InspireMD(US:NSPR)2024-11-12 15:20Financial Data and Key Metrics Changes - Total CGuard revenue for Q3 2024 was $1.81 million, representing a growth of over 16% compared to Q3 2023 [7][25] - Gross profit decreased by $24,000, or 5.6%, to $414,000, with gross margin decreasing to 22.9% from 28.1% year-over-year [26] - Total operating expenses increased by $2.8 million, or 46.1%, to $8.9 million compared to Q3 2023 [27] - Net loss for Q3 2024 totaled $7.9 million, or $0.16 per share, compared to a net loss of $5.2 million, or $0.15 per share in Q3 2023 [29][30] - Cash, cash equivalents, and marketable securities were $40.4 million as of September 30, 2024, compared to $39 million at the end of 2023 [30] Business Line Data and Key Metrics Changes - Sales of over 3,100 CGuard implants during Q3 2024 represented growth of nearly 14% year-over-year [7] - CGuard technology has captured double-digit market share across 30 countries, with over 60,000 implants sold to date [8] Market Data and Key Metrics Changes - If the 3,129 implants sold internationally during Q3 had been sold in the U.S., they would have generated over $14 million in revenue [9] - The current U.S. TCAR market leader reported about $49 million in revenue on 6,700 procedures last quarter, indicating significant potential for CGuard in the U.S. market [10] Company Strategy and Development Direction - The company anticipates the approval and launch of CGuard Prime in the U.S. in the first half of 2025, which is expected to drive significant revenue growth [11] - A PMA premarket approval application was submitted to the FDA, with a decision anticipated in early 2025 [12] - The company is investing in building a world-class commercial and operational engine to support the U.S. launch [17] - A strategic agreement was announced with the Jacobs Institute to conduct an early feasibility study of CGuard Prime for severe carotid stenosis [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting supply demands through contract manufacturing and internal production strategies [33] - The company is focused on targeting interventional cardiologists and neurointerventionalists for initial U.S. sales efforts [37][41] - Management highlighted the importance of physician enthusiasm for the product, indicating a strong interest from trial sites [40] Other Important Information - The company has established a new headquarters in Miami, Florida, to support its U.S. operations [17] - The FDA accepted the PMA submission effective September 15, 2024, triggering a 180-day review period [13] Q&A Session Summary Question: Update on U.S. sales force hiring and transition to new headquarters - Management expressed excitement about the new Miami facility and the interest from top talent in the industry [32] - Plans are in place to meet supply demands through various strategies, including contract manufacturing [33] Question: U.S. commercial strategy and targeted accounts - Initial focus will be on interventional cardiologists and neurointerventionalists for carotid stenting procedures [37][41] Question: CGuardians II trial design and SwitchGuard product features - CGuardians II IDE study is approved, with expectations for first enrollments before the end of the year [44] - Focus on usability and deliverability for the SwitchGuard product, with positive early feedback from vascular surgeons [45][46]