Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
REWALK ROBOTICS LTD. AND SUBSIDIARIES
REWALK ROBOTICS LTD. AND SUBSIDIARIESCONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY(Unaudited)(In thousands, except share data)
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.
9
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
d.As of June 30, 2022, the Company incurred a consolidated net loss of $8.8 million and has an accumulated deficit in the total amount of $203.0 million. The Company’s cash and cash equivalent as of June 30, 2022 totaled $78.8 million and the Company’s negative operating cash flow for the six months ended June 30, 2022 was $9.4 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 six months ended June 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.
10
11
12
13
14
15
NOTE 4:INVENTORIES
The components of inventories are as follows (in thousands):
June 30,
December 31,
2022
2021
Finished products
$
2,559
2,284
Raw materials
539
705
3,098
2,989
During the six months ended June 30, 2022, and 2021, the Company wrote off inventory in the amount of $16 and $58 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 June 30, 2022, non-cancelable outstanding obligations amounted to approximately $1.1 million.
b.Operating lease commitment:
(i)The Company operates from leased facilities in Israel, the United States and Germany. These leases expire between 2022 and 2023. A portion of the Company’s facilities leases is generally subject to annual changes in the Consumer Price Index (the “CPI”). The changes to the CPI are treated as variable lease payments and recognized in the period in which the obligation for those payments was incurred.
(ii)RRL and RRG lease cars for their employees under cancelable operating lease agreements expiring at various dates in between 2022 and 2025. A subset of the Company’s cars leases is considered variable. The variable lease payments for such cars leases are based on actual mileage incurred at the stated contractual rate. RRL and RRG have an option to be released from these agreements, which may result in penalties in a maximum amount of approximately $23 thousand as of June 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 June 30, 2022, are as follows (in thousands):
334
2023
514
2025
7
Total lease payments
902
Less: imputed interest
(85
)
Present value of future lease payments
817
Less: current maturities of operating leases
(610
Non-current operating leases
207
Weighted-average remaining lease term (in years)
1.46
Weighted-average discount rate
12.5
%
Lease expense under the Company’s operating leases was $184 thousand and $178 thousand for the three months ended June 30, 2022, and 2021, respectively. For the six months ended June 30, 2022, and 2021, the lease expense was $363 thousand and $364 thousand, respectively.
16
c.Royalties:
d.Liens:
As part of the Company’s other long-term assets and restricted cash, an amount of $659 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.
17
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.
18
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NOTE 7: SHAREHOLDERS’ EQUITY
a.Share option plans:
As of June 30, 2022, and December 31, 2021, the Company had reserved 364,701 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 six months ended June 30, 2022, and 2021.
A summary of employees and non-employees share options activity during the six months ended June 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 June 30, 2022
43,994
41.27
4.89
Options exercisable as of June 30, 2022
41,638
43.28
4.79
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 June 30, 2022 and 2021.
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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 six months ended June 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
97,735
1.14
Vested
(198,145
1.99
(210,641
1.53
Unvested RSUs as of June 30, 2022
1,045,233
1.51
The weighted average grant date fair value of RSUs granted during the six months ended June 30, 2022, and 2021, was $1.14 and $1.75, respectively.
As of June 30, 2022, there were $1.3 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 2.5 years.
The number of options and RSUs outstanding as of June 30, 2022, is set forth below, with options separated by range of exercise price.
Range of exercise price
Optionsand RSUsoutstandingas of
June 30,2022
Weighted
average
(years) (1)
Optionsoutstanding andexercisableas of
RSUs only
$5.37
12,425
6.75
10,095
$20.42 - $33.75
13,317
5.71
13,291
$37.14 - $38.75
8,946
1.48
$50 - $52.5
6,731
4.97
$182.5 - $524.25
2,575
3.35
1,089,227
(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 June 30, 2022, there are no outstanding options or RSUs held by non-employee consultants.
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c.Warrants to purchase ordinary shares:
The following table summarizes information about warrants outstanding and exercisable as of June 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 June 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.
(3)
Represents common warrants that were issued as part of the Company’s follow-on public offering in November 2018.
22
(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.
23
(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):
Six Months Ended
Cost of revenues
6
4
Research and development
33
Sales and marketing
96
77
General and administrative
191
273
Total
326
368
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.
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.
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As of June 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.
