Group 1: Financial Performance - InspireMD, Inc. reported a quarterly loss of $0.22 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.17, and compared to a loss of $0.21 per share a year ago, indicating an earnings surprise of -29.41% [1] - The company posted revenues of $1.53 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 9.21%, and showing a slight increase from year-ago revenues of $1.51 million [2] - Over the last four quarters, InspireMD has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Group 2: Stock Performance and Outlook - InspireMD shares have declined approximately 1.1% since the beginning of the year, while the S&P 500 has seen a decline of -3.7% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $1.93 million, and for the current fiscal year, it is -$0.79 on revenues of $8.22 million [7] - The estimate revisions trend for InspireMD is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Group 3: Industry Context - The Medical - Instruments industry, to which InspireMD belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

InspireMD First Quarter 2025 Financial Results [Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) 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](index=3&type=chunk)[6](index=6&type=chunk) - InspireMD has built and trained a commercial team in preparation for a potential large-scale U.S. launch following FDA approval[3](index=3&type=chunk) - Enrollment continues at an excellent pace for the CGUARDIANS II pivotal study, evaluating the CGuard Prime system for TransCarotid Artery Revascularization (TCAR) procedures[6](index=6&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) 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](index=1&type=section&id=Consolidated%20Statements%20of%20Operations) 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](index=4&type=chunk) - 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](index=8&type=chunk) [Consolidated Balance Sheets](index=2&type=section&id=Consolidated%20Balance%20Sheets) 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](index=10&type=chunk) 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](index=3&type=section&id=Forward-Looking%20Statements) 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](index=15&type=chunk) - 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](index=15&type=chunk) [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) 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](https://viavid.webcasts.com/starthere.jsp?ei=1713642&tp_key=1c3c464032) |

Core Insights - InspireMD, Inc. reported a total revenue increase of $18,000, or 1.2%, for Q1 2025, reaching $1,529,000 compared to $1,511,000 in Q1 2024, driven by the adoption of CGuard technology despite foreign exchange impacts and inventory management by distributors [4][6] - The company is optimistic about receiving FDA approval for the CGuard Prime carotid stent system in Q3 2025, which is expected to drive future growth [3][11] - Total operating expenses rose by $4,046,000, or 52.5%, to $11,752,000 in Q1 2025, primarily due to increased salaries and preparations for the CGuard Prime launch [6][7] Financial Performance - Gross profit for Q1 2025 remained unchanged at $292,000 compared to Q1 2024 [5] - Net loss for Q1 2025 was $11,166,000, or $0.22 per share, compared to a net loss of $7,032,000, or $0.21 per share, in the same period of 2024 [7][17] - Cash and cash equivalents and marketable securities decreased to $26,086,000 as of March 31, 2025, down from $34,637,000 as of December 31, 2024 [8] Operational Highlights - The company has established a world-class commercial team in preparation for the anticipated U.S. launch of CGuard Prime [3][11] - Continued enrollment in the CGUARDIANS II pivotal study for the CGuard Prime system is progressing at an excellent pace [11] - InspireMD is actively engaging with the FDA regarding the PMA application for CGuard Prime, with a focus on operational readiness for the U.S. market [11]

Financial Performance - For the three months ended March 31, 2025, revenue increased by $18,000, or 1.2%, to $1,529,000, compared to $1,511,000 for the same period in 2024[84] - Gross profit for the same period was $292,000, with a gross margin decrease to 19.1% from 19.3% year-over-year[86] - Net loss for the three months ended March 31, 2025, increased by $4,134,000, or 58.8%, to $11,166,000, primarily due to increased operating expenses[91] - As of March 31, 2025, the company had an accumulated deficit of $265 million and a net loss of $11.166 million, indicating ongoing financial challenges[92] Expenses - Research and development expenses rose by $1,434,000, or 54.6%, to $4,059,000, primarily due to increased costs associated with the SwitchGuard NPS development and regulatory approval[87] - Selling and marketing expenses increased by $1,513,000, or 122.3%, to $2,750,000, driven by compensation and travel expenses related to building U.S. commercial infrastructure[88] - General and administrative expenses increased by $1,099,000, or 28.6%, to $4,943,000, mainly due to higher compensation expenses and new hires for the Miami headquarters[89] Cash Flow and Financing - Cash and cash equivalents decreased to $12.383 million as of March 31, 2025, down from $18.916 million as of December 31, 2024[97] - Net cash used in operating activities increased by $3.728 million, or 73.6%, to $8.792 million for the three months ended March 31, 2025, compared to $5.064 million for the same period in 2024[98] - Cash provided by financing activities was $506,000 for the three months ended March 31, 2025, sourced from share issuance under the ATM Program[100] - Under the ATM Program, the company sold 920,898 shares for total gross proceeds of approximately $2.396 million as of the report issuance date[95] - The company raised approximately $42.2 million from a private placement offering in May 2023, with potential additional gross proceeds of $71.4 million if warrants are fully exercised[94] - Cash provided by investing activities decreased to $1.702 million for the three months ended March 31, 2025, down from $4.817 million for the same period in 2024[99] Market and Regulatory Developments - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated at approximately $1.3 billion, with a total available market of about $9.3 billion assuming full penetration[80] - The CGuard EPS received CE mark recertification in January 2024 under the EU's Medical Device Regulation[72] - The C-GUARDIANS pivotal study completed enrollment in June 2023 with 316 patients, evaluating the safety and efficacy of the CGuard Carotid Stent System[73] - In October 2023, CMS expanded coverage for carotid artery stenting to include asymptomatic and standard risk patients, supporting future growth in the U.S. market[78] Future Outlook - The company expects to continue incurring losses and negative cash flows until its product, CGuard EPS, achieves commercial profitability[92] - Future operating results may be affected by various factors, including regulatory approvals and economic conditions impacting customer demand[102] - The company has no off-balance sheet transactions or material changes to contractual obligations as of March 31, 2025[101]

