Q4 2025 Insulet Corp Earnings Call [BACKUP]
Flavia Pease: and our total company revenue to grow 20 to 22%. We expect a favorable impact of 100 basis points from foreign currency for the year. Our guidance reflects continued top-tier market-leading growth, but I know you will all ask me: Why is growth decelerating? Just a couple of quick notes on this. First, this year, we will be anniversarying the first full year of the US launch of Omnipod for Type 2, which was a significant contributor to last year's performance. In addition, we're beginning to annualize several of our international launches, which continue to ramp well, but create more challenging year-over-year comparisons. These year-over-year comp dynamics are reflected in our 2026 guidance. For US Omnipod, we expect our revenue to grow 20 to 22%, driven by increased penetration from MDI users and competitive gains.
Flavia Pease: and our total company revenue to grow 20 to 22%. We expect a favorable impact of 100 basis points from foreign currency for the year. Our guidance reflects continued top-tier market-leading growth, but I know you will all ask me: Why is growth decelerating? Just a couple of quick notes on this. First, this year, we will be anniversarying the first full year of the US launch of Omnipod for Type 2, which was a significant contributor to last year's performance. In addition, we're beginning to annualize several of our international launches, which continue to ramp well, but create more challenging year-over-year comparisons. These year-over-year comp dynamics are reflected in our 2026 guidance. For US Omnipod, we expect our revenue to grow 20 to 22%, driven by increased penetration from MDI users and competitive gains.
Flavia Pease: We expect year-over-year growth in US new customer starts for the year, and we assume similar trends in pricing, utilization, and retention as we saw in 2025. For international Omnipod, we expect 2026 revenue to grow 24% to 26%. On a reported basis, we expect a favorable impact of approximately 300 basis points from foreign currency. We expect year-over-year growth in international new customer starts for the year as we penetrate further in current markets and expand Omnipod 5 into new markets. Omnipod 5 is now available in 19 countries, including 5 recent additions in the Middle East, and we will continue to broaden our reach and plan to enter Spain by late 2026.
Flavia Pease: We expect year-over-year growth in US new customer starts for the year, and we assume similar trends in pricing, utilization, and retention as we saw in 2025. For international Omnipod, we expect 2026 revenue to grow 24% to 26%. On a reported basis, we expect a favorable impact of approximately 300 basis points from foreign currency. We expect year-over-year growth in international new customer starts for the year as we penetrate further in current markets and expand Omnipod 5 into new markets. Omnipod 5 is now available in 19 countries, including 5 recent additions in the Middle East, and we will continue to broaden our reach and plan to enter Spain by late 2026.
Flavia Pease: While volume remains the primary driver of our international revenue growth, our guidance also reflects a benefit from positive price mix realization as customers continue to transition from Omnipod DASH to Omnipod 5. Overall, our international growth guidance assumes stable utilization and slightly improving retention from 2026 relative to 2025. Turning to 2026 operating margin. In line with the annual guidance we provided at our recent Investor Day, we expect to drive approximately 100 basis points of operating margin expansion for the full year, reflecting strong top-line growth, modest gross margin expansion, a significant step-up in R&D investments to fuel our innovation pipeline, and leverage SG&A spend. Looking at a few items below our operating income.
Flavia Pease: While volume remains the primary driver of our international revenue growth, our guidance also reflects a benefit from positive price mix realization as customers continue to transition from Omnipod DASH to Omnipod 5. Overall, our international growth guidance assumes stable utilization and slightly improving retention from 2026 relative to 2025. Turning to 2026 operating margin. In line with the annual guidance we provided at our recent Investor Day, we expect to drive approximately 100 basis points of operating margin expansion for the full year, reflecting strong top-line growth, modest gross margin expansion, a significant step-up in R&D investments to fuel our innovation pipeline, and leverage SG&A spend. Looking at a few items below our operating income.
Flavia Pease: We expect 2026 net interest expense to total approximately $40 million, primarily due to lower interest income, and we expect 2026 non-GAAP tax rate to be in the range of 22% to 23%. Our team is actively focused on assessing potential opportunities to optimize our interest expense and tax rate over time. Turning to shares outstanding and EPS. I'm pleased to share that the board has approved an additional $350 million share repurchase authorization. We expect to deploy approximately $300 million of this authorization in Q1 2026. Our strong balance sheet gives us the flexibility to continue allocating capital in line with our long-standing principles, investing for growth while delivering long-term value for our shareholders.
Flavia Pease: We expect 2026 net interest expense to total approximately $40 million, primarily due to lower interest income, and we expect 2026 non-GAAP tax rate to be in the range of 22% to 23%. Our team is actively focused on assessing potential opportunities to optimize our interest expense and tax rate over time. Turning to shares outstanding and EPS. I'm pleased to share that the board has approved an additional $350 million share repurchase authorization. We expect to deploy approximately $300 million of this authorization in Q1 2026. Our strong balance sheet gives us the flexibility to continue allocating capital in line with our long-standing principles, investing for growth while delivering long-term value for our shareholders.
Around the world.
2025 was a year of significant progress at Insulet and the entire organization delivered on our goals without missing a beat.
Your dedication to our mission fills me with confidence today and well into our future.
Our results in the fourth quarter are a testament to the reliability consistency and broad appeal of Omnipod, coupled with the strength of our strategy and execution.
Total company revenues were $784 million advancing 29% constant currency.
U S revenues of $568 million increased 28% and international revenues of $214 million grew 42% constant currency.
Flavia Pease: Based on our current share count and repurchase plans, we expect the 2026 ending balance of our diluted share count to be around 70 million shares. Based on these factors, we expect 2026 adjusted EPS to increase by more than 25%. We expect free cash flow to be approximately flat from 2025 levels, supported by robust growth and continued margin expansion, partially offset by a ramp-up in capital expenditures to support our continued global manufacturing expansion plans. As I just mentioned, 2025 free cash flow included approximately $70 million related to a tax benefit from the One Big Beautiful Bill. Our team remains steadfast in its commitment to driving top-tier growth, expanding margins, and increasing profitability and free cash flow. These efforts are central to our long-term value creation strategy and enable us to reach and serve more people with diabetes around the world.
Flavia Pease: Based on our current share count and repurchase plans, we expect the 2026 ending balance of our diluted share count to be around 70 million shares. Based on these factors, we expect 2026 adjusted EPS to increase by more than 25%. We expect free cash flow to be approximately flat from 2025 levels, supported by robust growth and continued margin expansion, partially offset by a ramp-up in capital expenditures to support our continued global manufacturing expansion plans. As I just mentioned, 2025 free cash flow included approximately $70 million related to a tax benefit from the One Big Beautiful Bill. Our team remains steadfast in its commitment to driving top-tier growth, expanding margins, and increasing profitability and free cash flow. These efforts are central to our long-term value creation strategy and enable us to reach and serve more people with diabetes around the world.
This strong finish to the year enabled us to surpass $2 7 billion in revenue for the full year more than doubling our revenue base over the last three years and delivering approximately 30% year over year constant currency growth.
Our annual performance of $1 9 billion or 27% growth in the U S and $754 million or 39% constant currency growth in international markets highlights the progress and the impact we're making as we continue to unlock more of our $30 billion plus.
Total addressable market.
We achieved record new customer starts across both the U S and international in the fourth quarter and for the full year with the vast majority coming from people transitioning from multiple daily injections.
This reflects growing provider confidence.
Which as I, just mentioned is driven by strong clinical evidence and consistent real world outcomes.
Importantly, it also reinforces that Insulet is not only the market leader in AI D. But also the clear driver of overall market expansion and we intend to maintain this leadership position.
Flavia Pease: With that, operator, please open the line for questions.
Flavia Pease: With that, operator, please open the line for questions.
Operator: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again. Your first question today comes from the line of Jeff Johnson from Baird. Your line is open.
Operator: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. If you would like to withdraw your question, simply press star one again. Your first question today comes from the line of Jeff Johnson from Baird. Your line is open.
Turning to our key markets and starting with our largest U S type one.
Where we continue to focus on extending our leadership the.
The U S type one market is a more than $9 billion opportunity with a I D penetration at just 40%, which is well behind CGM penetration of 70%.
Jeff Johnson: Thank you. Good morning, everyone, and congratulations on a strong close to the year. Ashley, I just want to start from a high level, maybe with the first question here. You're, you're a couple months away from your one-year anniversary leading Insulet. You know, stock has had a great run in the first six months of your tenure. It's faced maybe some challenges here the last five or six months. What do you think is the most underappreciated part of the Insulet story at this point, especially from an investor perspective? Thank you.
Jeff Johnson: Thank you. Good morning, everyone, and congratulations on a strong close to the year. Ashley, I just want to start from a high level, maybe with the first question here. You're, you're a couple months away from your one-year anniversary leading Insulet. You know, stock has had a great run in the first six months of your tenure. It's faced maybe some challenges here the last five or six months. What do you think is the most underappreciated part of the Insulet story at this point, especially from an investor perspective? Thank you.
In 2025, we delivered year over year growth in type one new customer starts in both the fourth quarter and the full year driven by strong patient and prescriber preference for Omnipod.
In fact, both type one and type two users in the U S. Navy Army bought five their favorite pumps in 2025.
Ashley McEvoy: Yeah. Good morning, Jeff. Thanks for the question, and it's great to see Insulet continue to execute and live into our commitments that we shared in November at our Investor Day. I would highlight four key areas. I'll, number one is our tech lead, which we'll continue to innovate off of. I'll come back to that. I would say number two is our growing commercial prowess. I'll come back to that. Three is our manufacturing at scale, and four is our financial strength. So I'll start with just our tech lead. As we shared, we've invested over $3 billion to get here. Omnipod 5, you know. We're just 3.5 years into the launch into the US, 2.5 years in places like the UK and Germany, and we continue to post record NCS.
Ashley McEvoy: Yeah. Good morning, Jeff. Thanks for the question, and it's great to see Insulet continue to execute and live into our commitments that we shared in November at our Investor Day. I would highlight four key areas. I'll, number one is our tech lead, which we'll continue to innovate off of. I'll come back to that. I would say number two is our growing commercial prowess. I'll come back to that. Three is our manufacturing at scale, and four is our financial strength. So I'll start with just our tech lead. As we shared, we've invested over $3 billion to get here. Omnipod 5, you know. We're just 3.5 years into the launch into the US, 2.5 years in places like the UK and Germany, and we continue to post record NCS.
Omnipod strong clinical evidence broad access affordability and ease of use are enabling us to expand well beyond traditional endocrinology channels.
Our U S. Prescriber base now includes more than 30000 health care professionals up approximately 28% year over year.
The strength and reach of our commercial teams to position this segment to remain a meaningful and consistent contributor to our global customer growth.
Momentum in the U F type two continues to build as well.
In the fourth quarter type two new customer starts grew significantly both sequentially and year over year rapidly expanding our type two user base.
