|
|
|
(State or other jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.)
|
|
|
|
|
|
|
(Address of principal executive offices)
|
|
(Zip Code)
|
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Title of each class
|
|
Trading symbol
|
|
Name of exchange on which registered
|
|
|
|
|
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
Smaller reporting company
|
|
Emerging growth company
|
Page No. | ||
ii | ||
1 | ||
1 | ||
1-2 | ||
3 | ||
4-5 | ||
6 | ||
7 | ||
24 | ||
34 | ||
34 | ||
35 | ||
36 | ||
36 | ||
36 | ||
36 | ||
36 | ||
36 | ||
37 | ||
38 |
i
• | 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, including our ability to secure reimbursement, and generate sufficient revenue, from Medicare Administrative Contractors; |
• | 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 and other diseases 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, including the extent to which inflation or global instability may disrupt our business operations or our financial condition or the financial condition of our customers and suppliers; 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. |
ii
|
September 30,
|
December 31,
|
||||||
|
2022
|
2021
|
||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
CURRENT ASSETS
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Trade receivable, net
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Inventories
|
|
|
||||||
Total current assets
|
|
|
||||||
|
||||||||
LONG-TERM ASSETS
|
||||||||
|
||||||||
Restricted cash and other long-term assets
|
|
|
||||||
Operating lease right-of-use assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Total long-term assets
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
|
September 30, |
December 31,
|
||||||
|
2022
|
2021
|
||||||
(unaudited)
|
||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Current maturities of operating leases
|
$
|
|
$
|
|
||||
Trade payables
|
|
|
||||||
Employees and payroll accruals
|
|
|
||||||
Deferred revenues
|
|
|
||||||
Other current liabilities
|
|
|
||||||
Total current liabilities
|
|
|
||||||
|
||||||||
LONG-TERM LIABILITIES
|
||||||||
Deferred revenues
|
|
|
||||||
Non-current operating leases
|
|
|
||||||
Other long-term liabilities
|
|
|
||||||
Total long-term liabilities
|
|
|
||||||
|
||||||||
Total liabilities
|
|
|
||||||
|
||||||||
COMMITMENTS AND CONTINGENT LIABILITIES
|
||||||||
SHAREHOLDERS’ EQUITY
|
||||||||
|
||||||||
Share capital
|
||||||||
Ordinary share of NIS
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Treasury Shares at cost, |
( |
) | ||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total shareholders’ equity
|
|
|
||||||
Total liabilities and shareholders’ equity
|
$
|
|
$
|
|
REWALK ROBOTICS LTD. AND SUBSIDIARIES
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Cost of revenues
|
|
|
|
|
||||||||||||
|
||||||||||||||||
Gross profit
|
|
|
|
|
||||||||||||
|
||||||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, net
|
|
|
|
|
||||||||||||
Sales and marketing
|
|
|
|
|
||||||||||||
General and administrative
|
|
|
|
|
||||||||||||
|
||||||||||||||||
Total operating expenses
|
|
|
|
|
||||||||||||
|
||||||||||||||||
Operating loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Financial expenses, net
|
|
|
|
|
|
|
||||||||||
|
||||||||||||||||
Loss before income taxes
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
Taxes on income (tax benefit)
|
|
(
|
) |
|
|
|||||||||||
|
||||||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
||||||||||||||||
Net loss per ordinary share, basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
||||||||||||||||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted
|
|
|
|
|
REWALK ROBOTICS LTD. AND SUBSIDIARIES
Ordinary Shares
|
Additional
paid-in
|
Treasury |
Accumulated
|
Total
shareholders’
|
||||||||||||||||||||
Number
|
Amount
|
capital
|
Stock |
deficit
|
equity
|
|||||||||||||||||||
Balance as of July 1, 2021
|
|
$ |
|
$ |
|
$ |
(
|
)
|
$ |
|
||||||||||||||
Share-based compensation to employees and non-employees
|
-
|
-
|
|
|
|
|
||||||||||||||||||
Issuance of ordinary shares upon vesting of employees and non-employees RSUs
|
|
|
(
|
)
|
|
|
|
|||||||||||||||||
Issuance of ordinary shares in a “registered direct" offering, net of issuance expenses in the amount of $ |
|
|||||||||||||||||||||||
Exercise of pre-funded warrants and warrants (1) (2) |
