Welcome to the IRADIMED Corporation First Quarter of 2025 Financial Results Conference Call. Currently, all participants are in a listen-only mode. And 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 Factors 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.

Thank you, operator, and good morning. Thanks to everyone 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. But I'm 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 material 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, if Chinese tariffs should remain at 145%, our 3% cost of such high tariff parts goes to 4.35%. So we do not see the risk of material cost impacts directly from even this current first shot over the BOM high tariff that we 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 the 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 reiterate what I explained in prior calls. This new device, the 3870 MR IV pump, will be a 2026 revenue story. We are on track and remain expecting a clearance in mid-2025. However, we expect only light revenue from this new device in Q4 2025, as the sale on 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 general contractor has managed to mitigate well. We are far enough along 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 for the second quarter 2025 financial guidance, we expect revenue of $19.7 million to $19.9 million, with GAAP diluted earnings per share of $0.37 to $0.40 and non-GAAP diluted earnings per share of $0.41 to $0.44. We reiterate our 2025 revenue guidance of $78 million to $82 million for the full year, with GAAP diluted earnings per share of $1.55 to $1.65, and non-GAAP diluted earnings per share of $1.71 to $1.81. Now I'll turn the call over to Jack Glenn, our CFO, to review the quarter's financial results.

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 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, 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 continue 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, which were 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 recognized a 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. And with that, I will turn the call over for questions.

Thank you. The first question that we have today will be coming from the line of Frank Takkinen.

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's any anomalies in that number? Was there a catch-up in 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.

Sure, Frank. I can address that. From the disposable standpoint, we have previously stated that we generally expect disposables to grow alongside capital growth, particularly linked to pump utilization. In this quarter, we worked on reducing the backlog to meet customer demand, which influenced the numbers we saw in Q1. Looking ahead, it can be a bit challenging to predict due to shorter lead times, but we anticipate that disposables will align with overall capital growth.

Okay. That's helpful. And then, Roger, you made a comment around the composition of bookings were indicating a monitoring sales being in line with your expectations for this year, which I think was implied for that to reaccelerate 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?

Yeah. Thanks, Frank. Good to hear from you. Yes, as we spoke during the previous quarter, we were going to push hard on bringing up the Monitor sales in 2025, basically expecting that there'll be a dip 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 or six quarters for the old 3860 pump will come to an end. As we mentioned at least a quarter ago for 2025, we really did reemphasize the monitor with the sales force regarding commission structure and just highlighted it at our meeting in January, etc., and 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. But Monitor bookings in Q1 held up the rate that they had ended Q4 at. And thus far, we are only about five weeks into this Q2, and I can tell you that the bookings for the monitor have been very strong already for the start of Q2. So that's why I mentioned it looks like our plans are firming up as we expected along the lines of increasing the monitor bookings.

Great. That's great color. And then 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 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?

Well, yeah, that's a - if I can read it – I’ll have to read tea leaves, but it's more or less a guess. So just to refresh, right, we refiled the 3875 10-K back in October, and we got an AI letter of 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 plus questions in it. We worked for basically five months, coming up with responses to all those questions. That was returned about two weeks ago. Last week, we started hearing from the FDA interactively. We received emails like, '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 we are helping them to finalize and clarify some questions that are open in their mind. So 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 are two ways that it can go. These interactive questions can be a good sign. They can get things done quickly without the formalities of a formal AI letter, which is generally a good sign, but it could be that they get off the rails again as we go with too many of these sorts of questions. It's too soon to tell, Frank. If all goes well, though, this shouldn't go on for more than three weeks to four weeks. At that point, we'll know where we stand much better.

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

Thanks.

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

Well, thank you, operator. Once again, it's been my pleasure to report IRADIMED's performance for this opening quarter of 2025. The company's business foundation is strong. 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 look forward to reporting our continued positive momentum with the next call. Until then, thank you all.

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