Ashley McEvoy: This knowledge, this experience, and this tech lead really continue to prove the leadership that's resulted in number one most prescribed and number one most re-requested. And importantly, in my opening remarks, I really shared how, you know, we've built this meaningful pipeline that really addresses the biggest unmet needs in the market. And you heard us touch around really two algorithm improvements. Starting this actually weekend, we launched a limited market release with Omnipod 5, with a lower set point, advanced automated mode. It connects with Libre 3. We're gonna be launching our new data platform, so that one's going out into full market release in a couple of months. We will be launching our third generation algorithm with Omnipod 6. As we mentioned in our opening remarks, we're gonna be posting the data and the algorithm at the ADA.
Ashley McEvoy: This knowledge, this experience, and this tech lead really continue to prove the leadership that's resulted in number one most prescribed and number one most re-requested. And importantly, in my opening remarks, I really shared how, you know, we've built this meaningful pipeline that really addresses the biggest unmet needs in the market. And you heard us touch around really two algorithm improvements. Starting this actually weekend, we launched a limited market release with Omnipod 5, with a lower set point, advanced automated mode. It connects with Libre 3. We're gonna be launching our new data platform, so that one's going out into full market release in a couple of months. We will be launching our third generation algorithm with Omnipod 6. As we mentioned in our opening remarks, we're gonna be posting the data and the algorithm at the ADA.
This acceleration reflects strong clinical and real world outcomes continued investment in demand generation and the recent a D. A guideline update recommending a I D for people with type two who require insulin.
Type two prescriber base grew 62% in 2025 to now more than 6500 clinicians.
Most people with type two diabetes are being managed in primary care settings, therefore, expanding beyond endocrinology represents a meaningful and sustainable growth opportunity.
And a type two market of more than 12 billion, where AIG penetration remains below 5%, which is far behind roughly 55% as C. G. M adoption stronger education improved outcomes and increasing access are already accelerating adoption.
Ashley McEvoy: This is a meaningful advancement in personal automation as well as over-the-air connectivity, as well as on-the-body placement with a lot of variability, which is important for patients, as well as the Omnipod. You're gonna hear us talk about, there's been a lot of noise, if you will, in the industry, which is really good things for patients around this fully closed loop. We believe that we are in a class by ourselves of how we're gonna define what fully closed loop really means. I'll come back to that in inquiry, but it's a very strong pipeline. Our commercial prowess, I think, is really underappreciated. We have the largest sales force in the industry. We are gonna evolve that sales force for messaging, from selling on simplicity, ease of use, and our highly differentiated technology to our strength of clinical performance.
Ashley McEvoy: This is a meaningful advancement in personal automation as well as over-the-air connectivity, as well as on-the-body placement with a lot of variability, which is important for patients, as well as the Omnipod. You're gonna hear us talk about, there's been a lot of noise, if you will, in the industry, which is really good things for patients around this fully closed loop. We believe that we are in a class by ourselves of how we're gonna define what fully closed loop really means. I'll come back to that in inquiry, but it's a very strong pipeline. Our commercial prowess, I think, is really underappreciated. We have the largest sales force in the industry. We are gonna evolve that sales force for messaging, from selling on simplicity, ease of use, and our highly differentiated technology to our strength of clinical performance.
Importantly, we are unlocking this opportunity in a strategic and capital efficient way.
Our U S sales force, which is the largest in the industry reaches high prescribing offices that treat both type one and type two diabetes.
Giving us confidence in our ability to unlock the next 5% to 10% of type two penetration efficiently.
Our growing type two customer base continues to surface powerful stories about the impact Omnipod five can have.
Ashley McEvoy: Come back to that. And then as Flavia was mentioning in our opening remarks, 30,000, you know, prescribers with Omnipod, which is up 28%. Very strong brand loyalty, and we continue to have unparalleled access and affordability. We manufacture at scale. It's one thing to get regulatory approval, it's different than to manufacture. We produce tens of millions of pods with high quality, medical-grade quality, at consumer electronic scale. And when we say something, we execute on what we're gonna say. I'm really pleased the team is building out Malaysia. We're already margin accretive in Malaysia and Acton. We've improved productivity, and we've already started to break ground on Costa Rica. And last is just the financial wherewithal. You know, not only our recurring revenue model, 70% growth margin, expanding operating margin, EPS above revenue, and cash flow positive.
Ashley McEvoy: Come back to that. And then as Flavia was mentioning in our opening remarks, 30,000, you know, prescribers with Omnipod, which is up 28%. Very strong brand loyalty, and we continue to have unparalleled access and affordability. We manufacture at scale. It's one thing to get regulatory approval, it's different than to manufacture. We produce tens of millions of pods with high quality, medical-grade quality, at consumer electronic scale. And when we say something, we execute on what we're gonna say. I'm really pleased the team is building out Malaysia. We're already margin accretive in Malaysia and Acton. We've improved productivity, and we've already started to break ground on Costa Rica. And last is just the financial wherewithal. You know, not only our recurring revenue model, 70% growth margin, expanding operating margin, EPS above revenue, and cash flow positive.
<unk> the experience of Erkki. He knew something was wrong when he began experiencing pain and its feet and arm and an urgent care visits led them to an unexpected diagnosis of type two diabetes.
After reviewing insulin delivery options with this doctor Brookies chose omnipod because he shared I really loved the mission and the promise that was exuded from Omnipod to add normalcy to my diabetes and to show that my life could still be balanced and that this brand. This family will always be there and will form.
Ever evolve as medical technology does.
Stories like <unk> combined with the growing excitement among both health care professionals and people with type two diabetes continue to strengthen our conviction and the significant type two market opportunity.
Ashley McEvoy: So those are perhaps underappreciated tenets of the Insulet company. Thanks for the question, Jeff.
Ashley McEvoy: So those are perhaps underappreciated tenets of the Insulet company. Thanks for the question, Jeff.
Looking ahead, we expect to expand penetration even further with the launch of our fully closed loop offering planned in 2028, which will enable us to reach and serve the broader primary care population.
Jeff Johnson: Your next question comes from a line of Robbie Marcus from JP Morgan. Your line is open.
Operator: Your next question comes from a line of Robbie Marcus from JP Morgan. Your line is open.
Robbie Marcus: Oh, great. Good morning, and congrats on a good quarter. I wanted to ask... it's limited to one. I wanted to ask on new patient start trends, US and outside the US, and, you know, we've seen some of your competitors stumble a bit on new patient ads recently. You know, how are you thinking-- You mentioned record new patient starts. I believe that's a US and outside the US, but you could clarify that if I'm wrong. How are you thinking about, you know, finding sources of sustainability in the new patient growth? Type 2 is clearly a home run for you in the US. How do you keep that growing and getting larger and larger and continuing to win there? And then same question, outside the US, you've been moving into new geographies.
Robbie Marcus: Oh, great. Good morning, and congrats on a good quarter. I wanted to ask... it's limited to one. I wanted to ask on new patient start trends, US and outside the US, and, you know, we've seen some of your competitors stumble a bit on new patient ads recently. You know, how are you thinking-- You mentioned record new patient starts. I believe that's a US and outside the US, but you could clarify that if I'm wrong. How are you thinking about, you know, finding sources of sustainability in the new patient growth? Type 2 is clearly a home run for you in the US. How do you keep that growing and getting larger and larger and continuing to win there? And then same question, outside the US, you've been moving into new geographies.
Additionally, pharmacy access remains a critical differentiator in the U S, making it easier for people with diabetes to start and stay on therapy.
Over the past decade, we've built strong relationships with payers and pbms across the west backed by clinical and economic evidence that continues to resonate we have the broadest access in the market available on approximately 48000 U S pharmacies and covered for more than 90% of <unk>.
Short lives.
Or about 300 million of the 317 million insured people.
Our offering is affordable with most users paying about a dollar a day through our pay as you go model and preferred formulary position.
Robbie Marcus: How do you sustain your number one share there and continue to grow that over time? Thanks.
Robbie Marcus: How do you sustain your number one share there and continue to grow that over time? Thanks.
Ashley McEvoy: Thank you, Robbie. Yeah, we did, as I mentioned before, I think, in Investor Day, we enjoy very balanced growth from the US and OUS. We did enjoy record new customer starts in the US, as well as OUS. And, you know, our role as the category leader, you know, as we shared, we've generated about 65% of the market growth that's come from Insulet. And that really is the primary source of our volume, are coming from people not in the category, and those are people on multiple daily injections. And so we engineer our innovations to address, to bring new customers into the market. We do enjoy about 10% of our comes from switching, and we are switching from competitive AID, but our primary source is coming from, you know, MDI.
Ashley McEvoy: Thank you, Robbie. Yeah, we did, as I mentioned before, I think, in Investor Day, we enjoy very balanced growth from the US and OUS. We did enjoy record new customer starts in the US, as well as OUS. And, you know, our role as the category leader, you know, as we shared, we've generated about 65% of the market growth that's come from Insulet. And that really is the primary source of our volume, are coming from people not in the category, and those are people on multiple daily injections. And so we engineer our innovations to address, to bring new customers into the market. We do enjoy about 10% of our comes from switching, and we are switching from competitive AID, but our primary source is coming from, you know, MDI.
And we continue to invest in programs designed to further reduce the remaining barriers to access.
Including efforts to simplify the prior authorization process.
Provider, particularly among primary care prescribers, who treat large numbers of people with type two diabetes.
Omnipod also continued to drive stand out international performance.
Fueled by strong year over year and sequential growth in new customer starts.
Along with continued positive price mix realization driven by conversion from Omnipod Dash Omnipod side.
We continue to see solid performance across our established European markets.
Ashley McEvoy: That, you know, we can go into Type 1, where we continue to improve new customer starts and post new records in Type 1, both in the US as well as OUS. In the US, that's backed by strong ADA guidelines. You know, we mentioned that 40% of people on AID therapy, there's still a lot of room. When CGM has 70% penetration, there's a 30-point spread. So backed by science, making the education to really educate on our very strong clinical performance, as well as just kind of the unparalleled access and affordability in Type 1. Type 2, Robbie, you mentioned we're at the nascent stages, 5% penetration. We have a very strong value proposition. We have very strong science.
Ashley McEvoy: That, you know, we can go into Type 1, where we continue to improve new customer starts and post new records in Type 1, both in the US as well as OUS. In the US, that's backed by strong ADA guidelines. You know, we mentioned that 40% of people on AID therapy, there's still a lot of room. When CGM has 70% penetration, there's a 30-point spread. So backed by science, making the education to really educate on our very strong clinical performance, as well as just kind of the unparalleled access and affordability in Type 1. Type 2, Robbie, you mentioned we're at the nascent stages, 5% penetration. We have a very strong value proposition. We have very strong science.
Supported by new sensor integration, such as our launch with <unk> <unk> seven in Germany.
Our omnipod five launches in Canada and Australia.
Ashley McEvoy: You're gonna hear us talk more about kind of our strategic pivot, taking advantage of the largest channel of the number one sales force in the US, of migrating from really sharing our differentiated technology into proven clinical outcomes. It's something, quite frankly, you know, we own. There's a bit of a misperception in the marketplace that we have to correct and stand and set the record straight, which is in addition to our, if you will, preferred form factor and preferred user experience, we have very robust clinical performance on A1C reduction and improved time and range. Not just in our clinical trials, but importantly, in two independent studies just recently that compared AID systems, Omnipod's A1C was unsurpassed, and our time and range was similar.
