Welcome to the IRadimed Corporation Third Quarter 2021 Financial Results Conference Call. Currently, all participants are in a listen-only mode. And at the end of the call, we’ll conduct the question-and-answer session. As a reminder, this call is being reported today, October 29, 2021, and contains time-sensitive information that is accurate only as of today. Earlier, IRadimed released its financial results for the third quarter 2021. 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 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 not include the company’s expected future results. IRadimed reminds you that future results may differ materially from these forward-looking statements due to a number of 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’ll now turn the call over to Roger Susi, President and Chief Executive Officer of IRadimed Corporation. Sir, you may now begin.

Good morning, and thank you all for joining the call today. I’m again, happy and very pleased to report a very good quarter of revenue and earnings growth. As we reported in this morning’s press release, Q3 revenue was $10.9 million or nearly 42% over last year. Non-GAAP earnings were $0.23 or 103% over Q3 of last year. And on a sequential basis, we continued along our well-established trends would revenue growth of over 11% from Q2 this year, and earnings growth of over 74%. I’m proud of these results and the team’s performance in what remains in many ways, a very challenging environment. The team’s collective resiliency and dealing – in dealing with at the lingering effects of COVID are exhibited here every day. From a sales perspective, bookings for our products have been strong all year, and that did not change during Q3. In fact, we saw record bookings again this quarter. So passing our previous high water mark from Q2 this year, by nearly 10%. This level of demand for our products exceeded our expectations and allowed us to grow backlog, providing visibility into the coming quarters, along with growing our overall confidence. What may also be telling about the demand for our products is a comparison to 2019 with our year-to-date revenue expectations for Q4. We are now firmly on a pace to show revenue growth over the pre-pandemic 2019 time period of approximately 8%. But this level of visibility and confidence, we expect to report Q4 revenue of $11.5 million to $11.7 million with GAAP earnings per share of $0.17 to $0.18 and non-GAAP earnings per share of $0.20 to $0.21. These earnings estimates in our – include anticipated one-time cost related to our 510(k) application that Chris will discuss in just a moment. We are also increasing our full year financial guidance now expect revenue of $41.4 million to $41.6 with GAAP earnings per share of $0.60 to $0.61 and non-GAAP earnings per share of $0.70 to $0.71. Our previous full year guidance called for revenue of $40 million to $40.4 million and GAAP earnings of $0.53 to $0.55 and non-GAAP of $0.60 to $0.62. Now, I’ll turn the call over to Chris, who run through some of the more – some more of the details in depth.

Thank you. Good morning, everyone. First, I’ll start with an update on the regulatory status of our 510(k) application for our next generation IV pump. We continue to progress through the process and I’ve had some recent communication with FDA regarding their review of our application. Their review is comprehensive and as expected they have requested additional testing be performed on the new device. Much of this testing can be performed in-house while other testing will need to be performed by third parties. There are also administrative tasks that we need to work through in the form of meetings and other communications with FDA to clarify the need for additional testing regarding some of their requests. While we expected to receive comments on our application, the nature of their questions, we’ll take some additional time to resolve. These reasons, we now believe clearance is more likely to come in the second half of next year. We also expect to incur additional costs than initially anticipated related to the testing and administrative matters. We believe much of these costs will be incurred during Q4 and are not indicative of an ongoing run rate. Our estimates on timing of potential clearance are always based on our analysis of the information we have at the time. Despite the movement and our current estimate, we do not believe that this has any impact on the longer-term success of the next generation IV pump or of the company. Regarding supply chain. The trend of limited supplies and higher costs for certain materials that we noted last quarter continued during Q3. However, we have also been able to obtain favorable pricing for many other components using our products. Net for the quarter, we placed orders for materials going out 12 months at prices that were slightly…

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

Thank you and good morning really strong results.

Thanks.

I guess, for starters. Can you – it seems like the monitors particularly are putting up, some very solid numbers. Can you talk about the environment out there and perhaps what’s driving this upside?

Yes. I could take a crack at that Scott. Good to hear from you, how you doing? And good question. So yes, I’d say number one is, frankly, that we’re learning to sell it better. And I know that the investment world, sometimes it seems when a company makes a new device all the effort is in getting it designed and cleared and that as soon as it’s cleared, you hand it to the Salesforce, they take us, they just go from zero to 100 mile an hour selling it right out of the gate, but that is not reality. And I think it’s just taken a while for our team to really learn and understand the product and the environment, the use environment, the customers, and most of all, how to compete against the large well entrenched competition in the form of Philips in that space. So that’s probably the number one thing that’s been over these last couple of quarters, as you’ve seen and mentioned, that the monitor is just picking up and picking up and picking up. There’s also, a little bit of lift here. We see in just the last couple of months due to Philips having trouble, which is pretty well advertised in the news, with their giant recall and the respiratory area. And I think generally they had a comp, they had their earnings call just the other day and reported that revenue was down because of supply chain issues. So, I’d say a little bit of that is starting to help us too. So, I hope that answers your question, but that’s – I think the biggest factors, we’re just better at getting out there and competing and finding the customers, plus once you get it, you get over that, you got a few units planted in critical areas than confidence that the product works to the next customer goes up. So makes the job of introducing, a new device again, get less difficult, because it’s not quite so new, it’s more and more proven each day.

