Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
ii
i
September 30,
Treasury Shares at cost, 184,629 ordinary shares
REWALK ROBOTICS LTD. AND SUBSIDIARIES
)
-
Issuance of ordinary shares in a “registered direct" offering, net of issuance expenses in the amount of $3,228 (1)
Exercise of pre-funded warrants and warrants (1) (2)
Treasury Shares
REWALK ROBOTICS LTD. AND SUBSIDIARIESCONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY(Unaudited)(In thousands, except share data)
Purchase of treasury shares
(183
Issuance of ordinary shares in a "registered direct" offerings, net of issuance expenses in the amount of $2,918 (1)
28,427
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
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
d.As of September 30, 2022, the Company incurred a consolidated net loss of $14.3 million and has an accumulated deficit in the total amount of $208.4 million. The Company’s cash and cash equivalent as of September 30, 2022 totaled $74.0 million and the Company’s negative operating cash flow for the nine months ended September 30, 2022 was $14.0 million. The Company has sufficient funds to support its operations for more than 12 months following the issuance date of its condensed consolidated unaudited financial statements for the three and nine months ended September 30, 2022. The Company expects to incur future net losses and its transition to profitability is dependent upon, among other things, the successful development and commercialization of its products and product candidates, and the achievement of a level of revenues adequate to support its cost structure. Until the Company achieves profitability or generates positive cash flows, it will continue to need to raise additional cash. The Company intends to fund future operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing. In addition, the Company may seek additional capital through arrangements with strategic partners or from other Sources and will continue to address its cost structure. Notwithstanding, there can be no assurance that the Company will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.
8
9
10
11
Customer H
*
12
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.
13
NOTE 4: INVENTORIES
The components of inventories are as follows (in thousands):
December 31,
2022
2021
Finished products
$
2,807
2,284
Raw materials
523
705
3,330
2,989
During the nine months ended September 30, 2022, and 2021, the Company wrote off inventory in the amount of $32 and $ 65 thousand, respectively. The write off inventory were recorded in cost of revenue.
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 $1.6 million.
b.Operating lease commitment:
(i)The Company operates from leased facilities in Israel, the United States, and Germany. These leases in Israel and United States will expire in 2023 while the operating lease in Germany is renewed every month. A portion of the Company’s facilities leases is generally subject to annual changes in the Consumer Price Index (the “CPI”). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred.
(ii)RRL and RRG lease cars for their employees under cancelable operating lease agreements expiring at various dates in between 2022 and 2025. A subset of the Company’s cars leases is considered variable. The variable lease payments for such cars leases are based on actual mileage incurred at the stated contractual rate. RRL and RRG have an option to be released from these agreements, which may result in penalties in a maximum amount of approximately $18 thousand as of September 30, 2022.
The Company's future lease payments for its facilities and cars, which are presented as current maturities of operating leases and non-current operating leases liabilities on the Company's condensed consolidated balance sheets as of September 30, 2022, are as follows (in thousands):
165
2023
520
2025
14
Total lease payments
756
Less: imputed interest
(65
Present value of future lease payments
691
Less: current maturities of operating leases
(606
Non-current operating leases
85
Weighted-average remaining lease term (in years)
1.51
Weighted-average discount rate
12.5
%
Lease expense under the Company’s operating leases was $175 thousand and $179 thousand for the three months ended September 30, 2022, and 2021, respectively. For the nine months ended September 30, 2022, and 2021, the lease expense was $538 thousand and $543 thousand, respectively.
c.Royalties:
The Company’s research and development efforts are financed, in part, through funding from the Israel Innovation Authority (the “IIA”) and the Israel-U.S. Binational Industrial Research and Development Foundation (“BIRD”). During the three and nine months that ended September 30, 2022, the Company received $23 thousand and $207 thousand respectively from the IIA to fund its research and development efforts.
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 $3 and $2 thousand for the three months ended September 30, 2022 and 2021, respectively. For the nine months ended September 30, 2022, and 2021, the royalties expenses were $7 thousand and $8 thousand, respectively.
(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 $655 thousand has been pledged as security in respect of a guarantee granted to a third party. Such deposit cannot be pledged to others or withdrawn without the consent of such third party.
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
16
NOTE 7: SHAREHOLDERS’ EQUITY
a.Share option plans:
As of September 30, 2022, and December 31, 2021, the Company had reserved 2,934,679 and 233,957 ordinary shares, respectively, for issuance to the Company’s and its affiliates’ respective employees, directors, officers and consultants pursuant to equity awards granted under the Company’s 2014 Incentive Compensation Plan (the “2014 Plan”).
Options to purchase ordinary shares generally vest over four years, with certain options to non-employee directors vesting quarterly over one year. Any option that is forfeited or canceled before expiration becomes available for future grants under the 2014 Plan.