||||||||||||||||||||||||
Net loss
|
-
|
-
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||
Balance as of September 30, 2021
|
|
|
|
(
|
)
|
|
||||||||||||||||||
|
||||||||||||||||||||||||
Balance as of July 1, 2022
|
|
|
|
(
|
)
|
|
||||||||||||||||||
Share-based compensation to employees and non-employees
|
-
|
-
|
|
|
|
|
||||||||||||||||||
Issuance of ordinary shares upon vesting of RSUs by employees and non-employees
|
|
|
(
|
)
|
|
|
||||||||||||||||||
Treasury Shares |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
Net loss
|
-
|
-
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||
Balance as of September 30, 2022
|
|
|
|
( |
) |
(
|
)
|
|
REWALK ROBOTICS LTD. AND SUBSIDIARIES
CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share data)
Ordinary Share
|
Additional
paid-in
|
Treasury |
Accumulated
|
Total
shareholders’
|
||||||||||||||||||||
Number
|
Amount
|
capital
|
Stock |
deficit
|
equity
|
|||||||||||||||||||
Balance as of December 31, 2020
|
|
|
|
(
|
)
|
|
||||||||||||||||||
Share-based compensation to employees and non-employees
|
-
|
-
|
|
|
|
|||||||||||||||||||
Issuance of ordinary shares upon vesting of employees and non-employees RSUs
|
|
|
(
|
)
|
|
|
||||||||||||||||||
Issuance of ordinary shares in a “best effort” offering, net of issuance expenses in the amount of $
|
|
|
|
|
|
|
||||||||||||||||||
Issuance of ordinary shares in a “registered direct" offering, net of issuance expenses in the amount of $ |
|
|||||||||||||||||||||||
Exercise of pre-funded warrants and warrants (1) (2)
|
|
|
|
|
|
|||||||||||||||||||
Net loss
|
-
|
-
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||
Balance as of September 30, 2021
|
|
|
|
(
|
)
|
|
||||||||||||||||||
|
||||||||||||||||||||||||
Balance as of December 31, 2021
|
|
|
|
(
|
)
|
|
||||||||||||||||||
Share-based compensation to employees and non-employees
|
-
|
-
|
|
|
|
|||||||||||||||||||
Issuance of ordinary shares upon vesting of employees and non-employees RSUs
|
|
|
(
|
)
|
|
|
|
|||||||||||||||||
Treasury Shares |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
Net loss
|
-
|
-
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||
Balance as of September 30, 2022
|
|
|
|
( |
) |
(
|
)
|
|
(1) |
|
(2) |
|
REWALK ROBOTICS LTD. AND SUBSIDIARIES
|
Nine Months Ended
September 30, |
|||||||
|
2022
|
2021
|
||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
|
||||||||
Depreciation
|
|
|
||||||
Share-based compensation to employees and non-employees
|
|
|
||||||
Deferred taxes
|
|
(
|
)
|
|||||
Finance expense, net
|
|
|
||||||
Trade receivables, net
|
|
(
|
)
|
|||||
Prepaid expenses, operating lease right-of-use assets and other assets
|
(
|
)
|
|
|||||
Inventories
|
(
|
)
|
|
|||||
Trade payables
|
|
(
|
)
|
|||||
Employees and payroll accruals
|
(
|
)
|
|
|||||
Deferred revenues
|
(
|
)
|
|
|||||
Operating lease liabilities and other liabilities
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Cash flows from financing activities:
|
||||||||
Purchase of treasury shares |
( |
) |
||||||
Issuance of ordinary shares in a private placement, net of issuance expenses paid in the amount of $
|
|
|
||||||
Issuance of ordinary shares in a "registered direct" offerings, net of issuance expenses in the amount of $ |
|
|
||||||
Exercise of pre-funded warrants and warrants (1) (2)
|
|
|
||||||
Net cash provided by (used in) financing activities
|
(
|
) |
|
|||||
Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash
|
(
|
)
|
||||||
Increase (decrease) in cash, cash equivalents, and restricted cash
|
(
|
)
|
|
|||||
Cash, cash equivalents, and restricted cash at beginning of period
|
|
|
||||||
Cash, cash equivalents, and restricted cash at end of period
|
$
|
|
$
|
|
||||
Supplemental disclosures of non-cash flow information
|
||||||||
“Registered direct” offerings issuance cost not yet paid (1)
|
$
|
|
$
|
|
||||
Classification of other current assets to property and equipment, net
|
$
|
|
$
|
|
||||
Classification of inventory to property and equipment, net
|
$
|
|
$
|
|
||||
Classification of inventory to other current assets
|
$
|
|
$
|
|
||||
Supplemental cash flow information:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash included in other long-term assets
|
|
|
||||||
Total Cash, cash equivalents, and restricted cash
|
$
|
|
$
|
|
(1) |
|
(2) |
|
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.
