Insulet Corporation (PODD) Earnings Call Transcript & Summary

September 7, 2023

NASDAQ US Health Care Health Care Equipment and Supplies conference_presentation 34 min

Earnings Call Speaker Segments

Larry Biegelsen

analyst
#1

Good morning. I'm Larry Biegelsen, the medical device analyst at Wells Fargo. And it's my pleasure to host this session with the management team from Insulet. With us, we have: Jim Hollingshead, the CEO; Wayde McMillan, the CFO; and Trang Ly, Senior Vice President and Medical Director; also in the audience, Deb Gordon, Investor Relations. So in terms of format, it's going to be a fireside chat. If anybody has a question, please raise your hand, we'll come around with a mic. Jim, Wayde and Trang, thanks so much for being here.

James Hollingshead

executive
#2

Great to be here, Larry. Thank you.

Larry Biegelsen

analyst
#3

So let's start with the GLP-1s. The updates on GLP-1s are more and more positive each day, it seems. So Jim, can you please remind us of Insulet's stance here?

James Hollingshead

executive
#4

Yes, I just want to back up just in case there are investors in the room that don't know us very well. We're the world-leading provider of insulin delivery therapy in the form of the only FDA-approved wearable patch pump. Our flagship product, the Omnipod 5, is the only patch pump with automated insulin delivery, has proven to be a huge revolutionary product just as we hoped it would be. We're coming off of a fantastic Q2, where we have record new customer starts. We had 32% global growth and a U.S. growth number of 41%, which is the fourth straight quarter of U.S. growth that starts with a 4, with a 40%-plus growth in the U.S. We're very excited, we have the best competitive position we've ever been in. And we have a bunch of innovation coming. We also have just launched our Omnipod 5 product in the U.K. and Germany. So we're really excited about where we are. We're in a great competitive position. And we have tons of growth in front of us. The GLP question is the inevitable question, so I wanted to get those things out first. So with GLP-1s, first thing we'll say is that we're really happy to see innovation in the diabetes space. We think that the ongoing pharmaceutical innovation in the space is really good for the same customers that we serve. We get up every day to help people living with diabetes. Type 2 diabetes, in particular, is an incredibly difficult condition to live with. And that's why we're working so hard to reduce the burden of managing diabetes for people living with type 2 diabetes. We have on-label products, two on-label products for type 2, people with type 2 diabetes in Omnipod DASH and Omnipod GO, which we have a pilot with, which we've announced. And then Omnipod 5, we're in pivotal trial. GLP-1s, we think they're a great innovation, but they don't impact our market in a reasonable time frame. And the reason for that is at least twofold. The first is the magnitude of type 2 diabetes is enormous. So if you think about the size of the problem, the worldwide health care problem, or just take the U.S., you have more than 100 million people, somewhere between 100 million and 200 million people in U.S. who are obese. You have almost 100 million people who are prediabetic. And that condition continues to just progress. Once you're on that train, you're on that train. And the way we think about that and the way we've talked about it is that it's been a tidal flood. It's basically been floodwater level of epidemic with type 2 diabetes. People come on to that flow and they slow down and they end up in two pools that are relevant to insulin delivery. They end up at the end, at the late disease, they end up in a pool where they need intensive insulin, which is both basal and bolus. In the U.S. market, that's about 2.5 million people living with that. One step upstage of that or one pool before that coming out of the flood, people end up on basal or daily -- a basal rate daily insulin dose. That's between 3 million and 4 million people. We're usually conservative in how we talk about market numbers. We usually say 3 million, but it's between 3 million and 4 million people. This year, we're going to put several thousand people on Omnipod 5. And so the market need is just enormous. So the magnitude is huge. And the disease continues to progress. And so I'm actually going to turn to Dr. Trang Ly, who will talk about the clinicals on this. But we know the disease continues to progress. And so within any reasonable time frame, even if GLP-1s are wildly successful -- I mean, we're pro-pharma innovation. Even if they're wildly successful, that market need is going to remain. And therefore, for us, the business opportunity remains.

