LFWD 10-Q
Lifeward Ltd. (LFWD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly
period ended
or
For the transition period from______to______
Commission File
Number:
(Exact name of registrant as specified in charter)
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Israel |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
(Zip Code) |
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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:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered | ||
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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).
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.
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Large accelerated filer ☐ |
Accelerated filer ☐ |
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Smaller reporting
company |
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Emerging growth company
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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
REWALK ROBOTICS LTD.
FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2022
TABLE OF CONTENTS
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• |
our
expectations regarding future growth, including our ability to increase sales in our existing geographic markets and expand to new markets; | ||
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• |
our
ability to maintain and grow our reputation and the market acceptance of our products; | ||
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• |
our
ability to achieve reimbursement from third-party payors or advance Centers for Medicare & Medicaid Services (“CMS”) coverage
for our products; | ||
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• |
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; | ||
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• |
the
adverse effect that the COVID-19 pandemic has had and continues to have on our business and results of operations; | ||
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• |
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; | ||
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• |
our
limited operating history and our ability to leverage our sales, marketing and training infrastructure; | ||
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• |
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; | ||
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• |
our
expectations as to our clinical research program and clinical results; | ||
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• |
our
ability to obtain certain components of our products from third-party suppliers and our continued access to our product manufacturers; | ||
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• |
our
ability to improve our products and develop new products; | ||
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• |
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; | ||
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• |
our
ability to gain and maintain regulatory approvals and to comply with any post-marketing requests |
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the
risk of a cybersecurity attack or breach of our information technology systems significantly disrupting our business operations; | ||
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• |
our
ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others; | ||
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• |
the
impact of substantial sales of our shares by certain shareholders on the market price of our ordinary shares; | ||
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• |
our
ability to use effectively the proceeds of our offerings of securities; | ||
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• |
the
risk of substantial dilution resulting from the periodic issuances of our ordinary shares; | ||
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the
impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company; | ||
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market
and other conditions; and | ||
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• |
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. | ||
REWALK ROBOTICS LTD. AND SUBSIDIARIES
(In thousands, except share and per share data)
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March 31, |
December 31, |
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2022 |
2021 |
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(unaudited) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
$ |
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$ |
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Trade receivable, net |
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Prepaid expenses and other current assets |
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Inventories |
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Total current assets |
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LONG-TERM ASSETS |
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Restricted cash and other long-term assets |
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Operating lease right-of-use assets |
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Property and equipment, net |
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Total long-term assets |
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Total assets |
$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
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March 31, |
December 31, |
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2022 |
2021 |
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(unaudited) |
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LIABILITIES AND SHAREHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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Current maturities of operating leases |
$ |
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$ |
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Trade payables |
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Employees and payroll accruals |
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Deferred revenues |
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Other current liabilities |
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Total current liabilities |
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LONG-TERM LIABILITIES |
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Deferred revenues |
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Non-current operating leases |
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Other long-term liabilities |
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Total long-term liabilities |
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Total liabilities |
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COMMITMENTS AND CONTINGENT LIABILITIES |
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Shareholders’ equity: |
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Share capital |
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Ordinary
share of NIS and
December 31, 2021; Issued and outstanding: March 31, 2022 and December 31, 2021, respectively |
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Additional paid-in capital |
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Accumulated deficit |
( |
) |
( |
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Total shareholders’ equity |
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Total liabilities and shareholders’ equity |
$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
REWALK ROBOTICS LTD. AND SUBSIDIARIES
(Unaudited)
(In thousands, except share and per share data)
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Three Months Ended |
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March 31, |
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2022 |
2021 |
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Revenues |
$ |
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$ |
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Cost of revenues |
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Gross profit |
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Operating expenses: |
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Research and development |
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Sales and marketing |
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General and administrative |
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Total operating expenses |
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Operating loss |
( |
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( |
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Financial expenses (income), net |
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( |
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Loss before income taxes |
( |
) |
( |
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Taxes on income |
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Net loss |
$ |
( |
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$ |
( |
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Net loss per ordinary share, basic and diluted |
$ |
( |
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$ |
( |
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Weighted average number of shares used in computing net loss per ordinary share, basic and diluted |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
REWALK ROBOTICS LTD. AND SUBSIDIARIES
(Unaudited)
(In thousands, except share data)
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Ordinary Share |
Additional paid-in |
Accumulated |
Total shareholders’ |
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Number |
Amount |
capital |
deficit |
equity |
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Balance as of December 31, 2020 |
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( |
) |
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Share-based compensation to employees and non-employees |
- |
- |
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- |
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Issuance of ordinary shares upon vesting of RSUs by employees and non-employees |
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( |
) |
- |
- |
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Issuance
of ordinary shares in a private placement, net of issuance expenses in the amount of $ |
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- |
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Exercises of warrants (2) |
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- |
