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Lifeward CEO Issues Year-End 2024 Open Letter to Shareholders and Provides 2025 Commercial and Operational Priorities
Newsfilter· 2025-01-13 13:30
Company Overview - Lifeward designs, develops, and commercializes life-changing solutions for physical rehabilitation and recovery, including products like the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore Exo-Suit [6] - The company was founded in 2001 and operates in the United States, Israel, and Germany [7] - Lifeward's mission is to drive innovation to change the lives of individuals with physical limitations or disabilities [2] 2024 Achievements - Achieved a defined Exoskeleton category as an orthotic brace classified for lump sum payment with CMS, a significant industry milestone [3] - Delivered over 70 new ReWalk systems in 2024, more than double the prior year's total [5] - Established a pipeline of approximately 100 qualified users for future ReWalk submissions [5] - Successfully launched the NEO and NEO+ additions to the AlterG product line, expanding market penetration [5] - Completed operational consolidation of AlterG, including the closure of the Fremont facility, expected to reduce overhead and operating costs [5] - Recovered from initial headwinds in the U.S. capital equipment market, with over 140 AlterG units placed in Q4 2024, up 90% sequentially [5] 2025 Objectives - Focus on driving Exoskeleton adoption through digital marketing, building relationships with key centers, streamlining patient experience, and expanding physician education [5] - Expand AlterG penetration to national chains and international distributors with the new NEO and NEO+ offerings [5] - Complete FDA and CE clearance for ReWalk 7 in the first half of 2025, featuring cloud connectivity, multiple walking speeds, crutch-based control, and improved batteries [5] - Aim to achieve non-GAAP operating profitability by the second half of 2026 [4] - Hold an investor event in New York City on February 20, 2025, to provide more in-depth information and interaction [6] Financial Highlights - Preliminary 2024 financial results met revised revenue guidance [4] - Successfully raised $5 million in additional capital in early 2025 to support Exoskeleton and AlterG awareness, adoption, and liquidity [4] - Financial priorities include driving efficient, sustainable growth, increasing margins, and reducing expenses [5]
Lifeward Cancels Its Extraordinary General Meeting of Shareholders
GlobeNewswire· 2025-01-13 12:45
Company Announcement - Lifeward Ltd has cancelled its previously announced Extraordinary General Meeting of Shareholders scheduled for January 13, 2025 [1] - The Board of Directors has withdrawn the proposals set forth in the Definitive Proxy Statement filed on November 25, 2024 [1] - The Board intends to present these proposals at a subsequent meeting in 2025 [1] Company Overview - Lifeward designs, develops, and commercializes life-changing solutions in physical rehabilitation and recovery [2] - The company's mission is to drive innovation to change the lives of individuals with physical limitations or disabilities [2] - Lifeward's product portfolio includes the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore Exo-Suit [2] Company Operations - Lifeward was founded in 2001 and has operations in the United States, Israel, and Germany [3] - Lifeward, ReWalk, ReStore, and AlterG are registered trademarks of Lifeward Ltd and/or its affiliates [3]
Lifeward Announces Closing of $5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
GlobeNewswire· 2025-01-08 21:15
Company Overview - Lifeward Ltd is a global market leader in delivering life-changing solutions for rehabilitation, recovery, and enabling individuals with physical limitations or disabilities to pursue their passions [1] - The company designs, develops, and commercializes innovative products across the continuum of care in physical rehabilitation and recovery, including the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore Exo-Suit [6] - Founded in 2001, Lifeward has operations in the United States, Israel, and Germany [7] Capital Raising Activities - Lifeward closed a registered direct offering of 1,818,183 ordinary shares at $2.75 per share, raising approximately $5.0 million in gross proceeds [1][2] - In a concurrent private placement, the company issued unregistered short-term