Tandem Diabetes Care, Inc.

Thank you for standing by and welcome to Tandem's first quarter 2022 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 on your telephone. Please be aware that today's call is being recorded. Should you require any further assistance, please press star 0. I would now like to turn the call over to Susan Morrison, EVP and Chief Administrative Officer.

Thanks, and good afternoon, everyone. Welcome to Tandem's 2022 First Quarter Earnings Call. 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 our 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. In addition, today's discussion will include references to adjusted EBITDA, which is a non-GAAP financial measure. Adjusted EBITDA is a key measure used by us to evaluate operating performance, generate future operating plans, and make strategic decisions for the allocation of capital. Please refer to our press release issued earlier today for further information. Our call today will be hosted by John Sheridan, our President and Chief Executive Officer, and Lee Vossler, our Executive Vice President and Chief Financial Officer. Following their prepared remarks, we'll open up the call for questions. Thank you in advance for limiting yourself to one question and one follow-up before getting back into the queue. I'll now turn the call over to John.

Thank you, Susan, and welcome everyone to today's call. Our first quarter performance demonstrated the strength which we are executing across all areas of our business. We achieved record-breaking Q1 sales, both inside and outside the United States. We also received FDA clearance for the T-Slim X2 users to initiate a bolus delivery from iOS and Android smartphones, which is our top requested app feature. And we also made operational progress throughout the business. Our awesome employees delivered these accomplishments while continuing to navigate the broader headwinds being faced across the world. A special thanks to everyone on the team for sharing your talents with Tandem and our customers. Each of you plays a role in our success, and together we continue to make a positively different impact on people's lives with diabetes. We already reached a new milestone in 2022 as our installed base has surpassed more than 350,000 people worldwide. This represents an estimated 30% of people using insulin pumps in the geographies in which we serve, which was remarkable considering our commercial efforts outside the United States began to ramp less than four years ago. It's evident that we are making meaningful progress in our long-standing objective to bring the benefits of our technology to the diabetes community. We are also continuing to progress our goal to expand the insulin pump market. as about half our new customers in the U.S. in Q1 reported converting from multiple daily injections with a remainder from competitive offerings. At the same time, we are seeing strong customer retention. A key driver of this continued growth is the overwhelmingly positive experience customers and healthcare providers report from our Control IQ technology. This powerful diabetes management solution is now offered in all the geographies which we serve worldwide, and the feedback we hear and the data we see is consistent. Our T-Cell Next 2 with Control IQ technology provides immediate and sustained positive results. This was demonstrated at last week's Advanced Technologies and Treatment for Diabetes Conference in Barcelona, Spain, where data was presented from our Control IQ observational study, also referred to as the CLIO study. where users reported improved quality of life, reduced diabetes burden, and higher satisfaction with diabetes therapy, irrespective of age, baseline hemoglobin A1C, and the previous method of insulin delivery. Our Clio dataset is particularly insightful, as the study is fully enrolled with more than 2,000 customers, and it's now two-thirds complete. It's powerful information that will help inform our future algorithm advancements, as well as discussions with payers and further optimization of the user experience we provide. Additional presentations at the conference feature data demonstrating positive clinical outcomes from long-term use of Control IQ technology, as well as the successful adoption of Control IQ by people previously using MDI, as it's effective across all ages, including children. The ATDD conference, as well as next month's ADA scientific sessions, are important opportunities for us to showcase data that demonstrates the power of our technology. Experience matters, and with more than 60 million real-world customer days of use, our control IQ tube technology continues to set a high bar in advanced automated insulin dosing. It's an advantage that's not tied to one specific algorithm feature like our automated correction bolus or auto-population of CGM data, but rather the full customer experience with the ease of use of our technology, the improved clinical outcomes it provides, and through the positive interactions with our employees. Another competitive advantage that we offer is the ability to bring new software features and benefits to our customers who are within the typical warranty cycle. In February, we received FDA clearance of the mobile app that enables our T-Slim X2 pump users to bolus insulin from their smartphone. With this clearance, we added to the list of Tandem's firsts, as this is the first-ever FDA-cleared smartphone app capable of initiating insulin delivery on both iOS and Android operating systems. Following the clearance, our team kicked off training for our internal employees along with healthcare providers. Launch activities are underway this month as part of a paced rollout into the summer, and we are on track to offer our T-SLIM X2 US customers access to the mobile bolus delivery feature, and this will be free of charge. Mobile bolus clearance provides a great reason for our sales and clinical teams to reach out to healthcare providers. It also reinforces the importance of our strategic decision to expand our U.S. sales and clinical teams in the first quarter to further drive awareness of our technology solutions among people living with diabetes and healthcare providers. People have been excited to learn about our mobile bolus technology as it's been a top requested feature. Our interactions with healthcare providers have continued to be a mix of in-person and virtual. It varies widely by practice and geography. and overall the impact of the broader labor shortages in physicians' offices continues to weigh on many of our prescribers. This, along with the fluctuating COVID case rates, is a dynamic our U.S. field team continues to navigate well, staying both flexible and adaptable. Our international distribution partners are also successfully managing these headwinds outside of the United States. Turning to our product pipeline, we're making great progress across our family of products under development. MOBI, a novel, miniaturized, durable pump, is a focus for our R&D team as it provides us an opportunity to serve a new market segment. As a reminder, the MOBI pump is designed to be fully controlled through a mobile app on a user's personal smartphone, and the T-Connect mobile app that was cleared earlier this year for bolus insulin delivery is also the foundation of MOBI's mobile control functionality. The big development milestone for MOBI in Q1 was our undertaking of the largest human factor study in Tandem's history, which was recently completed. We are in the data analysis process now, and early data from the study is encouraging. It's been exciting and inspirational to hear the feedback from people who participated in the study, both people living with diabetes as well as our pump trainers, and how easy the system is to operate and how it will serve a current unmet need in the diabetes community. The data from our pivotal human factor study, along with other final test reports and development work are now taking place, and we intend to submit our 510K filing to the FDA in the third quarter. We'll be filing it through an ACE pump pathway in the U.S., which allows for MOBI to be integrated with interoperable CGMs, as well as our algorithms like Control IQ, without additional regulatory review. CGM work is another top priority for our development teams. and continues to progress well with both of our CGM partners, Dexcom and Abbott. We are in tight communications with both organizations as they each progress towards bringing their technology to market through the ICGM pathway. The last area of product development I'd like to highlight today is the extensive clinical work that we're undertaking to bring the benefits of our control IQ technology to more people living with diabetes. For example, our first Type 2 feasibility study for control IQ is anticipated to be fully enrolled this month. Also, the pediatric trial using control IQ continues to progress well, and as discussed in the past, we intend to use the data to pursue an age indication for children younger than six years old. And lastly, we're working to expand insulin indications for control IQ through the addition of LUNGEV, and we'll be kicking off a study this quarter. In addition to these products under development, we're making progress on our global digital health initiatives, which remain strategically important to us. These efforts and our longer-term pipeline are all designed to deliver on our commitments to meet the varying needs and preferences of people living with diabetes. Relentless innovation and revolutionary customer experience remain at the heart of our company. Looking across our business, we're also applying the lens of continued improvement to identify areas for process efficiency, lean optimization, and reduced environmental impact. I look forward to keeping you updated on the company's accomplishments to reduce the burden of diabetes management while working to deliver value to our shareholders. I'll now turn the call over to Lee to provide further color on the quarter as well as on our guidance for the year. Lee?