Ashley McEvoy: You're gonna hear us talk more about kind of our strategic pivot, taking advantage of the largest channel of the number one sales force in the US, of migrating from really sharing our differentiated technology into proven clinical outcomes. It's something, quite frankly, you know, we own. There's a bit of a misperception in the marketplace that we have to correct and stand and set the record straight, which is in addition to our, if you will, preferred form factor and preferred user experience, we have very robust clinical performance on A1C reduction and improved time and range. Not just in our clinical trials, but importantly, in two independent studies just recently that compared AID systems, Omnipod's A1C was unsurpassed, and our time and range was similar.
Carl.
And the ongoing transition from Omnipod dash to Omnipod five will continue to support positive price mix realization.
Pricing contributed high single digit growth in both the fourth quarter and the full year 2025.
Our international growth runway remains substantial the type one market alone exceeds 10 billion yet only one in four people with diabetes outside the U S is using AI D therapy, even a CGM penetration reaches around 65%.
As adoption of a idea accelerates worldwide, our proven commercial playbook, expanding product portfolio and growing geographic footprint position us extremely well to continue capturing share and delivering value and driving sustained international growth.
Ashley McEvoy: So we're gonna take that message and that science to the largest channel of our payor, which is our field force. Thanks for the question, Robbie.
Ashley McEvoy: So we're gonna take that message and that science to the largest channel of our payor, which is our field force. Thanks for the question, Robbie.
Operator: Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.
Operator: Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.
To bring this all together we have a large underpenetrated tam across U S type one U S type two and international markets with significant runway to unlock additional growth and one of the fastest growing categories in med Tech.
David Roman: Thank you. Good morning, everyone. Maybe just to follow up on Robbie's question here: Can you help us reconcile, like, a script trend to what you're seeing in reported revenue? I think this is a dynamic that caused quite a lot of noise intra-quarter. So can you maybe size up how new patient start trends and volume growth compares to revenue? And if script data is not the right barometer, what should investors be using to track performance? Then I have one financial follow-up.
David Roman: Thank you. Good morning, everyone. Maybe just to follow up on Robbie's question here: Can you help us reconcile, like, a script trend to what you're seeing in reported revenue? I think this is a dynamic that caused quite a lot of noise intra-quarter. So can you maybe size up how new patient start trends and volume growth compares to revenue? And if script data is not the right barometer, what should investors be using to track performance? Then I have one financial follow-up.
And our proven track record reinforced by our performance this year.
Underscoring our ability to continue to deliver top tier growth and value creation for shareholders.
Notably this top tier growth has allowed us to deliver meaningful margin expansion.
Ashley McEvoy: Sure. Let me just turn to Claudia. Go ahead, Claudia.
Ashley McEvoy: Sure. Let me just turn to Claudia. Go ahead, Claudia.
Even as we continue to invest thoughtfully to extend our competitive advantages and innovation clinical outcomes Axa brand and manufacturing.
Flavia Pease: Good morning, David. Thank you for the question. Yes, we know there had been a lot of questions around script data during Q4. So I think as a reminder, and we talked a little bit about this at the JPMorgan conference in January. The best, if you were gonna use script data, would be to use total pods, as that's the best reflection of the future revenue outlook. If the total pod data is not available, you can use total script. It will not capture potential changes to longer script fills, you know, going from a 30-day to a 60-day to a 90-day, but it's also a good second best option.
Flavia Pease: Good morning, David. Thank you for the question. Yes, we know there had been a lot of questions around script data during Q4. So I think as a reminder, and we talked a little bit about this at the JPMorgan conference in January. The best, if you were gonna use script data, would be to use total pods, as that's the best reflection of the future revenue outlook. If the total pod data is not available, you can use total script. It will not capture potential changes to longer script fills, you know, going from a 30-day to a 60-day to a 90-day, but it's also a good second best option.
For the year, we achieved record gross and operating margins deliver.
Delivering 180 basis points of gross margin expansion and 270 basis points of operating margin expansion.
We remain committed to investing with discipline and ensuring we sustain our strong growth we are delivering today, while also driving continued improvements in profitability.
The investments funded by our durable recurring revenue profitable business model and strong financial position.
Fueled significant progress across every aspect of our strategy in 2025.
We expanded our global scale this year with launches in nine new countries.
Flavia Pease: And then finally, you can use MDRX, but there is a little bit of noise on MDRX because of samples and also different channels. Specialty channel is not captured there, as you use IQVIA data. And then finally, in Q4, there's a little bit of, I'd say, seasonality, where you see higher volume going through wholesale with specialty pharma than in other quarters, which is not necessarily captured in script data, but affects revenue. So there are a few items that folks have to take into consideration when they extrapolate from scripts into dollars of revenue.
Flavia Pease: And then finally, you can use MDRX, but there is a little bit of noise on MDRX because of samples and also different channels. Specialty channel is not captured there, as you use IQVIA data. And then finally, in Q4, there's a little bit of, I'd say, seasonality, where you see higher volume going through wholesale with specialty pharma than in other quarters, which is not necessarily captured in script data, but affects revenue. So there are a few items that folks have to take into consideration when they extrapolate from scripts into dollars of revenue.
Launched RG seven CGM integration.
Increased for phone control adoption to more than 60% of U S user.
And continued building a foundation for our next generation systems.
We also advanced our clinical programs in meaningful ways, we published results from security do Dee Ann Radiant completed the strive study for Omnipod sex.
And moved into the next phase of our evolution studies supporting our fully closed loop system for adults with type two diabetes.
Collectively these programs further strengthen the scientific foundation behind Omnipod advancing our algorithms for optimal performance.
David Roman: Okay. And then are you willing to provide the difference between new patient start growth and overall revenue performance?
David Roman: Okay. And then are you willing to provide the difference between new patient start growth and overall revenue performance?
Fortifying the case for broader a idea adoption and enabling continued global expansion.
We invested in market development, and new more visible and impactful ways.
Flavia Pease: No, you know, we'll continue to provide, I'll say, qualitative commentary on the strength of our new customer starts, and we talk about them. Ashley just mentioned the strong performance in both US and OUS and the continued growth that we see as we continue to expand penetration of AID, but we're not gonna provide specificity on new customer start growth rates.
Flavia Pease: No, you know, we'll continue to provide, I'll say, qualitative commentary on the strength of our new customer starts, and we talk about them. Ashley just mentioned the strong performance in both US and OUS and the continued growth that we see as we continue to expand penetration of AID, but we're not gonna provide specificity on new customer start growth rates.
Our expanded sales force is now more than 25% larger than our nearest competitor.
Our DTC campaigns are generating record lead volume and activating new prescribers.
And our enhanced insights and analytics capability are helping us optimize our cost to acquire and cost to serve driving continued expansion and customer lifetime value.
These advances and efforts have solidified omnipod status as the most requested most preferred and most prescribed a I D systems.
Operator: Your next question comes from a line of Larry Biegelsen from Wells Fargo. Your line is open.
Operator: Your next question comes from a line of Larry Biegelsen from Wells Fargo. Your line is open.
Larry Biegelsen: Good morning. Thanks for taking the question, and congrats on the strong finish here. I'm gonna ask, you know, I think Jeff's question may be a little bit differently. So Ashley, you're guiding to 21 to 23% Omnipod growth for 2026, and, you know, you gave a three-year LRP of 20% recently. So my question is: how are you feeling about, you know, being able to sustain the 20% growth in light of new competition? And anything new you can offer on why you think investor concerns around competition are overblown. You know, do you think it's gonna be harder for new companies to scale or compete directly with Insulet in the patch pump market, or do you think their entries will have a rising tide effect? Thank you.
Larry Biegelsen: Good morning. Thanks for taking the question, and congrats on the strong finish here. I'm gonna ask, you know, I think Jeff's question may be a little bit differently. So Ashley, you're guiding to 21 to 23% Omnipod growth for 2026, and, you know, you gave a three-year LRP of 20% recently. So my question is: how are you feeling about, you know, being able to sustain the 20% growth in light of new competition? And anything new you can offer on why you think investor concerns around competition are overblown. You know, do you think it's gonna be harder for new companies to scale or compete directly with Insulet in the patch pump market, or do you think their entries will have a rising tide effect? Thank you.
Among new customers, 70% of those who walk into a prescribers office request a brand ask for Omnipod five and among existing users Omnipod five maintains the highest net promoter score in the category.
Now I wanted to take a few minutes to walk through how we will continue advancing the long term strategy, we outlined at our 2025 Investor day.
Extend our leadership and strength in patient and physician choice for Omnipod.
Innovation remains central to our strategic approach and in 2026, we will deliver a steady cadence of highly requested enhancements to reinforce our leadership in automated insulin delivery.
Ashley McEvoy: Thank you, Larry, for the question, and I, again, I'm really pleased to see the confidence in the company even increase since our investor day that we shared in November. You know, as we come as a company out of stealth mode to the position of market leadership, you know, performance trumps everything. And I, again, I'll go back to some elements that I think are maybe underappreciated. Getting regulatory approval is not really the definition of impact. And we have this 25-year head start with, you know, again, $3 billion of investment. That's enabled us a lot of knowledge, a lot of know-how, a lot of experience on scale. And I think in this marketplace, if you look at history, there's been a lot of attempts because it is an attractive market.
Ashley McEvoy: Thank you, Larry, for the question, and I, again, I'm really pleased to see the confidence in the company even increase since our investor day that we shared in November. You know, as we come as a company out of stealth mode to the position of market leadership, you know, performance trumps everything. And I, again, I'll go back to some elements that I think are maybe underappreciated. Getting regulatory approval is not really the definition of impact. And we have this 25-year head start with, you know, again, $3 billion of investment. That's enabled us a lot of knowledge, a lot of know-how, a lot of experience on scale. And I think in this marketplace, if you look at history, there's been a lot of attempts because it is an attractive market.
This includes algorithm updates that enable a 100 point target for tighter glycemic control increased time and automated mode and improved responsiveness to enhance both the user experience and clinical outcomes.
We will also expand our CGM integration to include freestyle Libre, three plus making omnipod five compatible with every major sensor.
And we will rollout omnipod discover globally.
Omnipod discover is a new data platform that deliver clear streamline insights to support efficient health care professional review of Omnipod, five data and enable more confident prescribing.
Ashley McEvoy: But I will tell you, there are a lot of barriers to entry, and those really come down to manufacturing at scale with high quality. It has to go to continuing to innovate with clinical performance and really unlocking the TAM. What's gonna enable us to deliver the top-tier performance is by continuing to bring new users into this category, and our pipeline is specifically designed to bring new users from MDI into the category. And I think the biggest unmet need for us is to really start to improve the acumen among the clinical base, particularly in the US, of our strong clinical performance. So in addition to being number one prescribed and number one most requested, predominantly because of our differentiated form factor, and user experience, we also want them to know and be well aware of just the strong, proven...
Ashley McEvoy: But I will tell you, there are a lot of barriers to entry, and those really come down to manufacturing at scale with high quality. It has to go to continuing to innovate with clinical performance and really unlocking the TAM. What's gonna enable us to deliver the top-tier performance is by continuing to bring new users into this category, and our pipeline is specifically designed to bring new users from MDI into the category. And I think the biggest unmet need for us is to really start to improve the acumen among the clinical base, particularly in the US, of our strong clinical performance. So in addition to being number one prescribed and number one most requested, predominantly because of our differentiated form factor, and user experience, we also want them to know and be well aware of just the strong, proven...
