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ReWalk(RWLK) - 2024 Q4 - Annual Report
2025-03-07 16:10
Acquisition and Market Expansion - The company acquired AlterG for approximately $19 million, with potential additional cash earnout payments based on revenue growth over the next two years[34]. - The ReWalk Personal Exoskeleton is now exclusively distributed by CorLife for workers' compensation claims, leveraging CorLife's extensive network[35]. - The AlterG Anti-Gravity systems are utilized in over 4,000 facilities globally across more than 40 countries, indicating strong market penetration[34]. - The company has distribution agreements in several European countries, enhancing its reimbursement success with private insurers and workers' compensation[72]. - The installed base of AlterG systems is over 6,000 units worldwide as of December 31, 2024, with a focus on expanding Medicare customer base following new payment rates effective April 1, 2024[96]. Product Development and Regulatory Compliance - The company is in the research stage of the ReBoot device, which received Breakthrough Device Designation from the FDA, but further investment is currently on hold[36]. - The company has submitted a premarket notification for the 7th generation ReWalk design in June 2024, currently pending FDA review[48]. - The ReStore device received 510(k) clearance in June 2019, enabling its marketing in the U.S. for assisting ambulatory functions in rehabilitation institutions[130]. - The company is working on product design improvements and expanded labeling for the ReWalk Personal Exoskeleton, with plans to launch following regulatory clearance[106]. - The company actively maintains compliance with both U.S. and EU regulatory requirements to ensure the continued availability of its products[134]. Financial Performance and Revenue Generation - Total revenue for the year ended December 31, 2024, was $25.663 million, a 85.5% increase from $13.854 million in 2023[181]. - Revenue from the United States increased to $14.425 million in 2024, up 89.5% from $7.636 million in 2023[181]. - Revenue from Europe rose to $9.546 million in 2024, a 89.1% increase from $5.044 million in 2023[181]. - The company relies on sales from ReWalk Personal Exoskeletons, AlterG Anti-Gravity systems, and MyoCycle FES cycles for revenue generation[30]. Market Opportunities and Challenges - Approximately 57% of the spinal cord injury population is covered by Medicare, which represents a significant market opportunity for the company's products[39]. - The ReWalk Personal Exoskeleton aims to reduce lifetime healthcare costs for individuals with SCI, making it economically attractive for users and payors[52]. - The company faces substantial doubt regarding its ability to continue as a going concern due to potential capital requirements and operating needs[30]. - The company expects that changes to Medicare and Medicaid programs could have a material adverse effect on the healthcare industry[166]. Insurance and Reimbursement - The company is pursuing various paths for reimbursement and support fundraising efforts, particularly through the Veterans Health Administration[38]. - The final lump-sum Medicare purchase fee for the ReWalk Personal Exoskeleton (HCPCS code K1007) is set at $91,032, established through a "gap filling" process by CMS[67]. - In Germany, agreements with insurers such as BARMER and DGUV have been made to provide coverage for ReWalk products, with a formalized reimbursement process finalized in February 2025[42]. - As of February 2025, approximately 45% of the 70 million people in Germany covered by Statutory Health Insurance have defined reimbursement processes for personal exoskeletons[71]. Employee and Operational Insights - The company had 80 employees as of December 31, 2024, with the majority engaged in sales and marketing activities[177]. - The company maintains a good relationship with its employees and has not experienced any work stoppages to date[178]. - The company has contracted with Sanmina Corporation and Cirtronics Corporation for manufacturing, ensuring efficient operations and scale-up capacity[172][173]. Legal and Regulatory Risks - The civil False Claims Act (FCA) can impose treble damages and civil penalties for false claims, potentially aggregating into millions of dollars[145]. - The company may face penalties for violations of healthcare fraud laws, including exclusion from federal healthcare programs and significant civil monetary penalties[152]. - Government authorities and third-party payors are increasingly regulating prices of medical products, leading to lower average selling prices[156]. - The company must comply with various federal and state data privacy and security regulations, including HIPAA and HITECH[150].