Trang Ly

executive
#5

Yes. Thanks, Jim. So I think just a few clarifying points with prediabetes, the close to 100 million that you talked about. During that stage, there's already beta cell loss. So these are people with abnormal fasting glucose levels, abnormal A1cs. And they're already in the process of beta cell apoptosis and death. And by the time you're diagnosed with type 2 diabetes, 50% of your beta cells have already gone. And so it is a progressive -- a chronic progressive disease. And what we see is an enormous market of advanced disease where products like Omnipod can deliver in terms of safe and effective insulin delivery. And so the -- in GLP-1, although highly effective in terms of glucose control and reduction in insulin requirements, it hasn't been shown to reverse the natural history of the disease. And so that's why we're so confident in the numbers and the size of the market as well as the fact that it's a severely underserved market right now.

Larry Biegelsen

analyst
#6

That's helpful. Jim, there was a little bit of a nuanced difference in your comments today versus the earnings call, when you talked about the TAM not having major -- today, you said basically, you don't think it's going to have a big impact on the TAM in a reasonable time frame, something along those lines.

James Hollingshead

executive
#7

I'm not trying to hedge off of the earnings call. But go ahead, ask me...

Larry Biegelsen

analyst
#8

What -- so you do think it will have some impact on the TAM over -- can you be more precise about over what the time frame you're talking about? I get the message, basically, it's 2.5 million type 2 insulin in terms of patients. There's probably only about 100,000, 150,000 people on a pump. So the market opportunity is still large. But I was just curious about what your message is on the long-term TAM.

James Hollingshead

executive
#9

We're right where we were with the earnings call. We don't think it impacts our long-term TAM. But there's not enough known yet. I think it's fair to say we don't know exactly. There's no molecular mechanism for the GLP-1s to reverse beta cell decline, which is what Trang has just said. It is -- I understand why investors are looking at this and saying, "Well, what happens with obesity? What happens what so on?" But the flow of that river is so enormous. You've got hundreds of millions of people living with type 2 diabetes right now around the world. The disease inevitably progresses to where some significant percentage of them need insulin therapy. And even if -- one way to look at it is the type 2 market for insulin delivery right now globally is about double potentially. As a potential addressable market, it's about double the population of the type 1 market. So even if GLP-1s were to cut -- there's nobody saying this is going to happen. But even if GLP-1s were to cut the type 2 market in half, we would still have enough market opportunity that's as large or larger than the type 1 opportunity. But nobody is talking, there's no mechanism there. So if you think about the magnitude of the problem, we've had this tidal flood of people, what we might see is GLP-1s impacting the time to progression to -- this is what people are worried about from looking at our business, time to progression on the insulin therapy. But GLP-1s have been in the insulin market really for 18 years. The original GLP-1s were approved 18 years ago. And then we had liraglutide approved in 2010 and then we had Ozempic. Ozempic has been the type 2 diabetes therapy since 2017, 2018. So we have 5 years of history of that. And whatever impact on progression, the insulin need is out there, is baked in the cake already with those GLP-1s. And if you look at GLP-1 adoption, it's gone up like a hockey stick. But insulin prescriptions are effectively flat in the U.S. And there's some -- there's also some demographic reasons around HbA1c levels in the market. So the magnitude of the market is massive. There's no molecular mechanism that stated in terms of there's no reversal of type 2 diabetes. And we're just getting started. We're going to put a few thousand people, that market is completely underpenetrated and underserved in its own therapy. And Trang, you might want to talk about some of the HBA1c numbers...

