InspireMD(NSPR)2025-03-12 18:32Financial Data and Key Metrics Changes - CGuard revenue reached a new quarterly high of 7 million in revenue for the full year 2024, up from 36,000 or 7.1% to 505,000 for Q4 2023, with gross margin decreasing to 24.1% from 28.7% [19][20] - Net loss for Q4 2024 totaled 0.19 per share, compared to a net loss of 0.16 per share for the same period in 2023 [22] - Total operating expenses for Q4 2024 were 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]