Q1 2025 Earnings Call Transcript

Good afternoon, ladies and gentlemen, and welcome to the Insulet Corporation First Quarter Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, June Lazaroff, Senior Director, Investor Relations.

Good afternoon, and thank you for joining Insulet's First Quarter 2025 Earnings Call. I would like to welcome Tim Scannell, Chair of our Board of Directors, to our call as well Ashley McEvoy, our new President and Chief Executive Officer. Joining Ashley is Ana Maria Chadwick, Chief Financial Officer and Treasurer. Also joining us for the Q&A portion of today's call is Eric Benjamin, Chief Product and Customer Experience Officer.

Both the replay of this call in the press release with our quarterly results and guidance will be available on the Investor Relations section of our website. Also on our website is supplemental earnings presentation. We encourage you to reference that document for a summary of key metrics and business updates. Before we begin, we remind 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 will also discuss non-GAAP financial measures, with respect to our performance, including adjusted operating adjusted operating income, EBITDA, adjusted tax rate and 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 performance from period to period, and we believe they are helpful for others as well. Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be will be on a year-over-year reported basis with the exception of revenue growth rates, which on a year-over-year constant currency basis.

With that, I will turn the call over to Tim Scannell, Chair of the Board of Directors.

Thank you, and good afternoon, everyone. It is a pleasure to join today's call and share our excitement at the Board level for welcoming Ashley McEvoy to Insulet as President and CEO. I would also like to thank Jim Hollingshead for his leadership of the company over recent years. Ashley is a battle-tested operator who comes to Insulet with a track record of driving durable growth and value creation in market-leading businesses.

She brings over 15 years of leadership experience at scaled consumer franchises complemented by more than a decade in senior leadership roles at Johnson & Johnson where she successfully restored 5 multibillion-dollar global businesses to above-market revenue growth and competitive margins. Ashley brings an exceptional combination of strategic vision, and operational discipline to Insulet. She understands what it takes to lead at scale and do it with speed, accountability and a relentless focus on execution. We appreciate that this transition has raised some questions regarding timing, but we are extremely confident that now is the right time with Insulet positioned for substantial further growth into type 1, type 2, and international markets to bring her leadership to the company.

The Insulet team is already executing well, as is demonstrated by our recent results and the guidance raised today. And moving forward, Ashley and the Insulet leadership team have the Board's full support and confidence to continue driving the company's strategy to lead with differentiated technology and improved the lives of more people with diabetes globally. We believe Ashley's leadership will ensure we continue to execute on that strategy. drive performance at global scale, and deliver value across our team, partners, customers, and shareholders. We are proud of Insulet's success and performance over time and we look forward to supporting Ashley's leadership success during Insulet's next phase of growth.

With that, I will turn the call over to Ashley.

Thank you, Tim, and good afternoon, everyone. Let me start by extending my gratitude, especially to our team for the warm welcome. I'm thrilled and honored to join you today on my first earnings call as the new President and CEO of Insulet. I want to share with you my excitement for this opportunity as well as my background and leadership philosophy to drive Insulet to its next chapter of growth and innovation.

What excites me most about Insulet is its unique position at the intersection of Consumer Health and MedTech. I come to this business as a seasoned operator with a passion for growing businesses and both the consumer and health care sectors. I have a deep appreciation for the consumers' increasing role in health care decisions and understanding that is especially relevant to a wearable technology like Omnipod. What excites me about MedTech today is the incredible progress and innovation towards smarter, less invasive, and more personalized solutions.

We're witnessing a shift where technology is improving clinical outcomes and reshaping the patient experience to become more intuitive and effortless. I also have a passion for scaling businesses, not just in terms of financial performance, but to a relentless focus on growth, innovation, and people. That's what makes this space so energizing. The opportunity to build something that matters and to do it in a way that meets the evolving expectations of patients, providers, and the broader health care ecosystem.

Taking Insulet from $2 billion in revenue and 500,000 global patients to have a substantially greater impact will all be about our people, our culture, our innovation agenda, and our capabilities. Developing portfolio road map, making strategic capital allocation, and executing on our plan will be particularly important as we continue growing within the type 1 market, expand our new type 2 indication, and advance globalization. I look forward to working with the team to strengthen our business practices, ensuring that we are operating with agility and sophistication required of a world-class leader, while maintaining our entrepreneurship and ingenuity.

