Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation First Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Deborah Gordon, Vice President, Investor Relations. .

Thank you, and good afternoon, and thank you for joining us for Insulet's First Quarter 2021 Earnings Call. With me today are Shacey Petrovic, President and Chief Executive Officer; and Wayde McMillan, Executive Vice President and Chief Financial Officer.

Both the replay of this call and the press release discussing our first quarter 2021 results and 2021 guidance will be available on the Investor Relations section of our website.

Before we begin, I would like to inform you that certain statements made by Insulet during the course of this call may be forward-looking and could materially differ from current expectations. Please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such statements.

We'll also discuss non-GAAP financial measures with respect to our performance, namely adjusted EBITDA in constant currency revenue, which is revenue growth, excluding the effect of foreign exchange.

These measures align with what management uses as supplemental measures in assessing our operating performance and we believe they are helpful to investors, analysts and other interested parties as measures of our operating performance from period to period.

Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year reported basis with the exception of revenue growth rates, which will be on a year-over-year constant currency basis. With that, I'll turn the call over to Shacey. .

Thanks, Deb. Good afternoon, everyone, and thank you for joining us. We are off to a strong start to the year, with first quarter revenue growth of 24%. Both our U.S. and international diabetes product lines achieved solid results with total Omnipod growth of 19%. We are on track to deliver another year of double-digit revenue growth.

We have sustained momentum across our business, and we are preparing for the highly anticipated launch of Omnipod 5. We continue to execute at a high level, which speaks to the strength of our team and our deep commitment to Insulet's mission to improve the lives of people with diabetes.

During the first quarter, we advanced each of our strategic imperatives, including expanding access and awareness, delivering consumer-focused innovation, growing our global addressable market and driving operational excellence.

Let's begin with access and awareness and how Omnipod remains well positioned to further eliminate access barriers and displace legacy therapies.

The progress we've made to date is largely due to the differentiated customer experience Omnipod provides, our tubeless form factor, simple user interface, unique business model and expanding presence in the U.S. pharmacy channel. There are millions of people around the globe living with diabetes, and yet this population is critically underserved.

There are far too many people that either don't have access to Omnipod, are unaware of our product, or in some cases, both. This must change as Omnipod can simplify lives and deliver improved outcomes.

The value Omnipod provides is clearly demonstrated by our ability to drive new customer growth from multiple daily injection users in the type one and type two segments. Approximately 80% of our new customers switch from MDI to Omnipod. Additionally, in the first quarter, between 35% and 40% of our new U.S. customers were type 2.

Much of this growth has been driven by Omnipod DASH, which offers tremendous benefits compared to existing therapies. As a result, we continue to transition a growing percentage of our U.S. pod volume through our pay-as-you-go model in the pharmacy channel.

This provides increased access for customers, low co-pays and no upfront costs or multiyear lock-in periods. It simplifies access, making Omnipod easier to prescribe for physicians, provides a number of benefits to payers and drives our recurring revenue. Today, our technology and form factors stand at the forefront of innovation, while our U.S.

pharmacy channel and pay-as-you-go business model are eliminating long-standing access barriers. This combination uniquely positions Insulet to further penetrate both the type one and type two insulin intensive markets. By the end of Q1, we had secured coverage for over 75% of U.S.

covered lives for Omnipod DASH, and the majority of our new customers across the globe start on Omnipod DASH. At the same time, we are focused on expanding Omnipod awareness, given the diabetes market is large, yet critically underserved. Last year, we launched our direct-to-consumer advertising campaign in the United States.

The reaction to date has been positive, and we have already started to see incremental new customer starts. We have also begun to pilot DTC in the United Kingdom. It is early days for both our domestic and international campaigns.

But we know there is tremendous opportunity to help more people across the globe learn about the life-changing benefits of Omnipod. Driving access and awareness are core components of our growth strategy and complement our commitment to delivering market-leading innovation.

We believe the combination of enhanced access and superior innovation, improves outcomes and makes living with diabetes or caring for loved ones less burdensome. All of this has resulted in consistently strong Omnipod adoption and customer retention and a global customer base that surpassed 0.25 million people in Q1.

We accomplished this despite not having an AID product in the market, and this will soon change with our Omnipod five automated insulin delivery system, which we believe is the future of insulin delivery. Omnipod five unlocks a new level of freedom and simplicity through easier insulin management and significantly improved glucose control.

The number of firsts Omnipod five brings to market is compelling. It is the first tubeless, entirely wearable AID system with a personalized, adaptive on-target algorithm embedded in every pod. This means there is no need to disconnect or interrupt therapy other than the few minutes it takes to change a pod every three days.

