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Welcome to the IRADIMED CORPORATION Second Quarter of 2025 Financial Results Conference Call. [Operator Instructions] This call is being recorded today, August 1, 2025, and contains time-sensitive accurate information only today. Earlier, IRADIMED released its financial results for the second 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 now like to turn the call over to Roger Susi, President and Chief Executive Officer of IRADIMED CORPORATION. Mr. Susi?

Thank you, operator. Good morning, and thank you all for joining us on today's call. I am indeed very pleased to report yet another record quarter, marking our 16th consecutive quarter of record revenues. For the second quarter of 2025, we achieved revenue of $20.4 million, a 14% increase over the same period last year. Gross profit came in at 78%, with earnings very strong as well. GAAP diluted earnings per share increasing 18% from Q2 of 2024. Pump shipments led performance in the quarter as our 3860 MRI IV pump continued to excel in Q2. In addition to the great pump performance, I am also very happy to report that shipments of our MRI patient monitor grew 9% and that bookings in Q2 indicate that our emphasis on monitoring sales for 2025 can be expected to achieve our plans with this product line as well. I'd like to quickly follow up on comments regarding tariffs and DOGE impacts, which we had discussed at some length during our earnings call of Q1. We can now look back and see that though tariffs have been collected on some of the components we utilized, the actual impact is still very small. We do feel, however, that as tariffs become stable and finalized, especially Chinese tariffs and as pre- tariff inventories dwindle here within our stocks, we will have a better idea of the measurable tariff impacts to manage and report upon in the future. As for DOGE effects upon various agencies and possible issues secondarily affecting IRADIMED, such impacts did not materialize. In fact, as announced on May 22, the FDA cleared our new 3870 IV pump systems for distribution. With this long awaited and hard- fought FDA action, the road ahead for IRADIMED is clear and wide. Since the founding of IRADIMED 20 years ago, this clearance and the sales growth that the new pump will ignite will prove to be a seminal event. Reflecting a moment, when I founded IRADIMED, frankly, though we had a strong vision that an MRI IV pump would be a highly successful niche device, my revenue targets from then now appear overly modest, being in the double digits. Now that revenue vision looks to be passing the $100 million revenue run rate, as we progress through 2026. I could not be prouder of what we have done with this fascinating MRI niche. Let me share how we envision these next several quarters. Most of you have seen the effect on the sales of our existing legacy pump, the original design core from 20 years ago, when we simply discontinued offering service contracts for units 7 years and older. This action led a number of customers to replace older 3860 pumps with newer, newly manufactured 3860 pumps. But now that we have a new state-of-the-art pump with 20 years of technological advancement, we anticipate a huge demand for replacing older 3860 model pumps starting at the 5-year-old level. For context, in the U.S. market alone, there are over 6,200 5-plus-year-old 3860, 61 pump channels up for replacement. We currently sell approximately 1,000 such channels annually into the domestic market. We will target adding to that base of 1,000 channels per year another 1,000 channels through update replacement sales from that 6,200 units that are over 5 years old. This will be our target in 2026. In subsequent years, we expect to increase the drawdown of old pump channels from 1,000 to over 2,000 and growing and so on. Again, adding the increased sales for replacements into the current base run rate of 1,000 a year, and you can understand why I see piercing that $100 million revenue run rate in 2026 and continuing strong growth for years afterwards. To put numbers on this, for our domestic opportunity only, as we sell 2,000 3870 pump channels annually, with a slightly higher ASP we anticipate, the 2025 domestic pump device revenue currently expected at $28 million in 2025 will become nearly $50 million, adding in disposables, then international sales plus the MRI monitor business, and one can understand my confidence in breaking through this $100 million revenue range. Now let's discuss our updated financial guidance. For the third quarter of 2025, we expect revenue of $20.5 million to $20.9 million, representing 12% to 14% growth over Q3 2024, which was $18.3 million. We anticipate GAAP diluted earnings per share of $0.41 to $0.45, and non-GAAP diluted earnings per share of $0.45 to $0.49, reflecting a 10% to 12% growth over Q3 2024's $0.40 to $0.43, respectively, tempered by anticipated, but short-lived operational inefficiencies during our facility transition, which we've just moved into our new building. For the full year 2025, we are raising our guidance to reflect our strong first half performance. We now expect revenues of $80 million to $82.5 million, up from our prior range of $78 million to $82 million, representing 9% to 13% growth over 2024's $73.2 million revenues. GAAP diluted earnings per share now expected to be $1.60 to $1.70, up from $1.55 to $1.65, and non-GAAP diluted earnings per share is $1.76 to $1.86, up from $1.71 to $1.81. These ranges account for approximately $2.6 million in stock-related compensation expense, net of tax for the full year and $0.6 million for Q3. We also remain committed to delivering value through our $0.17 per share quarterly dividend declared for Q3 and payable on August 28, 2025. Now, I'll turn the call over to Jack Glenn, our CFO, to review the quarter's financial results in detail.