warrants to purchase up to 1,818,183 ordinary shares, with a three-year term, immediate exercisability, and an exercise price of $2.75 per share [1] - H C Wainwright & Co acted as the exclusive placement agent for the offering [2] - The net proceeds will be used for continuing commercial efforts, working capital, and general corporate purposes [2] Regulatory and Legal Information - The ordinary shares were offered pursuant to a shelf registration statement on Form S-3 (Registration No 333-263984) previously filed with and declared effective by the SEC [3] - The warrants and underlying ordinary shares were issued in a private placement under Section 4(a)(2) of the Securities Act and Regulation D, and are not registered under the Securities Act or applicable state securities laws [4] Business Strategy and Mission - Lifeward's mission is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities [6] - The company is committed to delivering groundbreaking solutions that empower individuals to do what they love [6] - Lifeward's products deliver proven functional and health benefits in clinical settings as well as in the home and community [6]
Lifeward Announces $5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
GlobeNewswire· 2025-01-07 13:05
Company Overview - Lifeward Ltd is a global market leader in delivering life-changing solutions for rehabilitation, recovery, and enabling individuals with physical limitations or disabilities to pursue their passions [1] - The company designs, develops, and commercializes innovative products across the continuum of care in physical rehabilitation and recovery, including the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore Exo-Suit [6] - Founded in 2001, Lifeward has operations in the United States, Israel, and Germany [7] Capital Raising Activities - Lifeward has entered into a definitive agreement for a registered direct offering of 1,818,183 ordinary shares at $2.75 per share, with expected gross proceeds of approximately $5.0 million [1][2] - Concurrently, the company will issue unregistered short-term warrants to purchase up to 1,818,183 ordinary shares, exercisable immediately at $2.75 per share for a term of three years [1] - The offering is expected to close on or about January 8, 2025, subject to customary closing conditions [1] - H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering [2] Use of Proceeds - The net proceeds from the offering will be used for continuing commercial efforts, working capital, and general corporate purposes [2] Regulatory and Legal Information - The ordinary shares are being offered pursuant to a shelf registration statement on Form S-3 (Registration No. 333-263984) previously filed with and declared effective by the SEC [3] - The warrants and underlying ordinary shares are being issued in a private placement under Section 4(a)(2) of the Securities Act and Regulation D, and are not registered under the Securities Act or applicable state securities laws [4] Product Portfolio and Mission - Lifeward's mission is to relentlessly drive innovation to change the lives of individuals with physical limitations or disabilities, empowering them to do what they love [6] - The company's portfolio includes clinically proven and innovative rehabilitation products that deliver functional and health benefits in various settings [6]
Lifeward Announces Postponement of its Extraordinary General Meeting of Shareholders
Newsfilter· 2024-12-27 22:49
Company Overview - Lifeward is a global market leader in delivering life-changing solutions for rehabilitation, recovery, and empowering individuals with physical limitations or disabilities [7] - The company designs, develops, and commercializes innovative products such as the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore ExoSuit [11] - Founded in 2001, Lifeward has operations in the United States, Israel, and Germany [5] Shareholder Meeting Update - Lifeward has postponed its Extraordinary General Meeting of Shareholders from December 30, 2024, to January 13, 2025, due to an anticipated lack of quorum [7][8] - The record date for the meeting remains November 20, 2024, and shareholders who have already voted do not need to take further action unless they wish to change their vote [8] - The company plans to hold an Investor Day shortly after the postponed meeting, with the exact date to be confirmed [9] Proxy Statement and Shareholder Information - Lifeward filed a Definitive Proxy Statement with the SEC on November 25, 2024, which shareholders are urged to read carefully as it contains important information about the meeting [10] - Shareholders can access the proxy statement and other relevant documents on the SEC's website or the "SEC Filings" section of Lifeward's website [10]
