Insulet Corporation (PODD) Earnings Call Transcript & Summary
March 7, 2023
Earnings Call Speaker Segments
Jayson Bedford
analystAll right. Good morning. I think we'll start. Welcome to the 44th Annual Raymond James Institutional Investors Conference. My name is Jayson Bedford. I cover the medical technology sector here. It's really our pleasure to have with us the team from Insulet. Insulet has been a loyal participant in this conference for the last decade. And I think, I was looking back a decade ago, it was sub-$2 billion in market cap. So it's been a wonderful growth story over the years. With us today, we have the company's CEO, Jim Hollingshead. We have the company's CFO, Wayde McMillan; and VP of IR, Deb Gordon. So with that, I'm going to hand it over to Jim.
James Hollingshead
executiveThanks, Jayson, and good morning, everybody. Thanks for coming today. Let me start by introducing you to Christian, who you see here on this slide. Christian is 9 years old. And if you look really closely, on the back of his left arm there, you can see the Omnipod 5, which is our flagship insulin delivery product. Christian was diagnosed with type 1 diabetes just a couple of years ago. His favorite thing to do is to do hover boarding and skateboarding and to play with his sisters. And he and his family love the Omnipod 5 because it keeps his blood glucose in range all day long and overnight, which means he can just be a kid. He can be a 9-year-old kid, run around and do what he does. And it means that his parents can sleep through the night and not worry that his blood sugars are going to go dangerously low overnight. So this is why we do what we do. Because with our platforms and our offerings, we're able to massively simplify and improve the lives of people with diabetes. You all know the disclaimers. I'm going to use some -- I'm going to make some forward-looking statements and use some non-GAAP numbers. You guys all know to go on our website to find our filings to get other numbers that you need. And so this disclaimer is obviously required. You guys, I'm sure you get sick of seeing it every day, but we just flag it for you. This is what I want to do with our few minutes together. I want to talk about the massive growth opportunity that Insulet has in front of it, globally -- in the U.S. and globally with our offerings. I then want to talk about why Omnipod 5 is a revolutionary offering and is going to allow us to really capture that opportunity and grow -- continue to grow and reach the millions of people that we want to reach. I'm going to double-click on our expansion into type 2 diabetes. Right now, our products are used mostly, not exclusively but mostly, in the type 1 diabetes space. I want to give you a double click on our plans for type 2. And then I'm going to make some comments about our strong growth track record and our commitment to investor returns. In sum, our mission, as I've said, is to dramatically simplify life for people living with diabetes, and we do that through a number of levers. First and foremost is our Omnipod product platform, and I'm going to talk in some depth about the platform itself. What Omnipod does is it really reduces the burden of living with diabetes on a daily basis. People living with both type 1 and type 2 diabetes have a lot of things they have to manage, a lot of steps they have to go through. And our Omnipod product platform, and especially our Omnipod 5 platform, really simplify that experience and reduce the burden of living with diabetes. We also deliver terrific outcomes, and that's true of clinical outcomes. Our main metric is time in range, which is how people manage their blood glucose. Blood glucose is intended to be in a certain range. We deliver fantastic time in range. We also deliver fantastic quality of life. We make life really simple, and we make diabetes simpler to live with and try to put it into the background for our customers. We have a number of competitive advantages that allow us to grow. One of them is we have fantastic people. We have great talent. And I've been in the CEO chair for just about 9 months now, and I spent the first several months going around and meeting people in the company. I did dozens of one-on-one meetings with people. I have been universally impressed with the quality of the people we have at Insulet and really impressed with their level of engagement and commitment to our mission. We get out of bed every day at Insulet to help people, and you can see it all through the company. So we have a huge advantage in our talent. We have a terrific innovation pipeline. We have a lot of innovations coming on the back of our flagship launch -- our launch of our flagship product, Omnipod 5. We have other things in the pipe. We're extremely innovative, and we're moving really fast. We've crossed through now kind of the teenage years of being an awkward teenage company, and we're increasingly able to scale our operations. And we have massive advantage in scalability. We have an advantage in our ability to build these pods that I'll show you just in a second, to build them at scale with high quality. It's a huge competitive moat for us. And then we have a huge data infrastructure, and Omnipod 5 is a cloud-connected product. And we've been building, in advance of that, data infrastructure, including a data lake and cloud infrastructure and other capabilities that will prove to be an advantage for us going forward. And all of that allows us to have the market-leading technologies, the market-leading offers. We have