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ReWalk(LFWD) - 2019 Q1 - Quarterly Report

General and Where You Can Find Other Information This section defines company terms and directs readers to where they can access public filings and reports - The report defines 'ReWalk,' 'we,' 'us,' and 'our' as ReWalk Robotics Ltd. and its subsidiaries. Information regarding the company's annual reports (Form 10-K), quarterly reports (Form 10-Q), current reports (Form 8-K), and any amendments or exhibits are available for download, free of charge, on the company's website (www.rewalk.com) and the SEC's website (http://www.sec.gov)[8](index=8&type=chunk) PART I - FINANCIAL INFORMATION This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition ITEM 1. FINANCIAL STATEMENTS (unaudited) This section presents the unaudited condensed consolidated financial statements for ReWalk Robotics Ltd. and its subsidiaries, including balance sheets, statements of operations, changes in shareholders' equity, and cash flows, along with detailed notes explaining significant accounting policies, commitments, and recent financial activities CONDENSED CONSOLIDATED BALANCE SHEETS This section provides a snapshot of the company's financial position, detailing assets, liabilities, and shareholders' equity at specific points in time CONDENSED CONSOLIDATED BALANCE SHEETS | Metric | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | Change (YoY) | | :-------------------------------- | :---------------------------- | :----------------------------- | :----------- | | Cash and cash equivalents | $8,862 | $9,546 | -$684 | | Total current assets | $13,414 | $13,237 | +$177 | | Total long-term assets | $3,622 | $1,725 | +$1,897 | | Total assets | $17,036 | $14,962 | +$2,074 | | Total current liabilities | $7,271 | $5,382 | +$1,889 | | Total long-term liabilities | $7,710 | $7,635 | +$75 | | Total liabilities | $14,981 | $13,017 | +$1,964 | | Total shareholders' equity | $2,055 | $1,945 | +$110 | - Operating lease right-of-use assets were initially recognized at $1,994 thousand as of March 31, 2019, reflecting the adoption of ASU 2016-0210 - Issued and outstanding ordinary shares increased from 2,813,087 at December 31, 2018, to 3,695,174 at March 31, 2019, reflecting a one-for-twenty-five reverse share split effective April 1, 2019, with all prior periods adjusted retroactively1213 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS This section outlines the company's financial performance over a period, presenting revenues, expenses, and net loss CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | Change (YoY) | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Revenues | $1,581 | $1,579 | +$2 | | Cost of revenues | $655 | $897 | -$242 | | Gross profit | $926 | $682 | +$244 | | Total operating expenses | $4,501 | $6,524 | -$2,023 | | Operating loss | $(3,575) | $(5,842) | +$2,267 | | Net loss | $(4,000) | $(6,327) | +$2,327 | | Net loss per ordinary share | $(1.25) | $(5.26) | +$4.01 | - Gross profit margin improved to 59% in Q1 2019, up from 43% in Q1 2018106109 - Total operating expenses decreased by $2,023 thousand, or 31%, year-over-year14 CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY) This section details the changes in the company's shareholders' equity over a period, reflecting share issuances, net loss, and other equity adjustments CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY) | Metric | March 31, 2019 (in thousands) | December 31, 2018 (in thousands) | | :-------------------------- | :---------------------------- | :----------------------------- | | Ordinary Share Amount | $253 | $193 | | Additional paid-in capital | $158,720 | $154,670 | | Accumulated deficit | $(156,918) | $(152,918) | | Total shareholders' equity | $2,055 | $1,945 | - The company issued ordinary shares in a 'best efforts' offering, contributing $3,684 thousand to equity in Q1 201916 - Exercise of pre-funded warrants and warrants generated $107 thousand in additional proceeds in Q1 201916 CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS This section reports the cash generated and used by the company across its operating, investing, and financing activities CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | Metric | Three Months Ended March 31, 2019 (in thousands) | Three Months Ended March 31, 2018 (in thousands) | Change (YoY) | | :----------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Net cash used in operating activities | $(4,253) | $(5,026) | +$773 | | Net cash used in investing activities | $0 | $0 | $0 | | Net cash provided by (used in) financing activities | $3,580 | $(729) | +$4,309 | | Decrease in cash, cash equivalents, and restricted cash | $(673) | $(5,755) | +$5,082 | | Cash, cash equivalents, and restricted cash at end of period | $9,674 | $9,668 | +$6 | - Net cash used in operating activities decreased by $773 thousand, primarily due to reduced operating costs and changes in working capital155 - Net cash provided by financing activities increased significantly to $3.6 million, compared to $729 thousand used in the prior year, mainly due to proceeds from the 'best efforts' offering in Q1 2019156 NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS This section provides detailed explanations and additional