ReWalk(RWLK) - 2024 Q4 - Annual Results
2025-03-07 13:16
Revenue Performance - Lifeward reported record annual revenue of $25.7 million for 2024, an increase of 85% from 2023[4] - Fourth quarter revenue was $7.5 million, up 10% from $6.9 million in Q4 2023[5] - ReWalk Personal Exoskeleton sales surged 130% in 2024 due to newly established Medicare coverage[4] - Revenue for Q4 2024 reached $7,545 million, a 9.6% increase from $6,884 million in Q4 2023[25] - Gross profit for the year ended December 31, 2024, was $8,216 million, representing a 84.5% increase compared to $4,453 million in 2023[25] Financial Losses - Lifeward's operating loss for Q4 2024 was $15.2 million, compared to $6.1 million in Q4 2023[8] - Adjusted operating loss on a non-GAAP basis was $3.3 million in Q4 2024, slightly improved from a loss of $3.8 million in Q4 2023[8] - Operating loss for Q4 2024 was $(15,228) million, compared to $(6,137) million in Q4 2023, indicating a significant increase in losses[32] - Net loss for the year ended December 31, 2024, was $(28,942) million, up from $(22,133) million in 2023, reflecting a 30.5% increase in losses[25] - The company anticipates a quarterly adjusted operating loss of approximately $1 million by Q4 2025[12] Expenses - Total operating expenses in Q4 2024 were $17.1 million, up from $8.6 million in Q4 2023[7] - Research and development expenses for the year were $4,625 million, compared to $4,148 million in 2023, marking an increase of 11.5%[25] - Sales and marketing expenses for the year were $17,949 million, a 29% increase from $13,922 million in 2023[25] - GAAP research and development expenses for Q4 2024 were $1,131,000, representing 15.0% of revenue, compared to $1,318,000 (19.1%) in Q4 2023[33] - Non-GAAP research and development expenses for the year ended December 31, 2024, were $4,457,000, which is 17.3% of revenue, up from $3,815,000 (27.5%) in 2023[33] - GAAP sales and marketing expenses for Q4 2024 were $4,376,000, accounting for 58.0% of revenue, down from $4,846,000 (70.4%) in Q4 2023[33] - Non-GAAP sales and marketing expenses for the year ended December 31, 2024, were $15,813,000, representing 61.5% of revenue, compared to $12,614,000 (91.0%) in 2023[33] - GAAP general and administrative expenses for Q4 2024 were $1,771,000, which is 23.5% of revenue, down from $2,416,000 (35.1%) in Q4 2023[33] - Non-GAAP general and administrative expenses for the year ended December 31, 2024, were $7,277,000, representing 28.3% of revenue, compared to $6,477,000 (46.7%) in 2023[33] - The company reported a restructuring expense of $(176,000) for the year ended December 31, 2024, which is 1.3% of revenue[33] - Stock-based compensation expenses for Q4 2024 were $(92,000), accounting for 1.2% of revenue, compared to $(111,000) (1.6%) in Q4 2023[33] - The company incurred integration/rebranding costs of $(253,000) in Q4 2023, which is 3.7% of revenue[33] - The company reported a remeasurement of earnout liability of $184,000 in Q4 2024, which is 2.4% of revenue[33] Future Projections - The company expects full year revenue for 2025 to be between $28 million and $30 million, with adjusted gross margins of 47% to 49%[11] Asset and Liability Changes - Total current assets decreased to $21,294 million in 2024 from $39,222 million in 2023, a decline of 45.5%[27] - Cash and cash equivalents at the end of 2024 were $6,746 million, down from $28,083 million in 2023, a decrease of 76%[27] - Total liabilities decreased to $30,487 million in 2024 from $63,192 million in 2023, a reduction of 51.8%[27] - Non-GAAP net loss per share for the year was $(1.86), compared to $(1.77) in 2023, indicating a worsening financial position[31]
ReWalk(RWLK) - 2024 Q3 - Quarterly Report
2024-11-12 14:00
Financial Performance - Revenues for the three months ended September 30, 2024, were $6.128 million, an increase of 39% compared to $4.403 million for the same period in 2023[19]. - Gross profit for the three months ended September 30, 2024, was $2.220 million, compared to $863 thousand for the same period in 2023, reflecting a significant improvement[19]. - Operating loss for the three months ended September 30, 2024, was $(3.174) million, an improvement from $(7.942) million for the same period in 2023[19]. - Net loss for the three months ended September 30, 2024, was $(3.084) million, compared to $(7.531) million for the same period in 2023, indicating a narrowing loss[19]. - The net loss for the nine months ended September 30, 2024, was $13,664,000, compared to a net loss of $16,494,000 for the same period in 2023, indicating an improvement of about 17.5%[23]. - Gross profit for Q3 2024 was $2.22 million, representing 36.2% of revenue, up from 19.6% in Q3 2023[159]. - For the nine months ended September 30, 2024, gross profit was $6.37 million, or 35.2% of revenue, compared to 28.8% in the same period of 2023[160]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $998 thousand, down from $1.262 million for the same period in 2023, reflecting cost management efforts[19]. - Sales and marketing expenses for the three months ended September 30, 2024, were $4.156 million, slightly up from $4.088 million for the same period in 2023[19]. - Research and development expenses for Q3 2024 were $0.998 million, a decrease of 20.1% from Q3 2023[162]. - R&D expenses for the nine months ended September 30, 2024, increased by 23.5% to $3.49 million, primarily due to the acquisition of AlterG[163]. - Sales and marketing expenses for Q3 2024 were $4.16 million, a slight increase of 2% compared to Q3 2023[166]. - For the nine months ended September 30, 2024, sales and marketing expenses totaled $13.57 million, reflecting a 49.5% increase from the same period in 2023[167]. - General and administrative expenses for Q3 2024 were $0.24 million, a significant decrease of 93% compared to Q3 2023[169]. Cash Flow and Liquidity - Cash and cash equivalents at the end of the period on September 30, 2024, were $11,014,000, down from $33,286,000 at the end of September 30, 2023, representing a decrease of approximately 66.9%[23]. - The company reported a net cash used in operating activities of $17,749,000 for the nine months ended September 30, 2024, compared to $16,183,000 for the same period in 2023, showing an increase of about 9.7%[23]. - The company’s cash and cash equivalents totaled $10.7 million as of September 30, 2024, 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]. Assets