InspireMD(NSPR) - 2025 Q2 - Quarterly Results

Recent Business Highlights InspireMD achieved significant milestones, including FDA approval and U.S. commercial launch of its CGuard Prime carotid stent system, a successful $58 million capital raise, and CE Mark approval for CGuard Prime EPS in Europe, alongside strengthening its leadership team CEO Commentary CEO Marvin Slosman highlighted the U.S. approval and commercial rollout of the CGuard Prime carotid stent system as significant milestones, validating the company's vision and execution - CEO Marvin Slosman highlighted the U.S. approval and commercial rollout of the CGuard Prime carotid stent system as significant milestones, validating the company's vision and execution[3] - The company secured $58 million in gross proceeds, demonstrating investor confidence, and is focused on scaling with discipline to establish CGuard Prime as the standard of care[3] Key Achievements This section outlines InspireMD's key accomplishments, including regulatory approvals, market launches, capital raising, and leadership appointments - Received premarket application (PMA) approval from the U.S. FDA for the CGuard Prime carotid stent system[5] - Commenced commercial launch of the CGuard Prime carotid stent system in the U.S. Market[5] - Raised $58 million in gross proceeds from an equity private placement and warrant exercise to advance growth initiatives[5] - Received CE Mark approval under the European Medical Device Regulation (MDR) for CGuard Prime EPS, with plans to launch in the third quarter[5] - Strengthened leadership team with the appointment of Mike Lawless as Chief Financial Officer and Raymond W. Cohen to the Board of Directors[5] Financial Results - Second Quarter Ended June 30, 2025 InspireMD reported a modest revenue increase of 2.3% to $1.778 million in Q2 2025, primarily due to CGuard adoption and positive exchange rates, offset by declines in Russia and inventory management. Gross profit decreased by 5.4%, while operating expenses surged by 55.2% due to U.S. sales force expansion and launch preparations, leading to a higher net loss of $13.151 million Revenue and Gross Profit Q2 This section details the revenue and gross profit performance for the second quarter of 2025 compared to the prior year | Metric | Q2 2025 ($000) | Q2 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Revenue | 1,778 | 1,739 | 39 | 2.3% | | Gross Profit | 313 | 331 | (18) | (5.4%) | - Revenue increase driven by continued adoption of CGuard technology in existing markets and positive exchange rates, partially offset by decreased revenue from Russia and distributors managing CGuard inventory[4] Operating Expenses and Net Loss Q2 This section presents the operating expenses and net loss for the second quarter of 2025, highlighting significant increases due to strategic investments | Metric | Q2 2025 ($000) | Q2 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Total Operating Expenses | 13,332 | 8,591 | 4,741 | 55.2% |\n| Financial expense, net | (132) | 351 | (483) | - |\n| Net Loss | (13,151) | (7,909) | (5,242) | 66.3% |\n| Net loss per share (basic & diluted) | (0.26) | (0.22) | (0.04) | 18.2% | - Increase in operating expenses primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion, CGuard Prime launch preparation, U.S. facility rent, and CFO severance fees[7] - Financial expense, net, decreased due to the impact of foreign exchange and less interest income from investments in marketable securities and money market funds[8] Cash and Marketable Securities Q2 This section provides an overview of the company's cash and marketable securities position as of June 30, 2025 | Metric | June 30, 2025 ($000) | December 31, 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------------- | :----------------------- | :------------ | :--------- | | Cash and cash equivalents | 11,509 | 18,916 | (7,407) | (39.2%) |\n| Marketable securities | 7,865 | 15,721 | (7,856) | (50.0%) |\n| Total Cash & Marketable Securities | 19,374 | 34,637 | (15,263) | (44.1%) | Financial Results - Six Months Ended June 30, 2025 For the first half of 2025, revenue increased slightly by 1.8% to $3.307 million, while gross profit saw a minor decrease of 2.8%. Operating expenses significantly rose by 53.9% due to sales force expansion and product launch activities, leading to a net loss of $24.317 million, a substantial increase from the prior year Revenue and Gross Profit H1 This section details the revenue and gross profit performance for the six months ended June 30, 2025, compared to the prior year | Metric | H1 2025 ($000) | H1 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Revenue | 3,307 | 3,250 | 57 | 1.8% |\n| Gross Profit | 605 | 623 | (18) | (2.8%) | - Revenue increase driven by continued adoption of CGuard technology, offset by decreased revenue from Russia, the impact of exchange rates, and distributors managing CGuard inventory levels[10] Operating Expenses and Net Loss H1 This section presents the operating expenses and net loss for the six months ended June 30, 2025, highlighting significant increases due to strategic investments and launch preparations | Metric | H1 2025 ($000) | H1 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Total Operating Expenses | 25,084 | 16,297 | 8,787 | 