We are already a pioneer in advanced automation. There's even more work we can do to invest in and optimize our capabilities globally. Further, we will sharpen our focus on brand activation and direct-to-consumer strategies, leveraging the power of Omnipod to reach both health care professionals and patients directly. We'll also harness our unique wealth of data with over 365,000 customers cloud connected today to improve the prescriber and patient experience with Omnipod as we work to improve engagement, retention and outcomes.

My leadership philosophy is really centered on three pillars; purpose, people, and performance. I believe that living our purpose, which is profoundly impactful here at Insulet, serving people within the diabetes community. And by empowering our people further, we will deliver superior results. Insulet is already a standout success story.

We are one of the fastest-growing businesses in med tech, increasingly profitable and delivering positive free cash flow. This success is driven by winning technology and continued investment in market-leading innovation. With significant tailwinds at our back, now is the time to envision what it will take to expand from a med tech platform with the emerging global strait to a durable world leader in diabetes management, an engine of profitable growth and cash generation at scale. I plan to dive into our drivers and strategy with the support of our team and Board of Directors over the coming weeks and months.

In the meantime, I can assure you that our strategic priorities, mainly to advance innovation, drive strong growth in the U.S. type 1 and type 2 population and expand internationally are fully intact. As Ana will discuss shortly, we are executing as well as ever, evidenced by 30% growth in the first quarter and a strong set of catalysts ahead as we bring Omnipod 5 to more live globally. We look forward to giving you a more specific sense of our multiyear road map during Investor Day when the time is right. For now, my focus is going to be on learning the fundamental building blocks of this business.

I'm energized by the strength of Insulet's strategy and power of our differentiated technology and just two weeks in, I've hit the ground running with our passionate talented team. I plan to spend more time with our people, our partners, our customers, our partners and all of our folks in the manufacturing floors in the days and weeks ahead. I couldn't be more excited about this journey and the opportunity to share with all of you. With that, I will turn the call over to Ana discuss first quarter results and guidance.

Good afternoon. Before I get started, I would like to welcome Ashley to our team, and thank Jim Hollingshead for his leadership over recent years. Turning to our first quarter results. We entered the year with terrific momentum and are excited to see that continue.

Our team did an outstanding job growing new customer starts on a year-over-year and sequential basis on both the U.S. and international. Also within the U.S., new customer starts grew for both type 1 and type 2. In the first quarter, consistent with last quarter, over 85% of our U.S. new customer starts came from MDI. Also, over 30% of our U.S. new customer starts were type 2. This is proof of the value and simplicity we bring to people living with diabetes. Revenue for the total company was $569 million and grew 30% over prior year.

This strong performance was driven by total Omnipod growth of 29%. On a reported basis, foreign currency was an unfavorable impact of 100 basis points. Our estimated global utilization was stable with prior year. Our annualized retention rate remained steady in the U.S. and improved slightly in our international markets, driven by the launch of Omnipod 5. Gross margin was an impressive 71.9% and adjusted operating margin was 16.4%.

I will provide further color on margin later in my remarks, but I would like to take a moment now to discuss tariffs. As the market leader in automated insulin delivery with a global customer base of over 500,000, it is of utmost importance that we continue to provide product to our customers without interruption. We have invested over $1 billion in automation, engineering, quality management, and global facility expansion over the last decade. We now have manufacturing sites in the U.S., China, and Malaysia, forming a strong diversified position and resilient supply chain.

Further, we support the majority of our U.S. sales through our active Massachusetts facility as true pioneers in advanced automation. Given our actions and investments, along with the exemption in place for certain medical devices, we are well-positioned to manage through these uncertain times and execute our plans, while maintaining strong gross margins. Based on latest announcements by U.S. administration, we are estimating an impact of approximately 50 basis points from tariffs to gross margin this year. However, given our unique strength, we are able to more than offset this impact through underlying scale and efficiency.

In fact, we are raising our gross margin guidance today. I will provide further details shortly. Now, turning back to our first quarter results. U.S.

Omnipod revenue grew 26%, above the high end of our guidance range, driven by strong commercial execution as demand for Omnipod 5 continues to build. U.S. Omnipod revenue growth benefited by approximately 700 basis points from a prior year stocking dynamic, which we have discussed on previous calls. Partially offsetting that benefit was an approximate 450 basis point headwind related to the timing of rebates, which we had anticipated and which we expect to be neutral on a full year basis.