This is critical as interruptions in continuous insulin delivery lead to suboptimal outcomes. Managing diabetes will be easier and more discrete as Omnipod five customers will have complete smartphone control for all system functions.

At launch, we will offer full control from personal Android smartphones and every customer will also receive a controller that includes a SIM card. This marks another important distinction between Omnipod five and other options available in the market.

No other AID system offers real-time connectivity, even when not near WiFi and real-time remote monitoring through SIM and personal phone control. Omnipod five users will always be able to view their data on their smartphones and loved ones will always be able to know how their Podders are doing in real time on the Omnipod five VIEW app.

Omnipod five is the only system with customizable glucose targets for different times of day and also a hypo protect feature that can be used in times of greater hypoglycemia risk.

Additionally, our AID system is the only one to provide a smart bolus calculator that recommends more or less insulin based on a user's CGM trend, not just the CGM value alone. All of this while maintaining the same form factor our customers love.

We are confident that Omnipod five will mark a major improvement in quality of life and diabetes management. In the U.S., Omnipod five will be available only through the pharmacy channel. We'll utilize our unique pay-as-you-go model and will be priced at parity with Omnipod DASH.

As a result, the low monthly out-of-pocket costs for Omnipod five should be comparable to both Omnipod DASH and MDI. Like Omnipod DASH, we expect the majority of Omnipod five customers in the U.S. to have a monthly pharmacy co-pay of under $50. In addition, through our 30 Days of Freedom trial, anyone can try Omnipod five free for 30 days.

Our goal is to quickly secure broad affordable coverage and expanded access. We believe the broad coverage we have established for Omnipod DASH will continue to serve as a major competitive advantage and a strong foundation for our efforts to drive access to Omnipod 5.

Although Omnipod five has breakthrough device designation and the FDA has been incredibly supportive and collaborative throughout its review process, the clearance time line is taking longer than we had anticipated.

The feedback we have received to date has been in line with our expectations, and we remain optimistic that we will receive Omnipod five clearance by the end of June or shortly thereafter. But given the current environment and the associated lengthened review time, clearance could shift into the second half of the year.

As a result, we now expect to begin our limited commercial release in the second half of 2021. We do not expect this will have a material impact on revenue guidance, and our internal teams are certainly not standing still. We are building Omnipod five inventory.

We are developing commercial launch materials and testing our systems and processes, and we are securing coverage for Omnipod 5. Our teams are geared up for what we fully expect will be the best technology and customer experience on the market and a wildly successful launch.

The value Omnipod five offers to people with diabetes was clearly demonstrated via the impressive pivotal data we shared in March at ENDO 2021. Our pivotal study included children and adults ages six to 70.

Compared to standard therapy, Omnipod five achieved significantly higher time and range and improved A1c while maintaining or lowering hyperglycemia. After three months on Omnipod 5, 53% of children and 66% of adults achieved an A1c of less than 7%.

Time and range for children increased 16 points to 68%, while timing range for adults and adolescents increased nine points to 74%. Additionally, time in hypoglycemia was reduced for adults and remained very low in children.

Omnipod five will offer meaningful value for individuals living with diabetes as well as for their families, physicians and payers. It's a clear testament to our innovation team that we were able to achieve this very competitive time in range, while also delivering the strongest published hypoglycemia performance.

We have additional Omnipod five abstracts accepted for presentation at upcoming diabetes conferences in June. These address a number of important areas, including performance in preschool aged children, the transition from multiple daily injections directly on to Omnipod five and quality of life outcomes.

Also on the clinical front, we had impactful domestic and international data recently published in several leading peer-reviewed diabetes journals. Collectively, the results shared in these publications demonstrate that Omnipod can drive improved outcomes across a broad range of people living with either type one or type two diabetes.

These improved outcomes span multiple age groups and disease states as well as people coming from different forms of therapy. We continue to invest clinically and have a compelling road map, including our work to expand our Omnipod five indication to preschoolers down to H2 and to secure a type two indication.

The first phase of our preschool study is complete, and we are progressing well through our planned 12-month extension phase, which allows us to collect longer durable outcomes and allows our trial participants to continue on Omnipod 5, which they all elected to do.

Additionally, our type two feasibility study is now fully enrolled and the results are illuminating. During ENDO 2021, Dr. Bruce Bode presented early data from our type two study that showed encouraging results for Omnipod 5, with time and range that more than doubled in the first eight weeks.

The type two diabetes market offers tremendous opportunity for Insulet, and we will continue to innovate to further penetrate this largely underserved population.

The depth and breadth of the clinical data published and presented in just this last quarter demonstrates our commitment to building strong clinical evidence that supports how Omnipod will continue to improve outcomes for people living with insulin-dependent diabetes.

