Business context and reporting period
Registrant: The filing is for ReWalk Robotics Ltd., an Israel-based medical-device company—not a registrant named Lifeward Ltd. It covers the fiscal year ended December 31, 2022; the filing separately reports fourth-quarter revenue. The company develops and sells robotic exoskeletons for people with spinal cord injuries, a soft exo-suit for stroke rehabilitation, and distributed products. Its main markets are the United States and Europe.
Financial performance and liquidity
Amounts below are in U.S. dollars. Annual comparisons are 2022 versus 2021.
| Metric | 2022 | 2021 |
|---|---|---|
| Revenue | $5.511 million | $5.966 million |
| Gross profit / margin | $1.905 million / 35% | $2.903 million / 49% |
| Operating loss | $19.102 million | $12.655 million |
| Net loss | $19.569 million | $12.736 million |
| Net loss per share, basic and diluted | $0.31 | $0.27 |
| Cash used in operating activities | $17.891 million | $11.469 million |
| Cash and cash equivalents at year-end | $67.896 million | $88.337 million |
- Fourth-quarter 2022 revenue was $2.2 million, up 75% from $1.2 million in fourth-quarter 2021. The filing does not provide a clear fourth-quarter profit or cash-flow value in the supplied text.
- Revenue fell about 8% for the year. Personal-unit revenue was $4.762 million versus $4.820 million; rehabilitation-unit revenue was $749,000 versus $1.146 million.
- Gross margin contracted, principally due to higher inventory reserves for obsolete ReStore components, lower ReWalk Personal sales, and higher production and freight costs. Inventory reserves were $502,000 in 2022 versus $252,000 in 2021.
- Operating expenses rose to $21.007 million from $15.558 million: R&D was $4.031 million, sales and marketing $9.842 million, and general and administrative $7.134 million. The increases reflected development and personnel costs, CMS reimbursement work, resumed travel and trade-show activity, and proxy-related professional services.
- Year-end current assets were $72.510 million and current liabilities $4.782 million. The company reported no debt; the Kreos loan had been repaid in 2020. Total liabilities were $6.071 million, including lease and deferred-revenue obligations.
- Financing activities used $2.5 million in 2022, mainly for share repurchases; 2021 financing provided $79.512 million, primarily from equity offerings and warrant exercises. Management said cash was sufficient to fund planned operations for more than 12 months after financial-statement approval, while also warning that further capital may be needed before profitability or positive operating cash flow.
Material changes, outlook, and risks
- Management expects continued losses. It expects growth to depend on sales of ReWalk Personal, reimbursement expansion, and sales of ReStore and distributed products; it gave no specific quantified revenue or earnings guidance in the supplied filing text.
- The company submitted its first Medicare coverage case through Medicare Administrative Contractors in fourth-quarter 2022 and was pursuing a nationwide Medicare benefit-category determination. Until CMS acts, coverage decisions may be made case by case. Lack of broad reimbursement remains a central commercial risk.
- The company had placed 572 ReWalk Personal units and 128 rehabilitation units by year-end 2022, compared with 533 and 121, respectively, at year-end 2021. ReStore placements rose to 33 from 30.
- Development investment in ReBoot, a proposed home-use stroke exo-suit, was temporarily paused in 2023 pending further assessment of its clinical and commercial opportunity. The MediTouch distribution agreement was terminated effective January 31, 2023, due to unsatisfactory sales.
- The company repurchased about 2.9 million shares for $2.6 million during 2022; 2.75 million were repurchased in the fourth quarter at an average $0.87 per share. The board approved a further $5.8 million repurchase authorization, approved by an Israeli court in February 2023.
- Nasdaq notified the company in October 2022 that it failed the $1.00 minimum-bid-price requirement. The initial compliance period ran through April 10, 2023; the filing cautioned that failure to regain compliance could lead to delisting.
- Key risks include continuing operating losses and cash burn; uncertain reimbursement and market adoption; COVID-related effects not fully abated; dependence on Sanmina as sole manufacturer and a single Israeli manufacturing site; product safety, regulatory and clinical-evidence risks; foreign-exchange exposure; and potential shareholder dilution. Approximately 19.4 million warrants were outstanding at year-end.
- Product-safety history includes reports of falls and fractures and a prior Class II correction/recall that closed in 2019. A battery thermal-runaway correction was reported as closed in the U.S. and Europe; a related battery design-improvement project remained in process.
- The company disclosed ordinary-course legal matters and stated it did not believe their outcomes would materially adversely affect the business. It reported a $1.6 million contingent IIA grant-related obligation, payable in connection with qualifying sales, and restrictions on transferring certain grant-funded know-how outside Israel.
- The independent auditor issued an unqualified opinion on the financial statements. Management concluded disclosure controls and internal control over financial reporting were effective at year-end; the auditor did not attest to internal controls, consistent with the company’s smaller-reporting-company and non-accelerated-filer status.
Most important facts for investors to verify
- Whether Medicare or other payors expand coverage, and the outcome and economics of the initial Medicare claim and nationwide benefit-category process.
- Whether revenue growth can recover while gross margin improves, given the 2022 inventory reserve, lower rehabilitation sales, and higher operating expenses.
- Cash-burn pace and runway: 2022 operating cash use was $17.9 million, and management anticipates future losses despite $67.9 million of year-end cash.
- Nasdaq listing compliance status after the April 10, 2023 deadline, including any extension or delisting developments.
- Share-count and dilution impact of repurchases, subsequent share activity, outstanding warrants, and equity awards.
- Manufacturing continuity and product-safety status, including the single-site Sanmina dependency and remaining battery design work.