Earnings Call Transcript - PODD Q3 2025

Operator, Operator

Good morning, ladies and gentlemen, and welcome to the Insulet Corporation Third Quarter Earnings Call. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Clare Trachtman, Vice President, Investor Relations.

Clare Trachtman, Vice President, Investor Relations

Good morning, and welcome to our third quarter 2025 earnings call. Joining me today are Ashley McEvoy, President and Chief Executive Officer; Flavia Pease, Chief Financial Officer; and Eric Benjamin, Chief Operating Officer. On the call this morning, we will be discussing Insulet's third quarter results along with our financial outlook for the fourth quarter and full year 2025. With that, let me start our prepared remarks by reminding everyone that certain statements, including comments regarding our financial outlook for the fourth quarter and full year 2025, the anticipated impact of our strategic actions, the potential impact of various regulatory and operational matters in the macroeconomic environment on our results of operations contain forward-looking statements that involve risks and uncertainties. Of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, non-GAAP financial measures will be used to help investors understand Insulet's ongoing business performance, including adjusted operating income, adjusted EBITDA, adjusted tax rate and constant currency revenue, which is revenue growth excluding the effects of foreign exchange. A reconciliation of certain non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation and available in our earnings release issued this morning, which are both available on our website. Additionally, unless otherwise stated, all financial commentary regarding dollar and percentage changes will be on a year-over-year reported basis with the exception of revenue growth rates, which will be on a year-over-year constant currency basis. During the Q&A session this morning, Ashley, Flavia, Eric, and myself will be available to address questions. Now I'd like to turn the call over to Ashley.