Discover provide users with actionable guidance and reassurance strengthening engagement and adherence.
It also simplifies onboarding, reducing effort for new users and accelerating to startup experience.
Collectively these enhancements reduced day to day effort with fewer device interaction broader CGM choice and more actionable insights that help patients and clinicians with confidence.
In 2026, we will continue to purposely increase R&D investment to advance our next generation platforms, including Omnipod sick as well as our fully closed loop system protect to diabetes and future innovation.
This also includes continued progress across our clinical programs with ongoing work in stride and evolution.
Ashley McEvoy: Clinical performance, both efficacy and safety, and unsurpassed in the category. I think that will be new information for many more clinicians. Then I'm going to come back to just continuing to build on our commercial prowess as we go, Larry. Again, I think this company has been known as being really good at technology and really good at the supply chain. What's perhaps underappreciated is this evolving commercial of having the largest sales force selling on science. Very strong. We're bringing new prescribers into the category. We have this beloved brand that we are activating. When we activate DTC, we generate record new leads into the category. We're converting those leads into brand loyalty. They become new Omnipod podders, and then we continue to have unparalleled access and affordability.
Ashley McEvoy: Clinical performance, both efficacy and safety, and unsurpassed in the category. I think that will be new information for many more clinicians. Then I'm going to come back to just continuing to build on our commercial prowess as we go, Larry. Again, I think this company has been known as being really good at technology and really good at the supply chain. What's perhaps underappreciated is this evolving commercial of having the largest sales force selling on science. Very strong. We're bringing new prescribers into the category. We have this beloved brand that we are activating. When we activate DTC, we generate record new leads into the category. We're converting those leads into brand loyalty. They become new Omnipod podders, and then we continue to have unparalleled access and affordability.
Let me take a moment to share more on our next generation platform starting with Omnipod.
This system is designed to address the critical needs of users by meaningfully reducing day to day burden and increasing flexibility through improved connectivity expanded flexibility and on body placement real time software updates and more personalized automation.
It will feature a smarter algorithm to further personalize insulin delivery with pivotal data to be presented at Ada in June.
Importantly, we are designing a single update a bull pod platform that will be compatible across all CGM system.
These capabilities not only improve outcomes and the wear experience, but also accelerate our innovation cycle as we prepare for launch in 2027.
Ashley McEvoy: We've been at this pharmacy for nine years, and we've built remarkable relationships with the payers and the PBMs because we have very strong clinical and economic evidence, and we're going to take that strength and continue, because 100% of our portfolio is in pharmacy. So while others may be at the 10% or 30%, Omnipod's been at this for nine years and will continue to have unparalleled access and affordability. So thank you for the question, Larry. Go ahead.
Ashley McEvoy: We've been at this pharmacy for nine years, and we've built remarkable relationships with the payers and the PBMs because we have very strong clinical and economic evidence, and we're going to take that strength and continue, because 100% of our portfolio is in pharmacy. So while others may be at the 10% or 30%, Omnipod's been at this for nine years and will continue to have unparalleled access and affordability. So thank you for the question, Larry. Go ahead.
Turning next to our fully closed loop system for people with type two diabetes.
Which is designed to make AIG accessible to virtually everyone.
As the market leader in AI D. It's important that we define what fully closed loop truly mean for patients and providers.
It is a system that delivers therapy effortlessly adair.
Flavia Pease: Just one final add is also the financial strength that we have. We have best-in-class growth margin, which has built through these investments that Ashley talked about over the years. We have free cash flow positive, and that strength allow us to continue investing in the business, while at the same time being able to expand margins. That investment is in innovation. It is in unlocking the market with AID penetration, and is also in capacity to invest ahead of demand when you are in a disposable form factor construct.
Flavia Pease: Just one final add is also the financial strength that we have. We have best-in-class growth margin, which has built through these investments that Ashley talked about over the years. We have free cash flow positive, and that strength allow us to continue investing in the business, while at the same time being able to expand margins. That investment is in innovation. It is in unlocking the market with AID penetration, and is also in capacity to invest ahead of demand when you are in a disposable form factor construct.
Adapting automatically without any user intervention.
Dosing no mealtime actions and no required adjustments, while the parties one.
For us fully closely also means redefining the provider experience requires no clinician defined settings to start.
Simple enough for a patient to initiate on their own.
Collecting this definition, we believe are fully closed loop system will help address a significant unmet need for the five and a half million people with type two diabetes, who are on insulin.
Ashley McEvoy: Yeah, Eric's sitting here. You know, as we shared, Larry, we got $1 billion that we're going to invest in R&D in just the next three years. And we, you know, we also are planning new next-generation platforms beyond the three-year window to stay ahead.
Ashley McEvoy: Yeah, Eric's sitting here. You know, as we shared, Larry, we got $1 billion that we're going to invest in R&D in just the next three years. And we, you know, we also are planning new next-generation platforms beyond the three-year window to stay ahead.
Only about 25% of whom achieved recommended glucose targets today.
We expect to initiate our pivotal evolution study this year supporting a regulatory filing in 2027 and a commercial launch in 2028.
Operator: Your next question comes from the line of Michael Polark from Wolfe Research. Your line is open.
Operator: Your next question comes from the line of Michael Polark from Wolfe Research. Your line is open.
Finally operational excellence remains a core focus as we work to expand margins in 2026, while continuing to fund our R&D and commercial investment.
Michael Polark: Hey, good morning. Thank you for taking the question. I have a question on one of your sensor partners. So G7 is moving to 15-day from 10-day. Is this a different pod for Insulet, or is this the same pod? And if it's a different pod, can you comment on the company's readiness to provide integration with the 15-day sensor? I'm just remembering back to 2024, it took some time for the G7 pod to become widely available, and it kind of, I think, suppressed starts for a period of time before it was widely available. And so I'd like to understand the dynamics around the move from Dexcom to 15-day. Thank you.
Michael Polark: Hey, good morning. Thank you for taking the question. I have a question on one of your sensor partners. So G7 is moving to 15-day from 10-day. Is this a different pod for Insulet, or is this the same pod? And if it's a different pod, can you comment on the company's readiness to provide integration with the 15-day sensor? I'm just remembering back to 2024, it took some time for the G7 pod to become widely available, and it kind of, I think, suppressed starts for a period of time before it was widely available. And so I'd like to understand the dynamics around the move from Dexcom to 15-day. Thank you.
In 2025, we delivered significant margin expansion driven by scale and ongoing manufacturing productivity with our act in our Malaysia facilities ramping ahead of plan and.
In 2026, we expect additional leverage as we invest in more capacity and further automation.
And with the help of the AI, we are increasingly tapping into our unique cloud based data ecosystem to enhance customer service efficiency and satisfaction, reducing our cost to serve while strengthening retention.
Ashley McEvoy: Thank you, Mike. Here's Eric. Why don't you talk about our sensor integrations?
Ashley McEvoy: Thank you, Mike. Here's Eric. Why don't you talk about our sensor integrations?
Eric Benjamin: Mike, thanks for the question. As a reminder, we were actually ready with the 15-day launch, day one with Dexcom. So Omnipod 5 is compatible with the 15-day G7 now, and that's a great experience for customers. Then one of the key things we've been focused on, as you know, Mike, is accelerating sensor integration for customers. We were ready day one with 15-day. As Ashley mentioned earlier, we began the limited market release of our FreeStyle Libre Plus integration, just recently, and we're excited to bring that to market in the first half of 2026.
Eric Benjamin: Mike, thanks for the question. As a reminder, we were actually ready with the 15-day launch, day one with Dexcom. So Omnipod 5 is compatible with the 15-day G7 now, and that's a great experience for customers. Then one of the key things we've been focused on, as you know, Mike, is accelerating sensor integration for customers. We were ready day one with 15-day. As Ashley mentioned earlier, we began the limited market release of our FreeStyle Libre Plus integration, just recently, and we're excited to bring that to market in the first half of 2026.
Taken together these priorities position us extremely well to execute on our long term strategy and continued strengthening and driving choice for omnipod among patients and providers worldwide.
All of these investments strategy and consistent execution come together and the financial growth algorithm, we introduced at our 2025 Investor day.
Our 2026 guidance aligns fully with this growth outlook and Fabio will walk through the details in a moment.
Eric Benjamin: And then looking ahead to Omnipod 6, recognizing this need to evolve even faster with the market, it's part of why we're designing one pod that can be updated in market for faster innovation, so that with Omnipod 6, we can always push the latest technologies directly to pods the customers have. So we're accelerating innovation and sensor integrations now, pleased to be on market with Dexcom 15-day and assuring that we're positioned to do that going forward.
Eric Benjamin: And then looking ahead to Omnipod 6, recognizing this need to evolve even faster with the market, it's part of why we're designing one pod that can be updated in market for faster innovation, so that with Omnipod 6, we can always push the latest technologies directly to pods the customers have. So we're accelerating innovation and sensor integrations now, pleased to be on market with Dexcom 15-day and assuring that we're positioned to do that going forward.
This outlook is supported by our continued investment in innovation science market development demand generation and manufacturing balanced with the discipline that has defined our execution over the past several years.
We remain committed to delivering market, leading financial performance, while investing in the next wave of transformative innovation.
We entered 2026 with strong momentum and clear priorities that position us well and give us confidence in achieving our financial goals.
Operator: Your next question comes from a line of Travis Steed from Bank of America. Your line is open.
Operator: Your next question comes from a line of Travis Steed from Bank of America. Your line is open.
Flavia Pease: Hey, thanks for the question. You talked about changing your guidance philosophy, so just wanted to make sure we had understanding of how you kind of set this year's guidance versus prior years and kind of what's been kind of baked in into 2026 versus kind of what's left for upside. And also, do you expect record new starts in Q1 as well?
Travis Steed: Hey, thanks for the question. You talked about changing your guidance philosophy, so just wanted to make sure we had understanding of how you kind of set this year's guidance versus prior years and kind of what's been kind of baked in into 2026 versus kind of what's left for upside. And also, do you expect record new starts in Q1 as well?
To close 2025 was a year of tremendous growth for Insulet financial strategic and organizational.
We expect to build upon this in 2026 as we lighten the burden of living with diabetes for hundreds of thousands of people and in doing so drive penetration increase our scale and create value for our shareholders.
Ashley McEvoy: Thanks, Travis. Claudia, over to you.
Ashley McEvoy: Thanks, Travis. Claudia, over to you.
Flavia Pease: Yeah. Hi, Travis. Good morning. We continue to set guidance with a full intent to deliver. That has not changed. The guidance that we provided today reflects a balanced view of our outlook at this point. And we will experience normal seasonality in the first quarter, which has been the case historically between fourth quarter and first quarter. But outside of that, we are very confident and pleased to be able to provide an outlook of 25 to 27% for the first quarter and 20 to 22% for the full year.
