All right. Good morning. I think we'll get started here. My name is Jeff Johnson. I'm the Senior Medical Technology Analyst at Baird. Our first presentation this morning is from Insulet Corporation, a leader in the $3.5 billion global insulin pump market. With us today from Insulet, we're happy to have Chief Financial Officer Ana Maria Chadwick and Chief Product and Customer Experience Officer Eric Benjamin, as well as VP of IR Deb Gordon, out in the audience. Ana—or no, Eric, I think I'm gonna turn it over to you for a few minutes if you have a couple prepared remarks and slides to go through, and then we'll go right into Q&A for the remainder of the time. Thanks for being here.
Perfect.
Yeah.
Jeff, thank you. Good morning, everybody. It's a pleasure to be here. My name is Eric Benjamin, Chief Product and Customer Experience Officer for Insulet. I'm gonna make a few forward-looking statements. At Insulet, our mission is to improve the lives of people with diabetes, which we do through our unique Omnipod platform. You can see Shepherd and Emmett wearing Omnipod on their abdomens there. It's a small, wearable, fully disposable device that automates the delivery of insulin. It picks up a signal from a partner's continuous glucose monitor and modulates insulin every five minutes to deliver superior clinical outcomes and improved quality of life. The unique advantages of Omnipod include its disposable tubeless form factor.
It's available affordably in a pay-as-you-go format through the pharmacy channel in the U.S. and in many markets around the world, can be controlled with a compatible smartphone and is cloud connected. Together, these advantages made it the number one most prescribed automated insulin delivery system in the United States in 2023, and the patient-preferred automated insulin delivery system in 2023. It was also the most chosen automated insulin delivery system for those adopting technology for the first time in Europe, on the strength of just two markets that we'd launched in the U.K. and Germany. We are bringing the benefits of automated insulin delivery technology through Omnipod to large, under-penetrated markets. We operate in 25 countries around the world today, helping us reach approximately 14 million people around the world who live with insulin-requiring diabetes.
We think of those markets in different segments, because they're at different levels of adopting technology and bringing the benefits of automated insulin delivery to people who live with insulin-requiring diabetes. The most mature market is here in the United States, the U.S. Type 1 market, which we estimate to be approximately 40% penetrated. Our focus from our founding more than 20 years ago has been to bring the benefits of technology to those who are not yet using it, and so that's the 60% of people who live with Type 1 diabetes in the U.S. who are still taking multiple daily injections. Outside the U.S., in the markets that we serve today, we estimate that the Type 1 market is about 20% penetrated, so approximately half what it is here in the United States.
As I mentioned a few minutes ago, we've brought Omnipod 5 to just two of those 25 markets so far in 2023, an additional two in the second quarter. So we're now in four markets internationally and are leveraging the benefits of Omnipod 5 to drive penetration internationally. Excitingly, two weeks ago, we received clearance from FDA to market Omnipod 5 for those who live with insulin-requiring Type 2 diabetes here in the U.S. That's the next two market segments that we think about, approximately 2.5 million folks who live with insulin-requiring Type 2 diabetes and take multiple daily injections. We estimate that that market's less than 5% penetrated, and another 3 million-4 million folks who take basal insulin each day. Over time, we'll be bringing the benefits of automated insulin delivery through Omnipod to both of those segments.
Additionally, there are more than 3 million people that live with insulin-requiring Type 2 diabetes in the global markets that we serve, which is a future growth opportunity for Insulet. Our market-leading technology in large, under-penetrated markets has given rise to strong fundamentals. Over the last five years, top line revenue has grown at an annual rate of approximately 22% and will be a $2 billion business at the high end of guidance this year. Gross margin has expanded by almost 400 basis points over the last five years, and operating margin has expanded by more than 700 basis points in the last five years. Close with a couple quick updates on the business from the second quarter and recent catalysts. We announced strong results on our second quarter call last month. As a result, we increased guidance down the P&L.
So top-line revenue now 16%-19%, gross margin at the top end of our guide at 69%, and operating income at 14%, which is about 300 basis points improvement on a normalized basis from 2023. We also announced a number of recent catalysts that give us confidence and excitement to continue to bring the benefits of Omnipod and drive growth. We announced the launch of Omnipod 5 for those who live with Type 2 diabetes just two weeks ago. We announced the full market release of Omnipod 5 with G7 in June. We announced that we'd entered France and the Netherlands in June, and that we had brought our integration of Omnipod 5 with FreeStyle Libre 2 Plus, the first 2 Plus integration outside the U.S. to the U.K. and to Netherlands, also in June.
