Financial Data and Key Metrics Changes - Revenue for Q2 2022 totaled $1.5 million, representing a growth of nearly 48% compared to Q2 2021 [7] - Gross profit increased to $431,000 in Q2 2022 from $262,000 in Q2 2021, with gross margin rising to 28.1% from 25.2% [28][30] - Net loss for Q2 2022 was $4.636 million or $0.59 per share, compared to a net loss of $3.507 million or $0.46 per share in Q2 2021 [31] Business Line Data and Key Metrics Changes - Sales volume of CGuard EPS increased by 47.8% to $1.505 million in Q2 2022 from $1.019 million in Q2 2021, driven by growth in existing and new markets [27][28] - The volume of units sold increased by 60%, with 2,602 units sold in Q2 2022 compared to 1,623 in Q2 2021 [8] Market Data and Key Metrics Changes - Market share growth is now greater than 20% in over half of the markets, with some territories reaching up to 60% [10][39] - The company is focusing on converting open surgeries to endovascular treatments, as less than 35% of carotid artery disease cases are currently treated through endovascular stenting procedures [12][13] Company Strategy and Development Direction - The strategy focuses on converting open surgery to endovascular procedures and promoting CGuard as a first-line endovascular device [14] - The company is expanding its direct sales model, currently active in the UK and France, with plans to extend to additional territories [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing transition from open surgery to endovascular standard of care, highlighting the significant potential for market penetration [12][19] - The company is optimistic about the enrollment completion for the U.S. IDE trial, C-Guardians, expected by Q1 2023 [20] Other Important Information - The company has a significant presence at medical conferences, which aids in demonstrating CGuard and influencing market demand [15] - Discussions with potential distribution partners in Japan are ongoing, indicating a high level of interest in the CGuard product [21] Q&A Session Summary Question: Comments on Q2 numbers and ASP decline - Management noted that the ASP decline was predominantly due to currency exchange impacts, with a 12% effect, while unit sales grew by 60% [34][35] Question: Market share growth statistics - Market share is calculated based on carotid artery stenting (CAS) procedures, with over 20% share in more than 50% of markets and up to 60% in some [37][38] Question: Competitor's regulatory clearance and market opportunity - Management acknowledged the ongoing need for TCAR as an alternative delivery option in Europe and expressed excitement about serving that market [40][41] Question: Update on CGuard Prime and Switchguard development - Development efforts for CGuard Prime and Switchguard are on track, currently in the regulatory approval phase [43] Question: Enrollment status for CREST-2 trial - Management indicated that they do not have a firm number on patient enrollment but are optimistic about making CGuard available to the 20 sites involved [44][45]
InspireMD(NSPR) - 2022 Q2 - Earnings Call Transcript