Ashley McEvoy, President and Chief Executive Officer

Thank you, Clare, and welcome. Many of you already know Clare and we're excited to have such a respected and proven professional in her role. I'd like to welcome Flavia, who is joining us for her first call as Insulet's Chief Financial Officer. Flavia is a highly accomplished financial executive with world-class healthcare and med tech expertise, and we're thrilled to have her with us on the team. Her extensive leadership experience in complex global organizations combined with her proven ability to drive financial performance and create long-term value make her the ideal CFO to help guide Insulet's next phase of patient-centric growth. Flavia's thoughtful contributions and active engagement as a member of our Board were instrumental to our strong performance and are now enabling a seamless transition. And finally, I'd like to congratulate Eric on his well-deserved promotion to Chief Operating Officer. With more than a decade of experience at Insulet, Eric truly embodies our mission. His relentless drive to innovate and to find a better way has been a cornerstone of our success, and we're excited for the leadership he'll bring in this expanded role. I also want to introduce Manoj Raghunandanan as our Chief Growth Officer. Manoj brings 20 years of consumer health leadership to a newly created role overseeing market development, demand generation, commercial capabilities, and our global brand and customer experience. These leadership changes further strengthen our team, bringing proven industry and functional expertise that aligns with Insulet's unique and advantaged position at the nexus of consumer health, healthcare, and med tech. Our vision is a world where diabetes places less burden on daily life until there is a cure. Driven by empathy, powered by ingenuity, and validated by science, our mission is to transform life with diabetes for people everywhere. Now turning to our results. This was another standout quarter for Insulet, showcasing the durability of our recurring revenue model, which resulted in robust growth and improved profitability. We surpassed $700 million in quarterly revenue for the first time with 28% year-over-year growth at constant currency rates. This performance reflects continued strong retention and a record number of new Podders across the U.S. and globally, including continued acceleration in Type 2. Operating margins expanded 90 basis points year-over-year to 17.1%, as we generated operating leverage while continuing to strategically invest in our innovation roadmap and field expansion. I want to thank the Insulet team for their hard work this quarter and their tireless commitment to delivering for Podders worldwide. We continue to drive progress against our strategic objectives. In the U.S. Type 1 market, we are extending our lead with sequential and year-over-year growth in new customer starts, fueled by ongoing prescriber expansion and the highest number of competitive conversions since late 2023. Our growing prescriber base of more than 27,000 healthcare professionals underscores the strong return on our investments in expanding our sales force, improving our commercial execution, and increasing healthcare professional education and outreach. In U.S. Type 2, we are seeing strong momentum. New customer starts more than doubled year-over-year and grew sequentially. As we saw with Type 1, the power of real-world outcomes to turn skeptical providers and patients into believers is unmatched. In addition to the tremendous NCS growth, there was a large sequential uptake in Type 2 prescribers this quarter. Encouragingly, this was driven both by increased adoption among our existing Type 1 prescriber base and by our DTC efforts to activate new customers and increase the number of new prescribers. I want to highlight that our strong Type 1 foundation, the familiar prescriber base, our pharmacy access, and Part D coverage, along with our brand and community give us a substantial head start in developing the Type 2 market. Our conviction in our ability to unlock the Type 2 opportunity at scale is growing rapidly. Our international business continues to deliver robust growth, reflecting increasing global demand and successful execution. We're seeing consistent momentum across key geographies as we expand access, deepen customer engagement, and scale our operations worldwide. Revenue grew 40% year-over-year on a constant currency basis, driven by the continued rollout of Omnipod 5. In established markets like the U.K., France, and Germany, we're seeing robust growth supported by our launch of the latest sensor integration as well as ongoing positive price/mix realization from DASH to Omnipod 5 conversions. In Germany, for example, our G7 launch has fueled rapid uptake among new and existing customers. We're also benefiting from growing contributions from markets like Canada and Australia, where Omnipod 5 launched earlier this year and is taking share. Eliza and her mom Melissa, whom I met while visiting our team in Toronto, are among the first Canadians to benefit from Omnipod 5. Just 3 years old, Eliza struggled with overnight glucose control and Melissa rarely slept through the night. Since starting on Omnipod 5 in April, Eliza has seen her A1C drop from 8.6% to 6.8% and her time in range double. And Melissa and her husband are finally getting a full night of sleep. Eliza now loves to dance and swim and is fast becoming one of the faces of Omnipod in Canada as local demand grows. With more Omnipod 5 rollouts planned in 2026, our opportunities to grow in our existing international markets and help more people like Eliza and Melissa remain significant. Last quarter, I laid out a focused set of investment priorities that will enable us to move faster, deepen our competitive advantage, drive penetration, unlock new opportunities, and scale profitably. We will talk in great detail about these long-term priorities in 2 weeks at Investor Day. For now, let me share some of the progress we've made during the quarter. First, innovation. Our focus on accelerating the pace of innovation and being ready to launch alongside our partners is reflected in our integration work with Dexcom's 15-day sensor. When Dexcom launches, so will we. Libre 3 integration in the U.S. is on track for the first half of 2026 and is a top priority. Our experience across our markets shows that bringing new sensors online drives growth. We also continue to promote adoption of phone control. More than 55% of U.S. Omnipod users now control their system via smartphone, up from 45% last quarter. That shift toward app-based control improved convenience, retention, satisfaction, and outcomes. Looking further ahead, we've completed recruitment for our STRIVE pivotal trial for next-generation hybrid closed loop and for our Evolution 2 feasibility study for fully closed loop in Type 2. I'm excited to share more about these next-generation products and their market-changing potential at Investor Day. Next is market development. We are pressing the advantages of our unique pay-as-you-go pharmacy access. Omnipod is already easy to access and affordable. Our system is available in more than 47,000 U.S. pharmacies and covered by over 90% of commercial plans, allowing us to reach more than 300 million lives. Most users can start on Omnipod for about $1 a day without upfront costs or lock-in commitments. Our focus now is addressing the remaining barriers to access with targeted programs aimed at easing the prior authorization submission process, and we're continuing to expand access for underserved populations. More than 2/3 of our government insured customers pay less than $10 a month and over 60% pay zero. Third is demand generation. This quarter, we invested significantly in DTC investments, and they are yielding record levels of qualified leads. The majority of our DTC leads, approximately 65% in the quarter, come from patients treated by providers who are not currently called on by our sales force. These patients are actively requesting Omnipod 5, driving awareness and adoption with their providers. Upon seeing patient success, these providers continue to recommend Omnipod 5, creating a powerful flywheel effect that amplifies the return on our DTC investments far beyond the initial demand generated. Finally, it's global operational scale. Our manufacturing facilities in Acton and Malaysia are ramping ahead of plan, delivering strong customer service and improved margins. We're accelerating investments to further increase capacity at these facilities to support our strong growth trajectory. And we continue to integrate AI and cloud-based tools to streamline and scale our service operations efficiently. In closing, our momentum and our strategic progress give us confidence in our outlook and make us excited about the path ahead. Our growth is broad-based and durable. Our business model is scaling profitably. Our opportunities are vast and our team is energized and stronger than ever. We're eager to share deeper insights into our growth strategy, innovation roadmap, and long-term vision in a couple of weeks at Investor Day. I'll now turn the call over to Flavia to discuss our third quarter results and guidance.