Trang Ly

executive
#10

Yes. So the point is that despite GLP-1s being on the market for 18 years now, the A1c distribution of the type 2 population hasn't changed over 20 years. So you still have 50% of people with an A1c greater than 7% and at least 15% of people with an A1C greater than 9%. This is significant for advanced disease. And it's a situation where they need a second or third agent. And often, the recommended agent at that point in time is insulin. So I think there is a sort of miss out there that is an either/or phenomenon with GLP-1 or insulin. But it's -- in actual fact, it's not like that at all. As the disease progresses, you need to add insulin therapy, especially if your A1c is rising. And like I said, despite the benefits of GLP-1 on a population basis, we haven't seen improvement in target glucose levels. And so in the market that we serve today with Omnipod products, we see patients coming from multiple daily injections requiring high insulin needs coming to Omnipod. So in 2021, we published a paper on 3,500 type 2 users coming to Omnipod DASH. And at that time, their total daily insulin needs was about 104 units a day. And we saw a 32% reduction in daily insulin with continuous insulin delivery with our pump, and then on top of that, a 1.3% reduction in A1c percentage reduction. So pump therapy is highly effective because it's able to deliver insulin in a more physiological manner. And so we today treat patients with Omnipod who were already on GLP-1. And we saw that in our feasibility study as well. So the study we published this year in Diabetes Care, 24 patients, type 2 diabetes, who were started on Omnipod 5. Half of the patients were on a GLP-1. And their timing range was increased from 30% to 62.3% if they were using GLP-1s. And if they weren't using GLP-1s, it was around 30% going up to 52%. And so what we see is that GLP-1s are a fantastic medication, and it helps that insulin work more effectively. And so we see us as very much coexisting with GLP-1s as we do today already in the market.

Larry Biegelsen

analyst
#11

That's helpful. So I think you've addressed the TAM question. Investors are also concerned about the near term, where they've heard anecdotes from doctors of putting type 2 pump patients on a GLP-1 and the patient no longer needing a pump because they don't -- they're no longer needing prandial or mealtime insulin. What can you say about that? And can you talk maybe about the churn rate?

Trang Ly

executive
#12

Yes, I think that type 2 diabetes is a very heterogeneous disease, and there's different levels of disease progression. So I think early on in the disease process, where there is still beta cell function, there is that situation where we see people coming off insulin if those insulin requirements are low. But as your disease progresses and you have more advanced disease, then you have lost that beta cell function over time. And so GLP-1s are less effective at taking people off insulin entirely at that time. So what we've seen really in the market is maybe 5, 6 years ago, we saw a lot of people on the concentrated insulins and really, really high doses, more than 200 units a day. That's becoming less common with the GLP-1s and SGLT2. And so they're coming down. And then their total daily insulin comes down from about 200 down to, say, 150 or 100. And then you put them on an Omnipod, and then you're getting a further 30% reduction in total daily insulin as well. So that's what we're seeing in the market is that still an enormous need for people requiring insulin in that advanced disease. And really, what people fear is weight gain and hyperglycemia. And I think that products such as Omnipod 5 with very, very low hyperglycemia and essentially weight-neutral in our studies, have enormous potential at helping this severely underserved market.

Larry Biegelsen

analyst
#13

Anything you could say about churn?

Wayde McMillan

executive
#14

Sure. Happy to pick up on that for you, Larry. And I think Trang covered the clinical side of it really well there. If we wind back to the last few years, where we were primarily selling DASH to the type 2 population, we thought that as we increase the number of type 2s in our customer base that we may see an increase in attrition just because of the type 2 dynamic and a different customer. And we didn't. We actually were surprised to see our churn stay the same and our attrition rates stay the same for years on DASH. And it's still early days for Omnipod 5. And clearly, Omnipod 5 is not indicated for type 2. So our teams are not trained to sell it, and we're not marketing to type 2. But we have seen a strong type 2 increasing customers on Omnipod 5 as well, but just a little too early to tell. What we would say is we have not seen an impact to attrition, and it's been stable as we moved more customers to Omnipod 5 as well. So in a macro level, we have not seen this or any other factor really changing our attrition rate despite the fact that we've got a growing number of type 2 customers.

Larry Biegelsen

analyst
#15

Wayde, you provide us with the percent of new starts for type 2 each quarter. And if I look at kind of '22 over '21, it looks like type 2 new starts were flat to down in '22 and in first half of '23, by my math, call it, flattish. Is there anything you can say about type 2? I know you don't have a label for Omnipod 5 and that may explain it. But somebody could look at that and may infer that there's an impact from GLP-1s.

