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, 2021 as filed with the SEC on February 24, 2022 and amended on May 2, 2022 (the “2021 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 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 September 30, 2022, we had placed 33 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. On September 26, 2022, CMS affirmed that Medicare Administrative Contractors have the discretion to cover and reimburse for the ReWalk exoskeleton. Following this determination, the Company submitted the first case for Medicare coverage in early November and will continue to prepare further cases for submission for Medicare coverage and reimbursement. CMS has stated that it plans to further deliberate on a benefit category designation for the ReWalk exoskeleton and has said that it will provide more information in the near future.
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.
Third Quarter 2022 and Subsequent Period Business Highlights
| • | Total revenue for the third quarter of 2022 was $0.9 million, compared to $2.0 million in the third quarter of 2021; |
| • | Strong cash position with $74.0 million as of September 30, 2022; |
| • | The Company’s operating expenses were $5.7 million in the third quarter of 2022, compared to $3.8 million in the thirds quarter of 2021; |
| • | ReWalk submitted its first case to a MAC in early November and will continue to prepare further cases for submission for Medicare coverage and reimbursement. |
Evolving COVID-19 Pandemic
The impact of the COVID-19 pandemic has resulted in, and will likely continue to result in, significant disruptions to the global economy and the capital markets, as well as our business. A significant number of our global suppliers, vendors, distributors and manufacturing facilities are located in regions that have been affected by the pandemic. Those operations have been materially adversely affected by restrictive government and private enterprise measures implemented in response to the pandemic, which in turn, has negatively impacted our operations. Despite the distribution of COVID-19 vaccines, new and occasionally more virulent variants (including the BA.4 and BA.5 subvariants) of the virus that causes COVID-19, including the Delta and Omicron variants, have emerged, and there is significant uncertainty as to how the countries in which we do business will continue to respond to such outbreaks, including whether there will be future partial or total shutdowns, which would adversely affect our business.
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.
In addition, our future results of operations and liquidity could be adversely impacted by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions and operational challenges faced by our customers. The occurrence of new outbreaks of COVID-19 could result in a widespread health crisis that could adversely affect the economies and financial markets of many countries, resulting in an economic downturn or a global recession that could cause significant volatility or decline in the trading price of our securities, affect our ability to execute strategic business activities such as business combination, affect demand for our products and likely impact our operating results. These may further limit or restrict our ability to access capital on favorable terms, or at all, lead to consolidation that negatively impacts our business, weaken demand, increase competition, cause us to reduce our capital spend further, or otherwise disrupt our business.
During the pandemic, we have implemented remote working procedures in the United States, Germany and Israel and are establishing in-office measures to contain the spread of COVID-19 according to local regulations. With the vaccination of most of our employees, we gradually returned to in-office work arrangements during 2021 and 2022, but we believe there remains the potential risk for future disruptions with the continued spread of new variants. Despite this current situation and the challenges it imposes, we have developed several methods to continue to engage with our current and prospective customers with some partial success through video conferencing, virtual training events, and online education demos to offer our support and showcase the value of our products.
Results of Operations for the Three and Nine Months Ended September 30, 2022 and September 30, 2021
Our operating results for the three and nine months ended September 30, 2022, as compared to the same periods in 2021, are presented below (in thousands, except share and per share data). The results set forth below are not necessarily indicative of the results to be expected in future periods.