We continue to advance our pipeline, and we look forward to sharing additional clinical data in the future. Omnipod five is our top innovation priority. However, we are diligently working to advance a robust pipeline that extends well beyond.

We know that our success over the long term requires leadership in critical areas such as software development, data science and other core competencies. This includes the integration of Omnipod five and our future products with next generations of products by Dexcom and Abbott.

Beyond Omnipod 5, we have begun product development on innovations that we believe will offer significant value to people living with both type one and type two diabetes. Moving to global expansion. We are expanding access and awareness of Omnipod in a number of attractive markets.

Last year, we entered five new countries within Europe and the Middle East. This quarter, we expanded into Turkey, and we continued to gear up for an expected launch in Australia later this year. Our international expansion efforts will drive access to a huge global addressable market.

Across our current footprint, we estimate there are 11 million to 12 million people living with insulin-dependent diabetes. We see attractive future expansion opportunities that will further grow our total addressable market and bring our technology to people living with diabetes around the world.

The international launch of Omnipod DASH has been highly successful and work is underway to bring Omnipod five to our international markets. Lastly, we continue to invest significantly in our global manufacturing operations.

We are well positioned to meet growing consumer demand for Omnipod DASH as well as the commercial launch of Omnipod 5, our broader innovation pipeline and our future international expansion plans. Operational excellence is one of our key strategic imperatives that is enabling growth today and will do so well into the future.

As part of this strategy, Insulet is committed to responsible and sustainable growth. We have developed a comprehensive sustainability strategy that builds upon our existing capabilities, provides value to our stakeholders and considers the most important ESG issues that affect our business, society and planet.

We recently published our 2020 sustainability report, which outlines our commitment to addressing important ESG issues and highlights our key priorities. All of us at Insulet are dedicated to a business resiliency and responsible business practices that help our customers, our employees and our communities thrive.

In closing, we are off to a strong start in 2021. We expect to deliver another year of double-digit revenue growth, launch Omnipod five and advance our innovation pipeline to continue to bring life-changing innovations to people with diabetes in order to simplify and improve their lives. I'll now turn the call over to Wayde. .

increased scale and efficiencies provided by our global manufacturing operations and positive mix from the continued volume shift into the U.S. pharmacy channel. We also benefit from a planned reduction in COVID-related mitigation and safety-related costs.

We continue to expect operating expenses will largely rise in line with revenue growth this year as we invest in consumer-focused innovation and best position ourselves for increased market penetration. This includes investments in our sales and marketing teams ahead of the launch of Omnipod five and to support our international market initiatives.

As a result of our strong revenue growth, combined with gross margin expansion and the investments we are making across our business, we are reaffirming operating margin for full year 2021 in the low double-digit range, up significantly from 5.7% in 2020. We expect operating margin will improve sequentially throughout the year.

Lastly, we continue to expect capital expenditures to increase in 2021 as we further invest in our global manufacturing operations and strategic imperatives to support our strong growth expectations. Turning to our second quarter 2021 guidance. We expect total company revenue growth of 10% to 14%.

This includes total Omnipod revenue growth of 14% to 17%. We expect Q2 U.S. Omnipod revenue growth of 17% to 20%, driven primarily by our growing customer base fueled by Omnipod DASH volume growth and the mix benefit we realized in the pharmacy channel.

As a reminder, Q2 growth is impacted by the tough prior year comparison where we experienced a net impact of estimated distributor channel and end customer inventory levels at the start of the pandemic. We expect international Omnipod revenue growth of 10% to 13%.

This reflects the ongoing growth in our customer base from increased Omnipod DASH adoption, partially offset by the headwind of lower new customer starts in 2020, stemming from the pandemic as well as the continued pandemic impacts throughout many of our international markets.

Also, the benefit in Q1 from the timing of Omnipod DASH PDM orders is not expected to occur again in Q2. We also expect drug delivery revenue to decline 16% to 24% due to the normalization of order volumes in the current year as compared to elevated levels in the prior year due to the pandemic. In conclusion, we are off to a strong start in 2021.

We remain on track for robust revenue growth and operating margin expansion continue to advance our strategic imperatives and are in a solid financial position to continue to invest for growth. We are building a foundation for long-term sustainable revenue growth, margin expansion and increased value creation for our stakeholders.

With that, we'll turn the call over to the operator for Q&A..

Operator [Operator Instructions] Our first question comes from the line of Jeff Johnson from Baird..

Sorry, guys, I was on mute. Shacey, I just wanted to start with a question on the timing around Omnipod 5. It sounds like -- I don't want to put words in your mouth, but a couple of few weeks of potential delay here. That's kind of the wording we heard last night from one of your competitors on a mobile bolus app. So I guess, two things.