7
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
d.As of September 30, 2022, the Company incurred a consolidated net loss of $
8
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
a. |
Revenue Recognition
The Company generates revenues from sales of products. The Company sells its products directly to end customers and through distributors. The Company sells its products to private individuals (who finance the purchases by themselves, through fundraising or reimbursement coverage from insurance companies), rehabilitation facilities and distributors.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
||||||||||||
Units placed
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Spare parts, warranties and other
|
|
|
|
|
||||||||||||
Total Revenues
|
$
|
|
$
|
|
$
|
|
$
|
|
9
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
10
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
|
|
September 30,
|
|
|
December 31,
|
|
||
|
|
2022
|
|
|
2021
|
|
||
Trade receivable, net (1)
|
|
$
|
|
|
|
$
|
|
|
Deferred revenues (1) (2)
|
|
$
|
|
|
|
$
|
|
|
(1) |
|
(2) |
|
11
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
b. |
Concentrations of Credit Risks:
|
|
|
September 30,
|
|
|
December 31,
|
|
||
|
|
2022
|
|
|
2021
|
|
||
Customer A
|
|
|
|
%
|
|
|
|
%
|
Customer B
|
|
|
|
%
|
|
|
|
)
|
Customer C
|
|
|
|
%
|
|
|
|
) |
Customer D
|
|
|
|
%
|
|
|
|
)
|
Customer E
|
|
|
|
)
|
|
|
|
%
|
Customer F
|
|
|
|
)
|
|
|
|
%
|
Customer G
|
|
|
|
)
|
|
|
|
%
|
Customer H |
|
) |
% |
*) |
|
c. |
Warranty provision
|
|
|
US Dollars
in thousands
|
|
|
Balance at December 31, 2021
|
|
$
|
|
|
Provision
|
|
|
|
|
Usage
|
|
|
(
|
) |
Balance at September 30, 2022
|
|
$
|
|
|
12
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
d. |
Basic and diluted net loss per ordinary share
|
e. |
Treasury stock
|
The Company has repurchased its ordinary shares from time to time in the open market and holds such repurchased shares as treasury stock. The Company presents the cost to repurchase treasury stock as a reduction of shareholders’ equity.
f. |
New Accounting Pronouncements
|
i. |
Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity
|
ii. |
Financial Instruments
|
13
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 4: INVENTORIES
The components of inventories are as follows (in thousands):
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Finished products |
$ |
|
$ |
|
||||
Raw materials |
|
|
||||||
$ |
|
$ |
|
During the nine months ended September 30, 2022, and 2021, the Company wrote off inventory in the amount of $
NOTE 5: COMMITMENTS AND CONTINGENT LIABILITIES
a.Purchase commitments:
The Company has contractual obligations to purchase goods from its contract manufacturer as well as raw materials from different vendors. Purchase obligations do not include contracts that may be canceled without penalty. As of September 30, 2022, non-cancelable outstanding obligations amounted to approximately $
b.Operating lease commitment:
(i)The Company operates from leased facilities in Israel, the United States, and Germany.
(ii)
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 September 30, 2022, are as follows (in thousands):
2022 |
$ |
|
||
2023 |
|
|||
2024 | ||||
2025 |
|
|||
Total lease payments |
|
|||
Less: imputed interest |
( |
) |
||
Present value of future lease payments |
|
|||
Less: current maturities of operating leases |
( |
) |
||
Non-current operating leases |
$ |
|
||
Weighted-average remaining lease term (in years) |
|
|||
Weighted-average discount rate |
|
% |
Lease expense under the Company’s operating leases was $
14
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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”). During the three and nine months that ended September 30, 2022, the Company received $
Since the Company’s inception through September 30, 2022, the Company received funding from the IIA and BIRD in the total amount of $
Additionally, the Exclusive License Agreement between the Company and Harvard University’s Wyss Institute for Biologically Inspired Engineering “"Harvard”") requires the Company to pay Harvard royalties on net sales. See note 6 below for more information about the Collaboration Agreement and the License Agreement.