Wayde McMillan

executive
#16

Yes, glad you asked that question, Larry. Because I think you're right for '21 into '22. As we were focusing on Omnipod 5 without a type 2 indication in the second half of the year, that was definitely there. And what we report publicly is as a percentage -- as you said, as a percentage of new customer starts. Prior to Omnipod 5, we were seeing 35% to 40% of our new customer starts were type 2. And as we shifted from DASH into Omnipod 5, that percentage of new customer starts dropped to 15% to 20%. But what we've seen as sort of that first 6 months of pent-up demand for Omnipod 5, we've started to see an increase in off-label prescriptions for Omnipod 5 but also still strong sales. And our sales team can focus on DASH. They do not focus on Omnipod 5 obviously because it's not on-label yet. And so what we've seen there, Larry, is a strong actually -- so I'm with you on '21 to '22 because of our focus on Omnipod 5 in the second half of the year, but still strong. But we have had incredible take-up and new customer starts in type 2 here in 2023, so really strong Q1. And Q2 was a record all-time new customer starts for us. We had over 5,000 type 2 new customer starts just in the U.S.

Larry Biegelsen

analyst
#17

And that was a record number.

Wayde McMillan

executive
#18

That's a record number for us.

Larry Biegelsen

analyst
#19

That's helpful. And I know you're doing a type 2 study for Omnipod 5. Public information on ClinicalTrials.gov has that being completed, I think, in October '23. So we should assume -- I think we can expect a label sometime in '24, maybe late '24. I guess, my question is do you think the new starts -- the percent of new starts for type 2 can go back to that 35% to 40% once you have the label from the, call it, 20% in Q2?

James Hollingshead

executive
#20

I don't think we've guided to that number. I think there's really significant potential though if you look at it. So as Wayde said, we had record t2 starts. And we know that a significant part of that is physicians already running off-label from Omnipod 5, even though we're not promoting it, obviously. I do think there's massive pent-up demand in that market. And once we can promote it, I think we'll be very successful. But we haven't tried to project the percentage.

Larry Biegelsen

analyst
#21

Got it. And then I'll ask about it now because we've got a lot of e-mails on it. New England Journal, just a correspondent 10-patient study in type 1 for -- it was for Ozempic. Trang, what's your view with that?

Trang Ly

executive
#22

Yes, a small publication, 10 patients only, type 1 diabetes, really interesting data, Larry. So a few things to remind the audience. So in type 1 diabetes, it's very common to go through a honeymoon period. And so during that phase, either after often a significant diagnosis period of DKA, you do require that high insulin doses in the beginning. But very quickly, your insulin needs go down dramatically. And there is something about that residual beta cell function that happens in honeymoon. And this is really common with -- and that has nothing to do with GLP-1. So it's really common, insulin needs come down in that first year anyway. And then on top of that, in this study, it talked about carbohydrate restriction as well. So all the participants in -- that were discussed were all -- had carbohydrate restriction. So carbohydrate restriction plus the fact that they were in honeymoon could really -- those two factors itself could reduce insulin requirements to almost negligible. And so on top of that, they were given a medication, a GLP-1 that we know does work to stimulate insulin secretion. So these results are not unexpected in -- given that we know how these medications work. But really, early work and is an uncontrolled study, so more data to come. And just a reminder for the audience that liraglutide has been tested in the same patient population over a year and wasn't found to preserve beta cell function.

Larry Biegelsen

analyst
#23

Okay. So this was kind of a special population that we saw in these 10 patients...

Trang Ly

executive
#24

Newly diagnosed carbohydrate-restricted, yes.

Larry Biegelsen

analyst
#25

And so big picture, you don't see a threat...

Trang Ly

executive
#26

That's right.

Larry Biegelsen

analyst
#27

To pump utilization in the type 1 population from newer GLP-1s?

Trang Ly

executive
#28

That's right.

Larry Biegelsen

analyst
#29

Okay. And what would be the -- what would prevent -- so I understand this was kind of an enriched population. But what would prevent the companies from studying a GLP-1 in a type 1 population? I mean, we've heard hypoglycemic risk, we've heard DKA risk. Are there reasons that a GLP-1 might not be appropriate for type 1 patient?

