Financial Data and Key Metrics Changes - For Q1 2025, the company achieved revenue of 17.6 million in Q1 2024 [4][11] - Gross profit margin was reported at 76.1%, consistent with Q1 2024 [12] - GAAP diluted earnings per share increased by 16% to 0.32 in Q1 2024 [13] - Non-GAAP adjusted net income was 0.42 per diluted share, up 17% from 0.36 per diluted share in Q1 2024 [14] Business Line Data and Key Metrics Changes - Revenue from IV infusion pump systems grew 16% to 4.9 million [11][12] - Patient vital signs monitoring systems revenue remained steady at 16 million [12] Market Data and Key Metrics Changes - International sales declined 15% to 13 million, driven by pump revenue and FMD systems [12] Company Strategy and Development Direction - The company is focused on increasing monitoring sales in 2025, anticipating a decline in pump revenues later in the year [21] - The new 3,870 MRIV pump is expected to be a revenue driver in 2026, with clearance anticipated in mid-2025 [9][10] - The company is nearing completion of a new facility, with full operations expected by July 2025 [10] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the impact of tariffs, noting that only 3% of revenue is connected to high tariff sources [6][7] - The FDA's responsiveness has been positive, with ongoing interactions indicating progress towards device clearance [25][27] - The company expects Q2 2025 revenue guidance of 19.9 million, reiterating full-year revenue guidance of 82 million [10] Other Important Information - Operating expenses were 4.3 million, up 10% from $3.9 million in Q1 2024 [14] Q&A Session Summary Question: Any anomalies in disposable revenue growth? - Management indicated that some backlog was worked down in Q1, contributing to the growth, but expects future growth to align with capital growth [17][18] Question: Confidence in monitoring sales recovery? - Management emphasized efforts to boost monitoring sales through adjusted compensation structures, with strong bookings already seen in Q2 [20][22] Question: Status of FDA interactions and clearance timeline? - Management noted ongoing interactive questions from the FDA, suggesting a positive sign, with expectations for clarity in the next three to four weeks [24][27]
iRadimed(IRMD) - 2025 Q1 - Earnings Call Transcript