And finally, we just began producing pods at our new Malaysia manufacturing facility. In addition to recent catalysts, we've got a few upcoming catalysts that we're excited about. The much-anticipated iOS app for Omnipod 5 will be available to all customers here in the U.S. in October, and the integration of Omnipod 5 with FreeStyle Libre 2 Plus will be available here before the end of the year. Internationally, we'll be bringing the benefits of Omnipod 5 to the next tranche of markets, including Italy, the Nordics, Canada, Australia, Switzerland, Belgium, throughout 2025, and we'll also be bringing the integrations with G7 and FreeStyle Libre 2 Plus to global markets throughout 2025. So we are incredibly excited about the future of bringing the benefits of Omnipod to global markets and look forward to taking your questions.
All right, wonderful. So why don't we jump right into Q&A? And, from that small presentation, you covered about half my questions, so we can, I can cross those off the list. And, from last week at Wells, a certain analyst there, he badgered you enough on 2025 and third quarter and all that, so we can, maybe, maybe zoom out a little bit, higher level here. You know, as I look at the stock, the run the stock has gone on since the Type 2 indication, really over the last three months or so, stock has been up nice. You know, I think from here, from the two twenties now, your next path higher probably has to be focused on three things, I would think. You know, Type 1 is almost opening poker stakes right here.
We know the Type 1 market's going well. You guys continue to take share, but from here, the increment to me has to be probably Type 2, margins, and international, and those are the three things maybe we'll focus the first five or 10 minutes on here, so let's start on the Type 2 opportunity. You showed there U.S. penetration of Type 2, probably under 5%. You know, the pushback I get from investors, and I think it's the wrong pushback, but the pushback I get from investors is, theoretically, we've had reimbursement out there for Type 2 for years now in pumps, and we're at 5% penetration. So now, just because you get an on-label indication for Type 2, how does that really change things?
It's a great question. The first answer is our SECURE-T2D data that we presented at ADA. So at ADA, we presented the largest, most diverse study of diabetes technology in people who live with Type 2 diabetes, and the results were tremendous. The results showed about a 0.8% reduction in A1C headline and up to a 2-point A1C reduction for those with A1C over nine. Additionally, this was a really diverse study. So we had folks of all economic ranges. We had about 55% of the people in the study who were on a GLP-1, and we had 20%-25% of the folks in the study who were using basal insulin, not multiple daily injections. The strength of that data, we can now bring to HCPs in the U.S., and it is really strong data.
What we see in the market from having been the market leader in Type 2 with DASH and having seen some off-label use of Omnipod 5, it is, it really is a case where each healthcare provider has to experience success of offering technology to those who live with Type 2 diabetes in their own office. Once folks see that success, they'll do more of it. The data gives our team the opportunity to go have that conversation, talk about the data, and encourage folks to try it. Until now, it's been the other way around.
Until now, there have been, you know, 10,000 -ish endocrinologists, those who support endocrinologists, deciding one by one who's gonna try offering automated insulin delivery to somebody who lives Type 2, with Type 2 diabetes, and we couldn't really influence that conversation. As of two weeks ago, with Omnipod 5 on label, we can bring the strength of the SECURE-T2D data to all of the HCPs with whom we partner, encourage them to try it, and we know from real-world experience and from SECURE-T2D, they're gonna experience success.
Yeah. No, that makes a ton of sense, and I think, you know, what's interesting to me is, you know, I think some investors hear that, and they're like, "Okay, you're gonna go up, go out and push that. Is it really gonna work or not?" You know, I think back of, like, the DIaMonD trial from Dexcom in 2017, it was within the next six to 12 months after that, you kind of had that aha moment of, "Wow, we got to get all of our Type 1s on a CGM." I think to the mobile data from Dexcom on Type 2 and basal only, you know, even some of the AID data, once Control-IQ was out there, 670G was out there, and you started to see really good real-world data. All of a sudden, the Type 1 AID market took off.
Obviously, Omnipod 5 launching in mid-2022 helped that quite a bit. But it, I think there are precedents out there for. Docs are busy. If they don't have the data in front of them, they don't see tangible evidence that this is something they should be doing, but once they see that, you know, they internalize that, then they do change their behavior. I mean, is that a six-month process, a 12-month process? Should we think of 2025 seeing a real contribution from Type 2, or does it take longer than that? Yeah, just how to think about that, I guess.