Trang Ly

executive
#30

Yes, we actually -- in the real world, people do use a lot of GLP-1 off-label today in the type 1 population. Because in the general population, obesity levels are higher, and so the sort of this dual diagnosis of both type 1 and type 2 essentially. And so people are using GLP-1s off-label in type 1. And it does reduce your total insulin requirements, but it doesn't eliminate the need for insulin. And as we've seen with the fact that GLP-1s have been on the market for so long in type 2, there isn't anything suggesting that there is any delay in progression of beta cell loss. So we don't believe that, that's going to affect the need for intensive insulin therapy.

Larry Biegelsen

analyst
#31

Okay, got it. Obviously -- I think it's my last question on GLP-1s. There's a lot of concern around this. I know you know that. Is there -- are you guys considering doing some type of investor event to help frame the long-term opportunity? What are your thoughts on that?

James Hollingshead

executive
#32

We're looking more closely at this. I mean, this is a tide we've been swimming in for some time. And so the GLP-1s are -- as Trang said, there's -- insulin often comes alongside GLP-1s. A lot of patients are on both therapies. We've seen the progression of the disease. We've seen the market dynamics. So we live in that. But because of all the news and noise that's happened over the last couple of weeks, we're digging into this in more detail so that we can come with a better fact base. We're not quite ready to do that, but we'll be coming with that pretty soon.

Larry Biegelsen

analyst
#33

Okay, good to hear. So let's move on recent trends, which, Jim, as you said in your opening remarks, have been strong. You talked about record new starts worldwide, I think, in both the first quarter and second quarter.

James Hollingshead

executive
#34

That's right.

Larry Biegelsen

analyst
#35

How are you thinking about the momentum continuing into the second half of the year?

James Hollingshead

executive
#36

Momentum is great. That's why we raised our guidance so significantly. So momentum is great. And obviously, as we get new customer starts, we get the recurring revenue benefit of the new customer starts. So as we have increasing records -- actually, let me just say, we had a Q4 record. Q1 was just below the record and then Q2 was kind of a blowout. So it was a new record, right? But all 3 of those quarters were very, very strong. So we get that recurring revenue benefit off of new customer starts. And we see the demand and we see what's happening. And so we know there's just tons of momentum in the business. And that's why we raised our guidance so significantly. We're also really bullish. Although we've said publicly, this is probably a 2024 dynamic in terms of showing the numbers, we've just launched our Omnipod 5 in the U.K. and just now in Germany. So like in the first few days of the launch in Germany. Both of those launches are out of the gate really, really strongly. The demand for Omnipod 5 in our existing international markets is obviously really, really strong. And each of the markets have a slightly different dynamic. But both of those launches are going terrifically well. And then you couple that with all of the innovation we have coming in the next several months. We filed for, with the FDA, for approval of our iOS app. And so that's still in the FDA's hands. We continue to work really hard on sensor integration, so we can provide sensor of choice. So we want to be able to integrate and provide the choice for Libre sensors as well as the Dexcom G7. And that work is proceeding at pace. And we haven't announced timelines on that, but that work is going really well. And we have just launched our pilot with Omnipod GO, which is -- which we're not -- we plan to commercialize. We announced we're going to commercialize Omnipod GO at scale in 2024. But Omnipod GO is type 2-focused. Obviously, it's a basal type 2 offering. And that pilot is off to a good start as well. So we're very bullish on the second half. We can see into it, that's why we raised our guidance. And we think the momentum in the business is fantastic. I will also say we're in the best competitive position we've ever been in. So we've competed for a long time on ease of use and form factor and pharmacy economics. Those are all the advantages of the Omnipod platform: easy for a customer to get to, no big capital expenditure on the upfront, very easy wear experience, it's discrete, it's small, et cetera. So we've won on that for a long time even before we launched Omnipod 5. And where we had pressure in terms of market share was against systems that were doing automated insulin delivery from our competitors. And when we launched Omnipod 5, if you picture sort of a competitive landscape, we're well in front of ease to use, pharmacy channel economics. And then we jumped to an algorithm that is fantastic. The second algorithm is delivering fantastic real-world results. So we're in the best competitive position we've ever been in as a company. And we're really, really bullish on growth.

