Insulet Corporation

Good morning, ladies and gentlemen, and welcome to the Insulate Corporation's third quarter earnings call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star, then zero, on your touch-tone telephone. As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Claire Chapman. 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 Influx 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, and the macroeconomic environment on our results of operations contain forward-looking statements that involve risks and uncertainties. And 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, on today's call, non-GAAP financial measures will be used to help investors understand Influx's ongoing business performance, including adjusted operating income, adjusted EBITDA, adjusted tax rate, and constant currency revenue, which is a revenue growth excluding the effect 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 issue 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? Thank you, Claire, and welcome. Many of you already know Claire, 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 Insulate'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. Lavia'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 Ragunandanan 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 insulin'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 potters across the US 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 Insulate team for their hard work this quarter and their tireless commitment to delivering for potters 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 underscore 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 and 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 UK, France, and Germany, we're seeing robust growth supported by our launches of the latest sensor integrations, 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 three 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 and range double. And Melissa and her husband are finally getting a full night's sleep. Eliza now loves to dance, 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 two weeks and 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 improves 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 US 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 a dollar 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 two-thirds of our government-insured customers pay less than $10 a month, and over 60% pay zero. Third is demand generation. This quarter we invested meaningfully 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 is 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 gives 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 weeks at Investor Day. I'll now turn the call over to Flavia to discuss our third quarter results and guidance.