IRadimed - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 delivered record revenue of $19.51M, up 11% YoY, with GAAP diluted EPS of $0.37 (+16% YoY) and non-GAAP diluted EPS of $0.42 (+17% YoY). Gross margin held at 76.1%, consistent with Q1 2024.
• Segment performance: pumps $6.00M (+16% YoY), monitoring $6.54M (flat YoY), disposables $4.95M (+23% YoY), FMD $0.42M (+67% YoY), services $1.04M (down YoY).
• Guidance reaffirmed: FY25 revenue $78.0M–$82.0M; GAAP EPS $1.55–$1.65; non-GAAP EPS $1.71–$1.81. Q2 2025 guidance: revenue $19.7M–$19.9M; GAAP EPS $0.37–$0.40; non-GAAP EPS $0.41–$0.44.
• Dividend: $0.17 per share declared for Q2 (payable May 30, 2025). Operational catalysts include a new Orlando manufacturing facility targeted for June–July occupancy, and mid-2025 FDA 510(k) clearance timeline for the next-gen 3870 IV pump (commercial impact skewed to late 2025/2026).

What Went Well and What Went Wrong

What Went Well

• Fifteenth consecutive quarter of record revenue driven by strong 3860 pump shipments and outsized disposables growth (+23% YoY); gross margin steady at 76.1%.
• Domestic demand strengthened (82% of revenue vs 76% prior year), while bookings for monitoring systems showed early signs of recovery following incentive changes; management expects monitor emphasis to support mix in 2025.
• Management confidence and execution momentum: “We are excited to begin 2025 with our fifteenth consecutive quarter of record revenue… With our new manufacturing facility on track for completion in July 2025, we are well-positioned to support our planned growth” — Roger Susi.

What Went Wrong

• International revenue declined, with domestic mix rising, implying dependence on U.S. demand; services revenue fell YoY in Q1.
• Free cash flow fell to $0.37M (from $3.40M in Q1 2024) due to $3.92M in capex largely for the new facility; cash from operations grew modestly to $4.29M (+10% YoY).
• FDA clearance remains a timing variable; while mid-2025 timeline is reiterated, management acknowledged process uncertainty: “Too soon to tell… interactive questions… If all goes well… 3 or 4 weeks” — Roger Susi.

Transcript

Operator (participant)

Welcome to the IRadimed Corporation First Quarter of 2025 Financial Results conference call. Currently, all participants are in listen-only mode. At the end of the call, we will conduct a question-and-answer session. This call is being recorded today, Monday, May 5, 2025, and contains time-sensitive accurate information only today. Earlier, IRadimed released its financial results for the first quarter of 2025. A copy of this press release announcing the company's earnings is available under the heading News on their website at iradimed.com. A copy of the press release was also furnished to the Securities and Exchange Commission on Form 8-K and can be found at sec.gov. This call is being broadcast live over the internet on the company's website at iradimed.com, and a replay will be available on the website for the next 90 days.

Some of the information in today's session will constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements focus on future performance, results, plans, and events, and may include the company's expected future results. IRadimed reminds you that future results may differ materially from these forward-looking statements due to several Risk Factors. For a description of the relevant risks and uncertainties that may affect the company's business, please see the Risk Factor section of the company's most recent reports filed with the Securities and Exchange Commission, which may be obtained free from the SEC's website at sec.gov. I would like to turn the call over to Roger Susi, President and Chief Executive Officer of IRadimed Corporation. Mr. Susi?

Roger Susi (Founder, President, and CEO)

Thank you, Operator, and good morning. Thanks one and all for joining us on today's call. I am pleased to report another record quarter, making our 15th consecutive quarter of record revenues. For the first quarter of 2025, we achieved revenue of $19.5 million, which is an 11% increase over the same period last year. Gross profit came in at 76.1%, with earnings very strong as well, with GAAP diluted earnings per share increasing 16% from Q1 of 2024. Performance in the quarter was led by pump shipments, with bookings of our 3860 MRI IV pump continuing to excel in Q1. I am also very happy to report that shipments of our disposables grew well, and the bookings in Q1 indicate that our emphasis on the monitoring sales for 2025 can be expected to achieve our plans with this product line as well.

Our CFO, Jack Glenn, will walk you through the financial details in a bit, but I'd like to address two other issues: questions of tariff impact and the FDA, particularly our 510(k) clearance and DOGE impacts. Starting with the tariff impact, in a word, it's too soon to tell, but a review of the amount of foreign, specifically Chinese materials we utilize should provide a background. As you dive into our gross margin, or conversely, our cost of goods, you would see that about 12% of revenue is BOM cost, or the parts and stuff we buy to make our products. Examining this further, we find that about 3% of revenue, a quarter of this BOM cost, is connected to high tariff sources. If, even in a horrible worst case, Chinese tariffs should remain at 145%, our 3% cost of such high-tariff parts goes to 4.35%.

