Financial Data and Key Metrics Changes - For Q1 2019, revenue was $415,000, a decrease of 59% from the same period in 2018, primarily due to a 55% decrease in CGuard EPS sales and a 78% decrease in MGuard EPS sales [32][34] - The company's gross loss for Q1 2019 was $73,000, compared to a gross profit of $293,000 in Q1 2018, with gross margin decreasing to negative 17.6% from 29.1% [35] - Total operating expenses increased by 36% to $3.1 million in Q1 2019, up from $2.2 million in Q1 2018 [37] - Net loss for Q1 2019 totaled $3.2 million or $3.82 per share, compared to a net loss of $2.4 million or $0.54 per share in Q1 2018 [38] Business Line Data and Key Metrics Changes - CGuard EPS sales decreased from $831,000 in Q1 2018 to $376,000 in Q1 2019, while MGuard EPS sales fell from $176,000 to $39,000 during the same period [32][34] - The sterilization issue led to a backlog of approximately $600,000, which has since been resolved, and the majority of the backlog has been shipped [34][36] Market Data and Key Metrics Changes - Bookings for CGuard increased by 63% in India, 74% in Poland, close to 30% in Spain, and 288% in Switzerland compared to the same period last year [7] - The company is targeting a minimum $1 billion addressable market for CGuard, with an estimated 13 million people worldwide suffering from high-grade carotid artery stenosis [27][28] Company Strategy and Development Direction - The company is focused on expanding its sales efforts in key European markets while preparing for a US IDE filing expected mid-year [12] - Discussions are ongoing to introduce CGuard into higher regulatory territories, including China and Japan, and a regulatory dossier has been submitted to Brazil's ANVISA [13][14] - The establishment of Centers of Excellence (COEs) aims to educate clinicians on CGuard's benefits and generate new clinical data [18][22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the sterilization issue as a timing problem rather than a loss of revenue, expressing confidence that the deferred revenue will be recognized within the year [10][30] - The company completed an equity financing raising approximately $2.5 million, providing resources to execute growth and development plans [30] Other Important Information - The company has transitioned to a direct sales model in the Czech Republic and is building its direct sales model in the UK, with early successes reported [25] - The company is expanding its local sales and marketing focus by adding clinical specialist teams in key European markets [23] Q&A Session Summary - No specific questions or answers were recorded in the provided content, as the call concluded without a detailed Q&A segment [40]
InspireMD(NSPR) - 2019 Q1 - Earnings Call Transcript