and Liabilities - Total current liabilities decreased to $9.657 million as of September 30, 2024, from $11.795 million as of December 31, 2023, indicating improved financial health[17]. - Total liabilities decreased to $11.877 million as of September 30, 2024, from $16.682 million as of December 31, 2023, showing a reduction in overall debt[17]. - The balance of accumulated deficit increased to $249,547,000 as of September 30, 2024, from $230,244,000 as of September 30, 2023, reflecting a rise of approximately 8.4%[22]. - The company reported a total shareholders' equity of $33.893 million as of September 30, 2024, down from $46.510 million as of December 31, 2023[17]. - As of September 30, 2023, total shareholders' equity decreased to $51,776,000 from $58,974,000 as of June 30, 2023, reflecting a decline of approximately 12.3%[22]. Acquisition and Business Development - The Company acquired AlterG, Inc. for a cash purchase price of approximately $19 million, with potential additional cash earnouts based on AlterG's year-over-year revenue growth over the next two years[29]. - The acquisition of AlterG, Inc. resulted in $7.5 million of goodwill, which has an indefinite life and is not tax-deductible[88]. - The company has established distribution agreements in the U.S. for its ReStore Exo-Suit and is the exclusive distributor of MYOLYN MyoCycle devices[27]. - Lifeward Ltd. designs and develops medical devices, including the ReWalk Personal and Rehabilitation Exoskeleton devices for individuals with spinal cord injuries, which utilize patented technology for mobility[26]. - The company is pursuing updates with CMS to clarify Medicare coverage for personal exoskeletons, with 57% of the SCI population relying on Medicare and Medicaid as primary payors[144]. Shareholder Actions - A reverse share split of 1-for-7 was approved, reducing the number of issued and outstanding ordinary shares from approximately 60.1 million to 8.6 million[105]. - As of September 30, 2024, the company repurchased a total of 574,658 ordinary shares at a total cost of $3.5 million[118]. - The company received court approval for a share repurchase program totaling $8.0 million, which was later extended by an additional $5.8 million[117]. Future Outlook - The Company expects to incur future net losses and its transition to profitability depends on successful product development and commercialization, as well as establishing distribution contracts[33]. - The company intends to fund future operations through cash on hand, additional private and/or public offerings, and may seek additional capital through strategic partnerships[33]. - The company expects to save approximately $3 million in operating expenses from the consolidation of U.S. operations following the AlterG acquisition[179]. - The company has contractual obligations totaling $7.78 million as of September 30, 2024, including purchase obligations and operating lease obligations[191].
ReWalk(RWLK) - 2024 Q3 - Quarterly Results
2024-11-12 13:15
Revenue Performance - Lifeward reported third quarter 2024 revenue of $6.1 million, a 39% increase from $4.4 million in the same quarter of 2023[7]. - Revenue from Lifeward's historical products, including ReWalk exoskeletons, was $2.5 million, up 173% year-over-year, driven by increased ReWalk system sales[7]. - AlterG product revenue was $3.6 million, reflecting a $0.7 million increase from the previous year, following the acquisition completed on August 11, 2023[7]. - Revenue for the three months ended September 30, 2024, was $6,128,000, a 39% increase from $4,403,000 in the same period of 2023[22]. - Revenues based on customer location showed that the United States contributed $11,054,000 for the nine months ended September 30, 2024, compared to $4,298,000 in the same period of 2023[25]. Profitability and Loss - Gross margin improved to 36.2% in Q3 2024, compared to 19.6% in Q3 2023, while adjusted gross margin was 42.5%, down 2.6 percentage points year-over-year[8]. - The operating loss narrowed to $3.2 million in Q3 2024, compared to $7.9 million in Q3 2023, with adjusted operating loss at $4.1 million[10]. - Net loss for Q3 2024 was $3.1 million, or $0.35 per share, significantly improved from a net loss of $7.5 million, or $0.88 per share, in Q3 2023[11]. - Operating loss for the three months ended September 30, 2024, was $(3,174,000), significantly improved from $(7,942,000) in the same period of 2023[22]. - Non-GAAP net loss for the three months ended September 30, 2024, was $(3,960,000), compared to $(4,473,000) for the same period in 2023[26]. - Net loss for the nine months ended September 30, 2024, was $(13,664,000), compared to $(16,494,000) for the same period in 2023, showing a 17% reduction[22]. Expenses and Cost Management - Total operating expenses decreased to $5.4 million in Q3 2024 from $8.8 million in Q3 2023, with adjusted operating expenses slightly down to $6.7 million[9]. - Lifeward initiated actions to streamline U.S. operations, expecting to save approximately $3 million in operating expenses and improve gross margins by about two percentage points[2]. - GAAP research and development expenses for Q3 2024 were $998 thousand, accounting for 16.3% of revenue, down from $1,262 thousand and 28.7% in Q3 2023[28]. - Non-GAAP sales and marketing expenses for Q3 2024 were $3,676 thousand, or 60.0% of revenue, compared to $3,766 thousand and 85.5% in Q3 2023[28]. - GAAP general and administrative expenses for Q3 2024 were $240 thousand, representing 3.9% of revenue, significantly lower than $3,455 thousand and 78.5% in Q3 2023[29]. - Stock-based compensation expense for Q3 2024 was $290 thousand, or 4.7% of revenue, compared to $333 thousand and 7.5% in Q3 2023[27]. Guidance and Future Outlook - Lifeward revised its full-year 2024 revenue guidance to a range of $25 million to $26 million, anticipating sequential growth in Q4 2024[13]. - The company has approximately 70 qualified leads in the U.S. ReWalk pipeline for potential Medicare claims, indicating robust growth prospects[1]. Asset and Liability Management - Cash and cash equivalents decreased to $10,653,000 as of September 30, 2024, down from $28,083,000 at the end of 2023[23]. - Total assets decreased to $45,770,000 as of September 30, 2024, from $63,192,000 at the end of 2023[23]. - Total current liabilities decreased to $9,657,000 as of September 30, 2024, from $11,795,000 at the end of 2023[23].
