8-K
Lifeward Ltd. (LFWD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 28, 2023
ReWalk Robotics Ltd.
(Exact name of registrant as specified in its charter)
| Israel | 001-36612 | Not applicable |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 3 Hatnufa St., Floor 6, Yokneam Ilit, Israel | 2069203 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: +972.4.959.0123
| Not applicable |
|---|
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions \(see General Instruction A.2. below\):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Ordinary Shares, par value NIS 0.25 | RWLK | Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On April 28, 2023, ReWalk Robotics Ltd. (the “Company”) posted to the “Investors” section of its website an investor presentation slideshow (the “Presentation”), which is furnished herewith as Exhibit 99.1. The Company intends to use the Presentation from time to time in making presentations to analysts, potential investors, and other interested parties.
The information in this Current Report on Form 8-K, including Exhibit 99.1 (this “Report”), shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “1934 Act”), nor shall it be deemed “incorporated by reference” into any filing under the Securities Act of 1933, as amended, or the 1934 Act, except as may be expressly set forth by specific reference in such filing. Information contained on, or that can be accessed through, the Company’s website does not constitute a part of, and is not incorporated by reference into, this Report.
Item 9.01 Financial Statements and Exhibits.
(d)
| 99.1 | Investor presentation.* |
|---|---|
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* Furnished herewith
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ReWalk Robotics Ltd. | ||
|---|---|---|
| Dated: April 28, 2023 | By: | /s/ Michael Lawless |
| Name: | Michael Lawless | |
| Title: | Chief Financial Officer |
Exhibit 99.1
ReWalk Robotics Investor Presentation April 2023 Confidential – ReWalk Robotics 2023 NASDAQ:RWLK
Forward Looking Statements This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, Section 27A of the U.S. Securities Act of 1933, and Section 21E of the U.S. Securities Exchange Act of 1934. All statements contained in this presentation other than statements of historical fact are forward-looking statements. Such forward-looking statements may include projections regarding ReWalk's future performance and, in some cases, may be identified by words like "anticipate," "assume," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "future," "will," "should," "would," "seek," and similar terms or phrases. The forward-looking statements contained in this presentation are based on management's current expectations, which are subject to uncertainty, risks and changes in circumstances that are difficult to predict and many of which are outside of ReWalk's control. Important factors that could cause ReWalk's actual results to differ materially from those indicated in the forward-looking statements are more fully described in ReWalk’s periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled "Risk Factors" in ReWalk's annual and quarterly reports that ReWalk files with the SEC. In addition, this presentation contains estimates, projections and other information concerning market, industry and other data. ReWalk obtained this data from its own internal estimates and research and from academic and industry research, publications, surveys, and studies conducted by third parties, including governmental agencies. These data involve a number of assumptions and limitations, are subject to risks and uncertainties, and are subject to change based on various factors, including those discussed in ReWalk’s filings with the SEC. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by ReWalk. While management believes such information is generally reliable, ReWalk has not independently verified any third-party information. Forward-looking statements made in this presentation are based on a combination of facts and factors currently known to management and speak only as of the date hereof. Factors or events that could cause ReWalk's actual results to differ from the statements contained herein may emerge from time to time, and it is not possible for ReWalk to predict all of them. Except as required by law, ReWalk undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise. Confidential – ReWalk Robotics 2023
Advancing Quality of Life After Neurological Injury or Disability Confidential – ReWalk Robotics 2023 ReWalk Robotics Mission: To fundamentally improve the quality of life for individuals with neurological injury or disability through innovative technologies that enable mobility and wellness in rehabilitation and daily life. YouTube Link: youtu.be/UwIUJaYJ3iM
Neurologic disease or injury, including spinal cord injury (“SCI”) or stroke, historically results in a lifetime of disability and chronic health complications from a sedentary lifestyle. ReWalk Robotics provides solutions that leverage robotics and biomechanics to facilitate neurorehabilitation in the clinic and at home, profoundly restoring functional mobility for patients otherwise highly limited in their day-to-day lives. Getting People Back to Doing What They Love Confidential – ReWalk Robotics 2023
Strategic catalysts in 2023 FDA approval of stairs / curb capability CMS approval for Medicare reimbursement of exoskeletons FDA approval of next-generation of exoskeleton Consolidation activity through strategic acquisitions Market-leading innovation – First-to-market personal exoskeleton for spinal cord injury, with over 600 placements worldwide Large and growing market opportunity – $1.1 billion market forecast to grow 8% annually Strong cash position – Resources to fund organic growth, M&A, and internal development Strategic vision – Leverage leadership position in exoskeletons to become consolidator of broad portfolio of high-value NeuroRehabilitation solutions Experienced management – Multi-disciplinary leadership with successful track records in medical technology, life science tools, and biopharmaceuticals A Leader in NeuroRehabilitation Solutions Confidential – ReWalk Robotics 2023
A History of Innovation Confidential – ReWalk Robotics 2023 ReWalk Robotics has consistently pioneered NeuroRehabilitation solutions as standard of care 2014 2015 2019 2020 2021 2022 2023 …establish exoskeleton SOP with the Dept. of Veterans Affairs …establish HCPCS code for exoskeletons with Medicare …submit claim for Medicare coverage for personal exoskeleton use at home and in the community First to: …market exoskeleton with de novo FDA approval …establish exoskeletons within the Medical Device Directory in Germany …introduce soft-suit technology with the ReStore exo-suit for stroke rehabilitation …achieve two separate FDA Breakthrough Device Designations for next-gen. exoskeletons and exo-suits …earn FDA clearance of personal exoskeleton for use on stairs and curbs
NeuroRehabilitation Market is Sizeable and Growing Confidential – ReWalk Robotics 2023 NeuroRehabilitation Equipment Market1 $ in billions CAGR of 8.3% NeuroRehabilitation Equipment Market by Product Type1 Neurorehabilitation: The rehabilitation and management of patients with diseases, injury, or disorders of the nervous system. Primary goals are to improve function, reduce symptoms, and improve the well-being of the patient.
