Tandem Diabetes Care, Inc.

Thank you for standing by and welcome to Tandem Diabetes Care's fourth quarter 2023 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. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to EVP and Chief Administrative Officer Susan Morrison. Please go ahead.

Hello, everyone, and thanks for joining Tandem's 2023 fourth quarter and year-end earnings call. As a reminder, today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, product 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, quarterly report on Form 10-Q, and in our other SEC filings. 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, quarterly report on Form 10-K, and 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. I'll now turn the call over to John.

Thanks, Susan. We appreciate everyone joining us today. Looking back on 2023, we exited the year on a high note, demonstrating positive momentum across key areas of our business. In many ways, our efforts in 2023 focused on building and preparing for the future, as we executed on multiple strategic initiatives. Most notably is the unprecedented accomplishment of being in various stages of launching four new products in the United States. These include two CGM integrations, along with the introduction of Tandem Source, our next generation data management platform, and the milestone of adding Tandem Mobi, our new platform to our portfolio. Other strategic initiatives we completed include the onboarding of our European Distribution Center, and driving operational cost savings across all products and processes through lean activities and other manufacturing efficiencies. We've also been evolving our organization as we've expanded our leadership by attracting key talent with global experience to complement the team and help us prepare for the future. Lastly, we made meaningful advancement in progressing our channel strategy in the development and in the development activities of our longer-term portfolio. The team has been executing particularly well on our strategy to provide people with insulin-dependent diabetes and their care teams flexibility and choice in insulin delivery. These achievements were made possible thanks to the hard work and perseverance of our employees. Thank you, everyone, for your continued dedication and efforts to contribute to building our business and executing our vision to improve the lives of people with diabetes. Evidence of this vision was highlighted in recent months as we are now the only pump company to offer users choice in CGM integration in the U.S., having launched the T-SLIM X2 with both Dexcom's G7 and Abbott Freestyle Libre 2 Plus sensors. The diabetes community has been enthusiastic in the response to having choice in their therapy management. Thank you again to our CGM partners for your collaboration. We are proud to be a leader in sensor integration and being the first insulin pump company to offer compatibility with your incredible newest technologies. In addition to CGM integration, just last week, we achieved the defining milestone of launching TandemMobi. We are now offering people choice in insulin pump platforms so they can decide how they want to wear and operate this device while getting the benefits of our number one rated control IQ technology. The response from internal and external people who participated in the Early Access program, as well as their healthcare providers, has been emotional and inspiring. Participants say that Moby exceeded our expectations, sharing sentiments that is freeing and liberating. An external former MDI user put it very well, saying that Moby gave my brain time to process real world and not just how I manage my diabetes. It's this kind of feedback that underscores our progress in furthering our mission to improve the lives of people with diabetes through relentless innovation and revolutionary customer experience. Operational and commercial readiness for the TandemMobi launch was the primary focus of us in the fourth quarter. We are well equipped to continue scaling this exciting new technology, first with the Dexcom G6 integration, which is now available, followed by Dexcom G7 integration later in the second quarter, and then integration with the Freestyle Libre 3 technology. Another highlight that continues to stand out in the fourth quarter is that tandem customers are highly satisfied. We see this reflected in both independent and our own customer surveys and in our continued high renewal rate. With tandem technology, people are able to wake up happy by sleeping well through the night and thinking less about their diabetes. It's from their experience with our company and our AID solutions, which consistently demonstrate improved clinical outcomes. It was an honor to have the data from Control-IQ trials cited in recently updated American Diabetes Association Standards of Care to support their guidance that AID systems are preferred over non-automated pumps and multiple daily injection and should be offered for diabetes management to youth and adults with type 1 diabetes. We're continuing our commitment to AID advancement, which we delivered on in the fourth quarter with our receipt of FDA clearance to lower the age indication for Control-IQ. and expand its feature set with options for greater personalization. We're proud to offer the number one rated automated insulin delivery system by patients and healthcare providers, and we'll continue to innovate with new indications and features. As we've seen across the industry in the past five years, innovation drives technology adoption. It's a competitive market, yet remains large and under-penetrated. Approximately half of our new customers have converted from multiple daily injections, and the remainder from competitive conversions. With the launch of our new products this year, we are focused on increasing pump adoption, bringing the benefits of our technology to more people living with diabetes. As we expand the pump market, we expect to see new customers for multiple daily injections begin to outpace growth in competitive conversions. Turning to our performance outside the United States, 2023 was a year of transition for us. It included a number of unique one-time events that pressured our sales. such as the transition to our European distribution center to improve supply chain efficiency, and then the more recent change in the French reimbursement structure. With these events now behind us, our focus is returning to a meaningful growth rate. We welcome new commercial and international leadership with global diabetes experience. We're furthering our strategy to bring the benefits of our technology to more people worldwide. The geographies we serve are increasingly competitive. but we have a strong offering today with our number one rated T-SYNX2 with ControlIQ, and a significant opportunity as the markets we're in internationally are typically less than 20% penetrated. We are also focused on bringing our technology offerings outside the United States closer to parity with our U.S. portfolio. This began last month with our scaled international rollout of Dexcom's G7 integration, only one month following its broad U.S. availability. Other innovations we plan to begin offering internationally this year include the deployment of our Tandem Source data management application, the launch of our mobile application for the TSLM X2, which features the ability to deliver bolus from a phone along with valuable data insights, and the TSLM X2 integration with the Abbott Freestyle Libre 3 sensor. We're also taking steps to offer MOBI outside the United States, which includes regulatory work and localization. In addition, we are working to advance our portfolio of future products, which center around our three pump platforms, T-Slim, Mobi, and Sigi, each of which are designed to appeal to different segments of people living with diabetes. For our T-Slim and Mobi systems available today, we are working on exciting features, such as the extended wear infusion set and a toothless wear option from Mobi. For Sigi, we're in active development of an ergonomic patch pump that features the use of pre-filled insulin cartridges, and like all our pumps, is rechargeable, as it's part of our commitment to sustainability. We have a number of clinical studies underway and plan for this year in support of these development initiatives. We'll also be advancing our automated insulin delivery algorithm and expanding its indications to include people living with type 2 diabetes. As we look ahead, 2024 is positioned to be a year of tremendous opportunity for Tandem. The strengths that drove meaningful growth in the past are once again in place today. These include having a differentiated portfolio of technology solutions, our highly rated customer service, our number one rated automated insulin delivery algorithm, and our international opportunity. I'd now like to turn the call over to Leigh so she can share more details on the fourth quarter results and our financial expectations for 2024. Leigh? Thanks, John.