We continue to make great progress advancing the Omnipod 5 platform and brand through innovation and reach. In the U.S., we are seeing strong adoption of Omnipod 5 with Dexcom's G7 and early traction with Abbott's FreeStyle Libre 2 Plus sensors. We continue to receive positive feedback on the Omnipod 5 iOS app with G6. Over 40% of U.S. Omnipod 5 eligible customers are now using the iOS app as their preferred connected device, an increase from over 25% in the fourth quarter.

Continuing our cascade of launches, we are now deploying a limited market release of iOS with G7 with the full market release expected before the end of the second quarter. We are seeing strong traction from our commercial investments in the U.S. and continue to make great progress on our expansion strategy. To elaborate on key recent investments, in the first quarter, we continued growing our sales force to engage more patients and prescribers as we augment our reach into type 2. We have filled all of our expanded sales roles and have trained over 90% of new hires. This team is hard at work to increase the number of U.S.

HCPs engaging with type 2 patients and prescribing Omnipod 5 therapy. Today, nearly 25,000 U.S. HCPs are writing scripts for Omnipod 5. This is up over 20% from a year ago, and our team is just getting started. Additionally, we are advancing our DTC efforts and driving higher customer conversion, bringing more people into our customer base who express interest in Omnipod 5. Turning to international.

Our team delivered another outstanding quarter, achieving revenue of 36% above the high end of our guidance. On a reported basis, foreign currency was unfavorable 390 basis points over the prior year. International growth was primarily driven by strong demand for Omnipod 5 and customer base growth, including as we launched in additional markets. Of note, recently launched OP5 in Canada and Switzerland, bringing the total number of international market launches to 13. Next, we look forward to bringing Omnipod 5 to the Middle East.

We're also advancing our sensor integration road map, beginning with the rollout of G7, now live in both the U.K. and The Netherlands with more markets to come. We have said in the past that the power of Omnipod 5 is that it wins everywhere it goes. This could not be truer in our first quarter results. In addition to our strong revenue growth, we delivered significant gross margin expansion in the first quarter.

Gross margin was 71.9% and up 240 basis points, primarily driven by improved manufacturing and supply chain efficiencies and to a lesser extent, volume. Operating expenses increased as we continue to invest in our business and pipeline of innovation. A few examples of our recent areas of investment and resulting success include the completion of our RADIANT study and its presentation at ATTD. Ongoing enrollment in our STRIVE study, our work to advance sensor integrations and the seamless expansion of our commercial team.

We are also continuing to expand our platform through the limited market release of Omnipod Discover in the U.S. We are in the early stages of leveraging the power of our data to drive further ease of use, engagement and retention. Adjusted operating margin was 16.4% and adjusted EBITDA was 23.5% in the first quarter. Our team is executing well across our growth objectives and reinvestment plans, which have together generated meaningful operating leverage.

Our first quarter non-GAAP adjusted tax rate was 22.6%. During the quarter, we took several steps to strengthen and de-risk our capital structure. We have successfully issued $450 million senior unsecured notes. We are using proceeds from these notes along with cash on hand and proceeds from unwinding our cap call options to pay off our convertible notes due in 2026. To-date, we have extinguished $420 million of the convertible notes, and we expect to retire the remaining $380 million by the end of the year.

During the quarter, we also upsized our revolving credit facility from $300 million to $500 million and extended the maturity from 2028 to 2030. These proactive and strategic actions improve our financial flexibility through greater access to liquidity and lowering our cost of capital. Turning to cash and liquidity. We ended the quarter with approximately $1.3 billion in cash and the full $500 million available under our credit facility. Now, turning to guidance.

We are pleased to introduce strong second quarter guidance and raised our outlook for the full year given the momentum across our business. Starting with our outlook for second quarter revenue. We expect total company second quarter growth of 23% to 26%, which aligns with our expected total Omnipod growth. As a reminder, our revenue growth guidance is on a constant currency basis.

We assume a 100 basis point favorable impact from foreign currency to total revenue for the second quarter. For U.S. Omnipod, we expect second quarter growth of 22% to 25%. For international Omnipod, we expect second quarter growth of 27% to 30%.