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
39
(14
Bank commissions
5
44
(9
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):
Six Months EndedJune 30,
Revenues based on customer’s location:
United States
798
1,130
Europe
1,535
1,563
Asia-Pacific
111
57
Africa
2
Total revenues
2,446
2,752
25
Long-lived assets by geographic region (*):
Israel
580
629
375
493
Germany
70
43
1,025
1,165
*)
Long-lived assets are comprised of property and equipment, net, and operating lease right-of-use assets.
Major customer data as a percentage of total revenues:
Customer A
Customer B
Less than 10%.
We are an innovative medical device company that is designing, developing, and commercializing robotic exoskeletons that allow individuals with mobility impairments or other medical conditions the ability to stand and walk once again. We have developed and are continuing to commercialize our ReWalk Personal and ReWalk Rehabilitation devices for individuals with spinal cord injury (“SCI Products”), which are exoskeletons designed for individuals with paraplegia that use our patented tilt-sensor technology and an on-board computer and motion sensors to drive motorized legs that power movement.
In May 2021, the FDA granted breakthrough design designation to the ReWalk Personal stairs feature. In June 2022, we submitted a 510(k) application to the FDA for our ReWalk Personal exoskeleton system seeking clearance for the use of ReWalk Personal units on stairs and curbs in the United States, which is currently under review.
We have also developed and began commercializing our ReStore device in June 2019. ReStore is a powered, lightweight soft exo-suit intended for use in the rehabilitation of individuals with lower limb disability due to stroke. During the second quarter of 2020 we finalized and moved to implement two separate agreements to distribute additional product lines in the U.S. market. We will be the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States and will also have distribution rights for the MYOLYN MyoCycle FES cycles to U.S. rehabilitation clinics and personal sales through U.S. Department of Veteran Affairs (“VA”) hospitals. These new products will improve our product offering to clinics as well as patients within the VA as they both have similar clinician and patient profile.
Our principal markets are the United States and Europe. In Europe, we have a direct sales operation in Germany and the United Kingdom and work with distribution partners in certain other major countries. We have offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, where we operate our business from.
We have in the past generated and expect to generate in the future revenues from a combination of third-party payors, self-payors, including private and government employers, and institutions. While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States for electronic exoskeleton technologies such as the ReWalk Personal, we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics. In December 2015, the VA issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans across the United States. The VA policy is the first national coverage policy in the United States for qualifying individuals who have suffered spinal cord injury. As of June 30, 2022, we had placed 30 units as part of the VA policy.
According to a 2017 report published by the Centers for Medicare and Medicaid Services (“CMS”), approximately 55% of the spinal cord injury population which are at least five years post their injury date are covered by CMS. In July 2020, a code was issued for ReWalk Personal 6.0 (effective October 1, 2020), which might later be followed by coverage policy of CMS. On June 8, 2022, CMS held its First Biannual Healthcare Common Procedure Coding System (HCPCS) public meeting to discuss several preliminary benefit and payment decisions under the new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) rules. Included on the agenda was a discussion of the Medicare benefit category and payment determination for the ReWalk Personal 6.0. No preliminary determination was made during the meeting, and we are currently awaiting further feedback from CMS, which we expect to receive during the second half of 2022.
Additionally, to date, several private insurers in the United States and Europe have provided reimbursement for ReWalk in certain cases. In Germany, we continue to make progress toward achieving ReWalk coverage from the various government, private and worker’s compensation payors. In September 2017, each of German insurer BARMER GEK (“Barmer”) and national social accident insurance provider Deutsche Gesetzliche Unfallversicherung (“DGUV”), indicated that they will provide coverage to users who meet certain inclusion and exclusion criteria. In February 2018, the head office of German statutory health insurance (“SHI”), Spitzenverband (“GKV”) confirmed their decision to list the ReWalk Personal 6.0 exoskeleton system in the German Medical Device Directory. This decision means that ReWalk will be listed among all medical devices for compensation, which SHI providers can procure for any approved beneficiary on a case-by-case basis. During the year 2020 we announced several new agreements with German SHIs such as TK and DAK Gesundheit and others as well as the first German Private Health Insurer (“PHI”) that have chosen to enter into an agreement that outlines the process of obtaining a device for eligible insured patient. We are currently working with several additional SHIs and PHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal 6.0 device for their beneficiaries within their system.