Flavia Pease, Chief Financial Officer

Thank you, Ashley, and good morning, everyone. First, let me start by saying that it is an honor and a privilege to join Insulet at such an exciting time in the company's journey. Our commitment to improving the lives of people with diabetes is deeply inspiring, and I look forward to partnering with Ashley and the entire Insulet team to build on our strong foundation and continue to deliver industry-leading financial performance. With that, I'll turn to our third quarter performance and the outlook ahead. The Insulet team delivered a strong third quarter, marked by total revenues of over $700 million, an increase of 28% at constant currency rates and 30% at reported rates. Foreign currency contributed 170 basis points to third quarter reported growth. Notably, during the quarter, total Omnipod grew 29% as compared to the prior year on a constant currency basis. During the quarter, new customer starts grew both year-over-year and sequentially in our U.S. Type 1, U.S. Type 2, and International Type 1 markets. We achieved a record number of total new customer starts in the U.S. and internationally. Similar to previous quarters, over 85% of our U.S. new customer starts came from MDI, while competitive switches also contributed to growth. Additionally, more than 35% of our U.S. new starts were from Type 2. Our estimated global utilization and annualized global retention rate remain stable. Overall, our team continues to deliver robust top-line growth and improved profitability, resulting in increased earnings per share and strong cash flow generation. I will now walk through some additional details of our performance in the quarter. First, turning to our U.S. and international revenue drivers. U.S. Omnipod revenue grew 25.6% above the high end of our guidance range, driven by continuing demand for Omnipod 5 across Type 1 and especially among Type 2 customers. As a reminder, U.S. revenue growth this year has been impacted by rebate timing and prior year inventory stocking dynamics. Normalizing for these impacts, U.S. growth in the third quarter was approximately 30 basis points higher, representing an acceleration from normalized second quarter growth levels. In our international Omnipod business, we achieved revenue growth of 46.5% on a reported basis and 39.9% on a constant currency basis, which was also above the high end of our guidance. International revenues crossed $200 million for the first time. Our growth this quarter was fueled by robust demand for Omnipod 5 underscoring its market appeal and the benefit it delivers to patients. Positive price/mix realization also contributed to performance as customers shift from Omnipod DASH to Omnipod 5. We continue to see strong growth in the U.K., Germany, and France, in addition to other countries where we have launched Omnipod 5. On a reported basis, foreign currency contributed 660 basis points to growth compared to the prior year. Continuing down the P&L, our third quarter gross margin reached 72.2%, reflecting a 290 basis point expansion year-over-year. This improvement was fueled by strong top-line growth, supported by higher volumes, manufacturing productivity, and favorable pricing. As we all know, innovation is the lifeblood of any company. We remain relentlessly committed to advancing breakthrough solutions and strategically funding initiatives that empower us to better serve our Podders and unlock meaningful incremental value across our portfolio. During the quarter, R&D expenses increased 41%, up 80 basis points as a percentage of sales compared to the prior year. This increase in funding is focused on additional resources to support our innovation pipeline and associated clinical development. In addition, stronger-than-expected growth in the quarter created an opportunity to accelerate our commercial investments with a particular focus on demand generation. These investments included our direct-to-consumer campaigns, both digitally and in mass media, to enhance brand awareness globally. This resulted in a record number of DTC leads that will help support future growth. In addition, we expanded our commercial and customer experience teams as we continue to enhance penetration and extend our leadership in both Type 1 and Type 2. We look forward to further discussing many of these initiatives during our upcoming Investor Day on November 20. Third quarter adjusted operating margin was 17.1% and adjusted EBITDA margin was 22.7%. Our operating margin this quarter underscores the strength of our top-line performance, which enables us to continue investing in our innovation roadmap, and strategically accelerate targeted commercial investments aimed at fueling long-term growth. As Ashley mentioned, we are well-positioned to continue investing aggressively for future growth while also delivering meaningful margin expansion. Our third quarter non-GAAP adjusted tax rate was 22.5%. Turning now to cash and liquidity. We ended the quarter with approximately $760 million in cash and the full $500 million available under our credit facility. We continue to strengthen our balance