Royalties expenses in cost of revenue were $
(a) the grant recipient pays to the IIA a portion of the sale price paid in consideration for such IIA-funded know-how or in consideration for the sale of the grant recipient itself, as the case may be, which portion will not exceed six times the amount of the grants received plus interest (or three times the amount of the grant received plus interest, in the event that the recipient of the know-how has committed to retain the research and development activities of the grant recipient in Israel after the transfer); (b) the grant recipient receives know-how from a third party in exchange for its IIA-funded know-how; (c) such transfer of IIA-funded know-how arises in connection with certain types of cooperation in research and development activities; or (d) if such transfer of know-how arises in connection with a liquidation by reason of insolvency or receivership of the grant recipient.
d.Liens:
As part of the Company’s other long-term assets and restricted cash, an amount of $
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. It is possible that resolution of one or more of the legal matters currently pending or threatened could result in losses material to the Company’s consolidated results of operations, liquidity, or financial condition. While the outcome of any pending or threatened litigation and other legal matters is inherently uncertain, the Company is not currently party to any material litigation.
15
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
16
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 7: SHAREHOLDERS’ EQUITY
a.Share option plans:
As of September 30, 2022, and December 31, 2021, the Company had reserved
There were no options granted during the nine months ended September 30, 2022, and 2021.
A summary of employees and non-employees share options activity during the nine months ended September 30, 2022, is as follows:
Number |
Average exercise price |
Average remaining contractual life (in years) |
Aggregate intrinsic value (in |
|||||||||||||
Options outstanding as of December 31, 2021 |
|
$ |
|
|
$ |
|
||||||||||
Granted |
|
|
- |
- |
||||||||||||
Exercised |
|
|
- |
- |
||||||||||||
Forfeited |
( |
) |
|
- |
- |
|||||||||||
Options outstanding as of September 30, 2022 |
|
$ |
|
|
$ |
|
||||||||||
|
||||||||||||||||
Options exercisable as of September 30, 2022 |
|
$ |
|
|
$ |
|
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 and nine months that ended September 30, 2022, and 2021.
17
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The fair value of RSUs granted is determined based on the price of the Company’s ordinary shares on the date of grant.
RSUs generally vest over four years, with certain RSUs to non-employee directors vesting quarterly over one year. Any RSUs that is canceled before the vesting becomes available for future grants under the 2014 Plan.
A summary of employees and non-employees RSUs activity during the nine months ended September 30, 2022, is as follows:
Number of underlying outstanding RSUs |
Weighted grant value |
|||||||
Unvested RSUs as of January 1, 2022 |
|
$ |
|
|||||
Granted |
|
|
||||||
Vested |
( |
) |
|
|||||
Forfeited |
( |
) |
|
|||||
Unvested RSUs as of September 30, 2022 |
|
$ |
|
The weighted average grant date fair value of RSUs granted during the nine months ended September 30, 2022, and 2021, was $
As of September 30, 2022, there were $
The number of options and RSUs outstanding as of September 30, 2022, is set forth below, with options separated by range of exercise price.
