InspireMD, Inc. Q4 FY2025 earnings call

Marvin Flawson, Chief Executive Officer, was proud of the team's performance, highlighting the C-Guard Prime carotid stent platform's clinical evidence and mission to achieve market leadership. They are focusing on operational expansion, commercial coverage, and have built a U.S. commercial team to north of 30 people. They have completed over 500 cases, gained approvals in prominent IDNs, and are leveraging real-world experience. They plan to introduce improvements to the delivery system in Q4. Their clinical pipeline includes TCAR studies, with C-Guardians 2 trial completed and submission for approval to FDA, and C-Guardians 3 in progress. Shane Gleason, Chief Commercial Officer, provided details on account adoption, with over 80 centers having done cases and over 200 centers in the pipeline. The sales team is being built strategically, with half of territory managers starting in Q4.

For the fourth quarter of 2025, total revenue was $3.1 million, an increase of 62% compared to the fourth quarter of 2024. U.S. revenue was $866,000, representing 74% sequential growth versus the third quarter. International revenue was $2.3 million, reflecting 17% growth compared to the fourth quarter of 2024. Gross profit for the fourth quarter of 2025 was $1.2 million, or 37.5% of revenue, compared to gross profit of $469,000 or 24.1% of revenue for the fourth quarter of 2024. Total operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.4 million compared to the fourth quarter of 2024. Net loss for the fourth quarter of 2025 was $11.8 million, or 14 cents per and diluted compared to a net loss of $9.2 million, or 19 cents per basic and diluted share for the same period of 2024. For 2026, InspireMD expects revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting growth of approximately 45% to 65% over full year 2025.

InspireMD expects revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting growth of approximately 45% to 65% over full year 2025. Anticipates increasing sequential revenue growth in the second half of 2026 due to anticipated TCAR indication, enhanced clinical performance for CAS, and maturing approvals and contracts. OUS sales expected to continue with moderate growth, while U.S. sales will have controlled launch in first half and acceleration in second half with catalysts.

Q: Adam Mater with Piper Sandler asked about guidance construction, U.S. vs OUS business, Seaguard Prime integration, account adoption metrics, next-gen delivery system, and timing of Sea Guardians 2 data.

A: Mike Lawless talked about OUS sales moderate growth, U.S. controlled launch with second half acceleration. Shane Gleason provided account info on cases in 80 centers and over 200 in pipeline. Marvin Flawson and Shane Gleason discussed next-gen delivery system as continuous improvement with 30-day review for regulatory. Shane Gleason mentioned Sea Guardians 2 data to be revealed at Charing Cross Congress in back half of April.

Q: Frank Takinen with Lake Street Capital Markets asked about account adoption, productivity metrics, Salesforce hiring cadence.

A: Jane and Marvin Flawson talked about account adoption with goal of becoming everyday stent, productivity based on physician procedures, and Salesforce hiring at north of 30 people in U.S. commercial with opportunistic hiring.

Q: Jeremy Proman with Maxim Group asked about controlled launch, feedback from vascular surgeons.

A: Marvin Flawson and Shane Gleason discussed controlled launch as prescriptive with growth driver, and positive feedback from vascular surgeons on the new technology.