Medtronic plc (NYSE:MDT) Q4 2024 Earnings Call Transcript

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Brett Wall: Yes, absolutely. Larry, good to hear your voice. Thanks for the question. The TITAN 2 study, was a six month follow-up, with the actual study design, and we will follow those patients for 24 months. So we’ll be following, those patients that have, additional data as well. The form factor is about 2.8 cubic centimeters, really about the size of roughly half a stick of gum and it fits, in the ankle same place for everyone. This opens up a significant patient population. There’s over 4 million people in the United States, that have discontinued their dual drug therapy or failed two drugs, and they are now receiving incontinence devices at home, adult incontinence products as opposed to seeking additional therapy. This is a 15 minute procedure.

We now have established Category 3 reimbursement, and we’ll be utilizing that to further, develop out the reimbursement profile. This particular product and technology opens up a substantial population that is not seeking help or seeking a therapy right now. We’re in a modular submission. We’ll be submitting the data here shortly, and this is an exciting new technology that opens up this field and will contribute to its ongoing growth.

Larry Biegelsen: Okay. Thanks, Brett.

Geoff Martha: Yes. Thanks, Brett and thanks, Larry. [Operator Instructions] We’ll take the next question, please Brad.

Brad Welnick: The next question comes from Vijay Kumar at Evercore ISI. Vijay, please go ahead.

Vijay Kumar: Fantastic. Hi, Geoff. Thanks for taking the question. I had two product-related questions here. First one, just at a high level, right? You had three pretty meaningful product approvals in the past few months between EV-ICD, PFA and your RDN approval, right? You’re already doing mid-singles. With all of these incremental growth drivers coming in, is that now a mid-single plus? I’m just curious how you’re thinking about this new product opportunities.

Geoff Martha: Well, thanks for the question, Vijay, and thanks for pointing out the robust nature of the approvals. And these are really, we believe, and as you saw in the commentary, unquestionably differentiated products in large markets and growing markets that we have a high confidence in. And this gets to our commitment to make this growth durable. And as we’ve seen over the last couple of years, whether it be market conditions or internal things, which I am — we are working so hard to make sure these internal boogie men disappear through changing our fundamentals, this is the — this breadth of approvals in these high-growth markets, I believe, will help me for the first time sleep well. Because it gives you the durability that we’re talking about in that revenue number, which is so important.

Everything flows from there. So at this point, before we start talking about plus, I just want to make sure that we are very durable and reliable mid-single-digit growers in different types of environments, good and less good. And then we can flow from there about leverage on the P&L and things like that. So that’s my overview on those three — on the pipeline in general.

Vijay Kumar: And maybe my related product question here, perhaps for Mike on robotics here. You mentioned installed base went up in Europe. Any sense on what the size of that installed base is? In this U.S. clinical trial, you said it’s on plan. But any sense and when this trial might end, perhaps timing for an FDA approval?

Mike Marinaro: So thanks for the question, Vijay. First, we will continue — we are continuing forward with our installs, have added to the installed base. We’re not quoting numbers of installations at this time, but we are increasing on a quarter-on-quarter basis. Our procedure volume is picking up on a quarter-on-quarter basis as we work through availability of our instruments and then getting the system into the U.S. will really start to see acceleration of our program. Geoff commented and you just noted that the EXPAND URO study is on track, and we’re very excited in speaking with our investigators there, and they’re enthusiastic about the product and the program. And so that continues forward. We’re not going to give time lines of U.S. approval for that, but I will tell you it’s proceeding according to plan.

And then as Geoff noted, we’re very excited about the hernia IDE approval, which allows us to take a big step in the general surgery more quickly than we had anticipated and to start to engage the general surgeons with Hugo here in the United States in a segment where we are very active today. Of course, we have a large business and sales channel in the area of hernia repair. There’s a real hunger for capacity and a growing volume there in hernia in the United States. And so now running these IDEs in parallel will allow us to start to really pick up momentum as we contemplate the entry into the U.S. market. So we are on plan. I’m not giving specific dates for approval yet, but also very excited about the opportunity to move into general surgery and in with the general surgeon with this hernia IDE approval.

Vijay Kumar: That’s it. Thanks, guys.

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