market-leading revenue growth, and we're creating long-term value. We have a consistent track record, and we continue to create long-term value for our shareholders. Diabetes is a growing worldwide epidemic. More than 0.5 billion people around the world live with diabetes every day. 60 million plus, and this slide says 64 million people, need daily insulin injections, which is what our products deliver. So that's a massive global TAM. In the geographies in which we play, right now, our TAM is 11 million people. We're in the U.S. and 23 countries outside of the U.S. That split, you can see 45-55 with type 1 diabetes and type 2 diabetes. We announced in our Q3 call and then in Q4, we did file, we announced a new product called basal-only Pod. It will have a brand name. Right now, it's called basal-only Pod. When we add basal-only Pod just in the U.S., we add at least another 3 million people to our TAM. So our TAM is 14 million people. And there's lots of different estimates on each of these numbers on this page. I'll just tell you to give you some context there. We announced in our Q4 call just a couple of weeks ago or last week that we've crossed over the threshold of about 360,000 active patients on our Omnipod product platforms. So these numbers represent something like 30 to 40x our current installed base on the product. So we have a massive runway in front of us in terms of growth. So let's talk about Omnipod and what it does, and I want to start first with the Omnipod platform. That's it, right there. So right in the middle of the page is Alecia B. By the way, I should say every photo we have of a person in the slide deck is an actual, what we call, Podder. They're a natural user of the product, either Omnipod DASH or Omnipod 5. And people send us their photos all the time. You can see people uploading videos on social media all the time. We have a really active community of users. So that's Alecia, and right below her is the Omnipod. So that's a simple -- but you can see, I think if you look really closely, you may not be able to pick it up, I think we can see hers, too, right behind her sleeves. So you can see how small and unobtrusive it is. So there it is. That's the Omnipod. What does the Omnipod do? Well, a lot of times, when people look at our market, they think of us as kind of another player in the insulin pump space. And so you can see here on the left, a kind of more traditional insulin pump that somebody who's controlling the box that they might wear on their belt, you can see the tube and the needle insertion set. Those are kind of bulky items. And it's true, we do compete in that space. So Omnipod is an insulin pump. The platform is an insulin pump. But it has massive advantages of being unobtrusive, tubeless, wearable, disposable, really, really easy to use. And so a lot of times, people will analyze the market and they'll say, "Well, what's your share in the insulin pump space?" And it's true, with the launch of Omnipod 5, which I'll talk about more in a minute, we've been taking share from our competitors out of the installed base. But the real purpose of Omnipod 5 is to actually compete with what's on the right of this slide. So those are 14 syringes, and the average -- for Omnipod 5, each pod is worn for 3 days. And over those 3 days, the average number of self-injections it replaces, 14 injections, and you can see the hassle of that. So if you're injecting yourself with daily insulin, you're pulling out a needle constantly. You're watching your blood glucose constantly, and you're doing self-injections. That's a huge burden, and that's what Omnipod 5 is meant to replace. And that's actually our target market. And you can see with the percentages on the slide globally, only about 5% of people globally are even on a pump. And the reason that's true is because of the tube, the hassle, the durable medical equipment. So a traditional pump is not that convenient to use. The Omnipod platform is so convenient that we're growing the market. We're bringing thousands of people out of multiple daily injections, or MDI, and that's actually our plan. We want to make insulin delivery -- automated insulin delivery, in particular, accessible to millions and millions of people and grow on the right. We're growing on both, but our target market is on the right, and that's the larger opportunity. Even in the U.S. market where pumps are the most penetrated market in the world, pumps are still only penetrated about 30%, mid-30s, maybe. So even in the U.S. market, there's massive headroom for us to grow. And we're going to continue to bring MDI users into the market, making the market even bigger. So that's Omnipod as a platform. Omnipod 5 adds a new dimension. We've been winning with the Omnipod platform because of it's no needles or tubes, it's discrete, it's wearable, it's disposable, it's waterproof. You can do your daily activities wearing an Omnipod. It has pay-as-you-go economics. And so that tubed pump on the previous page, if you go get that product here in the U.S., you're going to go through the durable medical equipment channel. It's going to cost around $5,000 or $6,000. Your payer is going to outlay $4,000, $5,000 of that. You're going to have $1,000 co-pay. That puts a burden on the payer, puts a big co-pay burden on the patient. With Omnipod, both DASH and Omnipod 5, there is no up-front capital cost. And so you pay as you go. That's a huge benefit to patients. Our patients pay an average co-pay of less than $50 a month. The vast majority of our patients are less