ReWalk(RWLK) - 2024 Q2 - Quarterly Results
2024-08-15 12:15
Revenue Performance - Q2 2024 revenue reached $6.7 million, a 400% increase from $1.3 million in Q2 2023[4] - Revenue from historical products and services was $3.1 million, up 131% year-over-year, driven by increased ReWalk system sales due to Medicare coverage expansion[4] - Revenue for the three months ended June 30, 2024, was $6,707,000, a significant increase from $1,337,000 in the same period of 2023, representing a growth of 401%[20] - Revenues from the United States for the three months ended June 30, 2024, were $3,849,000, a substantial increase from $924,000 in the same period of 2023, representing a growth of 317%[25] - Lifeward expects full-year revenue for 2024 to be between $28 million and $32 million, anticipating sequential revenue improvement through the rest of the year[9] Profitability and Loss - Net loss for Q2 2024 was $4.3 million, or $0.50 per share, compared to a net loss of $4.6 million, or $0.55 per share, in Q2 2023[7] - The net loss for the three months ended June 30, 2024, was $4,304,000, slightly improved from a net loss of $4,642,000 in the same period of 2023[20] - Non-GAAP net loss for the six months ended June 30, 2024, was $8,883,000, compared to $7,297,000 for the same period in 2023, reflecting an increase of 21.8%[26] Operating Expenses - Total operating expenses increased to $7.2 million in Q2 2024 from $5.7 million in Q2 2023, primarily due to headcount additions and acquisition-related spending[6] - Operating expenses for the three months ended June 30, 2024, totaled $7,200,000, up from $5,734,000 in the same period of 2023, reflecting a rise of 25.7%[20] - The company reported a net cash used in operating activities of $13,290,000 for the six months ended June 30, 2024, compared to $8,739,000 for the same period in 2023, indicating an increase of 52.5%[24] Cash and Assets - As of June 30, 2024, the company had $15.1 million in unrestricted cash and cash equivalents, with no debt[8] - Cash and cash equivalents decreased to $15,131,000 as of June 30, 2024, down from $28,083,000 at the end of 2023[22] - Total assets decreased to $50,983,000 as of June 30, 2024, compared to $63,192,000 at the end of 2023, a decline of 19.2%[22] Gross Margin and Profit - Gross margin for Q2 2024 was 41.1%, down from 43.1% in Q2 2023, but adjusted gross margin improved to 46.9% from 43.3%[5] - The company reported a GAAP gross profit of $2,757,000 for Q2 2024, which is 41.1% of revenue, compared to $576,000 or 43.1% of revenue in Q2 2023[27] - Gross profit for the six months ended June 30, 2024, was $4,152,000, compared to $1,147,000 for the same period in 2023, indicating an increase of 263%[20] Research and Development - GAAP research and development expenses for Q2 2024 were $1,205,000, which is 18.0% of revenue, up from $816,000 or 61.0% of revenue in Q2 2023[27] - Non-GAAP research and development expenses for the first half of 2024 were $2,404,000, representing 20.0% of revenue, compared to $1,502,000 or 58.5% of revenue in the same period last year[27] Sales and Marketing Expenses - GAAP sales and marketing expenses for Q2 2024 were $4,403,000, accounting for 65.6% of revenue, a significant increase from $2,504,000 or 187.3% of revenue in Q2 2023[28] - Non-GAAP sales and marketing expenses for the first half of 2024 were $8,241,000, representing 68.7% of revenue, compared to $4,824,000 or 187.9% of revenue in the same period last year[28] New Products and Developments - The company launched the new NEO product line in June 2024, featuring advanced Differential Air Pressure Anti-Gravity Technology[2] - Lifeward completed its FDA submission for the 7th generation ReWalk design, enhancing daily life usability of the system[2] - The integration of AlterG is expected to expand Lifeward's scale and improve operational efficiency in upcoming quarters[3] Share Information - The weighted average number of shares used in computing net loss per ordinary share for the three months ended June 30, 2024, was 8,608,937, compared to 8,502,201 in the same period of 2023[20]
ReWalk(RWLK) - 2024 Q2 - Quarterly Report
2024-08-14 21:01
Financial Performance - Total revenues for the three months ended June 30, 2024, were $6.707 million, a significant increase from $1.337 million for the same period in 2023, representing a growth of approximately 401%[22] - Gross profit for the three months ended June 30, 2024, was $2.757 million, compared to $576 thousand for the same period in 2023, indicating a gross margin improvement[22] - Operating loss for the three months ended June 30, 2024, was $(4.443) million, slightly improved from $(5.158) million in the same period of 2023[22] - Net loss for the six months ended June 30, 2024, was $(10.580) million, compared to $(8.963) million for the same period in 2023, reflecting ongoing challenges in profitability[22] - For the six months ended June 30, 2024, total revenues were $11,990,000, up from $2,567,000 in the same period of 2023, indicating a 367% increase[62] - The Company reported product revenue of $5,128,000 for the three months ended June 30, 2024, compared to $989,000 for the same period in 2023, a 418% increase[62] - Total revenues for the six months ended June 30, 2024, were $11.99 million, a significant increase from $2.57 million for the same period in 2023, representing a growth of approximately 366%[137] - Revenue