REWALK ROBOTICS LTD.
FORM 10-Q
FOR THE QUARTER ENDED MARCH 31, 2023
TABLE OF CONTENTS
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i
Introduction and Where You Can Find Other Information
As used in this quarterly report on Form 10-Q (this “quarterly report”), the terms “ReWalk,” the “Company,” “RRL,” “we,” “us” and “our” refer to ReWalk Robotics Ltd. and its subsidiaries, unless the context clearly indicates otherwise. Our website is www.rewalk.com. Information contained in, or that can be accessed through, our website does not constitute a part of this quarterly report and is not incorporated by reference herein. We have included our website address in this quarterly report solely for informational purposes. Information that we furnish to or file with the Securities and Exchange Commission (the “SEC”), including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and any amendments to, or exhibits included in, these reports are available for download, free of charge, on our website as soon as reasonably practicable after such materials are filed with or furnished to the SEC. Our SEC filings, including exhibits filed or furnished therewith, are also available on the SEC’s website at http://www.sec.gov.
Special Note Regarding Forward-Looking Statements
In addition to historical information, this quarterly report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements may include projections regarding our future performance and, in some cases, can be identified by words like “anticipate,” “assume,” “believe,” “could,” “seek,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “future,” “should,” “will,” “would” or similar expressions that convey uncertainty of future events or outcomes and the negatives of those terms. These statements may be found in the section of this quarterly report titled “Part I, Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this quarterly report. These statements include, but are not limited to, statements regarding:
• | our expectations regarding future growth, including our ability to increase sales in our existing geographic markets and expand to new markets; |
• | our ability to maintain and grow our reputation and the market acceptance of our products; |
• | our ability to achieve reimbursement from third-party payors or advance Centers for Medicare & Medicaid Services (“CMS”) coverage for our products, including our ability to successfully submit cases for Medicare coverage through Medicare Administrative Contractors; |
• | our ability to regain and maintain compliance with the continued requirements of the Nasdaq Capital Market and the risk that our ordinary shares will be delisted if we do not comply with such requirements; |
• | the adverse effect that the COVID-19 pandemic has had and continues to have on our business and results of operations; |
• | our ability to have sufficient funds to meet certain future capital requirements, which could impair our efforts to develop and commercialize existing and new products; |
• | our limited operating history and our ability to leverage our sales, marketing and training infrastructure; |
• | our ability to grow our business through acquisitions of businesses, products or technologies, and the failure to manage acquisitions, or the failure to integrate them with our existing business, which could have a material adverse effect on our business, financial condition, and operating results; |
• | our expectations as to our clinical research program and clinical results; |
• | our ability to obtain certain components of our products from third-party suppliers and our continued access to our product manufacturers; |
• | our ability to improve our products and develop new products; |
• | our compliance with medical device reporting regulations to report adverse events involving our products, which could result in voluntary corrective actions or enforcement actions such as mandatory recalls, and the potential impact of such adverse events on our ability to market and sell our products; |
• | our ability to gain and maintain regulatory approvals and to comply with any post-marketing requests | |
• | our ability to maintain adequate protection of our intellectual property and to avoid violation of the intellectual property rights of others; |
ii
• | the impact of substantial sales of our shares by certain shareholders on the market price of our ordinary shares; |
• | our ability to use effectively the proceeds of our offerings of securities; |
• | the impact of the market price of our ordinary shares on the determination of whether we are a passive foreign investment company; |
• | market and other conditions, including the extent to which inflation or global instability may disrupt our business operations or our financial condition or the financial condition of our customers and suppliers; and |
• | other factors discussed in the “Risk Factors” section of our 2022 annual report on Form 10-K and in our subsequent reports filed with the SEC. |
The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The statements are based on our beliefs, assumptions, and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. There are important factors that could cause our actual results, levels of activity, performance, or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the statements. In particular, you should consider the risks provided under “Part I, Item 1A. Risk Factors” of our 2022 annual report on Form 10-K, and in other reports subsequently filed by us with, or furnished to, the SEC.
You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur.
