Tandem Diabetes Care, Inc.

Good day, and thank you for standing by. Welcome to the Tandem Diabetes Care First 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 1-1 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.

Hello, everyone, and thanks for joining Tandem's first 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. A list of factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is highlighted in our press release issued earlier today and under the risk factors portion and elsewhere in our most recent annual report on Form 10-K, and quarterly report on Form 10-Q. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or other factors. Today's discussion will also include references to a number of GAAP and non-GAAP financial measures. Non-GAAP financial measures are provided to give our investors information that we believe is indicative of our core operating performance and reflects our ongoing business operations. We believe these non-GAAP financial measures facilitate better comparisons of operating results across reporting periods. Any non-GAAP information presented should not be considered as a substitution, independently or superior, to results prepared in accordance with GAAP. 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. Leading today's call is John Sheridan, Tandem's President and CEO, who will be joined by Lee Vossler, our Executive Vice President and Chief Financial Officer. Following their prepared remarks, the operator will open up the call for questions. Thank you in advance for limiting yourself to one question before getting back in the queue. John, you may begin.

Thank you, Susan, and thanks everybody for joining us today. In the first quarter, we demonstrated strong execution throughout our business. We delivered more than 20% growth for the third quarter in a row with records first quarter sales in the United States and our highest quarter ever internationally. In addition to driving top-line growth, we are delivering on key operational initiatives to strengthen and enhance our business while increasing profitability. And in the first quarter, we demonstrated meaningful improvement in adjusted EBITDA year over year. Another highlight of the quarter was FDA's clearance of Control IQ Plus for people living with type 2 diabetes. followed by the New England Journal of Medicine's publication featuring the benefits of Control IQ+. I'd like to thank our employees for an impressive start of the year, which positions us to deliver on our goals in 2025 and beyond, while improving the lives of people with diabetes. Starting with a deeper look at our Q1 performance in the U.S., we continue to see growth year over year in new pump starts and achieved a double-digit increase in customers converting from multiple daily injections for the last four quarters in a row. This strength is from demand for our newest offering, Tandem Mobi, as well as our flagship pump, the T-Slim X2. The product mix between these two offerings is healthy, and the demand for Mobi is on track to contribute meaningfully to our near and longer-term financial goals. Our products are expanding the large and under-penetrated insulin pump market as approximately two-thirds of our new starts are coming from people converting from multiple daily injections. We also continue to see great loyalty from T-SLIM customers coming up for renewal. Renewal rates have remained at a consistently high level, along with our customer satisfaction scores. Our mix of new and renewing customers remains roughly 50-50, which we anticipate will continue throughout the year. Q1 was also our first quarter operating under our newly expanded fuel sales and clinical structure. This expansion and our realignment of existing territories has progressed according to plan and is now complete. We welcomed a high caliber of talent to compliment our more tenured field employees, and our territories are now poised to realize productivity gains throughout the remainder of this year. Another successful commercial initiative in Q1 was the launch of our best algorithm yet, Control IQ+. This algorithm makes better control easy, easy to start, easy to use, and easy to personalize. For example, our profile setting calculator is a software wizard that only requires a person's total daily insulin and weight to get them started on Control-IQ+. This is a feature that benefits both patients and healthcare providers and simplifies and streamlines onboarding to our AID technology, which is tested, trusted, and now better than ever. Control-IQ+, launched in late March, and is indicated for use by people with type 1 diabetes ages two and older. Following FDA's recent clearance, it's also now cleared for adults living with type 2 diabetes. The pivotal study supporting this clearance is the first and only large-scale randomized control trial of automated insulin delivery in people with type 2 diabetes. It was also the most rigorous evaluation of AID for people with type 2 ever conducted, and the outcomes were incredible. Significant improvements in time and range in A1C were demonstrated the people using control iq plus compared to a control group these results were seen cumulatively and across a broad range of ages they were also equally demonstrated in people who chose to count carbohydrates in the study compared to people who had used a more simplified approach by entering fixed dosing at meals this is significant as it makes the bolus process even easier without sacrificing improvement in clinical outcomes also The synergy between Control IQ Plus and GLP-1 receptor agonist use was highlighted at our ATTD presentation in March, showing how well these therapies work together. We are proud of the outcomes from our pivotal study and the tremendous accomplishment of being featured in the New England Journal of Medicine. This most recent publication marks the fourth time that our Control IQ technology has been featured in the journal, which is an unprecedented accomplishment in our industry and speaks to the strength of our studies and our AID algorithm. We are excited about the growth potential this Type 2 indication provides, as it more than doubles our addressable market. Control IQ Plus is now broadly available, and we have begun initial commercial efforts to people with Type 2 in select areas. We are using this early phase of launch to gather customer experience data on training and onboarding, as well as reimbursement and channel access to inform our expanded launch plans and expectations for the remainder of the year. Channel access continues to be a top initiative for our company, and Lee will discuss our Q1 progress more in her prepared remarks. Turning to our business outside the United States, the strong sales momentum we saw exiting 2024 continued in the first quarter, where we delivered our highest quarterly sales results ever. This was driven by demand for our T-SLIM X2 platform, which is available with Dexcom G6 and G7 sensor integration in approximately 25 countries. In addition to attracting new customers, we are also beginning to see customers renewing with Tandem, who first bought a pump when we entered these markets four or five years ago. It's a meaningful opportunity when you look at the historical pump adoption rates outside the United States, and it will serve as an additional source of growth as we look to the future. Operationally, our plans to begin direct sales OUS in select countries are progressing well. Transition service agreements are now in place in the select countries where we'll go direct in 2026. And we are developing and executing joint transition plans that are designed to ensure the proper business continuity and minimize potential disruption. We've also been furthering the efforts we began last year to hire in-country talent. We are preparing to enhance our sales efforts, support, and technology offerings outside the United States, both for our direct and distributor-led countries. It's a pivotal step for our company as we deepen relationships within the European diabetes community while strengthening our financial position to accelerate sales growth and drive margin expansion. I'd now like to turn the call over to Lee to talk about quarter one results and expectations for the year.