sheet, improve our financial flexibility, and lower our cost of capital. We have now successfully eliminated all convertible debt from our capital structure, by extinguishing $800 million of our convertible notes due in 2026 and the cap calls associated with the notes. During the quarter, we repurchased approximately 91,000 shares for $30 million. These purchases are intended to offset dilution from stock-based compensation. Now turning to our outlook for the fourth quarter and full year 2025. As the newly appointed CFO, one of my priorities is to evaluate and refine our guidance practices. My goal is to ensure these practices reflect the key drivers of shareholder value and provide investors with a clear understanding of our business and strategic direction. I believe guidance should reflect a balanced outlook for the business and acknowledge potential risks and uncertainties as well as potential upside opportunities. Our objective going forward will be focused on providing guidance that reflects a high degree of confidence in achieving while endeavoring to be more reflective of the underlying momentum in our business. Starting with the fourth quarter, we expect total Omnipod revenue growth of 27% to 30% and total company growth of 25% to 28%. On a reported basis, we expect a favorable impact of approximately 200 basis points from foreign currency. We expect fourth quarter U.S. Omnipod growth of 24% to 27% and international Omnipod growth of 37% to 40%. In our international business, on a reported basis, we expect a favorable impact of approximately 1,000 basis points from foreign currency. Turning to our full year 2025 outlook. We're raising our total Omnipod revenue growth to 29% to 30% from prior guidance of 25% to 28%. We're also raising our total company revenue growth to 28% to 29% from 24% to 27%. We expect a favorable impact of approximately 100 basis points from foreign currency for the year. For U.S. Omnipod, we are raising our revenue growth to 26% to 27% from 22% to 25%, driven by increased penetration from MDI users and competitive gains. We continue to expect year-over-year growth in U.S. new customer starts for the year. As a reminder, our U.S. growth guidance also assumes similar trends in pricing, utilization, and retention as we saw in 2024. For international Omnipod, we're raising our revenue guidance to 38% to 39% from 34% to 37%. On a reported basis, we expect a favorable impact of approximately 500 basis points from foreign currency. Like the U.S., we expect year-over-year growth in international new customer starts for the year. While volume remains the primary driver of our international revenue growth, our guidance also reflects a benefit from positive price/mix realization as customers transition from Omnipod DASH to Omnipod 5. We're also assuming stable utilization and slightly improving retention for 2025 relative to 2024. Turning to 2025 gross margin. Given our strong performance year-to-date, we now expect full year gross margin of more than 71% as compared to our prior guidance of approximately 71%. We're also narrowing our outlook for operating margin. We now expect an operating margin to be between 17.3% and 17.5%, reflecting stronger top-line growth and continued investments in R&D, market development, and demand generation. The updated outlook represents a 240 to 260 basis point improvement over the prior year period. We remain committed to enhancing profitability and will continue to deliver meaningful operating margin expansion year-over-year. At the same time, we're scaling our investments thoughtfully to support our long-term growth ambitions and ensure sustained value creation. Looking at a few items below our operating income, we now expect our 2025 net interest expense to be approximately $20 million higher than 2024 due to the transition from convertible debt to traditional debt, which carries higher coupon rates and the extension of our interest rate swaps. For the year, we now expect our non-GAAP tax rate to be in the range of 22% to 23%. We also expect the 2025 ending balance of our diluted share count to be around $71 million, which is approximately 5% or 3.5 million shares lower than prior year due to the extinguishment of our convertible debt. We remain confident in our ability to deliver strong free cash flow in 2025 compared to 2024, supported by robust growth and continued margin expansion. We anticipate a meaningful increase in capital expenditures during the fourth quarter as we invest strategically to enable long-term growth. As highlighted last quarter, we are actively assessing opportunities to accelerate our manufacturing expansion plans and look forward to sharing further updates at our upcoming Investor Day. 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. Finally, I want to extend my heartfelt thanks to the entire Insulet team for the warm welcome over the past month. Your dedication to our mission and your unwavering commitment to improving the lives of people with diabetes inspire me every day. I'm excited to be part of this journey with you. With that, operator, please open the call for questions.