Any forward-looking statement in this quarterly report speaks only as of the date hereof. Except as required by law, we undertake no obligation to update publicly any forward-looking statements, whether as a result of new information, future developments or otherwise.
iii
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operation should be read in conjunction with the unaudited condensed consolidated financial statements and the related notes included elsewhere in this quarterly report and with our audited consolidated financial statements included in our Form 10-K for the year ended December 31, 2022 as filed with the Securities and Exchange Commission (“SEC”) on February 23, 2023 and amended on May 1, 2023 (the “2022 Form 10-K”). In addition to historical condensed financial information, the following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. For a discussion of factors that could cause or contribute to these differences, see “Special Note Regarding Forward-Looking Statements” above.
Overview
We are a medical device company that is designing, developing, and commercializing innovative technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions. Our initial product offerings were the SCI Products. These devices are robotic exoskeletons that are designed for individuals with paraplegia that use our patented tilt-sensor technology and an onboard computer and motion sensors to drive motorized legs that power movement. These SCI Products allow individuals with spinal cord injury the ability to stand and walk again during everyday activities at home or in the community. In March 2023, we received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the ReWalk Personal 6.0 to enable the stairs functionality and add uses on stairs and curbs to the indication for use for the device in the U.S. The clearance permits U.S. customers to participate in more walking activities in their daily lives where stairs or curbs may have previously limited them. This feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over seven years and consisting of over 18,000 stair steps was collected to demonstrate the safety and efficacy of this feature and support the FDA submission.
We have sought to expand our product offerings beyond the SCI Products through internal development and distribution agreements. We have developed our ReStore Exo-Suit device, which we began commercializing in June 2019. The ReStore is a powered, lightweight soft exo-suit intended for use during the rehabilitation of individuals with lower limb disabilities 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 United States. We are the exclusive distributor of the MYOLYN MyoCycle FES Pro cycles to U.S. rehabilitation clinics and for the MyoCycle Home cycles available to US veterans through the U.S. Department of Veterans Affairs (“VA”) hospitals. In the second quarter of 2020, we also became the exclusive distributor of the MediTouch Tutor movement biofeedback systems in the United States; however, due to unsatisfactory sales performance of the MediTouch product lines, we terminated this agreement as of January 31, 2023. We refer to the MediTouch and MyoCycle devices as our “Distributed Products.” We will continue to evaluate other products for distribution or acquisition that can broaden our product offerings further to help individuals with neurological injury and disability.
We are in the research stage of ReBoot, a personal soft exo-suit for home and community use by individuals post-stroke, and we are currently evaluating the reimbursement landscape and the potential clinical impact of this device. This product would be a complementary product to ReStore as it provides active assistance to the ankle during plantar flexion and dorsiflexion for gait and mobility improvement in the home environment, and it received Breakthrough Device Designation from the FDA in November 2021. Further investment in the development path of the ReBoot has been temporarily paused in 2023 pending further determination about the clinical and commercial opportunity of this device.
Our principal markets are the United States and Europe. In Europe, we have a direct sales operation in Germany and work with distribution partners in certain other major countries. We have offices in Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, from where we operate our business.
We have in the past generated and expect to generate in the future revenue from a combination of third-party payors (including private and government payors) and self-pay individuals. While a broad uniform policy of coverage and reimbursement by third-party commercial payors currently does not exist in the United States for exoskeleton technologies such as the ReWalk Personal Exoskeleton, we are pursuing various paths of reimbursement and support fundraising efforts by institutions and clinics, such as the VA policy that was issued in December 2015 for the evaluation, training, and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans suffering from SCI across the United States.
We have also been pursuing updates with the Centers for Medicare and Medicaid Services (“CMS”), to clarify the Medicare coverage category (i.e., benefit category) applicable for personal exoskeletons. In 2021, the National Spinal Cord Injury Statistical Center (“NSCISC”) reported the Medicare and Medicaid are the primary payors for approximately 56% of the spinal cord injury population which are at least five years post their injury date. In July 2020, following a successful submission and hearing process, a code was issued for ReWalk Personal Exoskeleton (effective October 1, 2020), which may be used for purposes of claim submission to Medicare, Medicaid, and other payors. We are currently seeking a nationwide Medicare benefit category determination from CMS to designate the relevant Medicare benefit category. CMS has stated that, until a nationwide benefit category determination is issued, coverage and payment can be adjudicated on a case-by-case basis by the Medicare Administrative contractors (“MACs”).