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Revenues | | $ | 886 | | | $ | 1,972 | | | $ | 3,332 | | | $ | 4,724 | |
Cost of revenues | | | 665 | | | | 832 | | | | 2,100 | | | | 2,150 | |
| | | | | | | | | | | | | | | | |
Gross profit | | | 221 | | | | 1,140 | | | | 1,232 | | | | 2,574 | |
| | | | | | | | | | | | | | | | |
Operating expenses: | | | | | | | | | | | | | | | | |
Research and development, net | | | 1,065 | | | | 638 | | | | 2,928 | | | | 2,243 | |
Sales and marketing | | | 2,588 | | | | 1,821 | | | | 7,119 | | | | 5,105 | |
General and administrative | | | 2,001 | | | | 1,343 | | | | 5,282 | | | | 4,050 | |
| | | | | | | | | | | | | | | | |
Total operating expenses | | | 5,654 | | | | 3,802 | | | | 15,329 | | | | 11,398 | |
| | | | | | | | | | | | | | | | |
Operating loss | | | (5,433 | ) | | | (2,662 | ) | | | (14,097 | ) | | | (8,824 | ) |
Financial expenses, net | | | 1 | | | | 27 | | | | 69 | | | | 14 | |
| | | | | | | | | | | | | | | | |
Loss before income taxes | | | (5,434 | ) | | | (2,689 | ) | | | (14,166 | ) | | | (8,838 | ) |
Taxes on income (tax benefit) | | | 26 | | | | (14 | ) | | | 90 | | | | 40 | |
Operating loss | | | | | | | | | | | | | | | | |
Net loss | | $ | (5,460 | ) | | $ | (2,675 | ) | | $ | (14,256 | ) | | $ | (8,878 | ) |
| | | | | | | | | | | | | | | | |
Net loss per ordinary share, basic and diluted | | $ | (0.09 | ) | | $ | (0.06 | ) | | $ | (0.23 | ) | | $ | (0.21 | ) |
| | | | | | | | | | | | | | | | |
Weighted average number of shares used in computing net loss per ordinary share, basic and diluted | | | 62,793,847 | | | | 46,570,130 | | | | 62,611,580 | | | | 43,021,972 | |
Three and Nine Months Ended September 30, 2022 Compared to Three and Nine Months Ended September 30, 2021
Revenues
Our revenues for the three and nine months ended September 30, 2022, and 2021, were as follows:
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
| | (in thousands, except unit amounts) | | | (in thousands, except unit amounts) | |
Personal unit revenues | | $ | 822 | | | $ | 1,357 | | | $ | 2,837 | | | $ | 3,818 | |
Rehabilitation unit revenues | | | 64 | | | | 615 | | | | 495 | | | | 906 | |
Revenues | | $ | 886 | | | $ | 1,972 | | | $ | 3,332 | | | $ | 4,724 | |
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.
Revenues decreased by $1.1 million, or 55%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. The decrease is due to lower number of personal 6.0 units sold in Europe and a lower number of personal 6.0 and rehabilitation units sold in the United States. The sales of personal 6.0 units in the quarter were adversely affected by the timing of coverage decisions by insurers and delays in the training timetables for some candidates.
Revenues decreased by $1.4 million, or 29%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The decrease is due to lower number of personal 6.0 units sold in Europe and a lower number of personal 6.0 and rehabilitation units sold in the United States.
We expect that our future revenue growth to be driven by sales of our ReWalk Personal device to third-party payors as we continue to focus our resources on broader commercial coverage policies with third-party payors as well as sales of the ReStore and other products to rehabilitation clinics and personal users.
Gross Profit
Our gross profit for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Gross profit | | $ | 221 | | | $ | 1,140 | | | $ | 1,232 | | | $ | 2,574 | |
Gross profit was 25% of revenue for the three months ended September 30, 2022, compared to 58% for the three months ended September 30, 2021. Gross profit was 37% of revenue for the nine months ended September 30, 2022, compared to 54% for the nine months ended September 30, 2021. The decrease in gross profit for the three and nine months ended September 30, 2022, was mainly driven by the impact of fixed production costs being covered by the margin from fewer sales of the ReWalk Personal 6.0 devices, as well as rising production costs.
We expect our gross profit to improve, assuming we increase our sales volumes to better leverage our operations infrastructure, which could also decrease the product manufacturing costs. 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 the cost of product parts, especially as long as COVID-19 pandemic is affecting the market.
Research and Development Expenses, net
Our research and development expenses, net for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Research and development expenses, net | | $ | 1,065 | | | $ | 638 | | | $ | 2,928 | | | $ | 2,243 | |
Research and development expenses, net increased $427 thousand, or 67%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Research and development expenses increased $685 thousand, or 31%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The increase is attributable to increased personnel and personnel related expenses and subcontractors’ expenses primarily due to development projects offset partially with grant received from the IIA.
We intend to focus our research and development expenses mainly on our current products maintenance and improvement as well as developing our “soft suit” exoskeleton for additional indications affecting the ability to walk or a home use design such as the ReBoot design.
Sales and Marketing Expenses
Our sales and marketing expenses for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Sales and marketing expenses | | $ | 2,588 | | | $ | 1,821 | | | $ | 7,119 | | | $ | 5,105 | |
Sales and marketing expenses increased $767 thousand, or 42%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Sales and marketing expenses increased $2.0 million, or 40%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The increase for the three and nine months ended September 30, 2022, was driven mainly by higher consulting expenses related to CMS reimbursement progress , increase in tradeshow activities since Covid-19 restrictions are being lifted and personnel and personnel related expenses.
In the near term our sales and marketing expenses are expected to be driven by our efforts expand our reimbursement coverage of our ReWalk Personal device and to expand our current product commercialization.