So, Jeff, we think about a couple of things. We know that the folks who've already been prescribing Omnipod 5 to those who live with Type 2 diabetes off- label, and were experimenting with it, they're gonna do more pretty quickly, and we expect to see that. We also know that our direct-to-consumer advertising is gonna be a little bit more efficient now that we can have the right conversation with folks who contact us. So for the last two years, we've built tremendous capabilities to do direct-to-consumer advertising. For the last two years, when we've had an inbound request about Omnipod 5 from somebody who lives with Type 2 diabetes, we had to pivot that conversation and talk about DASH, because we could not talk to an inbound lead about Omnipod 5 if they lived with Type 2 diabetes.
We can now have exactly the right conversation, help them get Omnipod 5 and all the associated benefits. So we know that our DTC will also offer us a short-term benefit. I think. So all that to say, there are some short-term benefits that we'll see. Again, we're a recurring revenue business model, so those benefits are gonna help us drive new customers onto Omnipod with some, you know, call it smaller impact in the short term. I think the point that you're getting to is, you know, what does that look like over time? And the way we think about it is, we're at the very early stages of adoption, where we need to go help healthcare providers appreciate that folks who live with Type 2 diabetes should see the benefit of technology.
We're probably gonna have to show them the SECURE-T2D data a few times in every office, and then they're going to prescribe it to a couple of folks. We've got a very specific patient profile that our sales team is gonna go help our HCP partners try this on first. That's folks with A1C more than eight, who are already on a CGM, who are not getting the outcomes that they're seeking. What we know about that patient is it's the person who's already using some technology, who's looking for better, and for whom it's a pretty small change to just get onto Omnipod 5.
And we know from SECURE-T2D, they're gonna experience great clinical outcomes and improved quality of life. So we will do that office by office, and we expect each HCP to have to try it, as you said. That'll take a few quarters until that flows all the way through. In our business, again, because we're a recurring revenue business, that'll take, you know, longer until that starts showing up in revenue.
Yeah. No, that makes sense. And then, those efforts starting now, though, we kind of start the clock on some of those trials, give it a few months, how's the patient react? Okay, now I add a few more patients, things like that. We're kind of in that early stage of trialing that now or in the next month or two?
That's exactly right. So our team hit the ground running two weeks ago. We were ready to go, and our field team has been out beginning to share the SECURE-T2D data with the folks that we call on today, so that has begun. Oh, sorry, just quick build, if I may. In addition to those efforts in direct to consumer, we will also expand our sales force to make the most of this in 2025. That's a incremental expansion for us, so it'll be taking the commercial model that we know works well, that we have experience with.
We'll be expanding it a little bit into some folks who are not endocrinologists, but they're high decile writers of both rapid-acting insulin and CGM. So we know that they are good candidates to bring technology to those who live with Type 2 diabetes. We'll begin that expansion in the fourth quarter so that it can have impact in 2025.
Great. And maybe Ana Maria, I'll bring you into the conversation here on the Type 2. You know, we look at... the thing I love about your business and similar businesses to yours is that we can kind of track those new patient starts and get a good feel for kind of what the next 12 months of revenue should be, based on just how your new starts have trended over the last few quarters. Should we think of type two, which, you know, I know you've been adding 10% or 15%, 20% of your starts, depending on the quarter, is Type 2, but an uptick in T2 here, should that really be additive to that growth rate?
'Cause it feels like you have, you know, not to put words in your mouth or to push you on 2025, but it seems like you have, you know, close to 20% U.S. Omnipod growth already in the books for next year, based on the new starts here over the last few quarters. Obviously, we need to see how the second half turns out. But should Type 2 be somewhat additive to that? Do we just think of you need Type 2 to support, continue supporting that strong growth? Just how to think about the contribution.
Yeah. No, it's a great question, and the strength that Eric just mentioned here makes us feel very confident that this will be additive. We should expect that now that we have this new addressable market, that we can truly lean in to be a tailwind for us. So we feel really good with where we're sitting here in the second half of the year. As we've talked about, we're gonna see sequential growth, quarter-over-quarter of new customer starts in the U.S., and we anticipate the second half of the year, new customer starts in the U.S. to be stronger or higher than the second half of 2023, and this new information of Type 2 indication being expanded earlier than we thought is just gonna be a tailwind to that.
