Tandem Diabetes Care, Inc.

Thank you for standing by, and welcome to Tandem's third 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. Madam, you may begin.

Hello, everyone, and thanks for joining Tandem's 2023 Third Quarter 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-Q, and the Investor Center portion of our website for a reconciliation of these measures to their most direct 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. Dr. Jordan Pinsker, our medical director, will also be joining for the Q&A portion of today's call. I'll now turn the call over to John.

Thanks, Susan, and welcome, everyone, to today's call. In the third quarter and throughout 2023, Tandem has focused on bringing the benefits of our number one rated AID systems to more people living with diabetes worldwide, along with providing customer care excellence and making operational progress throughout our business. It's been a transitional time for Tandem as we prepare for the company's next phase of growth through our portfolio of innovation. We are executing on multiple near-term product launches while implementing scalable systems and processes to support our global operations and leverage our infrastructure. Reflecting on our third quarter results, our overall performance was above our baseline expectations, primarily due to the U.S. market. Over the past few weeks, I have had an opportunity to attend some of our regional sales meetings across the United States and was excited and encouraged by my conversations. My first takeaway is that the T-SWIM X2 with Control-IQ continues to be the best AID system available. This is also reflected in third-party research and our own customer satisfaction surveys. It's evident in our low attrition and higher percentage of customers choosing to purchase a new T-Slim X2 from Tandem after their warranty expires. My next takeaway is that overall competitive dynamics remain stable. Some products are newer than others, but the noise from the other AID offerings is in line with our expectations, and the diabetes community is learning more about what these products are and what they are not. Lastly, and most overwhelmingly, is the high level of enthusiasm and anticipation for our new sensor integrations and for Mobi Pump platform. Our sales team shared that some new and renewing T-SLIM customers are pausing as they wait for Mobi and G7 launches and are excited for their availability. These products are at various stages in the release process, and we are highly encouraged by the performance in the hands of our early users. Starting with CGM additions, I am proud of our team's demonstrated leadership in AID sensor integration. Developing pump and algorithm software for the compatibility with the new sensor is an extensive process, and the technical work is just part of the effort it takes to bring a newly integrated system to market. I would like to express our thanks to our CGM partners for their collaborations as we work to launch the T-Slim X2 with the Dexcom G7 and Abbott's Freestyle Libre sensors. The steps to bring the Dexcom G7 integrated system to market are well underway, and we made great progress in the early release phases. We are proud to be rolling out the first AID system in the world to use Dexcom's G7 sensor data and are planning for full availability of G7 across the U.S. by year's end. We've also been preparing for the launch of the T-SLIM X2 integration with the Abbott Freestyle Libre 2 sensor. Based on where we are and being mindful of the upcoming holiday season, We plan to initiate the U.S. launch of TSLIM with Freestyle Libre II later this quarter with broad availability early in the new year. This new integrated offering is an incredible accomplishment for our teams as we bring the benefits of AID technology to Abbott's customers in the U.S. for the first time. Now turning to MOVI, in my 10 years with Tandem, I've had the privilege of being part of launching many new innovations that have reduced the burden of diabetes and improved clinical outcomes. The excitement around the launching of Mobi is among the highest I've ever seen, and there is incredible interest by the healthcare providers, people using MDI, and current pumpers to learn more and gain access to our new pump technology. The most common feedback we hear is that people are surprised and thrilled about Mobi's tiny size, and the option it enables for wearability, including on-body wear via a patch accessory or clipped onto a waistband, or easily tucked into a jean coin pocket. The on-body wear options, combined with the ability to disconnect if needed, is a new paradigm. This distinguishes Tandem Mobi from on-market patch pumps. And of course, they also appreciate the benefit and discretion of its mobile app operation. For these reasons, we believe that Tandem Mobi is positioned to expand the insulin pump market and further our mission to improve the lives of more people living with diabetes. Our release of TandemMobi began in October with a limited number of users and will scale through the quarter. Throughout this process, we monitor key criteria and performance metrics, not only for the pump, but also for all the surrounding systems and processes across the company. We feel this rigor ultimately leads to a stronger commercial offering for customers and healthcare providers and delivers a positively different experience that Tandem has built its reputation upon. We are tracking to our plan to begin offering Moby more broadly in the US, beginning early in 2024. Simultaneously, with each of these new launches, we are developing plans for our new products in countries we serve internationally. Reflecting on our overall business outside the United States, our third quarter aligned with our base expectation, which contemplates the European summer holiday season, as well as competitive activities. During this period, our distribution partner in one of the largest European countries experienced capacity constraints and disruptions to its sales activities because their focus was on rolling out a T-Slim software update to their installed base. Software updatability is still a relatively new offering outside the United States, especially at such a large scale, and individual healthcare systems sometimes have different requirements for who does the update, where, and how they occur. Our commercial team has been very responsive in helping this distribution partner identify opportunities for process efficiency and to minimize constraints based on best practices from the US and other geographies. We're also working through the timing of G7 integration availability in our key European markets. Much like the US, enthusiasm is high for this new offering, and our preparations for launch are actively underway. This is impacting our distributors' fourth quarter forecasts, which they are adjusting anticipation of this launch occurring just after the first of the year. It is rare and exciting to have an opportunity like this one in front of us with so many new product launches in flight worldwide, each of which individually has the opportunity to change the trajectory of our business going forward. It's also an ideal time for us to welcome Mark Navarro as our EVP and Chief Commercial Officer. Mark will succeed Brian Hansen, who we thank for his passion and leadership, along with laying the foundation for Mark's long-term success at Tandem. As you saw from the press release issued this afternoon, Mark brings strategic and operational global experience in diabetes, as well as medical devices. He has a successful track record of delivering above-market growth, best-in-class customer experience, and scalable commercial operations. His knowledge in leading global commercial functions will be critically important as we prepare for the launch of multiple new products in the coming weeks and months, and we welcome him to our leadership team. 2023 has been a complicated year of transition, but we remain focused on executing diligently to scale our operations in preparation for this exciting next phase of growth. I'd now like to turn the call over to Leigh to share more on the three key results and financial expectations. Leigh?