Flavia Pease: Yeah. Hi, Travis. Good morning. We continue to set guidance with a full intent to deliver. That has not changed. The guidance that we provided today reflects a balanced view of our outlook at this point. And we will experience normal seasonality in the first quarter, which has been the case historically between fourth quarter and first quarter. But outside of that, we are very confident and pleased to be able to provide an outlook of 25 to 27% for the first quarter and 20 to 22% for the full year.
We operate from a position of strength with durable competitive advantages a.
Large and Underpenetrated market and a purpose driven highly motivated team committed to finding a better way, we look forward to extending our leadership in the year ahead and beyond.
Thank you for your continued support and interest in Insulet.
Now I'll turn the call over to Fabio <unk> to walk through the financials and guidance in more detail.
Thank you Ashley and good morning, everyone. The Insulet team had another strong year in 2025, and close with an impressive fourth quarter delivering over $780 million in total revenue an increase of 31, 2% at reported rates and 29%.
Michael Polark: Great. Thank you.
Travis Steed: Great. Thank you.
Operator: Your next question comes from a line of Joanne Wuensch from Citigroup. Your line is open.
Operator: Your next question comes from a line of Joanne Wuensch from Citigroup. Your line is open.
Joanne Wuensch: Good morning, and thank you so much for taking the question. ADA is going to be here before we know it. Is there anything in particular that we should look forward to there? And I'm also trying to key in on when are we gonna get a line of sight on some of the clinical steps for Omnipod 6? Thank you.
Joanne Wuensch: Good morning, and thank you so much for taking the question. ADA is going to be here before we know it. Is there anything in particular that we should look forward to there? And I'm also trying to key in on when are we gonna get a line of sight on some of the clinical steps for Omnipod 6? Thank you.
At constant currency rates.
During the quarter total Omnipod grew 31, 3% on a constant currency basis.
We generated total revenue of over $2 $7 billion in 2025, an increase of 37% at reported rates and 29, 5% at constant currency rates.
Ashley McEvoy: Yeah. Thank you, Joanne, for the question. So let me maybe just tee up one of the things that we'll be sharing at the ADA, which is our data from our feasibility study evolution, which is around what we're calling our fully closed loop, which not all fully closed loops meet the definition of our definition. And I think it's important. I'm going to spend a little bit of time on this quickly, and then Erik will cover the others. You know, we are designing, as the market leader, with our big eyes focused on the underserved type two market in the United States, where we have 5% penetration and there's 5.5 million people on insulin that we would like to be on AID therapy, since the ADA guidelines recommended AID therapy as the standard of care.
Ashley McEvoy: Yeah. Thank you, Joanne, for the question. So let me maybe just tee up one of the things that we'll be sharing at the ADA, which is our data from our feasibility study evolution, which is around what we're calling our fully closed loop, which not all fully closed loops meet the definition of our definition. And I think it's important. I'm going to spend a little bit of time on this quickly, and then Erik will cover the others. You know, we are designing, as the market leader, with our big eyes focused on the underserved type two market in the United States, where we have 5% penetration and there's 5.5 million people on insulin that we would like to be on AID therapy, since the ADA guidelines recommended AID therapy as the standard of care.
For the year total Omnipod grew 33% on a constant currency basis, showcasing sustained global demand for Omnipod side.
Across both fourth quarter and full year, we achieved record new customer starts in the U S International markets and company wide with growth accelerating on both a year over year and sequential basis.
In the U S. During the fourth quarter over 85% of new customer starts came from MTI and type two represented over 40% of all starts underscoring the significant expansion of this customer segment.
Ashley McEvoy: We have designed our fully closed loop to address the biggest barriers for those patients with type 2 to get onto AID therapy. It starts with our algorithm, which will be including no user intervention. It requires no dosing, it has no mealtime interactions, no adjustments while the pod, while the pod is worn. There's 2 other areas that are really important to the type 2 user base, one is the clinicians. And the clinicians, this will require no defined settings at start, which is a big barrier right now to the primary care prescribing base, that just don't have the time to go input all of those settings. And then third, Joanne, the big unlock is patients don't have to do 2-hour training. You know, this is something that they can initiate on their own.
Ashley McEvoy: We have designed our fully closed loop to address the biggest barriers for those patients with type 2 to get onto AID therapy. It starts with our algorithm, which will be including no user intervention. It requires no dosing, it has no mealtime interactions, no adjustments while the pod, while the pod is worn. There's 2 other areas that are really important to the type 2 user base, one is the clinicians. And the clinicians, this will require no defined settings at start, which is a big barrier right now to the primary care prescribing base, that just don't have the time to go input all of those settings. And then third, Joanne, the big unlock is patients don't have to do 2-hour training. You know, this is something that they can initiate on their own.
Our estimated global utilization and annualized retention rate remained roughly stable for the fourth quarter and the full year.
Now turning to our performance in greater detail.
U S. Omnipod revenue grew 28% in the fourth quarter and 27, 2% for the year above the high end of our guidance range driven by continued demand for Omnipod five across type one and type two customers.
As we commented last quarter U S revenue growth during 2025 was impacted by rebate timing and prior year inventory stocking dynamics.
Ashley McEvoy: So our combination of really modernizing the training so that they can do it at home on their own time, without 2 hours, really unlocking prescriber adoption, not having to put in settings, really important for the primary care audience, which is really who's gonna be managing patients who have type 2 diabetes. And then third, really a very CGM-like experience for people with type 2 diabetes. So we're gonna be sharing our data from our feasibility in at the ADA. But in addition to that, we have some our third generation algorithm in Omnipod 6, that Eric will touch on.
Ashley McEvoy: So our combination of really modernizing the training so that they can do it at home on their own time, without 2 hours, really unlocking prescriber adoption, not having to put in settings, really important for the primary care audience, which is really who's gonna be managing patients who have type 2 diabetes. And then third, really a very CGM-like experience for people with type 2 diabetes. So we're gonna be sharing our data from our feasibility in at the ADA. But in addition to that, we have some our third generation algorithm in Omnipod 6, that Eric will touch on.
Normalizing for these impact U S growth in the fourth quarter was approximately 30 basis points higher representing an acceleration from normalized third quarter growth levels.
Yeah.
Our international Omnipod business grew 57% on a reported basis and 41, 7% on a constant currency basis for the fourth quarter.
Eric Benjamin: Hey, Joanne. Just building on Ashley's comments about, you know, what's coming at the upcoming congresses. So at ATTD, we'll be showing the evolution data, as Ashley just described, on our way towards that truly transformative, fully closed loop system to unlock primary care. We'll also be showing some health economics data, showing favorable outcomes and ER visits for the unique, fully disposable experience that is Omnipod as compared to tube pumps. So really excited for what's coming at ATTD. Looking ahead to ADA, that's where we'll be publishing the pivotal results from Strive. That's the pivotal study that supports Omnipod 6. Excited to be reporting that out. And in addition, you know, Ashley mentioned this earlier, but there are more independent third-party studies comparing clinical results of on-market AID systems coming out.
Eric Benjamin: Hey, Joanne. Just building on Ashley's comments about, you know, what's coming at the upcoming congresses. So at ATTD, we'll be showing the evolution data, as Ashley just described, on our way towards that truly transformative, fully closed loop system to unlock primary care. We'll also be showing some health economics data, showing favorable outcomes and ER visits for the unique, fully disposable experience that is Omnipod as compared to tube pumps. So really excited for what's coming at ATTD. Looking ahead to ADA, that's where we'll be publishing the pivotal results from Strive. That's the pivotal study that supports Omnipod 6. Excited to be reporting that out. And in addition, you know, Ashley mentioned this earlier, but there are more independent third-party studies comparing clinical results of on-market AID systems coming out.
For the full year International Omnipod revenue grew 44, 1% on a reported basis and 39, 3% on a constant currency basis.
Volume was the primary driver of international Omnipod growth, while positive price mix realization continue to contribute as customers shift from Omnipod dash to Omnipod five.
As in prior quarters, we witnessed strong growth in the U K, Germany and France.
In addition to the other countries, where we have launched Omnipod fly.
In 2025 hour nine expansion markets collectively deliver growth in line with the U K and Germany combined reflecting.
Reflecting the broad market appeal of Omnipod, five and benefits to patients globally.
Eric Benjamin: And in two recent of those, Omnipod has shown unsurpassed A1C and similar time in range to those reporting time in range using an ICGM sensor. And so one of the other things that, you know, we're paying attention to is that it, it's really important to interpret clinical data based on A1C, and it's hard to compare across studies that don't use an ICGM sensor for time in range. And so there's more of those studies coming out, and you'll see us talking about those, too.
Eric Benjamin: And in two recent of those, Omnipod has shown unsurpassed A1C and similar time in range to those reporting time in range using an ICGM sensor. And so one of the other things that, you know, we're paying attention to is that it, it's really important to interpret clinical data based on A1C, and it's hard to compare across studies that don't use an ICGM sensor for time in range. And so there's more of those studies coming out, and you'll see us talking about those, too.
Continuing down the P&L.
Our fourth quarter gross margin was 72, 5%, reflecting a 40 basis point expansion year over year.
Our full year 2025 gross margin of 71, 6% reflected 180 basis point expansion year over year.
This improvement was fueled by robust topline growth continued manufacturing productivity gains at all accident and Malaysia facilities supported by positive pricing and increased volumes.
Operator: Your next question comes from a line of Richard Newitter from Truist. Your line is open.
Operator: Your next question comes from a line of Richard Newitter from Truist. Your line is open.
Richard Newitter: Hi, thanks for taking the questions, and congrats on the quarter. Maybe the first one, just your type two mix. I think you said you actually figure at about 40% of the new patient starts. I guess that would seem to imply that your type one segment maybe saw a moderating growth leveling off in the single-digit range. I guess, is that the right way to think of it going forward? And if so, what is that? Is that share? Is that just the market kind of has started to moderate, and we're getting near maturity? And then I have a follow-up. Thanks.
Richard Newitter: Hi, thanks for taking the questions, and congrats on the quarter. Maybe the first one, just your type two mix. I think you said you actually figure at about 40% of the new patient starts. I guess that would seem to imply that your type one segment maybe saw a moderating growth leveling off in the single-digit range. I guess, is that the right way to think of it going forward? And if so, what is that? Is that share? Is that just the market kind of has started to moderate, and we're getting near maturity? And then I have a follow-up. Thanks.
As mentioned last quarter, Malaysia became margin accretive just one year after coming online.
Turning to Opex, we continue to make purposeful investments too.
Both maintain and extend our leadership.
We're fortunate to be in a position, where we can meaningfully from our innovation pipeline and ensure we are forced to deliver truly transformational technology to the market.
In line with this commitment we increased R&D spending by 50% in the fourth quarter and 37% for the full year as we advanced our innovation roadmap and clinical development programs, including our strive and evolution studies.
Flavia Pease: Yeah, I'll start and maybe, Erik can add. So yeah, we had very strong, type two performance in the Q4, and there was a continuation of that strength throughout the year. We had, record new customer starts for both US and international, both year-over-year, excuse me, and sequentially. To your point, Richard, type one, it grew nicely year-over-year, and it was comparable to the Q3, which was a record, quarter for us in NCS. The level of penetration, obviously, in type one is, higher than type two, and as we continue to bring AID, into those markets, you will see, an accelerating growth in type two, just given that it's 5% today versus type one at 40% penetration of AID.