from the United States for the three months ended June 30, 2024, was $3.85 million, compared to $0.92 million for the same period in 2023, indicating a growth of approximately 318%[137] - As of June 30, 2024, total revenues from Europe were $2.31 million, compared to $0.41 million for the same period in 2023, reflecting a growth of approximately 463%[137] Cash and Assets - The company reported cash and cash equivalents of $15.131 million as of June 30, 2024, down from $28.083 million as of December 31, 2023[14] - The company has cash and cash equivalents totaling $5,233,000 as of June 30, 2024, compared to $5,075,000 as of December 31, 2023[56] - Total current assets decreased to $29.639 million as of June 30, 2024, down from $39.222 million as of December 31, 2023, primarily due to a reduction in cash and cash equivalents[14] - The company reported total inventories of $7,193 thousand as of June 30, 2024, up from $5,653 thousand on December 31, 2023, a 27.2% increase[83] - Trade receivables increased to $5,269 thousand as of June 30, 2024, from $3,120 thousand on December 31, 2023, representing a 68.9% increase[72] Liabilities and Financial Stability - Total liabilities decreased to $14.296 million as of June 30, 2024, from $16.682 million as of December 31, 2023, indicating improved financial stability[18] - The earnout liability decreased from $3,292,000 as of December 31, 2023, to $2,800,000 as of June 30, 2024, reflecting a reduction of 15%[60] - The company has established relationships with clinics and rehabilitation centers, professional sports teams, and organizations in the spinal cord injury community for product distribution[40] Research and Development - Research and development expenses for the three months ended June 30, 2024, were $1.205 million, up from $816 thousand in the same period of 2023, reflecting increased investment in product development[22] - The company continues to focus on expanding its market presence and enhancing product offerings, with ongoing efforts in clinical research and development[10] - The Company expects to incur future net losses and its transition to profitability depends on successful product development and commercialization, establishing distribution contracts, or acquiring additional product lines[42] Shareholder Information - The weighted average number of shares used in computing net loss per ordinary share for the three months ended June 30, 2024, was 8,608,937, reflecting a reverse share split effective March 15, 2024[22] - The balance of ordinary shares as of June 30, 2024, was 8,630,902, with total shareholders' equity at $36,687[29] - The Company approved a one-for-seven reverse share split, reducing the number of issued and outstanding ordinary shares from approximately 60.1 million to approximately 8.6 million[108] - The total authorized number of ordinary shares was adjusted to 25 million post-split shares[108] Acquisitions - The company acquired AlterG, Inc. for approximately $19 million, enhancing its product offerings in physical rehabilitation[38] - Total consideration for the acquisition of AlterG, Inc. amounted to $22,100 thousand, including cash and earnout payments[85] - Goodwill related to the acquisition of AlterG, Inc. is recorded at $7.5 million, which has an indefinite life[92] Compensation and Expenses - Share-based compensation to employees and non-employees increased to $757,000 for the six months ended June 30, 2024, compared to $622,000 for the same period in 2023[32] - The Company recognized total share-based compensation expenses of $757,000 for the six months ended June 30, 2024, up from $622,000 in the same period of 2023, reflecting an increase of about 22%[131] - Lease expense for the three months ended June 30, 2024, was $325 thousand, compared to $196 thousand for the same period in 2023, a 65.8% increase[98] Legal and Market Risks - The company is currently involved in litigation initiated by Creative Value Capital Limited Partnership regarding board member elections, with a hearing scheduled for August 26, 2024[139][140] - The company has not experienced any material changes to its market risk during the second quarter of 2024[194]
ReWalk(RWLK) - 2024 Q1 - Quarterly Report
2024-05-15 13:00
Financial Performance - Total revenues for Q1 2024 were $5,283,000, a significant increase from $1,230,000 in Q1 2023, representing a growth of approximately 329%[24] - Gross profit for Q1 2024 was $1,395,000, compared to $571,000 in Q1 2023, indicating an increase of about 144%[24] - Operating loss for Q1 2024 was $(6,502,000), which is a larger loss compared to $(4,375,000) in Q1 2023, reflecting a deterioration of approximately 48%[24] - Net loss for Q1 2024 was $(6,276,000), compared to $(4,321,000) in Q1 2023, marking an increase in losses of about 45%[24] - The company reported a net cash used in operating activities of $7.7 million for the three months ended March 31, 2024, compared to $5.2 million for the same period in 2023[30] - Interest income for Q1 2024 was $288,000, compared to $73,000 in Q1 2023, representing a substantial increase of 294%[136] - The company recognized a total financial income of $232,000 in Q1 2024, compared to $78,000 in Q1 2023, indicating a growth of 197%[136] Cash and Assets - Cash and cash equivalents decreased to $20,744,000 as of March 31, 2024, down from $28,083,000 at the end of 2023, a decline of approximately 