But the market is so vastly underpenetrated. And with the products that we have today and the products we are expecting to launch, we expect to continue to grow even in that new population, so expanding the market with MDIs and more competitive conversions. So we’re looking forward to growing that business outside the U.S. even further.
Larry Biegelsen: That’s helpful. And John, CMS is hosting the MEDCAC meeting, I think, on May 21, on outcome studies in – for devices in type 1 and type 2 insulin intensive patients. What are your expectations for the meeting? And specifically, what could this mean for the potential pump and TD review? Thanks.
John Sheridan: I’ll let Leigh answer that.
Leigh Vosseller: Yes. So Larry, it’s interesting, right? So we see this as a very positive move, the fact that they are reviewing the endpoints and inviting the diabetes community to come in and speak about it from the manufacturer’s perspective. And so people guarantee that we’re going to have representatives there talking about the wealth of data that we’ve accumulated and what we think is the best way to look at those endpoints. And we think it’s positive because that NCD is sitting out there and it’s expected to be reviewed. And so we hope that this is a positive step in that direction that we’ll hear something on that in the near future. But for now, there’s nothing that directly tied, but we’re optimistic that this will be beneficial for us in the long term.
Larry Biegelsen: Thank you.
Operator: Thank you. One moment for our next question. And our next question comes from the line of Danielle Antalffy from UBS. Your question, please.
Danielle Antalffy: Hi. Good afternoon, everyone. Thanks so much for taking the question. Congrats guys on this quarter, it’s great to see, excuse me. Leigh and John, just a question on what you’re seeing from a market growth perspective. I mean we all run surveys. Our survey is actually quite bullish on what we’re seeing from a market growth thinking installed base more than anything perspective here in the U.S.? I mean based on our survey, it looks like it’s tracking high teens, which I know sounds quite high relative to historical averages. Any comments there? I mean, are you seeing acceleration here given the number of integrated pumps out in the market, how technology has evolved over the last 5 years? Any comments there would be helpful. And then, of course, how sustainable that is? Or could it actually accelerate even further?
Leigh Vosseller: Yes. Great question, Danielle. And it’s really hard to put a fine point on the numbers specifically, trying to triangulate what everyone’s reporting based on that information. But what we think today is by the time we exited 2023, that pump penetration had grown to nearly 40% in the type 1 population, and that was up from mid- to high 30% range in 2022. And so the market has seemed to have grown every year probably since about 2018. And we point to the advancement in technology. So if you think about the CGM advancements, you think about the algorithm advancements. And so we have every reason to believe that with the new product portfolio that we’re offering, that will continue to grow in the future. And so we have great expectations for what this portfolio that we offer will bring to the market and how we’ll be attracting new patients. And so we expect continued growth in 2024 and the long term.
Danielle Antalffy: Got it. Thanks so much for that. And how important to that growth is the business model here. So you guys are – it looks like making progress on the pharmacy channel. But how critical is that piece of it? Thanks so much.
Leigh Vosseller: Yes, I do think it’s important. There’s a couple of factors. I mean, one really is the product portfolio, particularly for us, as we continue to offer choice and variability, it gives people – we’re going to be meeting the needs of more people who haven’t chosen pump therapy before. So to flip that around from a second ago that 60% of type point, 60% of almost 2 million people haven’t chosen pump therapy today. So we’ve got to figure out how to meet the needs of what they want in order to use from a product perspective. The business model will certainly complement that because improving the access, lowering the out-of-pocket will make a great difference in affordability for people. And so that’s why we’re focused on both pathways. And I think that they will work together to drive business for us and grow the market overall.
Danielle Antalffy: Thank you.
Leigh Vosseller: Thanks, Danielle.
Operator: Thank you. One moment for our next question. And our next question comes from the line of Matt Taylor from Jefferies. Your question, please.
Matt Taylor: Hi. Thanks for taking the question. I was hoping you could spend a minute on type 2 and maybe give us an update on what you’re seeing? Any type 2 trends. I’m curious what you would say to an investor who might be worried about GLP-1s impacting the type 2 opportunity. And then given you have now enrolled your trial, could you talk about when the data could come out, what that could show in the potential for type 2 to be a growth driver in the future?