53.9% |\n| Financial income, net | 162 | 733 | (571) | (77.9%) |\n| Net Loss | (24,317) | (14,941) | (9,376) | 62.8% |\n| Net loss per share (basic & diluted) | (0.48) | (0.43) | (0.05) | 11.6% | - Operating expenses increased due to higher salaries and share-based compensation for U.S. sales force expansion, development and regulatory activities for SwitchGuard NPS, CGuard Prime launch preparation, U.S. facility rent, promotional activities, and CFO severance fees[12] - Financial income, net, decreased primarily due to a reduction in income from investments in marketable securities and money market funds, as well as an increase in financial expenses from exchange rate fluctuations[14] Conference Call and Webcast Details Management will host a conference call on August 5, 2025, at 8:30 a.m. ET to discuss financial results and corporate developments, followed by a question-and-answer session - Conference call scheduled for Tuesday, August 5, 2025, at 8:30 a.m. ET[16] | Detail | Information | | :----- | :---------- | | Domestic Call | 1-800-579-2543 | | International Call | 1-785-424-1789 | | Conference ID | IMD2Q25 | | Webcast Link | https://viavid.webcasts.com/starthere.jsp?ei=1723041&tp_key=b02c396fff | About InspireMD, Inc. InspireMD is a developer of carotid stenting products utilizing its proprietary MicroNet™ mesh technology, aiming to set the industry standard for stroke prevention with superior acute results and durable, stroke-free long-term outcomes. The company's stock trades on Nasdaq under NSPR - InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting[18] - The company aims to provide outstanding acute results and durable, stroke-free long-term outcomes for stroke prevention[18] - InspireMD's common stock is quoted on Nasdaq under the ticker symbol NSPR[18] Forward-looking Statements This section contains cautionary statements regarding future events, financial performance, strategies, and regulatory environment, emphasizing that actual results may differ materially due to various known and unknown risks and uncertainties. Investors are advised to review SEC filings for detailed risk factors - This press release contains forward-looking statements regarding InspireMD's expectations, hopes, beliefs, intentions, or strategies concerning future events and financial performance[20] - Forward-looking statements are not guarantees of future performance and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified[20] - Risks include recurring losses, going concern doubts, need for additional capital, market acceptance, regulatory approvals, clinical trial results, competition, intellectual property protection, manufacturing dependence, and economic conditions[20] - Investors and security holders are urged to read the Company's filings with the SEC, including the Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, for more detailed information about risk factors[20] Investor Contacts Contact information for investor relations is provided through Webb Campbell of Gilmartin Group LLC and a general investor relations email - Investor inquiries can be directed to Webb Campbell at Gilmartin Group LLC or via investor-relations@inspiremd.com[21] Condensed Consolidated Financial Statements This section presents the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, and the condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024 Condensed Consolidated Statements of Operations This section provides the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 | Metric (U.S. dollars in thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------- | :------ | :------ | :------ | :------ | | Revenues | 1,778 | 1,739 | 3,307 | 3,250 | | Cost of revenues | 1,465 | 1,408 | 2,702 | 2,627 | | Gross Profit | 313 | 331 | 605 | 623 | | Research and development | 3,834 | 3,401 | 7,893 | 6,026 | | Selling and marketing | 4,172 | 1,445 | 6,922 | 2,682 | | General and administrative | 5,326 | 3,745 | 10,269 | 7,589 | | Total operating expenses | 13,332 | 8,591 | 25,084 | 16,297 | | Loss from operations | (13,019)| (8,260) | (24,479)| (15,674)| | Financial income (expense), net | (132) | 351 | 162 | 733 | | Net Loss | (13,151)| (7,909) | (24,317)| (14,941)| | Net loss per share – basic and diluted | (0.26) | (0.22) | (0.48) | (0.43) | | Weighted average shares | 51,003,900 | 35,877,926 | 50,508,660 | 35,060,450 | Condensed Consolidated Balance Sheets This section presents the unaudited condensed consolidated balance sheets as of June 30, 2025, and the audited balance sheets as of December 31, 2024 | Metric (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | ASSETS | | | | Cash and cash equivalents | 11,509 | 18,916 | | Marketable securities | 7,865 | 15,721 | | Total current assets | 25,463 | 40,521 | | Total non-current assets | 7,879 | 6,286 | | Total assets | 33,342 | 46,807 | | LIABILITIES AND EQUITY | | |\n| Total current liabilities | 9,068 | 7,678 | | Total long-term liabilities | 4,031 | 3,043 | | Total liabilities | 13,099 | 10,721 | | Total equity | 20,243 | 36,086 | | Total liabilities and equity | 33,342 | 46,807 | - All June 30, 2025, financial information is derived from the Company's 2025 unaudited financial statements (Form 10-Q), and December 31, 2024, information from the 2024 audited financial statements (Form 10-K)[27]