InspireMD (NSPR) Q3 2024 earnings summary

Executive summary

• Q3 2024 revenue reached $1.81 million, up 16.3% year-over-year, with over 3,100 CGuard implants sold and continued international expansion.

• Net loss for Q3 2024 widened to $7.89 million ($0.16/share), primarily due to a 46.1% increase in operating expenses.

• PMA application for CGuard Prime submitted to FDA; 180-day review period underway, with U.S. launch anticipated in H1 2025.

• FDA approved IDE for CGUARDIANS II pivotal study; completed enrollment in CREST-2 clinical trial.

• New headquarters established in Miami, Florida, to support U.S. commercialization.

Financial highlights

• Q3 2024 revenue: $1.81 million (up 16.3% year-over-year); nine-month revenue: $5.06 million (up 13.9%).

• Q3 2024 gross profit: $414,000 (down 5.6% year-over-year); gross margin fell to 22.9% from 28.1%.

• Q3 2024 operating expenses rose 46.1% to $8.88 million, mainly from higher compensation and development costs.

• Cash, cash equivalents, and marketable securities totaled $40.4 million as of September 30, 2024.

• Working capital at September 30, 2024: $39.1 million; current ratio: 6.4.

Outlook and guidance

• Anticipates U.S. approval and commercial launch of CGuard Prime in H1 2025, with significant revenue and margin growth expected.

• U.S. PMA approval would trigger a $17.9 million financing tranche, with further tranches tied to milestones through 2026.

• Management expects continued losses and negative cash flows until commercial profitability is reached.

• Commercial and operational infrastructure being built out in Miami to support U.S. launch.