than that. Many of our patients have a zero co-pay. They get that through the pharmacy channel. So it's a huge convenience for patients. It also takes risks off of payers. Payers lay out $4,000 up front. They don't know if the patient's going to benefit from that tubed offering. They don't know if the patient is going to use the tubed offering, and the patient gets locked into a 4-year contract. We're not -- our patients are not locked into a 4-year contract. That also means that people on a tube pump can switch to Omnipod anytime they want because it's a different part. It's a different benefit. So Omnipod is winning in all of that, has been winning in all that for quite a long time. In August, we went to full market release of the Omnipod 5. And what Omnipod 5 adds in is an automated insulin delivery algorithm, terrific algorithm. It manages time in range really effectively. It's especially good at preventing lows, so especially good at preventing hypoglycemia, which is what most physicians and patients worry about going too low, especially overnight. So it keeps time in range really tightly controlled. And it's novel. It's a learning algorithm. You put Omnipod 5 on your arm or on your abdomen. It works immediately straight out of the box, managing time in range. And then it chases that target all the time by sensing -- it connects to the Dexcom G6, senses from Dexcom G6 the blood glucose level and the trend. And then our algorithm predicts where your blood glucose is going, and it decides to either dose you with insulin or not based upon that 1-hour prediction, that 60-minute prediction. It does that in very small increments. We call them microboluses. And so it's a very tightly controlled system, and it learns your body. Over the first 3 or 4 pods, it actually learns how your body react to insulin, how much insulin you need, and it doses accordingly. So automated algorithm right out of the box and over the first 3 or 4 pods, which is over the first 8, 9, 10 or so days, it personalizes the algorithm to you. It's very, very effective, really revolutionary technology. So with all of the benefits of the form factor, the pharmacy channel, the economics, ease of use, now add in a highly competitive automated insulin delivery algorithm that produces terrific clinical results and terrific control. Omnipod 5 has become the obvious choice for consumers, and that's why we're leading with new customer starts in the U.S. market where we've launched. It wins on all dimensions. So let me double-click then on our plans for type 2 because as I said, Omnipod 5 right now is indicated only for type 1 diabetes. It's growing phenomenally. We've had outstanding growth since we went to full market release, U.S. growth in the 40s over the last 2 quarters, which is outstanding. We want to extend our platform into support for patients with type 2 diabetes. We are already the leader in pump technology for people with type 2 diabetes because our Omnipod DASH platform has an indication for use there. And up to the launch of Omnipod 5, it was -- type 2 patients represented roughly 30 -- a little over 30% of our new customer starts on our platform with DASH. Once we launched Omnipod 5, because of its indication for use in type 1, the numbers changed and the percentage went down. But we continue to have somewhere between 15% and 20% of our new customer starts who are type 2 patients, and DASH is a fantastic experience for those patients. We announced in our Q3 call and then in early Q4, we filed with the FDA for a new product that we're calling basal-only Pod. And the beauty of that product is it's utter simplicity. You can see here, what I've got across the top of the page is the journey of the patient for type 2 diabetes. Those patients are typically told early on to do diet and exercise. And then they're put on oral medications, usually metformin, which is a generic. And then they'll go on to other medications and then on to injectables. And at some point, they're told they need insulin. Omnipod DASH plays, right now, for people with intensive insulin needs, where they're doing a basal rate and a bolus typically. Omnipod basal-only moves upstream in that progression. It's intended for people who are going on to insulin for the first time who are going to use a basal-only rate. So they'd typically, right now, be told to inject themselves once in the morning with the base dose of insulin for the day. Now the challenge for those patients is first, they've been told through their whole patient journey that, that's a failure case. And so they don't want to go on insulin. And the other thing is they often don't like needles, and there's a lot of needle phobia in this space. And you have to remember to do that routine. And for most patients with type 2 diabetes, they're managing a lot. They usually have comorbidities. They've got a lot of things on. They're trying to manage their weight. They're trying to manage their diet. There's a lot of things going on. And so the intent of Omnipod DASH is to massively simplify that, is to accelerate, make it easier for people to get on to insulin when they need insulin, remove all the needle issues. It's the same basic platform. You put it on your arm. It works for 3 days. It will deliver a trickle rate of your daily basal dose of insulin. Unlike our other products, it doesn't require a lockdown phone controller, which we call a PDM or a personalized diabetes manager. It does not require a controller. It does not require a connection to a CGM. It's just a simple base rate injection