On a reported basis, we now assume a favorable foreign currency impact of 500 basis points. Now, turning to full year 2025 outlook. For the full year, we are raising our total Omnipod revenue growth guidance to a range of 20% to 23% and total company revenue growth guidance to a range of 19% to 22%. We now assume a 100 basis point favorable impact from foreign currency to total revenue for the year.

For U.S. Omnipod, we are raising our revenue guidance range to 18% to 21%, driven by strong Omnipod 5 adoption as we continue to grow our brand and reach in type 1 and type 2. We expect demand trends to continue benefiting from our differentiated Omnipod 5 platform relative to MDI. We remained confident in our expectation for year-over-year growth in new customer starts in 2025. And as a reminder, our U.S. growth guidance assumes similar trends in pricing, utilization, and retention for 2025, relative to 2024. For international Omnipod, we are raising our revenue guidance to 27% to 30%. On a reported basis, we now assume a 200 basis point favorable impact from foreign currency.

We expect continued growth in the U.K., Germany, France, and The Netherlands as those markets benefit from new sensor integrations and customer upgrade from Omnipod Dash to Omnipod 5. We also expect our newer markets to ramp throughout the year. We anticipate international new customer starts to grow year-over-year in 2025. While volume is expected to be the primary driver of our international revenue growth -- our guidance assumes a modest benefit from pricing as customers upgrade from Omnipod DASH to Omnipod 5. Additionally, we are assuming stable utilization trends. And based on first quarter performance, retention trends improving slightly for 2025 relative to 2024. Turning to gross margin.

For the full year, we are raising our gross margin guidance to approximately 71%. As mentioned, our full year gross margin guidance now assumes an impact of approximately 50 basis points from tariffs mostly related to production from China. Given our strong manufacturing position and efficiencies from scale, we're able to absorb this impact and raise gross margin guidance for the year. From a timing perspective, we now expect gross margin to be roughly stable from the first half to the second half, primarily influenced by timing of tariff impacts.

For the year, we are also reaffirming our adjusted operating margin guidance of approximately 16.5%, which reflects 160 basis points of expansion over prior year. As we previously communicated, our guidance includes plans to continue investing in R&D and sales and marketing. From a timing perspective, consistent with what we communicated last quarter, we expect operating margins to be higher in the second half of year as compared to the first half as we grow revenue and achieve operating leverage. As I have emphasized in the past, we have many catalysts for growth in 2025 and considerable opportunities to drive further margin expansion over the near and long term.

Even as we make continued investments in our robust innovation pipeline and commercial efforts. We continue to expect to drive over 100 basis points of operating margin expansion annually. Looking at a few items below our operating income. We expect our 2025 net interest expense to be approximately $30 million higher than 2024, largely due to our recent debt transactions and the renewal of our interest rate swaps.

For the year, we still expect our non-GAAP tax rate to be in the range of 20% to 25%. We expect the 2025 ending balance of our diluted share count to be around $71 million, which is approximately 5% or 3.5 million shares lower than prior year. I would like to highlight that our Board of Directors recently authorized the program to repurchase up to $125 million of common stock through December 31, 2026, to offset dilution from stock-based compensation. From a cash perspective, we expect to continue to increase our free cash flow over prior year.

Annual capital expenditures are expected to be slightly higher versus prior year as we continue to expand and optimize our manufacturing and supply chain operations and support global expansion. We remain focused on driving growth, margin expansion and increasing profitability free cash flow as we continue strengthening our overall financial profile and supporting long-term value creation. I will now turn the call back to Ashley.

Thank you, Ana. As we wrap reiterate just how excited I am about the future of Insulet. You heard today about our exceptional performance in the first quarter with 30% growth and in pax 70%-plus gross margin, the highest in diabetes technology space. And our strong operating income and cash flow generation.

This performance is a testament to our team, our technology and our strategy. And with well over $1 billion in cash on our balance sheet, we will continue investing to drive growth and expansion. We are the number one prescribed automated insulin delivery system in the United States and we will continue building significant commercial and brand strength, particularly as we expand our focus on the type 2 market. Our global launches are gaining momentum, and the advantage we hold with Omni 5 is undeniable.