One is, are some of these delays tied more to just the FDA is overwhelmed right now with COVID-related items? Or maybe overwhelmed in some other way? Are they nervous at all on phone and mobile bolusing apps and just kind of phone control? Just wondering kind of what you're hearing from the FDA for that delay? And how confident are you that it might be that short time period, however long you want to define that?.

Yes. Thanks, Jeff. Well, I think it's true. It's kind of an industry-wide thing. Like others, we are experiencing the longer-than-expected review process. I don't believe this is due to anything but just the workload, frankly, at the agency. And we're really sensitive to that.

They have done an incredible job navigating through all of the challenges related to the pandemic. Our local team, our review team has been incredibly responsive and collaborative. And so we feel very good about where we are, we're in the final stages of this review process.

And I don't believe that there's any sort of any other drivers outside of the workload tied to the pandemic. In fact, we gave ourselves quite a bit of buffer in the time line. And so my remarks are really prompted by the fact that we're getting through that buffer. And so the review process is taking a bit longer than we expected.

But we're in the final stages and feel good about where we are. .

I show our next question comes from the line of Robbie Marcus from JPMorgan..

Great. Two for me.

One, Wayde, I'd love to get a sense of after you gave guidance at the end of February on the fourth quarter earnings call, how the rest of third quarter trended? I know diabetes can sometimes have different trends than what we see across the rest of med tech in terms of procedure volumes? And then how it played out versus your expectations throughout the rest of the quarter?.

Robbie, yes, sounds good. And it's actually a really good question because there's quite a few dynamics rolling out. And I think diabetes does have some uniqueness to it. So why don't we think about it first in the U.S. and what we've seen in the U.S. is really at the end of 2020, we saw the access to customers and the market really start to turn.

We're still dealing with some pandemic issues in the U.S., but we really saw it start to level out in the end of Q4 '20 and obviously, with a 23% growth rate here in the quarter start to pick up.

One thing we've talked about in the past that was unexpected was we thought we would see seasonality change a little bit more in Q1 in -- moved into the pharmacy. We have 45% of our volume in the pharmacy now and we really didn't see that. So that was kind of a unique impact.

And we think it's really due to the fact that customers still have buying patterns that are related to the legacy market paradigm here in diabetes and the traditional order patterns of buying more in Q4 as well as people throughout the value chain, distributors, wholesalers, even physicians thinking about prescribing pumps at the end of the year versus the start of the year.

So I think it's going to take more time than we expected to see some of those seasonal trends take place. And as we think about the rest of the year for the U.S., I mean, really strong. We think we've got a strong guide for the second half, and we start to build momentum. Just a reminder that we do have an annuity model here at Insulet.

And so we start to build momentum. We had a record Q1 start -- new customer starts here. We had a record Q4 in 2020. So you put those two together, and we're starting to build momentum up again and you see that start to build in our growth rate here in the second half. That's implied in our guide. And then internationally, it's a different story.

We are seeing the pandemic persist. It was longer and more difficult through the end of 2020. And we can see that as it rolls into our annuity model here in the first half of 2021. And so we'll see that persist longer internationally.

Having said that, we still feel we had a pretty strong growth rate, 13% in the face of the challenges that the team has seen internationally. And just to highlight a couple of the things we're dealing with. We're -- our business is concentrated in a few of the larger regions like the U.K. and France.

And those are the regions where we've seen more lockdowns and more persistence of the pandemic. And so when some of those regions are more challenged, it's harder for our teams to get in and get customers started on new product.

But I mentioned in the prepared remarks, where we are seeing good traction is a lot of interest in our new DASH product, and so that is giving our teams reasons to meet with physicians and with customers. And so we are starting to see signs of improvement internationally as well.

We do think it will persist a little longer into the second half, and that's reflected in our growth rates. At the high end of our growth rates, we get up to that 17% range. And as you know, our expectations for the region are high-teens, low-20s.

So optimistically, if we see the pandemic start to calm down internationally as well, we'll start to get back into that high-teens growth rate..

I show our next question comes from the line of Larry Biegelsen from Wells Fargo..

Shacey, one on type two patients. This is the second quarter in a row, it was 35% to 40%. Do you see it stabilizing there? Or do you see it growing further? And secondly, how often are type two patients changing their pods.

They tend to use more insulin? So are they doing it more frequently than every three days on average?.

Yes. Larry, great questions. I'll start with the first one. We actually haven't really seen a change in utilization that is noticeable at the population level between type two and type 1. And I think that comes down to a reduction in total daily dose of insulin.

And in fact, we mentioned this in the press release, but we had some incredible data published this last quarter, most recently -- or on type two rather, the data was published in diabetes research and clinical practice.