device. We think it will drive up adherence on therapy, which is what many physicians worry about. We think it will get people onto insulin earlier and massively simplify their use of insulin. That -- in the U.S. alone, that represents an opportunity of 3 million patients. So we're very excited about that. The benefit to the business will be once those patients are using an Omnipod platform, they get used to the on-body wear experience, almost all of these patients progress down that purple line. Almost all of these patients will end up needing intensive insulin. And when they do, our intent is for them to transition on to Omnipod 5. Omnipod 5 has fantastic feasibility study data that we presented last year at ATTD for people with type 2 diabetes. When people with type 2 diabetes wear Omnipod 5, they dramatically increase their blood control -- their control of their time in range, dramatic increase in time in range. They also, interestingly, in our feasibility study, dramatically reduce their total insulin need. So the reduction -- they reduce the amount of insulin they need, which is a huge benefit to patients and to the system. We have announced that we got FDA approval. We announced on our Q4 call, the FDA has approved our protocol for our pivotal trial in the U.S. to get the indication for use for people with type 2 diabetes with Omnipod 5. We will be beginning the enrollment of that trial imminently. We intend to begin that in the very near term. That will be a 350-patient trial, each patient in for 90 days. Once we've completed it, we'll file with the FDA to extend the label for Omnipod 5 into type 2 diabetes, which we think will be another huge avenue of growth. And when all these piece parts are in place, we will have the broadest portfolio of insulin delivery offerings for people with type 2 diabetes. We think this represents a massive growth lever for us. More importantly, we think we'll really be able to simplify lives for people on insulin who have type 2 diabetes. That's just one of our avenues of innovation. Let me just give you a sense of where we're going. This is a notional 3-horizon slide. I'm sure you've seen this format before. It's not intended to imply any timing. So it'll just give you a sense of sequencing on how we see our road map unfolding. Right now, we're laser-focused on driving Omnipod 5. And that means continued growth in the U.S. where we enjoyed a really phenomenal success and phenomenal adoption of Omnipod 5 in the U.S. market. We will launch Omnipod 5 in our existing international markets. We've announced that this year and midyear, we'll be launching Omnipod 5 in the U.K. And by the end of the year, we'll be launching it in Germany. And our intent is to cascade those launches throughout our existing markets into 2024. We're working hard with both our partners, both our CGM partners, Dexcom and Abbott, working really closely with them. We're obviously already on market with the G6. With Abbott's big announcement yesterday, there are now 4 iCGM products available -- cleared in the U.S. market. And we want to be on all 4 of those sensors. We're working hard with Abbott to get on the Libre sensors. We're working hard on G7. Those take time, but we'll get our market with those as quickly as we can. Our goal is to provide as much choice as possible to our customers. So when we talk about the different CGMs, we talk about having an offering that we call SOC or sensor of choice. And we want people -- we want to live in a world where somebody going on to Omnipod 5 can have a drop-down menu in their start-up and they say, which sensor are you on? They choose a sensor, and it connects to the sensor. And that's what we're building to. That will take some time, but the choice will be terrific. And it's -- congratulations to Abbott on their new announcement. It's a big development in the market. And we're working on iOS phone control. Right now, we have our PDMs. Our phone controllers are based on an Android system, and we do offer an app in the Android space with several handsets so that we have full phone control for our products on the Android platform. We're working hard on getting the iOS or the Apple system launched. We're close to filing that product. It's been in the works for some time. We're really happy with that app. We want to extend that choice to our customers as well. So Omnipod 5, laser-focused on driving growth with that platform. We also intend to expand our TAM. I've already talked about what we intend to do in type 2 diabetes, which we see as a huge growth lever for us. We're going to continue to expand geographically. We're only in 23 markets outside the U.S. We will -- we continue to plan for a road map of other countries. The other thing that we want to talk about with you all in the Q&A, if you like, is how we're going to use data products. Data products will continue to be a growth lever for us. As I've said, every Omnipod 5 is cloud-connected, and that allows us to see usage patterns. We just -- in Berlin, at this year's ATTD, our presentation was around the first slice of our real-world evidence. And so we can see usage patterns from every single patient on the Omnipod 5 platform. That means that our data is different in character and is better from what our competitors can do. And I'm happy to talk about that in Q&A, but we showed some stunning results, stunning data at -- in Berlin. The first thing showed terrific time in range results but also showed the flexibility of the Omnipod 5 platform for our users. It turns out many