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, 2025 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 Lifeward Ltd. (Exact name of registrant as specified in charter) | Israel | | --- | | Not applicable | (State or other jurisdiction ...

Core Insights - Lifeward Ltd. reported a revenue of $5.0 million for Q1 2025, a decrease from $5.3 million in Q1 2024, primarily due to lower sales of ReWalk Exoskeletons and MyoCycles [4][9] - The company experienced a significant increase in gross margin to 42.2% in Q1 2025, up from 26.4% in Q1 2024, attributed to a favorable mix of payors and higher sales volume of AlterG systems [5][29] - Lifeward's operating loss improved to $4.9 million in Q1 2025 from $6.5 million in Q1 2024, indicating better cost management and operational efficiency [8][9] Financial Performance - Revenue from AlterG products and services increased by 17% to $3.3 million in Q1 2025, driven by higher international demand [4] - Operating expenses decreased to $7.0 million in Q1 2025 from $7.9 million in Q1 2024, reflecting cost savings from the closure of certain facilities [6][7] - The net loss narrowed to $4.8 million, or $0.46 per share, compared to a net loss of $6.3 million, or $0.73 per share, in the prior year [9][23] Market Developments - Lifeward launched the ReWalk 7 exoskeleton in the U.S. market following FDA clearance, marking a significant product advancement [6] - The company secured its first approval for a ReWalk 7 claim from a major U.S. commercial health insurance provider, expanding its market reach beyond Medicare [6] - Lifeward established a partnership with CorLife for exclusive distribution of the ReWalk Personal Exoskeleton to individuals with workers' compensation claims, aiming for greater market penetration [6] Liquidity and Guidance - As of March 31, 2025, Lifeward had $5.7 million in unrestricted cash and cash equivalents, with no debt, indicating a stable liquidity position [10] - The company expects full-year revenue for 2025 to be in the range of $28 million to $30 million, reflecting optimistic growth prospects [11]

Core Viewpoint - Lifeward Ltd. is set to release its first quarter 2025 financial results on May 15, 2025, before market opening, indicating a focus on transparency and communication with investors [1]. Company Overview - Lifeward is a global leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities [1]. - The company designs, develops, and commercializes solutions that provide functional and health benefits across various care settings, including clinical environments and home care [3]. - Lifeward's product portfolio includes notable innovations such as the ReWalk Exoskeleton, AlterG Anti-Gravity system, MyoCycle FES System, and ReStore Exo-Suit, showcasing its commitment to driving innovation in rehabilitation [3]. Financial Communication - The CEO Larry Jasinski and CFO Mike Lawless will host a conference call and live webcast on May 15, 2025, at 8:30 a.m. EDT to discuss the financial results, emphasizing the company's commitment to engaging with analysts and investors [2]. - Access to the conference call will be available through multiple channels, including toll-free numbers for various regions and a live webcast on the company's website [2].

Core Insights - Lifeward Ltd. has received approval from a major U.S. health insurance company for the ReWalk 7 Personal Exoskeleton, marking a significant step in expanding access for individuals with spinal cord injuries (SCI) [1][2] - The approval follows the Centers for Medicare & Medicaid Services (CMS) establishing a reimbursement pathway for personal exoskeletons in 2024, which is expected to enhance access for Medicare beneficiaries, who represent about one-third of individuals living with SCI [2][3] Company Overview - Lifeward is a leader in innovative medical technology aimed at transforming the lives of individuals with physical limitations or disabilities, with a mission to drive innovation in rehabilitation and recovery [4] - The company has launched the ReWalk 7, a device designed to assist paralyzed individuals in standing, walking, and navigating everyday environments [3][4] Market Context - The decision by a major commercial health insurer to cover the ReWalk 7 is seen as a pivotal moment that could encourage other insurers to follow suit, thereby solidifying Lifeward's growth trajectory [2][3] - The ReWalk 7 received FDA clearance in March 2025 and was launched for sales in the U.S. on April 15, 2025, indicating a timely entry into the market [1][3]

Core Viewpoint - Lifeward's collaboration with Beilinson Hospital represents a significant advancement in the adoption of exoskeleton technology in Israel, particularly for rehabilitation of soldiers injured in combat [1][3]. Company Overview - Lifeward Ltd. is a global leader in innovative medical technology, focusing on transforming the lives of individuals with physical limitations or disabilities [4]. - The company offers a range of products, including the ReWalk Exoskeleton, designed to aid in physical rehabilitation and recovery [4]. Key Developments - An Israeli soldier, paralyzed in both legs due to injuries sustained in the current war, has successfully completed training with the ReWalk Personal Exoskeleton, marking a historic first for injured soldiers in Israel [1][2]. - The soldier emphasized the life-changing impact of the ReWalk device, advocating for its approval for all paralyzed individuals [2]. Rehabilitation Insights - Dr. Yaron Watts from Beilinson Hospital described the use of the ReWalk during rehabilitation as a "precedent-setting historic event," highlighting its importance for other wounded soldiers [2][3]. - The Israeli Rehabilitation Department is now evaluating the safety and effectiveness of the ReWalk for other paralyzed veterans following the soldier's successful experience [3]. Future Implications - Lifeward's CEO, Larry Jasinski, expressed the company's commitment to expanding access to the ReWalk for eligible users, particularly for military personnel injured in combat [4].