NeuroRehabilitation: Growing Market Opportunities Confidential – ReWalk Robotics 2023 Market tailwinds that ReWalk will leverage: Technological advances. Continued innovation and efficiency improvements in robotics, sensors, power systems Market adoption. Introduction of VR & app-based patient services likely to increase patient adherence and improve outcomes Aging demographics. WHO forecasts proportion of age 65+ will grow from 7% (2000) to 16% (2050) Industry headwinds that create opportunity: Market access. ReWalk Robotics has been at the forefront of collaborating with payors, successfully navigating reimbursement hurdles in the US and Germany Scalability. High-touch sales process limits scalability for small, undercapitalized, single-product companies, benefitting ReWalk Robotics in leveraging sales efficiencies across multiple product offerings
Product Portfolio Confidential – ReWalk Robotics 2023 9
A Growing Portfolio of Solutions for NeuroRehabilitation Confidential – ReWalk Robotics 2023 ReWalk Personal Exoskeleton Cutting edge technology that provides paralyzed individuals with access to greater mobility and the health-related benefits of walking in daily life. ReStore Exo-Suit Versatile, robotic gait-training solution designed to promote restoration of functional walking patterns post-stroke through training in the clinic. MyoCycle FES Functional electrical stimulation (FES) bikes that enable users with weakness or paralysis to cycle under their own power in the clinic and at home. Core Product Distributed Product
Flagship Product – ReWalk Personal Exoskeleton Confidential – ReWalk Robotics 2023 The ReWalk Personal Exoskeleton enables paralyzed individuals with spinal cord injury to stand, walk, and ascend or descend stairs and curbs during everyday activities. The most widely available and utilized personal exoskeleton in the world Received CE clearance in 2012 FDA de novo approval in 2014 FDA stairs clearance in 2023 Over 600 personal systems placed worldwide
The Leader in Exoskeleton Technology Confidential – ReWalk Robotics 2023 Unprecedented freedom – Only personal exoskeleton enabling ambulatory access to real-world environments, including locations with stairs or curbs Natural gait – Only personal exoskeleton with six adjustable degrees of freedom for more natural walking Robust construction – Engineered and built for years of daily use to keep up with users wherever they want to go Customized fit – Customizable exoskeleton individually configured to optimize safety, function, and comfort Dedicated support – ReWalk customer support team available from initial evaluation through everyday use Vibrant community – A worldwide community of ReWalk Personal Exoskeleton users that share common experiences
Regular access to exoskeleton-assisted walking results in a multitude of health and wellness benefits for people with spinal cord injury2-8 Frequently reported benefits in literature include reductions in common comorbidities after SCI, including: Reduced spasticity Improved bowel/bladder function Reduced chronic pain Proven Health Benefits Confidential – ReWalk Robotics 2023 Health benefits reported by ReWalk users in a 2023 survey8
Confidential – ReWalk Robotics 2023 Germany 65M lives covered by DGUV (workers compensation) in Germany since 2019 Contractual coverage for 30% of all Germans through Statutory and Private health insurance plans 23.2M lives covered since 2020 Additional 2M covered lives added in 2021 US 9M US Veterans covered under VA Personal Exoskeleton policy since 2015 Over 225 systems covered through private and other insurance, on a case-by-case basis Medicare HCPCS code established 2020 Case-by-case submissions with Medicare started late 2022 Increasing Progress of Reimbursement/Coverage
SCI Market Potential – Driven by CMS Coverage Confidential – ReWalk Robotics 2023 Eligible Candidates11,12 Reimbursement Pathway13,14 Potential Total Addressable Market Prevalence of SCI Survivors US 296,0009 Germany 74,00010 Global 7.1 Million10 US 15,416 Germany 2,064 Global 17,480 Potential TAM $1.75B
Unique capabilities – only FDA and CE-cleared tool offering on-demand mechanical assistance to retrain post-stroke walking function during “push-off” (propulsion) Enhanced gait training – improves training specificity and intensity by promoting power and symmetry in forward propulsion, as well as effective paretic limb advancement Versatile solution – compatible with a wide array of clinic activities, from the treadmill to overground circuit training Improved treatment efficiency – acts as a second set of skilled hands, eliminating the need for an aide and/or allowing a more holistic approach to gait training Secondary Product Line – ReStore Soft Exo-Suit for Stroke Confidential – ReWalk Robotics 2023
