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Raymond James Institutional Investors Conference

Mar 7, 2023

Jayson Bedford
Managing Director, Raymond James

All right. Good morning. I think we'll start. Welcome to the 44th annual Raymond James Institutional Investor 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. I think I was looking back a decade ago, it was sub $2 billion in market cap. 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, VP of IR, Deborah Gordon. With that, I'm going to hand it over to Jim.

Jim Hollingshead
President and CEO, Insulet

Thanks, Jayson, good morning, everybody, thanks for coming today. Let me start by introducing you to Christian, who you see here on the slide. Christian is nine years old, 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 years ago. His favorite thing to do is to do hoverboarding and skateboarding and to play with his sisters. 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 nine-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. 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 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. 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 wanna talk about the massive growth opportunity that Insulet has in front of it, globally, in the U.S. and globally with our offerings. I wanna 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 wanna reach. I'm gonna 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 wanna give you a double click on our plans for Type 2. I'm gonna 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. I'm gonna 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. 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 and 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. I've been in the CEO chair for just about nine 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. 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 or 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 a, you know, an awkward teenage company, and we're increasingly able to scale our operations, and we have massive advantage and scalability. We have an advantage in our ability to build these pods that I'll, that I'll show you just in a second, to build them at scale with high quality. It's a huge competitive mode for us. We have a huge data infrastructure, and Omnipod 5 is a cloud-connected product.

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. 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 half a billion people around the world live with Diabetes every day. 60 million +, in the slide it says 64 million people, need daily insulin injections, which is what our products deliver. 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's 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. Well, 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. Our TAM is 14 million people. You know, 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 weeks ago or last week, that we've crossed over the threshold of about 360,000 active patients on our Omnipod product platforms.

These numbers represent something like 30-40 x our current installed base on the product. We have a massive runway in front of us in terms of growth. Let's talk about Omnipod and what it does, and I want to start first with the Omnipod platform. That's it right there. Right in the middle of the page is Alicia B. By the way, I should say, every photo we have of a person in a slide deck is an actual what we call Podder. They're an actual user of the product, either Omnipod DASH or Omnipod 5. People send us their photos all the time. You see people uploading videos on social media all the time. We have a really active community of users. That's Alicia, and right below her is the Omnipod. That's a simple wearable.

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. You can see how small and unobtrusive it is. 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. You can see here on the left a kind of more traditional insulin pump. That's 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. It's true, we do compete in that space. Omnipod is an insulin pump.

The platform is an insulin pump, but it has massive advantages of being unobtrusive, tubeless, wearable, disposable, really easy to use. A lot of times people analyze the market, and they'll say, "Well, what's your share in the insulin pump space?" 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. The real purpose of Omnipod 5 is to actually compete with what's on the right of this slide. Those are 14 syringes, and for Omnipod 5, each pod is worn for three days. Over those three days, the average number of self injections it replaces 14 injections. You can see the hassle of that.

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. That's what Omnipod 5 is meant to replace. That's actually our target market. You can see with the percentages on the slide globally, only about 5% of people globally are even on a pump. The reason that's true is because of the tube, the hassle, the durable medical equipment. 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 wanna 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's 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. Even in the U.S. market, there's massive headroom for us to grow, and we're gonna continue to bring MDI users into the market, making the market even bigger. That's Omnipod as a platform. Omnipod 5 adds a new dimension. We've been winning with the Omnipod platform because of its, you know, its no needles or tubes, it's discreet, 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. That tubed pump on the previous page, if you go get that product here in the U.S., you're gonna go through the durable medical equipment channel.

It's gonna cost around $5,000 or $6,000. Your payer is gonna outlay $4,000, $5,000 of that. You're gonna have a $1,000 copay. That puts a burden on the payer, puts a big copay burden on the patient. With Omnipod, both DASH and Omnipod 5, there is no upfront capital cost, you pay as you go. That's a huge benefit to patients. Our patients pay an average copay of less than $50 a month. The vast majority of our patients are less than that. Many of our patients have zero copay. They get that through the pharmacy channel. It's a huge convenience for patients. It also takes risks off of payers. Payers lay out $4 grand upfront. They don't know if the patient's gonna benefit from that tubed offering.

They don't know if the patient's gonna use the tubed offering, and the patient gets locked into a four-year contract. Our patients are not locked into a four-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. Omnipod's winning on all that, has been winning on all that for quite a long time. In August, we went to full market release of the Omnipod 5. 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. Keeps time in range really tightly controlled. 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. 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 one-hour prediction, that 60-minute prediction. It does that in very small increments. We call them microboluses. It's a very tightly controlled system, and it learns your body. Over the first three or four pods, it actually learns how your body reacts to insulin, how much insulin you need, and it doses accordingly.

