Welcome to the IRadimed Corporation First Quarter 2022 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.

As a reminder, this call is being recorded today, April 29, 2022 and contains time-sensitive information that is accurate only as of today. Earlier, IRadimed released its financial results for the fourth quarter 2022. A copy of its 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 of the call will be available on the website for the next 90 days.

Some of the information to be furnished in today's session will constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are those focused on the 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 again, maybe obtained for 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?.

Thanks, operator, and good morning and thank you all for joining us on the call this morning. Iradimed had another very good quarter of revenue and earnings growth as was reported in this year – in this morning's release. The trend of strong demand for our products remains intact and thus, we feel very good about the coming quarters as well.

As reported in this morning's release, first quarter revenue was $12.3 million, nearly a 34% increase over the first quarter last year. Non-GAAP earnings were $0.22 or 69% over Q1 2021. I'm very pleased with these results and the strong start our company has had in 2022.

Our sales team continues to perform well, increasingly driving customer demand for our products. Total Q1 bookings remained at record levels coming in 52% higher than Q1 last year. Strong demand for our products has given us additional visibility through a growing backlog, which increased from its year end level of 10.9 million.

Our engineering and regulatory teams continue to work closely on obtaining 510(k) clearance for our next generation IV pump, which has been branded the MRidium 3870. We continue working diligently to meet our timelines with second half of this year.

And while there is still much to complete, we are committed to doing everything we can do to achieve our goal. Regarding our new ferromagnetic detection system, we plan to install our first placements this quarter with a growing number of installations from that point on.

As I have said in the past, we are very – we feel very good about where we are with this product and believe that we have a technologically superior system compared to the others already in the field. Regarding our financial guidance, we have considered the booking trends and the added visibility we have through growing backlog.

We've also considered the macro risk associated with supply chain and feel confident in increasing our full year expectations. Those supply issues are a near daily consideration at some level and supply instability is now [ph] a familiar norm the world over as we have the means and tenacity to find work around solutions as necessary.

We have comfort that we can continue to make shipments without material delay. Considering Q1 with an eye on sales levels and deal count, we now expect the full year 2022 revenue of 52.5 million to 53.2 million with GAAP earnings of $0.89 to $0.95, and non-GAAP earnings of $0.96 to $1.3.

Additionally, the second quarter of this year, we expect revenue 12.5 million to 12.7 million with GAAP earnings of $0.21 to $0.23 and non-GAAP earnings of $0.23 to $0.25. Now, before turning the call over, I'd like to address the executive transition that we announced yesterday afternoon.

As disclosed, Chris Scott has resigned from the company effective May 27 to pursue other opportunities. Over the next 30 days, he'll be focused on a smooth transition of financial responsibilities to Matt Garner who will serve as interim CFO, while we go through a search process.

Chris has been a valued partner to me and the rest of the organization during his eight plus years here. He has supported the company every step of the way and will be missed. Sorry as we are to see him go, he leaves a very capable finance team and the company in good shape, which the finance team will now be led by Matt.

This has been the situation for a last several years. I'm confident in Matt's abilities to maintain the quality and integrity of our financial information during this search process. And now I'd like to turn the call over to Matt, so he can introduce himself and to review the financial results of the quarter.

Matt?.

Thank you, Roger, and good morning, everyone. Before summarizing the financial results, I'd like to spend a moment and introduce myself. I began with IRadimed in February 2014 as the Assistant Controller and in 2020 was elevated to the Controller role.

Over these last eight years with IRadimed, I've developed a deep understanding of the company and its culture. Overall, I have 15 years of experience within the medical equipment industry including seven years at Roger's former company. I also hold a bachelor's degree in accounting from Southern New Hampshire University.

I am thankful for the opportunity to serve as a company's Interim CFO, and look forward to interfacing with you while the search proceeds. Now on to the financial summary; as in the past, I will be discussing these results on a GAAP basis as well as on a non-GAAP basis.

You can find a description of our non-GAAP operating measures in this morning's earnings release. You can also find a reconciliation of these non-GAAP measures to the nearest GAAP measure on the last page of today's release.

As reported earlier this morning, first quarter 2022 revenue was $12.3 million, an increase of 33.5% compared to the first quarter of 2021. Revenue from domestic sales increased 37.2% to $10 million and revenue from international sales increased 19.5% to $2.3 million.

Overall domestic revenue accounted for 81.1% of total revenue for Q1 2022 compared to 78.8% for Q1 of 2021. Device revenue increased 38.8% to $8.5 million. This was driven by a 99.5% increase in monitor revenue resulting from continued customer acceptance and win rates.

The average selling price of our MRI compatible IV infusion system during the first quarter 2022 was approximately $33,800 compared to approximately $32,700 for the first quarter of 2021. This increase relates to higher domestic unit sales partially offset by an unfavorable product sales mix.

The average selling price of our MRI compatible patient vital signs monitoring system during the first quarter 2022 was approximately $46,800 compared to approximately $38,300 for the same period in 2021. This increase relates to higher domestic unit sales and price increases that we began implementing during the second half of 2021.

Revenue from disposables and service increased 25.9% to $3.3 million for the first quarter of 2022. And revenue from our maintenance contract was consistent at $0.5 million for both periods. Gross margin with 76.2% for the 2022 quarter compared to 76.6% for the 2021 quarter.

