ReWalk Robotics Ltd. (identified in the filing; request metadata names Lifeward Ltd.) — FY2021 Form 10-K
Reporting period: Fiscal year ended December 31, 2021. The filing also reports fourth-quarter 2021 revenue. The company develops and sells robotic exoskeletons and rehabilitation devices, including ReWalk Personal, ReStore and distributed products. Its principal markets are the United States and Europe.
Financial results and liquidity
| Metric | FY2021 | FY2020 |
|---|---|---|
| Revenue | $5.966 million | $4.393 million |
| Gross profit / margin | $2.903 million / 49% | $2.189 million / 50% |
| Operating expenses | $15.558 million | $14.193 million |
| Operating loss | $12.655 million | $12.004 million |
| Net loss | $12.736 million | $12.976 million |
| Net loss per share, basic and diluted | $0.27 | $0.82 |
| Cash used in operating activities | $11.469 million | $12.589 million |
Fourth-quarter 2021 revenue was $1.2 million, up 2% from the prior-year quarter. Revenue for the full year grew 36%. Cash and cash equivalents were $88.337 million at year-end, versus $20.350 million a year earlier; restricted cash was a further $0.713 million. Current assets were $92.521 million and current liabilities $4.038 million. Total liabilities were $5.367 million, principally lease liabilities and operating balances; the Kreos loan had been repaid in December 2020. Financing activities provided $79.512 million in 2021, primarily from equity offerings and warrant exercises. The company reported sufficient funds for more than 12 months following approval of the financial statements, but continued to anticipate losses and a need for additional capital until it achieves profitability or positive operating cash flow.
Changes and management commentary
- Revenue rose by $1.573 million, driven by increased rehabilitation-unit sales in the United States, including a multi-unit academic-center order, and increased personal-unit revenue in Germany as COVID-related restrictions eased.
- Personal-unit revenue increased to $4.820 million from $4.220 million; rehabilitation-unit revenue increased to $1.146 million from $0.173 million.
- Gross margin declined one percentage point. Management cited inventory write-offs of ReStore parts amid lower-than-expected pandemic-era sales and higher service costs, partly offset by sales mix and average selling price.
- Research and development expense fell 15% to $2.939 million. Sales and marketing expense rose 22% to $6.993 million, and general and administrative expense rose 13% to $5.626 million.
- ReWalk Personal placements reached 533, compared with 492 at year-end 2020; ReWalk Rehabilitation placements were 121 versus 119, and ReStore placements were 30 versus 21.
Outlook, risks and unusual items
The filing gives no quantified revenue or earnings guidance. Management’s priorities include expanding reimbursement for ReWalk Personal, commercializing ReStore and distributed products, and developing soft-exosuit technology, including ReBoot. ReBoot received FDA Breakthrough Device Designation in November 2021, but the company had not submitted a clearance or approval application; the designation does not guarantee approval. CMS had issued a product code for ReWalk Personal 6.0, but its Medicare benefit-category determination remained unresolved. A German court decision concerning direct compensation for ReWalk was also pending.
Material risks include limited and uncertain reimbursement, slow adoption and limited clinical evidence, continuing COVID-19 effects, dependence on a single manufacturer and supply-chain constraints, product safety and liability exposure, competition, and ongoing losses and potential future financing needs. The filing describes prior reports of falls and fractures and a voluntary correction classified by FDA as a Class II recall, closed in 2019. It also reports battery thermal-runaway complaints and a related correction; a separate battery-design improvement project was underway. The FDA notified the company in January 2022 that it had completed review of the post-market surveillance report and that the study requirement was fulfilled, with a labeling update to follow.
Other notable items: 2021 net loss was $12.736 million and accumulated deficit was $194.181 million. The company raised substantial capital through share offerings and warrant exercises, increasing issued shares to 62.480 million from 25.332 million; 19.421 million warrants remained outstanding at year-end. Non-cancelable purchase obligations were approximately $1.457 million. The IIA contingent royalty liability was $1.5 million. The independent auditor gave an unqualified opinion; management reported effective disclosure controls and internal control over financial reporting. The CFO had informed the company of his intention to resign effective March 12, 2022.
Most important facts for investors to verify
- Confirm the filing entity: this 10-K is for ReWalk Robotics Ltd.; the request metadata names Lifeward Ltd.
- Track whether CMS determines a Medicare benefit category and whether that leads to meaningful coverage, reimbursement rates and sales.
- Assess cash burn against the stated runway, planned spending and likely need for additional capital.
- Review dilution exposure from outstanding warrants, equity awards and future financing; reconcile share counts and warrant disclosures across filing dates.
- Monitor sales growth and margins by product, especially ReStore adoption, inventory write-offs and service costs.
- Verify the status of the German coverage litigation, ReBoot regulatory and clinical milestones, and the promised post-market labeling update.