We do not see the risk of material cost impacts directly from even this current first shot over the bow high tariff that we have put in place against China. Still, there are many other indirect effects of tariffs that are very difficult to predict at this time. For one, there is the threat that we already see with certain suppliers raising their pricing by using tariffs more as an excuse to gouge. We watch that carefully, though. We are actively dealing with such tactics and so far are managing those well. The good news thus far is that we do not see our customers reacting or feeling tariff pain. Therefore, we can report that we remain optimistic with the plans and guidance we have given.

As for DOGE impacts, particularly with the CDRH and FDA, it's interesting to note that we understand that some 20,000 jobs in this agency alone have reportedly been cut, yet we have felt nothing. We recently filed responses to the 50 or 60 additional information questions FDA asked us a few months ago regarding the 3870's 510(k) filed back in October. Within a week, we had an FDA response. This sort of engagement appears very quick, certainly as quick as we have seen, and would indicate that work at the FDA continues to get done. Along the lines of FDA and 510(k) clearance, we iterate what I explained in prior calls. This new device, the 3870 MRI IV pump, will be a 2026 revenue story. We are on track and remain expectant of clearance in mid-2025.

However, we expect only light revenue from this new device in Q4 of 2025, as the sell and shipment cycle is measured in months, even for an exciting and anticipated new offering. Moreover, as witnessed by the strong and continuing sales through customer replacement of the older 3860 IV pump, driven by discontinuing offering our extended maintenance on pumps seven years and older, the new 3870 pump sales are expected to dwarf sales of this older model as the quarters progress through 2026 and into 2027, certainly. Finally, with regard to our new facility under construction, I'm pleased to report that we are at the finish stage, with only minor material supply disturbances, which the GC has managed to mitigate well. At this point, we are far enough that potential surprise material cost impacts are well behind us.

We are confident in a June-July final certificate of occupancy, with plans to begin moving as early as the 4th of July weekend, with full operations in the new building by the end of July. Now, I'd like to outline what we expect to see in Q2 2025. As the second quarter 2025 financial guidance, we expect revenue of $19.7 million-$19.9 million, with GAAP diluted earnings per share of $0.37-$0.40 and non-GAAP diluted earnings per share of $0.41-$0.44. We reiterate our 2025 revenue guidance of $78 million-$82 million for the full year, GAAP diluted earnings per share of $1.55-$1.65, and non-GAAP diluted earnings per share of $1.71-$1.81. Now, I'll turn the call over to Jack Glenn, our CFO, to review the quarter's financial results.

Jack Glenn (CFO)

Thank you, Roger, and good morning, everyone. As in the past, our results are reported on a GAAP basis and non-GAAP basis. You can find a description of our non-GAAP operating measures in this morning's earnings release and a reconciliation of these non-GAAP measures to the GAAP measures on the last page of today's release. For the first quarter of 2025, we reported revenue of $19.5 million, an 11% increase compared to $17.6 million in Q1 of 2024. This growth was driven by sustained demand for our IV infusion pump systems, which grew 16% to $6 million, and disposable revenue, which increased 23% to $4.9 million. Patient vital signs monitoring system 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, reflecting higher pump utilization, and service revenue remained stable at $1 million. The gross margin was 76.1% for Q1 2025, consistent with Q1 of 2024, as we continued to manage our production costs effectively and maintain our ASPs for both products. Operating expenses were $9.4 million, or 48% of revenue, compared to $8.6 million, or 49% of revenue in Q1 of 2024. The dollar increase was primarily driven by higher general and administrative expenses up 16% to $4.6 million due to a rise in legal and professional costs tied to the regulatory effort for the new pump and increased personnel and benefit costs.

Sales and marketing expenses increased 9% to $4.2 million, reflecting all domestic sales territories being filled and higher commissions from strong domestic bookings in Q1. Research and development expenses decreased 24% to $0.6 million as we finalized key development phases for the 3870 pump. Operating income was $5.4 million, or a 14% increase from $4.7 million in Q1 of 2024, maintaining a solid operating margin of 28%. We recognize the tax expense of $1.3 million, resulting in an effective tax rate of 21.2% for Q1 2025, compared to 21.1% in Q1 of 2024. GAAP net income was $4.7 million, or $0.37 per diluted share, a 16% increase from $4.1 million, or $0.32 per diluted share in Q1 2024. On a non-GAAP basis, adjusted net income was $5.3 million, or $0.42 per diluted share, up 17% from $4.6 million, or $0.36 per diluted share in Q1 2024.

Cash flow from operations was $4.3 million in Q1 2025, up 10% from $3.9 million in Q1 2024. Free cash flow, a non-GAAP measure, was $0.4 million, down from $3.4 million in Q1 2024 due to $3.9 million in capital expenditures in the quarter, of which $3.5 million was for the new facility. We expect to spend approximately $3 million more on the facility through its completion in July of 2025. I will turn the call over for questions, Operator.