Range of exercise price |
Options September 30, |
Weighted average remaining contractual life (years) (1) |
Options September 30, |
Weighted average remaining contractual life (years) (1) |
||||||||||||
RSUs only |
|
- |
- |
- |
||||||||||||
$ |
|
|
|
|
||||||||||||
$ |
|
|
|
|
||||||||||||
$ |
|
|
|
|
||||||||||||
$ |
|
|
|
|
||||||||||||
$ |
|
|
|
|
||||||||||||
|
|
|
|
(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:
The Company granted
18
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
c.Warrants to purchase ordinary shares:
The following table summarizes information about warrants outstanding and exercisable as of September 30, 2022:
Issuance date |
Warrants outstanding |
Exercise price per warrant |
Warrants outstanding exercisable |
Contractual term |
||||||||||||
(number) |
(number) |
|||||||||||||||
December 31, 2015 (1) |
|
$ |
|
|
See footnote (1) |
|||||||||||
December 28, 2016 (2) |
|
$ |
|
|
See footnote (1) |
|||||||||||
November 20, 2018 (3) |
|
$ |
|
|
|
|||||||||||
November 20, 2018 (4) |
|
$ |
|
|
|
|||||||||||
February 25, 2019 (5) |
|
$ |
|
|
|
|||||||||||
April 5, 2019 (6) |
|
$ |
|
|
|
|||||||||||
April 5, 2019 (7) |
|
$ |
|
|
|
|||||||||||
June 5, 2019, and June 6, 2019 (8) |
|
$ |
|
|
|
|||||||||||
June 5, 2019 (9) |
|
$ |
|
|
|
|||||||||||
June 12, 2019 (10) |
|
$ |
|
|
|
|||||||||||
June 10, 2019 (11) |
|
$ |
|
|
|
|||||||||||
February 10, 2020 (12) |
|
$ |
|
|
|
|||||||||||
February 10, 2020 (13) |
|
$ |
|
|
|
|||||||||||
July 6, 2020 (14) |
|
$ |
|
|
|
|||||||||||
July 6, 2020 (15) |
|
$ |
|
|
|
|||||||||||
December 8, 2020 (16) |
|
$ |
|
|
|
|||||||||||
December 8, 2020 (17) |
|
$ |
|
|
|
|||||||||||
February 26, 2021 (18) |
|
$ |
|
|
|
|||||||||||
February 26, 2021 (19) |
|
$ |
|
|
|
|||||||||||
September 29, 2021 (20) |
|
$ |
|
|
|
|||||||||||
September 29, 2021 (21) |
|
$ |
|
|
|
|||||||||||
|
|
(1) |
Represents warrants for ordinary shares issuable upon an exercise price of $ |
|
(2) |
Represents common warrants that were issued as part of the $ |
19
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(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, |
|
|
||
(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, |
|
|
||
(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, |
|
|
||
(15) |
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering. |
|
|
||
(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, |
(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, |
|
(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. |
20
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
(19) |
Represents warrants that were issued to the placement agent as compensation for its role in Company’s private placement offering in February 2021. |
|
(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 employees and non-employees in the condensed consolidated statements of operations as follows (in thousands):
Nine Months Ended September 30, |
||||||||
2022 |
2021 |
|||||||
Cost of revenues |
$ |
|
$ |
|
||||
Research and development |
|
|
|
|||||
Sales and marketing |
|
|
||||||
General and administrative |
|
|
||||||
Total |
$ |
|
$ |
|
e.Equity raise:
1. 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
21
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
On September 27, 2021,
As of September, 30, 2022, a total of
f. Treasury stock:
On June 2, 2022, the Company’s Board of Directors approved a share repurchase program to repurchase up to $
As of September 30, 2022, pursuant to the Company’s share repurchase program, the Company had repurchased a total of
As to ordinary shares repurchased after September 30, 2022, see Note 10.
NOTE 8: FINANCIAL EXPENSES (INCOME), NET
The components of financial expenses (income), net were as follows (in thousands):
Three Months Ended September 30, |
Nine Months Ended
September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Foreign currency transactions and other |
$ |
|
$ |
|
|
$ | $ | ( |
) |
|||||||
Bank commissions |
|
|
||||||||||||||
$ |
|
$ |
|
$ | $ |
|
NOTE 9: GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER AND PRODUCT DATA
Summary information about geographic areas:
ASC 280, “Segment Reporting” establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company manages its business on the basis of
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
Revenues based on customer’s location: |
||||||||||||||||
United States |
$ | $ |
$ |
|
$ |
|
||||||||||
Europe |
|
|
||||||||||||||
Asia-Pacific |
|
|
||||||||||||||
Africa |
|
|
||||||||||||||
Total revenues |
