REWALK ROBOTICS LTD. – 10-Q – 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 endedDecember 31, 2021 as filed with theSEC onFebruary 24, 2022 and amended onMay 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. InMay 2021 , the FDA granted breakthrough design designation to the ReWalk Personal stairs feature. InJune 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 inthe United States , which is currently under review. We have also developed and began commercializing our ReStore device inJune 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 inthe United States and will also have distribution rights for the MYOLYN MyoCycleFES cycles toU.S. rehabilitation clinics and personal sales throughU.S. Department of Veteran Affairs ("VA") hospitals. These new products will improve our product offering to clinics as well as patients within theVA as they both have similar clinician and patient profile.
Our principal markets are
direct sales operation in
distribution partners in certain other major countries. We have offices in
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 inthe 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. InDecember 2015 , theVA issued a national policy for the evaluation, training and procurement of ReWalk Personal exoskeleton systems for all qualifying veterans acrossthe United States . TheVA policy is the first national coverage policy inthe United States for qualifying individuals who have suffered spinal cord injury. As ofSeptember 30, 2022 , we had placed 33 units as part of theVA policy. According to a 2017 report published by theCenters 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. InJuly 2020 , a code was issued for ReWalk Personal 6.0 (effectiveOctober 1, 2020 ), which might later be followed by coverage policy of CMS. OnJune 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. OnSeptember 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. 24 -------------------------------------------------------------------------------- Additionally, to date, several private insurers inthe United States andEurope have provided reimbursement for ReWalk in certain cases. InGermany , we continue to make progress toward achieving ReWalk coverage from the various government, private and worker's compensation payors. InSeptember 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. InFebruary 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 firstGerman 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
million in the third quarter of 2021; • Strong cash position with$74.0 million as ofSeptember 30, 2022 ;
• The Company's operating expenses were
2022, compared to
• 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 theU.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 areGermany andthe 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 asVA 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 inthe United States ,Germany andIsrael 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. 25 --------------------------------------------------------------------------------
Results of Operations for the Three and Nine Months Ended
Our operating results for the three and nine months endedSeptember 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 Nine Months Ended September 30, 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 )
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
Ended
Revenues Our revenues for the three and nine months endedSeptember 30, 2022 , and 2021, were as follows: Three Months Ended Nine Months Ended September 30, 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.
26 -------------------------------------------------------------------------------- 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 endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . The decrease is due to lower number of personal 6.0 units sold inEurope and a lower number of personal 6.0 and rehabilitation units sold inthe 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$1.4 million , or 29%, for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The decrease is due to lower number of personal 6.0 units sold inEurope and a lower number of personal 6.0 and rehabilitation units sold inthe United States . We expect that our future revenue growth to be driven by sales of our ReWalk Personal device to third-party payors as we continue to focus our resources on broader commercial coverage policies with third-party payors as well as sales of the ReStore and other products to rehabilitation clinics and personal users.
Gross Profit
Our gross profit for the three and nine months ended
2021 were as follows (in thousands):
Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Gross profit$ 221 $ 1,140 $ 1,232 $ 2,574 Gross profit was 25% of revenue for the three months endedSeptember 30, 2022 , compared to 58% for the three months endedSeptember 30, 2021 . Gross profit was 37% of revenue for the nine months endedSeptember 30, 2022 , compared to 54% for the nine months endedSeptember 30, 2021 . The decrease in gross profit for the three and nine months endedSeptember 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. 27
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Research and Development Expenses, net
Our research and development expenses, net for the three and nine months ended
Three Months Ended Nine Months EndedSeptember 30 ,September 30, 2022 2021
2022 2021
Research and development expenses, net
Research and development expenses, net increased$427 thousand , or 67%, for the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . Research and development expenses increased$685 thousand , or 31%, for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The increase is attributable to increased personnel and personnel related expenses and subcontractors' expenses primarily due to development projects offset partially with grant received from the IIA. We intend to focus our research and development expenses mainly on our current products maintenance and improvement as well as developing our "soft suit" exoskeleton for additional indications affecting the ability to walk or a home use design such as the ReBoot design.