26%[16] - Total current assets decreased to $32,786,000 as of March 31, 2024, from $39,222,000 at December 31, 2023, a reduction of about 16%[16] - As of March 31, 2024, the company reported a cash balance of $396,000, an increase from $348,000 at December 31, 2023, reflecting a usage of $198,000 and a provision of $246,000 during the period[78] - The fair value of total assets measured at fair value was $5,169 thousand as of March 31, 2024, compared to $5,075 thousand at the end of 2023, reflecting a slight increase of about 1.85%[55] Liabilities and Equity - Total liabilities decreased to $14,603,000 as of March 31, 2024, down from $16,682,000 at December 31, 2023, a decrease of approximately 12.5%[21] - Total shareholders' equity fell to $40,615,000 as of March 31, 2024, compared to $46,510,000 at December 31, 2023, a decline of about 12.6%[19] Expenses - Research and development expenses increased to $1,291,000 in Q1 2024, up from $752,000 in Q1 2023, representing a rise of approximately 72%[24] - Sales and marketing expenses surged to $5,014,000 in Q1 2024, compared to $2,484,000 in Q1 2023, indicating an increase of about 102%[24] - Lease expenses for the three months ended March 31, 2024, were $328,000, compared to $192,000 for the same period in 2023[100] - General and administrative expenses increased to $220,000 in Q1 2024 from $193,000 in Q1 2023, which is an increase of 14%[130] Acquisitions and Investments - The company paid approximately $19 million for the acquisition of AlterG, Inc., with potential additional cash earnouts based on revenue growth over the next two years[36] - The total consideration for the acquisition of AlterG, Inc. amounted to $22.1 million, which includes cash payments of $18.493 million and earnout payments of $3.607 million[86] - The company has $7.5 million of goodwill related to the acquisition of AlterG, Inc., which has an indefinite life and is not tax-deductible[93] Future Outlook - The company expects to incur future net losses, with its transition to profitability dependent on successful product development and commercialization[40] - The company has sufficient funds to support its operations for more than 12 months following the issuance date of its financial statements[39] Shareholder Information - The company approved a one-for-seven reverse share split, reducing the number of issued and outstanding ordinary shares from approximately 60.1 million to approximately 8.6 million[109] - As of March 31, 2024, there were 2,734,504 warrants outstanding and exercisable, with various exercise prices ranging from $8.75 to $65.63[123] - The total unrecognized compensation costs related to non-vested share-based compensation arrangements amounted to $2.3 million, expected to be recognized over approximately 2.7 years[116] Revenue Breakdown - Revenue breakdown by geographic area shows the United States contributed $3,747,000, Europe $1,169,000, Asia-Pacific $180,000, and the rest of the world $187,000 for Q1 2024[138] - Major customer data indicates Customer A accounted for 26% of total revenues in Q1 2024, while Customer B contributed less than 10%[139] Legal and Regulatory - The company is involved in various legal claims, but is not currently party to any material litigation that could materially affect its financial condition[107] - On April 11, 2024, CMS approved a final payment level of $91,032 for Medicare reimbursement of the ReWalk Personal Exoskeleton, effective April 1, 2024[140]
ReWalk(RWLK) - 2024 Q1 - Quarterly Results
2024-05-15 12:15
Revenue Performance - Q1 2024 revenue reached $5.3 million, a 340% increase compared to $1.2 million in Q1 2023[3] - Revenue from the former ReWalk business was $2.5 million, up 90% year-over-year, driven by increased access through Medicare payment[3] - Total revenues for Q1 2024 reached $5,283,000, a significant increase from $1,230,000 in Q1 2023, representing a growth of 329%[25] - Lifeward expects 2024 revenue to be between $28 million and $32 million, with sequential improvement anticipated in Q2 2024[8] Profitability and Loss - Operating loss for Q1 2024 was $6.5 million, compared to a loss of $4.3 million in Q1 2023[5] - Net loss for Q1 2024 was $6.3 million, or $0.73 per share, compared to a net loss of $4.3 million, or $0.51 per share, in Q1 2023[6] - GAAP net loss for Q1 2024 was $6,276,000, compared to a net loss of $4,321,000 in Q1 2023, indicating a worsening of 45.4%[26] - Non-GAAP net loss per share for Q1 2024 was $(0.62), compared to $(0.45) in Q1 2023, reflecting a decline of 37.8%[26] Expenses - Total operating expenses increased to $7.9 million in Q1 2024 from $4.9 million in Q1 2023, largely due to additional headcount from the AlterG acquisition[5] - Research and development expenses for Q1 2024 were $1,291,000, accounting for 24.4% of total revenue, compared to $752,000 or 61.1% in Q1 2023[28] - Sales and marketing expenses surged to $5,014,000 in Q1 2024, representing 94.9% of total revenue, up from $2,484,000 or 202.0% in Q1 2023[29] - GAAP operating loss for Q1 2024 was $6,502,000, which is 123.1% of revenue, compared to $4,321,000 or 351.3% of revenue in Q1 2023[27] Cash and Equity - As of March 31, 2024, the company had $20.7 million in unrestricted cash and cash equivalents with no debt[7] - Cash and cash equivalents decreased to $20,744,000 as of March 31, 2024, down from $28,083,000 at the end of 2023, a reduction of 26.3%[20] - Total current liabilities decreased to $10,092,000 as of March 31, 2024, down from $11,795,000 at the end of 2023, a decline of 14.4%[21] - Shareholders' equity decreased to $40,615,000 as of March 31, 2024, down from $46,510,000 at the end of 2023, a drop of 12.6%[21] Market and Integration - The finalized Medicare payment for personal exoskeletons is expected to significantly expand access for individuals with spinal cord injury[2] - The integration of the former ReWalk and AlterG commercial teams is expected to enhance sales effectiveness in Q2 2024[3]
