InspireMD (NSPR) investor relations material

Executive summary

• Achieved record Q3 2025 revenue of $2.52 million, up 39% year-over-year, driven by the U.S. launch of CGuard Prime and international demand.

• Over 100 CGuard Prime cases completed in the U.S. since FDA approval in June/July 2025, with strong physician and hospital engagement.

• Expanded U.S. commercial team to over 30 and welcomed Dr. Peter Soukas as Chief Medical Officer.

• Nearly 70,000 stents sold globally as the market shifts to a stent-first approach for carotid intervention.

• Substantial doubt exists about ability to continue as a going concern due to recurring losses and negative cash flows.

Financial highlights

• Q3 2025 revenue reached $2.52 million, a 39% increase year-over-year; U.S. revenue was $497,000, marking the first commercial U.S. sales.

• International revenue was $2.0 million, up 12% from Q3 2024, with strong global demand.

• Gross profit rose to $864,000, with gross margin improving to 34.2% from 22.9% year-over-year.

• Operating expenses increased 57% to $13.9 million, mainly due to U.S. commercial expansion and new headquarters.

• Net loss widened to $12.7 million ($0.17/share) from $7.9 million ($0.16/share) in Q3 2024.

• Cash and equivalents rose to $63.4 million as of September 30, 2025, up from $19.4 million at June 30, 2025, due to PIPE, warrant exercises, and milestone-based financings.

Outlook and guidance

• Q4 2025 revenue expected to be $2.5–$3.0 million, with stable international sales and sequential U.S. growth.

• Further 2026 growth expectations to be provided with Q4 results.

• Gross margins anticipated to expand as U.S. sales mix increases, approaching typical medical device margins.

• Expect continued losses and negative cash flows until commercial profitability is reached; plans to raise additional capital.