iRhythm Technologies, Inc. (NASDAQ:IRTC) Q1 2024 Earnings Call Transcript

Marie Thibault: Good afternoon. Thanks for taking the questions and congrats on a very nice Q1. I wanted to ask a little bit more on guidance. You had a very nice quarter, and I know that was against the face of dealing with some weather disruption early in the quarter. Can you help us think about how you set that guide? Was there a little prudence baked in? How should we consider this new revenue range?

Brice Bobzien: Yes. Marie, this is Brice again. Thanks for the question. I think what it was important for us to do was to pass through the beat from the first quarter. We did talk about a little bit of disruption early on. However, we saw incredible recovery in the back half, and continued momentum into Q2. And so the way we feel about guidance moving forward, we certainly have tailwinds at our back. We’ve talked a lot about them in Quentin’s prepared remarks as well as just the opportunity we have in front of us, and we feel good about it. But I’ll tell you, when you look at the guidance setup, you’re going to see growth rates that are relatively consistent at midpoint and then at the top end of the range, it does have growth accelerating.

We absolutely believe that’s achievable, and we feel great about it. However, it does take some execution, right? We’re in the midst of the launch of the Zio Monitor product, right? We’re navigating the conversations with the FDA. It requires commercial launch internationally. There are some things we have to execute on, and we truly believe we’re going to be able to execute on all those. However, until we see that execution play through, we’re going to be thoughtful on the guidance for the last three quarters of the year.

Operator: Thank you. Your next question comes from Joanne Wuensch from Citibank. Your line is now open.

Joanne Wuensch: Good afternoon and thank you for taking the questions. Just a few catch up here. Where are you on the FDA warning letter resolution? Anything new on the Department of Justice? And what is the current thinking of timing for monitor for AT? Thank you.

Quentin Blackford: Joanne, thanks for the question. Look, from an FDA perspective, I would tell you, we continue to be really encouraged with the work that’s going on with the FDA. I think the collaboration is as high as it’s ever been. And I applaud our own teams, but also applaud the FDA just with the approach here that the two sides have taken. And again, I couldn’t feel better about it. I feel like we’re making great progress with it. We originally had anticipated that we would see an approval sometime around the mid part of the year. It’s probably a couple — maybe a few months later behind that as we work through this and just go back and forth. And my confidence level has never been higher that we’re going to ultimately see an approval here.

It’s just a matter of the back and forth with the agency and making sure we’re answering all those questions in a way that addresses the questions they have. So we feel good about the momentum there and the progress that’s being made there, again, I think getting the new MCT category code created being the first product put into that category code just continues to validate the progress that’s being made and appreciate the relationship again with the agency. With respect to MCT, I continue to believe we’ll get on file in the back half of this year with the agency. It’s probably a little bit skewed towards the latter part of the back half of the year, but still expect to have MCT filed in the second half of 2024, which means we’re bringing that product into the market in 2025.

So excited with MCT. I’ll remind you, when you think about growth levers in the future, we only have about 7% of that MCT marketplace despite the fact that we have about 70% of the long-term cardiac monitoring place. And every 10 points of growth that we can capture in that MCT space is pushing up on nearly $100 million of incremental revenue to us. So MCT is an important one. And we’re very excited about the enhanced features that are going to come in that MCT product once we get it through. And then on the DOJ, not anything to update on at this point in time. We continue to answer questions when they come and provide information when the questions come. But there really hasn’t been a lot of dialogue or back and forth here, and there’s not much to update on at this point in time.

Certainly, if that changes, and there is something to update on, we’ll be certain to it, but there’s just not a lot to update here.

Operator: Thank you. The next question on the line comes from Kallum Titchmarsh of Morgan Stanley. Please go ahead. Your line is open.

Kallum Titchmarsh: Hi guys, thanks for taking the question. Just stick to MCT here, if that’s okay. You alluded to about 7% share in this market for AT today. So realistically, I think after those first couple of years of launch of MCT, where do you think your share could move to in this market? Because it seems as though there are a couple of pretty small lightweight high-tech MCT devices coming through the market today from competitors. So I’m just curious what it is about your product that’s encouraging you about a potential uptake here? Thanks a lot.

Quentin Blackford: Yes. Look, how far we can get, Kallum. I think we’re going to wait and see with the success that we have in the market. I think what’s really fascinating and one of the reasons that we believe we have a high degree of opportunity to win here is the exact same customer call point that is prescribing long-term cardiac monitoring today in the way of Zio is also writing scripts for competitive MCT products because our product isn’t quite what they’re looking for. And I think we know very well why that is. One is the duration of where while the data is incredibly compelling with respect to why 14 days of monitoring is sufficient. And I can tell you that data only continues to build. The customers want to see out to 30 days of monitoring or up to 30 days.

And so we need to continue to work towards closing that gap. And frankly, just continue to compel them with data as well, but we need to meet the customer where the customer wants to be met. And that’s one of the things that we’re doing in this enhanced MCT product. The other thing that a lot of our competitors will offer is a downgradable capability when insurance is not able to be found for the actual MCT device, can they step down into something like an event monitor. Those are capabilities that we’re building into our products as well and begin to eliminate the argument from a physician’s perspective on why Zio MCT is not the right product for them. So — whether we can get all the way to 70% of the MCT market like we have in long-term cardiac monitoring market, certainly, we’re not setting our expectations that way, but there is a lot of room to run in there to capture market share and have success.