In Germany, we continue to make progress toward achieving coverage from the various government, private and worker’s compensation payors for our SCI products. 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 Exoskeleton system in the German Medical Device Directory. This decision means that ReWalk is 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 and 2021, we announced several new agreements with German SHIs, including TK and DAK Gesundheit, as well as the first German Private Health Insurer (“PHI”), which outline the process of obtaining our devices for eligible insured patients. We are also currently working with several additional SHIs on securing a formal operating contract that will establish the process of obtaining a ReWalk Personal Exoskeleton for their beneficiaries within their system. Additionally, to date, several private insurers in the United States and Europe are providing reimbursement for ReWalk in certain cases.
First Quarter 2023 and Subsequent Period Business Highlights
| • | Total revenue for the first quarter of 2023 was $1.2 million, as compared to $0.9 million in the first quarter of 2022, up 40%; |
| • | Gross margin was 46.4% in Q1’23, as compared to 30.3% in Q1’22, a 16 percentage point increase; |
| • | Operating expenses were $4.9 million in the first quarter of 2023, as compared to $4.6 million in the first quarter of 2022; |
| • | In March 2023, the ReWalk Personal Exoskeleton technology received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for use on stairs and curbs, making it the only personal exoskeleton to receive FDA clearance for this indication. |
COVID-19 Pandemic Impact
The impact of the COVID-19 pandemic resulted in significant disruptions to the global economy and the capital markets, as well as our business.
For example, shut-downs and other limitations imposed in response to the COVID-19 pandemic adversely affected our ability to engage with our existing customers and perform product repairs, as well as to identify and provide product demonstrations and trainings to potential new customers, who largely remained at home during local movement restrictions, and to rehabilitation centers, which temporarily shifted priorities and responses to pandemic-related medical equipment. In addition, staffing shortages within the healthcare system itself resulted in a diminished demand for our SCI Products as the attention of healthcare workers and potential patients turned elsewhere.
Although we have since restarted market development and access programs, we have not seen a full return to pre-pandemic levels, and we believe that our business will continue to be adversely impacted in the short term by the effects of the pandemic-related restrictions and shut-downs.
Results of Operations for the Three Months Ended March 31, 2023 and March 31, 2022
Our operating results for the three months ended March 31, 2023, as compared to the same period in 2022, are presented below. The results set forth below are not necessarily indicative of the results to be expected in future periods.
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Revenues | | $ | 1,230 | | | $ | 876 | |
Cost of revenues | | | 659 | | | | 611 | |
| | | | | | | | |
Gross profit | | | 571 | | | | 265 | |
| | | | | | | | |
Operating expenses: | | | | | | | | |
Research and development, net | | | 752 | | | | 907 | |
Sales and marketing | | | 2,484 | | | | 2,184 | |
General and administrative | | | 1,710 | | | | 1,462 | |
| | | | | | | | |
Total operating expenses | | | 4,946 | | | | 4,553 | |
| | | | | | | | |
Operating loss | | | (4,375 | ) | | | (4,288 | ) |
Financial expenses (income), net | | | (78 | ) | | | 24 | |
| | | | | | | | |
Loss before income taxes | | | (4,297 | ) | | | (4,312 | ) |
Taxes on income | | | 24 | | | | 38 | |
| | | | | | | | |
Net loss | | $ | (4,321 | ) | | $ | (4,350 | ) |
| | | | | | | | |
Net loss per ordinary share, basic and diluted | | $ | (0.07 | ) | | $ | (0.07 | ) |
| | | | | | | | |
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted | | | 59,515,524 | | | | 62,493,496 | |
Three Months Ended March 31, 2023 Compared to Three Months Ended March 31, 2022
Revenues
Our revenues for the three months ended March 31, 2023 and 2022 were as follows:
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
| | (in thousands, except unit amounts) | |
Personal unit revenues | | $ | 1,106 | | | $ | 770 | |
Rehabilitation unit revenues | | | 124 | | | | 106 | |
| | | | | | | | |
Revenues | | $ | 1,230 | | | $ | 876 | |
Personal unit revenues consist of ReWalk Personal 6.0 and Distributed Products sale, rental, service and warranty revenue for home use.