Sales and Marketing Expenses
Our sales and marketing expenses for the three and nine months ended
30, 2022
Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Sales and marketing expenses$ 2,588 $ 1,821 $ 7,119 $ 5,105 Sales and marketing expenses increased$767 thousand , or 42%, for the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . Sales and marketing expenses increased$2.0 million , or 40%, for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The increase for the three and nine months endedSeptember 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
Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021
General and administrative expenses
General and administrative expenses increased$658 thousand , or 49%, for the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . General and administrative expenses increased$1.2 million , or 30%, for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The increase in the three and nine months endedSeptember 30, 2022 , was mainly driven by increased professional services expenses related to the 2022 proxy process offset partially with a decrease in insurance costs. 28 --------------------------------------------------------------------------------
Financial Expenses, Net
Our financial expenses, net, for the three and nine months ended
2022
Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 Financial expenses, net$ 1 $ 27 $ 69 $ 14 Financial expenses, net, decreased by$26 thousand , for the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . Financial expenses, net, increased by$55 thousand , for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The change was primarily due to exchange rate fluctuations.
Income Taxes
Our income taxes for the three and nine months ended
2021 were as follows (in thousands):
Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021
Taxes on income (tax benefit)
Taxes on income increased$40 thousand for the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . Taxes on income increased$50 thousand or 125% for the nine months endedSeptember 30, 2022 , compared to the nine months endedSeptember 30, 2021 . The increase in the three and nine months endedSeptember 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 withU.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.
29 --------------------------------------------------------------------------------
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 endedSeptember 30, 2022 , we incurred a consolidated net loss of$14.3 million and as ofSeptember 30, 2022 , we had an accumulated deficit of$208.4 million . Our cash and cash equivalents as ofSeptember 30, 2022 , were$74.0 million and our negative operating cash flow for the nine months endedSeptember 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 endedSeptember 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, onOctober 10, 2022 , we received a deficiency letter from theNasdaq 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, orApril 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.
Equity Raises
Beginning with the filing of our Form 10-K onFebruary 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 endedDecember 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 endedDecember 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 theSEC inMay 2022 . 30 --------------------------------------------------------------------------------
Equity Offerings and Warrant Exercises
OnFebruary 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 valueNIS 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 fromFebruary 19, 2021 , untilAugust 26, 2026 . Additionally, we issued warrants to purchase up to 655,290 ordinary shares, with an exercise price of$4.578125 per share, exercisable fromFebruary 19, 2021 , untilAugust 26, 2026 , to certain representatives ofH.C. Wainwright as compensation for its role as the placement agent in ourFebruary 2021 Offering. OnSeptember 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 theSEC onMay 9, 2019 , and declared effective by theSEC onMay 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 onSeptember 27, 2021 , and the offering closed onSeptember 29, 2021 . Additionally, we issued warrants to purchase up to 960,811 ordinary shares, with an exercise price of$2.5438 per share, exercisable fromSeptember 27, 2021 , untilSeptember 27, 2026 , to certain representatives ofH.C. Wainwright as compensation for its role as the placement agent in ourSeptember 2021 private placement offering. As ofSeptember 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
OnMay 10, 2016 , we entered into our Equity Distribution Agreement withPiper Jaffray , as amended onMay 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 throughPiper 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. WherePiper 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 ofPiper Jaffray , when combined with the reimbursement ofPiper 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. 31 -------------------------------------------------------------------------------- We may instructPiper Jaffray not to sell ordinary shares if the sales cannot be effected at or above the price designated by us in any instruction. We orPiper 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 byPiper Jaffray or us at any time on the close of business on the date of receipt of written notice, and byPiper 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 onFebruary 20, 2019 to facilitate ourFebruary 2019 "best efforts" public offering. As ofSeptember 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 paidPiper 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 endedDecember 31, 2021 or during the nine months endedSeptember 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 withPiper Jaffray . Under ourSeptember 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 onMarch 29, 2022 . Such limitations may inhibit our ability to access capital efficiently.
Share Repurchase Program
InJune 2022 , we announced that our Board had approved a program to repurchase up to$8.0 million of our ordinary shares, par valueNIS 0.25 per share, subject to receipt of Israeli court approval. InJuly 2022 , we announced that we had received approval from an Israeli court for the share repurchase program, valid throughJanuary 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 ofSeptember 30, 2022 , we have repurchased approximately$183,540 of our ordinary shares under the repurchase program. 32 --------------------------------------------------------------------------------
Cash Flows for the Nine Months Ended
(in thousands):
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