Automated algorithm right out of the box and over the first three or four pods, which is over the first eight, nine, 10 or so days, it personalizes the algorithm to you. Very, very effective, really revolutionary technology. 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. Excuse me. 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 two quarters, which is astounding. We wanna extend our platform into support for patients with Type 2 diabetes. We are already leader in pump technology for people with Type 2 diabetes because our Omnipod DASH platform has an indication for use there. Up to the launch of Omnipod 5, Type 2 patients represented roughly 30%-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. We continue to have somewhere between 15%-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. The beauty of that product is its 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 go on to other medications, then onto 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 gonna use a basal-only rate. They'll typically right now be told to inject themselves 1 in the morning with a base dose of insulin for the day. The challenge for those patients is, first, they've been told through their whole patient journey that that's a failure case, they don't wanna go on insulin. The other thing is they often don't like needles. You know, there's a lot of needle phobia in this space, you have to remember to do that routine. For most patients with Type 2 diabetes, they usually have comorbidities. They've got a lot of things going on. They're trying to manage their weight. They're trying to manage their diet. There's a lot of things going on.

The intent of Omnipod DASH is to massively simplify that, is to accelerate, make it easier for people to get on insulin when they need insulin, remove all the needle issues. You know, it's the same basic platform. You put it on your arm. It works for three 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 personal, personalized diabetes manager. Does not require a controller. Does not require 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.

In the U.S. alone, that represents an opportunity of 3 million patients. 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. When they do, our intent is for them to transition onto 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 reduced their total insulin need.

They reduced 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'll 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.

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 timings. It'll just give you a sense of sequencing, how we see how we see our roadmap unfolding. Right now, we're laser focused on driving Omnipod 5, and that means continued growth in 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, in 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. 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 four you know, ICGM products available, cleared in the U.S. market, and we wanna be on all four 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 to market with those as quickly as we can.

Our goal is to provide as much choice as possible to our customers. When we talk about the different CGMs, we talk about having an offering that we call SoC or sensor of choice. We want people and we wanna live in a world where somebody going on to Omnipod 5 can have a drop-down menu in their startup, and they say, "Which sensor are you on?" They choose the sensor, and it connects to the sensor. That's what we're building to. That will take some time, but the choice will be terrific and is, you know, we, you know, congratulations to Abbott on their new announcement. It's a big development in the market. We're working. Excuse me. 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 wanna extend that choice to our customers as well. 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 gonna continue to expand geographically. We're only in 23 markets outside the U.S. We've continued to plan for a roadmap of other countries.

The other thing that we wanna talk about with you all if in Q&A, if you like, is how we're gonna use data products. Data products will continue to be a growth lever for us. As I've said, every Omnipod 5 is cloud connected. That allows us to see usage patterns. We just in Berlin, at this year's ATTD, our presentations were around the first slice of our real-world evidence. 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. Happy to talk about that in Q&A, but we showed some stunning results, stunning data at, in Berlin.

First thing showed terrific time in range results, 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, 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 and target in addition to time in range, that provides tons of flexibility for our customers. We will continue then to innovate on all of that. 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, 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're working on next-generation hardware, different footprints, different form factors, and we're working, as I said, on next-gen algorithms. We have a very vibrant innovation roadmap. There are lots of things coming, right now, we're thrilled to be enjoying the adoption and success we are 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 five 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 Insulet has delivered +20% growth annually. That's a remarkable achievement. You know, we call ourselves a hyper-growth company. We're very proud of that growth. We continue to plan for that level of growth. We're gonna drive growth for our shareholders and deliver results. You can see the way we do that is we continue to invest in innovation. 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 gonna continue to drive innovation and continue to lead with innovation and grow the business with our innovation. Even with all of that, we have a strong track record of improving our operating margins.

Over that same time period, with 23% CAGR revenue, we have an 11-point increase in our operating income and will 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. Just in quick sum, massive growth opportunity, massive market, under-penetrated. We're the market leader with the best technology. Omnipod 5 is going to realize that opportunity. We're gonna build off the Omnipod 5 platform and drive tons of revenue and tons of adoption and growth. We're gonna meet the needs of millions of patients with Omnipod 5.

We're gonna 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. We're committed to growing revenue, delivering value, growing earnings for shareholders. I'm just gonna finish with this. I started with this story. This is Brandt. Brandt is six years old. He was diagnosed with Type 1 diabetes when his family was on vacation, and he was hospitalized. They didn't know what was going on with him. Took him to the hospital. Turns out he had Type 1 diabetes, and it had an event. He stayed in the hospital for a few days. They sent him home, and the doctor said, "We'd like to put...

He's a great candidate for a pump because he's so active. We wanna put him on an insulin pump. Let's 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. Brandt went home. Went online and looked at what was available. His mom came home from the doctor, you know, a week later with brochures for all the competitors in the market. 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." He's obviously a very smart kid, first. Second, they love the Omnipod 5. They're having a great experience with it.

