iRadimed(US:IRMD)2026-02-10 17:00Financial 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%, while non-GAAP Diluted Earnings Per Share was $0.54, up 23% [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, 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] - Ferromagnetic detection systems also saw solid gains, contributing to overall revenue growth [10] 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. market performance [11] - There are approximately 6,400 5+-year-old 3860/3861 pump channels in the U.S. market that are up for replacement, with a target of adding an additional 1,000 channels per year through replacement sales [5][6] Company Strategy and Development Direction - The company anticipates a significant increase in revenue from the large replacement opportunity, which is expected to be a key growth driver for the next several years [5][7] - The new 3870 MR IV pump is expected to penetrate greenfield opportunities more effectively and increase utilization among existing customers [4][5] - The company plans to maintain quarterly revenue in the first half of 2026, driven by growth in MRI monitoring and the 3860 pump backlog, with significant bookings expected for the 3870 systems [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 3870 pump and other product lines [7] - The initial market feedback for the 3870 pump has been very positive, with excitement from users regarding its modernized design and functionality [16][18] - The company is working on regulatory approvals for the 3870 in Europe and Japan, with expectations for CE mark by the end of 2026 and clearance in Japan by summer 2027 [33] Other Important Information - Cash and cash equivalents at year-end were $51.2 million, with cash flow from operations of $5.9 million for Q4 and $24.9 million for the full year [12] - The company is managing inventory levels closely during the transition from the 3860 to the 3870 pump [30] Q&A Session Summary Question: Initial market feedback from the pilot for the 3870 pump - Management reported very positive feedback from initial users, with additional orders already on the books [15][16] Question: Gross margin scaling expectations - Management anticipates gross margins to remain in line initially but expects improvement in the second half of the year as production ramps up [19][20] Question: Future R&D efforts post-3870 launch - The R&D team is already working on a next-generation MRI monitor, expected to launch in 2028 [22] Question: Strength of disposables and services growth - Management indicated that growth in disposables is expected to align with capital sales, with potential for increased utilization with the new 3870 pump [27][28] Question: Inventory levels and backlog for the 3860 - Management confirmed they are managing inventory levels closely and are in good shape to fulfill backlog while transitioning to the 3870 [29][30] Question: Regulatory process updates for the 3870 in Europe and Japan - Management confirmed that CE mark is expected by the end of 2026, with Japan clearance anticipated by summer 2027 [33]