ReWalk(LFWD)

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ReWalk(LFWD) - 2020 Q3 - Earnings Call Transcript
2020-11-10 16:40
ReWalk Robotics Ltd. (RWLK) Q3 2020 Earnings Conference Call November 10, 2020 8:30 AM ET Company Participants Ori Gon - Chief Financial Officer Larry Jasinski - Chief Executive Officer Conference Call Participants Operator Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2020 ReWalk Robotics LTD Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] I wou ...
ReWalk(LFWD) - 2020 Q3 - Quarterly Report
2020-11-10 14:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | ...
ReWalk(LFWD) - 2020 Q2 - Earnings Call Transcript
2020-08-12 15:59
ReWalk Robotics Ltd. (RWLK) Q2 2020 Earnings Conference Call August 12, 2020 8:30 AM ET Company Participants Ori Gon - Chief Financial Officer Larry Jasinski - Chief Executive Officer Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by, and welcome to the Second Quarter 2020 ReWalk Robotics Limited Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there’ll be a quest ...
ReWalk(LFWD) - 2020 Q2 - Quarterly Report
2020-08-12 13:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 or | Israel | Not applicable | | --- | --- | | (Sta ...
ReWalk(LFWD) - 2020 Q1 - Earnings Call Transcript
2020-05-28 17:48
ReWalk Robotics Ltd. (RWLK) Q1 2020 Earnings Conference Call May 28, 2020 8:00 AM ET Company Participants Ori Gon – Chief Financial Officer Larry Jasinski – Chief Executive Officer Conference Call Participants RK – H.C. Wainwright Ori Gon Hello. Good morning, everyone, and welcome to ReWalk Robotics First Quarter 2020 Earnings Call. This is Ori Gon, ReWalk’s Chief Financial Officer, and with me on today's call is Larry Jasinski, Chief Executive Officer. This morning, the company issued a press release detai ...
ReWalk(LFWD) - 2020 Q1 - Quarterly Report
2020-05-28 13:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) Israel Not applicable (State or other jurisdict ...
ReWalk(LFWD) - 2019 Q4 - Earnings Call Transcript
2020-02-21 13:33
ReWalk Robotics Ltd. (RWLK) Q4 2019 Results Earnings Conference Call February 20, 2020 8:30 AM ET Company Participants Larry Jasinski - CEO Ori Gon - CFO Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by, and welcome to the Fourth Quarter ReWalk Robotics Ltd Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers presentation there will be a question-and-answer session. [Operator Instru ...
ReWalk(LFWD) - 2019 Q4 - Annual Report
2020-02-20 14:02
Product Overview - ReWalk Personal and ReWalk Rehabilitation products are designed for individuals with spinal cord injuries, with ReWalk Personal intended for everyday use and ReWalk Rehabilitation for clinical settings[20]. - The ReWalk Personal device allows users to achieve a functional walking speed and is equipped with safety features such as crutches and fall protection[21]. - The ReStore system, designed for stroke rehabilitation, received FDA clearance in June 2019 and has been placed in 16 clinics as of December 31, 2019[58]. - The ReStore product is marketed directly to rehabilitation clinics, with a focus on educating clinical managers about its clinical and economic benefits[54]. Regulatory Approvals - The company received FDA clearance for ReWalk Personal in June 2014 and has been marketing it in Europe since 2012[26]. - The FDA granted "de novo" classification for ReWalk in June 2014, classifying it as Class II medical device, enabling individuals with spinal cord injuries to perform ambulatory functions[90]. - In June 2019, the FDA issued 510(k) clearance for ReStore, allowing it to be marketed in the U.S. for assisting ambulatory functions in rehabilitation institutions[91]. - The company emphasizes the importance of maintaining compliance with medical device regulations and gaining regulatory approvals for its products[13]. - The company has received CE mark for all ReWalk systems distributed in the E.U., complying with relevant directives and standards[97]. Market and Economic Impact - The National Spinal Cord Injury Statistical Center estimates that complications related to paraplegia cost approximately $500,000 in the first year post-injury, highlighting the economic burden of spinal cord injuries[33]. - As of 2019, there were approximately 291,000 people in the United States living with spinal cord injuries, with an annual incidence of about 17,730 new cases[34]. - ReWalk's products may potentially reduce lifetime healthcare costs for individuals with spinal cord injuries, making them