Stroke Market Potential Confidential – ReWalk Robotics 2023 Personal Sales (Future State) Stroke Rehabilitation Centers20 Direct Sales Presence In-Clinic Sales (Current State) Inpatient Facilities Outpatient Clinics US 115217 44,00018 Germany 28819 11,00019 Global 27,80019 1M19 Incidence Prevalence US 795,00021 7M22 Germany 198,00019 1.75M19 Global 7.1 Million19 168M19 Medical Eligibility23 Direct Sales Presence Clinic Market 1,824 Personal Market 5.8M Potential Total Addressable Market Potential TAM $55M
Stroke Market Potential Confidential – ReWalk Robotics 2023 Personal Sales (Future State) Stroke Rehabilitation Centers20 Clinic Market 1,824 Personal Market 5.8M Direct Sales Presence In-Clinic Sales (Current State) Inpatient Facilities Outpatient Clinics US 115217 44,00018 Germany 28819 11,00019 Global 27,80019 1M19 Incidence Prevalence US 795,00021 7M22 Germany 198,00019 1.75M19 Global 7.1 Million19 168M19 Medical Eligibility23 Direct Sales Presence Future product lines will leverage ReStore’s in-clinic presence to expand into the larger personal market Potential TAM $46B Potential Total Addressable Market
Broad indications – widely applicable across the NeuroRehabilitation spectrum, with specialized models for in-clinic and at-home use Easy to use – simple setup, with intuitive controls allowing home users and clinicians to rapidly achieve therapeutic goals Proven – FDA cleared to prevent muscle atrophy, reduce spasms, increase blood flow, and increase range of motion Engaging – stores workout data, providing weekly progress reports, with performance tracking and comparison to incentivize progress Isokinetic technology – intuitively provides assistance or resistance as needed, depending on functional capabilities Distributed Product Line – MyoCycle FES Confidential – ReWalk Robotics 2023
MyoCycle FES Market Potential Confidential – ReWalk Robotics 2023 SCI Stroke MS US 296,00024 7M25 1.0M26 Personal (Home Use) Sales Medical Eligibility27 US Clinic Market 3,600 US Personal Market 67,000 Total 70,600 Potential Total Addressable Market NeuroRehab Focused Clinics31 ReWalk Dist. Rights28 Inpatient Facilities Outpatient Clinics US 115229 44,00030 Capital (In-Clinic) Sales Potential TAM $1.7B
Consolidation Strategy Confidential – ReWalk Robotics 2023 21
Enhancements to technology and features of ReWalk Exoskeleton Expansion of access through greater reimbursement coverage Internal development of new products Increasing penetration for distributed products Consolidation Will Add Scale and Supplement Growth Confidential – ReWalk Robotics 2023 Approved, commercially established, adjacent products High clinical benefit to patients Capitalizes on our key capabilities to maximize financial synergies Profitable within twelve months of purchase Consolidation Accelerates Path to Profitability Organic Acquisition
Distribution of NeuroRehabilitation Technology Providers NeuroRehabilitation Market Attractive for Consolidation Confidential – ReWalk Robotics 2023 Fragmented industry with many small players Mostly private companies with limited access to capital Innovative technologies with distribution constraints Complementary products sold to the neurorehabilitation clinic or for home/community use Opportunity for ReWalk Robotics to Leverage Its Leadership Position and Capital For illustrative purposes from proprietary ReWalk research
Leverage Key Capabilities Acquisition Program Designed to Accelerate Path to Profitability Confidential – ReWalk Robotics 2023 Field Sales & Marketing Clinical R&D Regulatory / Quality Reimbursement Operations / Integration Public company resources Opportunity for ReWalk Robotics to Leverage Its Position and Capital Acquisition Criteria Approved, commercially established, adjacent product(s) High clinical value and benefit to patients Leverages our key capabilities to maximize financial synergies and profit accretion Profitable within twelve months of purchase ReWalk Exoskeleton ReStore Exo-suit Potential Acquisition C MyoCycle (Distributed) Potential Acquisition A Potential Acquisition B