And this looked at almost 3,600 patients and demonstrated statistically significant reduction in A1c, but maybe even more surprisingly a 32% reduction in total daily dose of insulin. And that was regardless of which therapy they were coming from multiple daily injections or previous pump therapy.

So I think that points to the value of Omnipod and site rotation among other things, and it's probably playing out in the patient experience out there, which is why we don't see, broadly, utilization increasing in the population. It was steady this quarter. And then the other question that you had, on type 2... .

35% to 40%..

Was 35% to 40%. It actually has ticked up every quarter. It's just a broad range. So it is growing, and it is probably growing faster than our total new customers, which are growing quickly as well..

I show our next question comes from the line of Marissa Bych from Morgan Stanley..

This is Marissa Bych from Morgan Stanley. I just wanted to go back, Wayde, and I appreciate your commentary on the second quarter guidance and the ex U.S. COVID-19 impact is very understandable.

In the U.S., it seems like the sequential growth that we're expecting for the second quarter versus the first quarter is a little bit lower than history, just based on pharmacy seasonality.

Is that really the entirety of the story in the U.S.? Or is there anything else that we're missing in terms of COVID resurgences or really anything else?.

Yes. Marissa, I think you've got most of it. I would just highlight one of the things I called out in the prepared remarks was the tough comp we have, and that's because of the inventory build we saw last year in Q2 at the start of the pandemic. That's about a 5% impact to the growth rate.

So if you add -- if you just add that tough comp for the inventory last year, that puts us into the mid-20s, even above the Q1 growth rate and so that's in there. But as you mentioned, there's also some dynamics between Q1 and Q2. The pharmacy channel, we're still learning.

It's still new to us and we're still monitoring it and to see how that plays out. But another way to think about Q2 for us is we have -- at the high end of our guide, a similar sequential dollar growth rate, $12 million growth rate, same as we experienced last year. So that's another thing to ground on. We'll see how it goes.

We're also closely watching the pandemic in the U.S. We're not free and clear of that yet, and the teams are doing a great job selling through it. Our virtual training capabilities are really helping us here. And we'll see how that continues to play out in the U.S. We're very optimistic with vaccine rollout across the U.S.

and things continued to improve. And again, if you normalize for the growth rate that puts us into that mid-20s. And then our implied growth rate in the U.S. for the second half is mid to high-20s. And so in an annuity model, just a reminder for everybody, it takes several quarters to build up the new customer starts.

Last year, Q2 for us was a low new customer start quarter, but we still had 30% growth because of the momentum coming into the quarter. So we're excited here to be building momentum again, setting record new customer start quarters.

And if we can continue to do that, you'll see the growth rates climb into that guidance -- implied guidance of high 20% growth rates in the second half..

I show our next question comes from the line of Margaret Kaczor from William Blair..

This is actually Brandon on for Margaret. I wanted to follow up on the type two Omnipod five data. It sounds really encouraging that the data is coming out nicely. I was wondering if you could give us a little bit more details on what the next steps are there.

Does the -- do the algorithms need to be tweaked for the type two patient? Or can we kind of move forward with what you have now and run additional data, if that's what's needed? So just trying to understand what next steps are for type two and Omnipod 5..

Sure, Brandon. Thank you for the question. And yes, as I mentioned, this has been an area of focus for us. We're really excited about the early data that Dr. Bruce Bode presented at ENDO. And we believe that the data was very positive so far with our feasibility study.

So we will take this data and if it remains positive as we close out the feasibility data, we will be able to move into a pivotal. But we'll sort of reserve the right to potentially make changes to the algorithm depending on the final results that we get out of our feasibility study. But so far, so good. The data is really encouraging to date..

I show our next question comes from the line of Jayson Bedford from Raymond James..

I apologize if this has been asked. I've kind of been jumping between calls here. And I don't mean to be critical with the question because obviously, the growth is impressive here. But you've developed a history of exceeding estimates. This quarter, I'd say it was at the high end but didn't necessarily exceed.

Was there anything specific that you saw in the month of March that maybe you didn't expect?.

Jayson, it's Wayde. I can take that one. Well, first of all, international was above the high end of the range and the U.S. was right at the high end of the range. So there wasn't anything too much to really complain about, as you said.

The one thing that was a little surprising to us is we were expecting some more favorable seasonality in Q1 in the pharmacy channel. Now that we've got 45% of our volume rolling through there. It was a small thing, but that was one thing that we are expecting to see.

And we do think that will continue to develop, it just may take a few years to change behavior, not just for customers but all through the value chain. But other than that, as you know, Jayson, we've got a lot of new things going on in both regions, but in particular in the U.S., the pay-as-you-go model is still relatively new.

Our move into type two is new. The DTC campaigns are new. Even DASH uptake is still accelerating for us. So as we think about guidance, we've got a lot of puts and takes, and we're very happy still dealing with the pandemic to print the 23% growth rate.