Operator, Operator

As a reminder, the speakers available for Q&A today are Ashley McEvoy, Flavia Pease, and Eric Benjamin. Our first question is from Robbie Marcus from JPMorgan.

Robbie Marcus, Analyst

Good morning and congratulations on a successful quarter, and welcome Flavia. I would like to ask a broader question. It’s impressive to see another strong quarter with record new patient growth, both in the U.S. and internationally, with 85% coming from MDI. We have also seen double-digit new patient growth in both Type 1 and Type 2 diabetes in the U.S. Clearly, Omnipod 5 is achieving success, both domestically and abroad. Despite the increasing competition and discussions around patch pumps, you are managing to stand out and deliver outstanding results. Can you elaborate on how Omnipod 5 is succeeding? Is it due to the device's design, the algorithm, the simpler onboarding process, or something else? What insights can you share about the current market dynamics, and what gives you confidence in sustaining such impressive results moving forward?

Ashley McEvoy, President and Chief Executive Officer

Thanks, Robbie, for the question. It's important to note that our growth is broad-based and balanced, indicating that our strategy is effective. This success stems from strong scientific evidence demonstrated by our SECURE-T2D trial and RADIANT trial, along with compelling real-world data. Additionally, we have a beloved brand; customers appreciate our unique product design, and we will continue to lead in that area. Another factor is our advantage in access and affordability. Our supply chain is also a key strength; we have invested over $1 billion to build a highly resilient supply chain capable of operating at competitive costs, producing millions of pods. Finally, the flexibility of our balance sheet allows us to keep investing in innovation to maintain our position as a market leader.

David Roman, Analyst

I wanted to start on the Type 2s. You're about a year into having the indication for Type 2 in the U.S. Can you talk a little bit more about how the adoption has built over the past year, where we are in kind of an uptake? And how we should think about that segment going forward? And maybe just perhaps related to that, you talked about DTC advertising as one of the big drivers here of SG&A growth in the quarter. Can you just maybe help pull the thread all the way through from that investment to new patient starts to revenue and maybe how that ties to the Type 2 adoption as well?

Ashley McEvoy, President and Chief Executive Officer

Yes, thank you, David. It's a great milestone to be a year into this. We are starting from a strong position thanks to our 25 years of experience working with patients who have Type 1 diabetes. There is a similar engagement with prescribers, especially endocrinologists. In the third quarter, we observed that prescribers who usually treat Type 1 for automated insulin delivery are now also starting to prescribe for Type 2. This trend is not only accelerating the adoption of Type 2 but also positively influencing the prescribing habits for Omnipod within the Type 1 community. We experienced a 26% increase in our prescriber base for Type 2 this quarter, with year-over-year NTS rising 100%, and a quarter-over-quarter increase of 26%. This growth is attributed to three main factors: strong scientific backing, the reputation we've built with this target audience, and significant investment in direct-to-consumer marketing during the past quarter, which resulted in high levels of engagement from new potential patients outside our usual outreach. All these elements are generating positive momentum for us a year into the Type 2 launch, with many more opportunities ahead.

Joanne Wuensch, Analyst

I too am going to go for a big picture question. It is rare that we see an entire new team from the CEO to the CFO to Investor Relations, and just watching a company knock it out of the park. I am really curious what the 3 of you or 2 of you or collectively are planning to do differently to keep this momentum generally.

Ashley McEvoy, President and Chief Executive Officer

Well, listen, thank you, Joanne. I have to first say it's really a nice combination to see some very strong talent elevated, taking over more responsibility in the company. People like Amit Guliani, who is now our new Chief Technology Officer, and people like Eric Benjamin, who spent nearly a decade at Insulet now assuming the post as Chief Operating Officer. And then obviously welcoming Flavia and some new capability with Manoj. I would describe it, Joanne, as the following. We have remarkable technology. We sell on passion. We're going to sell more on science. We have invested ahead of the curve of our supply chain, which is giving us really scale affordability. And we now are the market leader, and we spent 25 years working on disrupting the market leader; we now are the market leader. So we are going to really start to continue to invest in things like market development and demand generation to create that enduring competitive moat going forward.

Flavia Pease, Chief Financial Officer

Yes. Joanne, just to add, as Ashley has said, even in her first 6 months, I think what all of us that are newer to the team have inherited is a strategic and capital allocation strategy that are going to remain intact. We're just going to continue to build from a very strong foundation. In my first 30 days, I've really been focusing on just continuing to understand those priorities, our innovation roadmap, our commercial plans, and the significant opportunities that we have to continue expanding penetration in this large market we operate in. Then, going forward, how can I partner with the team to further activate levers that are going to allow us to continue delivering sustainable top-tier growth, expanding our margins, and ensuring that we continue to execute with discipline and precision? So it's a really great time to be joining the Insulet team now in this new capacity and continue to improve the lives of people with diabetes and deliver shareholder value.

Travis Steed, Analyst

Maybe I'll start with maybe just high level, some kind of puts and takes on 2026 and how we should think about the year with Libre integration possibly and Type 2 accelerating. Can you continue to put up record new starts? Also, I wanted to touch on evaluating and refining our guidance practices. If you could elaborate on that, I think you said reflect a balanced outlook for the business and acknowledge potential risk. So I just wanted to make sure I elaborate on how you think about guidance going forward.

Ashley McEvoy, President and Chief Executive Officer

Thank you, Travis. I'll start and I'll turn it to Flavia later. I would say clearly, we're really pleased with the momentum that we have in the U.S. and O.U.S., and we see a clear pathway to delivering continued top-tier growth, backed by these proven leadership in these very large underpenetrated markets. And I think that we're confident in the strong growth and improved profitability when we expect that to continue in 2026. So we're going to provide 2026 specific guidelines on our Quarter 4 call, consistent with historical practice. But I'll turn it over to Flavia to speak a little bit about your philosophy on guidance.

