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 the mic. Jim, Wayde, and Trang, thanks so much for being here.
Great to be here, Larry. Thank you.
So, let's start with the GLP-1s. You know, the updates on GLP-1s, you know, are more and more positive, each day it seems. So, Jim, can you please remind us of Insulet's stance here?
Yeah, can I, I just want to back up.
Sure.
Just in case there are investors in the room who don't know us very well. We're the world's 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 had 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 four, with a 40%+ growth in the U.S. We're very excited. We're in the best competitive position we've ever been in, and we have a bunch of innovation coming.
We have also just launched our Omnipod 5 product in the UK 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.
Sure
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 this 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 unlabeled products, two unlabeled products for Type 2, people with Type 2 diabetes in Omnipod DASH and Omnipod GO, which we're in pilot with, which we've announced, and then Omnipod 5, we're in a pivotal trial. GLP-1s, we think they're great innovation, but they don't impact our market in a reasonable timeframe.
The reason for that is at least twofold. The first is the magnitude of Type 2 diabetes is enormous. If you think about the size of the problem, the worldwide healthcare problem, or just take the U.S., you have more than 100 million people, somewhere between 100 million-200 million people in the U.S. who are obese. You have almost 100 million people who are pre-diabetic, and that condition continues to just progress. Once you're on that train, you're on the train. 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 onto that flow, and they flow 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 and 4 million people. We're usually conservative in how we talk about market numbers. We usually say three, but it's between three and four 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 in this, but we know the disease continues to progress. And so within any reasonable timeframe, even if GLP-1s are wildly successful, and we're, 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.
Yeah. Thanks, Jim. So I think just a few clarifying points with prediabetes. You know, 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, GLP-1s, 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.
That, that's helpful. You know, Jim, there was a little bit of a nuance difference in your comments today versus the earnings call when you talked about the TAM, you know, not having a major on the, on the. You know, today you said basically, you don't think it's going to have a big impact on the TAM in a reasonable timeframe, something along those lines. What, what
I'm not trying to hedge off of the earnings call.
No, no.
But
But what
Yeah.
So, you do think it will have some impact on the TAM over. Can you be more precise about over what timeframe you're talking about? And I get the message.
Yes.
It's basically, you know, 2.5 million Type 2 insulin-intensive patients. There's probably only about 150,000, you know, people on a pump. So the market opportunity is still large, but I was just curious about what you're saying, what your message is on the long-term TAM.
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. I understand why investors are looking at this and saying, "Well, what happens with obesity? What happens with 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, you know, one way to look at it is, you know, 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, you would still have a market opportunity that's as large or larger than the Type 1 opportunity. But nobody's 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...
You know, this is what people are worried about from, from looking at our business, time to progression onto insulin therapy. But GLP-1s have been in the insulin market really for 18 years. You know, 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 five years of history with that. And, you know, whatever impact on progression to 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 US. And there's some also some demographic reasons around HbA1c levels in the market.
So, the magnitude of the market is massive. There's no molecular mechanism that's stated in terms of there's no reversal of type 2 diabetes. And, you know, we're just getting started. We're going to put a few thousand people, that market's completely underpenetrated and underserved, and it's in therapy. And, Trang, you might want to talk about some of the HbA1c numbers.
Yeah. So the point is that it, you know, 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's a sort of myth out there that it's a 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.
Like I said, despite the benefits of GLP-1 on a population basis, we haven't seen improvement in target glucose levels. 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. 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 you know, 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 are 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 those patients were on a GLP-1, and their Time in 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 very much coexisting with GLP-1 as we do today already in the market.
That's helpful. So I think you know 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?
Yeah. 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, you know, what we've seen really in the market is, you know, maybe five, six years ago, we saw a lot of people on concentrated insulins and really, really high doses, more than 200 units a day.
That's becoming less common with the GLP-1s and SGLT2s, and so they're coming down, and then, you know, their total daily insulin comes down from, you know, above 200 down to, say, 150, 100, and then you put them on an Omnipod 5, 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 it's still an enormous need for people requiring insulin in that advanced disease. And really, what people fear is weight gain and hypoglycemia. And I think that, you know, products such as Omnipod 5 with very, very low hypoglycemia and essentially weight neutral in our studies have enormous potential at helping this severely underserved market.
Anything you can say about churn?
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 increased 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 rate 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 increase in 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've 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.
Wayde, you provide us with the % of new starts for Type 2 each quarter. If I look at kind of 2022 over 2021, it looks like, you know, Type 2 new starts were flat to down in 2022 and, you know, in first half of 2023, 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, you know, infer that there's an impact from GLP-1s.
Yeah, glad you asked that question, Larry, because, you know, I think you're right for 2021 into 2022. We were focusing on Omnipod 5 without a Type 2 indication in the second half of the year, that was definitely there. 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%-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%-20%. What we've seen as sort of that first six months of, you know, 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. Our sales team can focus on DASH.
They do not focus on Omnipod 5, obviously, because it's not on label yet. So what we've seen there, Larry, is a strong actually. So I'm with you on 2021-2022 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 a 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.
That was a record number?
That's a record number for us.
That's helpful. And, you know, I know you're doing a Type 2 study for Omnipod 5. You know, public information on clinicaltrials.gov has that being completed, I think, in October 2023. So, you know, we should assume. I think we can expect a label, you know, sometime in 2024, maybe late 2024. I guess my question is, do you think the new starts, or the percent of new starts for Type 2, can go back to that 35%-40% once you have the label from the, call it, 20% in Q2?
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, as Wayde said, we had record T2 starts, and we know that a significant part of that is physicians already writing off-label for 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 a percentage.
Got it. And then, I'll ask about it now, because we got a lot of emails on it. New England Journal, just a correspondence, a 10-patient study, in Type 1, for it was for Ozempic. Trang, what's your view of that?
