iRadimed(US:IRMD)2026-02-10 17:02Financial Data and Key Metrics Changes - IRadimed achieved record revenue for the 18th consecutive quarter, with Q4 2025 revenue reaching $22.7 million, a 17% increase from Q4 2024, and full-year revenue of $83.8 million, up 14% year-over-year [3][10] - GAAP Diluted Earnings Per Share for Q4 was $0.50, up 25%, and for the full year, it reached $1.75, up 17% [3][12] - Gross margins remained strong at approximately 77% for the year and 75% for Q4 [3][11] Business Line Data and Key Metrics Changes - MRI-compatible infusion pump systems contributed $9.1 million in Q4, up 20% year-over-year, while patient vital signs monitoring systems contributed $7.1 million, up 7.5% [10] - Disposable revenue grew 18% to $4.3 million, reflecting increased utilization of devices [10][11] Market Data and Key Metrics Changes - Domestic sales accounted for 81% of total revenue in Q4 and 84% for the full year, indicating strong U.S. performance [11] - There are approximately 6,400 5+-year-old 3860/3861 pump channels in the U.S. market that are up for replacement [6] Company Strategy and Development Direction - The company anticipates a significant increase in revenue from the new 3870 MR IV pump, with an expected average selling price increase of 10%-14% [4] - The strategy includes targeting an additional 1,000 replacement sales annually from existing 5+-year-old units, aiming for a $100 million-plus revenue run rate during 2026 [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a $100 million-plus revenue run rate during 2026, driven by the new product launch and existing product sales [7][8] - The company is focused on optimizing the new 3870 pump based on initial user feedback before the broader launch [15][31] Other Important Information - Cash flow from operations was $5.9 million for Q4 and $24.9 million for the full year, with cash and cash equivalents ending at $51.2 million [12] - The company is working on a next-generation MRI monitor expected to launch in 2028 [21] Q&A Session Summary Question: Initial market feedback on the 3870 pump - Management reported very positive feedback from initial users, leading to confidence in scaling the launch [15][16] Question: Gross margin trends - Management expects gross margins to remain stable in the first half of the year, with potential improvement in the second half due to higher volumes and ASP [18][19] Question: R&D efforts post-3870 launch - The R&D team is already working on a next-generation MRI monitor, with plans for a market launch in 2028 [20][21] Question: Strength of disposables and services - Management indicated that disposable revenue growth is expected to align with capital sales, with potential for increased utilization with the new 3870 pump [26][27] Question: Inventory levels and backlog for the 3860 - Management is closely monitoring inventory levels to ensure fulfillment of backlog while transitioning to the 3870 [28][29] Question: Regulatory updates for the 3870 in Europe and Japan - Management confirmed that CE mark approval is expected by the end of 2026, with Japan clearance anticipated by summer 2027 [32]