Welcome to IRADIMED CORPORATION First Quarter of 2024 Financial Results Conference Call. [Operator Instructions] This call is being recorded today, May 2, 2024, and contains time-sensitive accurate information only today. .

Earlier, IRADIMED released its financial results for the first quarter of 2024. A copy of this press release announcing the company's earnings is available under the heading News on the website, 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 iramimed.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 focused 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 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 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?.

Good morning. Thank you all for joining us on today's call. As recently reported, I'm once again very pleased to announce yet another consecutive quarter of record IRADIMED net revenue generated in our recent Q1 2024 quarter. This is our 11th revenue increase in a row. .

As this morning's press release announced, in the first quarter of 2024, revenue came in at $17.6 million, representing a 13.7% increase over the first quarter of '23. GAAP diluted earnings per share for the first quarter were $0.32. While non-GAAP diluted earnings were $0.36 per share, a 20% increase over Q1 of '23. .

All product lines performed well with our inside and outside teams executing exceptionally well. From the revenue standpoint in Q1, the MR patient monitor bested the IV pump and increased by 38%, compared to Q1 of '23.

However, this doesn't show the strength of one product line over the other as bookings for the MR IV pump product in Q1, greatly exceeded expectations. So we actually expect that in Q2, the table may turn in favor of pump revenue..

As I previously discussed, we notified customers with pumps 7 years and older that our extended maintenance would no longer be offered for such older devices. This, as expected, has prompted the uptick in pump orders we've seen in Q1, which we hope to continue to see in the upcoming quarters as well.

To be sure, our major products remain viable and fitting for their markets, while we continue to make inroads with our newer FMD product. .

Previously, I had spoken about reducing our delivery time for disposables and the associated reduction of backlog, though as seen in financial disclosures, the disposable business remains strong and growing, we have managed to reduce the lead time of these products and continue to work to improve these lead times, though orders continue growing, production is not outpaced..

Along those lines, we recently began construction on our new 61,000 square foot manufacturing facility here in Orlando, Florida, to consolidate operations, improve efficiencies and prepare for the continued and expanding growth we foresee. We anticipate spending approximately $13 million on its development over the next 12 months.

And we will keep you posted in these coming quarters as construction progresses towards a moving date..

Now regarding the progress of our 510(k) submission for the new 3870 MRI IV pump. The team is focused and pushing very hard, yet we are still not quite there due primarily to some expanded testing.

As previously reported, we have engaged a third-party consultant with 2 very recent ex-FDA reviewers on their staff, from whom we are getting excellent input. Their feedback has, however, driven us to repeat some of the previous tests, mainly because of devices under test for many months ago, and they have undergone some changes.

Our ex-FDA consultants sleeve, the FDA would be much more comfortable with all testing done on the absolute final configuration of the device. .

Therefore, the aim is to have the test reports referenced, the very latest version of the device, thus removing any questions, is anticipated that these steps should impact the delivery of the 510(k) by approximately 9 to 10 weeks.

Still remain on plan with expected clearance in Q1 2025 and plan to show the revenue from the new device in the back half of 2025..

Now I'd like to present our expected financial performance guidance for the coming quarter and the balance of the year. For the second quarter of 2024 financial guidance, we expect revenues of $17.6 million to $17.8 million. GAAP diluted earnings per share of $0.33 to $0.36 and non-GAAP diluted earnings per share of $0.36 to $0.39.

We reiterate our guidance for the full year of 2024. We expect to report revenues of $72 million to $74 million, with GAAP diluted earnings per share of $1.37 to $1.47 and non-GAAP diluted earnings per share of $1.52 to $1.62. .

Lastly, I'm pleased to report that our Board of Directors has declared a quarterly cash dividend of $0.15, payable on May 30, 2024. And we expect to pay the quarterly cash dividend going forward, to reward our loyal shareholders. Now I'd like to 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 have been reported on both a GAAP 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 measure on the last page of today's release..

As we reported earlier this morning, revenue in the first quarter of 2024 was $17.6 million, an increase of 14% compared to the first quarter of 2023. Domestic sales increased 12% to $13.4 million and International sales increased 20% to $4.2 million. .

Overall, Domestic revenue accounted for 76% of total revenue for Q1 2024 compared to 77% for Q1 2023. Device revenue increased 13% to $11.9 million, driven by a 38% increase in Monitor revenue.

