InspireMD(NSPR) - 2025 Q1 - Quarterly Results

InspireMD First Quarter 2025 Financial Results Business and Operational Highlights InspireMD is advancing its commercial and operational readiness for the anticipated U.S. launch of its CGuard Prime carotid stent system, with optimism for FDA PMA approval in Q3 2025 and ongoing enrollment in the CGUARDIANS II pivotal study - The company is optimistic about receiving FDA PMA approval for the CGuard Prime carotid stent system in the U.S. during the third quarter of 2025[3][6] - InspireMD has built and trained a commercial team in preparation for a potential large-scale U.S. launch following FDA approval[3] - Enrollment continues at an excellent pace for the CGUARDIANS II pivotal study, evaluating the CGuard Prime system for TransCarotid Artery Revascularization (TCAR) procedures[6] Financial Performance For Q1 2025, InspireMD reported a 1.2% revenue increase to $1.53 million, flat gross profit at $0.29 million, and a 52.5% surge in operating expenses to $11.75 million, widening the net loss to $11.17 million, with cash decreasing to $26.09 million Consolidated Statements of Operations Revenue for Q1 2025 grew modestly by 1.2% year-over-year to $1.529 million, while gross profit was unchanged at $292,000, and operating expenses increased substantially by 52.5% to $11.752 million, leading to a higher net loss of $11.166 million Consolidated Statements of Operations Summary | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenues | $1,529,000 | $1,511,000 | +1.2% | | Gross Profit | $292,000 | $292,000 | 0.0% | | Total Operating Expenses | $11,752,000 | $7,706,000 | +52.5% | | Net Loss | ($11,166,000) | ($7,032,000) | +58.8% | | Net Loss Per Share | ($0.22) | ($0.21) | +4.8% | - The slight revenue increase was attributed to the adoption of CGuard technology, partially offset by foreign exchange impacts and distributors managing inventory levels in anticipation of CGuard Prime approval in Europe[4] - The 52.5% increase in operating expenses was primarily driven by higher salaries and share-based compensation related to U.S. sales force expansion, along with costs for launch preparation and recruitment[8] Consolidated Balance Sheets As of March 31, 2025, the company's liquidity included $26.086 million in cash, cash equivalents, and marketable securities, a decrease from $34.637 million at year-end 2024, with total assets at $38.672 million and total liabilities at $10.327 million - Cash, cash equivalents, and marketable securities decreased by $8.55 million during the first quarter, from $34.637 million on December 31, 2024, to $26.086 million on March 31, 2025[10] Consolidated Balance Sheets Summary | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,383,000 | $18,916,000 | | Marketable securities | $13,703,000 | $15,721,000 | | Total Current Assets | $32,144,000 | $40,521,000 | | Total Assets | $38,672,000 | $46,807,000 | | Total Liabilities | $10,327,000 | $10,721,000 | | Total Equity | $28,345,000 | $36,086,000 | Forward-Looking Statements The press release contains forward-looking statements regarding the company's strategies, future financial performance, and expectations, including potential FDA approval and U.S. commercial launch of CGuard Prime, which are subject to numerous risks and uncertainties - The report includes statements about future events and performance which are not guarantees and are based on current assumptions[15] - Key risks highlighted include a history of recurring losses, the need to raise additional capital, securing regulatory approvals, market acceptance of products, and intense competition[15] Conference Call Information InspireMD management will host a conference call and webcast on May 9 at 8:30 a.m. ET to discuss the first-quarter 2025 financial results and provide a corporate update Conference Call Details | Detail | Information | | :--- | :--- | | Date & Time | Friday, May 9 at 8:30 a.m. ET | | Domestic Dial-in | 1-800-579-2543 | | International Dial-in | 1-785-424-1789 | | Conference ID | IMD1Q25 | | Webcast | Webcast Link |