Operator (participant)

Thank you. If you would like to ask a question, please press star one one on your telephone. You will then hear an automated message advising your hand is raised. If you would like to remove yourself from the queue, press star one one again. We also ask that you please wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster. The first question that we have today will be coming from the line of Frank Takkinen.

Frank Takkinen (Senior Research Analyst)

Great. Thanks for taking the questions. I was hoping to start with a question on disposables. Obviously, that was a really great number in the first quarter. I was curious if there were any anomalies in that number. Was there a catch-up and kind of burning down some of the backlog? Is this a new run rate in the disposable line item? Any color around that would be helpful. Thank you.

Jack Glenn (CFO)

Sure, Frank. I can address that one. I think from the disposable standpoint, what we've said in the past, typically we would expect the disposables to grow commensurate with the capital growth and certainly tied to the pump utilization, most of that. The quarter, there was some working down of the backlog as we strived to decrease our backlog, our lead time on the disposables due to making sure we're meeting customer demand. We did some of that in Q1, so that played a part in that. Going forward, certainly, I think it's always a little bit hard because the lead times are shorter for the visibility for us, but I would expect it to be sort of in line with kind of the growth overall on the capital side.

Frank Takkinen (Senior Research Analyst)

Okay. That's helpful. Roger, you made a comment around the composition of bookings. We're indicating monitoring sales being in line with your expectations for this year, which I think was implied for that to re-accelerate a little bit as you adjusted some of the incentive compensation around that product. Can you maybe go a little bit deeper into the composition of the backlog and why you feel pretty confident that monitors is going to recover through the year?

Roger Susi (Founder, President, and CEO)

Oh, yeah. Thanks, Frank. Good to hear from you. Yes. As we spoke before, previous quarter, right, that we were going to push hard on bringing up the monitor sales in 2025, basically expecting that there'll be a droop in the pump revenues later in the year. Certainly, once this new pump is cleared, this huge run rate that we've experienced in the last five, six quarters for the old 3860 pump, it will come to an end. As we mentioned at least a quarter ago for 2025, we really did re-emphasize the monitor with the sales force vis-à-vis commission structure and just highlighting it at our meeting in January, etc. That is showing fruit. We did well. Bookings were strong in Q1. Usually, Q1 is kind of weak, generally, after a good big Q4 finish.

Monitor bookings in Q1 held up the rate that they had ended Q4 at. Thus far, we're only not even five weeks into this Q2. I can tell you that the bookings for the monitor have been very strong already for the start of Q2. That's why I mentioned it looks like our plans are firming up as we expect it along the lines of increasing the monitor bookings.

Frank Takkinen (Senior Research Analyst)

Great. Great. That's great color. Just one last one. I wanted to follow up on some of the FDA interactions. I heard your comment that you submitted the file and then you had heard back or submitted the file to answering the questions, and then you had heard back from the FDA. What's left now where we stand today until we should see the clearance occur?

Roger Susi (Founder, President, and CEO)

That's a—if I can read it, I'll have to read tea leaves, but it's more or less a guess. Just to refresh, right, we refiled the 3870 510(k) back in October, and we got an AI letter relatively quickly after that. I think it's four or five weeks or so after we submitted. We got a letter with, like I said, 50+ questions in it. We worked basically for five months coming up with responses to all those questions. That was returned, I believe, about two weeks ago. Last week, we started hearing from the FDA interactively, quick emails, "Hey, could you find us this in the filing? Hey, did you answer this? You used a different phrase than we like to see for this," and helping them finalize and clarify some questions that are open in their mind. We'll see how that continues.

We had two such email questions last week, and we returned those late Friday. We'll take it week-by-week, but there's two ways that can go. These interactive questions can be a good sign. They get things done quickly without the formalities of a formal AI letter. That's generally a good sign. It could be that they get off the rails again as we go with too many of these sorts of questions. Too soon to tell, Frank. If all goes well, though, this shouldn't go on for more than three or four weeks. At that point, we'll know where we stand much better.

Frank Takkinen (Senior Research Analyst)

Got it. Okay. That's helpful. Appreciate the color. Thanks, and congrats on a solid start to the year.

Roger Susi (Founder, President, and CEO)

Thanks.

Operator (participant)

Thank you. That does conclude today's Q&A session. I would like to turn the call back over to Roger for closing remarks.

Roger Susi (Founder, President, and CEO)

Thank you, Operator. Once again, it's been my pleasure to report about IRadimed's performance for this opening quarter of 2025. The company's business foundation is strong, and we look forward to attaining our plan for the year as guided. At this point, the execution of those plans is the order of business, and I will look forward to reporting our continued positive momentum with the next call. Until then, thank you all.

Operator (participant)

Thank you. This concludes today's call, and you may now disconnect.