Flavia Pease: Yeah, I'll start and maybe, Erik can add. So yeah, we had very strong, type two performance in the Q4, and there was a continuation of that strength throughout the year. We had, record new customer starts for both US and international, both year-over-year, excuse me, and sequentially. To your point, Richard, type one, it grew nicely year-over-year, and it was comparable to the Q3, which was a record, quarter for us in NCS. The level of penetration, obviously, in type one is, higher than type two, and as we continue to bring AID, into those markets, you will see, an accelerating growth in type two, just given that it's 5% today versus type one at 40% penetration of AID.
At the same time, we remain disciplined and targeted in our SG&A investments.
We continue to prioritize market development initiatives to unlock AIB penetration.
And demand generation efforts, including expanding our commercial and customer experience teams to drive share and increase retention of our leading AI technology across both type one and type two diabetes.
For the year, we successfully optimize both our cost to acquire and our cost to serve too.
Two key metrics, we remained focus on improving as we enhance customer lifetime value.
Fourth quarter adjusted operating margin of 18, 7% reflected robust revenue growth strong gross margins and continued investment to advance innovation and key commercial strategies.
Flavia Pease: But we continue to source a lot of our volume from MDI, as we talked about, the 85%. That's really our strategy to drive that penetration in those customer segments and internationally, which is also still very underpenetrated. Erik?
Flavia Pease: But we continue to source a lot of our volume from MDI, as we talked about, the 85%. That's really our strategy to drive that penetration in those customer segments and internationally, which is also still very underpenetrated. Erik?
Our full year adjusted operating margin was 17, 6%.
Head of our most recent guidance and representing 270 basis points of expansion versus the prior year.
Eric Benjamin: Yeah, Richard, thanks for the question. I think as Flavia described, type one in the US is more penetrated, and the level of new customer starts in the market is high, and so it continues to be a significant driver of growth. Ashley described it well. We've got a balanced growth portfolio, and type one is a big part of that. Type two, the level of new customer starts in the market has been low, and we are accelerating that as we launch Omnipod 5 with type two, and did so over the course of 2025, which is why you saw that mix grow. You also saw our type one new customer starts outside the US grow significantly year over year. And those three levers, US type one, US type two, international type one, are gonna contribute a balanced contribution to our growth over time.
Eric Benjamin: Yeah, Richard, thanks for the question. I think as Flavia described, type one in the US is more penetrated, and the level of new customer starts in the market is high, and so it continues to be a significant driver of growth. Ashley described it well. We've got a balanced growth portfolio, and type one is a big part of that. Type two, the level of new customer starts in the market has been low, and we are accelerating that as we launch Omnipod 5 with type two, and did so over the course of 2025, which is why you saw that mix grow. You also saw our type one new customer starts outside the US grow significantly year over year. And those three levers, US type one, US type two, international type one, are gonna contribute a balanced contribution to our growth over time.
As Ashley mentioned, we are well positioned to continue investing robustly for future growth, while delivering meaningful margin expansion for years to come.
Fourth quarter net interest expense was $9 $2 million, an increase of $11 million relative to prior year.
Primarily driven by the debt refinancing.
Full year net interest expense was $24 $7 million, an increase of $22 million compared to the prior year.
Again, primarily driven by the impact of our senior unsecured notes issued in March.
Richard Newitter: Okay, that's helpful. Thanks. And maybe could you, following up to Travis's question, can you put some assumption bars or around the upper and lower ends of your range? Or maybe said another way, what would have to happen for the, to the biggest needle mover in your assumption set to be at the upper end or above?
Richard Newitter: Okay, that's helpful. Thanks. And maybe could you, following up to Travis's question, can you put some assumption bars or around the upper and lower ends of your range? Or maybe said another way, what would have to happen for the, to the biggest needle mover in your assumption set to be at the upper end or above?
Our fourth quarter non-GAAP adjusted tax rate was 22% and our full year non-GAAP adjusted tax rate was 22, 3%.
Fourth quarter, adjusted EPS was $1 55 inch.
Increasing 35% from $1.15 in the prior year comparable period, while full year 2025, adjusted EPS was $4 97 up 53% from $3.24 in the prior year.
Flavia Pease: ...Well, we provided a guidance range. So to me, that is the upper and lower end of, you know, the bars that you're describing, Richard. And I think we obviously, as I said earlier, we continue to set guidance with the full intent of delivering, and this is our best outlook at this point, given where we are in the year. Obviously, if we can advance AID penetration even further and faster, that will translate into us being closer to the top end of the range.
Flavia Pease: ...Well, we provided a guidance range. So to me, that is the upper and lower end of, you know, the bars that you're describing, Richard. And I think we obviously, as I said earlier, we continue to set guidance with the full intent of delivering, and this is our best outlook at this point, given where we are in the year. Obviously, if we can advance AID penetration even further and faster, that will translate into us being closer to the top end of the range.
During the year, we repurchased approximately 184000 shares for $59 $6 million.
Turning to cash and liquidity.
We ended the quarter with $716 million in cash and the full $500 million available under our credit facility.
Ashley McEvoy: Thank you, Richard, for the question.
Ashley McEvoy: Thank you, Richard, for the question.
We delivered more than $375 million in free cash flow for 2025% to 24% increase over last year.
Operator: Your next question-
Operator: Your next question-
Ashley McEvoy: Time for one more question?
Ashley McEvoy: Time for one more question?
Operator: Certainly. Your final question comes from the line of Danielle Antalffy from UBS. Your line is open.
Operator: Certainly. Your final question comes from the line of Danielle Antalffy from UBS. Your line is open.
Danielle Antalffy: Hey, good morning, everyone. Congrats on a strong end to the year, ladies, plus Eric. So my question is on the competitive mode. Ashley, you touched on this earlier. I do think it's underappreciated. I specifically wanted to see if you could talk a little bit about the sampling at the physician's office and sort of if you could walk through how this works, like who trains the patient to ensure they get the optimal experience? And appreciate it's still early, but what are you seeing for capture rates with that program? Thanks so much.
Danielle Antalffy: Hey, good morning, everyone. Congrats on a strong end to the year, ladies, plus Eric. So my question is on the competitive mode. Ashley, you touched on this earlier. I do think it's underappreciated. I specifically wanted to see if you could talk a little bit about the sampling at the physician's office and sort of if you could walk through how this works, like who trains the patient to ensure they get the optimal experience? And appreciate it's still early, but what are you seeing for capture rates with that program? Thanks so much.
2025 free cash flow included approximately a $70 million tax benefit related to the one big beautiful Bill.
As a reminder, free cash flow includes capital expenditures, which grew meaningfully in the fourth quarter to $135 million, reflecting our continued investment in manufacturing capacity.
This included further expansion of our Malaysia operations with additional lines coming online as well as the start of development of our new facility in Costa Rica, which is expected to be operational in 2029.
Ashley McEvoy: Thank you, Danielle, for the question. I guess just for context, again, I think the company is best known for just having really differentiated technology and investing ahead of the curve in supply chain and maybe pioneering this, you know, pharmacy pay-as-you-go model. What I would like to see at the end of this year is, you know, a better appreciation of the commercial prowess that we've been building over the past couple of years. So we have been expanding our sales force. We expanded it around 25% last year. We're continuing to do that. We call on over 17,000, so, you know, full coverage of the endos, really 10,000 of the highest prescribers. And what we're evolving is our messaging, as I mentioned earlier.
Ashley McEvoy: Thank you, Danielle, for the question. I guess just for context, again, I think the company is best known for just having really differentiated technology and investing ahead of the curve in supply chain and maybe pioneering this, you know, pharmacy pay-as-you-go model. What I would like to see at the end of this year is, you know, a better appreciation of the commercial prowess that we've been building over the past couple of years. So we have been expanding our sales force. We expanded it around 25% last year. We're continuing to do that. We call on over 17,000, so, you know, full coverage of the endos, really 10,000 of the highest prescribers. And what we're evolving is our messaging, as I mentioned earlier.
These investments strengthen our global footprint advanced our automation initiatives and position us to support industry, leading growth, while continuing to expand margins over time.
Now.
Ashley McEvoy: In addition to selling what they've come to love, which is really this differentiated technology platform that's simple and easy to use, it's why it's the gateway to the category to new users. It's easy for them to explain. It's also coming to educate on our really strong clinical performance, and we will continue that messaging in 2026. To make it easy to get people on pod, we're really the only AID offering that can get people on a sample. So, right in the practice, they can go put a pod. It's a very capital-efficient way for us to initiate trial. We've gotten a lot of really good feedback, both from young children as well as grandparents, around once. It's kind of that moment of delight. You know, once they try it on, they get the wow factor, and we have very strong conversion ratios.
Ashley McEvoy: In addition to selling what they've come to love, which is really this differentiated technology platform that's simple and easy to use, it's why it's the gateway to the category to new users. It's easy for them to explain. It's also coming to educate on our really strong clinical performance, and we will continue that messaging in 2026. To make it easy to get people on pod, we're really the only AID offering that can get people on a sample. So, right in the practice, they can go put a pod. It's a very capital-efficient way for us to initiate trial. We've gotten a lot of really good feedback, both from young children as well as grandparents, around once. It's kind of that moment of delight. You know, once they try it on, they get the wow factor, and we have very strong conversion ratios.
With that.
We expect a favorable impact of 100 basis points from foreign currency for the year.
Ashley McEvoy: In addition to, you know, the called on universe, we also have this darling brand, is what I say, that I think is a bit underappreciated, where we activate directly to consumer, make them aware of the category, make them aware of Omnipod 5, and people go in and ask their doctors for that, and they specifically ask for Omnipod, and that's a new category user. And we, those then become new patients, but they also become new prescribers. And that's why you heard us talk about, when we ended the year, we had 30,000 prescribers, writing for Omnipod, which is up 28%. And we're going to continue that flywheel of really creating the market and creating demand for Omnipod. Thank you for the question, Danielle.
Ashley McEvoy: In addition to, you know, the called on universe, we also have this darling brand, is what I say, that I think is a bit underappreciated, where we activate directly to consumer, make them aware of the category, make them aware of Omnipod 5, and people go in and ask their doctors for that, and they specifically ask for Omnipod, and that's a new category user. And we, those then become new patients, but they also become new prescribers. And that's why you heard us talk about, when we ended the year, we had 30,000 prescribers, writing for Omnipod, which is up 28%. And we're going to continue that flywheel of really creating the market and creating demand for Omnipod. Thank you for the question, Danielle.
Our guidance reflects continued top tier market, leading growth, but I know you. All asked me why is growth decelerating.
Just a couple of quick notes on this first this year, we will be anniversary. The first full year of the U S launch of Omnipod for type two which was a significant contributor to last year's performance.
In addition, we're beginning to annualize several of our international launches, which continue to ramp well, but create more challenging year over year comparisons.
Operator: This concludes our question and answer session and today's conference call. We thank you for your participation, and you may now disconnect.
Operator: This concludes our question and answer session and today's conference call. We thank you for your participation, and you may now disconnect.
These year over year comp dynamics are reflected in our 2026 guidance.
For U S. Omnipod, we expect our revenue to grow 20% to 22% driven by increased penetration from MDI users and competitive games.