Rehabilitation unit revenues consist of ReStore, Distributed Products and SCI Products sale, rental, service and warranty revenue to clinics, hospitals for treating patients with relevant medical conditions or medical academic centers.
Revenues increased by $354 thousand, or 40%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. The increase is due to higher number of ReWalk Personal 6.0 units sold in the United States, partially offset by fewer sold in Europe.
In the future, we expect our growth to be driven by sales of our ReWalk Personal device through expansion of coverage and reimbursement by commercial and government third-party payors, as well as sales of Distributed Products and the ReStore device to rehabilitation clinics and personal users.
Gross Profit
Our gross profit for the three months ended March 31, 2023 and 2022 was as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Gross profit | | $ | 571 | | | $ | 265 | |
Gross profit was 46% of revenue for the three months ended March 31, 2023 compared to 30% for the three months ended March 31, 2022. The increase in gross profit for the three months ended March 31, 2023 was primarily driven by the higher volume of units sold and an increase in our average selling price due to a change in sales mix.
We expect gross profit and gross margin will increase in the future as we increase our revenue volumes and realize operating efficiencies associated with greater scale which will reduce the cost of revenue as a percentage of revenue. Improvements may be partially offset by the lower margins we currently expect from ReStore and our Distributed Products as well as due to an increase in material costs.
Research and Development Expenses, net
Our research and development expenses, net, for the three months ended March 31, 2023 and 2022 were as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Research and development expenses, net | | $ | 752 | | | $ | 907 | |
Research and development expenses, decreased by $155 thousand, or 17%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. The decrease is attributable to decreased consulting and subcontractors expenses due to the accomplishment of significant milestones in multiple projects.
We intend to focus our research and development expenses mainly on our current products maintenance and improvement as well as in support of the FDA submission for clearance of the ReWalk 7.0 next generation model.
Sales and Marketing Expenses
Our sales and marketing expenses for the three months ended March 31, 2023 and 2022 were as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Sales and marketing expenses | | $ | 2,484 | | | $ | 2,184 | |
Sales and marketing expenses increased by $300 thousand, or 14%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. The increase was driven by higher consulting expenses related to the CMS reimbursement process and higher travel expenses.
In the near term our sales and marketing expenses are expected to be driven by our efforts expand the reimbursement coverage of our ReWalk Personal device and to support our current commercial product activities.
General and Administrative Expenses
Our general and administrative expenses for the three months ended March 31, 2023 and 2022 were as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
General and administrative | | $ | 1,710 | | | $ | 1,462 | |
General and administrative expenses increased by $248 thousand, or 17%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. The increase was driven by increased payroll and related expenses as well as professional services expenses.
Financial Expenses (Income), Net
Our financial expenses (income), net, for the three months ended March 31, 2023 and 2022 were as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Financial expenses (income), net | | $ | (78 | ) | | $ | 24 | |
Financial income, net, increased by $102 thousand for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. This increase was primarily due to interest received from a time deposit and exchange rate fluctuations.
Income Taxes
Our income tax for the three months ended March 31, 2023 and 2022 was as follows (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Taxes on income | | $ | 24 | | | $ | 38 | |
Income taxes decreased by $14 thousand, or 37%, for the three months ended March 31, 2023 compared to the three months ended March 31, 2022 mainly due to tax income from previous years.
Critical Accounting Policies and Estimates
Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of our condensed financial statements requires us to make estimates, judgments and assumptions that can affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We base our estimates, judgments and assumptions on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known. Besides the estimates identified above that are considered critical, we make many other accounting estimates in preparing our condensed financial statements and related disclosures. See Note 2 to our audited consolidated financial statements included in our 2022 Form 10-K for a description of the significant accounting policies that we used to prepare our consolidated financial statements.
There have been no material changes to our critical accounting policies or our critical judgments from the information provided in “Part II, Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations - Critical Accounting Policies” of our 2022 Form 10-K, except for the updates provided in Note 3 of our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of this quarterly report.
