InspireMD(US:NSPR)2020-08-05 17:19Financial Data and Key Metrics Changes - For Q2 2020, total revenue was $313,000, a decrease from $1.354 million in Q2 2019, representing a 77% decline [18][26] - For the first half of 2020, total revenue was $1.347 million compared to $1.769 million for the same period in 2019, indicating a 24% decrease [18] - The net loss for Q2 2020 was $2.48 million or $0.20 per share, compared to a net loss of $2.206 million or $1.59 per share in Q2 2019 [30] Business Line Data and Key Metrics Changes - Sales volume of CGuard EPS decreased by 76% from $1.1 million in Q2 2019 to $300,000 in Q2 2020 [26][27] - Sales volume of MGuard EPS fell by 82% from $238,000 in Q2 2019 to $42,000 in Q2 2020 [28] - Gross margin decreased to -38.3% in Q2 2020 from 32.6% in Q2 2019 [29] Market Data and Key Metrics Changes - The company is seeing a resurgence of elective procedures in key markets, particularly in Italy, Spain, and Germany [18] - Brazil's healthcare market is expected to reach $1.8 billion with a CAGR of 9% through 2023, representing a significant opportunity for expansion [10] Company Strategy and Development Direction - The company aims to convert vascular surgeons to adopt carotid artery stenting as a standard of care, similar to other vascular conditions [21] - Plans to expand into growth markets in South America and the Asia-Pacific region are ongoing, with Brazil being a key focus [18][24] - The company is pursuing both standard and special reimbursement pathways in France to expedite market entry [38] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the adverse impact of COVID-19 on elective procedures but remains optimistic about recovery as healthcare systems adapt [7][19] - The company is focused on operational efficiency and cost reduction to navigate the challenges posed by the pandemic [8][20] - Management believes that the technology represents a significant advancement in treating carotid artery disease and is optimistic about future growth [19] Other Important Information - The company completed an equity financing raise of $11.5 million to support its operations during challenging times [9] - The FDA granted conditional approval for the Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard EPS [15][16] Q&A Session Summary Question: What is the plan regarding launching in Brazil and the timeline? - The groundwork is in place for launching CGuard in Brazil, with contracts established and preparations made for market entry [33][36] Question: Can you explain the dual pathway for reimbursement in France? - The company is pursuing both standard and special reimbursement pathways, with the standard expected to be quicker, while the special may take 9-12 months [37][39] Question: What has historically held back carotid stenting from becoming more prevalent? - Early generation carotid stents did not perform as expected compared to open surgical procedures, which has affected adoption rates [44] Question: What advancements are being made in peri-procedural devices? - The company is exploring various options for peri-procedural devices to enhance the CGuard offering and broaden its portfolio [51]