Larry Biegelsen

analyst
#37

That's helpful. And you talked about number of prescribers going from 11,000 to 15,000 from Q1 to Q2. What types of physicians are starting to prescribe Omnipod 5? And what are the implications of that for you?

James Hollingshead

executive
#38

Yes. So I mean, our main call point continues to be endocrinology practices. And there's about, plus or minus, 7,500 endo practices in the U.S. Obviously, most of our scripts are coming out of those practices. As the prescriber base grows, what we're seeing is we're getting more endos and more physician assistants in those practices. So we're penetrating the large practices more effectively. But we're also getting new prescription writers. And so we're getting PCP practices who are writing. Interestingly, GO is aimed at the PCP really. It's both endo and PCP. But it's really a PCP main target because a lot of PCP practices are managing type 2 diabetes patients earlier in their disease. But we're getting PCPs writing DASH and also writing Omnipod 5. And the other thing that's really interesting dynamic for us is we're reaching physician practices through our direct-to-consumer and direct-to-physician media that we don't necessarily reach first with our sales force. And so our DTC capabilities are driving demand both for a patient to walk into their doctor and say, "I saw this Omnipod 5 thing in the ad and I want to see if I can get on that." But you also have physicians seeing that media and then we're getting trial out of that. Once we get trial in a script, our sales force then goes and drives more penetration in those markets. So we're seeing a mix of those things. And I think that it's really just the beginning, especially as we reach into high-writing PCP practices with Omnipod GO. We'll get more penetration in those practices. They'll see how easy the product is to use. And then as those patients progress, which they almost always do on to intensive insulin, then they'll already be prepared. They'll know how to use a Pod form factor and they'll go on to Omnipod 5.

Larry Biegelsen

analyst
#39

You talked about Omnipod GO starting. I think you said so far so good, something along those lines, I'm paraphrasing. The Street expectations are very low, were underestimating GO.

James Hollingshead

executive
#40

Well, it's a new-to-world product, right? And so we haven't really put it in our guidance, right, because it's new-to-world. I mean, I'll just describe the product. But I'll just say it's not in our guidance. New-to-world is new to us. And so the Omnipod GO product is incredibly simple to use. It's intended for people who need daily basal insulin. It's the Pod form factor, so you fill it with your insulin. And it's already geared to give you your daily basal rates. So there will be different SKUs for different basal rates. You fill it with your insulin. You put it on your arm. It senses that it's on your arm. And it waits a few seconds -- several seconds, about a minute or so. And then it auto-injects the needle. So boom, you're done. For 3 days, you're now going to get a triple rate of insulin at your basal rate. And then it reminds you when it's empty and it's time to put on a new one. So it runs for 72 hours and then you just put on a new one, so very, very simple way to get your basal insulin. It's really effective. One of the big barriers for basal insulin is needle phobia. We know this. And so people that don't want to start their insulin in a timely manner, it removes a huge barrier, really simple to use. We believe it's going to drive high adherence for basal insulin as well because people forget to take their jab or whatever. So really, really simple. It's new to us. So it's new-to-world, and we'll see how it adopts. We know from customer research, there's patient demand and physicians are really interested in this product as we go out in the world. So we're bullish on that. For us, it's a new thing because it's a new commercial model because now we're really calling in a more concerted way on high-writing PCP practices. And it's a different selling motion, as people would say. Because what we're doing is, first of all, we're sampling into those practices, which is new for us. And we have to figure out how to do that, and we haven't really done concerted sampling in the past. And also, we're training the trainer in those offices so that it can be set up in office and the patient goes home with a sample on their arm and then they go to the pharmacy to get the script. So those are all new things for us from a business model point of view. And that's why we're giving ourselves some time to pilot it. We want to make sure we understand how to do all of those steps in a physician practice. And as we learn from the pilot, we'll refine. And we've given ourselves some runway so that's why we're saying we'll commercialize in 2024. And we'll see. It's a big market. There's 3 million to 4 million patients out there that need basal insulin. And we think we're solving a real problem both for them and for the physicians.