Total revenue for the second quarter of 2022 was $1.6 million, compared to $1.4 million in the second quarter of 2021;
Strong cash position with $78.8 million as of June 30, 2022;
The Company’s operating expenses were $5.1 million in the second quarter of 2022, compared to $3.9 million in the second quarter of 2021;
In June 2022, the Company announced that its Board of Directors (the “Board”) had approved a program to repurchase up to $8.0 million of the Company’s ordinary shares, par value NIS 0.25 per share, subject to receipt of Israeli court approval. In July 2022, the Company announced that it had received approval from an Israeli court for the share repurchase program, valid through January 20, 2023. The process to begin repurchasing shares is underway;
●
On June 8th, the Company presented before CMS at its Healthcare Common Procedure Coding System (HCPCS) meeting, detailing why CMS should promptly assign the ReWalk Personal Prosthetic Exoskeleton to the “artificial leg” prosthetic benefit category. No preliminary determination was made during the meeting, and ReWalk is currently awaiting further feedback from CMS, which it expects to receive during the second half of 2022.
Although we have seen the U.S. and German markets start to fully open for the first time since the pandemic started in early 2020, allowing us to restart market development and access programs, the COVID-19 pandemic has continued to affect our ability to engage with our SCI Products, ReStore and Distributed Products existing customers, conduct trials of product candidates, deliver ordered units or repair existing systems and provide training for our products to new patients, who have largely remained at home due to local movement restrictions, and to rehabilitation centers, which have temporarily shifted priorities and responses to pandemic-related medical equipment. In addition, staffing shortages within the healthcare system itself has resulted in a diminished demand for our SCI Products as the attention of healthcare workers and potential patients has turned elsewhere. As a result, our sales and results of operations have been adversely impacted. We believe that these adverse impacts may continue as long as the pandemic continues to impact our key markets, which are Germany and the United States, especially as long as our ability to conduct trials of product candidates is limited or if our existing customers can’t train with our SCI Products and as long as capital budgets for rehabilitation devices such as the ReStore remain reduced or on-hold. Additionally, some clinics, such as VA clinics, and many other healthcare facilities, have historically been enforcing in-clinic restrictions, which have to date affected our ability to demonstrate our devices to patients or start training for qualified potential customers; although we are starting to see this trend revert back to pre-pandemic levels. We continue to monitor our sales pipeline on a day-to-day basis in order to assess the effect of these limitations as some have short term effects and others affect our future pipeline development. While our sole manufacturer, Sanmina Corporation, has not shut down its facilities during the COVID-19 pandemic, supply chain delays, component shortages have had a limited impact on our manufacturing and are also leading to price increases of specific parts. Other adverse impacts on our production capacity as a result of government directives or health protocols can occur. Moreover, the current limitations on our sales activities has made it difficult to effectively forecast our future requirements for systems. For more information, see “Part I, Item 1A. Risk Factors.” of our 2021 Form 10-K in addition to the “Risk Factors” section included below.
Revenues increased by $134 thousand, or 9%, for the three months ended June 30, 2022, compared to the three months ended June 30, 2021. The increase is due to higher number of personal 6.0 units sold in Europe and higher number of distributed products sold in the United States.
Revenues decreased by $306 thousand, or 11%, for the six months ended June 30, 2022, compared to the six months ended June 30, 2021. The decrease was driven primarily by a lower number of personal 6.0 and rehabilitation units sold in the United States during Q1-22.
Under the program, share repurchases may be made from time to time using a variety of methods, including open market transactions or in privately negotiated transactions. Such repurchases will be made in accordance with all applicable securities laws and regulations, including restrictions relating to volume, price and timing under applicable law, including Rule 10b-18 under the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”). The timing and amount of shares repurchased will be determined by our management, within guidelines to be established by the Board or a committee thereof, based on its ongoing evaluation of our capital needs, market conditions, the trading price of our ordinary shares, trading volume and other factors, subject to applicable law. For all or a portion of the authorized repurchase amount, we may enter into a plan compliant with Rule 10b5-1 under the Exchange Act that is designed to facilitate these repurchases.
The repurchase program does not require us to acquire a specific number of shares, and may be suspended or discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future, and any such share repurchases will be funded from available working capital.
1,147
2,124
1,878