of our users like to use different glucose targets. And the younger you are, the more likely you are to use a different glucose target at different times of the day. Omnipod 5 performs really well at time in target in addition to time in range, and that provides tons of flexibility for our customers. We will continue then to innovate on all of that. So data will become really important for us. We have usage data on every Omnipod 5 user. We'll be able to protect the privacy of those users, protect the security of the data, but use that de-identified data to drive massive improvement in the patient experience. We'll be able to improve our algorithms over time. We'll be able to improve workflows for physicians. And ultimately, we'll be able to help payers manage their population of diabetes patients better. That will be a massive moat around our business and will drive huge product preference for us over time. We'll also -- we're working on next-generation hardware, different footprints, different form factors. And we're working, as I said, on next-gen algorithms. So we have a very vibrant innovation road map. There are lots of things coming. But right now, we are thrilled to be enjoying the adoption and success we have with Omnipod 5. We're absolutely committed to creating value for shareholders. We're very proud of our track record of growth. Over the last 5 years, we've had a revenue CAGR of 23%, and we announced 22% growth for 2022 just on our quarterly call. That represents the seventh consecutive year that insulin has delivered plus -- 20% plus growth annually. That's a remarkable achievement. We call ourselves a hypergrowth company. We're very proud of that growth. We continue to plan for that level of growth. We're going to drive growth for our shareholders and deliver results. And so you can see, the way we do that is we continue to invest in innovation. So we spend quite a lot of money in R&D, and we know it. And we're doing it very deliberately because we believe we have an edge. We're the market leader. We're going to continue to drive innovation and continue to lead with innovation and grow the business with our innovation. But even with all of that, we have a strong track record of improving our operating margins. So over that same time period, with 23% CAGR in revenue, we have an 11-point increase in our operating income. And we'll continue to drive profitability into the business over time. We're very proud of what we deliver for shareholders, and we're very grateful to shareholders for supporting us in what we deliver every day to people living with diabetes. So just in quick sum, massive growth opportunity, massive market, underpenetrated. We're the market leader with the best technology. Omnipod 5 is going to realize that opportunity. We're going to build off the Omnipod 5 platform and drive tons of revenue and tons of adoption and growth. We're going to meet the needs of millions of patients with Omnipod 5. We're going to embark upon a real portfolio of growth for type 2 diabetes, people living with type 2, which will include basal-only and Omnipod 5 as we get the label for it. And we're committed to growing revenue, delivering value, growing earnings for shareholders. And I'm just going to finish with this. I started with a story. This is Grant. Grant is 6 years old. He was diagnosed with type 1 diabetes when his family was on vacation and he was hospitalized. And they didn't know what was going on with him. Took him to the hospital, it turns out he had type 1 diabetes, and he had an event. And so he stayed in the hospital for a few days. They sent them home. And the doctor said, "We'd like to put -- he's a great candidate for a pump because he's so active. So we want to put him on an insulin pump. But let him stabilize, send him home for a few days, teach him how to do MDI, let him stabilize, and then we'll get you all set up on a pump." And so Grant went home and went online and looked at what was available. And his mom came home from the doctor a week later with brochures for all the competitors in the market. And as soon as she laid them down, he pointed to the Omnipod 5, and he said, "Mom, that's the one I want. That's it. That's it right there." And so he's obviously a very smart kid, first. But second, they love the Omnipod 5. They're having a great experience with it. And this one -- Grant often chokes me up because there's a video that was posted by the family, and they sent us, of him getting his Omnipod 5. And he runs around and he cries and he hugs his mom. And that's really why we do what we do. For Grant and for -- actually, for customers of all ages, that's the kind of simplicity we want to deliver for people as they live with this condition, diabetes, that creates such a burden for them. And very grateful for Grant's family to fill us in on the story and really excited about what we're doing. So thank you. With that, I think we're ready to take some questions.
Jayson Bedford
analystYes. Thanks, Jim. Well done. We'll -- we've got about, I want to say, 5 minutes here. So I guess just to start with before we go into the pipeline, there's a little bit of investor concern around pump market growth. You guys have grown quite well and are expanding the market more than the others. But are there any kind of structural impediments or pump growth getting to where -- or sorry, pump penetration getting to where CGM penetration is today in type 1? So let's assume 60%, 65% CGM penetration in people with type 1 diabetes in the U.S. Can pump penetration get there?