Core Viewpoint - InspireMD, Inc. is set to present at the Bank of America 2025 Healthcare Conference, highlighting its focus on carotid artery disease treatment and stroke prevention through its CGuard™ Prime carotid stent system [1]. Company Overview - InspireMD, Inc. develops the CGuard™ Prime carotid stent system aimed at treating carotid artery disease and preventing strokes [1]. - The company utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing superior acute results and long-term stroke-free outcomes [2]. Event Details - The presentation at the Bank of America 2025 Healthcare Conference is scheduled for May 14, 2025, at 1:15 PM Eastern Time / 10:15 AM Pacific Time [1]. - A live audio webcast and replay of the presentation will be available for 90 days on the company's website [2].

Core Viewpoint - InspireMD, Inc. is set to release its first quarter 2025 financial results on May 9, 2025, and will host a conference call to discuss these results and recent highlights [1]. Company Overview - InspireMD, Inc. develops the CGuard™ Prime carotid stent system aimed at treating carotid artery disease (CAD) and preventing strokes [1]. - The company utilizes proprietary MicroNet technology to establish its products as the industry standard for carotid stenting, focusing on delivering excellent acute results and long-term, stroke-free outcomes [3]. - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR [3]. Conference Call Details - The conference call will take place at 8:30 a.m. Eastern Time on May 9, 2025, and will be accessible via telephone and webcast [1][2]. - Domestic callers can dial 1-800-579-2543, while international callers can reach the call at 1-785-424-1789 [2]. - A replay of the webinar will be available shortly after the call and archived on InspireMD's website [2].

Core Viewpoint - InspireMD, Inc. is set to present at the 24th Annual Needham Virtual Healthcare Conference on April 9, 2025, showcasing its CGuard™ Prime carotid stent system aimed at treating carotid artery disease and preventing strokes [1]. Company Overview - InspireMD, Inc. develops the CGuard™ Prime carotid stent system, utilizing proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, focusing on achieving excellent acute results and long-term stroke-free outcomes [2]. - The company's common stock is traded on Nasdaq under the ticker symbol NSPR, and it regularly updates investors through its website [2]. Event Details - The presentation will be accessible via a live audio webcast, with a replay available for 90 days on the company's website [2].

Financial Data and Key Metrics Changes - CGuard revenue reached a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% growth year-over-year, with $7 million in revenue for the full year 2024 [7][22] - Gross profit for Q4 2024 decreased by $36,000 or 7.1% to $469,000, compared to $505,000 for Q4 2023, primarily due to increased cost of goods sold [19][20] - Net loss for Q4 2024 totaled $9.1 million or $0.19 per share, compared to a net loss of $5.4 million or $0.16 per share for the same period in 2023 [22] - Total revenue for the full year 2024 increased 13% to $7 million from $6.2 million in 2023 [22] - Gross margin decreased to 21.5% for the full year 2024 from 29.1% in 2023 [24][25] Business Line Data and Key Metrics Changes - CGuard stents sold for Q4 2024 totaled 3,512 units, contributing to 12,100 units sold for the full year [7] - The company has sold over 60,000 implants to date, indicating a strong global commercial foundation [7] Market Data and Key Metrics Changes - The company estimates that more than 7,000 US TCAR procedures were performed in Q4, with global unit sales close to 50% of the US-only TCAR market [8] - The anticipated US market entry of both CAS and TCAR platforms is expected to significantly expand revenue upon regulatory approval [9] Company Strategy and Development Direction - The company is focused on the anticipated US launch of CGuard Prime in the first half of 2025, with a robust commercial and operational launch plan [10][11] - The new headquarters in Miami, Florida, is strategically positioned to support the US launch and commercialization of CGuard Prime [11] - Ongoing investments in both CAS and TCAR are aimed at serving a broad physician base and leading product innovation [16] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the first half approval for CGuard Prime, citing productive interactions with the FDA [34] - The company is not providing forward-looking revenue guidance but is optimistic about growth following potential US FDA approval [26][27] Other Important Information - The CGUARDIANS pivotal clinical trial demonstrated a major adverse events rate of just 0.95% through 30 days and 1.95% through 12 months post-procedure, the lowest event rate reported in a pivotal study of carotid stent or embolic protection device [13] - The company is preparing for a significant increase in operating expenses due to hiring and clinical trial costs [59] Q&A Session Summary Question: US approval timing for CGuard Prime - Management remains optimistic about first half 2025 approval and has had productive discussions with the FDA [34] Question: CGUARDIANS II and III enrollment and timing - Enrollment for CGUARDIANS II is going well, and the timeline for integration into the competitor neuroprotection system is still tracking for early 2026 [37] Question: High-level business outlook for 2025 - The international business continues to grow, and the second half of 2025 will be a foundational building time post-approval [45] Question: Commercial launch process and adoption expectations - Hospitals will not consider a product until it is approved, but the company is preparing for launch by holding its place in line for VAC reviews [53] Question: Operating expenses growth throughout 2025 - Significant growth in operating expenses is expected due to the expansion of the sales organization and ongoing clinical trials [59]

