• Revenue (Q4 2024): $1.95 million, a 10.6% increase year-over-year.
• Full Year Revenue (2024): $7 million, a 13% increase from 2023.
• Gross Profit (Q4 2024): $469,000, a decrease of 7.1% from Q4 2023.
• Gross Margin (Q4 2024): 24.1%, down from 28.7% in Q4 2023.
• Operating Expenses (Q4 2024): $9.8 million, a 55.8% increase from Q4 2023.
• Net Loss (Q4 2024): $9.1 million or $0.19 per share, compared to $5.4 million or $0.16 per share in Q4 2023.
• Gross Margin (Full Year 2024): 21.5%, down from 29.1% in 2023.
• Operating Expenses (Full Year 2024): $35 million, a 52.5% increase from 2023.
• Net Loss (Full Year 2024): $32 million or $0.76 per share, compared to $19.9 million or $0.82 per share in 2023.
• Cash and Cash Equivalents (End of 2024): $34.7 million, down from $39 million at the end of 2023.

• Warning! GuruFocus has detected 5 Warning Signs with NSPR.

Release Date: March 12, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• CGuard revenue reached a new quarterly high of $1.95 million in Q4 2024, reflecting a 10.6% growth year-over-year.
• InspireMD Inc (NASDAQ:NSPR) is on track for anticipated US approval and launch of CGuard Prime in the first half of 2025.
• The C-GUARDIANS pivotal clinical trial showed unprecedented low major adverse event rates, supporting the efficacy of CGuard Prime.
• InspireMD Inc (NASDAQ:NSPR) has strategically positioned its new headquarters in Miami, Florida, to support the anticipated US launch.
• The company has onboarded over a dozen world-class field sales professionals, preparing for a robust US market entry.

Negative Points

• Gross profit for Q4 2024 decreased by 7.1% to $469,000 due to increased costs of goods sold.
• Gross margin decreased to 24.1% in Q4 2024 from 28.7% in Q4 2023, primarily due to higher material and labor costs.
• Total operating expenses for Q4 2024 increased by 55.8% to $9.8 million, driven by higher salaries and share-based compensation.
• Net loss for Q4 2024 totaled $9.1 million, an increase from a net loss of $5.4 million in the same period in 2023.
• Cash and cash equivalents decreased to $34.7 million as of December 31, 2024, from $39 million the previous year.

Q & A Highlights

Q: Can you provide more details on the US approval timing for CGuard Prime and any potential impacts from changes at the FDA? A: Marvin Slosman, CEO, stated that they remain optimistic about receiving approval in the first half of 2025. They have been engaging in a productive, interactive review process with the FDA, and there are no significant impacts from the broader changes at the FDA affecting their timeline.

Q: Could you elaborate on the progress and timing for the C-GUARDIANS II and III studies? A: Marvin Slosman, CEO, mentioned that enrollment for C-GUARDIANS II is progressing well, with a commercial launch expected in early 2026. For C-GUARDIANS III, they anticipate initiating the study in Q2 2025, with approval and launch of SwitchGuard expected in the second half of 2026.

Q: How are you preparing for the commercial launch in the US, and what are your expectations for adoption at specific sites? A: Shane Gleason, Chief Commercial Officer, explained that while they cannot promote the product before approval, they are preparing by holding places in line for value analysis committee reviews. Adoption will vary by site, but there is significant enthusiasm for the product, and they expect some sites to adopt it quickly based on existing data.

Q: Can you provide insights into the commercial infrastructure and OpEx growth for 2025? A: Shane Gleason, Chief Commercial Officer, noted that they have onboarded 13 personnel, including four sales directors, and will continue hiring territory managers and clinical specialists. Craig Shore, CFO, added that OpEx will grow due to increased hiring and ongoing R&D expenses related to their clinical trials and PMA submission.

Q: On a scale of 1 to 10, what are your expectations of meeting your goals for this year? A: Marvin Slosman, CEO, confidently stated that their expectations are always a 10, indicating strong confidence in meeting their projected goals.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.