Release Date: August 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- InspireMD Inc (NSPR, Financial) presented one-year outcomes data for the C-GUARDIANS clinical trial, showing a major events rate of just 1.95%, the lowest of any carotid pivotal trial to date.
- The company is on track to submit a premarket approval application to the FDA this quarter, aiming for a US commercial launch of CGuard Prime in the first half of 2025.
- InspireMD Inc (NSPR) raised $17.9 million in gross proceeds from the exercise of Series H warrants, supporting its financial position.
- The company reported a 5.4% increase in total CGuard revenue for the quarter, with significant growth in production to meet anticipated market demand.
- InspireMD Inc (NSPR) is actively preparing for US market entry, including establishing a US headquarters in Southeast Florida and building a world-class commercial team.
Negative Points
- Gross profit decreased by 32.6% to $331,000, primarily due to increased material and labor costs, and additional expenses related to scaling up for the US launch.
- Operating expenses increased by 48% to $8,591,000, driven by higher compensation and development expenses, including non-cash share-based compensation.
- Net loss for the second quarter of 2024 was $7,909,000, compared to a net loss of $5,077,000 in the same period of 2023.
- The company faces challenges in navigating value analysis committees and reimbursement processes for the US market entry.
- Despite positive trial results, InspireMD Inc (NSPR) still needs to secure FDA approval and successfully execute its US commercial launch strategy.
Q & A Highlights
Q: Can you provide feedback on the full data from the C-GUARDIANS trial presented at LINC, particularly regarding the low adverse event rates?
A: Marvin Slosman, CEO: We are pleased with the best-in-class data, which is consistent with our ongoing trials outside the US and real-world experience. This bolsters our confidence in obtaining FDA approval and highlights the reliability of our results.
Q: What is the plan for US commercialization and sales force hiring for the CGuard launch in 2025?
A: Marvin Slosman, CEO: We are focused on US readiness, including operational and commercial preparations. We have engaged recruiting firms and are receiving strong interest from high-quality talent. We aim to time our hires appropriately to ensure a robust launch without overspending.
Q: Could you provide more details on the C-GUARDIANS II TCAR study, including trial design and market interest?
A: Marvin Slosman, CEO: We have received significant interest from the vascular surgery community. We are awaiting FDA approval to start the trial, which will focus on both the stent with a TCAR indication and the SwitchGuard NPS kit. The timelines remain consistent with previous guidance.
Q: Regarding the CREST-2 trial, will the data be split by stent technology, and when can we expect the results?
A: Shane Gleason, VP of Global Marketing: Initially, the data will not be split by stent type, but this is planned for the future. Our stents represent about 4% of the total, so we don't expect significant differences in the overall results. The pace of enrollment was favorable, indicating strong interest in our technology.
Q: How do you anticipate the outcomes of the CREST-2 trial impacting the market, particularly regarding asymptomatic patients?
A: Shane Gleason, VP of Global Marketing: The trial aims to compare intensive medical management with interventions. If interventions show favorable outcomes, more asymptomatic patients may be treated. If not, the market may remain unchanged, as the trial focuses on patients who are not typically treated today.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