We've also made and will continue to make significant investments in manufacturing and advanced automation, providing us with economies of scale and most importantly, expanding access for more patients around the world. Our pay-as-you-go model has provided a significant first-mover advantage and our relentless focus on innovation and supply chain strength will become increasingly critical differentiators in the long term. We have a strong track record of performance, and we are focused on continuing that momentum as we build out commercial capabilities, particularly in type 2 diabetes and as we expand additionally into more global markets.

Our updated 2025 guidance reflects our continued confidence in the path ahead. Finally, I'd like to take a moment to congratulate team in flat, your passion for improving patients' lives, deep commitment to innovation and persistent hard work have brought this company to where it is today. And I am thrilled to embark on the next phase of our growth and impact together. Thank you.

With that, operator, please open the call for questions.

Thank you. [Operator Instructions] Speakers available today are actually Ashley McEvoy, Ana Chadwick and Eric Benjamin. Our first question comes from Travis Steve from Bank of America.

Hi, everybody. Congratulations Ashley on the new role. I guess I'll start a question there. Just kind of curious what excited you about the role of Insulet, what you've learned in the first couple of weeks in the role?

And how you're thinking the vision for the business? I know you've kind of talked about taking this business the $4 billion to $6 billion in revenue and globalizing the business. So just kind of curious your strategy behind that. And then -- and also another port topic is kind of your view on margins in business and how you think about is there going to be a change in the longer-term margin targets for this company over time versus kind of the last CEO?

Yes. No, thank you, Travis. It's awesome to be here and been very humbled as well. And I would first start with the space.

Diabetes is extremely passionate about diabetes. It's one of the most impactful and innovative rich areas in health care. And we know it has a vast population that can benefit from better med tech. I come with a huge amount of humility with going to honor my prior two predecessors, both Stacy and Jim you can see the business has remarkable momentum.

And as I mentioned, I think that insulin plays at this unique intersection of consumer health and med tech. And we know that it has the absolute best insulin delivery platform on the market, no question, with a highly differentiated form factor and ease of use. So early takeaways, I'd say, day nine, unbelievably talented team, very patient-centric. I've got over 100 different e-mails on day one from the Powder community, walk the Acton plant unbelievable advanced automation just invested in our line four there.

And I would just say, listen, the strategy is intact. I think that the -- the company has a very clear pathway to go achieve future value creation. And in the near term, think we're going to honor that strategy because it's working. I think you asked a question, Travis, about margin and you'll hire on it.

This is a very fast-growing asset. You heard us talk about raising gross margin and operating margin this year is growing about 160 basis points versus last year. And a continuation of continuous operating margin improvement year-over-year. Thank you for the question, Travis.

Our next question comes from Robbie Marcus from JPMorgan. Please go ahead. Your line is open.

Great. And I'll add my congratulations. Two for me. One, Ashley, maybe just to follow-up.

There were a lot of Street notes published over the past few weeks since you had the meeting great with the sell side. And I felt inappropriately took away that you were going to focus on the top line at the expense and margin expansion. Just wanted you to have a minute to comment on that specifically given margin expansion and free cash flow has been such a critical part of the story the past few years? And then any comments you have on type 2 pump adoption in the U.S., how the launch is going and how you see that playing out versus expectations?

Thanks a lot.

No. Thank you, Robbie. And again, I would say that the business strategy as well as the financial strategy are going to really remain intact of double-digit growth. You heard Ana mentioned that continued improvement 71% gross margin, continuing improvement on operating margin.

And that obviously results into a very strong free cash flow. So on that, I'm going to invite Eric to talk a bit about our type 2, what we're learning.

Hey, Robbie, thanks for the question. We are really pleased with how the type 2 launch is going, and we're executing the three-part strategy that we've described. First, we're bringing the SECURE-T2D data to our current call point and driving activation of our HCP partners in that call plane, but just helping them see how impactful Omnipod 5 can be to improve the lives of people who live with type 2 diabetes. That's going well.

Second thing, Ana described our sales force expansion, our U.S. team completed hiring and is about 90% of the way through training, those expanded roles. As a reminder, that brings us to calling on about 40% of the population live with type 2 insulin intensive diabetes from 30%. So a pretty significant expansion in the HCPs that we're reaching through that sales force expansion. And our team did a terrific job delivering the quarter while executing those changes.