On a dollar basis, I think the strongest of all the companies out there and we're continuing to expand our leadership position. And so I think as we're approaching $1 billion, our growth rates don't look as impressive as some others, but we're happy to be growing stronger on a dollar basis..

I show our next question comes from the line of Danielle Antalffy from SVB Leerink..

This question, Shacey, is around the type two opportunity. And you guys have been so successful there. So I don't want to sound too greedy, but it feels like there's still such an untapped opportunity today, even with all the work you've done and all the success you've had at the primary care physician level.

We've been doing a lot of work here and talking to primary care physicians. And it feels like they manage so many of these patients, there's still a lot of opportunities.

So just curious if you could talk a little bit more about whether there's any special efforts towards the primary care physician, are you expanding your touch with the primary care physicians or just how you're going after that market from the physician level, I guess, versus patients..

Sure, Danielle, and it's a great question, something we think a lot about. I think you're right, our success in the type two population does not rest on Omnipod 5. For the insulin-dependent type two user, we have an outstanding value proposition with Omnipod DASH. And you can see it in the adoption trajectory.

We are uniquely differentiated in this space because of the simplicity of DASH, because of our market access position with DASH and because of our business model, and it's showing in the growth of that segment. And then I referenced the clinical data earlier.

You add to that clinical outcomes and the data that was published this quarter, looking at those 3,600 patients and showing a 32% reduction in total daily dose of insulin and such an improvement in A1c, that's just really, really powerful.

And so I think we -- I guess the other thing that we do is really address a recognized and frustrating compliance challenge that exists for the clinician and for the patient. And that's because of pods' form factor and simplicity.

So I think at a high level, we believe that Omnipod has the potential to change how clinicians are thinking about therapy in insulin-dependent type two patients. And that's because of all the things that we know already, our simplicity, our user interface, but also the simplicity in access and prescribing.

With no upfront cost, no lock-ins and for a physician, it's just a very easy e-script. And then clinicians and patients can try Omnipod for free. And that -- those are tactics all designed to change physician behavior and patient behavior. And we're having a lot of success with that in the Endo office today.

But you're right, we also have begun to pilot new approaches in our messaging, in our education and in our physician targeting because we know there's there is such a huge opportunity and because we are so well positioned in it. So we're looking at our calls to action in DTC and how we target patients and clinicians.

We're looking at piloting physician targeting of PCPs and looking at our training and support model. So all sorts of things. And I think ultimately, you're right to that awareness, both among people living with insulin-dependent type two and their clinicians. Awareness is really critical to continuing to unlock this opportunity.

So I think the good news is we're having a lot of success today in the Endo office with Omnipod DASH. I think as you look to the future, there's even more exciting things on the horizon, both with Omnipod five and with our ability to move potentially into new physician segments..

I show our next question comes from the line of Joanne Wuensch from Citibank..

I'm trying to get some timing on a couple of things. Sort of out there is the pediatric label for Omnipod 5, the type two label for Omnipod five and then the integration with Abbot's Libre.

Can you just -- if you want to get in quarters or even first half versus second half, sort of get us an idea of when you think we might be seeing those approvals?.

Well, the one thing that we have given a time line publicly on is the pediatric label. And so all of our internal efforts on that front are on track. We have collected the data, finished the study, everything looks good, and we're getting ready to submit shortly to the FDA on that front.

And so that would put us on track in a normal world, put us on track for a label expansion by the end of this year. Obviously, we do recognize, though, that we do have challenges today in terms of the workload and what the FDA is contending with. So I just caution everybody. We're on track on our end and working certainly hard to make that happen.

We haven't given time lines yet on the Type two label indication or on Libre label indication. Just to indicate that, that work is underway. But to give you some sense of things, just remember that we are right now in a feasibility study for type 2, so the next step would be to move into a pivotal study.

So there still is some clinical work to do before we're ready to submit to the FDA for the label expansion. And then Libre, what we've said is that work is underway. That will also include a submission to the FDA, but not any clinical work. So that just kind of gives you a sense of what's ahead of us.

And we'll get more granular with our time lines once we have Omnipod five into full commercial release, which is 100,000% where most of the team is focused today..

I show our next question comes from the line of Kyle Rose from Canaccord..

Just two on my side, and I'll ask them up front. Just from a big picture perspective, it kind of feels like the company, and for that matter, the broader diabetes industry is kind of shifting more towards a software focus rather than just purely on the hardware side.

I mean you've obviously got big investments there, and you've done a lot of work already when we think about DASH and the apps in the Omnipod five side.