economically attractive for users and third-party payors[32]. - Approximately 55% of the spinal cord injury population, at least five years post-injury, is covered by CMS, which may influence future reimbursement policies[45]. Sales and Distribution - The company aims to expand its market opportunities by providing solutions for spinal cord injury patients in both clinical and home settings[33]. - As of December 31, 2019, the company had placed 119 ReWalk units in rehabilitation centers and 453 personal units for home or community use, compared to 119 and 399 units, respectively, as of December 31, 2018, indicating a growth in personal unit placements of 13.5%[39]. - The VA accounted for 15.0% of the company's total revenues for the year ended December 31, 2019, with 24 units placed under the VA policy[42]. - The company has established relationships with rehabilitation centers and the spinal cord injury community, which are crucial for generating sales of ReWalk Personal[38]. Financial Performance - Total revenues decreased to $4.873 billion in 2019 from $6.545 billion in 2018, representing a decline of approximately 25.6%[116]. - Revenue from the United States dropped to $2.003 billion in 2019, down 43.7% from $3.558 billion in 2018[116]. - Gross margin improved to 56% in 2019 compared to 43% in 2018[118]. - A 10% increase in the value of the NIS against the U.S. dollar would have decreased the net loss by approximately $430 thousand in 2019[421]. - A 10% increase in the value of the euro against the U.S. dollar would have decreased the net loss by approximately $70 thousand in 2019[421]. Research and Development - The company plans to expand the use of its lightweight "soft suit" exoskeleton to other medical conditions, including multiple sclerosis, cerebral palsy, and Parkinson's disease[68]. - The company has entered into a Research Collaboration Agreement with Harvard to develop technologies for lower limb disabilities, requiring quarterly payments to fund the research[71]. - The company is committed to enhancing its product line through a robust research and development program involving both in-house and external personnel[67]. - The company’s research and development efforts are conducted at its facility in Yokneam, Israel, allowing for effective collaboration between research and manufacturing teams[69]. Competition and Market Challenges - The company faces competition from various providers of mobility systems and prosthetic devices, including Ekso Bionics and Cyberdyne, which may impact market share and pricing strategies[60]. - The company had 40 pending insurance coverage cases in the United States as of December 31, 2019, highlighting ongoing reimbursement challenges[44]. - The company is pursuing reimbursement from private insurers and worker's compensation in various European countries, with a successful policy established in Italy for exoskeleton systems[49]. Employee Relations and Operations - The company considers its relationship with employees to be good, with no significant work stoppages reported to date[114]. - As of December 31, 2019, the company had 50 employees, with 19 in the U.S., 20 in Israel, and 11 in Europe, primarily engaged in sales, marketing, and R&D[113]. - The company has contracted with Sanmina Corporation for the manufacture of all products, ensuring efficient operations and substantial scale-up capacity[108]. Compliance and Quality Management - The company maintains compliance with FDA's Quality System Regulation and the European Union's Quality Management Systems requirements[94]. - The new Medical Device Regulation adopted by the European Union will take effect on May 26, 2020, imposing stricter controls on medical devices[99].
ReWalk(LFWD) - 2019 Q3 - Earnings Call Transcript
2019-11-13 17:51
ReWalk Robotics Ltd. (RWLK) Q3 2019 Earnings Conference Call November 13, 2019 8:30 AM ET Company Representatives Larry Jasinski - Chief Executive Officer Ori Gon - Chief Financial Officer Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright Operator Ladies and gentlemen, thank you for standing by, and welcome to the Q3 2019, ReWalk Robotics Ltd. Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers presentation there will be a question-and-an ...
ReWalk(LFWD) - 2019 Q3 - Quarterly Report
2019-11-13 14:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to ______ Commission File Number: 001-36612 ReWalk Robotics Ltd. (Exact name of registrant as specified in charter) | Israel | Not applicable | | --- | --- | | ...