information supporting the condensed consolidated financial statements NOTE 1:- GENERAL This note provides an overview of ReWalk Robotics Ltd., its products, and highlights the going concern uncertainty due to accumulated deficits - ReWalk Robotics Ltd. designs, develops, and commercializes the ReWalk system, an exoskeleton for wheelchair-bound individuals, with two product types: ReWalk Personal for home use and ReWalk Rehabilitation for clinical settings22 - The company authorized a 1-for-25 reverse share split on March 27, 2019, effective April 1, 2019, retroactively adjusting all share and per share amounts22 - As of March 31, 2019, the company had an accumulated deficit of approximately $157 million and negative cash flow from operations of $4.3 million, raising substantial doubt about its ability to continue as a going concern23 NOTE 2:- UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS This note clarifies the basis of preparation for the unaudited interim financial statements and their indicative nature - The accompanying interim financial statements are unaudited, prepared in accordance with U.S. GAAP and PCAOB standards for interim information, and include all necessary adjustments for fair presentation26 - The results for the three months ended March 31, 2019, are not necessarily indicative of the results that may be expected for the full year ending December 31, 201926 NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES This note details the key accounting policies applied in preparing the financial statements, including revenue recognition and lease accounting Disaggregation of Revenues (in thousands) | Category | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :---------------------- | :-------------------------------- | :-------------------------------- | | Units placed | $1,474 | $1,528 | | Spare parts and warranties | $107 | $51 | | Total Revenues | $1,581 | $1,579 | - The company adopted ASU 2016-02, Leases (Topic 842), effective January 1, 2019, recognizing right-of-use assets of $2,099 thousand and corresponding lease liabilities of $2,249 thousand upon adoption3741 - This adoption did not materially impact the statements of operations or cash flows3741 Warranty Provision (in thousands) | Metric | US Dollars (in thousands) | | :---------------------- | :------------------------ | | Balance at December 31, 2018 | $304 | | Provision | $88 | | Usage | $(103) | | Balance at March 31, 2019 | $289 | NOTE 4:- INVENTORIES This note provides a breakdown of the company's inventory components, including finished products and raw materials Inventories (in thousands) | Component | March 31, 2019 | December 31, 2018 | | :---------------- | :------------- | :---------------- | | Finished products | $2,086 | $2,240 | | Raw materials | $392 | $0 | | Total | $2,478 | $2,240 | NOTE 5:- COMMITMENTS AND CONTINGENT LIABILITIES This note outlines the company's contractual obligations, lease commitments, contingent liabilities, and ongoing legal proceedings - Non-cancelable outstanding purchase obligations amounted to approximately $323 thousand as of March 31, 201948 Future Lease Payments (in thousands) | Year | Amount | | :--- | :----- | | 2019 | $524 | | 2020 | $638 | | 2021 | $613 | | 2022 | $566 | | 2023 | $439 | | Total lease payments | $2,780 | | Present value of future lease payments | $2,143 | - The company has a contingent liability to the Israel Innovation Authority (IIA) amounting to $1.5 million as of March 31, 2019, related to royalty-bearing grants505152 - Royalties expenses of $3 thousand were recorded in Q1 2019505152 - An ongoing shareholder class action lawsuit in the U.S. District Court for the District of Massachusetts, alleging violations of the Securities Act and Exchange Act, has seen partial dismissal of claims5758 - The company is currently unable to reasonably estimate a possible loss, and no litigation reserve has been recorded5758 NOTE 6:- RESEARCH COLLABORATION AGREEMENT AND LICENSE AGREEMENT This note describes the company's agreements with Harvard for developing soft suit exoskeleton technologies and related payment obligations - The company has a Research Collaboration Agreement and an Exclusive License Agreement with Harvard, extended to May 16, 2022, for developing lightweight 'soft suit' exoskeleton system technologies596061 - Total payment obligation under these agreements is $6.6 million, with $243 thousand recorded as research and development expenses for Q1 2019626364 - The first milestone has been achieved626364 NOTE 7:- SHAREHOLDERS' EQUITY This note details changes in shareholders' equity, including share splits, public offerings, and the status of the Timwell Investment Agreement - A 1-for-25 reverse share split became effective on April 1, 2019, changing authorized ordinary shares from 250,000,000 to 60,000,000 and par value to NIS 0.2565 Share-based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Cost of revenues | $4 | $4 | | Research and development, net | $61 | $114 | | Sales and marketing | $72 | $155 | | General and administrative | $182 | $523 | | Total | $319 | $796 | - The company raised $4.37 million in gross proceeds from a February 2019 public offering of 760,000 ordinary shares at $5.75 per share8081 - The remaining $15 million from the Timwell