And finally, with the indication, we're pleased with how our direct-to-consumer advertising effectiveness is going. We generate tremendous interest in Omnipod with our direct-to-consumer advertising. And now as folks reach out to us for more information, we can serve them and help them get on Omnipod even more effectively. Those three things together are what drove our new customer start portion that came from type 2 diabetes over 30% in the quarter from about 25% where it was before we started the launch.

So type 2 launch is going great.

Our next question comes from Jeff Johnson from Baird. Please go ahead. Your line is open.

Thank you. Good afternoon, everyone, and again, Ashley, congratulations on the new role. I just want to ask two modeling questions, I guess. When I look at when I look at the strength of the U.S. to start the year, obviously, nice upside versus, I think, what most of us were expecting for sure.

The guidance for mid-20% growth in second quarter, you did mid-20% growth in the first quarter and then the guidance for the full year at 2018 to 2021. It would imply a second half kind of in that lower double digit, maybe even below the low teens. Sure feels like conservatism there, but is there anything else going on in that back half implied guidance that we should be thinking about differently than how the first half of the year is playing out.

Jeff, thanks. I'm going to turn to Ana, who will comment.

Sure. Jeff, First and foremost, we said guidance, as you know, with the full intent to deliver. The trends of the business are really strong. We're only in the first quarter. especially in the context of a new CEO transition, our view is that the rate of the guide here that we did is very strong, and we intend to deliver our guide.

Our next question comes from Larry Biegelsen from Wells Fargo. Please go head. Your line is open.

Good afternoon, thanks for taking the question, and congratulations, Ashley, nice to reconnect with you. I was going to ask Ashley a big picture question, but I was surprised to hear, Ana, when you talked about new starts, being up quarter-over-quarter in the first quarter. I think you said in both the U.S. and internationally. Looking back at our model, I don't think we've seen new starts up sequentially in Q1 for many years.

So it looks like new start growth was quite strong. on a year-over-year basis in the first quarter. Can you confirm that? And any color on what the drivers of that strong new start growth were?

Thank you, for the warm welcome, and I'll turn it to Ana.

Great. Larry, correct. Everything you stated there is correct. We're seeing significant strength in our new customer starts quarter-over-quarter sequential and year-over-year. I'll pass it over to Eric to comment a little bit more.

Larry, Ana said it well, I think what we're seeing is just the differentiation of Omnipod 5, pay-as-you-go, wearable, disposable affordable now with multiple sensor options and the iOS phone control and the type 2 indication, it is what customers want, and that's we're seeing in the market. If you just look back over the last four quarters, we've grown quarter-over-quarter as there's been a couple of launches by our tube competitors, and it hasn't affected our business. And so I think what you're seeing is just the category that we play in with the differentiation of Omnipod 5 is different. And that's what gave us a great quarter.

Our next question comes from Joanne Wuensch from Citi. Please go ahead. Your line is open.

Good evening. Thank you for taking the question, and Ashley as role that you're in this position. So much to ask, but I really want to spend a minute on gross margins. We're outside the LRP.

I know we're not going to have an Analyst Day to the fall. But what is your view of expanding gross and operating margins over the next couple of years? And how do you balance those goals with the investments that you need to make to get to that much bigger organization that you have planned? Thank you.

Thanks, Joanne. I'll start here with the gross margin. First of all, we're extremely pleased. We have in the low 70s here, industry-leading gross margins and it's a power to the team.

They continue to execute manufacturing and supply chain efficiencies. We continue to see the strength. And as it relates to the op margin, we are reaffirming here that 16.5%, which is 160 basis points year-over-year. Our approach to investing has not changed.

We put everything through our rigorous models here. And we want to maintain that flexibility as we reach into these new opportunity that it's really a greenfield both in the U.S. type 2 with the little penetration that's out there. It's our market to go reach and also as we expand international. So it's about positioning and continuing our strategy.

Our next question comes from Patrick Wood from Morgan Stanley. Please go ahead. Your line is open.

Amazing. Thank you so much for taking the question. I'd love to -- as there's a topic digging into type 2. I'm just curious what feedback you're getting from whether it's the PCPs or the in terms of patient flow and journey. Is this a multiple visit kind of thing that competes them to switch over?

