2/26/2025

speaker
Operator
Conference Call Operator

Good day and welcome to the Tandem Diabetes fourth quarter and year-end 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker 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, 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, 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 thanks for joining Tandem's fourth quarter and year-end 2024 earnings call. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, our product pipeline, development timelines, in 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, 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. Participating on today's call are John Sheridan, Tandem's President and CEO, Mark Navarro, Executive Vice President and Chief Commercial Officer, and Lee Vossler, Executive Vice President and Chief Financial Officer. Following their prepared remarks, the operator will open the call for questions. Thank you in advance for limiting yourself to one question before getting back in the queue. I'll now turn the call over to John.

speaker
John Sheridan
President and Chief Executive Officer

Thanks, Susan, and thank you, everyone, for joining us on today's call. 2024 was a pivotal year for Tandem, marked by an impressive 18% increase in worldwide sales. I am proud that we set new sales records, both in the US and internationally, while delivering industry-leading customer satisfaction and expanding our portfolio of technology solutions. A highlight of the year was the introduction of our category-defining platform, Tandem Mobi, which experienced continued growth throughout 2024 as awareness of our newest offering increased. Additionally, we implemented operational efficiencies that set the stage for sustained profitability in 2025 and beyond. These achievements were made possible thanks to the resilience, perseverance, and hard work of our employees. Thank you, everyone, including our distributors, suppliers, clinical partners, for your continued dedication and efforts that contribute to furthering our mission. Tandem now offers the most robust ecosystem in insulin therapy management in the world. With our flagship T-Slim and Tandem Mobi, we provide the greatest choice in pump platforms. We offer customers a seamless cloud-based experience with our apps and operating system support, and enable HCPs with our web-based data management platform, Tandem Source. We also integrate with multiple leading CGM sensors, and next month, we will launch our third automated insulin delivery algorithm with Control IQ+. ControlIQ has long been considered the best automated insulin delivery algorithm, with more than 240 million patient days of data logged in our system and 70-plus peer-reviewed manuscripts and published abstracts. Over the past five years, it has provided immediate and sustained results across all patient populations. Now we're raising our own bar with the launch of ControlIQ+. ControlIQ Plus offers superior glucose control and best-in-class outcomes by predicting, calculating, and adjusting insulin doses including delivering automated correction boluses. Driven by customer feedback, we have added new clinical features, such as an extended bolus lasting up to eight hours and the option to set a temporary basal rate. Activating Control IQ Plus is easy. We have introduced a simple setup wizard that allows users to set it in accordance to AACE guidelines, switch it on, and witness immediate results. This is particularly beneficial to people coming from MDI In the U.S., customers also are now able to choose between English and Spanish. Control IQ Plus was originally approved for individuals with Type 1 diabetes age 2 and older. As highlighted in yesterday's press release, we're excited that it is now FDA cleared for people living with Type 2 diabetes 18 years and up. This more than doubles our addressable market in the United States, positioning us for significant long-term growth. This expanded label indication encompasses all insulin-requiring people with type 2 diabetes and is based on a recently completed pivotal trial. This trial represents the first large-scale randomized control study of an automated insulin delivery system in more than 300 people with type 2 diabetes. Full study results will be presented at the International Conference of Advanced Technologies and Treatments for Diabetes in Amsterdam next month. With Tandem's robust expanded portfolio, we also began executing a multi-channel pair strategy with the addition of the pharmacy channel, which we expect will ensure our best-of-class products are matched with ease of access and improved affordability. We also began investing in important commercial initiatives to fortify our business fundamentals and advance our short and longer-term sales and profitability goals. For instance, in the fourth quarter, we initiated recruitment efforts to support a strategic sales expansion and territory realignment which took effect at the beginning of this year. We identified opportunities to modernize the tools and systems used by our commercial teams, enhance their efficiency and effectiveness. Additionally, leveraging the robust performance of our OUS business and recognizing the vast potential within the markets we serve, we have begun a multi-year transition to direct commercial operations in select European countries. Overall, 2024 was a successful year for Tandem with a return to growth. Importantly, we also initiated fundamental changes to key business processes, broadened market access options, and expanded organizational capabilities to accelerate revenue growth and profitability in 2025 and beyond. And taking a deeper look at the fourth quarter, there are many wins to celebrate. Outside the U.S., we delivered strong double-digit growth driven by demand for the T-Slim pump platform. In the U.S., we saw strength from both T-Slim and Mobi pump platforms And then key performance indicators, such as year-over-year growth in the customers coming from multiple daily injections and customers renewing from tandem once again. Our Wednesday quarter also came with some challenges. The fourth quarter in the U.S. did not come together as anticipated. We experienced more muted seasonality in the last few weeks of the year, where historically we have seen acceleration throughout December. Additionally, shipping delays by carriers who did not deliver to customers before the end of the year as planned impacted the timing of revenue reporting. Despite these factors, the underlying trends of our business remain strong and favorable. I will now ask Mark to provide more additional detail on the commercial insights. Mark?

Disclaimer

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