Yeah, fair enough. And then, I had one other question on Type 2. Oh! Just, you know, we talked about 40% penetration. That lines up pretty good with my numbers as well on Type 1 in the U.S. for pump use. You know, I think in the past, you guys and some of your competitors have talked about maybe 60%-65% being the upper bound of what you'd expect, at least in the short run, on pumps. I think we all think it could maybe go higher than that over time, given the outcomes we're seeing with AIDs and T1s. But from 5% in Type 2, you know, over the next one to two years, where do you think that could go, penetration-wise, and over the next maybe three to five years? Either one of you, I guess. Where do you think that could go? U.S. Type 2.
Yeah. So look, as we showed on the chart, we're very in the very early innings of the U.S. type two market, and so we think about that continuing to rise, and it'll be hitting, you know, sort of the, it'll be continuing to steepen that growth trajectory over each of the next couple of years, so we see it accelerating over time. Haven't yet put out a number on where we see that going in the Type 2 market. We've actually said we see type one getting to more than 70% in the U.S. over time, as it has now been shown to be standard of care.
We see, you know, the same kind of opportunity that, as automated insulin delivery is shown to be standard of care for Type 2, we're gonna keep driving penetration in that market and keep accelerating.
Would it be crazy at some point? I mean, we've seen, you know, pump penetration pre-AID. So if I go to 2019-ish or so before Control-IQ launched, before O5 launched, we were probably adding less than a point of penetration a year to the Type 1 market in pumps, somewhere in that ballpark. My math for this year, if the second half turns out the way we model the market, is you're probably gonna add, you as an industry, probably gonna add 4 -5 points of penetration this year. It might be a little high, but four, pretty solidly. Is it crazy to think in the next few years, Type 2, you could start seeing multiple points, 3-4 points of Type 2 penetration per year?
I think two things on the way we think about that. The first is we are excited to see penetration rise in Type 2. That will be fueled by Omnipod 5 and SECURE-T2D. There are some strengths of Omnipod 5 that are even more pronounced in Type 2 than they are in Type 1. The affordability through the pharmacy channel, the ease of use, the pay-as-you-go, are all strengths in Type 2. So short version, we see rising penetration, and we see continued success for Omnipod as penetration rises. I think what to the conversation that we started here, what we don't know is how long that's gonna take until we hit the same sort of steepness
Yeah
... as we're now seeing in type one. We know we have work to do to go to each of our HCP partners, show them the benefit of SECURE-T2D, get them the experience prescribing technology to those who live with Type 2 diabetes, and we know we're just earlier on the penetration curve. So what we know is we're gonna work up that penetration curve. We're gonna see adoption increase. We don't yet know exactly how fast that's gonna go.
Yeah, fair enough. All right. I wanna move on to the international and the margins, but each time you answer a question it brings up another question in my mind, and that is, just from a competitive standpoint, you know, I think, to be fair, we've seen some okay, I don't know how great, and we'll talk tomorrow to Tandem and push them a little bit on traction they're having with their Mobi device and things like that. But, you know, we've been a big proponent of patch pump being the form factor that is preferred by a lot of patients out there. You guys are the only patch on the market right now. Do those benefits of patch over tubed pump play even more so in the Type 2 market?
Again, not asking you to comment on your competitor's product, but do you think there's a place in Type 2 for multiple players, or do you think this will truly be kind of dominated, however you would define that, by a patch?
I think what we see is that there are a lot of benefits to the tubeless patch form factor. That's why we enjoy leadership in the Type 1 market today, and we see those benefits as even more pronounced in the Type 2 market. You know, just some data points, you know, we were able to enroll our SECURE-T2D study and show great outcomes in a very real world, very diverse population, and in large part because of the ease of use of Omnipod 5. You know, there were some heartwarming stories as we went through that, as there always are, both from patients, but actually also from healthcare providers, who were frankly surprised by how well a really diverse population of folks living with late-stage Type 2 did on technology.
And in part, that's because when healthcare providers still picture pumps, they're picturing legacy technology. They're picturing tubes, and they're picturing capital equipment, and they're imagining a $1,000 outlay for a person with diabetes, which is really hard if you're somebody living with Type 2 in an economically disadvantaged socioeconomic situation. So again, we've got a lot of benefits in Omnipod 5 that are even more pronounced as we bring Omnipod 5 to those who live with Type 2 diabetes and show what technology can do for that large market.
Okay, I'm gonna hold myself to two and a half minutes on the other two topics, so we have five minutes at the end for other questions. But, Ana Maria, maybe on the international, you know, you started the year at 7%-10% constant currency guidance. We're now sitting at 18%-21% constant currency guidance for the year. Obviously, you've seen a significant uptick in traction for Omnipod 5 in the U.K., Germany, as Eric mentioned. You've been in France now for a couple of months. You know, I guess, one, the numbers speak for themselves, but how are doctors and patients reacting to Omnipod 5 there? And how much staying power?