Recent Accounting Pronouncements
See Note 3 to our unaudited condensed consolidated financial statements set forth in “Part I, Item 1. Financial Statements” of this quarterly report for information regarding new accounting pronouncements.
Liquidity and Capital Resources
Sources of Liquidity and Outlook
Since inception, we have funded our operations primarily through the sale of certain of our equity securities and convertible notes to investors in private placements, the sale of our ordinary shares in public offerings and the incurrence of bank debt.
During the three months ended March 31, 2023, we incurred a consolidated net loss of $4.3 million and have an accumulated deficit in the total amount of $218.1 million. Our cash and cash equivalent as of March 31, 2023, totaled $61.9 million and our negative operating cash flow for the three months ended March 31, 2023, was $5.2 million. We have sufficient funds to support our operation for more than 12 months following the issuance date of our condensed consolidated unaudited financial statements for the three months ended March 31, 2023.
We expect to incur future net losses and our transition to profitability is dependent upon, among other things, the successful development and commercialization of our products and product candidates, the establishment of contracts for the distribution of new product lines, or the acquisition of additional product lines, any of which, or in combination, would contribute to the achievement of a level of revenues adequate to support our cost structure. Until we achieve profitability or generate positive cash flows, we will continue to need to raise additional cash from time to time.
We intend to fund future operations through cash on hand, additional private and/or public offerings of debt or equity securities, cash exercises of outstanding warrants or a combination of the foregoing. In addition, we may seek additional capital through arrangements with strategic partners or from other sources and we will continue to address our cost structure. Notwithstanding, there can be no assurance that we will be able to raise additional funds or achieve or sustain profitability or positive cash flows from operations.
Our anticipated primary uses of cash are (i) sales, marketing and reimbursement expenses related to market development activities of our ReStore and Personal 6.0 devices, broadening third-party payor and CMS coverage for our ReWalk Personal device and commercializing our new product lines added through distribution agreements; (ii) research and development of our lightweight exo-suit technology for potential home personal health utilization for multiple indications and future generation designs for our spinal cord injury device; (iii) routine product updates; (iv) general corporate purposes, including working capital needs; and (v) potential acquisitions of business. Our future cash requirements will depend on many factors, including our rate of revenue growth, the expansion of our sales and marketing activities, the timing and extent of our spending on research and development efforts and international expansion. If our current estimates of revenue, expenses or capital or liquidity requirements change or are inaccurate, we may seek to sell additional equity or debt securities, arrange for additional bank debt financing, or refinance our indebtedness. There can be no assurance that we will be able to raise such funds at all or on acceptable terms.
Beginning with the filing of our Form 10-K on February 17, 2017, we were subject to limitations under the applicable rules of Form S-3, which constrained our ability to secure capital with respect to public offerings pursuant to our effective Form S-3. These rules limit the size of primary securities offerings conducted by issuers with a public float of less than $75 million to no more than one-third of their public float in any 12-month period. At the time of filing our 2022 Form 10-K, on February 23, 2023, we were subject to these limitations, because our public float did not reach at least $75 million in the 60 days preceding the filing of our 2022 Form 10-K. We will continue to be subject to these limitations for the remainder of the 2023 fiscal year and until the earlier of such time as our public float reaches at least $75 million or when we file our next annual report for the year ended December 31, 2023, at which time we will be required to re-test our status under these rules. If our public float is below $75 million as of the filing of our next annual report on Form 10-K, or at the time we file a new Form S-3, we will continue to be subject to these limitations, until the date that our public float again reaches $75 million. These limitations do not apply to secondary offerings for the resale of our ordinary shares or other securities by selling shareholders or to the issuance of ordinary shares upon conversion by holders of convertible securities, such as warrants. We have registered up to $100 million of ordinary shares warrants and/or debt securities and certain other outstanding securities with registration rights on our registration statement on Form S-3, which was declared effective by the SEC in May 2022.
Share Repurchase Program
In June 2022, we announced that our Board had approved a program to repurchase up to $8.0 million of our ordinary shares, par value NIS 0.25 per share, subject to receipt of Israeli court approval. In July 2022, we announced that we had received approval from an Israeli court for the share repurchase program, valid through January 20, 2023.
