InspireMD(US:NSPR)2022-11-08 17:56Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was $1.431 million, an increase of 33.6% compared to $1.071 million in Q3 2021 [22] - CGuard revenue grew by nearly 39% year-over-year, reaching over $1.4 million [7] - Gross profit increased to $366,000 in Q3 2022 from $92,000 in Q3 2021, representing an increase of almost 300% [23] - Gross margin improved to 25.6% in Q3 2022 from 8.6% in Q3 2021 [23] - Net loss for Q3 2022 was $4.529 million, or $0.58 per share, compared to a net loss of $4.071 million, or $0.53 per share, in the same period in 2021 [25] Business Line Data and Key Metrics Changes - The company sold 2,624 CGuard stent systems in Q3 2022, a growth of 54% year-over-year compared to 1,709 units sold in Q3 2021 [7] - The increase in sales was driven by growth in existing markets and U.S. sales related to the C-Guardians FDA clinical trial [22] Market Data and Key Metrics Changes - The company enjoys greater than 20% market share in approximately half of its markets, with some territories exceeding 80% [8] - The regulatory landscape in Europe is undergoing significant changes with new compliance regulations under the MDR certification for CE Mark [11] Company Strategy and Development Direction - The company is focused on dominating the carotid revascularization space with the CGuard stent system and plans to launch new delivery systems to enhance market share [9][19] - A strategic partnership with NAMSA has been established to accelerate new product development and commercialization [16] - The company aims to change the paradigm of carotid stenosis management with its CGuard EPS stent platform [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the enrollment progress for the C-Guardians trial, expecting completion by Q1 2023 [28] - The company is closely monitoring the regulatory compliance process in Europe and is prioritizing inventory management to mitigate potential delays [31][33] - Management remains optimistic about the growth potential in Asia, particularly Japan, where discussions with potential distributor partners are ongoing [18] Other Important Information - The CGuard Optima study was presented at the 2022 TCT conference, highlighting the device's performance in preventing carotid artery-related complications [13][14] - The company is developing two new delivery systems to enhance the utilization of CGuard across the vascular specialist community [19] Q&A Session Summary Question: Status of enrollment for C-Guardians trial - Management confirmed that enrollment is progressing well, with expectations to complete by the end of Q1 2023 [28] Question: Update on CREST-2 trial - Management noted that the process of finalizing contracts with sites has been slower than anticipated, but they expect progress as more sites are added [30] Question: CE Mark certification timeline - Management indicated that estimating the timeline for CE Mark certification is challenging due to regulatory complexities, but they are working closely with their notified body [31][32] Question: Impact of currency fluctuations on ASPs and market share - Management acknowledged the impact of currency fluctuations but confirmed that local currency ASPs have increased mid-single digits, with market share gains in several regions [34][36] Question: Terms of potential partnership in Japan - Management discussed considerations for distributor partnerships in Japan, including regulatory paths, distributor capabilities, and potential investment structures [38]