Thank you, Roger, and good morning, everyone. As in the past, our results are reported on a GAAP basis and a 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 measure on the last page of today's release. For the 3 months ended June 30, 2025, we reported revenue of $20.4 million, a 14% increase from $17.9 million in the second quarter of 2024. This growth was driven by strong performance across all product lines with MRI compatible IV infusion pump systems contributing $8.2 million, up 19% year-over-year and patient vital signs monitoring systems contributing $5.9 million, up 9%. Disposables' revenue grew 14% to $4.2 million, reflecting increased utilization of our devices while Ferromagnetic Detection Systems and Services revenue also saw a solid gain. Domestic sales increased 18% to $18.2 million, and international sales decreased 9% to $2.2 million. Overall, domestic revenue accounted for 89% of total revenue for Q2 2025 compared to 86% for Q2 2024. Gross profit was $16 million, up 14% from $14 million in Q2 of 2024 with a gross margin of 78%, consistent with the prior year. The strong margin performance was supported by increased overhead absorption, as we built inventory ahead of the new facility's opening. Operating expenses for the quarter were $9.2 million, up 9% from $8.4 million in Q2 of 2024, driven by higher sales and marketing expenses to support our growth and modest increases in general and administrative costs. Research and development expenses remained steady at approximately $0.9 million. Income from operations grew 21% to $6.8 million from $5.6 million in Q2 2024. Tax expense for the quarter was $1.6 million, resulting in an effective tax rate of 21.2%. Net income was $5.8 million or $0.45 per diluted share, an 18% increase from $4.9 million or $0.38 per diluted share in Q2 of 2024. On a non-GAAP basis, net income was $6.4 million or $0.49 per diluted share, up 17% from $0.42, excluding $0.6 million of stock-based compensation expense net of tax. Now turning to our balance sheet. We ended the quarter with cash and cash equivalents of $53 million, up from $52.2 million at year- end 2024. Cash flow from operations was a strong $7.7 million for the quarter, up 17% from $6.6 million in Q2 of 2024 and $12 million for the first half, up 14% from $10.5 million. Free cash flow was $4.9 million for the quarter and $5.3 million for the first half, reflecting capital expenditures of $6.7 million year-to-date, primarily related to the new facility. We expect final payments of approximately $1.1 million for the facility in Q3, bringing the total construction cost to approximately $12.6 million. And with that, I will turn the call over to the operator for questions. Operator?

[Operator Instructions] Our first question comes from the line of Frank Takkinen from Lake Street Capital Partners.

Congrats on all the progress and congrats on the 3870 clearance. I was hoping to start with one on kind of current backlog. I saw the comment and heard your positive remarks about a record backlog. Can you talk about the composition of that backlog and then kind of marry that into how you expect 3860 sales to trend in front of 3870 launching?

Sure. Sure. I can take that one, Frank. Yes, as we said, it was a record backlog as of June 30, and it was composed of both -- certainly, as we discussed the pumps, but also a very strong monitoring backlog as well. And so that certainly gives us, I think, good visibility into the second half of the year, especially with -- before we commercialize and introduce the 3870 that we have a strong backlog of 3860s to get us through what we see to the second half of the year.

Frank, I think -- Frank, it was just good to hear your voice. Thanks for the question. Maybe that was a 2-parter, you also want to know how the -- maybe the 3860s, the old pump, the legacy pump orders would trend. So -- I mean, they're still trending extraordinarily strong, and that's why we're so bullish as the year wraps up. We really feel at this point that we're more or less in control of how that will trail off, so -- and that comes to the timing of when we actually unleash our sales team to go out and actively in mass, start discussing this new pump. So they're not doing that at this point. We don't want them to do that. But certainly, somewhere in December is where we'll do that. And -- so we think the orders are still -- for the older pump will still be rather significant, quite strong right up until we do start to talk about the 3870 somewhere in December.

Got it. Very helpful. Clear. And then Roger, I wanted to follow up on some of your comments. I appreciate all the color on kind of 3870 renewal potential. How do you think about the cadence of that ramp to the $50 million of pump revenue? I assume it builds over time, but any thoughts around how that kind of scales throughout 2026 would be helpful.