On December 19, 2022, our board of directors approved the extension of our on-going share repurchase program, with such extension to be in the aggregate amount of up to $5.8 million. The extension was approved by an Israeli court on February 9, 2023, and will expire on the earlier of August 9, 2023, or reaching the additional $5.8 million of repurchases of our ordinary shares.
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. As of March 31, 2023, we have repurchased approximately 3.7 million of our ordinary shares at an aggregate amount of $3.3 million under the repurchase program.
Cash Flows for the Three Months Ended March 31, 2023 and March 31, 2022 (in thousands):
| | Three Months Ended March 31, | |
| | 2023 | | | 2022 | |
Net cash used in operating activities | | $ | (5,233 | ) | | $ | (5,708 | ) |
Net cash used in investing activities | | | — | | | | (3 | ) |
Net cash used in financing activities | | | (771 | ) | | | — | |
Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash | | | (11 | ) | | | — | |
Net cash flow | | $ | (6,015 | ) | | $ | (5,711 | ) |
Net Cash Used in Operating Activities
Net cash used in operating activities decreased by $475 million or 8% primarily due to decreased insurance prepaid expenses, decreased inventory purchases.
Net Cash Provided by Financing Activities
Net cash used in financing activities was $771 for the three months ended March 31, 2023 compared to $0 for the three months ended March 31, 2022. The increase is due to the repurchase program of our ordinary shares.
Obligations and Contractual Commitments
Set forth below is a summary of our contractual obligations as of March 31, 2023.
| | Payments due by period (in dollars, in thousands) | |
Contractual obligations | | Total | | | Less than 1 year | | | 1-3 years | |
| | | | | | | | | |
Purchase obligations (1) | | $ | 2,064 | | | $ | 2,064 | | | $ | — | |
Collaboration Agreement and License Agreement obligations (2) | | | 65 | | | | 65 | | | | — | |
Operating lease obligations (3) | | | 1,437 | | | | 662 | | | | 775 | |
Total | | $ | 3,566 | | | $ | 2,791 | | | $ | 775 | |
(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) | 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, 2023; 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. Our Collaboration Agreement with Harvard was concluded on March 31, 2022. |
(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 3.615: $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: $1.088, both of which were the applicable exchange rates as of March 31, 2023.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements or guarantees of third-party obligations as of March 31, 2023.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes to our market risk during the first quarter of 2023. For a discussion of our exposure to market risk, please see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our 2022 Form 10-K.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required financial disclosure.
As of the end of the period covered by this quarterly report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Exchange Act). Based upon, and as of the date of, this evaluation, the Chief Executive Officer and the Principal Financial Officer concluded that our disclosure controls and procedures were effective such that the information required to be disclosed by us in our SEC reports is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
During the quarter ended March 31, 2023 there were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
There have been no material changes to our legal proceedings as described in “Part I, Item 3. Legal Proceedings” of our 2022 Form 10-K, except as described in Note 5 in our condensed consolidated financial statements included in “Part I, Item 1” of this quarterly report.
ITEM 1A. RISK FACTORS
There have been no material changes to our risk factors from those disclosed in “Part I, Item 1A. Risk Factors” of our 2022 Form 10-K except as noted below:
Risks Related to Our Business and Our Industry
We do not satisfy all listing requirements for the Nasdaq Capital Market. We can provide no assurance that we will be able to comply with the continued listing requirements over time and that our common stock will continue to be listed on the Nasdaq Capital Market.
As previously disclosed, on October 10, 2022, we received a notification letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company did not satisfy the requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a) (“Rule 5550(a)”) to maintain a minimum bid price of $1 per sharefor the 30 consecutive business days prior to such date. On April 11, 2023, we received a second notification letter from Nasdaq indicating that we have been provided with an additional period of 180 calendar days, or until October 9, 2023, to regain compliance with Rule 5550(a)(2). If at any time before October 9, 2023, the bid price of our ordinary shares closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will provide written confirmation that we have regained compliance. We intend to monitor closely the closing bid price of our ordinary shares and to consider plans for regaining compliance with Rule 5550(a). While we plan to review all available options, there can be no assurance that we will be able to regain compliance with the applicable rules during the second 180-day compliance period, or at all. As in the past, the Nasdaq notification letters are notices of deficiency, not delisting, and do not currently affect the listing or trading of ReWalk ordinary shares on The Nasdaq Capital Market.