James Hollingshead
executiveThat's a really useful question. I think, first of all, I should say the CGMs have been paving the road for us for years. And so the ones -- as the CGMs got on the market, they do a couple of things. They drive benefits for customers who -- and those customers see the value of the data. But they also get used to an on-body wear experience. They also, to some extent, have paved the road in reimbursement, right? And so they're paving the road, and we're coming behind them. I think logically, you could ask that question, will pumps penetrate to that level? But I have to say that I'm very optimistic about what we can do with our pumps. And so if you talk to physicians, it's -- there's a learning curve now that physicians are going through. And if you think about the traditional pump, think about our competitors' pumps that have a cannula and a tube, things that get caught on doorknobs, that's the big complaint about pumps. And there's a perception in the physician base that pumps are difficult to learn. And so a lot of times, what you'll hear from physicians is, "I just don't think that patient could handle a pump." It's totally different for Omnipod 5. And so -- and it's so easy to set up Omnipod 5. And for that matter, it's easy to set up DASH. With Omnipod 5 in automated mode, the simplicity is really great. So I think that if you thought of it as an adoption curve, a lot of people will do that kind of technology, fast follower into mass market adoption curve analysis on the market. If you think of it that way with tube pumps, I do think tube pumps hit a ceiling, but I think their ceiling is well below our ceiling. I think that what happens is because of the simplicity of the Omnipod platform, and especially of Omnipod 5, we're going to be able to bring more people into the market than the tube pump players can. And we're seeing that now with improved new customer starts. So I tend to think of us as being, frankly, it sounds corny, but somewhat different category than the tube pump players. And I think we can drive adoption well above what's been modeled maybe by some of the third-party industry analysts.
Jayson Bedford
analystIf I'm someone with type 1 diabetes and I'm only using CGM, why wouldn't I bring on a pump?
James Hollingshead
executiveBecause you might perceive the pump as being obtrusive. You may not want to deal with that, right? And that's why I think we're having such rapid adoption of Omnipod 5 because the on-body experience of Omnipod 5 and the outcomes from Omnipod 5, depending on the demographic, right? There are a lot of people -- I was talking to a physician in Orange County, and he was describing a group of patients who he has -- who take off their tubed pump to go do an activity. They take it off to go play beach volleyball or do something. You don't have to do that with Omnipod 5. You can wear your Omnipod 5 swimming. It's waterproof. You can wear it to do whatever activities you want. And so if you're a type 1 patient and you're holding off on getting a pump because of the obtrusiveness and the hassle of a tube pump, Omnipod 5 creates a new opportunity for you. And I think that's one of the many reasons we're seeing such great growth right now.
Jayson Bedford
analystAnd we might as well get this question out of the way on the webcast. With Abbott, where are you in development and any comments on timing?
James Hollingshead
executiveWe don't report our time lines, as you well know, on these products with Abbott. First of all, congratulations to our partners at Abbott. That's a great milestone for them to have hit, getting FDA clearance on both FreeStyle Libre 2 and on FreeStyle Libre 3 all at once. It's fantastic for them and for the market. We've been working closely with Abbott for some time to complete our data integration with the FreeStyle family of sensors, and this was an expected milestone inside our existing work plan. We didn't know exactly when FDA clearance would come, but we were assuming in effect that FDA clearance would come. At one point, we got to the point where we said to ourselves, you have this, it will get FDA cleared because of our work with them and looking at the algorithm. And so we knew it was going to come. It doesn't really change our time lines. We're working hard, and we want to get on market with FreeStyle Libre as soon as we can.
Jayson Bedford
analystOkay. And maybe just the last question before we break. You've had great success in the U.S. here with Omnipod 5. Internationally -- international seems like it's the next beacon here. What do you need to do? What hurdles do you need to get over here to launch this? I realize U.K. and Germany this year, but what else do you need to do for this to be ready for launch?
James Hollingshead
executiveAt this point, the real -- the finishing steps involve mostly cloud infrastructure. And so in the U.K. and Germany, we're ready to -- we're effectively ready to do that. We're planning for launch. There is massive pent-up demand in Europe at ATTD. We heard from KOLs from all over our European markets about please now, please as quickly as you can. Because Omnipod 5 is cloud-connected, the way we manage that data, the way we manage data privacy and security is regulated both at the EU level and then at the local market level and then at the local customer level. So you have to engage in BAA agreements. You have to -- so there's a cascade. The cloud infrastructure is well in train. And then since we're launching it, you can tell it's well in train. We have some specific things to do for each market. And so we plan to accelerate those launches into Europe. We're very excited about bringing Omnipod 5 to customers in Europe.
Jayson Bedford
analystOkay. With that, we're out of time. So thank you so much. We'll see you downstairs at the breakout.
James Hollingshead
executiveThank you all.
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