Has this been a, you know, inventory channel fill and initial backlogs you're kind of eating through, and then we'll normalize to something below this kind of 20 -ish percent growth in as we get into next year, or is there some real sustainability here on a multi-year basis?
This is great question, and international has been an incredible pleasant surprise for us. When we started the year, my first quarter here, we raised guidance 500 basis points for the full year, and when we finished here the second quarter, we raised guidance again another 600 basis points. So what that's telling us is, everywhere we're going with Omnipod 5, we're winning. And the other thing that it tells us is, that the rate and pace in which we saw that adoption come in much faster than, of course, we anticipated and guided to.
So what that tells us for 2025 and beyond, and I'm not gonna here provide guidance for 2025, we're gonna do that as we wrap up 2024, is that we're gonna be in more markets doing the same play we just did with U.K., Germany, and we're at the early stages here in France, and of course, Netherlands being a bit of a smaller market. We're gonna go to Italy, we're gonna go to Nordics and other markets, and I anticipate that same tailwind to continue.
All right, fair enough. And then, I think there's six or seven markets you've talked about entering in 2025. You're in 25 markets today outside the U.S. You know, one, how do you quantify those six or seven markets? Are they, on a combined basis, equivalent to U.K. and Germany, something like that? Just trying to gauge the size of that opportunity, number one. And number two, you're in 25 markets. That's, you know, significantly fewer markets than we see for a Medtronic or something like that with their pump business. Obviously, there's a lot of cost, and companies today paying attention to returns on being in some of those smaller markets. But how do you think about expanding that geographic footprint beyond 25 countries over the next, you know, couple, few years?
Yeah, so, great question, and there's two very distinct paths here. First is launching Omnipod 5, increasing sensors of choices in the existing markets. We're very active with DASH, and we're gonna be launching Omnipod 5. Then. And that's where we're gonna be, the Nordics, Italy, and some of those others where we currently have a presence, and we're just expanding our product offering. The second part of your question is expanding beyond those twenty-five or so markets. There, I would.
The main thing that we look for is, we look for being the right market, and those are much higher lifts, not only in effort, in decisions of sales force, direct, indirect, and so on. So you would see that happening at a much slower pace over time. We haven't announced yet specific new markets, but that's in the queue, and we're gonna be working that in 2025 and beyond.
Okay, and just to size again, those six or seven that you plan to launch into in 2025, are they, in aggregate, as big as U.K. and Germany, half the size of U.K. and Germany, just in the aggregate opportunity going in there?
Yeah. Maybe, Eric, do you wanna chime in here?
Yeah, reasonable to assume pretty similar-
Okay.
to U.K. and Germany.
Okay, so as U.K. and Germany have been big contributors, those countries in aggregate could be good contributors.
They'll be good contributors.
Yeah, fair enough. All right, and then on the margin side. So, the first question, you know, on the slide you had up, Eric, and maybe this is for Ana Maria, but the slide you had up, you know, fantastic margin progression over the last five years or so. But if there was one thing I was gonna pick on, when you went from, I think, 12 something, if you had it in front of me, I'd remember now, but 12.5% down to 9.5% margin from 2021 to 2022 before going back up to 13% in 2023. And 2022 happens to be that year where you launched O5. That was a big launch year. Obviously, you had to put resources in the field to launch O5.
I mean, the returns on that launch have been fantastic, but it did drive margins down in the short run. You know, do we have to think about anything, worry about anything on the Type 2 launch, where you're gonna be overspending initially to drive that initial traction? You know, yeah, I guess I'll just start there. Can 2025 still be a solid margin expansion year, even though I know we're not talking specifics?
Yeah. So, I'll start that. 2025 should continue to be a solid expansion of margin. Again, we're not guiding to the specifics. First of all, we're of a different scale than we were back then. Second, as Eric pointed out, our strategy on how we're gonna launch that Type 2 starts with those current calling points that we have and grows from there. So you'll see that gradually move, and at the same time, we're growing our top line. So the leverage we should get out of that should allow for some margin expansion as we move here in 2025 and beyond.
Okay. And I think, you know, if the investors in this room are similar to the investors I speak to on a regular basis, probably half of them will want that 200-300 basis points a year, and half of them want you to reinvest some, drive that top line. If you do 100, 150, that's more than enough. You know, where do you where. And I know you guys haven't had an Analyst Day in a while, an LRP out there, and so it's a tough question to answer necessarily, but just your view
Yeah
... of what's the right balance you strike between top-line growth, sustaining something, you know, probably in the upper teens, I think, is what the minimum you'd have to do at this point for where your stock's at valuation-wise, sustaining that top line versus delivering, letting more flow through to the bottom line?