Core Viewpoint - Lifeward Ltd. has launched the ReWalk 7 Personal Exoskeleton in the U.S., enhancing assistive technology for individuals with spinal cord injuries, showcasing the company's leadership and technological advancements in the industry [1][2][5]. Product Launch and Market Impact - The ReWalk 7 received FDA clearance in March 2025 and follows the ReWalk 6.0 system, which improved user capabilities for navigating stairs and curbs [2]. - The introduction of a Medicare reimbursement pathway in 2024 has facilitated broader market access for the ReWalk 7, supporting Lifeward's mission to empower the spinal cord injury community [2][5]. Technological Enhancements - The ReWalk 7 features cloud connectivity for data-driven updates, two customizable walking speeds, and a new crutch control unit for enhanced user control [7]. - Complementary devices, including a wrist control smartwatch and a mobile application, simplify mode selection and progress tracking, integrating the device into daily routines [7]. User-Centric Development - Lifeward collaborated with over two dozen end users and physical therapists to gather feedback, leading to improvements in training efficiency and safety [9]. - The development process included the introduction of a therapist handheld device for better session control, resulting in a device that enhances user confidence and control [9]. Financial Performance - Following the launch announcement, LFWD's shares increased by 1.4% on April 15, although the company has experienced an 18% decline in shares year-to-date, compared to an 11.1% decline in the industry and an 8.4% drop in the S&P 500 Index [4].

Core Viewpoint - Lifeward Ltd. has launched the ReWalk 7 Personal Exoskeleton, enhancing the walking experience for individuals with spinal cord injuries through innovative features and improved user control [1][3]. Product Features - The ReWalk 7 includes customizable walking speeds, allowing users to transition smoothly between different environments [5]. - A new Crutch Control feature enables users to manage device functions such as standing, walking, and speed selection with ease [5]. - The introduction of a Wrist Control smartwatch and MyReWalk mobile app facilitates operation mode selection, goal setting, and usage tracking [5]. - Enhanced battery life and improved accessibility features allow users to walk longer distances and navigate stairs and curbs [5][6]. - A new handheld device for therapists improves training efficiency and safety during rehabilitation sessions [5][4]. Development and Feedback - The ReWalk 7 was developed over several years, incorporating feedback from over two dozen end users and physical therapists to optimize its functionality in real-world settings [3][4]. - Clinicians reported that the new features would enhance training sessions, while users expressed increased confidence and control with the updated crutch control unit [4]. Regulatory and Market Access - The ReWalk 7 received FDA clearance in March 2025, following previous advancements in technology and market access for the ReWalk product line [5]. - In 2024, the Centers for Medicare & Medicaid Services finalized a reimbursement pathway for personal exoskeleton use, expanding access for individuals with spinal cord injuries [6]. Company Overview - Lifeward Ltd. is dedicated to developing innovative medical technologies aimed at transforming the lives of individuals with physical limitations or disabilities [8]. - The company’s portfolio includes various products designed for rehabilitation and recovery, emphasizing its commitment to driving innovation in the medical technology sector [8].

Core Insights - Lifeward Ltd. has received FDA 510(k) clearance for its ReWalk 7 Exoskeleton, a significant advancement for individuals with spinal cord injuries, enhancing user experience and mobility outcomes [1][2][4] Company Developments - The FDA clearance is a milestone that reinforces Lifeward's leadership in the medical exoskeleton market, positioning the company for expansion and continued innovation [2][4] - The ReWalk 7 is the seventh generation of Lifeward's exoskeleton technology, designed to improve the quality of life for users by enabling independent standing and walking [6][9] - Lifeward's market capitalization currently stands at $16.1 million, with an expected earnings growth of 91.4% for the current year compared to the industry's 15% growth [5] Market Performance - Following the announcement of the ReWalk 7, Lifeward's shares fell by 5.6%, closing at $1.51, and have decreased by 52.2% over the past six months, contrasting with the industry's 8.4% growth [3] - The anticipated commercial rollout of the ReWalk 7 is expected to strengthen Lifeward's competitive edge and revenue streams [9] Strategic Partnerships - Lifeward has expanded its partnership with MYOLYN, Inc. to enhance access to the MyoCycle Functional Electrical Stimulation Cycling Therapy System, broadening distribution rights and referral sales for home-based therapy [10]

