11/6/2025

speaker
Operator
Conference Operator

Good day, and thank you for standing by. Welcome to the Tandem Diabetes Care Third Quarter 2025 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead.

speaker
Susan Morrison
Executive Vice President and Chief Administrative Officer

Hello, everyone, and welcome to Tandem's third quarter 2025 earnings call. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, our product pipeline, development timelines, and financial performance and operating plans, and speak only as of today's date. There are risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward-looking statements, which are described in our press release issued earlier today and under the risk factors portion of our most recent quarterly report on Form 10-Q. Today's discussion will also include references to both GAAP and non-GAAP financial measures. Please refer to our earnings release issued earlier today and available on the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure and other information regarding our use of non-GAAP financial measures. John Sheridan, Tandem's President and CEO, will be leading today's call, and he'll be joined by Lee Vossler, Executive Vice President, and Chief Financial Officer. Following their prepared remarks, the operator will open up the call for questions. Thanks in advance for limiting yourself to one question before getting back into the queue. I'll now turn the call over to John.

speaker
John Sheridan
President and Chief Executive Officer

Thank you, Susan. Good afternoon, everyone, and welcome to our call today. In the third quarter, we achieved significant strategic milestones and delivered record Q3 sales. This year has represented a period of transformation for Tandem, and we are doing the right thing to position our company for success. Our substantial progress is starting to become evident in our financial results and serves as a testament to our strategic vision, hard work, and the collective dedication of our entire team. There are three primary initiatives that we've been prioritizing to evolve our business, which will be the focus of my prepared remarks today. These include modernization of our commercial operations, driving innovation, and reshaping our business model. In the U.S., we are beginning to see measurable benefits from our commercial change implemented throughout the year. We have redefined end-to-end processes, begun deploying new technology platforms, and restructured the organization to deepen our capabilities and to improve efficiencies. As a result, we're beginning to see improved sales productivity and effectiveness and plan to build on this momentum in the coming quarter and years. Pumped shipments for Q3 met our expectations with favorable underlying sales trends, and September was our strongest month of the quarter. About two-thirds of our new customers continue to adopt our technology from multiple daily injections. We also continue to see a healthy mix of both T-Slim and Mobi adoption, highlighting the value of our portfolio approach in the highly segmented market. Outside of the U.S., our commercial transformation is focused on preparing for direct operations in Europe. We had executed well against our transition plans, and I've been impressed with the high caliber experienced people joining us. Our direct sales initiatives will begin in the UK, Switzerland, and Austria in early 2026, with additional countries to follow later in the year. In some locations, we've already started to hire our sales reps. Many of these individuals currently sell our technology through a distributor, which helps support a smooth transition. Establishing direct international operations is a critical step to strengthen our financial position by accelerating sales growth and driving margin expansion. It's also an opportunity to deepen our relationships with the European diabetes community and bring the benefits of Tandem's incredible technology to more people living with diabetes worldwide. Our second business initiative is focused on driving innovation. We have several recent and upcoming launches which deliver on our portfolio promise of expanding choice. For example, the potential for Mobi is still not fully unlocked. We are awaiting FDA clearance for our Mobi control app for Android, which is currently only available in iOS. Adding Android capability is an exciting opportunity as it significantly expands the worldwide addressable market. In addition, last week we announced that T-Cell Next 2 is now fully available with Abbott's Freestyle Libre 3 Plus integration in the U.S., marking the first step in a broader global rollout. This integration has been in the early access phase of launch in the U.S. over the past several months with positive user feedback. We're excited to offer integration with Abbott's latest generation sensor as it provides even more CGM users access to the life-changing benefits of our Control IQ Plus algorithm. We are expanding the international rollout of our source cloud infrastructure, which supports both the expansion of Mobi outside of the United States and enables iOS and Android mobile app applications for T-SIM X2. Our T-SIM mobile app is now live in five countries with another seven scheduled for deployment before the end of the year and the remaining to follow soon after. This is a milestone in bringing our data management solutions to users worldwide and a testament to the world-class capabilities we are building in this space. Lastly, we continue to receive positive feedback from people with type 2 diabetes who experienced real-world results similar to those in our study in the New England Journal of Medicine earlier this year. Control IQ Plus offers immediate and sustained improvement, even without carb counting and regardless of bolus strategy, including when people don't bolus at all. Importantly, we're seeing that insulin-dependent people Using GLP-1s get even better outcomes when used with Control IQ+. In line with our expectations, T-Slim's screen display resonates strongly with the Type 2 users, along with the 300-unit reservoir, as it reduces the frequency of cartridge changes, helping reduce the daily burden of diabetes. Following this positive feedback, we expanded our Type 2 commercial efforts, moving from pilot to full promotion of Control IQ+, for people with Type 2 diabetes. The market is highly under-penetrated and requires development. We're seeing evidence as the territories that participated in our pilot launch activities are now the most productive in bringing our technology to people with Type 2. Serving this population is a focus for us because it offers meaningful longer-term growth opportunity, doubling our addressable market in the U.S. The third initiative driving our business transformation is shaping our business model to drive growth and improve gross margin and profitability. we have been identifying and implementing changes to increase efficiency through linear operations, greater automation, and the implementation of new processes and systems. A major focus of reshaping our business model has been our pursuit and advancement of a multi-channel reimbursement strategy. There are two key pharmacy-related accomplishments this quarter. First, we've successfully increased pharmacy benefit coverage for TandemMobi to more than 40% of U.S. lives, a milestone we plan to build on in 2026. The next highlight is that we started selling T-SIM supplies to our large existing customer base through the pharmacy benefit in September. As you recall, we previously shared this as a goal for Q4, and it's now off to a great start. Early uptake has been encouraging, with customers citing affordability, convenience, and simplified refills as the top reasons for switching to their pharmacy benefits. This supports our thesis that pharmacy access is not only more efficient for tandem, but also more appealing to our customers. Operationalizing pharmacy access for new and existing customers required significant internal effort. We've assembled a skilled team of market access and pharmacy distribution leaders with experience across leading PPMs, pharma, and med tech organizations, enabling faster contracting and smooth implementation. Their expertise has accelerated this strategic shift making our AID technology more affordable and accessible, while establishing a scalable foundation for future growth. As you can see, we've meaningfully advanced our key initiatives in support of Tandem's mission and financial goals. I want to thank our employees, as taking on these initiatives simultaneously has been quite an undertaking. The team's efforts are making a positive impact and starting to yield tangible results, positioning Tandem as a continued global leader in diabetes care. I'll now turn the call over to Lee, who will expand on our third quarter results and future expectations. Lee?

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