Flavia Pease, Chief Financial Officer

Yes. Thanks, Ashley. Travis. Obviously, we set guidance with the intent to deliver, and that is clearly not changing. I think what we will try to do as we continue to mature and evolve as an organization is try to have a balanced view of our expectations, acknowledging that there are risks and uncertainties but also potential upside opportunities. So we are not changing how we guide other than ensuring that we have a balanced view going forward. I think we're also, as Clare and I continue to onboard and going forward into 2026, we look into what KPIs make the most sense to continue to provide as drivers of the performance of the business and help shareholders really understand our strategic direction. So we might evolve a little bit the metrics that we focus on and guide to, but more to come on that when we guide to 2026.

Jeff Johnson, Analyst

Ashley, I'm sure that you're going to get a lot of these questions here for the next year or 2. But just as we see 2-piece patch potential market entrances over the next 18 to 24 months or so, I'd love to hear some early and I'm sure we'll get more at the Analyst Day, but kind of early thoughts you have on how you protect and maybe even extend your competitive moat there on the patch pump side.

Ashley McEvoy, President and Chief Executive Officer

Thank you, Jeff. First of all, our main focus is on expanding the market and transitioning individuals from MDI therapy. We continue to lead the market, and you'll hear more about our performance and the growth percentage that Insulet has contributed to the category at Investor Day. Our goal is to make AID accessible to as many patients as possible coming from MDI therapy. This quarter, we experienced one of the strongest performances in sourcing competitively over the last two years. This highlights the unique technology that Omnipod 5 offers to more customers globally. It reflects the efforts we've made to create a seamless customer experience, from introducing the product to potential customers through various channels to helping them get started with the pod and ensuring they continue using it. We are investing in our future pipeline, which you will hear more about at Investor Day. In Quarter 3, we increased the number of users on phone control from 45% to 55%. At the ADA, we presented evidence indicating that individuals using phone control tend to bolus more frequently, which positively impacts health outcomes. We will continue to invest in demand and capacity, ensuring that we maintain a diversified and resilient supply chain to serve more Podders worldwide.

Michael Polark, Analyst

I have a question about the performance outside the United States, which has been impressively strong for two consecutive years. It looks like this trend is likely to continue into 2026. I want to ensure that our models this year are accurately set as we move forward. Is there anything regarding volume as you implement O5 and transition from DASH? I've heard about the pricing and mix, but I'm curious about volume dynamics such as initial fill trends and distributor stocking. These were positive factors mentioned when O5 was launched in the U.S., but I haven't heard anything about the international markets. What should we keep in mind as we look ahead to the next couple of years globally?

Ashley McEvoy, President and Chief Executive Officer

Yes. Let me just start, Mike, and I'll turn it to Flavia. I would say we have very robust durable growth in O.U.S. performance. What we're seeing are the conversion, I would say, the upgrades of turning some of our DASH markets into Omnipod 5 markets. We are benefiting from price/materialization, but also a very accelerated volume uptick. That's what's really enabling this business and internationally to post performance to like 40% and to have some of our NGS looking at 68% growth. I'll turn it over to Flavia.

Flavia Pease, Chief Financial Officer

Yes, Michael. So, to your specific question, there is no material or immaterial, for that matter, impact of distributor stocking in the quarter or over the last several quarters. To Ashley's point, the growth internationally really has been primarily driven by volume. There is a bit of price/mix realization as you pointed out, as we continue to upgrade from DASH to Omnipod 5. We still have headroom to go on that conversion. But again, the primary driver is volume, and there's no noise on stocking.

Gursimran Kaur, Analyst

This is Simran on for Larry. I guess I just wanted to focus a little bit more on U.S. Omnipod. Obviously, a really strong quarter, and it looks like you raised your guidance by more than double the beat. What exactly is driving the upside to U.S. expectations from kind of how you were guiding previously. And I guess, should we kind of continue to think about U.S. new starts on a quarterly basis being record new starts moving forward? And just a little bit more about how should we think about sort of sustainability of some of those underlying trends that you're seeing in the U.S. business going forward?