Larry Biegelsen

analyst
#41

That's helpful. So Wayde, we heard already this morning, momentum in the U.S. remains good from Jim. You were kind enough to give us some color on 2024 for international. How should we be thinking about the business as a whole, maybe U.S. 2024, any puts and takes, top and bottom line?

Wayde McMillan

executive
#42

Yes. So if we start with the U.S., as Jim just said, really strong momentum. We've got a lot of new innovation coming to market. As Trang covered, a lot of clinical data coming to market for us. So a lot of strength heading into 2024. We haven't put numbers to it yet. We'll give some color on our Q3 call. And then we'll eventually give guidance in our Q4 call as per usual. But I think we should think about the U.S. continuing to grow really strong. And as you move to international, we're happy to see, as Jim just said, bringing Omnipod 5 to international markets. We're already seeing significant take-up in the U.K., and we just launched in Germany. We're going to bring it to more customers in Europe throughout next year. So that will continue to build momentum. What we've reminded people is, given the annuity nature of our revenue model, it takes some time for customers to have an impact to the growth rate. So what we want to do is make sure everybody understood, although as exciting as it is that Omnipod 5 is launching internationally, it will take some time to take up the growth rate. And so we gave some color on the second half, where we see second half international getting back into that high single digits, low double digits type of growth rate.

Larry Biegelsen

analyst
#43

And any reason international can't -- the growth eventually can't replicate what we see in the U.S.?

Wayde McMillan

executive
#44

There's a couple of things. Yes, the dynamics are different. And so it is a slower ramp internationally. So it will not replicate the first 4 quarters. I shouldn't say it will not. It is hard to see that it would replicate what we're seeing in the U.S., where we had 40% growth in the U.S. in the first 4 quarters of Omnipod 5. Outside the U.S., what's different is customers are locked into a 4-year period. So even our own Omnipod-ers will have to wait until their lock-in period on their pump expires. This is in most countries in Europe. And so we'll be launching Omnipod 5, but it will take a few years for Omnipod 5 to get the uptick like we've seen in the U.S., which was almost immediate because we were selling Omnipod 5 in the U.S. through the pharmacy channel, which is an option for all customers, whether you're on a competitive pump or our existing Omnipod products before Omnipod 5 or clearly if you're an MDI user. And so for those reasons, we think the international ramp will not look like the accelerated ramp, where we quickly went into the 40% growth in the U.S.

Larry Biegelsen

analyst
#45

Anything on margins? You seem to allude to some margin headwinds in '24 on the Q2 call? Maybe I misheard.

Wayde McMillan

executive
#46

So the message was that we're on track. And we're at 66% margins in the quarter. And we're still guiding to 65% to 66% for the year. But we've got some tailwind there. Our manufacturing facilities are performing really well. We continue to get the premium in the pharmacy channel for that mix favorability in the U.S. And so although there are still some inflationary headwinds and as we ramp Omnipod 5 at a slightly higher cost, there's some headwinds there. But it has not changed our confidence, Larry, that we'll continue to expand both gross margins and operating margins starting in 2024 and continuing from there.

Larry Biegelsen

analyst
#47

Okay, that's helpful. So we covered a lot of ground. Jim, I wanted to make sure I gave you kind of the last word here.

James Hollingshead

executive
#48

Well, thank you, Larry. First of all, I'll just thank everybody for coming. And Larry, I want to thank you for moderating and having us today. As we said, we're coming off of 4 great quarters, a really strong Q2. The business has fantastic momentum. I think we're in the best competitive position we've ever been in. And we're seeing growth both across type 1 -- the type 1 population and the type 2 population. We're about to have the largest portfolio -- actually, we already have the largest portfolio of insulin delivery products for type 2 patients. And we'll soon have a label for Omnipod 5. And we'll be off to the races there. We have tons of innovation coming in the next 18 months or so over that span, consistent innovation. And we have a lot of innovation in the pipeline that we're still working on. So we're really bullish on the business and on ongoing growth. And we thank you all for coming today.

Larry Biegelsen

analyst
#49

All right. Jim, Trang and Wayde, thanks so much for being here.

Wayde McMillan

executive
#50

Great. Thanks, Larry.

Trang Ly

executive
#51

Thanks.

This call discussed

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