There were no options granted during the 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
remaining
contractual
life (in years)
Aggregate
intrinsic
value (inthousands)
Options outstanding as of December 31, 2021
61,832
38.34
4.55
Granted
Exercised
Forfeited
(17,838
31.13
Options outstanding as of September 30, 2022
43,994
41.27
4.64
Options exercisable as of September 30, 2022
42,440
42.58
4.57
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
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 shares
underlying
outstanding
RSUs
Weighted average
grantdate fair
value
Unvested RSUs as of January 1, 2022
1,356,284
1.61
2,152,757
1.00
Vested
(421,782
1.65
(210,641
1.53
Unvested RSUs as of September 30, 2022
2,876,618
1.15
The weighted average grant date fair value of RSUs granted during the nine months ended September 30, 2022, and 2021, was $1.00 and $1.69, respectively.
As of September 30, 2022, there were $3.0 million of total unrecognized compensation costs related to non-vested share-based compensation arrangements granted under the Company’s 2014 Plan. This cost is expected to be recognized over a period of approximately 2.9 years.
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
Optionsand RSUsoutstandingas of
September 30,2022
Weighted
average
life (years) (1)
Optionsoutstanding andexercisableas of
RSUs only
$5.37
12,425
6.49
10,871
$20.42 - $33.75
13,317
5.46
$37.14 - $38.75
8,946
1.23
$50 - $52.5
6,731
4.72
$182.5 - $524.25
2,575
3.10
2,920,612
(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 47,522 fully vested RSUs on June 30, 2022, to a non-employee consultant. As of September 30, 2022, there are no outstanding options or RSUs held by non-employee consultants.
18
c.Warrants to purchase ordinary shares:
The following table summarizes information about warrants outstanding and exercisable as of September 30, 2022:
Issuance date
Warrants
Exercise price
per warrant
outstandingand
exercisable
Contractual
term
(number)
December 31, 2015 (1)
4,771
7.500
See footnote (1)
December 28, 2016 (2)
1,908
November 20, 2018 (3)
126,839
November 20, 2023
November 20, 2018 (4)
106,680
9.375
November 15, 2023
February 25, 2019 (5)
45,600
7.187
February 21, 2024
April 5, 2019 (6)
408,457
5.140
October 7, 2024
April 5, 2019 (7)
49,015
6.503
April 3, 2024
June 5, 2019, and June 6, 2019 (8)
1,464,665
June 5, 2024
June 5, 2019 (9)
87,880
June 12, 2019 (10)
416,667
6.000
December 12, 2024
June 10, 2019 (11)
50,000
June 10, 2024
February 10, 2020 (12)
28,400
1.250
February 10, 2025
February 10, 2020 (13)
105,840
1.563
July 6, 2020 (14)
448,698
1.760
January 2, 2026
July 6, 2020 (15)
296,297
2.278
December 8, 2020 (16)
586,760
1.340
June 8, 2026
December 8, 2020 (17)
108,806
1.792
February 26, 2021 (18)
5,460,751
3.600
August 26, 2026
February 26, 2021 (19)
655,290
4.578
September 29, 2021 (20)
8,006,759
2.000
March 29, 2027
September 29, 2021 (21)
960,811
2.544
September 27, 2026
19,420,894
Represents warrants for ordinary shares issuable upon an exercise price of $7.50 per share, which were granted on December 31, 2015 to Kreos Capital V (Expert) Fund Limited, or Kreos, in connection with a loan made by Kreos to us and are currently exercisable (in whole or in part) until the earlier of (i) December 30, 2025 or (ii) immediately prior to the consummation of a merger, consolidation, or reorganization of us with or into, or the sale or license of all or substantially all the assets or shares of us to, any other entity or person, other than a wholly-owned subsidiary of us, excluding any transaction in which the Company’s shareholders prior to the transaction will hold more than 50% of the voting and economic rights of the surviving entity after the transaction. None of these warrants had been exercised as of September 30, 2022.
(2)
Represents common warrants that were issued as part of the $8.0 million drawdown under the Loan Agreement which occurred on December 28, 2016. See footnote 1 for exercisability terms.
19
(3)
Represents common warrants that were issued as part of the Company’s follow-on public offering in November 2018.
(4)
Represents common warrants that were issued to the underwriters as compensation for their role in the Company’s follow-on public offering in November 2018.
(5)
Represents warrants that were issued to the exclusive placement agent as compensation for its role in the Company’s follow-on public offering in February 2019.
(6)
Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s registered direct offering of ordinary shares in April 2019.
(7)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s April 2019 registered direct offering.
(8)
Represents warrants that were issued to certain institutional investors in a warrant exercise agreement on June 5, 2019, and June 6, 2019, respectively.
(9)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 warrant exercise agreement and concurrent private placement of warrants.
(10)
Represents warrants that were issued to certain institutional investors in a warrant exercise agreement in June 2019.