Investment Agreement (Second and Third Tranches) is at significant risk of not closing due to negotiation issues, leading the company to evaluate alternative pathways for the Chinese market8283 NOTE 8:- FINANCIAL EXPENSES, NET This note provides a breakdown of financial expenses, net, primarily related to foreign currency transactions and loan interest Financial Expenses, Net (in thousands) | Component | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Foreign currency transactions and other | $3 | $(19) | | Financial expenses related to loan agreement with Kreos | $404 | $495 | | Bank commissions | $11 | $9 | | Total Financial expenses, net | $418 | $485 | - Financial expenses, net, decreased by $67 thousand (14%) year-over-year, mainly due to less interest expenses attributable to the Loan Agreement with Kreos117 NOTE 9:- GEOGRAPHIC INFORMATION AND MAJOR CUSTOMER AND PRODUCT DATA This note presents revenue and long-lived asset data disaggregated by geographic region and identifies major customer contributions Revenues by Customer's Location (in thousands) | Region | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------ | :-------------------------------- | :-------------------------------- | | United States | $497 | $1,178 | | Europe | $1,079 | $341 | | Asia-Pacific | $5 | $2 | | Latin America | $0 | $58 | | Total | $1,581 | $1,579 | Long-lived Assets by Geographic Region (in thousands) | Region | March 31, 2019 | December 31, 2018 | | :------ | :------------- | :---------------- | | Israel | $193 | $206 | | United States | $279 | $330 | | Germany | $60 | $90 | | Total | $532 | $626 | - Major customer data shows Customer A accounted for 37.2% of total revenues in Q1 2018 but less than 10% in Q1 2019, while Customer B accounted for 12.9% in Q1 201987 NOTE 10:- SUBSEQUENT EVENTS This note discloses significant events occurring after the balance sheet date, including a reverse share split and a registered direct offering - The 1-for-25 reverse share split became effective on April 1, 201988 - On April 5, 2019, the company closed a registered direct offering, issuing 816,914 ordinary shares at $5.2025 per share and warrants to purchase up to 408,457 ordinary shares at an exercise price of $5.14, generating approximately $4.25 million in gross proceeds8990 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This section provides management's perspective on the company's financial condition and operational results, covering revenue, expenses, liquidity, and key business highlights Special Note Regarding Forward-Looking Statements This section cautions readers about forward-looking statements, outlining inherent risks and the company's non-obligation to update them - The report contains forward-looking statements based on management's beliefs and assumptions, which are subject to important factors that could cause actual results to differ materially9395 - Key risks include the ability to secure capital, maintain Nasdaq listing, achieve reimbursement, develop new products, and manage litigation9498 - The company undertakes no obligation to publicly update any forward-looking statements97 Overview This section provides a general description of ReWalk Robotics' products, reimbursement efforts, and ongoing financial challenges including net losses - ReWalk Robotics develops and commercializes robotic exoskeletons (ReWalk Personal and ReWalk Rehabilitation) and is developing a lightweight 'soft suit' exoskeleton for various lower limb disabilities99 - Reimbursement efforts include a VA national policy for veterans (19 units placed as of March 31, 2019) and coverage decisions from German insurers100101 - The company has incurred net losses and negative cash flow from inception, expecting this to continue, and plans to focus resources on regulatory activities for ReStore, commercialization, and reimbursement coverage102 First Quarter 2019 and Subsequent Period Business Highlights This section highlights key business achievements and financial performance for Q1 2019, including revenue, gross margin, and product launch progress - Total revenue for Q1 2019 was $1.6 million, with gross margin improving to 59% from 43% in the prior year quarter106 - 14 units were placed in Q1 2019, with strong sales in Europe ($1.1 million, 10 units placed, 5 rented units converted to purchases)106 - The company is on track to launch ReStore in the United States and Europe in late Q2 or Q3 2019, pending regulatory clearances, and has regained compliance with Nasdaq listing requirements after fundraising and a reverse split106 Three Months Ended March 31, 2019 Compared to Three Months Ended March 31, 2018 This section provides a detailed comparative analysis of the company's financial performance for the first quarter of 2019 versus 2018 Revenues This section analyzes the company's revenue performance, detailing unit placements and revenue sources for the comparative periods Revenue Performance (in thousands, except unit amounts) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | Change (YoY) | | :---------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Personal units placed | 14 | 22 | -8 | | Rehabilitation units placed | 0 | 1 | -1 | | Total units placed | 14 | 23 | -9 | | Personal unit revenues | $1,546 | $1,499 | +$47 | | Rehabilitation