Coverage for ReWalk Personal Exoskeleton Expands as Hungary Joins the U.S. and Germany with a Policy Providing Access to Exoskeletons
GlobeNewswire News Room· 2024-11-19 13:30
Core Article Summary - The Hungarian government has established a new state insurance code to provide coverage for exoskeleton training for individuals with spinal cord injuries, following research by Semmelweis University [1][2] - The ReWalk Exoskeleton, developed by Lifeward, has been available in Hungary since 2019 and has shown long-term therapeutic benefits in preventing health complications for spinal cord injury patients [2] - Lifeward's CEO highlighted the expansion of exoskeleton access to Germany, the United States, and Hungary, emphasizing the importance of such policies for the industry [3] Company Overview - Lifeward is a global leader in rehabilitation and recovery solutions, focusing on empowering individuals with physical limitations or disabilities [4] - The company's product portfolio includes the ReWalk Exoskeleton, AlterG Anti-Gravity System, MyoCycle FES System, and ReStore ExoSuit [4] - Lifeward operates in the United States, Israel, and Germany, with a mission to drive innovation and deliver life-changing solutions [5] Industry Impact - The decision by Hungary's government is seen as a progressive step that could improve the lives of many citizens with spinal cord injuries [3] - Lifeward is actively pursuing expansion of coverage through private insurers and Medicare Advantage in the United States, as well as adding contracts in Germany [3] - The ReWalk Exoskeleton is the only exoskeleton with both US and EU official certifications (FDA, CE/MDR) and is approved for home use, ensuring independent walking for users [3] Research and Development - Research conducted by Dr Péter Cserháti at Semmelweis University demonstrated the positive effects of exoskeleton rehabilitation on preventing health complications in spinal cord injury patients [2] - The ReWalk system has been in use at Hungary's National Medical Rehabilitation Institute since 2019, prior to its integration into Semmelweis University's Rehabilitation Clinic [2] Market and Distribution - Lifeward's products are distributed in Hungary by Fototronic Kft, which highlighted the unique certifications and home-use approval of the ReWalk Exoskeleton [3] - Approximately 300 new cases of spinal cord injury are reported annually in Hungary, indicating a significant potential market for exoskeleton solutions [3]
ReWalk(LFWD) - 2024 Q3 - Earnings Call Transcript
2024-11-12 16:30
Financial Data and Key Metrics - Revenue for Q3 2024 was $6.1 million, up 39% from $4.4 million in Q3 2023 [23] - Gross profit for Q3 2024 was $2.2 million (36.2% of revenue), compared to $0.9 million (19.6% of revenue) in Q3 2023 [28] - Adjusted operating expenses for Q3 2024 were $6.7 million, the lowest in the previous five quarters [20] - The company ended Q3 with $10.7 million in cash and equivalents and no debt [31] - Full-year 2024 revenue guidance revised to $25 million to $26 million [32] Business Line Performance - ReWalk exoskeleton revenue was $2.5 million in Q3 2024, up 73% from Q3 2023, driven by increased sales in the U.S. and Germany [23] - AlterG revenue was $3.6 million in Q3 2024, up from $3.0 million in Q3 2023 [24] - ReWalk placements resulted in 20 more individuals regaining ambulation in Q3 2024 [14] - AlterG backlog increased for the third consecutive quarter, with 74 systems in backlog at the end of Q3 2024 [27] Market Performance - U.S. leads expanded 62% year-over-year due to expanded Medicare coverage and commercialization efforts [16] - The U.S. pipeline for ReWalk includes approximately 70 qualified contacts with Medicare and other payors [16] - Germany has 45 ReWalk cases in process at the end of Q3 2024 [25] - Active rentals for ReWalk systems include 23 in Germany and 2 in the U.S. at VA hospitals [26] Strategy and Industry Competition - The company is focused on operational efficiency, including the closure of two