Yeah, 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, you know, after often a significant diagnosis period of DKA, you do require that high insulin dosage in the beginning, but very quickly, your insulin needs go down dramatically. And there is, you know, 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, you know, in this study, it talked about carbohydrate restriction, as well.
So, you know, 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 themselves could reduce insulin requirements to almost negligible. And so on top of that, they were given a medication, 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, early work and an uncontrolled study, so more data to come. And just a reminder for the audience that, you know, liraglutide has been tested in the same patient population in over a year and wasn't found to preserve beta cell function.
Okay. So this was kind of a special population that we saw in these 10 patients, and so
Newly diagnosed, carbohydrate restricted. Yes.
It's a big picture. You don't see a threat.
That's right
Yeah, to you know, pump utilization in the Type 1 population from newer GLP-1s.
That's right.
Okay. And what would be the—what would prevent these? 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 there are hypoglycemic risks. We've heard DKA risks.
Yeah.
Are there reasons that, you know, a GLP-1 might not be appropriate for Type 1 patients?
Yeah, we actually, you know, in the real world, people do use a lot of GLP-1 off-label today in the Type 1 population because, you know, in the general population, obesity levels are high. And so, there's 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, you know, with the fact that GLP-1s have been on the market for so long in Type 2, you know, there isn't anything suggesting that there is any delay in progression of beta cell loss. So we don't believe that, you know, that's going to affect the need for intensive insulin therapy.
Okay, got it. Obviously, you know, I think, I think it's my last question on GLP-1s. You know, 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?
We're looking more closely at this. I mean, this is a tide we've been swimming in for some time, and so, you know, the GLP-1s are, as Trang said, there's insulin often comes in 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, I would say.
Okay, good to hear. So let's move on to recent trends, which, Jim, as you said, in your opening remarks have been strong. You talked about, you know, record new starts worldwide, I think, in both the first quarter and second quarter.
That's right.
How are you thinking about the momentum continuing to the second half of the year?
Momentum's great. That's why we raised our guidance so significantly. So momentum's 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 three of those quarters were very, very strong. So we get that recurring revenue benefit off the 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 in the numbers. You know, we've just launched Omnipod 5 in the UK 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. You know, we've 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. We want to be able to integrate and provide the choice for Libre sensors as well as the Dexcom G7. That work is proceeding apace, and we haven't announced timelines on that, but that work is going really well. We have just launched our pilot with Omnipod GO, which we plan to commercialize. We announced we're going to commercialize Omnipod GO at scale in 2024. Omnipod GO is a Type 2-focused audit, it's a basal Type 2 offering, and that pilot is off to a good start as well. 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 of 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. You know, 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 discreet, 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.
When we launched Omnipod 5, if you picture, you know, sort of a competitive landscape, we were way out in front of ease of use, pharmacy channel economics, and then we jumped to an algorithm that is fantastic. The second-to-none algorithms 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.
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?
Yeah. So, I mean, our main call point continues to be endocrinology practices, and there's about ±7,500 endo practices in the U.S. Obviously, most of our scripts are coming out of those practices. Well, as the prescriber base grows, what we're seeing is you'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, we're getting PCP practices who are writing. And interestingly, GO is aimed at the PCP really. It's, it's both endo and PCP, but it's really a PCP-aimed 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.
The other thing that's a 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. So the, you know, our DTC capabilities are driving demand both for patients walk into their doctor and say, "I saw this Omnipod 5 thing, you know, 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 and 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 onto 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.
You talked about Omnipod GO starting.
Mm-hmm.
I think you said so far, so good.
Mm-hmm.
Something along those lines. I'm paraphrasing.
Yeah.
The Street expectations are for very low. You know, we're underestimating Go?
Well, it's a new world product, right? And so, you know, we haven't, we haven't really put it in our guidance, right? Because it's, it's new to world. Maybe I'll just describe the product, but I'll just say it's not in our guidance. It's new to world. It's 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, it's already geared to give you your daily basal rate. So there'll be different SKUs for different basal rates. But you fill it with your insulin, you put it on your arm, it senses that it's on your arm, 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 three 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. You know, it's really effective. One of the big barriers for basal insulin is needle phobia. We know this. And so, you know, people that don't want to start their insulin in a timely manner, it's, 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 the 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 them, you know, 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 we, you know, as we learn from the pilot, we'll refine, and we've given ourselves some runway so that. That's why we're saying we'll commercialize in 2024. And we'll see. It's a big market.
There's three-four million patients out there that need basal insulin, and we think we're solving a real problem, both for them and for the physician.
That's helpful. So, Wayde, you know, 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, you know, the business as a whole, maybe U.S., 2024, any puts and takes, top and bottom line?
Yeah, 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 if you move to international, you know, 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'll 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'll 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.
Any reason international can't, the growth eventually can't replicate what we see in the U.S.?
There's a couple things. Yeah, the dynamics are different, and so it is a slower ramp internationally, so it will not replicate the, you know, first four 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 four quarters of Omnipod 5. Outside the U.S., what's different is customers are locked into a four-year period. So even our own Omnipoders 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 uptake 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.
Anything on margins? You seem to allude to some margin headwinds in 2024 on the Q2 call. Maybe I misheard.
So the message was that we're on track and we're, you know, we're at 66% margins in the quarter, and we're still guiding to 65%-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.
Okay, that's helpful. So, we covered a lot of ground. Jim, you know, I wanted to make sure I gave you kind of the last word here.
Well, thank you, Larry. First of all, just thank everybody for coming. And Larry, I want to thank you for for moderating and having us today. As we said, you know, we're coming off of four 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 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. We thank you all for coming today.
All right, Jim, Trang, and Wayde, thanks so much for being here.