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Net loss |
- |
- |
- |
( |
) |
( |
) | |||||||||||||
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Balance as of March 31, 2021 |
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( |
) |
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Balance as of December 31, 2021 |
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( |
) |
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Share-based compensation to employees and non-employees |
- |
- |
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- |
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Issuance of ordinary shares upon vesting of RSUs by employees and non-employees |
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( |
) |
- |
- |
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Net loss |
- |
- |
- |
( |
) |
( |
) | |||||||||||||
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Balance as of March 31, 2022 |
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( |
) |
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(1) |
See Note 7.e. to the condensed consolidated financial statements. | |
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(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
(Unaudited)
(In thousands)
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Three Months Ended |
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March 31, |
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2022 |
2021 |
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Cash flows used in operating activities: |
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Net loss |
$ |
( |
) |
$ |
( |
) | ||
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Share-based compensation to employees and non-employees |
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Deferred taxes |
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Changes in assets and liabilities: |
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Trade receivables, net |
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Prepaid expenses, operating lease right-of-use assets and other assets |
( |
) |
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Inventories |
( |
) |
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Trade payables |
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( |
) | ||||
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Employees and payroll accruals |
( |
) |
( |
) | ||||
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Deferred revenues |
( |
) |
( |
) | ||||
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Operating lease liabilities and other liabilities |
( |
) |
( |
) | ||||
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Net cash used in operating activities |
( |
) |
( |
) | ||||
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Cash flows used in investing activities: |
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Purchase of property and equipment |
( |
) |
( |
) | ||||
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Net cash used in investing activities |
( |
) |
( |
) | ||||
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Cash flows from financing activities: |
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Issuance
of ordinary shares in a private placement, net of issuance expenses paid in the amount of $ |
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Exercise of warrants (1) |
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Net cash provided by financing activities |
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Increase (decrease) in cash, cash equivalents, and restricted cash |
( |
) |
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Cash, cash equivalents, and restricted cash at beginning of period |
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Cash, cash equivalents, and restricted cash at end of period |
$ |
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$ |
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Supplemental disclosures of non-cash flow information |
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Expenses related to offerings not yet paid (1) |
$ |
|
$ |
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Classification of inventory to property and equipment, net |
$ |
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$ |
|
||||
|
Classification of inventory to other current assets |
$ |
|
$ |
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||||
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Classification of other current assets to property and equipment, net |
$ |
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$ |
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||||
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Supplemental cash flow information: |
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Cash and cash equivalents |
$ |
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$ |
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Restricted cash included in other long-term assets |
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Total Cash, cash equivalents, and restricted cash |
$ |
|
$ |
|
||||
|
(1) |
See Note 7.e. to the condensed consolidated financial statements. | |
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(2) |
See Note 7.c. to the condensed consolidated financial statements. |
The accompanying notes are an integral part of these consolidated financial statements.
7
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 $
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, |
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2022 |
2021 |
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Units placed |
$ |
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$ |
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Spare parts and warranties |
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Total Revenues |
$ |
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$ |
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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.
The
Distributed Products are sold with an assurance-type warranty that is covered by the vendor ranging from
Contract balances (in thousands)
|
March 31, |
December 31, |
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2022 |
2021 |
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|
Trade receivable, net (1) |
$ |
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$ |
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Deferred revenues (1) (2) |
$ |
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$ |
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(1) |
Balance presented net of unrecognized revenues that were not yet collected. |
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(2) |
During
the three months ended March 31, 2022, $ |
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.
11
REWALK 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, |
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2022 |
2021 |
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Customer A |
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% |
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) | ||||
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Customer B |
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% |
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) | ||||
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Customer C |
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% |
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) | ||||
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Customer D |
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% |
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) | ||||
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Customer E |
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% |
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) | ||||
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Customer F |
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) |
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% | ||||
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Customer G |
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) |
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% | ||||
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Customer H |
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) |
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% | ||||
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Customer I |
) | % | ||||||
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Customer J |
) | % | ||||||
*) Less than 10%
The
Company’s trade receivables are geographically diversified and derived primarily from sales to customers in various countries, mainly
in the United States and Europe. Concentration of credit risk with respect to trade receivables is limited by credit limits, ongoing credit
evaluation and account monitoring procedures. The Company performs ongoing credit evaluations of its distributors based upon a specific
review of all significant outstanding invoices. The Company writes off receivables when they are deemed uncollectible and having exhausted
all collection efforts. As of March 31, 2022 and December 31, 2021 trade receivables are presented net of allowance for doubtful accounts
in the amount of $
c.Warranty provision
The
Company provided a two-year standard warranty for its products. In the beginning of 2018, our service policy for new devices sold includes
|
US Dollars in thousands |
||||
|
Balance at December 31, 2021 |
$ |
|
||
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Provision |
|
|||
|
Usage |
( |
) | ||
|
Balance at March 31, 2022 |
$ |
|
||
12
REWALK 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
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
REWALK 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 |
$ |
|
$ |
|
||||
|
Raw materials |
|
|
||||||
|
$ |
|
$ |
|
|||||
In the
three months ended March 31, 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 March 31, 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 March 31, 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 |
|
% |
14
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Lease
expense under the Company’s operating leases was $
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 $
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 revenues were $
As
of March 31, 2022, the contingent liability to the IIA amounted to $
(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 $
15
REWALK 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
The 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.
