IceCure(ICCM) - 2023 Q4 - Annual Report

Overview & Key Highlights IceCure Medical reported 26% global ProSense® sales growth in FY2023, marking its commercial transition and completing the ICE3 breast cancer study - The company is transitioning from a research and development focus to a commercial phase, highlighted by a significant increase in product sales[1] - The most significant milestone achieved is the completion of the ICE3 breast cancer study, with full results set for FDA submission in April 2024, potentially boosting commercial demand[3][6] 2023 Key Financial Highlights | Metric | Value/Status | | :--- | :--- | | Global Product Sales Growth | 26% Increase | | U.S. Product Sales Growth | 24% Increase | | Cash and Cash Equivalents (Dec 31, 2023) | $11.1 million | | Q1 2024 Capital Raise (ATM) | $3 million (gross proceeds) | | Cash and Cash Equivalents (Mar 31, 2024) | Approx. $11 million | 2023 and Recent Significant Operating, Clinical, Regulatory & Commercial Highlights In 2023, IceCure completed its ICE3 breast cancer study, expanded global regulatory approvals and distribution, and advanced its technology pipeline - The ICE3 breast cancer study successfully completed, demonstrating a 96.39% local recurrence-free rate with no significant device-related adverse events, with full results set for FDA submission in April 2024[5][6] - Regulatory approvals for ProSense® were secured in Brazil, Canada, and China, expanding the total to 15 countries with various indications[8] - Global commercial rollout is gaining momentum with new distribution agreements and system installations in Portugal, India, and Brazil[9] - The company is advancing its technology pipeline, filing a 510(k) submission with the FDA for its next-generation single probe XSense™ System and cryoprobes[11] Financial Results for the Twelve Months Ended December 31, 2023 FY2023 revenues increased to $3.2 million with 26% ProSense® sales growth, and net loss improved 14% to $14.7 million from expense reductions FY 2023 vs FY 2022 Financial Performance (in millions) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $3.2M | $3.1M | +3.2% | | ProSense® & Disposables Sales | $3.0M | $2.3M | +26% | | Gross Profit | $1.3M | $1.4M | -7.1% | | Operating Expenses | $16.9M | $18.2M | -7.1% | | Net Loss | ($14.7M) | ($17.0M) | +14% (improvement) | | Net Loss Per Share | ($0.32) | ($0.46) | +30.4% (improvement) | - Operating expenses decreased due to reductions in R&D (down to $8.3 million from $9.1 million) and G&A (down 30% to $4.2 million), partially offset by increased Sales and Marketing expenses (up to $4.4 million from $3.2 million) to support commercialization[14][15][16] - Cash and cash equivalents stood at $11.1 million as of December 31, 2023, down from $23.7 million at the end of 2022, with an expense reduction plan implemented for 2024[18] Financial Statements The 2023 consolidated financial statements reflect reduced assets, a narrowed net loss, and significant cash usage Consolidated Balance Sheets As of December 31, 2023, total assets decreased to $16.4 million from $30.2 million, primarily due to reduced cash, with equity at $12.2 million Consolidated Balance Sheet Summary (U.S. dollars in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total Current Assets | 14,184 | 28,130 | | Cash and cash equivalents | 10,533 | 23,659 | | Total Assets | 16,410 | 30,188 | | Total Current Liabilities | 3,871 | 4,336 | | Total Liabilities | 4,247 | 4,766 | | Total Shareholders' Equity | 12,163 | 25,422 | Consolidated Statements of Comprehensive Loss For FY2023, revenues increased to $3.23 million, while expense management reduced operating loss to $15.6 million and net loss to $14.7 million Consolidated Statement of Comprehensive Loss Summary (U.S. dollars in thousands) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenues | 3,229 | 3,085 | | Gross profit | 1,300 | 1,445 | | Operating loss | (15,576) | (16,739) | | Net loss | (14,652) | (16,978) | | Basic and diluted net loss per share | (0.32) | (0.46) | Consolidated Statements of Cash Flows In 2023, the company used $12.5 million in cash for operations, resulting in a net decrease of $13.2 million and a year-end cash balance of $10.5 million Consolidated Statement of Cash Flows Summary (U.S. dollars in thousands) | Account | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2122 | | :--- | :--- | :--- | | Net cash used in operating activities | (12,521) | (14,292) | | Net cash provided by (used in) investing activities | (713) | (891) | | Net cash provided by financing activities | 83 | 13,577 | | Increase (decrease) in cash and cash equivalents | (13,151) | (1,606) | | Cash and cash equivalents end of the year | 10,533 | 23,659 | Reconciliation of US GAAP to Non-US GAAP Financial Measures IceCure uses non-GAAP measures to assess core business performance, with non-GAAP gross profit from system and disposable sales increasing 47% to $1.03 million in 2023, and non-GAAP gross margin improving to 35% - The company uses non-GAAP financial measures to better assess the commercial performance of its business by isolating gross profit and margin from system and disposable sales[20] GAAP to Non-GAAP Reconciliation (U.S. dollars in thousands) | Metric | 2023 | 2022 | | :--- | :--- | :--- | | GAAP Gross Profit | $1,300 | $1,445 | | GAAP Gross Margin % | 40% | 47% | | Revenues from sales of systems and disposables | $2,955 | $2,338 | | Non-GAAP Gross Profit | $1,026 | $698 | | Non-GAAP Gross Margin % | 35% | 30% |