Financial Data and Key Metrics Changes - CGuard revenue reached a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% growth year-over-year, with $7 million in revenue for the full year 2024, up from $6.2 million in 2023 [7][22] - Gross profit for Q4 2024 decreased by $36,000 or 7.1% to $469,000, compared to $505,000 for Q4 2023, with gross margin decreasing to 24.1% from 28.7% [19][20] - Net loss for Q4 2024 totaled $9.1 million or $0.19 per share, compared to a net loss of $5.4 million or $0.16 per share for the same period in 2023 [22] - Total operating expenses for Q4 2024 were $9.8 million, an increase of 55.8% compared to $6.3 million for Q4 2023 [20] Business Line Data and Key Metrics Changes - The company sold 3,512 CGuard stents in Q4 2024, contributing to a total of 12,100 units sold for the full year [7] - The increase in revenue was driven by growth in existing and new markets, indicating a strong commercial foundation [18][22] Market Data and Key Metrics Changes - The company estimates that more than 7,000 US TCAR procedures were performed in Q4 2024, with global unit sales close to 50% of the US-only TCAR market [8] - The anticipated US market entry of both CAS and TCAR platforms is expected to significantly expand revenue upon regulatory approval [9] Company Strategy and Development Direction - The company is focused on the anticipated approval and launch of CGuard Prime in the US, with a robust commercial and operational launch plan in place [10][11] - The new headquarters in Miami, Florida, is strategically positioned to support the US launch and commercialization of CGuard Prime [11] - The company is building a world-class commercial team and has onboarded over a dozen field sales professionals to support the launch [12] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the first half of 2025 for US approval of CGuard Prime, citing productive interactions with the FDA [34] - The company is not providing forward-looking revenue guidance but is optimistic about growth following potential FDA approval [26][27] Other Important Information - The CGUARDIANS pivotal clinical trial demonstrated a major adverse events rate of just 0.95% through 30 days and 1.95% through 12 months post-procedure, the lowest event rate reported in a pivotal study of carotid stents [13] - The company is preparing for the second tranche of financing, which would raise an additional $17.9 million upon FDA approval [14] Q&A Session Summary Question: US approval timing for CGuard Prime - Management remains optimistic about first half 2025 approval and has had productive discussions with the FDA [34] Question: CGUARDIANS II and III studies - Enrollment for CGUARDIANS II is going well, and the timeline for integration into competitor neuroprotection systems is still tracking for early 2026 [37] Question: High-level business outlook for 2025 - The international business continues to grow, and the second half of 2025 will be a foundational building time post-approval [45] Question: Commercial launch process and adoption expectations - Hospitals will not consider a product until it is approved, but the company is preparing for launch by holding places in line for VAC reviews [53] Question: Operating expenses growth in 2025 - Significant growth in operating expenses is expected due to hiring in the sales organization and ongoing clinical trials [59]

Company Performance - InspireMD, Inc. reported a quarterly loss of $0.19 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.20, but worse than the loss of $0.16 per share from the previous year, indicating a 19% increase in loss year-over-year [1] - The company posted revenues of $1.95 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 6.50% and showing a year-over-year increase from $1.76 million [2] - InspireMD has surpassed consensus EPS estimates two times and revenue estimates three times over the last four quarters [2] Stock Movement and Outlook - InspireMD shares have increased by approximately 6.1% since the beginning of the year, contrasting with the S&P 500's decline of 5.3% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the trends in earnings estimate revisions [3][4] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $1.88 million, and for the current fiscal year, it is -$0.73 on revenues of $10.54 million [7] Industry Context - The Medical - Instruments industry, to which InspireMD belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - AngioDynamics, another company in the same industry, is expected to report a quarterly loss of $0.13 per share, reflecting an 18.8% year-over-year change, with revenues projected to be $70.58 million, down 6.1% from the previous year [9]