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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 | | --- | --- | | ...
ReWalk(LFWD) - 2019 Q2 - Earnings Call Transcript
2019-08-12 09:16
Rewalk Robotics Ltd. (RWLK) Q2 2019 Earnings Conference Call August 8, 2019 8:30 AM ET Company Participants Ori Gon - CFO Lawrence Jasinski - CEO & Director Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright & Co. Operator Good morning, ladies and gentlemen, and welcome to the Q2 2019 ReWalk Robotics Earnings Conference Call. [Operator Instructions] I would now like to turn the conference over to your host, Mr. Ori Gon, CFO. Please go ahead, sir. Ori Gon Thank you, Tiffany. Good morning, ...
ReWalk(LFWD) - 2019 Q2 - Quarterly Report
2019-08-09 20:05
Financial Performance - Total revenue for Q2 2019 was $0.9 million, a decrease of $893 thousand, or 50%, compared to Q2 2018[111] - Revenues decreased by approximately $891 thousand, or 27%, for the six months ended June 30, 2019 compared to the same period in 2018[113] - Personal unit revenues for Q2 2019 were $851 thousand, down from $1.77 million in Q2 2018[113] - Gross profit for Q2 2019 was $435,000, representing 50% of revenue, up from 43% in Q2 2018[115] - Gross profit for the first half of 2019 was $1,361,000, or 55% of revenue, compared to 43% in the same period of 2018[115] - The company anticipates continued net losses and negative cash flow from operations in the near term[109] Unit Sales and Product Development - 14 units were placed during Q2 2019, including 13 ReWalk Personal and 1 ReStore[111] - The number of Personal units placed decreased from 21 in Q2 2018 to 13 in Q2 2019[113] - Future growth is expected to be driven by sales of the ReWalk Personal device and the ReStore device to rehabilitation institutes[114] - The company plans to focus R&D on the ReStore product for stroke patients and future developments for conditions like multiple sclerosis and Parkinson's disease[118] Expenses and Cost Management - Research and development expenses decreased by $37,000, or 2%, for Q2 2019 compared to Q2 2018, and by $774,000, or 19%, for the first half of 2019[117] - Sales and marketing expenses decreased by $394,000, or 20%, for Q2 2019 compared to Q2 2018, and by $1,143,000, or 27%, for the first half of 2019[119] - General and administrative expenses decreased by $942,000, or 42%, for Q2 2019 compared to Q2 2018, and by $1,479,000, or 35%, for the first half of 2019[121] - Financial expenses, net, decreased by $169,000, or 32%, for Q2 2019 compared to Q2 2018, and by $236,000, or 23%, for the first half of 2019[122] Cash Flow and Financing - As of June 30, 2019, the company had cash and cash equivalents of $24 million and an accumulated deficit of approximately $162 million[129] - The company will need to seek additional financing if cash requirements exceed current estimates over the next 12 months[133] - Net cash used in operating activities decreased to $7.956 million for the six months ended June 30, 2019, compared to $9.068 million for the same period in 2018, primarily due to a reduction in operating costs offset by changes in working capital[161] - Net cash provided by financing activities increased to $22.473 million for the six months ended June 30, 2019, compared to $3.579 million for the same period in 2018, primarily due to higher proceeds from equity raise activities[162] - The company intends to continue using at-the-market offerings opportunistically to raise additional funds, subject to limitations under Form S-3[156] Debt and Obligations - The Company agreed to repay $3.6 million to Kreos, which included prepayment costs and end of loan payments, by issuing 192,000 units and 288,000 pre-funded units[139] - As of June 30, 2019, the outstanding principal amount under the Kreos Loan Agreement was $7.9 million[141] - Total contractual obligations as of June 30, 2019, amounted to $16.702 million, with $7.956 million due within one year[164] - The company has purchase obligations totaling $1.353 million, primarily dependent on a contract manufacturer for production[164] Fundraising Activities - The Company raised $20.2 million in gross proceeds from several fundraising events[111] - The Company raised approximately $13.1 million in gross proceeds from its follow-on public offering on November 20, 2018, selling 728,019 units at $7.5 per unit and 1,050,373 pre-funded units at $7.25 per unit[146] - The Company entered into a public offering of 760,000 ordinary shares at a price of $5.75 per share, generating total gross proceeds of $4.37 million on February 15, 2019[148] - The Company signed a purchase agreement for the issuance of 816,914 ordinary shares at $5.2025 per share, raising approximately $4.25 million on April 3, 2019[149] - As of June 30, 2019, the Company had sold 302,092 ordinary shares under the ATM Offering Program for net proceeds of $14.5 million[154] - The Company issued warrants to purchase up to 1,464,665 ordinary shares with an exercise price of $7.50 per share in June 2019[150] - The Company entered into a purchase agreement for the issuance of 833,334 ordinary shares at $6.00 per share and warrants to purchase up to 416,667 ordinary shares at the same price on June 12, 2019[151] - The Company has been subject to limitations under Form S-3, restricting capital raises to approximately $13.1 million in any 12-month period due to a public float of less than $75 million[142] - The company has incurred total expenses of approximately $1,171 thousand in connection with the ATM Offering Program as of June 30, 2019[154] Market Expansion Efforts - The company is currently in discussions with RealCan to explore alternative pathways for commercializing products in China, indicating ongoing efforts to penetrate this key market[159]
ReWalk(LFWD) - 2019 Q1 - Quarterly Report
2019-05-08 14:45
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, 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 (State or other jurisdict ...
ReWalk(LFWD) - 2019 Q1 - Earnings Call Transcript
2019-05-08 03:44
Rewalk Robotics Ltd (RWLK) Q1 2019 Earnings Conference Call May 7, 2019 8:30 AM ET Company Participants Ori Gon - CFO Lawrence Jasinski - CEO & Director Conference Call Participants Swayampakula Ramakanth - H.C. Wainwright & Co. Operator Good day, ladies and gentlemen, and welcome to the First Quarter 2019 ReWalk Robotics Ltd. Earnings Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's call, Mr. Ori Gon, Chief ...
ReWalk(LFWD) - 2018 Q4 - Earnings Call Transcript
2019-02-08 15:43
ReWalk Robotics Ltd (RWLK) Q4 2018 Earnings Conference Call February 8, 2019 8:30 AM ET Company Participants Lisa Wilson - IR Lawrence Jasinski - CEO & Director Ori Gon - CFO Conference Call Participants Operator Good day, ladies and gentlemen, and welcome to the ReWalk Robotics Year-End 2018 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Ms. Lisa Wilson, Investor Relations for ReWalk R ...