InspireMD, Inc. Q3 FY2024 earnings call

• Q3 financial results showed strong growth in CGuard revenue and implant sales.
• Proud of consistent quarter-over-quarter growth and solid commercial foundation.
• Anticipated approval and launch of CGuard Prime in the U.S. in the first half of 2025, with a PMA submission to the FDA completed in the third quarter.
• Strengthened positioning with a new world-class headquarters in Miami, Florida.
• FDA approved the Investigational Device Exemption Application to initiate the CGuardians 2 pivotal study for CGuard Prime TCAR indicated carotid stent system.
• Entered into a strategic agreement with the Jacobs Institute for an early feasibility study of CGuard Prime for severe carotid stenosis and acute ischemic stroke procedures.

For the third quarter of 2024, InspireMD reported total CGuard revenue of $1.81 million, representing a growth of more than 16% over the third quarter of the previous year. Over 3,100 CGuard implants were sold during the quarter, a growth of nearly 14% compared to the same period last year. Globally, 3,129 implants were sold in international markets during the quarter. If these units were sold in the U.S. at current market ASPs, they would have generated over $14 million in revenue. CGuard has captured double-digit market share across 30 countries with over 60,000 implants sold to-date.

• Anticipates CGuard Prime approval and launch in the U.S. in the first half of 2025.
• If CGuard implants sold internationally in Q3 were sold in the U.S., they would have generated over $14 million in revenue.
• Future growth in the U.S. market with the launch of CGuard Prime and SwitchGuard neuroprotection system.
• Milestones for financing tranches include FDA clearance for SwitchGuard TCAR kit and completion of four quarters of commercial sales of CGuard in the U.S. by the back half of 2026.

• Risks associated with forward-looking statements as actual results may differ materially.
• Uncertainties related to regulatory approvals for CGuard Prime and SwitchGuard neuroprotection system.
• Competition in the medical device market which could impact market share and revenue.

Q: Could you provide an update on U.S. sales force hiring and the transition to the new headquarters in Miami, and confidence in supply for the U.S. launch?

A: Marvin Slosman mentioned being thrilled with the Miami facility and the level of talent attracted. They are using a contract manufacturing approach and building their own supply strategy to ensure meeting supply demands. Shane Gleason noted they are building the commercial leadership team with senior executives hired and on track for U.S. launch.

Q: What is the U.S. commercial strategy initially, targeting which accounts and physician specialties?

A: Shane Gleason stated initial focus will be on interventional cardiologists and neurointerventionalists for CAS procedures. They will target where carotid stenting procedures are performed. Marvin Slosman added focus on the neuro community and ongoing investment in the TCAR side.

Q: Can you tell us about the CGuardians II pivotal study design, enrollment pace, and SwitchGuard product features?

A: Shane Gleason said CGuardians II is a 50-patient study using CGuard Prime in a short delivery system with commercially available TCAR NPS, with first enrollments expected before the end of the year. For SwitchGuard, focus is on usability, access, and deliverability, with feedback from leading vascular surgeons incorporated into the design to create a next-level product.