If we do not regain compliance with Rule 5550(a) during the applicable cure period, Nasdaq will notify us that our ordinary shares are subject to delisting. We would then be permitted to appeal any delisting determination to a Nasdaq Hearings Panel, and our ordinary shares would remain listed on the Nasdaq Capital Market pending the panel's decision after the hearing. If we do not appeal the delisting determination or do not succeed in such an appeal, our ordinary shares would be removed from trading on the Nasdaq Capital Market. Any delisting determination could seriously decrease or eliminate the value of an investment in our ordinary shares and other securities linked to our ordinary shares. While an alternative listing on an over-the-counter exchange could maintain some degree of a market in our ordinary shares, we could face substantial material adverse consequences, including, but not limited to, the following: limited availability for market quotations for our ordinary shares; reduced liquidity with respect to our ordinary shares; a determination that our ordinary shares are “penny stock” under SEC rules, subjecting brokers trading our ordinary shares to more stringent rules on disclosure and the class of investors to which the broker may sell the ordinary shares; limited news and analyst coverage, in part due to the “penny stock” rules; decreased ability to issue additional securities or obtain additional financing in the future; and potential breaches under or terminations of our agreements with current or prospective large shareholders, strategic investors and banks. The perception among investors that we are at heightened risk of delisting could also negatively affect the market price of our securities and trading volume of our ordinary shares. In the event of a delisting, we can provide no assurance that any action taken by us to restore compliance with listing requirements would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement, or prevent future non-compliance with Nasdaq’s listing requirements.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Items 2(a) and 2(b) are not applicable.
(c) Stock Repurchases.
Issuer Purchases of Equity Securities
The following table sets forth information regarding the ordinary shares repurchased under our share repurchase program during the three months ended March 31, 2023:
Period | | Total Number of Shares Purchased | | | Average Price Paid Per Share | | | Total Number of Shares Purchased as Part of a Publicly Announced Plan | | | (In Thousands) Maximum Value of Shares That May Yet Be Purchased Under the Plan | |
January 1 - January 31, 2023 | | | | | | | | | | | | |
Share repurchase program (1) | | | 730,350 | | | $ | 0.84 | | | | 730,350 | | | $ | 4,730 | |
| | | | | | | | | | | | | | | | |
February 1 - February 28, 2023 | | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | — | | | $ | — | | | | — | | | $ | 4,730 | |
| | | | | | | | | | | | | | | | |
March 1 - March 31, 2023 | | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | — | | | $ | — | | | | — | | | $ | 4,730 | |
Quarter Total | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | 730,350 | | | $ | 0.84 | | | | 730,350 | | | $ | 4,730 | |
(1) Ordinary Shares were repurchased by us through our publicly announced share repurchase program approved by our Board of Directors on June 2, 2022, and approved by an Israeli court on July 20, 2022. The program was scheduled to expire on the earlier of January 20, 2023, or reaching $8.0 million of repurchases. On December 22, 2022, our Board of Directors approved an extension of the repurchase program, with such extension to be in the aggregate amount of up to $5.8 million. The extension was approved by an Israeli court on February 9, 2023, and will expire on the earlier of August 9, 2023, or reaching the additional $5.8 million of repurchases of our ordinary shares.
Repurchases may take place in open market transactions or in privately negotiated transactions and may be made from time to time depending on market conditions, share price, trading volume and other factors our board of directors deems appropriate. Our board of directors may also suspend and/or discontinue the repurchase program at any time, in its sole discretion. All repurchases will be made in accordance with all applicable securities laws and regulations.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBIT INDEX
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. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ReWalk Robotics Ltd. |
| |
Date: May 11, 2023 | By: | /s/ Larry Jasinski |
| | Larry Jasinski |
| | Chief Executive Officer (Principal Executive Officer) |
| | |
Date: May 11, 2023 | By: | /s/ Michael Lawless |
| | Michael Lawless |
| | Chief Financial Officer |
| | (Principal Financial Officer) |
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