facilities, to streamline operations and reduce costs [19] - The ReWalk 7-0 system, under FDA review, is expected to receive clearance in early 2025 [21] - The AlterG NEO model has received strong market reaction, with 40 orders to date [18] - The company anticipates AlterG will be accretive to operations in 2025, driven by revenue recovery and cost reductions [34] Management Commentary on Operating Environment and Future Outlook - Management expressed optimism about the growth potential of ReWalk, particularly with Medicare coverage expansion [10][16] - The company expects a strong Q4 for AlterG, setting up well for 2025 [19] - The path to profitability requires quarterly revenue levels of $12 million to $13 million, which the company is aggressively targeting [35] - Management is confident in achieving commercial goals without needing additional cash, supported by current cash reserves and operational efficiencies [36][54] Other Important Information - The company plans to host an Investor Day after the end of the year to provide more insight into its commercial goals and technology expansion [36] - The Medicare claims processing time frame has been about 150 days, which the company is working to shorten [15] - The company has built a dedicated team of clinicians and case managers to support the volume of claims expected in future quarters [15] Q&A Session Summary Question: Comfort level with revised guidance and Medicare reimbursement issues - Management is comfortable with the revised guidance and noted that Medicare claims processing is taking longer than expected, averaging 150 days [38][39] Question: Potential for positive surprises in AlterG revenue - AlterG is improving quarter-over-quarter, with a strong Q4 expected and 40 orders for the new NEO model already in place [41][42] Question: Timeline to profitability - ReWalk growth is the primary driver to reach breakeven, with AlterG expected to recover and grow in parallel [43][44] Question: Cash burn and sustainability - The company expects Q4 cash burn to improve significantly and is confident in sustaining operations without additional cash through 2025 [48][49][54] Question: ReWalk system placements and Medicare Part B patients - The company did not disclose the number of Part B patients among the 20 new ReWalk placements in Q3 [58] Question: Supplemental insurance payments - Supplemental insurance payments are contingent on Medicare claim approval, and the company is working to encourage patients to obtain supplemental insurance [60][61] Question: Medicare accounts receivable and potential write-offs - Medicare claims do not go back far, and the company reserves a portion of claims for potential non-approval [63][64] Question: Reimbursement process improvements - The company has made significant progress in understanding Medicare requirements and has built systems to streamline the process [65]
Lifeward (LFWD) Reports Q3 Loss, Lags Revenue Estimates
ZACKS· 2024-11-12 15:21
Earnings Performance - Lifeward reported a quarterly loss of $0 45 per share, missing the Zacks Consensus Estimate of a loss of $0 27 per share [1] - The company's earnings surprise was -66 67% for the quarter [2] - Over the last four quarters, Lifeward has surpassed consensus EPS estimates two times [2] Revenue Performance - Lifeward posted revenues of $6 13 million for the quarter ended September 2024, missing the Zacks Consensus Estimate by 26 87% [3] - This compares to year-ago revenues of $4 4 million [3] - The company has not been able to beat consensus revenue estimates over the last four quarters [3] Stock Performance - Lifeward shares have lost about 56 5% since the beginning of the year, compared to the S&P 500's gain of 25 8% [4] - The stock's immediate price movement will depend on management's commentary on the earnings call [4] Earnings Outlook - The current consensus EPS estimate is -$0 15 on $9 95 million in revenues for the coming quarter and -$1 65 on $30 32 million in revenues for the current fiscal year [8] - The estimate revisions trend for Lifeward is mixed, translating into a Zacks Rank 3 (Hold) [7] Industry Context - Lifeward belongs to the Zacks Internet - Software industry, which is currently in the top 21% of the 250 plus Zacks industries [9] - The top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [9] Peer Comparison - Zoom Video Communications, another stock in the same industry, is expected to post quarterly earnings of $1 30 per share, representing a year-over-year change of +0 8% [10] - Zoom Video Communications' revenues are expected to be $1 16 billion, up 2 3% from the year-ago quarter [11]