(11)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s June 2019 registered direct offering and concurrent private placement of warrants
(12)
Represents warrants that were issued to certain institutional purchasers in a private placement in the Company’s best efforts offering of ordinary shares in February 2020. During the year ended December 31, 2021, 3,740,100 warrants were exercised for total consideration of $4,675,125.
(13)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s February 2020 best efforts offering. During the year ended December 31, 2021, 230,160 warrants were exercised for total consideration of $359,625.
(14)
Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in July 2020. During the year ended December 31, 2021, 2,020,441 warrants were exercised for total consideration of $3,555,976.
(15)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s July 2020 registered direct offering.
(16)
Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in December 2020. During the year ended December 31, 2021, 3,598,072 warrants were exercised for total consideration of $4,821,416.
(17)
Represents warrants that were issued to the placement agent as compensation for its role in the Company’s December 2020 private placement. During the year ended December 31, 2021, 225,981 warrants were exercised for total consideration of $405,003.
(18)
Represents warrants that were issued to certain institutional purchasers in a private placement in our private placement offering of ordinary shares in February 2021.
20
Represents warrants that were issued to the placement agent as compensation for its role in Company’s private placement offering in February 2021.
Represents warrants that were issued to certain institutional purchasers in a private placement in our registered direct offering of ordinary shares in September 2021.
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
Cost of revenues
Research and development
60
34
Sales and marketing
167
120
General and administrative
409
438
Total
646
599
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 10,921,502 ordinary shares, par value NIS 0.25 per share at $3.6625 per ordinary share and warrants to purchase up to an aggregate of 5,460,751 ordinary shares with an exercise price of $3.6 per share, exercisable from February 19, 2021 until August 26, 2026. Additionally, the Company issued warrants to purchase up to 655,290 ordinary shares, with an exercise price of $4.578125 per share, exercisable from February 19, 2021 until August 26, 2026, to certain representatives of H.C. Wainwright & Co., LLC (“H.C. Wainwright”) as compensation for its role as the placement agent in our February 2021 Offering.
21
On September 27, 2021, the Company signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary shares, par value NIS 0.25 per share, pre-funded warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary warrants to purchase up to an aggregate of 8,006,759 ordinary shares at an exercise price of $2.00 per share. The Pre-Funded Warrants have an exercise price of $0.001 per Ordinary Share and are immediately exercisable and can be exercised at any time after their original issuance until such pre-funded warrants are exercised in full. Each ordinary share was sold at an offering price of $2.035 and each pre-funded warrant was sold at an offering price of $2.034 (equal to the purchase price per ordinary share minus the exercise price of the pre-funded warrant). The offering of the ordinary shares, the pre-funded warrants and the ordinary shares that are issuable from time to time upon exercise of the pre-funded warrants was made pursuant to the Company’s shelf registration statement on Form S-3 initially filed with the Securities and Exchange Commission (“SEC”) on May 9, 2019, and declared effective by the SEC on May 23, 2019, and the ordinary warrants were issued in a concurrent private placement. The ordinary warrants are exercisable at any time and from time to time, in whole or in part, following the date of issuance and ending five and one-half years from the date of issuance. All of the pre-funded warrants were exercised in full on September 27, 2021, and the offering closed on September 29, 2021. Additionally, the Company issued warrants to purchase up to 960,811 ordinary shares, with an exercise price of $2.5438 per share, exercisable from September 27, 2021, until September 27, 2026, to certain representatives of H.C. Wainwright as compensation for its role as the placement agent in our September 2021 registered direct offering.
As of September, 30, 2022, a total of 9,814,754 previously issued warrants with exercise prices ranging from $1.25 to $1.79 have been exercised for total gross proceeds of approximately $13.8 million.
f. Treasury stock:
On June 2, 2022, the Company’s Board of Directors approved a share repurchase program to repurchase up to $8 million of its Ordinary Shares, par value NIS 0.25 per share. On July 21, 2022, the Company received approval from an Israeli court for the share repurchase program, valid through January 20, 2023.
As of September 30, 2022, pursuant to the Company’s share repurchase program, the Company had repurchased a total of 184,629 of its outstanding ordinary shares at a total cost of $183,540.
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
Foreign currency transactions and other
1
22
Bank commissions
5
27
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 one reportable segment and derives revenues from selling units and services (see Note 1 for a brief description of the Company’s business). The following is a summary of revenues within geographic areas (in thousands):
Revenues based on customer’s location:
United States
1,193
1,951
Europe
2,023
2,711
Asia-Pacific
113
58
Africa
3
4
Total revenues
3,332
4,724
Long-lived assets by geographic region (*):
Israel
515
629
303
493
Germany
57
43
875
1,165
*)
Long-lived assets are comprised of property and equipment, net, and operating lease right-of-use assets.
Nine Months EndedSeptember 30,
Major customer data as a percentage of total revenues:
Customer A
Customer B
Less than 10%.
•
1,637