unit revenues | $0 | $80 | -$80 | | Other revenues | $35 | $0 | +$35 | | Total Revenues | $1,581 | $1,579 | +$2 | - Revenues remained flat year-over-year at $1.6 million, with other revenues in Q1 2019 associated with usage of ReStore clinical trial units107 - Future growth is expected to be driven by sales of ReWalk Personal devices to third-party payors and ReStore devices to rehabilitation institutes108 Gross Profit This section discusses the company's gross profit and gross margin trends, attributing changes to sales mix and future expectations Gross Profit (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | Change (YoY) | | :---------- | :-------------------------------- | :-------------------------------- | :----------- | | Gross profit | $926 | $682 | +$244 | | Gross margin | 59% | 43% | +16 ppts | - The increase in gross profit was mainly driven by a higher average selling price due to a change in sales mix109 - Gross profit is expected to remain at current levels and potentially improve with increased sales volumes and decreased manufacturing costs, though this may be partially offset by lower margins from the new ReStore device and increased product part costs110 Research and Development Expenses This section analyzes changes in R&D expenses, focusing on cost reductions and future development priorities for new products Research and Development Expenses (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expenses, net | $1,414 | $2,151 | - R&D expenses decreased by $737 thousand, or 34%, primarily due to decreased costs associated with the development and clinical study of the ReStore soft suit exoskeleton112 - Near-term R&D focus is on the ReStore system for stroke patients, and longer-term on a 'soft suit' exoskeleton for additional indications and the next generation of the ReWalk device113 Sales and Marketing Expenses This section examines the decrease in sales and marketing expenses due to cost reduction efforts and outlines future commercialization focus Sales and Marketing Expenses (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------------------ | :-------------------------------- | :-------------------------------- | | Sales and marketing expenses | $1,587 | $2,336 | - Sales and marketing expenses decreased by $749 thousand, or 32%, driven by lower personnel and personnel-related costs and consulting expenses due to cost reduction efforts114 - Near-term sales and marketing expenses are expected to be driven by efforts to commercialize the ReStore device and increase reimbursement for the ReWalk Personal device115 General and Administrative Expenses This section details the reduction in general and administrative expenses, primarily due to lower compensation costs in the prior year General and Administrative Expenses (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | General and administrative | $1,500 | $2,037 | - General and administrative expenses decreased by $537 thousand, or 26%, primarily due to cash and non-cash compensation recorded in Q1 2018 related to severance accrual for the company's former chief financial officer116 Financial Expenses, Net This section analyzes the decrease in net financial expenses, mainly attributed to reduced interest costs from the Kreos Loan Agreement Financial Expenses, Net (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :---------------------- | :-------------------------------- | :-------------------------------- | | Financial expenses, net | $418 | $485 | - Financial expenses, net, decreased by $67 thousand, or 14%, mainly due to less interest expenses attributable to the Loan Agreement with Kreos117 Income Taxes This section reports the company's income tax expense for the period, noting a slight increase compared to the prior year Income Taxes (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :---------- | :-------------------------------- | :-------------------------------- | | Income taxes | $7 | $0 | - Income taxes increased by $7 thousand for Q1 2019 compared to zero in the prior year period118 Critical Accounting Policies and Estimates This section confirms no material changes to critical accounting policies, referencing updates in the financial statements notes - There have been no material changes to the company's critical accounting policies or judgments from the information provided in the 2018 Form 10-K, except for updates in Note 3 of the current report's financial statements120 Recent Accounting Pronouncements This section directs readers to Note 3 for information regarding the adoption of new accounting pronouncements - Information regarding new accounting pronouncements is provided in Note 3 to the unaudited condensed consolidated financial statements121 Liquidity and Capital Resources This section discusses the company's cash position, financing plans, and the substantial doubt about its ability to continue as a going concern Sources of Liquidity and Outlook This section outlines the company's current cash position, future financing plans, and the unreliability of the Timwell Investment Agreement - As of March 31, 2019, the company had $8.9 million in cash and cash equivalents, but an accumulated deficit of approximately $157 million and anticipated further losses raise substantial doubt about its ability