ReWalk(LFWD) - 2024 Q3 - Quarterly Report
2024-11-12 14:00
Revenue and Profitability - Revenue for the nine months ended September 30, 2024, was $18.118 million, compared to $6.970 million for the same period in 2023[19] - Gross profit for the nine months ended September 30, 2024, was $6.372 million, compared to $2.010 million for the same period in 2023[19] - Net loss for the nine months ended September 30, 2024, was $13.664 million, compared to $16.494 million for the same period in 2023[19] - The company reported a net loss of $13,664 thousand for the nine months ended September 30, 2024, compared to a net loss of $16,494 thousand for the same period in 2023[23] - The company incurred a consolidated net loss of $13.7 million and has an accumulated deficit of $249.5 million as of September 30, 2024[32] - The company's total revenues for the nine months ended September 30, 2024, were $18.1 million, with product revenue contributing $13.7 million[54] - Revenue for the three months ended September 30, 2024 increased by $1.7 million (39%) compared to the same period in 2023, driven by increased ReWalk system sales due to Medicare coverage expansion, stronger sales in Germany, and higher AlterG sales[157] - Revenue for the nine months ended September 30, 2024 increased by $11.1 million compared to the same period in 2023, primarily due to increased ReWalk system sales from Medicare coverage expansion, stronger sales in Germany, and the revenue contribution from the AlterG acquisition[158] - Gross profit for the three months ended September 30, 2024, was $2.2 million, representing 36.2% of revenue, compared to $0.9 million (19.6% of revenue) for the same period in 2023[159] - Gross profit for the nine months ended September 30, 2024, was $6.4 million, representing 35.2% of revenue, compared to $2.0 million (28.8% of revenue) for the same period in 2023[160] - The company incurred a consolidated net loss of $13.7 million for the nine months ended September 30, 2024, with an accumulated deficit of $249.5 million and negative operating cash flow of $17.7 million[178] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2024, were $3.494 million, compared to $2.830 million for the same period in 2023[19] - Sales and marketing expenses for the nine months ended September 30, 2024, were $13.573 million, compared to $9.076 million for the same period in 2023[19] - General and administrative expenses for the nine months ended September 30, 2024, were $3.424 million, compared to $7.579 million for the same period in 2023[19] - Share-based compensation increased to $1,047 thousand for the nine months ended September 30, 2024, from $955 thousand in the same period in 2023[23] - Research and development expenses for the three months ended September 30, 2024, decreased by $0.3 million (20.1%) to $0.9 million, primarily due to the completion of the ReWalk 7 development program[162] - Research and development expenses for the nine months ended September 30, 2024, increased by $0.7 million (23.5%) to $3.5 million, primarily due to the acquisition of AlterG and new product development projects[163] - Sales and marketing expenses for the nine months ended September 30, 2024, increased by $4.5 million (49.5%) to $13.6 million, driven by higher personnel-related expenses and promotional activities following the AlterG acquisition[167] - General and administrative expenses for the three months ended September 30, 2024, decreased by $3.2 million (93%) to $0.3 million, primarily due to a reduction in M&A-related expenses[169] - General and administrative expenses for the nine months ended September 30, 2024, decreased by $4.2 million (54.8%) to $3.4 million, primarily due to a reduction in M&A-related expenses and income from the remeasurement of the earnout liability[170] - Financial income, net, for the nine months ended September 30, 2024, decreased by $0.6 million (52.7%) to $0.5 million, primarily due to a lower cash balance resulting from the AlterG acquisition and funding of growth[172] - The company expects to save approximately $3 million in operating expenses and improve gross margins by closing two U.S. facilities and reducing