Release Date: November 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- InspireMD Inc (NSPR, Financial) reported a 16% increase in CGUARD revenue, reaching $1.81 million for Q3 2024.
- The company achieved a 14% growth in CGUARD implants sold, totaling over 3,100 units for the quarter.
- InspireMD Inc (NSPR) has captured double-digit market share across 30 countries with its carotid stent technology.
- The company anticipates the approval and launch of CGUARD Prime in the US in the first half of 2025, which could significantly boost revenue.
- InspireMD Inc (NSPR) has strengthened its operational capabilities with a new headquarters in Miami, Florida, positioning it well for the anticipated US launch.
Negative Points
- Gross profit decreased by 5.6% to $414,000, with a decline in gross margin from 28.1% to 22.9% year-over-year.
- Total operating expenses increased by 46.1% to $8.9 million, driven by higher compensation, clinical, and development costs.
- The company reported a net loss of $7.9 million for Q3 2024, compared to a $5.2 million loss in the same period last year.
- Despite revenue growth, the company faces significant challenges in managing costs and achieving profitability.
- The US market entry is contingent upon FDA approval, which introduces regulatory risk and potential delays.
Q & A Highlights
Q: Can you provide an update on the U.S. sales force hiring and the transition to the new headquarters in Miami? How confident are you in your ability to supply the market?
A: Marvin Slosman, CEO: We are thrilled with our new Miami facility, which serves as a unified base for our operations. We are continuing to operate from our Tel Aviv facility and are implementing a contract manufacturing approach to ensure we meet supply demands. Shane Gleason, CCO: We are building our commercial leadership team this year and plan to start fielding the team early next year. We have already hired four senior-level commercial executives and are on track to fill other roles.
Q: What is your U.S. commercial strategy, and which physician specialties will you target initially?
A: Shane Gleason, CCO: Our initial focus will be on interventional cardiologists and neuro interventionalists performing carotid stenting procedures. We have claims data to identify where procedures are performed and are in contact with thought leaders. Marvin Slosman, CEO: We are also focusing on the neuro community, as they are currently performing transfemoral CAS procedures.
Q: Can you provide details on the CGuardians II IDE study and the SwitchGuard product?
A: Shane Gleason, CCO: The CGuardians II IDE study is approved and involves 50 patients using the CGUARD Prime in a short delivery system tailored for TCAR procedures. We expect first enrollments by the end of this year. The SwitchGuard product focuses on usability, access, and deliverability, with feedback from leading vascular surgeons indicating we have made significant advancements.
Q: How are you preparing for the potential U.S. launch of CGUARD Prime?
A: Marvin Slosman, CEO: We submitted our PMA premarket approval application to the FDA and anticipate a decision in early 2025. We are prepared to execute a robust commercial and operational launch plan if approved. Our Miami headquarters positions us well to support the anticipated U.S. launch.
Q: What are your financial highlights for the third quarter of 2024?
A: Craig Shore, CFO: Revenue increased by 16.3% to $1.81 million, driven by growth in existing and new markets. Gross profit decreased slightly due to increased expenses, and total operating expenses rose by 46.1% due to higher compensation and development costs. Net loss was $7.9 million, with cash equivalents and marketable securities at $40.4 million.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