The decrease in gross margin percent is primarily due to unfavorable labor and overhead expenses partially offset it by higher domestic sales.

While the supply chain remains challenging, we continue to believe that any negative impact from higher costs will likely be limited and partially offset by higher levels of unit production resulting in gross margins that are consistent with our historical ranges.

Operating expenses were $6.3 million or 50.2% of revenue compared to $5.3 million or approximately 57.3% of revenue for the first quarter of 2021. On a dollar basis this increase is primarily due to higher sales commissions, payroll and benefit cost, sales activity expenses and engineering cost for prototyping and design.

As a result, income from operations grew 73% to $3.1 million for the 2022 quarter. We recognize a tax expense during the first quarter 2022 of approximately $573,000 resulting in an effective tax rate of 18.7% compared to a tax expense of approximately $384,000 in the 2021 quarter.

This increase is due to higher taxable income partially offset by benefits associated with stock compensation and research and development credits. On a GAAP basis net income was $0.20 per share compared to $0.11 for the 2021 quarter.

On a non-GAAP basis adjusted income was $0.22 per diluted share for the 2022 quarter compared to $0.13 for the first quarter 2021. Cash from operations grew to $1.4 million for the three months ended March 31, 2022 from $0.9 million for the same period in 2021.

For the three months ended March 31, 2022 and 2021 our free cash flow and non-GAAP measure was $1.2 million and $0.8 million respectively. And with that, I will turn the call over for questions.

Operator?.

Thank you. [Operator Instructions] Our first question comes from the line of Scott Henry with ROTH Capital. Your line is open..

Thank you, and good morning. First Chris, best of luck to you, it's been a pleasure working with you. Second Roger, you told us the name of the next generation pump.

What was that again?.

We call it 3870 it's a model. We use the same MRidium name of the – was carried to these pumps for all these years. We had a 3850, current pumps 3860, this one we call it 3870..

Perfect.

And is there any update as far as correspondence with FDA and how we should think about the timeline for approval of that product?.

Yes. We've had a couple of calls. Actually Scott in the last six weeks – in the last six weeks. So the communications have been I'd say good, okay. So that's – those communications are in the form of what we call information requests, clarifications to the questions that we've been trying to answer formally. You can submit and have such calls.

So they've engaged with us and that's been positive. And on this end as I said we're working. We're – it's all hands on deck there, regulatory and engineering side answering this host of questions and we plan to get them to the FDA in August.

And then we hope that they can pull their support in and take care of business on their end and get this thing done..

Okay. Thanks for the update there.

And I think I heard on the FMD product, no revenues in Q1 but should we expect to see revenues in Q2?.

Well, yes. Yes, we're going to install – we're going to start install a couple of these ones that we've had these orders booked on..

And you booked the revenues post installation.

Is that correct?.

Yes..

Okay. Just a couple final questions.

How is the pricing environment? I mean, given kind of the inflationary backdrop? Do you feel that you have some pricing power to maybe not immediately, but certainly raise price over time?.

The answer is yes, but I got to point out. I was a little proactive on that and as I said we had some pretty good increases that we started on about this time last year and you're seeing the fruit of that particularly in the monitor. As you saw the average price that Matt quoted, that has been pretty significant..

Okay, great. And then final question, maybe for Matt just get him involved.

The tax rate should we still be thinking about kind of a 24%, 25% tax rate for the full year certainly a lower than that in the first quarter?.

Thereabouts, I mean, for what we're looking at, we've got roughly at 23% for the full year..

Okay. Perfect. Thank you for that color. And thanks for taking the questions, guys..

All right, Scott. Appreciate it..

Thank you. [Operator Instructions] Our next question comes from the line of Lisa Springer of Singular Research. Your line is open..

Thank you. Good morning. Roger, I was wondering if you can comment on in terms of the surge in monitor sales in terms of customer segments.

Was there any particular group of customer that was driving that, or was it kind of spread across your whole customer base?.

The monitor, Lisa?.

Yes..

Yes. Yes, it's across the whole customer base. We find ourselves as these quarters have rolled along since we launched the monitor. We're participating in larger and larger deals as well. So that's very encouraging, meaning, we're moving from selling maybe one or two monitors up to eight, 10, 12. So it's pretty exciting..

For sure. Okay. And have you seen any impact on your European sales from the Ukraine’s war? [ph].

Maybe too soon to tell if it's because of the Ukraine issues, but the European business is, I'd have to say international has been a little sluggish, and as you noticed, we're – we said, we're kind of favorable from the mix being domestic a little bit stout.

I don't think that – I don't – I can't tell you if that's anything to do with hesitations in Europe from the Ukraine thing or not, but I guess it's probably a good question and a logical thing to think if – but at this point, I don't have any reason to tell you yes or no..

Okay. Thank you, Roger..

Thank you. At this time, I'd like to turn the call back over to Roger Susi for any closing remarks.

Sir?.

Well, I'll wrap up the call by saying again how pleased I am with our Q1 results and with how well the business is operating. I continue to believe strongly with customers are realizing the value of our that our products bring, which shows in the high level of bookings that we achieved quarter after quarter here these last few quarters.

I guess, I'd like to say that Chris will be here working through the rest of the month to help Matt and everyone through this transition. And he's going to be missed, but Matt’s got to do what he's got to do, and as he sees fit and we wish him well. We're off to a great start in 2022. And I look forward to speaking with you all again next quarter.

So thank you very much..

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