headcount by over 35% following the AlterG acquisition[179] Cash Flow and Financial Position - Net cash used in operating activities for the nine months ended September 30, 2024, was $17,749 thousand, compared to $16,183 thousand for the same period in 2023[23] - Cash, cash equivalents, and restricted cash decreased from $28,792 thousand at the beginning of the period to $11,014 thousand at the end of September 30, 2024[23] - The company's cash and cash equivalents totaled $10.7 million, with a negative operating cash flow of $17.7 million for the nine months ended September 30, 2024[32] - Net cash used in operating activities increased by $1.6 million, or 9.7%, for the nine months ended September 30, 2024, primarily due to increased trade receivables and inventory purchases[188] - Net cash used in investing activities decreased by $18.1 million, primarily due to the acquisition of AlterG in 2023[189] - Net cash used in financing activities decreased by $1 million, or 100%, for the nine months ended September 30, 2024, due to the expiration of the share repurchase program[189] Liabilities and Equity - Total current liabilities as of September 30, 2024, were $9.657 million, down from $11.795 million as of December 31, 2023[17] - Total long-term liabilities as of September 30, 2024, were $2.220 million, down from $4.887 million as of December 31, 2023[17] - Total shareholders' equity as of September 30, 2024, was $33.893 million, down from $46.510 million as of December 31, 2023[17] - Total shareholders' equity decreased from $58,974 thousand as of June 30, 2023, to $33,893 thousand as of September 30, 2024, reflecting a net loss of $13,664 thousand during the period[22] - The company's earnout liability decreased by $2.5 million, resulting in a balance of $792,000 as of September 30, 2024[52] - The company's total contractual obligations as of September 30, 2024, amounted to $7.78 million, including purchase obligations, collaboration and license agreements, operating lease obligations, and earnout liabilities[191] - The company's operating lease obligations include payments for facilities in the United States and Israel, as well as motor vehicles[191] Acquisitions and Investments - The company acquired AlterG, Inc. for a cash purchase price of approximately $19 million, with additional earnouts based on AlterG's year-over-year revenue growth over the next two years[29] - The company acquired AlterG in August 2023 for approximately $19 million, with additional earnouts based on revenue growth over the next two years[140] - Goodwill from LCAI acquisition recorded at $7.5 million, with intangible assets valued at $14.1 million[84][85] - Total amortized intangible assets amount to $10,020 thousand, with estimated amortization expenses of $842 thousand for the remaining period of fiscal 2024, $3,307 thousand for fiscal 2025, $3,143 thousand for fiscal 2026, $2,172 thousand for fiscal 2027, and $556 thousand for fiscal 2028[89][90] - Non-cancelable purchase commitments as of September 30, 2024, amount to approximately $5.9 million[91] - Future lease payments for facilities and cars total $1,024 thousand, with a present value of $981 thousand after deducting imputed interest of $43 thousand[94] - The company received $2.8 million in funding from the Israel Innovation Authority (IIA), with $1.6 million being royalty-bearing grants, $400 thousand in convertible preferred shares, and $806 thousand without future obligation[95] - Royalties paid to the IIA as of September 30, 2024, total $114 thousand, with royalty expenses of $2 thousand for the three and nine months ended September 30, 2024[96] - The company's contingent liability to the IIA amounts to $1.6 million as of September 30, 2024[97] - Royalty payments for the three and nine months ended September 30, 2024, were $0 and $55 thousand, respectively, compared to $31 thousand for the limited consolidation period ended September 30, 2023[101] - The company has pledged $361 thousand as security for a guarantee granted to a third party, which cannot be withdrawn without the third party's consent[102] Shareholder and Equity Information - Net loss per ordinary share for the nine months ended September 30, 2024, was $1.58, compared to $1.94 for the same period in 2023[19] - The company's reverse share split reduced the number of issued and outstanding ordinary shares from approximately 60.1 