General and Administrative Expenses
Our general and administrative expenses for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
General and administrative expenses | | $ | 2,001 | | | $ | 1,343 | | | $ | 5,282 | | | $ | 4,050 | |
General and administrative expenses increased $658 thousand, or 49%, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. General and administrative expenses increased $1.2 million, or 30%, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The increase in the three and nine months ended September 30, 2022, was mainly driven by increased professional services expenses related to the 2022 proxy process offset partially with a decrease in insurance costs.
Financial Expenses, Net
Our financial expenses, net, for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Financial expenses, net | | $ | 1 | | | $ | 27 | | | $ | 69 | | | $ | 14 | |
Financial expenses, net, decreased by $26 thousand, for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Financial expenses, net, increased by $55 thousand, for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The change was primarily due to exchange rate fluctuations.
Income Taxes
Our income taxes for the three and nine months ended September 30, 2022, and 2021 were as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | | | 2022 | | | 2021 | |
Taxes on income (tax benefit) | | $ | 26 | | | $ | (14 | ) | | $ | 90 | | | $ | 40 | |
Taxes on income increased $40 thousand for the three months ended September 30, 2022, compared to the three months ended September 30, 2021. Taxes on income increased $50 thousand or 125% for the nine months ended September 30, 2022, compared to the nine months ended September 30, 2021. The increase in the three and nine months ended September 30, 2022, was mainly due to deferred taxes and timing differences in our subsidiaries.
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 2021 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 2021 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 nine months ended September 30, 2022, we incurred a consolidated net loss of $14.3 million and as of September 30, 2022, we had an accumulated deficit of $208.4 million. Our cash and cash equivalents as of September 30, 2022, were $74.0 million and our negative operating cash flow for the nine months ended September 30, 2022, was $14.0 million. We believe we have sufficient funds to support our operations for more than 12 months following the issuance date of our condensed consolidated unaudited financial statements for the three and nine months ended September 30, 2022.
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 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.
Further, on October 10, 2022, we received a deficiency letter from the Nasdaq Stock Market LLC (“Nasdaq”) notifying us that because the closing bid price of our ordinary shares had been below the minimum $1.00 per share for 30 consecutive business days, we are out of compliance with the requirements for continued listing on Nasdaq, and are subject to potential delisting. If we are unable to re-achieve compliance with the Nasdaq listing requirements within 180 days, or April 10, 2023, after receipt of a delisting notice, and if we are unable to obtain an extension therefore, we would be subject to delisting, which likely would further impair the liquidity and value of our ordinary shares.
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 pursuant to our ATM Offering Program (as defined below) or other 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 annual report for the year ended December 31, 2020, we were no longer subject to these limitations, because our public float had reached at least $75 million in the 60 days preceding the filing of that annual report. Likewise, because our public float was at least $75 million within the 60 days preceding the date of our 2021 Annual Report, we are not currently subject to these limitations, and will continue to not be subject to these limitations for the remainder of the 2022 fiscal year and until such time as we file our next annual report for the year ended December 31, 2022, at which time we will be required to re-test our status under these rules. If our public float subsequently drops 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 become subject to these limitations again, 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 new registration statement on Form S-3, which was declared effective by the SEC in May 2022.
Equity Offerings and Warrant Exercises
On February 19, 2021, we 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, we 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 as compensation for its role as the placement agent in our February 2021 Offering.
On September 27, 2021, we signed a purchase agreement with certain institutional investors for the issuance and sale of 15,403,014 ordinary shares, 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 our shelf registration statement on Form S-3 initially filed with the 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, we 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 private placement 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.
ATM Offering Program
On May 10, 2016, we entered into our Equity Distribution Agreement with Piper Jaffray, as amended on May 9, 2019, pursuant to which we may offer and sell, from time to time, ordinary shares having an aggregate offering price of up to $25.0 million through Piper Jaffray acting as our agent (the “ATM Offering Program”). Subject to the terms and conditions of the Equity Distribution Agreement, Piper Jaffray will use its commercially reasonable efforts to sell on our behalf all of the ordinary shares requested to be sold by us, consistent with its normal trading and sales practices. Piper Jaffray may also act as principal in the sale of ordinary shares under the Equity Distribution Agreement. Such sales may be made under our Form S-3 in what may be deemed “at-the-market” equity offerings as defined in Rule 415 promulgated under the Securities Act, directly on or through the Nasdaq Capital Market, to or through a market maker other than on an exchange or otherwise, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and/or any other method permitted by law, including in privately negotiated transactions.
