IRADIMED CORP Q1 FY2025 earnings call

• Achieved another record quarter, 15th consecutive quarter of record revenues. Revenue of $19.5 million, 11% increase y-o-y. Gross profit 76.1%, GAAP diluted earnings per share up 16% from Q1 2024. - Performance led by pump shipments, disposables shipments grew well. Monitoring sales plans on track. - Tariff impact: too soon to tell direct material cost impacts, but managing indirect effects like supplier pricing gouging. - FDA: filed responses to 50 or 60 info questions regarding 3870s 510(k) quickly, engagement appears quick. - New facility: near completion, expected June-July final certificate of occupancy, begin moving 4th of July weekend, full operations by end of July.

For the first quarter of 2025, IRADIMED achieved revenue of $19.5 million, an 11% increase over the same period last year. The IV Infusion Pump Systems revenue grew 16% to $6 million. Disposable revenue increased to 23% to $4.9 million. Patient vital signs monitoring systems revenue remained steady at $6.5 million. Domestic sales accounted for 82% of total revenue in Q1 2025, up from 76% in Q1 of 2024. Domestic revenue increased 19% to $16 million, while international sales declined 15% to $3.5 million. Device revenue increased 9% to $13 million in the first quarter, driven by the increase in pump revenue and FMD systems. Revenue from disposables increased 23% in the quarter, and service revenue remained stable at $1 million. The gross margin was 76.1% for Q1 2025, consistent with Q1 of 2024.

• Q2 2025 guidance: revenue $19.7 million to $19.9 million, GAAP diluted earnings per share $0.37 to $0.40, non-GAAP diluted earnings per share $0.41 to $0.44. - Full year 2025 guidance: revenue $78 million to $82 million, GAAP diluted earnings per share $1.55 to $1.65, non-GAAP diluted earnings per share $1.71 to $1.81.

• Tariff indirect effects: threat of suppliers raising prices using tariffs as an excuse. - FDA approval process uncertainties: ongoing interactive questions with FDA regarding 510(k) clearance for new pump.

Q: Concerns about anomalies in disposable revenue in Q1.

A: Disposables grew commensurate with capital growth, tied to pump utilization, some backlog working down in Q1 to reduce lead time.

Q: Monitor sales composition and recovery.

A: Reemphasized monitor sales with sales force and commission structure, Q1 monitor bookings held up, strong bookings in early Q2.

Q: FDA 510(k) clearance progress.

A: Refiled 3870s 510(k) in October, got letter with questions, worked on responses for five months, returned responses two weeks ago, having interactive emails with FDA to finalize clarifications, too soon to tell exact timeline but interactive questions can be positive sign