ReWalk(RWLK) - 2023 Q4 - Annual Report
2024-02-26 16:00
Acquisition and Product Development - The company acquired AlterG, Inc. on August 11, 2023, enhancing its product offerings in physical and neurological rehabilitation with Anti-Gravity systems utilized in over 4,000 facilities globally[23] - The ReBoot personal soft exo-suit is in the research stage, aimed at post-stroke rehabilitation, and received Breakthrough Device Designation from the FDA in November 2021[24] - The company is currently offering its 6th generation ReWalk Personal Exoskeleton and is in research and development for the 7th generation device[36] - The company is working on product design improvements for the ReWalk Personal Exoskeleton, with plans to launch following regulatory clearance[94] - A new model of the AlterG system is planned for mid-2024, aimed at reducing manufacturing costs to make it more affordable for rehabilitation clinics[95] - The company has entered into a research collaboration with Harvard to develop lightweight soft suit exoskeleton technologies for lower limb disabilities[98] Regulatory Approvals and Reimbursement - On November 1, 2023, CMS confirmed that personal exoskeletons will be included in the Medicare brace benefit category starting January 1, 2024[29] - CMS proposed a preliminary payment determination of $94,617 for the ReWalk Personal Exoskeleton under HCPCS code K1007, reflecting the unique features of the technology[30] - The ReWalk Personal Exoskeleton received FDA clearance for use on stairs and curbs in March 2023, expanding its usability in real-world environments[34] - The ReWalk Personal Exoskeleton is included in the Medicare brace benefit category, with claims to be billed using HCPCS code K1007 starting January 1, 2024[54] - A preliminary payment determination of $94,617 for the ReWalk Personal Exoskeleton was proposed by CMS, effective from April 1, 2024[55] - The GKV-Spitzenverband confirmed the listing of the ReWalk Personal Exoskeleton in the German MDD, allowing for reimbursement on a case-by-case basis[59] Market and Financial Performance - Record annual revenue for 2023 was $13.9 million, compared to $5.5 million in 2022, an increase of 151%[169] - Revenue based on customer location for 2023: United States $7.636 million, Europe $5.044 million, Asia-Pacific $0.387 million, Rest of the world $0.787 million[164] - Cash position remained strong with $28.1 million as of December 31, 2023, with no debt[169] - The VHA accounted for 12% of total revenue for the year ended December 31, 2023, with 42 units placed under their policy[50] - The geographical breakdown of revenue shows significant growth in the U.S. market, increasing from $2.303 million in 2022 to $7.636 million in 2023[164] Clinical and Community Engagement - The company has established relationships with clinics and rehabilitation centers, professional sports teams, and organizations in the SCI community to enhance product distribution[25] - The company actively engages with the spinal cord injury community to promote the adoption of exoskeleton technology through partnerships and education[91] - The company recognizes the need for further clinical evidence and education to accelerate the adoption of the ReStore soft exosuit in stroke therapy programs[79] - The Stride Smart software provides real-time data analytics for clinicians, focusing on five key performance indicators to enhance rehabilitation[68] Challenges and Compliance - The company must navigate complex compliance efforts due to varying state and federal laws regarding healthcare privacy and security[135] - The commercial success of the company's product candidates will depend on governmental payor programs, including Medicare and Medicaid, providing adequate coverage and reimbursement levels[138] - The company faces potential penalties and enforcement actions if found in violation of healthcare laws, which could adversely affect operations and results[137] - Future healthcare reform measures could limit government payments for healthcare products, impacting coverage and demand for the company's products[150] Research and Development Funding - The company has received $2.6 million in funding from the Israel Innovation Authority for research and development efforts through December 31, 2023[96] - The Human Robot Interaction Consortium has allocated NIS 1.745 million for ReWalk-specific projects over the first 18-month period, with an additional NIS 1.336 million for the second 18-month period[96] Product Features and Market Potential - The ReWalk Personal Exoskeleton is designed for daily use and consists of a battery-powered wearable exoskeleton with integrated motors and sensors for user-controlled movement[34] - The ReStore soft exo-suit device offers competitive advantages such as a design that supports natural