Piper Jaffray is entitled to compensation at a fixed commission rate of 3% of the gross sales price per share sold through it as agent under the Equity Distribution Agreement. Where Piper Jaffray acts as principal in the sale of ordinary shares under the Equity Distribution Agreement, such rate of compensation will not apply, but in no event will the total compensation of Piper Jaffray, when combined with the reimbursement of Piper Jaffray for the out-of-pocket fees and disbursements of its legal counsel, exceed 8.0% of the gross proceeds received from the sale of the ordinary shares.
We may instruct Piper Jaffray not to sell ordinary shares if the sales cannot be effected at or above the price designated by us in any instruction. We or Piper Jaffray may suspend an offering of ordinary shares under the ATM Offering Program upon proper notice and subject to other conditions, as further described in the Equity Distribution Agreement. Additionally, the ATM Offering Program will terminate on the earlier of (i) the sale of all ordinary shares subject to the Equity Distribution Agreement, (ii) the date that is three years after a new registration statement on Form S-3 goes effective, (iii) our becoming ineligible to use Form S-3 and (iv) termination of the Equity Distribution Agreement by the parties. The Equity Distribution Agreement may be terminated by Piper Jaffray or us at any time on the close of business on the date of receipt of written notice, and by Piper Jaffray at any time in certain circumstances, including any suspension or limitation on the trading of our ordinary shares on the Nasdaq Capital Market, as further described in the Equity Distribution Agreement. We temporarily suspended use of the ATM Offering Program on February 20, 2019 to facilitate our February 2019 “best efforts” public offering. As of September 30, 2020, we had sold 302,092 ordinary shares under the ATM Offering Program for net proceeds to us of $14.5 million (after commissions, fees, and expenses). Additionally, as of that date, we had paid Piper Jaffray compensation of $471 thousand and had incurred total expenses (including such commissions) of approximately $1.2 million in connection with the ATM Offering Program. No sales were made under the ATM Offering Program during the year ended December 31, 2021 or during the nine months ended September 30, 2022.
We intend to continue using the at-the-market offering or similar continuous offering programs opportunistically to raise additional funds, although we are currently subject to restrictions on using the ATM Offering Program with Piper Jaffray. Under our September 2021 purchase agreement with certain investors, equity or debt securities convertible into, or exercisable or exchangeable for, ordinary shares at a conversion price, exercise price or exchange price which floats with the trading price of the ordinary shares or which may be adjusted after issuance upon the occurrence of certain events or (ii) enter into any agreement including an equity line of credit, whereby the Company may issue securities at a future-determined price, other than an at–the-market facility with the placement agent, H.C. Wainwright & Co, LLC, beginning on March 29, 2022. Such limitations may inhibit our ability to access capital efficiently.
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.
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 September 30, 2022, we have repurchased approximately $183,540 of our ordinary shares under the repurchase program.
Cash Flows for the Nine Months Ended September 30, 2022 and September 30, 2021 (in thousands):
| | Nine Months Ended September 30, | |
| | 2022 | | | 2021 | |
Net cash used in operating activities | | $ | (13,978 | ) | | $ | (8,903 | ) |
Net cash used in investing activities | | | (25 | ) | | | (28 | ) |
Net cash provided by (used in) financing activities | | | (183 | ) | | | 79,808 | |
Effect of Exchange rate changes on Cash, Cash Equivalents and Restricted Cash | | | (182 | ) | | | — | |
Net cash flow | | $ | (14,368 | ) | | $ | 70,877 | |
Net Cash Used in Operating Activities
Net cash used in operating activities increased by $5.0 million or 57% primarily due to lower revenue collection, higher consulting and professional services expenses.
Net Cash Provided by Financing Activities
Net cash provided by financing activities decreased by $79.9 million for the nine months ended September 30, 2022 compared to the nine months ended September 30, 2021, primarily due to the proceeds received through our February 2021 and September 2021 Offering and warrants exercises received during the nine months ended September 30, 2021.