million to 8.6 million, with a total authorized number of ordinary shares adjusted to 25 million post-split[105] - As of September 30, 2024, there were $1.7 million of total unrecognized compensation costs related to non-vested share-based compensation arrangements, expected to be recognized over approximately 2.3 years[113] - The company repurchased a total of 574,658 ordinary shares at a cost of $3.5 million under its share repurchase program as of September 30, 2024[118] - Total warrants outstanding and exercisable as of September 30, 2024 were 2,498,574 with exercise prices ranging from $8.75 to $52.50 per share[119] - Share-based compensation expenses totaled $1.047 million for the nine months ended September 30, 2024, up from $955,000 in the same period of 2023[130] - The company repurchased 574,658 ordinary shares at a total cost of $3.5 million under the share repurchase program as of September 30, 2024[187] Product and Market Information - The company specializes in medical devices, including the ReWalk Personal and ReWalk Rehabilitation Exoskeleton devices for individuals with spinal cord injury[26] - The company's product offerings include ReWalk Personal, ReWalk Rehabilitation, ReStore, MyoCycle, and AlterG Anti-Gravity systems[58] - ReWalk Personal and ReWalk Rehabilitation products are designed for paraplegic individuals, with ReWalk Rehabilitation offering adjustable parts for clinical use[60] - Medicare reimbursement pathway established for ReWalk products, with variable consideration reassessed at each reporting period[61] - AlterG Anti-Gravity systems used in physical and neurological rehabilitation, with rental revenue accounted for under ASC Topic 842[62][63] - SCI Products offered in a rent-to-purchase model, with service revenue recorded as services are rendered[64] - SCI Products include a five-year warranty, with the first two years as assurance type and the remaining as service type warranty[66] - The company received FDA 510(k) clearance for the ReWalk Personal Exoskeleton with stair and curb functionality in March 2023, expanding its usage in real-world environments[138] - The company submitted a 510(k) premarket notification for the ReWalk 7 Personal Exoskeleton in June 2024, which is pending FDA review[138] - The AlterG anti-gravity systems are utilized in over 4,000 facilities globally across more than 40 countries[140] - CMS established a final lump-sum Medicare purchase fee schedule amount of $91,032 for personal exoskeletons (HCPCS code K1007) in April 2024[146] - The company launched the AlterG NEO, which has generated orders for approximately 40 units since its introduction in June 2024[150] - The company is in the research stage of ReBoot, a personal soft exo-suit for post-stroke individuals, which received FDA Breakthrough Device Designation in November 2021[141] Geographic and Customer Revenue - Total revenues for the nine months ended September 30, 2024 were $18.118 million, with the United States contributing $11.054 million (61% of total)[134] - Europe accounted for $5.896 million (32.5%) of total revenues for the nine months ended September 30, 2024[134] - Customer A represented 16.4% of total revenues for the nine months ended September 30, 2024, while Customer B accounted for less than 10%[135] Operational and Strategic Updates - The company rebranded as Lifeward Ltd. on September 10, 2024, following a name change from ReWalk Robotics Ltd.[24] - Lifeward Ltd. operates through three wholly owned subsidiaries: Lifeward Inc., Lifeward GMBH, and Lifeward CA, Inc.[25] - The company plans to streamline U.S. operations by closing two facilities and focusing on Massachusetts, Israel, and Germany, with manufacturing to be handled by Cirtronics Corporation[136] - Long-lived assets decreased to $2.162 million as of September 30, 2024 from $3.123 million at December 31, 2023, with the largest portion located in the United States ($1.777 million)[134] - The company expects to save approximately $3 million in operating expenses and improve gross margins by approximately two percentage points through the integration of AlterG and the closure of two U.S. facilities[148] - The company's public float was below $75 million as of February 27, 2024, limiting primary securities offerings to no more than one-third of their public float in any 12-month period[185] - The company's collaboration agreement with Harvard concluded on March 31, 2022, with all product development milestones met as of September 30, 2024[191] - The company had no off-balance sheet arrangements or guarantees of third-party obligations as of September 30, 2024[193] - There were no material changes to the company's market risk during the third quarter of 2024[194]