Revenue from Disposables and Services increased 17% to a record $5.2 million for the first quarter of 2024, while our maintenance contracts remained stable at $487,000..

The gross margin was 76.1% for the first 2024 quarter compared to 75.7% for the 2023 quarter. The increase in gross margin is primarily due to increased revenue, decreased raw material costs and direct labor efficiencies offset by overhead spending. .

Operating expenses were $8.6 million or 49% of revenue compared to $7.7 million or 50% of revenue for the first quarter of 2023. On a dollar basis, this increase is primarily due to higher sales and marketing expenses for higher sales commissions, sales activity expenses and payroll and benefit expenses..

As a result, income from operations grew 18.5% to $4.7 million for the 2024 first quarter. We recognized a tax expense of approximately $1.1 million during the first quarter of 2024, resulting in an effective tax rate of 21.1% for the quarter, which was in line with the effective tax rate of 20.9% in 2023.

On a GAAP basis, net income was $0.32 per diluted share compared to $0.27 for the 2023 quarter..

On a non-GAAP basis, adjusted net income was $0.36 per diluted share for the 2024 first quarter, compared to $0.30 for the first quarter of 2023. Cash from operations was $3.9 million for the 3 months ending March 31, 2024, down from $4.6 million for the same period in 2023..

For the 3 months ended March 31, 2024, our free cash flow, a non-GAAP measure, was $3.4 million. This compares to a negative free cash flow figure of $1.9 million in the first quarter of 2023, when we purchased the land for our future facility for $6.2 million. Our cash and cash equivalents totaled $45.1 million as of March 31, 2024..

And with that, I will now turn the call over to the operator for questions. .

[Operator Instructions].

Our first question comes from the line of Jason Wittes of ROTH Capital Partners. .

In terms of the Monitor business, yes, it did look quite strong, obviously.

Have you sent any communications to the field about your Monitors and about the competition that may have spurred on some growth in this quarter?.

Jason, good to hear from you. I'm not quite sure I understand the question, though.

How about -- give it to me again?.

I mean I know that you basically sounded a directive to the field or to your customers that you're no longer going to service the pumps after 7 years. Have you done anything similar with Monitors that might have spurred on growth? Or how would you -- the growth was surprising this quarter.

So I'm just curious if there were any -- what's behind it or what your thoughts are in terms of what's behind it?.

No, it's -- maybe it was buried a little bit in my comments when I said it doesn't really show so much strength of one product line pump or monitor over the other. It's a matter of timing more than anything else.

So -- but no, we absolutely -- the Monitor, actually, we've come out with the competitive nature of the Monitor is that it's quite advanced, and it's state-of-the-art as is. So we wouldn't be absolutely not putting out any sort of a letter obsoleting any facet of it, including support. There's -- we haven't even been selling them for 5 years.

So yes, that's just -- I just have to say, it's just simply the strength of the team going out and selling monitors. .

Sounds good. Yes, it's impressive. It was a strong number, much stronger than I was anticipating. And then in terms of what you said about the submission for the 510(k) for the new pump, I guess that would put it I think originally, it was last communication, it was sort of expected second quarter.

And now I guess you're saying 9 to 10 weeks, I guess that would put it into the third quarter in terms of when you would submit that 510(k) ?.

Yes, to put months on it, we'd anticipated getting it out of here by the end of this month. That's what we've been focusing on. But with this curve ball here, it's an abundance of caution to redo some of these tests. And of course, then getting them scheduled has been a delay because we rely on third parties and all of that..

So, yes, we think it's going to add about 9, 10 weeks to that. So that puts us somewhere very end of July or early August. We think of it more monthly rather than something that's tied to a quarter. .

I appreciate that precision. It's good to hear that. And then maybe a final question. I mean the communicate you put out, definitely seems to be spurring on growth in pumps. If you look at -- I don't know if you can give any color in terms of if you look at who's been upgrading or who's been replacing.

Has it been many of those -- I mean I don't know if you can give us any parameters that can kind of show how many of those pumps that are getting replaced now are the ones that got to communicated that they're no longer to be service after 7 years?.