This one, Grant often chokes me up because there's a video that was posted by the family 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 wanna deliver for people as they live with this condition, diabetes, that creates such a burden for them. Very grateful for Grant's family to fill us in on the story and really excited about what we're doing. Thank you. With that, I think we're ready to take some questions.

Jayson Bedford
Managing Director, Raymond James

Yep. Thanks, Jim. Well done. We'll we've got about, I wanna say five minutes here. 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 for pump growth getting to where, or sorry, pump penetration getting to where CGM penetration is today in Type 1? Let's assume 60-65% CGM penetration in people with Type 1 diabetes in the U.S. Can pump penetration get there?

Jim Hollingshead
President and CEO, Insulet

That's a really useful question, Jayson. I think, first of all, I should say the CGMs have been paving road for us for years. So as the CGMs get on the market they do a couple of things. They drive benefits for customers who... Those customers see the value of the data. They also get used to an on-body wear experience. They also, to some extent, have paved the road in reimbursement, right? They're paving road, and we're coming behind them. I think logically you could ask that question, "Will pumps penetrate to that level?" I have to say that I'm very optimistic about what we can do with our pumps.

If you talk to physicians, it's, you know, there's a learning curve now that physicians are going through. If you know, think about the traditional pump, think about our competitors' pumps that, you know, have a cannula and a tube, things that get caught on doorknobs. That's the big complaint about pumps. There's a perception in the physician base that pumps are difficult to learn. A lot of times what you'll, you know, what you'll hear from physicians is, "Oh, I just don't think that patient could handle a pump." It's totally different for Omnipod 5, you know. 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.

I think that if you thought of it as an adoption curve, you know, a lot of people will do that kind of technology, you know, fast follower into, you know, mass market, adoption curve, analysis on the market. If you think of it that way with two pumps, I do think two 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 gonna be able to bring more people into the market than the two pump players can. We're seeing that now with improved new customer starts. I tend to think of us as being in a, you know, frankly, that sounds corny but somewhat different category than the two pump players.

I think we can drive adoption, you know, well above what's been modeled maybe by some of the third-party industry analysts.

Jayson Bedford
Managing Director, Raymond James

If I'm someone with Type 1 diabetes, and I'm only using CGM, why wouldn't I bring on a pump?

Jim Hollingshead
President and CEO, Insulet

Because you might perceive the pump as being intrusive. You may not wanna deal with that, right? 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, you know, depending on the demographic, right? There are a lot of people. You know, 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. You know, 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. You know, it's waterproof. You can wear it to do whatever activities you want.

If you're a Type 1 patient, and you're holding off on getting a pump because of the intrusiveness and the hassle of a tube pump, Omnipod 5 creates a new opportunity for you. I think that's one of the many reasons we're seeing such great growth right now.

Jayson Bedford
Managing Director, Raymond James

We might as well get this question out of the way on the webcast. With Abbott, where are you in development? Any comments on timing?

Jim Hollingshead
President and CEO, Insulet

We, we don't report, we don't report our timelines, 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. 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, "Yeah, this...

It'll get FDA cleared because of our work with them and looking at the algorithm. We knew it was gonna come. It doesn't really change our timelines. You know, we're working hard, and we wanna get on market with FreeStyle Libre as soon as we can.

Jayson Bedford
Managing Director, Raymond James

Okay. Maybe just 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.

Jim Hollingshead
President and CEO, Insulet

Yeah.

Jayson Bedford
Managing Director, Raymond James

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.

Jim Hollingshead
President and CEO, Insulet

Yeah.

Jayson Bedford
Managing Director, Raymond James

What else do you need to do for this to be ready for launch?

Jim Hollingshead
President and CEO, Insulet

At this point, the finishing steps involve mostly cloud infrastructure. In the U.K. and Germany, 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, you know, please as quickly as you can. Omnipod 5 is cloud connected, the way we manage that data, the way we manage data privacy and security is regulated both at the E.U. level and then at the local market level, and then at the local customer level. You have to engage in BAA agreements. You have to... There's a cascade. The cloud infrastructure is well in train, and since we're launching you can tell it's well in train.

We have some specific things to do for each market. We plan to accelerate those launches into Europe. We're very excited about bringing Omnipod 5 to customers in Europe.

Jayson Bedford
Managing Director, Raymond James

Okay. With that, we're out of time. Thank you so much.

Jim Hollingshead
President and CEO, Insulet

Great.

Jayson Bedford
Managing Director, Raymond James

We'll see you downstairs.

Jim Hollingshead
President and CEO, Insulet

Thank you all.

Jayson Bedford
Managing Director, Raymond James

when we break out.

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