InspireMD, Inc. Q2 FY2025 earnings call

• FDA premarket approval received for CGuard Prime Carotid Stent System, commencing U.S. commercial launch.
• Strategic execution of commercial playbook in U.S. centers, with strong early interest and successful approvals/orders in numerous accounts.
• Clinical pipeline progress: C-GUARDIANS II study ongoing for TCAR, C-GUARDIANS III now expected to clear and launch in 2027, and acute stroke study in progress.
• Recent financing events: Raised $40.1 million via private placement and $17.9 million from warrant exercises, bolstering balance sheet.

For the second quarter of 2025, total revenue increased by 2% to $1.8 million. Gross profit decreased by $18,000 to $313,000, with gross margin dropping to 17.6% from 19.0% in the prior year. Total operating expenses were $13.3 million, a 55% increase compared to the prior year, primarily due to headcount-related expenses and U.S. headquarters setup. Net loss for the quarter was $13.2 million. Globally, over 60,000 implants have been sold to date.

• Not providing specific guidance at this stage but will share Q3 results.
• Milestones for future financings include completion of 4 quarters of commercial sales of CGuard Prime in the U.S. (anticipated in back half of 2026) and FDA clearance for SwitchGuard TCAR neuroprotection system and related stent.
• Emphasized methodical launch to lay foundation for future expansion.

• Uncertainties in achieving strong commercial adoption trajectory overnight.
• Variability in clinical trial enrollment, FDA regulatory timelines, and approval processes for new products.
• Competition in the carotid intervention market.

Q: Congrats on the progress. Can you share more on U.S. account openings since FDA approval and any targets?

A: We have a commercial organization of around 20 people, planning to add 10 more by year-end. We've done procedures with double-digit physicians and secured stocking orders in accounts. Early reception has been as expected.

Q: About C-GUARDIANS III and SwitchGuard, why the change in expected timeline to 2027?

A: It's due to considering variability in clinical enrollment, FDA requirements, and development processes; we're expanding the timeline to account for uncertainties but remain aggressive to beat expectations.

Q: Refresh on account metrics, high potential accounts, and target sales footprint?

A: Carotid stenting has ~60,000 annual procedures by 4,000 physicians. We target locations with high procedure density and physicians with above-average volumes, tracking metrics like revenue, physician interest, and secured business.