Obligations and Contractual Commitments
Set forth below is a summary of our contractual obligations as of September 30, 2022.
| | Payments due by period (in thousands) | |
Contractual obligations | | Total | | | Less than 1 year | | | 1-3 years | |
| | | | | | | | | |
Purchase obligations (1) | | $ | 1,637 | | | $ | 1,637 | | | $ | — | |
Collaboration Agreement and License Agreement obligations (2) | | | 63 | | | | 63 | | | | — | |
Operating lease obligations (3) | | | 756 | | | | 652 | | | | 104 | |
Total | | $ | 2,456 | | | $ | 2,352 | | | $ | 104 | |
(1) | The Company depends on one contract manufacturer, Sanmina, for both the ReStore products and the SCI Products. We place our manufacturing orders with Sanmina pursuant to purchase orders or by providing forecasts for future requirements. |
(2) | Our Collaboration Agreement with Harvard was originally for a term of five years, commencing in May 2016, and was subsequently amended in April 2018 to extend the term by one additional year. The Collaboration Agreement expired as of March 31, 2022. Under the Collaboration Agreement, we were required to pay in quarterly installments the funding of our joint research collaboration with Harvard, subject to a minimum funding commitment under applicable circumstances. Our License Agreement with Harvard consists of patent reimbursement expenses payments and a license upfront fee payment. There are also several milestone payments contingent upon the achievement of certain product development and commercialization milestones and royalty payments on net sales from certain patents licensed to Harvard. All product development milestones contemplated by the License Agreement have been met as of September 30, 2022; however, there are still outstanding commercialization milestones under the License Agreement that depend on us reaching certain sales amounts, some or all of which may not occur. |
(3) | Our operating leases consist of leases for our facilities in the United States and Israel and motor vehicles. |
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 3.54:$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 0.98 euro:$1:00, both of which were the applicable exchange rates as of September 30, 2022.
Off-Balance Sheet Arrangements
We had no off-balance sheet arrangements or guarantees of third-party obligations as of September 30, 2022.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes to our market risk during the second quarter of 2022. For a discussion of our exposure to market risk, please see Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk” of our 2021 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 September 30, 2022, 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 2021 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.
There have been no material changes to our risk factors from those disclosed in “Part I, Item 1A. Risk Factors” of our 2021 Form 10-K, except as disclosed in our Quarterly Report on Form10-Q for the three months ended March 31, 2022, and 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 (the “Bid Price 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 share. The Company became deficient with Rule 5550(a) as of October 10, 2022 as its closing bid price was less than $1 per share for 30 consecutive business days. As in the past, the Bid Price Letter is a notice of deficiency, not delisting, and does not currently affect the listing or trading of ReWalk ordinary shares on The Nasdaq Capital Market.
We have 180 calendar days, or until April 10, 2023, to regain compliance with Rule 5550(a)(2). If at any time before April 10, 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. Additionally, we may be eligible for a second 180-day period to satisfy Rule 5550(a)’s minimum bid price requirement, if, as of April 10, 2023, we continue to have a market value of publicly held shares of at least $1 million, meet all other initial listing standards of the Nasdaq Capital Market (with the exception of the bid price requirement) and provide written notice of our intention to cure the deficiency during such second compliance period. 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 180-day compliance period, any subsequent extension period, or at all.
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
| | | | | | | | | | | (In Thousands) | |
| | | | | | | | | | | Maximum Value | |
| | | | | | | | Shares Purchased as | | | of Shares That | |
| | Total | | | Average | | | Part of a | | | May Yet Be | |
| | Number of | | | Price | | | Publicly | | | Purchased | |
| | Shares | | | Paid Per | | | Announced | | | Under the | |
Period | | Purchased | | | Share | | | Plan | | | Plan | |
July 1 - July 31, 2022 | | | | | | | | | | | | |
Share repurchase program (1) | | | — | | | $ | — | | | | — | | | | — | |
| | | | | | | | | | | | | | | | |
August 1 - August 31, 2022 | | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | — | | | $ | — | | | | — | | | | — | |
| | | | | | | | | | | | | | | | |
September 1 - September 30, 2022 | | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | 184,629 | | | $ | 0.99 | | | | 184,629 | | | $ | 7,815 | |
Quarter Total | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Share repurchase program (1) | | | 184,629 | | | $ | 0.99 | | | | 184,629 | | | $ | 7,815 | |
(1) | Shares were purchased through the Company’s publicly announced share repurchase program approved by the Company’s Board on June 2, 2022 and approved by an Israeli court on July 20, 2023. The program expires at the earlier of January 20, 2023 or reaching $8.0 million of repurchases. |
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES.
Not applicable.
ITEM 5. OTHER INFORMATION
Not applicable.
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 |
^ | Portions of this exhibit (indicated by asterisks) have been omitted under rules of the SEC permitting the confidential treatment of select information. |
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: November 7, 2022 | By: | /s/ Larry Jasinski | |
| | Larry Jasinski | |
| | Chief Executive Officer | |
| | (Principal Executive Officer) | |
| | | |
Date: November 7, 2022 | By: | /s/ Michael Lawless | |
| | Michael Lawless | |
| | Chief Financial Officer | |
| | (Principal Financial Officer) | |
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