$ | $ |
$ |
|
$ |
|
22
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
September 30, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Long-lived assets by geographic region (*): |
||||||||
Israel |
$ |
|
$ |
|
||||
United States |
|
|
||||||
Germany |
|
|
||||||
$ |
|
$ |
|
*) |
Long-lived assets are comprised of property and equipment, net, and operating lease right-of-use assets. |
Nine Months Ended |
||||||||
2022 |
2021 |
|||||||
Major customer data as a percentage of total revenues: |
||||||||
Customer A |
% | ) | ||||||
Customer B |
) |
% |
*) |
|
NOTE 10: SUBSEQUENT EVENTS
|
• | Total revenue for the third quarter of 2022 was $0.9 million, compared to $2.0 million in the third quarter of 2021; |
• | Strong cash position with $74.0 million as of September 30, 2022; |
• | The Company’s operating expenses were $5.7 million in the third quarter of 2022, compared to $3.8 million in the thirds quarter of 2021; |
• | ReWalk submitted its first case to a MAC in early November and will continue to prepare further cases for submission for Medicare coverage and reimbursement. |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenues | $ | 886 | $ | 1,972 | $ | 3,332 | $ | 4,724 | ||||||||
Cost of revenues | 665 | 832 | 2,100 | 2,150 | ||||||||||||
Gross profit | 221 | 1,140 | 1,232 | 2,574 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development, net | 1,065 | 638 | 2,928 | 2,243 | ||||||||||||
Sales and marketing | 2,588 | 1,821 | 7,119 | 5,105 | ||||||||||||
General and administrative | 2,001 | 1,343 | 5,282 | 4,050 | ||||||||||||
Total operating expenses | 5,654 | 3,802 | 15,329 | 11,398 | ||||||||||||
Operating loss | (5,433 | ) | (2,662 | ) | (14,097 | ) | (8,824 | ) | ||||||||
Financial expenses, net | 1 | 27 | 69 | 14 | ||||||||||||
Loss before income taxes | (5,434 | ) | (2,689 | ) | (14,166 | ) | (8,838 | ) | ||||||||
Taxes on income (tax benefit) | 26 | (14 | ) | 90 | 40 | |||||||||||
Operating loss | ||||||||||||||||
Net loss | $ | (5,460 | ) | $ | (2,675 | ) | $ | (14,256 | ) | $ | (8,878 | ) | ||||
Net loss per ordinary share, basic and diluted | $ | (0.09 | ) | $ | (0.06 | ) | $ | (0.23 | ) | $ | (0.21 | ) | ||||
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted | 62,793,847 | 46,570,130 | 62,611,580 | 43,021,972 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
(in thousands, except unit amounts) | (in thousands, except unit amounts) | |||||||||||||||
Personal unit revenues | $ | 822 | $ | 1,357 | $ | 2,837 | $ | 3,818 | ||||||||
Rehabilitation unit revenues | 64 | 615 | 495 | 906 | ||||||||||||
Revenues | $ | 886 | $ | 1,972 | $ | 3,332 | $ | 4,724 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Gross profit | $ | 221 | $ | 1,140 | $ | 1,232 | $ | 2,574 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Research and development expenses, net | $ | 1,065 | $ | 638 | $ | 2,928 | $ | 2,243 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Sales and marketing expenses | $ | 2,588 | $ | 1,821 | $ | 7,119 | $ | 5,105 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
General and administrative expenses | $ | 2,001 | $ | 1,343 | $ | 5,282 | $ | 4,050 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Financial expenses, net | $ | 1 | $ | 27 | $ | 69 | $ | 14 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Taxes on income (tax benefit) | $ | 26 | $ | (14 | ) | $ | 90 | $ | 40 |
Nine Months Ended September 30, | ||||||||
2022 | 2021 | |||||||
Net cash used in operating activities | $ | (13,978 | ) | $ | (8,903 | ) | ||
Net cash used in investing activities | (25 | ) | (28 | ) | ||||
Net cash provided by (used in) financing activities | (183 | ) | 79,808 | |||||
Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash | (182 | ) | — | |||||
Net cash flow | $ | (14,368 | ) | $ | 70,877 |
Payments due by period (in thousands) | ||||||||||||
Contractual obligations | Total | Less than 1 year | 1-3 years | |||||||||
Purchase obligations (1) | $ | 1,637 | $ | 1,637 | $ | — | ||||||
Collaboration Agreement and License Agreement obligations (2) | 63 | 63 | — | |||||||||
Operating lease obligations (3) | 756 | 652 | 104 | |||||||||
Total | $ | 2,456 | $ | 2,352 | $ | 104 |
(1) | The Company depends on one contract manufacturer, Sanmina, for both the ReStore products and the SCI Products. We place our manufacturing orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements. |
(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 September 30, 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. |
