales from certain patents licensed to Harvard. All product development
milestones contemplated by the License Agreement have been met as of March 31, 2022; however, there are still outstanding commercialization
milestones under the License Agreement that depend on us reaching certain sales amounts, some or all of which may not occur.
(3)
Our
operating leases consist of leases for our facilities in the United States and Israel and motor vehicles.
We calculated the payments due under
our operating lease obligation for our Israeli office that are to be paid in NIS at a rate of exchange of NIS 3.176: $1.00, and the payments
due under our operating lease obligation for our German subsidiary that are to be paid in euros at a rate of exchange of €1.00:
$1.109, both of which were the applicable exchange rates as of March 31, 2022.
Off-Balance
Sheet Arrangements
We
had no off-balance sheet arrangements or guarantees of third-party obligations as of March 31, 2022.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There
have been no material changes to our market risk during the first quarter of 2022. For a discussion of our exposure to market risk, please
see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our 2021 Form 10-K.
ITEM
4. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms,
and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial
Officer, as appropriate, to allow timely decisions regarding required financial disclosure.
As
of the end of the period covered by this quarterly report, we carried out an evaluation, under the supervision and with the participation
of our management, including our Chief Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation
of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act). Based upon, and as of
the date of, this evaluation, the Chief Executive Officer and the Principal Financial Officer concluded that our disclosure controls and
procedures were effective such that the information required to be disclosed by us in our SEC reports is recorded, processed, summarized
and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to our management, including
our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
33
Changes
in Internal Control over Financial Reporting
During
the quarter ended March 31, 2022, there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f)
and 15d-15(f) of the Exchange Act) that materially affected, or that are reasonably likely to materially affect, our internal control
over financial reporting.
PART II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
There
have been no material changes to our legal proceedings as described in “Part I, Item 3. Legal Proceedings” of our 2021 Form
10-K, except as described in Note 5 in our condensed consolidated financial statements included in “Part I, Item 1” of this
quarterly report.
ITEM 1A. RISK
FACTORS
There
have been no material changes to our risk factors from those disclosed in “Part I, Item 1A. Risk Factors” of our 2021 Form
10-K except as noted below:
34
Risks
Related to Government Regulation
We
are subject to extensive governmental regulations relating to the manufacturing, labeling, and marketing of our products, and a failure
to comply with such regulations could lead to withdrawal or recall of our products from the market.
Our
medical products and manufacturing operations are subject to regulation by the FDA, the European Union, and other governmental authorities
both inside and outside of the United States. These agencies enforce laws and regulations that govern the development, testing, manufacturing,
labeling, storage, installation, servicing, advertising, promoting, marketing, distribution, import, export and market surveillance of
our products.
Our
products are regulated as medical devices in the United States under the FFDCA as implemented and enforced by the FDA. Under the FFDCA,
medical devices are classified into one of three classes (Class I, Class II or Class III) depending on the degree of risk associated with
the medical device, what is known about the type of device, and the extent of control needed to provide reasonable assurance of safety
and effectiveness. Classification of a device is important because the class to which a device is assigned determines, among other things,
the necessity and type of FDA review required prior to marketing the device. For more information, see “Part I, Item 1. Business—Government
Regulation” above.
In
June 2014, the FDA granted our petition for “de novo” classification, which provides a route to market for medical devices
that are low to moderate risk, but are not substantially equivalent to a predicate device, and classified ReWalk as Class II subject to
certain special controls. The ReWalk is intended to enable individuals with spinal cord injuries to perform ambulatory functions under
supervision of a specially trained companion, and inside rehabilitation institutions. The special controls established in the de novo
order include the following: compliance with medical device consensus standards; clinical testing to demonstrate safe and effective use
considering the level of supervision necessary and the use environment; non-clinical performance testing, including durability testing
to demonstrate that the device performs as intended under anticipated conditions of use; a training program; and labeling related to device
use and user training. In order for us to market ReWalk, we must comply with both general controls, including controls related to quality,
facility registration, reporting of adverse events and labeling, and the special controls established for the device. Failure to comply
with these requirements could lead to an FDA enforcement action, which would have a material adverse effect on our business.