Or is it happening pretty quickly? Are there any sticking points? Like how is that journey for the patient speed of conversion, I guess, relative to how maybe you thought it would be at the start of this journey.

Patrick, it's Eric. I can take that one. Patrick, I think the headline is it's right on our expectations, and there's both a health care provider side of that, and there's a patient side of it. On the health care provider side, the first thing that our team is working on is just helping the health care riders that we call on, appreciate the value of bringing automated insulin delivery to their type 2 patients who use insulin.

And that's the first part is our team has to help them. We're using the strong clinical data of secure T2D to make that case and we're having good success. Once the health care provider is brought in, the journey is pretty similar, by and large, with what we see with type 1. Our team serves offices really well. The and there -- actually, we've heard some heartwarming story that was in Pittsburgh last week and an office had just trained an 80-year-old woman who initially had a little sort of uncertainty about how she was going to do with the technology.

She did tremendously reduce hypoglycemia, really high time range, was thrilled and our team was joking that they were going to get her to teach the next train. So, I think what we're seeing is Omnipod 5 can be used really effectively by people with type 2 diabetes. And our coverage is good and our team does the same kind of work as we do with type 1 to just help folks through the journey to get on products and have a great experience.

Our next question comes from Marie Thibault from BTIG. Please go ahead. Your line is open.

Thanks for taking the question. Congrats on a great quarter. I wanted to kind of pick up on what we were just speaking about here and some of the trends that you're seeing with some of these early Type 2 users. I think you said the U.S. guide assumes a similar trend in retention this year as you saw last year.

And I'm just wondering what you're seeing in the early Type 2 users retention the same as the type 1 users? Or is there any risk around that assumption in the guide? Thanks for taking the question

Hey, Marie, Eric here. I can take that one. So our guide has as Ana described, sort stable retention and stable utilization on a portfolio basis of sort of full company. We are, of course, watching the really important metrics of utilization and attrition for type 2 as we ramp that launch.

And right now, they're behaving just like we expected. So utilization is very similar type 1 to type 2 and retention is a little bit less, so attrition a little bit higher for type 2, but still very strong. And again, both consistent with our expectations.

Our next question comes from Michael Polark from Wolfe Research. Please go ahead. Your line is open.

Question about international and what's ahead. The Middle East launches for 05 seem interesting to me. When are those expected? And can you remind us what is the scale of the pod business in the Middle East today and kind of how would you dimensionalize that opportunity for the international franchise maybe compared to Germany, U.K., I don't know, size it up?

How excited are you about that one? Thank you.

Hey, Mike, Eric here. So maybe to hit Middle East first, and then we'll step back and look at the whole international opportunity. Middle East launches, we expect sometime between end of 2025 and early 2026. We're finalizing the details with local partners and local regulatory authorities. At this point, the majority of folks in our international markets have access to Omnipod 5. So the Middle East launches are smaller than the launch of our smaller markets than the launches that we've done already for Omnipod 5. If we just step back and think about the portfolio of opportunity that we're pursuing in international, we've really got markets at 3 different stages.

We've got markets like the U.K. and Germany, which are approaching their second anniversary of the Omnipod 5 launch here in June and in August. And in those markets, we're investing in evidence to help build access commercial footprint and strength and innovation, all three of those to drive durable, profitable growth on top of the strength we've already driven not Omnipod 5. So we've built display book based on learnings in the U.S., we're now applying it to our first two big markets where we launched first internationally. Our U.K. team, in particular, has done a really nice job -- there's some additional funding that's just become available and that team is collaborating with health care systems to ensure that Omnipod 5 is the easiest option for folks, which has been terrific.

So that playbook, we've built, applying it now the U.K. and Germany. We've got other markets like France and Netherlands that are still sort of getting through the Omnipod 5 launch. We've got the 9 countries we just launched at the beginning of 2025. That will be in launch mode all year. And as those start to mature, we'll apply that same playbook for durable, profitable growth, evidence to build access, commercial footprint and continued innovation.

So -- as a reminder, international is about 3.5 million people who live with type 1 diabetes. It's only 20% to 25% penetrated. And so we've got a long runway of continuing to improve lives with Omnipod.

Next question comes from Matt O'Brien from Piper Sandler. Please go ahead. Your line is open.