It's a great question, and it's the debate we have with management constantly, and it's the rate and pace in which we want to invest in ourselves, and I'll tell you, we wanna go as fast as we possibly can because investing in Insulet is the highest return we're gonna get, so we'll continue to balance that. We have put out there as a flag that anticipate 100 basis points of up margin expansion. That has been kind of that guide out there, and I feel with the growth that we've been having and the growth that we're anticipating continuing to have, that that should be a minimum floor that you should anticipate continuing out there from a margin expansion, and again, we'll provide more color as we progress here in 2025 guidance.
All right, perfect. And in our last couple minutes, I guess bigger picture question for you, Eric. As we've seen, you know, I kind of alluded to it earlier, that we were penetrating maybe half a point to a point a year in the U.S. T1, more like or more recently in the 3-4 to 5 point range or so. Is there any capacity issues or constraints or anything? You know, I think new patient add, new patient adds across the market in the U.S., so you plus others, have probably pushed 100,000 new patients going on a pump a year, the last year or over the last 12 months. That's up decently from even all of 2023 and definitely up from 2022.
Do we reach a point where you just can't physically add more than 100,000 patients, for example, to the U.S. market in a given year because of just how much training time or endo office visit capacity, however, to think about that?
I think the way we think about it is there are. Because of a combination of factors, there is a rate at which penetration is gonna rise, and we're definitely in the steep part of that curve. Whether we're exactly in, it can't go higher than here, you know, we don't have a strong perspective on that one way or the other. What we see is continued strength in the Type 1 business, 'cause we're only 40% penetrated, and we're on our way to 70+, now that we've shown that automated insulin delivery should be standard of care, led by Omnipod 5. Look, there are some real factors. You know, you hit on it. Endos are very busy. There are less and less endos over time. We have offsetting strengths.
The simplicity of Omnipod lets community endos, some NPs, and some GPs even prescribe Omnipod 5. In the first quarter, there were about 20,000 HCPs that wrote a script for Omnipod 5 in a market where there are 7,000-8,000 endocrinologists. And so again, some of the unique simplicity benefits of Omnipod 5 give us the opportunity to make sure that we can go get technology in the hands of folks who want it.
Okay, and last question in the last 50 seconds. So there's been a couple patch pump competitive products approved here just in the last week or two. Obviously, small companies that probably don't have the resources. They're not linked fully with algorithms to be true AIDs, things like that, so really no concern there. But, you know, every tubed pump company is trying to get to patch. You guys aren't trying to get to a tubed pump, as far as I know, anyway. So, you know, it tells you where interest in the market is going.
So what do you do? You know, my guess, and I'd love to hear if you agree with this, kind of it's probably not until 2027, that maybe a true AID, algo-driven, patch pump competitor is out there, whether that's Tandem, whether Medtronic gets back into the market over the next couple of years. But you've probably got two or three years, but what do you do in two or three years? Is there a competitive offset there? What's pod gonna look like, Omnipod gonna look like in a few years that differentiates from other patches that'll come to market?
Maybe three quick perspectives. So first, we agree the future is tubeless, and that's what we are all in on bringing the benefits of tubeless AID to people around the world. The second thing, we have a very large and sustainable competitive advantage in the manufacturing infrastructure, cost and capability, cost structure and capabilities to produce tens of billions of high-quality, safety-critical Omnipods every year. It's really hard to build that scale, and we've got two decades of experience getting to where we are today. In terms of what we do from here, it's building out the whole Omnipod 5 platform, sensor integrations with both of our terrific partners, phone control on both Android and iOS, and then it's improvement in automation.
We ran a study outside the U.S. at the end of 2023, doing some early clinical research on enhanced algorithms, presented that data earlier this year, and announced at ADA that we have two more trials coming, one testing fully closed loop in those who live with Type 2 diabetes, and one that will be an iteration on the automation provided with Omnipod 5. So from here, Jeff, we focus forward.
All right. That is great. We are out of time, so we'll leave it there. Please join me in thanking Ana Maria and Eric for a wonderful presentation of pod here, and the next presentation is set to begin at 9:05 A.M. Eastern Time, including Cardinal Health, Align Technology, Penumbra, and Oculis Holding. Thank you.