35
In
June 2019, the FDA issued a 510(k) clearance for our ReStore device. ReStore is intended to be used to assist ambulatory functions in
rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia or hemiparesis due to stroke who have
a specified amount of ambulatory function. In order for us to market ReStore, we must comply with both general controls, including controls
related to quality, facility registration, reporting of adverse events and labeling, and the special controls established for the device
that include clinical testing, non-clinical performance testing, and a training program. Failure to comply with these requirements could
lead to an FDA enforcement action, which would have a material adverse effect on our business.
In
the E.U. we are subject to regulations and standards regulating the design, manufacture, clinical trials, labeling and adverse event (i.e.,
vigilance) reporting for medical devices. The Medical Devices Regulation (EU) 2017/745 (MDR) became fully applicable on May 26, 2021,
repealing and replacing the pre-existing E.U. Medical Devices Directive 93/42/EEC. Devices that comply with the requirements of the MDR,
subject to certain transitional provisions that allow continued compliance of certain products to the Directive until May 2024 at the
latest, are entitled to bear the CE mark, indicating that the device conforms to the essential requirements of the MDR and, accordingly,
can be commercially distributed throughout the European Economic Area (i.e., the E.U. Member States plus Norway, Iceland, and Lichtenstein).
We comply with the E.U. requirements and have received the CE mark for all of our ReWalk systems including the ReStore device which are
distributed in the E.U. As compared with the Directive, the MDR includes additional premarket and post-market requirements, as well as
potential product reclassifications and more stringent commercialization requirements that could adversely affect our CE mark. Failure
to comply with these new requirements could lead to substantial penalties, including fines, revocation or suspension of CE mark and criminal
sanctions.
Following
the introduction of a product, the governmental agencies will periodically review our manufacturing processes and quality controls, and
we are under a continuing obligation to ensure that all applicable regulatory requirements continue to be met. The process of complying
with the applicable good manufacturing practices, adverse event reporting and other requirements can be costly and time consuming, and
could delay or prevent the production, manufacturing, or sale of our devices. In addition, if we fail to comply with applicable regulatory
requirements, it could result in fines or delays of regulatory clearances, closure of manufacturing sites, seizures or recalls of products
and damage to our reputation, as well as enforcement actions against us. For example, the FDA could request that we recall our ReWalk
Personal 6.0 or ReStore device in case of product defects, or require us to conduct post-market surveillance studies. If we fail to recall
the device and/or conduct requested postmarket surveillance studies to FDA’s satisfaction, we could be subject to FDA enforcement
action.
In
addition, governmental agencies may impose new requirements regarding registration or labeling that may require us to modify or re-register
our products or otherwise impact our ability to market our products in those countries, such as the May 2021 Medical Device Regulation
changes in the European Union. The process of complying with these governmental regulations can be costly and time consuming, and could
delay or prevent the production, manufacturing, or sale of our products.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS
There
are no transactions that have not been previously included in a Current Report on Form 8-K.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
Not
applicable.
ITEM 4.
MINE SAFETY DISCLOSURES .
Not
applicable.
ITEM
5. OTHER INFORMATION
Not
applicable.
36
ITEM
6. EXHIBIT INDEX
Exhibit
Number
Description
10.1
Employment
Agreement dated December 10, 2019, by and between the Company and Almog Adar. ^
10.2
Separation
Agreement, dated March 8, 2022, by and between the Company and Ori Gon.
31.1
Certification
of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act 2002.
31.2
Certification
of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act 2002.
32.1
Certification
of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
32.2
Certification
of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*
101.INS
XBRL
Instance Document
101.SCH
XBRL
Taxonomy Extension Schema Document
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase Document
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase Document
101.LAB
XBRL
Taxonomy Extension Label Linkbase Document
101.DEF
XBRL
Taxonomy Extension Definition Linkbase Document
_______________________
*
Furnished
herewith.
^
Portions
of this exhibit (indicated by asterisks) have been omitted under rules of the SEC permitting the confidential treatment of select information.
37
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ReWalk
Robotics Ltd.
Date:
May 13, 2022
By:
/s/
Larry Jasinski
Larry
Jasinski
Chief
Executive Officer
(Principal
Executive Officer)
Date:
May 13, 2022
By:
/s/
Almog Adar
Almog
Adar
Director
of Finance and Corporate Financial Controller
(Principal
Financial and Principal Accounting Officer)
38
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.