to continue as a going concern124 - The company plans to finance operating costs over the next twelve months using existing cash, reduced operating spend, issuances under its ATM Offering Program, and other future equity and debt securities125 - The Investment Agreement with Timwell is no longer considered a reliable source of ongoing liquidity, with a significant risk that the remaining $15.0 million of issuances will not close126 Loan Agreement with Kreos and Related Warrant to Purchase Ordinary Shares This section details the company's loan agreement with Kreos Capital, including interest rates, repayment schedules, and outstanding principal - The company has a $20 million loan agreement with Kreos Capital, with an interest rate of 10.75% per year, secured by a first priority security interest over all company assets130 - A Second Amendment in November 2018 resulted in the repayment of a $3.0 million Kreos Convertible Note and a revised repayment schedule for the remaining loan principal132135 - As of March 31, 2019, the outstanding principal amount under the Kreos Loan Agreement was $8.3 million136 Equity Raises This section summarizes the company's history of equity raises, including IPO, ATM programs, and public offerings, and discusses limitations - The company has conducted several equity raises, including an IPO ($36.3 million net proceeds in Sept 2014), an ATM Offering Program (up to $25 million), and various follow-on public offerings (e.g., $13.1 million gross in Nov 2018, $4.37 million gross in Feb 2019, $4.25 million gross in April 2019)137140141142 - Due to Form S-3 limitations, the company can only sell approximately $8.5 million in primary offerings under Form S-3 in any 12-month period while its public float is less than $75 million143 - Future capital raises may require more costly or time-consuming methods like Form S-1 registration statements or private placements, which could result in substantial shareholder dilution144 ATM Offering Program This section describes the company's at-the-market equity offering program, including sales, proceeds, and temporary suspension - Under the Equity Distribution Agreement with Piper Jaffray, the company may sell up to $25.0 million in ordinary shares, with Piper Jaffray receiving a 3.0% fixed commission rate145146 - As of March 31, 2019, 302,092 ordinary shares were sold under the program for $14.5 million in net proceeds147 - The program was temporarily suspended on February 20, 2019147 - Recent agreements impose restrictions on certain equity/debt issuances for six months after April 5, 2019, and February 25, 2019, with specific conditions for ATM sales148 Timwell Private Placement This section details the Timwell Investment Agreement, highlighting the significant risk to the remaining tranches and alternative market strategies - The $20 million Investment Agreement with Timwell Corporation involved three tranches, with the first tranche ($5 million for 160,000 shares) closing on May 15, 2018150151 - The remaining $15 million from the Second and Third Tranches are at significant risk of not closing due to negotiation issues on definitive joint venture and license agreements152 - The company is evaluating alternative pathways with RealCan (Timwell's affiliate) or other groups to commercialize products in the Chinese market152 Cash Flows for the Three Months Ended March 31, 2019 and March 31, 2018 This section provides a comparative analysis of cash flows from operating and financing activities for the specified periods Net Cash Used in Operating Activities This section analyzes the decrease in net cash used in operating activities, primarily due to a reduction in operating costs and changes in working capital Net Cash Used in Operating Activities (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(4,253) | $(5,026) | - Net cash used in operating activities decreased by $773 thousand, primarily due to a reduction in operating costs and changes in working capital155 Net Cash Provided by (Used in) Financing Activities This section details the significant increase in net cash provided by financing activities, driven by proceeds from a public offering Net Cash Provided by (Used in) Financing Activities (in thousands) | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash provided by (used in) financing activities | $3,580 | $(729) | - Net cash provided by financing activities increased to $3.6 million, compared to $729 thousand used in the prior year, primarily due to higher proceeds from the 'best efforts' offering in Q1 2019156 Obligations and Commercial Commitments This section presents a table of the company's contractual obligations, including purchase, lease, and debt commitments Contractual Obligations as of March 31, 2019 (in thousands) | Contractual obligations | Total | Less than 1 year | 1-3 years | 3-5 years | More than 5 years | | :---------------------- | :------- | :--------------- | :-------- | :-------- | :---------------- | | Purchase obligations | $323 | $323 | $0 | $0 | $0 | | Collaboration Agreement and License Agreement obligations | $2,888 | $925 | $1,763 | $200 | $0 | | Operating lease obligations | $2,780 | $686 | $1,232 | $862 | $0 | | Long-term debt obligations | $10,290 | $3,990 | $6,300 | $0 | $0 | | Total | $16,281 | $5,924 | $9,295 | $1,062 | $0 | - Collaboration Agreement and License Agreement obligations exclude contingent milestone payments, which are not included due to their uncertain achievement and timing160 Off-Balance Sheet Arrangements This section confirms the absence of any off-balance sheet arrangements or third-party guarantees for the company - The company had no off-balance sheet arrangements or guarantees of third-party obligations as of March 31, 2019160 ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This section states that there have been no material changes to the company's market risk during the first quarter of 2019, referring to the 2018 Form 10-K for a detailed discussion of market risk exposure - There have been no material changes to the company's market risk during the first quarter of 2019161 - For a discussion of market risk exposure, refer to Part II, Item 7A of the 2018 Form 10-K161 ITEM 4. CONTROLS AND PROCEDURES This section details the company's disclosure controls and procedures, confirming their effectiveness as evaluated by management, and reports no material changes in internal control over financial reporting during the quarter Disclosure Controls and Procedures This section confirms management's evaluation of disclosure controls and procedures, concluding their effectiveness for timely and accurate reporting - Management, including the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of disclosure controls and procedures as of March 31, 2019163 - Based on this evaluation, they concluded that the disclosure controls and procedures were effective in ensuring timely and accurate reporting of information required by the Exchange Act163 Changes in Internal Control over Financial Reporting This section reports no material changes in internal control over financial reporting during the quarter ended March 31, 2019 - During the quarter ended March 31, 2019, there were no changes in internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting164 PART II - OTHER INFORMATION This part provides additional information beyond the financial statements, including legal proceedings, risk factors, and exhibits ITEM 1. LEGAL PROCEEDINGS This section states that there have been no material changes to the company's legal proceedings from those described in its 2018 Form 10-K, except as detailed in Note 5 of the condensed consolidated financial statements - No material changes to legal proceedings from the 2018 Form 10-K, except as described in Note 5 of the condensed consolidated financial statements167 ITEM 1A. RISK FACTORS This section updates the company's risk factors, including going concern issues, funding limitations, Nasdaq compliance, and regulatory challenges - The company faces substantial doubt about its ability to continue as a going concern due to an accumulated deficit of approximately $157 million and the need for additional financing169 - Limitations under Form S-3 restrict primary offerings to approximately $8.5 million in any 12-month period, and recent agreements impose further restrictions on certain equity/debt issuances for six months170171 - Despite regaining compliance with Nasdaq's $2.5 million shareholders' equity requirement, the company's listing remains subject to ongoing monitoring, with a risk of delisting if compliance is not maintained175176 - The 1:25 reverse share split, effective April 1, 2019, has seen the market price of ordinary shares fall substantially post-split, potentially affecting market capitalization and liquidity179 - The ongoing mandatory FDA postmarket surveillance study for the ReWalk Personal 6.0 is experiencing 'inadequate' enrollment progress, which could lead to FDA enforcement actions, including marketing limitations or a requirement to stop marketing the device196197 ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS This section confirms that there are no unregistered sales of equity securities or use of proceeds that have not been previously disclosed in a Current Report on Form 8-K - There are no transactions regarding unregistered sales of equity securities or use of proceeds that have not been previously included in a Current Report on Form 8-K198 ITEM 3. DEFAULTS UPON SENIOR SECURITIES This section states that there are no defaults upon senior securities to report - This item is not applicable199 ITEM 4. MINE SAFETY DISCLOSURES This section states that there are no mine safety disclosures to report - This item is not applicable200 ITEM 5. OTHER INFORMATION This section states that there is no other information to report - This item is not applicable201 ITEM 6. EXHIBITS This section lists all exhibits filed as part of the Form 10-Q, including various agreements, certifications, and XBRL documents - The exhibits include the form of placement agent warrant and securities purchase agreement related to the February 2019 public offering, certifications from principal executive and financial officers (Sarbanes-Oxley Act), and XBRL instance and taxonomy documents202 SIGNATURES This section confirms the official signing of the report by the Chief Executive Officer and Chief Financial Officer - The report is duly signed on behalf of ReWalk Robotics Ltd. by Larry Jasinski, Chief Executive Officer, and Ori Gon, Chief Financial Officer, on May 8, 2019206