InspireMD, Inc. Q4 FY2024 earnings call

• Strong fourth quarter and full-year performance with CGuard revenue growth. • On track for US approval and launch of CGuard Prime in the first half of 2025, with global Q4 sales indicating potential US market revenue. • Regulatory status: Submitted final module of PMA application to FDA and engaged in interactive review. • Clinical pipeline: FDA approval for IDE to begin CGUARDIANS II pivotal study, and engaged in filing for CGUARDIANS III IDE. • New headquarters in Miami, Florida, strategically positioned for US launch. • Built commercial and operational engine, onboarded over a dozen field sales professionals.

CGuard revenue reached a new quarterly high of $1.95 million in the fourth quarter of 2024, reflecting a 10.6% year-over-year growth. For the full year 2024, CGuard revenue was $7 million. Unit sales for CGuard stents were 3,512 in the fourth quarter and 12,100 for the full year. CGuard revenue contributes significantly to the company's overall performance, with the product benefiting patients with carotid artery disease.

• No forward-looking revenue guidance provided today. • Optimistic about 2025 with focus on US approval and launch of CGuard Prime, and building commercial and operational capabilities for post-approval. • Anticipate foundational building in the second half of 2025 post-US approval.

• Uncertainties related to regulatory approval timing, as regulatory processes can be complex and subject to external factors. • Risks associated with forward-looking statements where actual results may differ from expectations.

Q: On a scale of one to 10, what are your expectations of meeting your goals for this year?

A: Our expectations are always 10, consistently shooting for the top to meet set expectations.