We expect year over year growth in U S. New customer starts for the year, and we assume similar trends and pricing utilization and retention as we saw in 2025.
For International Omnipod, we expect 2026 revenue to grow 24% to 26%.
On a reported basis, we expect a favorable impact of approximately 300 basis points from foreign currency.
We expect year over year growth in international New customer starts for the year as we penetrate further in current markets and expand omnipod five into new markets.
Omnipod five is now available in 19 countries, including five recent additions in the middle East.
And we will continue to broaden our reach and plan to enter Spain by late 2026.
While volume remains the primary driver of our international revenue growth.
Our guidance also reflects a benefit from positive price mix realization as customers continue to transition from Omnipod dash to Omnipod five.
Overall, our international growth guidance assumes stable utilization and slightly improving retention from 2026 relative to 2025.
Turning to 2026 operating margin.
In line with the annual guidance, we provided at our recent Investor Day, we expect to drive approximately 100 basis points of operating margin expansion for the full year.
Reflecting strong topline growth modest gross margin expansion, a significant step up in R&D investments to fuel, our innovation pipeline and leverage SG&A spend.
Looking at a few items below our operating income.
We expect 2000 22026 net interest expense to total approximately $40 million, primarily due to lower interest income and.
And we expect 2026 non-GAAP tax rate to be in the range of 22% to 23%.
Our team is actively focused on assessing potential opportunities to optimize our interest expense and tax rate overtime.
Turning to shares outstanding and EPS.
I'm pleased to share that the board has approved an additional $350 million share repurchase authorization we.
We expect to deploy approximately $300 million of this authorization in the first quarter of 2026.
Our strong balance sheet gives us the flexibility to continue allocating capital in line with our long standing principles.
Investing for growth, while delivering long term value for our shareholders.
Based on our current share count and repurchase plans, we expect that 2026, ending balance of our diluted share count to be around 70 million shares.
Based on these factors, we expect 2026, adjusted EPS to increase by more than 25%.
We expect free cash flow to be approximately flat from 2025 levels supported by robust growth and continued margin expansion.
Partially offset by a ramp up in capital expenditures to support our continued global manufacturing expansion plan.
As I just mentioned 2025 free cash flow included approximately $70 million related to a tax benefit from the one big beautiful Bill.
Our team remains steadfast in its commitment to driving top tier growth expanding margins and increasing profitability and free cash flow.
These efforts are central to our long term value creation strategy and enable us to reach and serve more people with diabetes around the world.
With that operator, please open the line for questions.
Thank you we will now begin the question and answer session. If you would like to ask a question. Please press star one on your telephone keypad. If you would like to withdraw your question simply press Star one again.
Your first question today comes from the line of Jeff Johnson from Baird. Your line is open.
Thank you and good morning, everyone and congratulations on a strong close to the year actually I just want to start from a high level, maybe with the first question here, you're a couple months away from your one year anniversary leading insulin.
Stock has had a great run in the first six months of your tenure tenure at its base, maybe some challenges here in the last five or six months. What do you think is the most underappreciated part of the insulin story at this point, especially from an investor perspective. Thank you.
Yeah. Good morning, Jeff. Thanks for the question and it's great to see and play continue to execute and live into our commitments that we shared in November at our Investor Day.
I would highlight four key areas.
Number one is our tech read which will continue to innovate off of I'll come back to that I.
I would say never too is our growing commercial proudly I'll come back to that three as our manufacturing at scale and four is our financial strength. So I'll start with just our tech read as we shared we've invested over $3 billion to get here Omnipod five we're just three and a half year into the launch into the U F two and a half year.
In places like the UK, and Germany, and we continue to post record NCR.
This knowledge this experience in this tech read really continue to prove the leadership. That's resulted in number one most prescribed the number one most requested and importantly in my opening remarks, I really shared how we built this meaningful pipeline that really addresses the biggest unmet needs in the market and you heard it cuts.
Around really two algorithm improvements starting this actually weekend, we launched a limited market release with omni channel five with a lower step point advanced automated mode. It connects with Libre three we're gonna be launching our new data platform. So that was going out into full market release in a couple of months.
We will be launching our third generation algorithm with Omnipod Zach as we mentioned in our opening remarks, we're gonna be posting the data on the algorithm at the 80, a and this is a meaningful advancement in personal automation as well as over the air connectivity as well as on the bond placement with a lot of variability, which is important for patients as well as in one part in.
You're going to hear us talk about there's been a lot of noise. If you will in the industry, which is really good thing for patients around the fully closed loop. We believe that we are in a class by yourself of how we're going to define what fully purpose really me I'll come back to that in any agree but it's a very strong pipeline and then our commercial prowess. I think is really underappreciated, we have the largest sales force in the <unk>.
Interest rates were going to evolve that salesforce for messaging from selling on simplicity and ease of use and our highly differentiated technology to our strength of clinical performance come back or not.
And then as Bobby was mentioned in her opening remarks 30000.
Prescribers with Omnipod, which is up 28%.
Very strong brand loyalty and we continue to have unparalleled access and affordability.
We manufacture at scale, what this one thing to get regulatory approval, it's different than to manufacturer, we produce tens of millions of pods with high quality medical grade quality and consumer electronic scale and when we say something we execute and what we're gonna say I'm really pleased the team is building out Malaysia, we're already margin accretive in Malaysia and actively improve.
Productivity and we've already started to break ground in Costa Rica, and last is just the financial wherewithal and you know not only a recurring revenue model, 70% gross margin expanding operating margin EPS above revenue and cash flow positive. So those are perhaps underappreciated tenants of.
The Insulet company. Thanks for the question Jeff.
Yeah.
Your next question comes from the line of Robbie Marcus from Jpmorgan. Your line is open.
Oh, great good morning, and congrats on a good quarter.
I wanted to ask I guess, it's limited to one I wanted to ask on.
New patient start trends U S and outside the U S and we've seen some of your competitors stumble a bit on new patient adds recently.
How are you thinking you mentioned record new patient starts I believe that the U S and outside the U S. But you could clarify that if I'm wrong, how are you thinking about.
Finding sources.
Sustainability and the new patient growth type two is clearly a home run for you in the U S. How do you keep that growing and getting larger and larger and continuing to win there and then same question outside the U S. You've been moving into new geographies. How do you sustain your number one share there and continue to grow that over time.
Thank you Robin Yes, we did as I mentioned before I think in Investor day, we enjoy a very balanced growth from the U S and O U S. We did enjoy record new customer starts in the U S as well as O U S and.
Our role as the category leader as we shared we've generated about 65% of the market growth has come from Insulet.
And that really is the primary source of our volume are coming from people not in the category and those are people on multiple daily injections and so we engineer our innovations to address to bring new customers into the market. We do enjoy about 10% of our comfort switching and we are switching from competitive AIG, but our primary source is coming from.
MDI and that we can go into Taiwan, where we continue to improve new customer starts and post new record in type one.
And both in the U S as well as O U S. In the U S. That's backed by strong Ada guidelines.
We mentioned that 40% of people in AAV therapy, there's still a lot of room. When CGM has 70% penetration. There's a 30 point spread so backed by science, making the education to really educate on our very strong clinical performance.
And as well as just kind of the unbelieving unparalleled access and affordability in type one type two Rami you mentioned, we're at the nascent stages, 5% penetration, we have a very strong value proposition with very strong science.
Youre going to hear us talk more about kind of our strategic pivot taking advantage of the largest channel of the number one salesforce in the U S of migrating from really Sherry, our differentiated technology into proven clinical outcomes is something quite frankly, we own there was a bit of a misperception in the marketplace that we have to correct and scan and sell.
The record straight which is in addition to our if you will preferred form factor and preferred user experience. We are very robust clinical performance on a one <unk> reduction and improved time and range not just in a clinical trial, but importantly in two independent studies, just recently that compared AIB systems Omnipod.
<unk> was unsurpassed in our time in range with somewhere so we're going to take that message and that science to the largest channel of our of our P&L, which is our field force. Thanks for the question Ravi.
Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.
Okay.
Thank you good morning, everyone, maybe just sort of follow up on Robbie's question here can you help us reconcile.
Script trends to what Youre seeing in reported revenue I think this is a dynamic that caused quite a lot of noise.
For quarter. So could you maybe size up how new patient start trends and volume growth compares to revenue and script data is not the right.
Ramat or what should investors be using to track performance then I had one financial follow up.
Sure. They just turned the father of go have fun at good morning, David. Thank you for the question. Yes, we know there had been a lot of questions around script data during the fourth quarter. So I think as a reminder, and we talked a little bit about this in a.
The JP Morgan conference.
In January the best if.
You were going to use script data the best would be to use total pods.
And that's the best reflection of the future revenue.
Outlook.
Not the total Pos data is not available you can use a total script it will not capture potential changes.
Two longer.
<unk> sales going from a 30 days to 60 days or 90 days, but it's also a good.
Second our best option and then finally, you can use <unk>, but theres a little bit of noise on MDI.
Because of samples and also different channels specialty channel was not capture there.
You'd like you'd via the data and then finally in the fourth quarter, there's a little bit of I'd say seasonality, where you see higher volume going through wholesale with specialty pharma than in other quarters.
Quarters, which is not necessarily captured in script data, but affects revenue. So there are a few.
Items that folks have to take into consideration when they extrapolated from the script and $2 of revenue.
Okay.
Okay, and then are you willing to provide the difference between new patient start growth and overall revenue.
Revenue performance.
No I will continue to provide a I'll say qualitative commentary on our the strength of our new customer starts.
And we talk about them actually just mentioned the the straw.
Strong performance in both U S and O U S and the continued growth that we see as we continue to expand our penetration of AIG, but we're not going to provide specificity on new customers start growth rates.
Your next question comes from a line of Larry <unk> from Wells Fargo. Your line is open.
Yeah.
Good morning, Thanks for taking the question. So the question and congrats on the strong finish here.
I'm going to ask.
I think jeffs question, maybe a little bit differently, so actually youre guiding to 21% to 23% Omnipod growth for 2026.
Gave a three year <unk> of 20% recently.
So my question is how are you feeling about being able to sustain the 20% growth in light of new competition and anything new you can offer on why you think investor concerns around competition overblown.
I think it is going to be harder for new companies to scale or compete directly with insulet in the patch pump market, where do you think they're entries will have a rising tide effect. Thank you.
Thank you Larry for the question and again I'm really pleased to see the confidence in the company even increased since our Investor day that we shared in November as become as a company out of stealth mode to the position of market leadership.
You know performance trumps everything and I again, I'll go back to some elements that I think are maybe underappreciated I'm getting regulatory approval is not really the definition of impact.
And we have this 25 year head start with.
With you know against $3 billion of investments that's enabled us a lot of knowledge a lot of tech know how a lot of experience on scale and I think in this marketplace. If you look at history, there's been a lot of attempts because it is an attractive market but.
But I will tell you there are a lot of barriers to entry and and those really come down to manufacturing at scale with high quality. It has to go to continuing to innovate with clinical performance and really unlocking the cam what's going to enable us to deliver the top tier performance is by continuing to bring new.