But just what other investments do you need to make from a software perspective for future projects? I'm just trying to understand how much of the investment has already been made versus some of the investments that need to be made in the future? And then with respect to the launch of O5, just any commentary around expectations for covered lives when you do move into the controlled launch? And how we should think about maybe the first 12, 18 months from a reimbursement perspective?.

Great. Kyle, both good questions. So first on software. This has been a significant focus and it's funny because we say software, other people say digital. There's actually a lot included in that. When we think about software, we're thinking, obviously, about software developers.

But we think about cybersecurity, we think about interfacing with consumer devices and obviously, our sensor partners and potentially other diabetes technologies. We obviously think about mobile technology, cloud computing and data science. So there's just a lot wrapped into that.

We mentioned last year, we doubled our product development headcount and most -- or teams and most of that doubling took place, in fact, virtually all of it took place in some sort of software function. So we have been building rapidly. And I think I look back and think about where we are in our in these final stages of the clearance for Omnipod 5.

And I think it's so great we made these investments, and we've built such dramatic capabilities here because it is a moat for others behind us to get really good at remote insulin delivery from either a PDM and/or mobile phones. Those are not easy to do. And then obviously, all of the integrations with our partners. I wouldn't say we're done.

This is an area that will be continued investment for us for quite some time to come. We have no shortage of really exciting disruptive innovation programs ahead of us, and we will continue to invest here.

And we've always said we'll get a little bit more maybe public about what those programs might look like as we think about once we've got Omnipod five into full market release.

But areas of investment for us are, for example, continuing to advance our algorithms because that will provide ease of use, more automation and better outcomes continuing to interface with, obviously, additional sensors but also additional phone platforms, continuing to build value in digital.

So things like data, insights and decision support and serving up, generating insights for patients, payers and clinicians. Just as some examples. So we've got work going on in all those areas. And I don't think that's going to slow down anytime soon, and we'll continue to build capabilities there.

And then the second question around Omnipod five and covered lives. As I mentioned in my prepared remarks, the teams are doing a great job here. We're really encouraged by the discussions that have been being had by payers. We're definitely educating the pharmacy channel for the first time on automated insulin delivery and the value of Omnipod 5.

Those conversations are going well. We already have some coverage established. And as we've always said, as the clinical data gets published, we expect more coverage. And then, of course, on clearance, we expect more coverage. And so we're building -- we're right where we expect to be at this point.

Really, really delighted with the team's work and really optimistic that we're going to launch with a decent coverage position. And also build very rapidly from there. So that -- and all of our tactics are really designed to make that happen.

The ones that I mentioned in my script around leveraging the data, pricing at parity, all of that is designed to make sure that we establish rapid access..

I show our next question comes from the line of Ravi Misra from Berenberg Capital..

So I guess I just want to step back to the broader diabetes landscape, if I may, for a second. Becton announced that it's spinning off its business this morning in the diabetes world.

And just looking at their revenue numbers and their kind of focus, can you maybe think about or maybe help us think about how you think about kind of where we are progressing as an industry? I mean, to me, I would think perhaps it's a signal that pumps are the way given that this is a business with flattish revenue focused on needles.

But just curious to see how you guys are thinking about it up there..

Sure. Yes, Ravi, good question. I mean I think you're right. We certainly believe and we've been very public about our belief that this market will double and that we're going to take a very exciting position in this fast-growing market and that is being driven by so many things. We've talked about what's been happening with CGM adoption.

It's actually almost breathtaking when you look back five years and think about what's happened to the blood glucose monitoring business and what's happened with CGM.

It's been a pretty remarkable transformation in the market and the value of real-time CGM data and what that has meant in terms of technology integration and technology adoption among pump therapy. And that is, I would say, still maturing in type one and at the very, very early stages in type 2.

And so I do think, potentially, you could look at that move as just an endorsement of where the market is heading from a pump utilization, technology utilization perspective, both CGM and pumps, really when you look at their business. And I think we feel very well positioned in terms of specifically patch pumps.

There's been a lot of activity out there, players trying to get into patch pumps. BD is one of them. And so I think it also points to how hard what we do is and how well positioned we are.

And when you think about the challenge it takes to do something like we do with Omnipod, just the incredible investment that it takes to serve this market, it is about our IP position. It is about the incredible manufacturing capability.

But it's also about what it takes to serve the commercial market and build the brand and create awareness, et cetera. And that's an area where a player, for example, like BD just didn't have a strong commercial presence there. So I think it's -- from our perspective, we feel very well positioned in a market that is growing very rapidly.

And that's going to happen, I think, explosively in type 1, and we're just at the beginning stages in type 2. So it's a long tail from here, and we feel very well positioned in that space..

I show our next question comes from the line of Anthony Petrone from Jefferies..