We were anticipating that very question just before the call. So we didn't -- we don't have some definitive metric to give you, but we will shortly. We'll pass that along. But generally, it's a substantial part of the bookings that I mentioned, this big -- a rather large booking uptick in in Q1. And it's pretty substantially from that.

But like I say, we'll get some -- we'll have some numbers to share with you very shortly. .

Our next question comes from the line of Frank Takkinen of Lake Street Capital. .

Roger, Jack, congrats on a good start to the year. I was hoping to ask one on the guidance. Obviously, you had a nice outperformance versus your Q1 expectations, and then you kind of hinted at the expectation for pumps to be strong next quarter from some of the Q1 ordering.

I was curious kind of the thought process you went through when thinking about slightly increasing the guidance versus reiterating it? Was it just a function of conservatism? Or was there anything else baked into that thought process?.

Well, I think, Chris, that yes, I think if you -- from our past experience here, I think we've tried to be somewhat conservative in the guidance we give. And I think that still is -- the second half of the year is certainly some much bigger numbers in order to hit that. So -- but we feel confident.

And certainly, as we progressed throughout the year, we'll certainly maybe provide updates that. But for right now, we think that's the best position for us to reiterate our guidance for the year as is. .

Perfect. Perfect. So then on the -- maybe just a follow-up on backlog, generally speaking. Obviously, a little plus/minus here. So I think if I heard correctly, you burned down some of the disposable backlog, but perhaps the pump commentary resulted in pump backlog increasing.

Can you just net out total backlog, how much visibility you have and how that gives you confidence going through the rest of the year?.

Well, of course, we don't give the exact numbers, as you know. But again, it's probably very much in line with where the backlog was as we came into the end of the year. So remains strong, gives us good visibility, for at least a quarter out for sure, but very strong and stable backlog.

And especially, again, a lot of that, too, due to the pump backlog going into this Q2. .

Yes. Maybe to add a little more color, Frank, to topic, though we are trying to shave that lead time and associated backlog with the with the disposable side, which we're making progress, as I said.

Yes, due to the orders on the hardware side, what Jack saying is that the backlog remains pretty consistent as it's been in the last half a dozen quarters. .

Got it. That's helpful. And then maybe just one more for me on the Monitor side. I think, Roger, we've talked about in the past, the day-to-day business or quarter-to-quarter business, you talk about the active systems being replaced on the Monitor side and your share of that market and then the broader 10,000 or so pieces of equipment install.

Maybe just give us an update how you feel you're penetrated into those? How you feel about the low-hanging fruit opportunity still existing within those? And just anything else you could talk about in those monitoring markets. .

Yes. Well, good question. So we still don't have the lion's share of the market. We're still the underdog. So that means there's still quite a bit to go. We estimate we're just nudging close to 30-ish percent of this business, right? So there's still plenty more for us to go..

Having said that, of course, with every incremental percentage gains still against a well-entrenched competitor. The low-hanging fruit is a little higher on the tree. It's life. That's the way it works.

So the team is jumping getting, getting their ladders and trying to reach up to a little bit more than they had to do the quarter before and the quarter before that, certainly. .

But we still are scratching away at that existing open share of what's the Monitor business, which is, by and large, one-to-one with magnets. And that's still where we're operating at. We have had a little luck.

We're starting to -- the real upside, as we've mentioned and presented in the past is to have this multiplier effect for the transport strategy, like we developed with the pumps happen with the monitor..

And we need to put maybe 1 or 2 more little features onto the pump to really make that very smooth, but we're already starting to get some nibbles there. And a few of these monitors each quarter that we bring in are related to let's say, more than one per magnet, an extra one. And there's leaning storage starting to adopt this transport theory.

That's yet to be rolled out over the coming quarters, as I said, we still got our hands full just nipping away at the existing placements of monitors. So we'll eat pretty well for still a number of quarters doing what we've been doing.

And then we hope to roll out this transport strategy and really get the multiplier effect on top of these monitors, so where they're not just one monitor per each MRI. .

This concludes the question-and-answer session. I would now like to turn it back to Roger Susi for closing remarks. .

Well, thank you, operator. Good. Again, we are pleased with our Q1 2024 results, as stated. And we also say, as guided that we expect continued strong performance as the new year progresses. So we look forward to reporting our future successes to you, and thank you all. .

Thank you. This concludes the call. You may now disconnect..