The
Company has recorded expenses in the amount of $
16
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 7:SHAREHOLDERS’ EQUITY
a.Share option plans:
As
of March 31, 2022, and December 31, 2021, the Company had reserved
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 |
|
$ |
|
|
$ |
- |
||||||||||
|
Granted |
- |
- |
- |
- |
||||||||||||
|
Exercised |
- |
- |
- |
- |
||||||||||||
|
Forfeited |
( |
) |
|
- |
- |
|||||||||||
|
Options outstanding at the end of the period |
|
$ |
|
|
$ |
- |
||||||||||
|
|
||||||||||||||||
|
Options exercisable at the end of the period |
|
$ |
|
|
$ |
- |
||||||||||
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
REWALK 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 |
|
$ |
|
|||||
|
Granted |
|
|
||||||
|
Vested |
( |
) |
|
|||||
|
Forfeited |
( |
) |
|
|||||
|
Unvested RSUs at the end of the period |
|
$ |
|
|||||
The
weighted average grant date fair value of RSUs granted during the three months ended March 31, 2022, and 2021 was $
As
of March 31, 2022, there were $
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) |
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
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 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) |
|
$ |
|
|
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 $ |
19
REWALK ROBOTICS LTD. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
|
(2) |
Represents common
warrants that were issued as part of the $ |
|
(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. |
20
REWALK 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, |
|
|
|
|
(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. |
|
|
|
|
(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 |
$ |
|
$ |
|
||||
|
Research and development, net |
|
|
( |
) | ||||
|
Sales and marketing |
|
|
||||||
|
General and administrative |
|
|
||||||
|
Total |
$ |
|
$ |
|
||||
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
On September
27, 2021,
As
of March 31, 2022, a total of
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 |
$ |
|
$ |
( |
) | |||
|
Bank commissions |
|
|
||||||
|
$ |
|
$ |
( |
) | ||||
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:
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 March 31, |
||||||||
|
2022 |
2021 |
|||||||
|
Revenues based on customer’s location: |
||||||||
|
United States |
$ |
|
$ |
|
||||
|
Europe |
|
|
||||||
|
Asia-Pacific |
|
|
||||||
|
Africa |
|
|
||||||
|
Total revenues |
$ |
|
$ |
|
||||
|
March 31, |
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. |
| Three
Months Ended March 31, |
||||||||
|
2022 |
2021 |
|||||||
|
Major customer data as a percentage of total revenues: |
||||||||
|
Customer A |
% | ) | ||||||
|
Customer B |
% | |||||||
|
Customer C |
% | |||||||
|
Customer D |
% | |||||||
|
Customer E |
% | ) | ||||||
|
Customer F |
% | |||||||
|
Customer G |
) | % | ||||||
|
Customer H |
% | |||||||
|
Customer I |
% | |||||||
|
*) |
Less
than |
23
| • |
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. |
|
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 |
||||||
|
|
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 |
||||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
Gross
profit |
$ |
265 |
$ |
707 |
||||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
Research
and development expenses |
$ |
907 |
$ |
795 |
||||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
Sales
and marketing expenses |
$ |
2,184 |
$ |
1,671 |
||||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
General
and administrative |
$ |
1,462 |
$ |
1,262 |
||||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
Financial
expenses (income), net |
$ |
24 |
$ |
(4 |
) | |||
|
|
Three
Months Ended March 31, |
|||||||
|
|
2022 |
2021 |
||||||
|
Income
taxes |
$ |
38 |
$ |
45 |
||||
|
|
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 |
|||
|
|
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.
|
Exhibit
Number |
|
Description |
|
101.INS |
|
XBRL
Instance Document |
|
101.SCH |
|
XBRL
Taxonomy Extension Schema Document |
|
101.PRE |
|
XBRL
Taxonomy Extension Presentation Linkbase Document |
|
101.CAL |
|
XBRL
Taxonomy Extension Calculation Linkbase Document |
|
101.LAB |
|
XBRL
Taxonomy Extension Label Linkbase Document |
|
101.DEF |
|
XBRL
Taxonomy Extension Definition Linkbase Document |
|
* |
Furnished
herewith. |
|
|
|
|
^ |
Portions
of this exhibit (indicated by asterisks) have been omitted under rules of the SEC permitting the confidential treatment of select information. |
|
|
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