Core Insights - Lifeward Ltd. has received 510(k) FDA clearance for its latest personal exoskeleton device, the ReWalk 7, which is designed for individuals with spinal cord injury (SCI) [1][2] - The ReWalk 7 features new enhancements and upgrades, continuing Lifeward's commitment to providing advanced exoskeleton technology [2] - The company plans to begin sales of the ReWalk 7 in the United States as soon as it becomes available [3] Company Developments - Lifeward has a history of innovation, having previously received FDA clearance for the ReWalk 6.0 in 2023, which allowed use on stairs and curbs, and a national reimbursement policy from CMS in 2024 for eligible beneficiaries [2] - The company was the first to receive FDA clearance for an exoskeleton medical device for individuals with SCI in 2014 [2] - Lifeward's mission is to drive innovation in medical technology to improve the lives of individuals with physical limitations or disabilities [3] Product Portfolio - Lifeward's product offerings include the ReWalk Exoskeleton, AlterG Anti-Gravity System, ReStore Exo-Suit, and MyoCycle FES System, all aimed at enhancing rehabilitation and recovery [3]

Financial Data and Key Metrics Changes - Lifeward reported record revenue of $7.5 million in Q4 2024, compared to $6.9 million in Q4 2023, marking an increase of approximately 8.7% [17] - For the full year 2024, revenue reached $25.7 million, an 85% increase from the previous year, representing the highest annual revenue performance in the company's history [17] - GAAP gross margin for Q4 2024 was 24.4%, down from 35.5% in Q4 2023, primarily due to restructuring charges [23] - Non-GAAP adjusted gross margin was 45.4% in Q4 2024, slightly below the 46.9% in Q4 2023 [24] - GAAP operating loss for Q4 2024 was $15.2 million, compared to a loss of $6.7 million in the prior year [26] - Non-GAAP adjusted operating loss improved to $3.3 million in Q4 2024 from $3.8 million in Q4 2023 [27] Business Line Data and Key Metrics Changes - Revenue from traditional products and services, including ReWalk's exoskeletons and Myocycles, was $2.0 million in Q4 2024, while AlterG products generated $5.5 million, the highest quarterly revenue since acquisition [18] - ReWalk sales were below expectations due to delays in Medicare cases, but a growing volume of qualified leads is anticipated to improve predictability in future performance [18][20] - AlterG systems ended Q4 2024 with a backlog of 25 orders, indicating a seasonal decline but an expected 20% revenue growth in Q1 2025 compared to Q1 2024 [22] Market Data and Key Metrics Changes - The company has over 110 qualified candidates for future ReWalk claim submissions in the U.S. and 44 cases in Germany [20] - Active rentals for ReWalk systems consist of 27 cases, with 24 in Germany and 3 in the U.S. [21] - The workers' compensation market represents about 6% of all spinal cord injuries, a segment previously limited for the company but now accessible through the CorLife partnership [52] Company Strategy and Development Direction - Lifeward aims to maintain reasonable growth while reducing quarterly operating losses, targeting a loss at or below $1 million in Q4 2025 [11] - The company is focusing on higher-margin opportunities and operational efficiencies, including a sustainable growth plan to reduce costs [13][29] - Lifeward plans to expand its market access through partnerships, including a new agreement with CorLife for workers' compensation and an expanded distribution agreement with MYOLYN [38][39] Management's Comments on Operating Environment and Future Outlook - Management views 2024 as a year of meaningful achievements, establishing long-term access to technologies and launching a pathway toward profitability [9] - The company anticipates full-year revenue for 2025 in the range of $28 million to $30 million, with adjusted gross margins between 47% to 49% [30] - Management expressed confidence in the sustainable growth plan, which aims to balance top-line growth with spending discipline [91] Other Important Information - The company ended 2024 with $6.7 million in cash and equivalents and no debt, raising an additional $5 million in January 2025 [27][28] - Lifeward received a going concern qualification from auditors, prompting actions to address balance sheet adequacy [28] Q&A Session Summary Question: How does the company see the growth of each component in the 2025 guidance? - Management indicated that the guidance reflects growth across all three major product lines: ReWalk, AlterG, and MyoCycles, with MyoCycles expected to show the biggest percentage growth due to an expanded distribution agreement [47][49] Question: What impact will the CorLife partnership have on the workers' compensation segment? - The CorLife partnership is expected to provide a larger conduit into the workers' compensation market, allowing for efficient processing and quicker payment cycles [51][52] Question: Will the next-generation ReWalk be introduced this year? - Management confirmed that the next-generation ReWalk is expected to be on the market by mid-2025, pending FDA clearance [54] Question: How are recent announcements factored into revenue guidance? - Management stated that recent partnerships have been factored into the revenue guidance conservatively, with expectations for growth in both CorLife and MYOLYN agreements [57][58] Question: What are the common reasons for patient attrition in ReWalk? - Patient attrition was attributed to seasonal factors and deferrals rather than losses, with management noting that these are common in the patient population [66][67] Question: What are the learnings from Medicare reimbursements? - The reimbursement cycle with Medicare has been longer than expected, but management anticipates it will shorten as they gain more experience [72][74] Question: Is the focus on workers' compensation a reaction to federal government policies? - Management clarified that the focus on workers' compensation is driven by opportunity rather than a reaction to government policies [77]