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InspireMD(NSPR) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $1.74 million, a 5.4% increase from $1.65 million in Q2 2023, driven by growth in existing and new markets [14][17] - Gross profit decreased by $160,000 or 32.6% to $331,000, with gross margin dropping to 19% from 29.8% due to increased material and labor costs [17][18] - Net loss for Q2 2024 was $7.91 million or $0.22 per share, compared to a net loss of $5.08 million or $0.24 per share in Q2 2023 [18] Business Line Data and Key Metrics Changes - CGuard revenue for the quarter was $1.74 million, with 2,969 CGuard implants sold, representing nearly 6% growth year-over-year [14][15] - The company has sold over 55,000 CGuard devices to date, establishing a strong market presence [15] Market Data and Key Metrics Changes - The current served market outside the U.S. is approximately 40,000 total procedures, compared to 155,000 in the U.S., indicating significant growth potential in the U.S. market [14][15] - The average sales price (ASP) for CGuard in the U.S. is projected to be significantly higher than the current transfer price of $600 per system in international markets [14][15] Company Strategy and Development Direction - The company is focused on achieving U.S. approval for the CGuard Prime Carotid Stent System in the first half of 2025, with a robust commercial launch planned [4][5] - A strategic agreement has been established with the Jacobs Institute to conduct a feasibility study for CGuard Prime, reflecting the company's commitment to innovation and growth in the neuro community [13] - The company is building a U.S. headquarters in Southeast Florida to support its commercial operations and training [8][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the consistency of clinical outcomes from the C-GUARDIANS trial, which is expected to bolster FDA approval efforts [21] - The company anticipates a significant increase in operating expenses, projected to rise by 30% to 40% next year due to U.S. readiness and ongoing clinical trials [26] - Management highlighted overwhelming interest from the vascular surgery community regarding the CGuard product, indicating strong market demand [28] Other Important Information - The company completed enrollment in the CREST-2 clinical trial, which evaluates the effectiveness of carotid stenting versus intensive medical management [11][12] - The company raised $17.9 million from the exercise of Series H warrants, contributing to a cash position of $47.2 million as of June 30, 2024 [18] Q&A Session Summary Question: Feedback on C-GUARDIANS data presented at LINC - Management noted the consistency of the data with real-world outcomes and expressed confidence in FDA approval based on these results [20][21] Question: U.S. commercialization and operating expenses - Management emphasized the focus on U.S. readiness and the hiring of a strong sales force, with a projected increase in operating expenses due to clinical trials and U.S. operations [22][24][26] Question: C-GUARDIANS II trial details - Management reported strong interest from the vascular surgery community and confirmed that trial enrollment is on track, awaiting FDA approval [28][29] Question: CREST-2 data presentation and outcomes - Management indicated that initial analyses will not differentiate by stent type, but future analyses may provide insights into CGuard's performance [30][32] Question: Market impact of CREST-2 outcomes - Management discussed the potential for increased treatment of asymptomatic patients if stenting shows favorable outcomes compared to medical management [36][37] Question: Commercial strategy and value analysis committees - Management is ramping up outreach efforts to ensure quick access to value analysis committees post-approval, leveraging physician enthusiasm for the new technology [39]