Ashley McEvoy, President and Chief Executive Officer

Thank you for the question. It's really a combination of both factors. Our core business, which has been focused on Type 1 in the U.S. for 25 years, still has a penetration rate of 40%, indicating significant potential for growth. There is still clinical inertia, where prescribing practices are not aligning with the AID standard of care guidelines that recommend AID therapy at diagnosis. We will continue our education efforts in this area, particularly in Quarter 3, where we've seen an increase in prescribing behavior. Additionally, we are also focusing on Type 2 diabetes, where penetration rates are surprisingly low, under mid-single digits, and there is a lot of room for growth. We are educating endocrinologists first, along with high-prescribing primary care physicians, about the science and adoption of care. Our field teams are being equipped to educate others, and we are facilitating peer-to-peer education with AID advocates to enhance adoption among the Type 2 community. We are also engaging directly with consumers to raise awareness that individuals with Type 2 diabetes should consult their prescribers about Omnipod, which has generated significant leads in Quarter 3. Overall, we are seeing robust performance from our core business while also gaining strong momentum with our new indication and customer base of Type 2 diabetes patients.

Matthew Taylor, Analyst

This is Matt on for Matt Taylor. I just wanted to ask maybe one specific question on contracting in the pharmacy channel. So as you see kind of more competition come in there, would you characterize any differences in your contracting dynamics that is anything on price or tenor?

Ashley McEvoy, President and Chief Executive Officer

Matt, thank you for the question. The short answer to that is, no. I would say that we've been at this for almost 8, 9 years of really leading the pay-as-you-go business model in the pharmacy. Not only where people can pick up their insulin in about 47,000 pharmacies but equally with payers around taking the very strong health economic story and clinical outcome story to payers that has really enabled us to procure 300 million lives out of 317 million available lives and the majority of those at a preferred status. For the majority, it translates to about $1 a day. We're also working with a lot of our patients who have the government as some of their payers to make sure that they have good affordability and access. We're currently focused on the very few minority where they are getting stuck, if you will, on prior authorizations to streamline that approval process. We've seen a meaningful uptick in our ability to get that need from 75% getting prior authorization through with a 90% completion rate. Again, that's the minority because for the majority, we have preferred status and do not need a prior authorization.

Felipe Lamar, Analyst

This is Felipe on for Rich. Just on converting Type 2 patients, could you just talk about how maybe the customer acquisition cost compares to that of Type 1? And just maybe how your scale could give you an advantage over the long-term in converting that patient population considering how early we are in adoption stages.

Ashley McEvoy, President and Chief Executive Officer

Yes. Thank you. It's a great question, and we're always looking at. We're not going to share that with us with you all the time, but we do look at the cost to acquire and the cost to serve and the lifetime value of our customer base. The person who is leading all that work is Eric Benjamin. So Eric, why don't you talk about that?

Eric Benjamin, Chief Operating Officer

Thanks for the question. Just a little bit of color. As Ashley described earlier, we have the advantage of having a common call point that we've been in for 25 years as we've built the Type 1 business. Those who are already prescribing AID for Type 1 are familiar with technology, and so it's a really strong commercial synergy to be able to bring the SECURE-T2D data to that call point and help turn that existing call point already filled with technology into advocates and believers in AID for Type 2. That's been a big part of our initial launch strategy, activating our current call point. We have had nice success; we have more to go. So we've had success activating that call point, but we have more to see. We are also activating new prescribers. Obviously, we watch those efficiency metrics closely. In the early days as we're getting folks to startup, that is a higher cost. It takes some time to educate new providers on the benefits of Omnipod and how technology works. We've got good at it; folks know that Omnipod is easy to write. We see high interest from new writers when our team enters new accounts to get them ramped. So as we're expanding the call point, we're doing that effectively and efficiently with a close eye on overall customer acquisition cost.

Jonathan Block, Analyst

Actually, maybe a little bit high level, but I'm just curious, DTC driving solid leads, spoke favorably to that and type 2 in the quarter already surpassing 35% of U.S. new starts. So at a high level, any refined thoughts on where pump penetration can go within the T2D segment of the market? Just based on what you're seeing to date, would love to hear your thoughts.

Ashley McEvoy, President and Chief Executive Officer

Thank you, Jon. We hope you're coming to our Investor Day on November 20 in Acton because we have long awaited to share our story of what we think our growth algorithm is and what our pipeline looks like and showcase our talent and really our steely determination to serve more Podders. I would say a couple of things around Type 2. It is a very large underpenetrated market in the U.S. It is globally as well. Right now, we're indicated for the U.S. Our approach is differentiated versus maybe what some other offerings may be happening in the marketplace. It is about starting with the equity that we've made with the call base over 25 years with Type 1 diabetes, where there is beautiful synergistic value that we've earned over 25 years, and we're going to parlay that into the Type 2 community. Interestingly enough, endocrinologists write more scripts for people with Type 2 diabetes than they do for Type 1 for AID therapy in the U.S. of what we're experiencing. We will couple that with continuing to invest in the science, continuing to invest in innovation, making it a frictionless experience, and last is kind of activating using the power of the brand to make AID therapy seem less scary by activating our DTC efforts, which really help consumers to go ask for Omnipod specifically.