walking patterns and is lighter and less expensive than rigid exoskeletons[89] - The ReStore system targets a market of approximately 800,000 stroke incidences annually in the U.S., with 80% of survivors facing lower limb disabilities[79] - The ReBoot product, a soft exoskeleton for home use, has an estimated market of approximately 400,000 annual stroke patients requiring walking assistance[81] Global Operations and Compliance - The company has distribution agreements in several European countries, successfully achieving reimbursement policies, such as the one established in Italy for exoskeleton systems[64] - The company must navigate various foreign regulations for clinical trials and marketing, which can vary significantly by country[128] - Following Brexit, the UK has established its own medical device regulations, requiring compliance with the Medical Devices Regulations 2002[127] - The company has received a Notified Body Certificate of Conformity under the MDD for all ReWalk systems, allowing continued marketing in the EU during the transition period[126]
ReWalk(RWLK) - 2023 Q4 - Annual Results
2024-02-26 16:00
Revenue Performance - Record annual revenue for 2023 was $13.9 million, an increase of 151% compared to $5.5 million in 2022[2] - Total revenue for Q4 2023 was $6.9 million, up 216% from $2.2 million in Q4 2022[5] - Revenue from the former AlterG business contributed $4.7 million in Q4 2023, while revenue from the former ReWalk business was $2.2 million, flat year-over-year[5] - Lifeward anticipates revenue for Q1 2024 to be between $5.0 million and $5.5 million, with growth expected in subsequent quarters[10] - Revenue for the quarter ended December 31, 2023, was $6,884 million, a significant increase from $2,179 million for the same period in 2022, representing a 215% growth[21] - Revenue from the United States for the three months ended December 2023 was $3,338,000, compared to $1,110,000 in the same period of 2022, representing a growth of 200.5%[30] Gross Margin and Profitability - Gross margin for Q4 2023 was 35.5%, compared to 30.9% in Q4 2022; adjusted gross margin was 47.0% in Q4 2023, down from 52.8% in Q4 2022[6] - Gross profit for the quarter was $2,443 million, compared to $673 million in the prior year, reflecting a gross margin improvement from 30.9% to 35.5%[21] - Non-GAAP net loss for the quarter was $(3,296) million, an improvement from $(4,345) million in the prior year, with a non-GAAP net loss per share of $(0.05) compared to $(0.07)[22] Operating Expenses and Losses - Total operating expenses in Q4 2023 were $8.6 million, with $3.2 million attributed to AlterG; excluding AlterG, operating expenses were $5.4 million, down 4% from the previous year[7] - Operating loss for the quarter was $(6,137) million, which is 89.1% of revenue, compared to $(5,005) million or 229.6% of revenue in the same quarter last year[23] - Total operating expenses for the quarter were $8,580 million, up from $5,678 million in the same quarter last year, driven by increased sales and marketing expenses[21] Net Loss and Cash Flow - Net loss for Q4 2023 was $5.6 million, or $(0.13) per share, compared to a net loss of $5.3 million, or $(0.09) per share, in Q4 2022[8] - Net loss for the quarter was $(5,639) million, slightly higher than $(5,313) million in the previous year, with a basic net loss per share of $(0.13) compared to $(0.09)[22] - Net cash used in operating activities for the twelve months ended December 2023 was $(20,667,000), compared to $(17,891,000) for the same period in 2022[28] Future Expectations and Integration - Lifeward expects 2024 revenue to be between $28 million and $32 million, with non-GAAP gross margin expanding to the high 40%s[10] - The integration of commercial and operational resources is expected to yield $3 million in annual net savings starting in 2024[2] Regulatory Changes - The Centers for Medicare & Medicaid Services finalized the 2024 Home Health Rule, including exoskeletons in the Medicare brace benefit category, effective January 1, 2024[2] Assets and Liabilities - Cash and cash equivalents decreased to $28,083,000 in December 2023 from $67,896,000 in December 2022, reflecting a decline of 58.7%[26] - Total assets decreased to $63,192,000 in December 2023 from $74,236,000 in December 2022, a reduction of 14.9%[26] - Current liabilities increased to $11,795,000 in December 2023 from $4,782,000 in December 2022, indicating a rise of 146.5%[26] - The company reported a total of $12,525,000 in intangible assets as of December 2023, with goodwill amounting to $7,538,000[26] Research and Development - Research and development expenses for the quarter were $1,318 million, accounting for 19.1% of revenue, up from $1,103 million or 50.6% of revenue in the same quarter last year[23] Financial Income and Amortization - The company reported financial income of $420 million for the quarter, compared to $69 million in the same quarter last year[21] - The company incurred $846 million in amortization of intangible assets during the quarter, which represented 12.3% of revenue[23] Sales and Marketing Expenses - GAAP sales and marketing expenses for December 2023 were $4,846,000, representing 70.4% of revenue, compared to $4,088,000 in September 2023[24] - Non-GAAP sales and marketing expenses were $4,023,000 for December 2023, accounting for 58.4% of revenue, up from $3,766,000 in September 2023[24]