(In Thousands) | ||||||||||||||||
Total Number of | Maximum Value | |||||||||||||||
Shares Purchased as | of Shares That | |||||||||||||||
Total | Average | Part of a | May Yet Be | |||||||||||||
Number of | Price | Publicly | Purchased | |||||||||||||
Shares | Paid Per | Announced | Under the | |||||||||||||
Period | Purchased | Share | Plan | Plan | ||||||||||||
July 1 - July 31, 2022 | ||||||||||||||||
Share repurchase program (1) | — | $ | — | — | — | |||||||||||
August 1 - August 31, 2022 | ||||||||||||||||
Share repurchase program (1) | — | $ | — | — | — | |||||||||||
September 1 - September 30, 2022 | ||||||||||||||||
Share repurchase program (1) | 184,629 | $ | 0.99 | 184,629 | $ | 7,815 | ||||||||||
Quarter Total | ||||||||||||||||
Share repurchase program (1) | 184,629 | $ | 0.99 | 184,629 | $ | 7,815 |
(1) | Shares were purchased through the Company’s publicly announced share repurchase program approved by the Company’s Board on June 2, 2022 and approved by an Israeli court on July 20, 2023. The program expires at the earlier of January 20, 2023 or reaching $8.0 million of repurchases. |
Exhibit Number | Description | |||
101.INS | XBRL Instance Document | |||
101.SCH | XBRL Taxonomy Extension Schema Document | |||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document | |||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document |
* | Furnished herewith. |
** | Filed herewith. |
^ | Portions of this exhibit (indicated by asterisks) have been omitted under rules of the SEC permitting the confidential treatment of select information. |
ReWalk Robotics Ltd. | ||||
Date: November 7, 2022 | By: | /s/ Larry Jasinski | ||
Larry Jasinski | ||||
Chief Executive Officer | ||||
(Principal Executive Officer) | ||||
Date: November 7, 2022 | By: | /s/ Michael Lawless | ||
Michael Lawless | ||||
Chief Financial Officer | ||||
(Principal Financial Officer) |
__________________________ |
____________________________
|
Michael Lawless | Larry Jasinski |
Chief Executive Officer | |
ReWalk Robotics, Inc. |
Notice:
|
You have been granted the following Restricted Stock Units. This is an inducement grant, as described in NASDAQ Listing Rule
5635(c)(4). Accordingly, the Restricted Stock Units have been granted outside of the Plan. However, the Restricted Stock Units are subject to the terms and conditions of, and will be governed in all respects as if issued under, the Plan,
this Notice of Restricted Stock Unit Grant and the Restricted Stock Unit Award Agreement attached hereto as Attachment A (this Notice of Restricted
Stock Unit Grant, together with the Restricted Stock Unit Award Agreement, this “Agreement”).
|
Type of Award:
|
Restricted Stock Units.
|
Period of Restriction:
|
Subject to the terms and conditions of the Plan and those of this Agreement, the Period of Restriction applicable to the Total
Number of Shares Underlying Restricted Stock Units shall commence on the Date of Grant and shall lapse on the dates listed below as to the percentages of the Total Number of Shares Underlying Restricted Stock Units set forth opposite each
such date.
|
Date
|
Percentage
|
25%
|
|
25%
|
|
25%
|
|
25%
|
Acknowledgement
|
|
and Agreement:
|
The undersigned Participant acknowledges receipt of, and understands and agrees to, the terms and conditions of this Agreement
and the Plan.
|
REWALK ROBOTICS LTD.
|
PARTICIPANT
|
By:
|
|
Name:
|
|
Title:
|
|
Date:
|
Date:
|
|
/s/ Larry Jasinski
|
|
|
Larry Jasinski
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
ReWalk Robotics Ltd.
|
|
|
/s/ Michael Lawless
|
|
|
Michael Lawless
|
|
|
Chief Financial Officer
(Principal Financial Officer)
|
|
|
ReWalk Robotics Ltd.
|
|
• |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
• |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ Larry Jasinski
|
|
|
Larry Jasinski
|
|
|
Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
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ReWalk Robotics Ltd.
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the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
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the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company
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/s/ Michael Lawless
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Michael Lawless
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Chief Financial Officer
(Principal Financial Officer)
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ReWalk Robotics Ltd.
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