Users into this category and our pipeline is specifically designed to bring new users from MDI into the category and I think the biggest unmet need for us to really start to improve the acumen among the clinical base, particularly in the U S of our strong clinical performance. So in addition to being number one.
Prescribed a number one most requested predominantly because of our differentiated form factor and user experience. We also want them to know and be well aware of just a strong proven clinical performance, both efficacy and safety and unsurpassed in the category I think that will be new information for many more clinicians.
And then I'm going to come back to just continuing to build on our commercial.
As we go Larry again, I think this company has been known as being really good at technology and really good at the supply chain with perhaps underappreciated is it evolving commercial of having the largest sales force selling on science very strong, we're bringing new prescribers into the category. We have this beloved brand that we are activating when we add.
Active H D. T C. We generate record new leads into the category. We're converting those leads into brand loyalty they become new Omnipod powders and then we continue to have unparalleled access and affordability we've been at the pharmacy for nine years, and we've built a remarkable relationships with the payers and the P. B.
Because we have very strong clinical and economic evidence and we're gonna take that strength and continue because 100% of our portfolio. The pharmacy, so while others may be at the 10% or 30% Omnipod has been at this for nine years and will continue to have unparalleled access and affordability. So thank you for the question Larry.
I had one final one it is also the financial strength that we have we have best in class gross margin, which has built through these investments that Ashley talked about over the years, we have a free cash flow positive and that strength allow us to continue investing in the business.
While at the same time being able to expand margins and that investment is in innovation. It is in unlocking.
Unlocking the market with AIG penetration and it's also in capacity to invest ahead of demand. When you are in a disposable form factor cost structure, yeah, Eric sitting here as we shared Larry we've got $1 billion that we're going to invest in R&D and just the next three years and we you know we also are planning new next generation platforms beyond the three year window to stay.
[noise] ahead.
Your next question comes from the line of Michael Pollard from Wolfe Research. Your line is open.
Hey, good morning. Thank you for taking the question I have a question on one of your sensor partners. So <unk> is moving to 15 day from 10 day.
This is a different path for input or is this the same pod and if there's a different part can you comment on the company's readiness to provide.
Integration of the 15 data center I'm, just remembering back to 2024. It took some time for the <unk> part to become widely available and I kind of think suppress starts for a period of time before.
It was widely available and so I'd like to understand the dynamics around the move from <unk> to 15 day. Thank you.
Mike adherence, Eric why don't you talk about our sensor integration.
Mike Thanks for the question.
As a reminder, we were actually ready with a 15 day launch day, one with Datacom. So omnipod.
Compatible with the 15 day G. Seven now and that's a great experience for customers and one of the key things that we've been focused on as you know Mike was accelerating sensor integration for customers.
We were ready day, one with 15 day as I mentioned earlier, we began the limited market release of our freestyle Libre plus integration just recently and we're excited to bring back to market in the first half of 2020.
And then looking ahead to Omnipod <unk>, recognizing the need to evolve even faster with the market. It's part of why we're defining one that can be updated in market for faster innovation.
We can always push the latest technologies directly deposited customers out so we're accelerating innovation and sensor integration now.
In a market with exon 50 day, and assuring that we're positioned to do that going forward.
Yeah.
Your next question comes from the line of Travis Steed from Bank of America. Your line is open.
Hey, Thanks for the question you talked about changing your guidance philosophy. So I just wanted to make sure we had.
Understanding of how you kind of thought this year's guidance versus prior years and kind of what's been kind of baked in.
And the 2026 versus kind of what's left from Buck for upside and also do you expect record new starts.
Q1 as well.
Thanks Travis.
Over to you Yeah, Hi, Travis good morning, we continue to assess guidance with a fully intend to deliver that has not change the guidance that we provided today reflects a balanced view of our outlook at this point.
And.
We will experienced normal seasonality in the first quarter, which has been the case historically between fourth quarter and first quarter, but outside of that we are very confident and pleased to be able to provide an outlook of 25% to 27% for the first quarter.
And 20% to 22% for the full year.
Thank you.
Your next question comes from the line of Joanne Wuensch from Citigroup. Your line is open.
Yeah.
Good morning, and thank you so much for taking the question.
A da is gonna be here before we know it is there anything in particular that we should have a car or two there and I'm also trying to key in on what are we going to get a line of sight on some of the clinical steps for Omnipod six.
Yeah. Thank you Joanne for the question. So let me maybe just tee up one of the things that we'll be sharing at the a D a which is our.
From a piece of data from our feasibility study evolution, which is around what we're calling our fully closed loop, which not all fully closed lips meet the definition of our definition.
And I think it's important and I'm going to spend a little bit of time on this quickly and then Eric will cover the other.
We are designing as the market leader with our big eyes focused on the underserved type two market in the United States, where we have 5% penetration and there's five 5 million people on insulin.
That we would like to be on Aig's therapy since the Ada guidelines recommended age IAC therapy as the standard of care. We have designed our fully closed loop to address the biggest barriers for those patients with type two to get onto a IV therapy. It starts with our algorithm, which will be including no user intervention.
Intervention it requires no dosing it has no real time interactions no adjustments was appointed by the hottest one there's two other areas that are really important to the type two user base, who wanted the clinicians and the clinicians. This will require no defined studies at start which is a big bet.
Barrier right now to the primary care prescribing base that just don't have the time to go input all of the studies and then third Joanne the big unlock if patients don't have to do to our training. You know this is something that they can initiate on their own. So our combination of really modernizing the training so that they can do it at home.
On their own time without two hours really unlocking prescriber adoption not having to put in setting really important for the primary care audience, which is really who is going to be managing patients who have type two diabetes and then third really various CGM like experience for people with type two diabetes. So we're gonna be sharing our day.
From our feasibility in AR at the a J, but in addition to that we had some our third generation algorithm on Omnipod checks that Eric will touch on.
Hey, Joanne just building on.
Absolutely the comments about what's coming up the upcoming.
Congress of ATB will be showing the evolution data is actually just described on our way towards that truly transformative.
Unblock primary care will also be showing some health economics data showing favorable outcomes in ER visits for the unique fully exposed to bowl.
But as omnipod compared to tube pump, so really excited for what's coming at ATV looking ahead to 88, that's where we'll be publishing the pivotal results from strive.
Pivotal data support Omnipod <unk> excited to be reporting that out.
In addition.
As I mentioned earlier.
There are more independent third party studies, comparing clinical results of on market AIB systems coming out and in two recent are both omnipod as Sean unsurpassed, a onesie and similar time in range to those reporting time in range using an ICBM sensor and so one of the other things.
But we're paying attention to it but it's really important to interpret clinical data based on a one three and it's hard to compare.
Cross studies that don't use CGM sensor for time and range and so there was more of those studies coming out.
You'll see us talking about those too.
Okay.
Your next question comes from the line of Richard Annuity Suntrust. Your line is open.
Alright, thanks for taking the questions and congrats on the quarter.
Maybe the.
The first one just your type two mix I think you said you exited the year at about 40% of our new patient starts.
That would seem to imply that your type one segment, maybe saw a moderating growth leveling off in the single digit range. I guess is that the right way to think of think of it going forward.
And if so what does that share or is it just the market.
Sorry did moderate.
We're getting near maturity.
And a follow up thanks.
Yeah, I'll start and maybe Eric can add so yeah, we had very strong.
Type two performance in the fourth quarter and there was a continuation of that strength throughout the year.
We had record new customer starts for both U S and international both year over year excuse me in sequentially.
To your point Richard type one.
It grew nicely year over year, and it was comparable to the third quarter, which was a record quarter for us in NCS.
The level of penetration obviously in type one is a higher than type two and as we continue to bring AI into those markets you.
You will see.
It's accelerating.
Growth in type two just given that it's 5% today versus type one at 40%, but attrition of AIG, but we continue to source.
A lot of our volume from MDI as we talked about the 85%.
And that's really our strategy to drive that penetration in those customer segments and internationally, which is also still very underpenetrated Eric.
Richard Thanks for the question I think it was.
Flavio described type one in the U S is more penetrated in the level of new customer starts and the market is high and so it continues to be a significant driver of growth actually described it well we've got a balanced growth okay.
Type one is a big part of that type to the level of new customer starts in the market has been low and we are accelerating that as we launch on may five.
Type two and did so over the course of 2025, which is why you saw that mix right.
You also saw our type one new customer start outside the U S grew significantly year over year and those three levers U S type one type two international type one are going to contribute a balanced contribution to our growth over time.
Okay. That's helpful. Thanks, and then.
Maybe can you following up to <unk> question can you put some assumption bars or around the upper and lower ends of your range or maybe said another way.
What would have to happen.
The biggest needle mover and your assumption set to be at the upper end or above.
Well, we provided a guidance range. So to me that is the upper and lower end of our of the.
The the the bar that you're describing Richard.
I think we obviously as I said earlier, we continue to set guidance for the full intent of delivering and this is our best outlook at this point given where we are in the year obviously.
If we can advance AIG penetration, even farther and faster that will translate into us being closer to the top end of the range.
Thank you Richard for the question.
Your next question anchored by more questions. Certainly your final question comes from the line of Danielle <unk> from UBS. Your line is open.
Hey, good morning, everyone. Congrats on a strong end to the year and ladies plus Eric.
My question is on the competitive moat Ashley you touched on this earlier I do think it's underappreciated I specifically wanted to see if you could talk a little bit about the sampling at the physician's office and sort of if you could walk through how this works like who trains the patients to ensure they get the optimal experience.
I appreciate it's still early but what are you seeing for capture rate with that program. Thanks. So much.
Thank you Danielle for the question and I guess I'll just for context again I think the company is best known for just having really differentiated technology and investing ahead of the curve as hygiene and maybe pioneering this.
Pharmacy pay as you go model and.
What I would like to see at the end of this year is a better appreciation of the commercial prowess that we have been building over the past couple of years.
So we have been expanding our sales force we expanded it around 25% last year, we're continuing to do that we call on over 17000, so full coverage of the Endo really 10000 of the highest prescribers.
And what we're evolving as our messaging as I mentioned earlier in addition to selling what they have come to love, which is really this differentiated technology platform that is simple and easy to use it's why it's the gateway to the category today user it's easy for them to explain is also coming to educate on our really.
Strong clinical performance.
And we will continue that messaging in 2026 to make it easy to get people on pause, we're really the only AI offering that can get people in a sample so right in the practice. They can go put upon it's a very capital efficient way for us to initiate trial, we've gotten a lot of really good feedback both from young children as well as grandparents.
Around once it's kind of that moment of delight once they try it on they get the well factor and we have very strong conversion ratios are in addition to the called on universe. We also have the Darling brand is what I say that I think is a bit underappreciated, where we activate directly to consumer.
I'm aware of the category make them aware of Omnipod five and people go in and after doctors for that and they specifically asked for Omnipod and not the new category user and we lose them become new patients, but they also become new prescribers and that's why you heard us talk about when we entered the year, we had 30000 prescribers.
Writing for Omnipod, which is up 28% and we're going to continue that flywheel of really creating the market and creating demand for omnipod. Thank you for the question Danielle.
And this concludes our question and answer session and today's conference call. We thank you for your participation and you may now disconnect.
Okay.
Yeah.
Yeah.