Quick two part t question on Omnipod 5. I guess, is there a way to maybe sort of look at the existing Omnipod user base and how it's segmented between BGM and CGM? And how do you see those individual patient populations over time gravitating to O5.

Does one trend faster than the other? Or does everyone sort of converge on an integrated basis? And then if you have any early opinion on retention specifically, how do you see retention on O5 versus a stand-alone Omnipod user trending once the cycle begins?.

Great. Thanks, Anthony. So maybe I'll take the retention one first, just to say that our retention has been very stable. So I think that's a great thing, just especially when you think about how dynamic the market is with new innovations coming. It's great to see that our retention has been stable.

And I would expect that to likely be the same with Omnipod 5, primarily because we have done so much work on the access front. And because we're focused on establishing broad affordable access for Omnipod 5, we know that, that is one of the major reasons for people trading off the product as tied to access and cost.

And so we have prioritized that with DASH, frankly, and then now with Omnipod 5. And I believe that's one of the drivers behind the stability in our retention for patients. As it relates to our user base and who's going to convert more quickly, BGM or CGM users, we certainly see CGM users as a very logical target for this.

And we've said in the past, that's about half of our population. So that's great. But honestly, I think this product is going to be a winner with our patient-based period. There's a lot of exciting benefits around phone control, et cetera. And when I think about what's been happening with our user base, CGM adoption has grown very rapidly.

So every day, that number ticks up a little bit and then that target population becomes even bigger for Omnipod 5. And that's certainly the trend across the United States. And so we've got a really big, exciting target for Omnipod five and a really exciting product to bring to those people. .

I show our next question comes from the line of Matt O'Brien from Piper Sandler..

This is Korinne on for Matt.

So just on the 30-day trial that you're doing, how quickly do you think that will shift over to Omnipod 5? Will that be immediately once you launch it? Are you still going to be using DASH for a little bit? And then just on that topic as well, how many patients are you seeing actually stay on Omnipod after doing this trial? Is there a way to quantify that yet?.

Yes. Korinne, great question. So we won't stop doing 30 Days of Freedom for DASH. This is part of our great position that we have with our business model to be able to essentially sample the product where others can't.

And so it's a tactic to help drive more people who are sitting on multiple daily injections, injecting themselves four to five times a day, really be able to get over the hurdle of trying a new technology. It's been wildly successful for us. The vast majority of people who use the 30 Days of Freedom trial stay on the product.

So it's been a successful tactic for us and one we will continue. And we will likely offer that once we move into full market release. So once we have broader access established for Omnipod five is when we will start to offer that with Omnipod 5. But we'll offer it with both. Remember that Omnipod five is indicated for type 1.

We still anticipate great utilization and growth among certain type one segments as well as obviously the type two user. And so we'll offer them both free trials..

I show our next question comes from the line of Matt Taylor from UBS..

I just had one on phasing. We know that the pandemic depression of new starts is still having an impact here in Q2, but now you've had a couple of quarters of record new starts.

Could you just help us think about how that will start to roll in? And does that help you start to inflect more here in the second half? And any other nuances to help understand the gating over the quarters?.

Yes, Matt. And it is a unique dynamic with our annuity model. And so it definitely makes sense to spend a little more time on that. And you're referencing the U.S., first of all, I would say, just at the high level, we do think that we're through the majority of the pandemic impact in the U.S. We turned the corner at the end of 2020.

And we're now, as you said, in more of an acceleration mode. We had record new customer starts in Q4. Again, here a record for Q1 in the U.S. And so what that positions us for is the strong 23% growth in Q1 with a very tough comp in Q2, still in the high-teens, 20% range.

But what that does specific to your question, Matt, is it positions us for that 24% to 28% growth rate in the second half and starts to get us into the high-20% growth rates. And we haven't been in the 30% growth rate since before the pandemic. A couple of quarters before the pandemic, we were 30%.

As the annuity continues to build here, we're confident that we'll get into the mid- to high-20s. And then just to touch on international because it is a different dynamic. I mentioned earlier, pandemic persisting longer. And so we will take a little longer to build the momentum back up again internationally.

But we've got confidence that we'll do that and we expect international to be high-teens, low-20s nearing the end of this year and after we get on the other side of the pandemic next year. .

Thank you. I'm showing no further questions at this time in the queue. I would like to turn the call back over to Shacey Petrovic for closing remarks. Please go ahead..

Thank you. And thank you, everyone, for joining us today. There is just so much to be excited about at Insulet, and there's much more we can and will accomplish for our customers.

We have passionate employees, transformative innovations and a differentiated business model to continue to displace legacy therapies and to simplify and improve the lives of people with diabetes. Thank you all, and have a great evening..

Thank you for attending today's conference call. This concludes the program. You may all disconnect. Good day..