Yes. Well, it will -- our plan, as we mentioned before, and I think we went over this on previous calls, is in Q4, we'll sell a few 3870s. It will be insignificant to revenue, but the purpose is not how much we generate revenue, it's to generate a few -- it's basically to generate feedback from a few of our stronger users as to any user suggestions or little tweaks that we might want to -- last-minute tweaks put into the product. So we plan to start that all right around Christmas time, New Year's. And of course, then we will also be fully out showing the 3870 by that point as well. And so the bookings of the new pump in the first quarter, they won't be all the way ramped up to these numbers I was talking about at that point, certainly. They'll be just starting to bring in revenue. And as you understand, I think everybody understands, there's a pipeline and an inertia to people writing POs, even though due to this resale of 3860s that we've had going on, there will be a number of customers who have the funds budgeted, and we'll be switching those to the new pump as we can. But Q1 on pump bookings overall, I expect to be weak. And we'll fill it with the revenue won't be though because we have such a huge backlog. So you won't really see it by looking at revenue, but bookings we anticipate in Q1 for pumps should be a little bit weak. But then by second quarter, we should be back to pretty strong run rate on booking pumps, which will just accelerate through Q3 and Q4 so that certainly by the end of 2026, as I think you could glean from what I was saying earlier, the overall run rate of the business will be towards that $100 million number and past it.

Got it. That makes sense. And then just last one for me. Obviously, you have a very large opportunity to harvest the renewal cycle with the 3870. But curious if you think the functionality and improvements of the 3870 could expand the overall market and demand in the pump area.

I haven't really even factored that in. But as you've heard us say over the last few years, you've been on these calls for a while, and those that have been on this call for a while heard us say, that this new pump is 20-year -- it's 2 decades improved over what we've been selling. And so we think and we decided to address one of the Achilles heels of this old pump, which was its usability. We made the new pump. As we've talked about in the past, it has a very -- compared to the old pump, let's call it, much more modern and interactive user interface. We have little graphics and animations on it that help lead the user through the use of the pump. To some extent, we think that is the single largest deterrent that slows down the adoption of the older pump. And so yes, we feel that with the new pump being much more modern and with this much more user-friendly help that comes on the screen to guide the users through its use, that the greenfield, those folks that have sat on the fence and not adopted the older pump, we should knock them off at an accelerating rate. I didn't factor that into these numbers I'm talking about. So that is upside.

Our next question comes from the line of Jason Wittes from ROTH.

And solid quarter here. So first off, on the new pump, is there an ASP increase that we should be factoring in here?

I missed that.

What was the pricing on the new pump?

Oh, yes. Yes, I kind of alluded to that in what I said. We anticipate the ASP will be a little bit higher. We've had this question a few times in previous calls. And now, we're finally in the last -- just these last few weeks since we got clearance from FDA, we've really put the pencil to the pricing and modeled the pricing. So it looks like it's coming out where it's probably going to be around 12-ish percent more than the ASP of the existing pump.

Okay. That's good to hear. I guess, is there -- I mean, would that be -- is that possible to put some upward pressure on the gross margins from that pricing? Can we assume that as well? Or is it too early to make that call?

Well, yes, it should be reflected in that. And it might actually be reflected a little bit more so even in the gross margin because...

I meant gross margins, yes. But I'll take -- I actually -- operating margins will be more important, so that's even better to hear. And then on the backlog, how long is it taking you guys to fulfill your backlog at this point? What is the, I guess, timing from an order to -- that goes in backlog to getting fulfilled?

Well, it's a little different between the pump and the monitor. The monitor backlog is running, as I recall, about 4 weeks, 5 weeks, somewhere in there. A pump backlog is running about 5 months, 5, 6 months, and we're letting that take place. As I mentioned, we anticipate bookings for pumps will be low in Q1 as we transition. But revenue won't be because we got this huge backlog of these older pumps to deliver. So yes, it's -- there's a good length of time in the backlog.

Okay. That's helpful. And then it sounds like customers -- there are going to be some upgrades from the backlog, but it doesn't sound like per se customers expecting pumps in the next -- certainly, for the rest of this year are necessarily going to be motivated to upgrade. They'll be happy getting just a new pump. Is that the right way to think about it? Or do you anticipate there's some upgrades there as well?

In this year, no, we're only targeting a limited number of facilities, basically 3, that we're going to deliver 40 to 50 of the new pumps and to watch those customers, I mentioned before, that we want to just use more as just any things that we need to put a finishing touch to that may come up during watching how people actually interact with and use the pump. And that's why we're going to deliberately have this delay in Q1 is because we're going to wait for that 2, 3 months of education from what we can learn from initially planting about 40 pumps.

At this time, I would now like to turn the conference back over to Roger Susi for closing remarks.

Again, thank you, operator. I'd like to thank those who have ridden along with us on this MRI niche journey, which though always maintaining great revenue growth and margins, at times provide a few white knuckle twists and turns, mainly due to the clearance process for this new pump. But it is with very clear vision we now see that road ahead, providing us many more years of rewarding growth as we can after nearly 20 years, offer our customers a path to move their MRI IV solution delivery onto our new exciting pump platform. Thank you.