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 replacement of older pump models, 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] 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 increased disposable sales [7][8] - The company plans to maintain quarterly revenue in the first half of 2026, with significant growth expected in the second half [8] Other Important Information - The company ended the year with cash and cash equivalents of $51.2 million, and cash flow from operations was $5.9 million for Q4 and $24.9 million for the full year [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 from the pilot - Management reported very positive feedback from initial users of the 3870 pump, leading to confidence in scaling the launch [15][16] Question: Gross margin scaling - Management indicated that gross margins are expected to remain stable in the first half of the year but may improve in the second half due to higher volumes and ASP [18][19] Question: Updates on disposables and services growth - Management noted 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 stated that inventory levels are being closely monitored to ensure fulfillment of backlog while transitioning to the 3870 [28][29] Question: Regulatory process for 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]