InspireMD (NSPR) Q4 2025 earnings summary

Executive summary

• Achieved significant progress in U.S. commercial rollout of CGuard Prime, with over 500 cases completed and approvals in major IDNs, establishing the product as a go-to device for many physicians.

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

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

• Strong physician support and momentum in account penetration, with cases performed in 80+ centers and a pipeline of over 200 centers in evaluation or approval stages.

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

Financial highlights

• Q4 2025 revenue reached $3.1 million, up 62% year-over-year and 25% sequentially from Q3; full year 2025 revenue was $9.0 million, a 28% increase over 2024.

• U.S. Q4 2025 revenue was $0.9 million, up 74% sequentially; international Q4 revenue was $2.3 million, up 17% year-over-year, with FX contributing 7% to growth.

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

• Q4 2025 operating expenses were $13.3 million; full year 2025: $52.3 million, mainly due to increased commercial staffing and marketing.

• 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 2025 net loss was $48.8 million ($0.76 per share).

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

Outlook and guidance

• 2026 revenue expected to be $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 introduction.

• OUS sales expected to maintain moderate growth, with U.S. growth accelerating in H2 2026 as catalysts materialize.

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