InspireMD(US:NSPR)2024-03-06 16:30Financial Data and Key Metrics Changes - Total revenue for Q4 2023 increased by 71.6% to $1.76 million compared to $1.03 million in Q4 2022, driven by CE Mark recertification and growth in existing and new markets [54][45][6] - Gross profit for Q4 2023 rose by 155.1% to $505,000, with gross margin increasing to 28.7% from 19.3% in Q4 2022 [60][61] - Total operating expenses for Q4 2023 were $6.3 million, up 23% from $5.1 million in Q4 2022, primarily due to salary and share-based compensation increases [15] Business Line Data and Key Metrics Changes - CGuard stent sales reached $3.1 million, a year-over-year increase of over 74%, contributing to a total of more than 48,000 stents sold globally [6][45] - The company reported a 38% year-over-year sales growth on an adjusted basis, despite previous CE Mark suspension impacting sales [6] Market Data and Key Metrics Changes - The Centers for Medicare and Medicaid Services (CMS) expanded coverage for CAS and TCAR procedures, allowing for tailored treatment plans for asymptomatic patients at high or standard risk [51] - The company is focusing on both U.S. and international markets, with plans to integrate new product pipelines into open markets [18][59] Company Strategy and Development Direction - The company aims to lead the carotid revascularization market with its CGuard platform, focusing on building a body of data and real-world evidence to support U.S. market entry [43][44] - Plans for the C-GUARDIANS II trial and the introduction of CGuard Prime are in place, with expectations for FDA approval in the first half of 2025 [49][50] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting a robust response to the CE Mark recertification and the potential for significant market growth [43][54] - The company is committed to a methodical approach in product development and market entry, ensuring alignment with physician feedback and regulatory requirements [26][29] Other Important Information - The company welcomed Pete Ligotti as the new Executive Vice President and General Manager of North America, bringing extensive experience to the team [53] - The C-GUARDIANS trial reported the lowest 30-day MACE rate of any carotid pivotal trial to date, reinforcing confidence in the CGuard product [48][30] Q&A Session Summary Question: Insights on international business for 2024 and new products - Management indicated continued investment in international markets and integration of new products, aiming for double-digit growth [18] Question: Timeline for U.S. TCAR study and commercial timing for SwitchGuard - The study is expected to commence later this year, with commercial timing for SwitchGuard likely in late 2025 [25][70] Question: Data disclosure strategy for C-GUARDIANS trial results - Management intends to disclose data as quickly as possible, balancing timing with relevant conferences for maximum impact [66][67] Question: Plans for commercial sales force and hiring - The company plans to build its commercial infrastructure in the back half of the year, focusing on optimal territory coverage and training [68] Question: R&D expenses related to C-GUARDIANS II - A step-up in R&D expenses is anticipated as the EFS and trial for SwitchGuard commence [75]