InspireMD (NSPR) Q4 2025 earnings summary

Executive summary

• Achieved significant progress in U.S. commercial rollout of CGuard Prime, surpassing 500 completed cases and gaining approvals in major U.S. IDNs.

• Built a U.S. commercial team of over 30, with most in the field, and established presence in 80+ centers, with 200+ in the pipeline.

• Leveraged extensive real-world experience from 70,000+ cases in 30 international markets to support U.S. launch.

• Completed enrollment in CGUARDIANS II pivotal trial and submitted PMA-S to FDA for TCAR indication.

• Focused on operational expansion, including U.S.-based production and increased manufacturing capacity to meet growing demand.

Financial highlights

• Q4 2025 revenue reached $3.1M, up 62% year-over-year and 25% sequentially; full year 2025 revenue was $9.0M, up 28%.

• U.S. Q4 revenue was $866K, up 74% sequentially; international Q4 revenue was $2.3M, up 17% year-over-year.

• Q4 gross profit was $1.2M (37.5% margin), up from $469K (24.1%) in Q4 2024; full year gross profit was $2.7M (29.5% margin).

• Q4 net loss was $11.8M ($0.14/share), compared to $9.2M ($0.19/share) in Q4 2024; full year net loss was $48.8M ($0.76/share).

• Cash and equivalents at year-end were $54.2M, up from $34.6M a year prior.

Outlook and guidance

• 2026 revenue expected between $13M–$15M, representing 45%–65% growth over 2025.

• Sequential revenue growth anticipated in H2 2026, driven by FDA label expansion for TCAR and enhanced delivery system launch.

• OUS sales expected to maintain moderate growth; U.S. growth to accelerate in H2 as catalysts materialize.

• Management anticipates further catalysts in 2026 to accelerate adoption and growth.