Danielle Antalffy, Analyst

Congrats on a good quarter there. Sorry about that, Eric. It's not often you get to say good morning, ladies, as a group. So I couldn't resist. But just a question following up on the Type 2 versus Type 1, but more around endos versus primary care. Eric, I was just curious if maybe you could talk a little bit about the difference in the go-to-market strategy, number one, between the two? And then number two, though, maybe more relevant how you guys think you are positioned right now within primary care? How much runway is there still to go to get some of these doctors online and prescribing?

Eric Benjamin, Chief Operating Officer

Danielle, thanks for the question. A couple of things. It is two different calls that our team makes as you described. We've been in the specialty call point for 25 years. Those folks know about technology. They know how to write technology. There, we're selling science. We're selling the benefits of Omnipod, and we're selling the fact that we're the #1 prescribed product that should be first-line for folks who are considering AID, and that message resonates. As we go beyond, we expanded the sales force very actively earlier this year to call on another decile of primary care providers. That was effective. As we make those calls and expand the call point, it's an activation. It's a nurture call where we're introducing technology often to offices that haven't prescribed AID before. We are selective about entering places that have high opportunities so they see and treat a lot of diabetes. Omnipod has strong proven outcomes and is easy to use, differentiated. Our team can assess pretty quickly whether it's an office that's ready to become a regular AID writer or whether we just go activate a patient who may have been interested in technology from DTC on more of a one-off basis. We see a lot of runway to do that effectively as we keep ramping our commercial strength in the market, and the team is executing really well.

Matthew O'Brien, Analyst

Welcome Flavia. The commentary about your highest competitive conversion rate in years was interesting to me. Is that a global comment? Or is that just domestic-focused? If it is global, can you just talk a little bit more about what's driving that? I know Omnipod 5 was great, but the sudden acceleration in terms of competitive conversions is kind of unique versus what you've been doing and what you've been seeing. Any commentary there would be very helpful.

Ashley McEvoy, President and Chief Executive Officer

Thank you, Matthew. I'll start and maybe turn to Eric. That is a U.S. number, just to clarify, and I would say, while we've been in the U.S. with Omnipod 5 for coming up on 3 years, we weren't the first AID. I think we're seeing is the highly differentiated form factor that customers love. We hear that again and again from all of our Pod community. We also hear the comfort level that prescribers are getting with Omnipod 5 performance, backed by very strong evidence. The SECURE-T2D trial, RADIANT trial, and real-world evidence are showing that it works. It reduces A1C, improves time and range, and prevents lows without promoting weight gain. In fact, you need to use less insulin. That's a very compelling value proposition. Coupled with what I would say is very differentiated access and affordability of really pioneering the pay-as-you-go business model in pharmacy where people pick up their insulin and working with payers to demonstrate our health economics and clinical outcomes to go get preferred status. That really is driving increased adoption and really enabling Omnipod 5 to be the preferred AID of choice, enabling our market leadership now for Type 1 but also the Type 2 indication. We're still very early innings of this.

William Plovanic, Analyst

I wanted to go back to the DTC marketing you mentioned. I believe there was a conversation about both digital and mass media, and I'm also interested in hearing more about the prescribers and the patients. Any additional information would be appreciated.

Ashley McEvoy, President and Chief Executive Officer

Thanks, Bill. I'm going to turn it to Eric to talk about DTC.

Eric Benjamin, Chief Operating Officer

Bill, it's Eric. When we do demand generation, three things happen that all work together. The first is we've built a proven demand generation engine that can produce leads—so interested, qualified customers who are interested in Omnipod. That's effective. The two things that we also described are those folks then show up in physician offices, and healthcare providers really appreciate a motivated customer asking about technology. We're creating a new market especially in Type 2, where there's some skepticism in the market about whether folks who live with Type 2 diabetes are ready for technology. An activated lead walking into a healthcare provider office helps those providers see that technology is good for that population. We see this too. Finally, we had about 65% of the leads that we generated in the quarter are actually from customers that were cared for by folks with whom we don't have a direct sales relationship. Those become warm invitations for our team to go have a conversation with those healthcare providers and assess if they might be good prescribers of Omnipod for the future.

Operator, Operator

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

Ashley McEvoy, President and Chief Executive Officer

Thank you for joining. I just wanted to also thank the Insulet team. It's been a very strong quarter, and I'm very proud of how they continue to serve many more Podders around the world. Thank you for joining.

Operator, Operator

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