I would love to just stay on this market acceleration topic for a second. Q1 has been really good for pretty much everybody that's reported so far. And I guess the thing I'm curious about is what really is driving that. And I think about this industry, type 1 was kind of stuck at 25% penetration forever, it's now up to about 45% in terms of pump utilization, whatever it is like eight years later.

It's about 20% increase or 20-point increase in utilization in type 1. Can we get that kind of growth in the type 2 market over the same kind of time frame? Can we go from 5% to 25% over the next, I don't know, seven to eight years? And what would stop us from doing that.

Hey, Matt, thanks for the question. Look, what we've said is that that we see type 2 penetration today is around 5%. And as a reminder, we've said we think that can somewhere between double and triple. Look, what we are still quite early in the type 2 launch, and that launch is building.

And right now, we're making that market. And so we need another few quarters to know how fast market penetration is really going really going to drive to go. What we know is we're on our plan. We're executing well, and we're continuing to build the launch, which is great.

We also see the same thing that I think you were describing, which is that there's been this technology renaissance in type 1 that has helped accelerate penetration. And that same technology renaissance does apply to type 2. And this is sort of what we're seeing in these early experiences in our type 2 launches that HCPs are really happy with the life-changing impact. Well, HCPs and PWDs are really happy with the life-changing impact of Omnipod 5 for the folks who really needed to live insulin-intensive type 2 diabetes. So we have reason to believe we're going to get there, just too early for us to call the pace.

Our next question comes from Steve Lichtman from Oppenheimer. Please go ahead. Your line is open.

Thank you. Congratulations to Ashley and congratulations on the quarter. You talked about the continued progress in type 2, and you highlighted the expanded commercial sales force. Can you delve click on the DTC efforts?

How deep are you into that work? Can you talk about sort of any return that you've seen on some of the programs that you have put in place? Any more color overall on that effort would be helpful. Thanks.

Great. I'll start with that one. And we're super excited with the DTC. As we've talked about before, the same advertising that we put out there is now more efficient.

It's seen by people who now we can lean in and do those sales. What we're seeing is not only more leads, but also our ability to convert those leads. So we're seeing higher conversion -- we're very excited. We continue to lean in into our DTC spend, and we have that built into our guidance and our plan here.

Our next question comes from Bill Plovanic from Canaccord Genuity. Please go ahead. Your line is open.

Hi. Great. Thank you for taking the question. This is Zachary [ph] for Bill today. Have you reaped any benefits of Abbott's partnership with Epic RO? And can you give any details about what that partnership looks like? Is there a CGM being listed in the drop-down menu? Just what are you seeing there?

Hi, Zachary. Thanks for the question. It's Eric. I'm not familiar with the details of how their partnership with Epic shows up in offices.

Our next question comes from Issie Kirby from Redburn Atlantic. Please go ahead.

Hi. Good evening. Thank you for taking my question. I wanted to ask about the Malaysia ramp and the extent to which that impacted gross margins at this quarter -- and then just on manufacturing and capacity with respect to tariffs, I would love get updated thoughts on your volumes that are coming out of China any thoughts on potentially repositioning those to Malaysia Acton perhaps over the next few years?

Thanks so much.

Thanks, Issie, I'll take that. Malaysia, starting there is right on track. We have talked about being accretive to margins in the first year of operations, and that will happen here as we move into the third quarter of this year. So we're excited and the performance is strong.

From a tariff perspective, I indicated, we are under the exemption for MEGTEC. So the -- there are certain component parts and supply chain components that we bring in that are impacted. And we expect a small amount of impact, 50 basis points here for 2025 and on top of that, we had guided at the beginning of the year at 70.5% gross margin. We have raised that gross margin to 71% and including absorbing the 50 basis points of tariff impact that we're currently estimating.

So the operations are going really well. The team is performing well, and we're very excited by having industry-leading gross margins that we have.

This will conclude our Q&A section. I would now like to turn the conference back to Ashley McEvoy.

Thank you so much for the warm welcome, everyone, for spending time with us tonight. Clearly, we had a very strong quarter, and I would just wrap that. I think you've heard that the strategy is intact, and we are going to continue driving robust growth and doing so profitably on a global scale. And this company is all about having patients front and center.

So my big acknowledgment to the Insulet team, and thank you for joining us tonight.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. Have a wonderful day, and you may all disconnect.