Deep and Talented Leadership Team Larry JasinskiChief Executive Officer Mike LawlessChief Financial Officer Jeannine LynchVice President, Strategy & Market Access Kathleen O'DonnellVice President, Marketing & New Business Development Miri ParienteVice President, Operations, Regulatory & Quality David HexnerVice President, Research & Development Ami KraftExecutive Advisor to the CEO Judy KulaVice President, Customer Service, Human Resources & Business Affairs Confidential – ReWalk Robotics 2023
Financial Summary Confidential – ReWalk Robotics 2023 $67.9 M Cash & Cash Equivalents (as of Dec. 31, 2022) Cash No Debt Debt Expected cash into 2025+, depending on acquisitions Cash Runway Well Positioned for Funding Internal Growth and Consolidation Strategy
2023 Milestones & Catalysts Confidential – ReWalk Robotics 2023 FDA clearance for use of our ReWalk Personal exoskeletons on stairs and curbs extends competitive advantage Exoskeleton reimbursement coverage by Medicare with claims processed and paid by MACs 510k submission for FDA clearance of the next-generation ReWalk 7.0 exoskeleton Acquisition(s) of complementary product lines within NeuroRehabilitation market Submission of 35+ additional claims to Medicare for reimbursement
Expanding addressable market in United States and Germany; first Medicare claims ongoing ReWalk Robotics Well Positioned for Future Growth Large, growing and fragmented NeuroRehabilitation market with many attractive candidates for consolidation Fundamentally changes lives for individuals with spinal cord injury Leading Innovative Technology Proven model for the distribution of complementary products to the clinical and home-use markets Resources to fund multiple years of organic growth while also making acquisitions of adjacent product lines Confidential – ReWalk Robotics 2023 Growing Reimbursement Coverage Attractive Market Opportunity Key Capabilities for Success Strong Balance Sheet
NASDAQ:RWLK Thank you! Confidential – ReWalk Robotics 2023
1 Allied Health Neurorehabilitation Market Report: https://www.alliedmarketresearch.com/neurorehabilitation-market-A10461 2 Asselin et al., Arch Phys Med Rehab (2021) 3 Gorman et al., J Clin Med (2021) 4 Duddy et al., Sensors (2021) 5 Shackleton et al., J Rehab Med (2019) Juszczak et al., Topics Spin Cord Inj Rehab (2018) 6 Faulkner et al., Journ Spinal Cord Med (2021) 7 Knezevic et al., Arch Phys Med Rehab (2021) 8 ReWalk user survey, 2023 N=41 9 National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2021. 10 Estimates based on scaling US statistics for total German and Global population sizes. 11 31% meet LOI eligibility criteria based on 2020 NSCISC annual report: www.nscisc.uab.edu/public/2020%20Annual%20Report%20-%20Complete%20Public%20Version.pdf 12 Of LOI-eligible, an estimated 30% meet additional eligibility criteria based on aggregate of 50% screen failure rate in literature: https://pubmed.ncbi.nlm.nih.gov/32800962/ plus ReWalk’s historical experience related to additional limiters (e.g. available transportation and time to attend training, motivation, companion availability, etc.) which are not accurately reflected within research populations. 13 56% of US SCI prevalence market cite Medicare or Medicaid as primary 14 30% of German Market covered for exoskeleton coverage by insurance contracts Confidential – ReWalk Robotics 2023 References
15 www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk 16 www.strokeinfo.org/stroke-facts-statistics/ 17 www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf 18 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023) 19 Estimates based on scaling US statistics for total German and Global population sizes 20 Designated Primary Stroke Center www.ncbi.nlm.nih.gov/pmc/articles/PMC8886184/ 21 www.nichd.nih.gov/health/topics/stroke/conditioninfo/risk 22 www.strokeinfo.org/stroke-facts-statistics/ 23.67% Survivors report persistent physical disability www.strokeinfo.org/stroke-facts-statistics/ 24 National Spinal Cord Injury Statistical Center, Facts and Figures at a Glance. Birmingham, AL: University of Alabama at Birmingham, 2021. 25 www.strokeinfo.org/stroke-facts-statistics/ 26 www.healthline.com/health/multiple-sclerosis/facts-statistics-infographic#1 27 Estimated at 30% eligibility across multiple disease states 28 Population percentage with enrolled VA benefits (2.7%) https://department.va.gov/about/# 29 MedPAC 2021 Report: www.medpac.gov/wp-content/uploads/2021/10/mar21_medpac_report_ch9_sec.pdf 30 www.ibisworld.com/industry-statistics/number-of-businesses/physical-therapy-rehabilitation-centers-united-states/ (accessed Jan 2023) 31 Locust Walk commissioned report. Sources: Wall Street Research, Locust Walk Analytics, GlobalData Confidential – ReWalk Robotics 2023 References (cont’d)