IRADIMED CORP Q4 FY2025 earnings call

• IRadimed achieved 18th consecutive quarter of record revenue, with Q4 2025 at $22.7 million (+17% YOY) and full-year 2025 at $83.8 million (+14% YOY).
• GAAP diluted EPS for Q4 was $0.50 (+25%) and full-year was $1.75 (+17%). Non-GAAP diluted EPS for Q4 was $0.54 (+23%) and full-year was $1.93 (+16%).
• Gross margins were strong, ~77% for full year and 75% for Q4.
• 3870 MR IV pump: Anticipates ASP increase of 10%-14%, significant replacement opportunity in US with ~6,400 5+ year old 3860/3861 pumps, targeting 1,000 replacements per year starting Q2 2026, aiming for $100M+ revenue run rate in 2026.
• December 2025 delivery of 23 3870 systems, clinical support until April launch, bookings to build in Q2 and ramp in H2 2026.

For the fourth quarter of 2025, MRI-compatible infusion pump systems contributed $9.1 million, a 20% year-over-year increase. Patient vital signs monitoring systems had $7.1 million, a 7.5% increase. Disposable revenue was $4.3 million, up 18%. Ferromagnetic detection systems also saw solid gains. For the full year 2025, revenue was $83.8 million, with domestic sales accounting for 81% of Q4 revenue and 84% of full-year revenue.

• Q2 2026 revenue to be driven by MRI monitoring and 3860 pump backlog.
• 3870 bookings to build in Q2, with initial shipments in April 2026 of 100-130 3870 pump channels.
• Aiming for $100M+ revenue run rate in 2026.

• Potential challenges in transitioning from 3860 to 3870.
• Regulatory delays for 3870 in Europe/Japan (CE mark end of 2026, Japan clearance in following summer).
• Market acceptance risks for the 3870 pump.

Q: Congrats on a solid finish to the year. Roger, any anecdotal thoughts on initial market feedback from the pilot of the 3870?

A: Feedback has been tremendous. Had orders on the books, feedback from users (including an anesthesiologist) has been positive. Did a couple-month test with first user to learn and make tweaks.

Q: How should we think about gross margin scaling?

A: Initially in first half of 2026, margin may be in line with previous, but anticipate higher margins in second half as volumes increase and ASP rises.

Q: What's next for the R&D team now that 3870 is launched?

A: Already working on next-generation MRI monitor, planned for market in 2028.

Q: Can you talk about strength in disposables and services and primary drivers of growth?

A: Disposable growth commensurate with capital side, expected to increase utilization with 3870 due to improved user interface.

Q: How do inventory levels and backlog look for 3860?

A: Managing 3860 inventory closely to fulfill backlog, monitoring transition to 3870 closely, with increased 3870 inventory in Q4.

Q: Any changes or tweaks based on early feedback for 3870?

A: Made some tweaks based on real users' feedback during the preview launch to optimize the product.

Q: Updates on regulatory process for 3870 in Europe and Japan?

A: CE mark expected end of 2026, Japan clearance likely in following summer.