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Dec 31, 2022
InspireMD Q4 2022 Earnings Report
InspireMD's Q4 2022 financial results were announced, revealing a decrease in revenue due to CE Mark delays, alongside progress in the C-Guardian US IDE trial.
Key Takeaways
InspireMD reported a decrease in total revenue for Q4 2022, primarily due to the temporary expiration of the CE Mark, which impacted sales in EU countries. The company is progressing with its U.S. IDE trial and anticipates CE Mark recertification. Total revenue decreased to $1,026,000 from $1,380,000 during the fourth quarter of 2021. Net loss for the fourth quarter of 2022 totaled $4,845,000, or $0.60 per basic and diluted share, compared to a net loss of $4,097,000, or $0.53 per basic and diluted share, for the same period in 2021.
Total revenue decreased by 25.7% to $1,026,000 compared to Q4 2021.
Sales of CGuard EPS decreased by 20.6% to $1,026,000 due to CE Mark expiration.
Gross profit decreased by 32.7% to $198,000 compared to Q4 2021.
Net loss totaled $4,845,000, or $0.60 per share, compared to a net loss of $4,097,000, or $0.53 per share, for the same period in 2021.
Revenue by Segment
Forward Guidance
InspireMD anticipates CE Mark recertification and plans to gain market share in key European territories. The company also expects to complete enrollment in the U.S. IDE trial by the end of Q2 2023.
Positive Outlook
- Expectation of obtaining CE Mark recertification under MDR in the next few weeks
- Plans to work to continue to gain share in key European territories
- Driven by conversion of existing endovascular carotid procedures to CGuard from other stent systems
- Potential introduction of two new delivery systems, SwitchGuard TCAR and CGuard Prime TFEM, later this year, subject to regulatory approval
- U.S. IDE trial continues to progress, with 20 sites enrolling patients
Challenges Ahead
- Revenues in Q4 of 2022 and Q1 of 2023 were impacted by the temporary lapse of CE Mark
- Delays in the European regulatory bodies in the MDR recertification process
- Risk of not obtaining CE Mark recertification under MDR
Historical Earnings Impact
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