ReWalk(LFWD) - 2024 Q3 - Quarterly Results
2024-11-12 13:15
Revenue Growth and Performance - Q3 2024 revenue was $6.1 million, a 39% increase compared to $4.4 million in Q3 2023[7] - Revenue from Lifeward historical products and services, including ReWalk exoskeletons, increased by 173% to $2.5 million in Q3 2024[7] - Revenue for Q3 2024 increased to $6.128 million, up 39.2% from $4.403 million in Q3 2023[22] - Revenue from the United States for the nine months ended September 30, 2024, was $11.054 million, up 157.2% from $4.298 million in the same period in 2023[25] Gross Profit and Margins - Gross margin in Q3 2024 was 36.2%, up from 19.6% in Q3 2023, with adjusted gross margin at 42.5%[8] - Gross profit for Q3 2024 rose to $2.220 million, a 157.2% increase from $863,000 in Q3 2023[22] - GAAP gross profit for Q3 2024 was $2,220 thousand, representing 36.2% of revenue, compared to $863 thousand or 19.6% in Q3 2023[27] - Non-GAAP gross profit for Q3 2024 was $2,610 thousand, representing 42.5% of revenue, compared to $1,985 thousand or 45.1% in Q3 2023[27] Operating Expenses and Cost Management - Lifeward expects to save $3 million in operating expenses and improve gross margins by approximately 2 percentage points by closing two U.S. facilities[2] - GAAP R&D expenses for Q3 2024 were $998 thousand, representing 16.3% of revenue, compared to $1,262 thousand or 28.7% in Q3 2023[28] - Non-GAAP R&D expenses for Q3 2024 were $960 thousand, representing 15.7% of revenue, compared to $1,216 thousand or 27.7% in Q3 2023[28] - GAAP sales & marketing expenses for Q3 2024 were $4,156 thousand, representing 67.8% of revenue, compared to $4,088 thousand or 92.8% in Q3 2023[28] - Non-GAAP sales & marketing expenses for Q3 2024 were $3,676 thousand, representing 60.0% of revenue, compared to $3,766 thousand or 85.5% in Q3 2023[28] - GAAP general & administrative expenses for Q3 2024 were $240 thousand, representing 3.9% of revenue, compared to $3,455 thousand or 78.5% in Q3 2023[29] - Non-GAAP general & administrative expenses for Q3 2024 were $2,024 thousand, representing 33.0% of revenue, compared to $1,888 thousand or 43.0% in Q3 2023[29] Operating and Net Loss - Lifeward's operating loss in Q3 2024 was $3.2 million, a significant improvement from $7.9 million in Q3 2023[10] - Net loss for Q3 2024 improved to $3.084 million, down 59.1% from $7.531 million in Q3 2023[22] - GAAP operating loss for Q3 2024 was $(3,174) thousand, representing (51.8)% of revenue, compared to $(7,942) thousand or (180.4)% in Q3 2023[27] - Non-GAAP operating loss for Q3 2024 was $(4,050) thousand, representing (66.2)% of revenue, compared to $(4,884) thousand or (111.1)% in Q3 2023[27] - Non-GAAP net loss for Q3 2024 was $3.960 million, an improvement from $4.473 million in Q3 2023[26] - Non-GAAP net loss per share for Q3 2024 was $0.45, compared to $0.52 in Q3 2023[26] Cash and Financial Position - As of September 30, 2024, Lifeward had $10.7 million in unrestricted cash and cash equivalents with no debt[12] - Cash and cash equivalents decreased to $10.653 million as of September 30, 2024, from $28.083 million at the end of 2023[23] - Total current assets declined to $25.614 million as of September 30, 2024, compared to $39.222 million at the end of 2023[23] - Net cash used in operating activities for the nine months ended September 30, 2024, was $17.749 million, slightly higher than $16.183 million in the same period in 2023[24] Product Performance and Market Demand - Lifeward sold 20 ReWalk systems for the second consecutive quarter, indicating steady demand[1] - The U.S. ReWalk pipeline has approximately 70 qualified leads for potential Medicare and other payor claims, showing robust growth[1] - The AlterG NEO launch generated orders for approximately 40 units since its introduction in June 2024, becoming a growth driver for the AlterG product line[4] Revenue Expectations and Forecast - Lifeward revised its 2024 full-year revenue expectations to a range of $25 million to $26 million, anticipating the highest quarterly revenue in Q4 2024[13]