
Financial Performance and Operational Update Management Commentary and Operational Highlights Management reported a 58% year-to-date increase in U.S. HIFU treatment volumes, with Q3 revenue flat due to pandemic-related capital spending and logistical delays, while maintaining a strong EUR 45.4 million cash position - U.S. HIFU treatment volumes increased by 58% year-to-date, indicating strong adoption of Focal One therapy78 - Third-quarter revenue was impacted by the COVID-19 pandemic's effect on hospital capital spending and logistical delays78 - The company maintains a strong cash position of EUR 45.4 million (USD 52.6 million)718 Nine Months 2021 Financial Results Nine-month 2021 total revenue grew 14.4% to EUR 30.1 million, driven by Distribution, despite declines in HIFU and LITHO, with net loss narrowing to EUR 0.7 million Nine Months 2021 Key Financials (vs. 9M 2020) | Metric | 9M 2021 (EUR Million) | 9M 2020 (EUR Million) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | 30.1 | 26.3 | +14.4% | | Gross Profit | 12.2 | 11.4 | +7.0% | | Operating Loss | (2.1) | (1.5) | Widened | | Net Loss | (0.7) | (2.5) | Narrowed | | Diluted EPS (EUR) | (0.02) | (0.09) | Improved | Nine Months 2021 Revenue by Business (vs. 9M 2020) | Business Segment | 9M 2021 Revenue (EUR Million) | 9M 2020 Revenue (EUR Million) | YoY Change | | :--- | :--- | :--- | :--- | | Distribution | 16.7 | 11.0 | +52.4% | | LITHO | 7.7 | 8.3 | -7.4% | | HIFU | 5.7 | 7.1 | -18.9% | Third Quarter 2021 Financial Results Q3 2021 total revenue was flat at EUR 9.4 million, with Distribution and LITHO growth offset by a 25.6% decline in HIFU, leading to a widened operating loss of EUR 1.9 million Third Quarter 2021 Key Financials (vs. Q3 2020) | Metric | Q3 2021 (EUR Million) | Q3 2020 (EUR Million) | Change | | :--- | :--- | :--- | :--- | | Total Revenue | 9.4 | 9.4 | Flat | | Gross Profit | 3.6 | 4.0 | -10.0% | | Operating Loss | (1.9) | (0.3) | Widened | | Net Loss | (1.0) | (1.0) | Flat | | Diluted EPS (EUR) | (0.03) | (0.03) | Flat | Third Quarter 2021 Revenue by Business (vs. Q3 2020) | Business Segment | Q3 2021 Revenue (EUR Million) | Q3 2020 Revenue (EUR Million) | YoY Change | | :--- | :--- | :--- | :--- | | Distribution | 5.0 | 4.4 | +13.4% | | LITHO | 2.5 | 2.4 | +3.0% | | HIFU | 1.9 | 2.6 | -25.6% | Unaudited Condensed Consolidated Financial Statements Consolidated Statements of Operations Consolidated operations show Q3 2021 revenues flat at EUR 9.44 million with increased operating loss, while nine-month revenues rose to EUR 30.09 million and net loss significantly narrowed to EUR 0.67 million Q3 2021 Statement of Operations Highlights (in thousands of Euros) | Line Item | Q3 2021 | Q3 2020 | | :--- | :--- | :--- | | TOTAL REVENUES | 9,440 | 9,433 | | GROSS PROFIT | 3,625 | 3,964 | | S, G & A expenses | (4,446) | (3,167) | | OPERATING PROFIT (LOSS) | (1,885) | (293) | | NET INCOME (LOSS) | (1,015) | (1,001) | Nine Months 2021 Statement of Operations Highlights (in thousands of Euros) | Line Item | 9M 2021 | 9M 2020 | | :--- | :--- | :--- | | TOTAL REVENUES | 30,092 | 26,298 | | GROSS PROFIT | 12,211 | 11,350 | | OPERATING PROFIT (LOSS) | (2,073) | (1,451) | | NET INCOME (LOSS) | (665) | (2,484) | Consolidated Balance Sheets As of September 30, 2021, the balance sheet strengthened with cash doubling to EUR 45.4 million, total assets increasing to EUR 73.7 million, and shareholders' equity rising to EUR 48.0 million Balance Sheet Highlights (in thousands of Euros) | Account | Sep 30, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | 45,411 | 24,696 | | TOTAL CURRENT ASSETS | 64,672 | 45,393 | | TOTAL LIABILITIES | 25,646 | 28,945 | | TOTAL SHAREHOLDERS' EQUITY | 48,040 | 26,248 | Consolidated Statements of Cash Flows For the nine months ended September 30, 2021, operating activities generated EUR 1.8 million cash, with financing activities providing EUR 20.4 million, resulting in a net cash increase of EUR 20.7 million Nine Months 2021 Cash Flow Summary (in thousands of Euros) | Cash Flow From | 9M 2021 Amount | | :--- | :--- | | Operating Activities | 1,774 | | Investing Activities | (988) | | Financing Activities | 20,384 | | Net Increase in Cash | 20,716 | Statements of Operations by Division For the first nine months of 2021, Distribution was the primary driver with EUR 16.7 million revenue and EUR 2.1 million operating profit, while HIFU recorded an operating loss of EUR 3.3 million Nine Months 2021 Performance by Division (in thousands of Euros) | Division | Total Revenues | Gross Profit | Operating Profit (Loss) | | :--- | :--- | :--- | :--- | | HIFU | 5,717 | 2,150 | (3,269) | | ESWL | 7,667 | 3,526 | 585 | | Distribution | 16,708 | 6,536 | 2,067 |