InspireMD (NSPR) Q4 2024 earnings summary

Executive summary

• Achieved record CGuard revenue of $1.95M in Q4 2024, up 10.7% year-over-year, and $7.01M for the full year, with 3,512 stents sold in Q4 and 12,100 for the year.

• Advanced CGuard Prime toward anticipated U.S. FDA approval, with PMA application submitted and pivotal CGUARDIANS II study initiated.

• Building a robust U.S. commercial infrastructure, including a new Miami headquarters and onboarding of over a dozen field sales professionals.

• C-GUARDIANS pivotal trial showed major adverse event rates of 0.95% at 30 days and 1.95% at 12 months, the lowest ever in a pivotal carotid stent study.

• Established Miami headquarters to support expected U.S. launch in 2025.

Financial highlights

• Q4 2024 revenue increased 10.7% to $1.95M from $1.76M in Q4 2023; full-year revenue rose 13% to $7.01M from $6.2M.

• Q4 gross profit decreased 7.1% to $469K, with gross margin down to 24.1% from 28.7% year-over-year due to higher material and labor costs.

• Q4 operating expenses rose 55.8% to $9.8M, mainly from increased salaries and share-based compensation for U.S. launch preparation.

• Q4 net loss widened to $9.17M ($0.19/share) from $5.41M ($0.16/share) year-over-year; full-year net loss was $32M ($0.76/share) vs. $19.9M ($0.82/share) in 2023.

• Cash and equivalents plus marketable securities stood at $34.7M at year-end 2024, down from $39M at year-end 2023.

Outlook and guidance

• Expects U.S. FDA approval and launch of CGuard Prime in the first half of 2025, with foundational commercial buildout in the second half.

• No forward-looking revenue guidance provided; will update after potential FDA approval.

• CGuard Prime II commercial launch targeted for early 2026; SwitchGuard approval and launch expected in the second half of 2026.

• Anticipates key clinical, regulatory, and commercial milestones in coming months.