IceCure Medical Ltd. — 2023 Form 20-F
Period and context: This is an annual report for the fiscal year ended December 31, 2023, filed April 3, 2024—not a standalone 2022 Q4 filing. The filing does not provide separate Q4 results. IceCure is an Israeli commercial-stage medical-device company developing and selling liquid-nitrogen cryoablation systems, led by ProSense, for tumor treatment. Financial statements are prepared under U.S. GAAP and reported in U.S. dollars.
Key financial metrics
| Metric (US$ thousands, except per-share data) | 2023 | 2022 |
|---|---|---|
| Revenue | 3,229 | 3,085 |
| Gross profit / gross margin | 1,300 / 40% | 1,445 / 47% |
| Operating loss | (15,576) | (16,739) |
| Net loss | (14,652) | (16,978) |
| Basic and diluted loss per share | $0.32 | $0.46 |
| Net cash used in operating activities | (12,521) | (14,292) |
| Cash and cash equivalents at year-end | 10,533 | 23,659 |
| Short-term deposits at year-end | 529 | — |
Revenue rose 5% year over year. Product-system and disposable sales totaled $2.955 million, up 26%; revenue from exclusive distribution agreements fell to $274,000 from $747,000. Gross margin contracted as Japan distribution revenue declined and product-related costs increased. R&D expense fell 9% to $8.273 million; sales and marketing expense rose 38% to $4.437 million; general and administrative expense fell 29% to $4.166 million.
Cash used in investing activities was $713,000, including $480,000 of property and equipment purchases; financing provided $83,000, versus $13.577 million in 2022, primarily reflecting the prior-year offering. Cash, cash equivalents and short-term deposits totaled $11.062 million at year-end; working capital was $10.313 million. The balance sheet reported $599,000 of lease liabilities and no conventional borrowings were identified in the provided financial statements. Accumulated deficit was $90.061 million.
Material changes and operating developments
- Revenue growth was led by systems ($1.452 million, up 45%) and disposables ($1.503 million, up 13%); Japan distribution-agreement revenue declined 63% to $274,000.
- Geographically, U.S. revenue increased to $751,000 from $604,000 and China revenue to $440,000 from $104,000; Japan revenue declined to $480,000 from $1.130 million.
- The company delisted from the Tel Aviv Stock Exchange in July 2023; its ordinary shares trade on Nasdaq as ICCM. Year-end shares outstanding were 45,729,684.
- Terumo halted distribution activity in Singapore effective March 31, 2023. The company also reported that its Chinese distributor arrangement has a three-year minimum purchase target of $3.5 million.
Outlook, risks, contingencies, and unusual items
- Going concern: Management and the auditor identify substantial doubt about the company’s ability to continue as a going concern. Management says year-end resources, and approximately $11 million of cash, cash equivalents and short-term deposits at March 31, 2024, are insufficient to fund planned operations for at least 12 months beyond the report filing date. The company expects continued losses and needs additional capital; financing is not assured.
- Subsequent financing: Under a January 2024 at-the-market equity distribution agreement, IceCure may sell up to $9.7 million of shares. By March 29, 2024, it had sold 2,209,465 shares for approximately $3.0 million gross and $2.8 million net, diluting existing holders.
- Regulatory and clinical outlook: The FDA denied the company’s De Novo request for ProSense in breast cancer in September 2023. Following supervisory review, the FDA agreed in January 2024 to reopen the file if IceCure submits the full five-year ICE3 trial dataset and a comparison with the LUMINA study. The company reported the final ICE3 follow-up concluded March 15, 2024, with 96.39% of patients local-recurrence-free, and planned to submit data in April 2024. FDA authorization for malignant breast tumors remained outstanding. The filing describes XSense and MultiSense development, but gives inconsistent timing for the XSense 510(k) submission; confirm current status directly.
- Commercialization: Material growth depends on regulatory clearances, clinical evidence, physician adoption, distribution, medical-association guidance, coding and reimbursement. U.S. breast-cancer procedures had a temporary Category III code and case-by-case facility payment potential, conditional on FDA marketing authorization; permanent Category I coding and broader reimbursement were not assured.
- Litigation: A shareholder class-action certification motion concerning a 2021 private placement remained pending. The plaintiff alleges disclosure and approval deficiencies and asserts substantial potential damages; the company disputes the claims. A separate accessibility-related action was dismissed with prejudice in March 2023.
- Other risks: The company relies on third-party manufacturers and distributors, has limited product-sales revenue, faces competition and uncertain reimbursement, and may need further equity or debt financing. Its Israeli operations are exposed to the ongoing regional conflict; ten employees were called up as reservists and had returned by the report date, while the company stated supply chains had not been affected to that point. Currency movements, IIA grant royalty and technology-transfer conditions, and potential dilution are additional risks.
- Controls and dividends: Management reported effective disclosure controls and internal control over financial reporting as of December 31, 2023; the auditor did not attest to internal-control effectiveness under the emerging-growth-company exemption. IceCure has never paid cash dividends and does not expect to do so in the foreseeable future.
Most important facts for investors to verify
- Available cash, operating cash burn, and the timing, amount and terms of any additional financing; assess the going-concern disclosure against current cash needs.
- FDA decisions and the actual status and content of the ICE3 submission, breast-cancer indication, XSense clearance and MultiSense development.
- Whether system and disposable sales continue to grow, and whether the falling Japan-related revenue and lower gross margin stabilize or worsen.
- Distributor performance and minimum-purchase progress, especially in China, and the effect of Terumo’s Singapore exit.
- Practical reimbursement, CPT coding and medical-guideline progress, rather than payment potential alone.
- Developments in the pending shareholder litigation, Israeli operating conditions, and any changes in supply, staffing or regulatory risks.