Okay, great. Thank you, Roger for that color. That was helpful. Next question, with regards to the – excuse me, the regulatory pathway for the pump. We always knew it’s a challenge to get pumps through the FDA. Eventually it happens, but, there’s expected to be a couple delays along the way, but my question is, how confident are you of the second half 2022 approval timeline versus, where you were a quarter ago? I mean, we know it’s going to be a little later, but how was your confidence level given this increased interaction that you’ve had with the FDA?

Well, that’s why, Chris?

What you said, we’re competent with, at this point with what we see and know that, the back half of the year is the likely spot. Yes. The FDA has been a little challenged. Some of the reasons it’s been, it was slow to get the whole thing started was there a little busy there at the FDA last year with all the emergency use issues they had to deal with? That’s been some of the explanation we’ve gotten from our people at the FDA that are handling this thing. So, we hope that that’s easing off right, as COVID eases off and does start to go into work. They’re still working remotely, most of them. And without the burden of all those EAU things, which I think is trailing off, they’ll be able to spend more time on, the conventional business of the FDA, like clearing IV pumps.

Okay, great. And the final question is a little bit more of a big picture question. Given the supply chain issues, sort of inflationary environment as well. Do you expect to have some pricing power perhaps to take price on some of your product offerings? Given this backdrop, it seems like some of your competitors may struggle to fill their demand as well, but all of this could potentially lead to higher some pricing power for you. What are your thoughts on that topic?

Well, I think I mentioned this before, maybe the last call I mentioned that I kind of said it as a priority earlier this year, back in the spring to start to try to move some of this pricing that we have, especially with the big GPOs upwards, and over the last nine months, we have been successful at moving prices in that direction. So, we think, we’re getting into a very good position with exactly that increasing prices a bit to cover costs that have been coming up on us this past year. And then I think it’s starting to even reflect in some of the – when you look at the earnings, right. Some of this absorption Chris mentioned, we’ve gotten better absorption. So costs are from our burden, the way we burden our labor here is that, is less of a negative factor. But also we’re starting to see the average pricing of certainly in the more, more along the lines of the monitor equipment, in the pump equipment that we’ve been able to move that northward pretty well.

Okay, great. Thank you for taking the questions and congratulations again on the strong results.

Thanks.

Thanks Scott.

[Operator Instructions] Speakers, our next question is from the line of Lisa Springer of Singular Research. Your line is now open.

Thank you. Good morning and congratulations on very nice quarter.

Thanks, Lisa. Good morning.

I wanted to ask you, do you feel that your access to customers is back at pre-COVID levels? And could you comment on the company’s efforts to make sales outside your traditional hospital departments other than radiology?

Yes. I could take that, I guess again. So it’s been pretty much opened up for most of the year with the Delta variant tear about seems like early in that third quarter, a couple of months ago, we had heard of, I believe it was only one particular hospital group that had gone back onto restrict access. And we were for a time worried that that was going to spread like the Delta variant virus itself, but it didn’t. So and I believe they came back off of that those precautions, they reenacted. So nobody else followed suit. So it’s, yes, to answer your question just real directly, it’s not access is not a big limiting factor anymore. And I think a second part of your question was, are we able to get into now? I was speaking about generally access to the hospitals and primarily our radiology and anesthesia context. Your second part of your question may be more about how we also have this call point in ICU to, yes really push forward the multi pump business. So ICU’s are still a little snug not like they were, but yes, there’s still a bit of difficulty to actually get into the ICUs. And so maybe we don’t actually have so many meetings actually in ICU, but we can get the ICU people out of there for a meeting let’s say down the hallway, that sort of thing. So that still has a ways to go before it’s business as usual.

Okay. And did you have any sales of the FMD device during the quarter?

I believe, we did – then we had a triple, we had an order for three of them here about 60 days ago.

So, I think the sales occurred, the deliveries have not yet occurred. I think they’re tied to either new construction or refurbishment of an existing MRI. So that I think those will come I believe its next year, right? Yes, I think that, I think the deliveries will come next year.

Yes. These things are – these things are going in on the installation them and the delivery is way different for that device than pumps and monitors. It generally goes along as Chris said with construction so. Getting an order and then getting the exact time they want to put in that’s two different things.

Okay. And Roger, could you comment on the R&D pipeline beyond the new infusion device? What would be next up and do you anticipate maybe doing any other regulatory filings next year?

Well, the short answer to that is, no, there won’t be any other regulatory filings coming up in these next 10, 12 months. And working on the next thing we’ve got a couple of irons in the fire, but frankly, we are working very hard with the FDA to clear the current pump. So, we have, as you can see by the amount of money we spend on R&D, we don’t have a lot of extra people laying around. And so when heavy demands come in for things like more testing, as Chris mentioned for the pump that takes up our capacity pretty well.

Okay, great. Thank you very much.

Thank you, participants. I’ll now turn the call back over to Roger Susi for final remarks.

All right. Thank you, operator. As I said at the beginning of the call, very pleased with these results and proud of how the team continues to perform. Overall our business remains robust demand of our products is as high as it has ever been with two, three representing our second high watermark in a row. As Chris mentioned, we are cautious about global supply chain issues. However, we have been able to hold gross margins at our historical levels, and we are making progress on our 510(k) application. Although, it will take a little longer and a little more money than initially anticipated. We remain steadfast in our opinion and our optimism. Excuse me, and look forward to speaking with you once again soon. Thank you all.

And that concludes today’s conference call. Thank you all for joining. You may now disconnect.