InspireMD (NSPR) Q4 2025 earnings summary

Executive summary

• Q4 2025 revenue reached $3.1 million, up 62% year-over-year and 25% sequentially, with strong U.S. commercial traction from the CGuard Prime launch and over 500 cumulative procedures performed.

• Full year 2025 revenue was $9.0 million, a 28% increase over 2024, supported by international growth and U.S. expansion.

• Built a U.S. commercial team exceeding 30 people, focusing on operational expansion and manufacturing capacity.

• Leveraged experience from 70,000+ cases in 30 international markets to support the U.S. launch.

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

Financial highlights

• Q4 2025 revenue was $3.1 million, with U.S. revenue at $866,000 (up 74% sequentially) and international revenue at $2.3 million (up 17% year-over-year, with FX contributing 7%).

• Q4 2025 gross profit was $1.2 million (37.5% margin), up from $469,000 (24.1%) in Q4 2024; full year gross profit was $2.7 million (29.5% margin).

• Q4 2025 net loss was $11.8 million ($0.14 per share), compared to $9.2 million ($0.19 per share) in Q4 2024; full year net loss was $48.8 million ($0.76 per share).

• Cash and equivalents plus marketable securities totaled $54.2 million at year-end 2025, up from $34.6 million a year earlier.

• Operating expenses rose to $13.3 million in Q4 and $52.3 million for the full year, mainly due to increased commercial staffing and marketing.

Outlook and guidance

• 2026 revenue expected in the range of $13–$15 million, representing 45–65% growth over 2025.

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

• OUS sales expected to show moderate growth, while U.S. growth will accelerate in H2 2026 as catalysts materialize.

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