John Sheridan: Sure. Well, Matt, I think recently, we just published some data from an early study we did on type 2. And there was a significant percentage of the people in the study were using GLP-1s. And when they started the study, they had to be on them for at least 6 months and they had to have insulin intensive type 2. And all of them were using MDI and none of them were achieving their diabetes objectives. They all had high A1cs. And after they started using Control-IQ, they actually required less insulin, and they dropped their A1c substantially. So we believe that Control-IQ, the AID systems that are out in the marketplace today, and when it comes to the type 2 population or complementary to the use of the GLP-1s. And I don’t think we believe that it’s going to have a substantial impact on the need for insulin, particularly in these groups where they do use a lot of insulin.
I would say that the study is – as you say, it’s nearly complete – it’s nearly enrolled. It’s a 3-month study. We’re certainly going to try to get through it as quickly as we can. I think that it’s possible that at the end of this year, when you look at some of the fall conferences that we might have some data to present at those. But we’ll just have to wait and see. There’s some unpredictability about it. But I think that we are definitely getting ready internally. We’re preparing the organization, we’re developing our commercial strategy, and we’re definitely getting ready to be very active in the type 2 space.
Matt Taylor: Thanks for that, John.
John Sheridan: Yes.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Joanne Wuensch from Citi. Your question, please.
Unidentified Analyst: Hey, good afternoon. This is Anthony on for Joanne. Thanks for taking our questions. On the guidance for EBITDA breakeven this year, does that imply some sort of volume or user base going through Mobi to hit that, just given the lower COGS profile? Or are you sort of able to hit that irregardless [ph] of what – how many patients you’ve got on Mobi this year?
Leigh Vosseller: Yes, great question. So Mobi is unique in this year and that – not unique necessarily, but because we’re at lower volumes and still scaling, we’re not going to see that great gross margin benefit that we expect to see in the years beyond. And so this year, at the beginning, it’s a bit of a headwind. In the back half of the year, it starts to become accretive, but really 2025 is when we expect it to make a difference. And so I would say that our goal of breakeven this year is somewhat independent of Mobi in the first scaling phase. But we’re monitoring closely, and we’re also paying attention to our investments to make sure we’re investing in an appropriate way to drive the top line but still achieve that breakeven target.
Unidentified Analyst: Got it. Helpful. And then can you just talk about what you’re seeing in the competitive environment, OUS, just as Omnipod 5 to ramp a little bit more here? Thanks.
John Sheridan: Yes. I would say that the competitive environment OUS is within our expectations. I mean we certainly – there’s – the two large players are on the market and have been in the market for a while. I think that Omnipod is getting into new markets. We also – there’s also another competitor out there, Ypsomed [ph] that’s getting into the markets as well. There’s more noise, OUS for sure. I would say that there’s also a lot of variability because it’s not homogeneous. There’s multiple different markets and the competitive environment is different in many of them. So I think that right now, what we’re focused on is really getting our technology into the OUS markets. We’re really focused on bringing everything that we’ve got here in the U.S. to the OUS markets as quickly as possible.
We think that will be a significant competitive response to what’s going on there. And so there’s things happening this year and next that are exciting. And we’re also expanding the size of our footprint, OUS by adding people in the markets who are in country, who can support the distributors and also work closely with our KOLs, so that people are aware of the technology and the company’s goals in terms of where we’re going. So I know it’s a really important market for us. I think that we’ve got a lot going on. We’re excited about it and stay tuned.
Unidentified Analyst: Thank you.
Operator: Thank you. One moment for our next question. And our next question comes from the line of Jayson Bedford from Raymond James. Your question, please.
Jayson Bedford: Good afternoon, and congrats on the quarter. Leigh, I thought I heard you mention some benefit from U.S. customers waiting for Mobi. And I got the impression that this was separate from the Mobi Choice dynamic. I guess, first, is that correct? And if so, is there a way to quantify this benefit? And then I’ll ask my second one upfront here. Typically, you give an installed base of users? Do you have that number for this quarter? Thanks.
