2/10/2022

speaker
Adrienne
Operator

Welcome to the Dexcom fourth quarter 2021 earnings release conference call. My name is Adrienne and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star then 1 on your touchtone phone. Please note this conference call is being recorded. I'll now turn the call over to Shawn Christensen. Shawn, you may begin.

speaker
Shawn Christensen
Conference Call Moderator

Thank you, operator, and welcome to Dexcom's fourth quarter and full year 2021 earnings call. Our agenda begins with Kevin Sayre, Dexcom's chairman, president, and CEO. We'll provide a summary of our fourth quarter and full year highlights and ongoing strategic initiatives, followed by a financial review and outlook from Jeremy Sylvain, our chief financial officer. Following our prepared remarks, we will open the call up for your questions. We ask analysts to limit themselves to one question so we can provide an opportunity for everyone participating today. Please note that there are also slides available related to our fourth quarter performance on the Dexcom Investor Relations website on the events and presentations page. With that, let's review our safe harbor statement. Some of the statements we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs, expectations, and assumptions about future events, strategies, competition, products, operating plans, and performance. All forward-looking statements included in this presentation are made as of the date hereof based on information currently available to Dexcom, are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in Dexcom's annual report on Form 10-K, most recent quarterly report on Form 10-Q, and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this presentation or to conform these forward-looking statements to actual results. Additionally, during the call we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP and cash-based results. Unless otherwise noted, all references to financial metrics are presented on a non-GAAP basis. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. Please refer to the tables in our earnings release and the slides accompanying our fourth quarter and full year earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure. Now, I will turn it over to Kevin.

speaker
Kevin Sayre
Chairman, President and CEO

Thank you, Sean, and thank you, everyone, for joining us. I want to take time at the start to highlight some of Dexcom's key accomplishments in 2021 that reflect our progress relative to the priorities that we establish at the start of the year and our long-term goals. Total revenue grew 26% on an organic basis over the prior year, with rising CGM awareness and Dexcom brand loyalty leading to another year of record new patient additions. This translates to nearly $500 million of organic growth for the year. leading us to exceed the midpoint of our original guidance for the year by more than $160 million. We laid the foundation for significant expansion of our addressable markets in the future with differentiated product solutions and clinical evidence. In June, we presented results from the mobile randomized controlled trial for people with type 2 diabetes being managed with basal insulin. The results were clear. Dexcom CGM can do significantly more to help these people manage diabetes. And with this conclusion being validated in the Journal of the American Medical Association, as well as in the recently updated ADA Standards of Care, we are hopeful that we can bring access to our technology for the estimated 3 million people on basal insulin therapy in the U.S. and many more outside the U.S. Alongside the mobile clinical evidence, we drove several updates to our product portfolio to broaden the ways that customers can engage with our technology. We've consistently spoken about our investments in software and data infrastructure as a significant competitive advantage. In the third quarter, we received two key FDA clearances for Dexcom software tools that reflect this commitment and strength. Our real-time API allows us to directly integrate Dexcom CGM data in real time to the displays of approved third-party apps. And our app-in-app solution creates an FDA-cleared Dexcom app experience that can be integrated directly with the app of a Dexcom partner. Both of these creative solutions have already been rolled out with Dexcom partners, and we believe they position us well to provide extensive options for our customers, partners, and potential partners as CGM use continues to expand into new populations. We again strengthen our product portfolio through differentiated software with the CE mark and launch of our Dexcom 1 product in the fourth quarter of 2021. In a relatively short period since launch, we've already seen strong adoption in both Type 1 and Type 2 customers, and the health systems in two of our four launch countries established reimbursement. With a focus on ease of use and affordable price point, we believe that Dexcom 1 will be a significant part of our story as we look to extend CGM access globally. Perhaps most importantly, in 2021, we completed the pivotal trials in support of our next generation G7 system and submitted the results for both CE mark and FDA clearance. As many of you recently saw in our January presentation and will soon see in a publication, the performance of the G7 system is outstanding, achieving unsurpassed performance levels relative to the FDA's ICGM special controls. Even with customers on our G6 system expressing record net promoter scores at the end of 2021, we are incredibly excited for them to experience G7. We believe that we are very close to receiving CDMark and are navigating the final stages of that review. In the meantime, our teams continue to work to prepare the manufacturing scale-up and commercial efforts in anticipation of G7 launches throughout the year, as well as launches with some of our partners on their upcoming connected insulin delivery devices. On that front, we were excited to see the news of the FDA's recent clearance of Insulet's Omnipod 5, the first tubeless automated insulin delivery pump. With this clearance for Insulet and the ongoing success of Control IQ for tandem diabetes, we believe that we are enabling automated insulin delivery for the best tubeless pump on the market and the best tethered pump. The outcomes that customers are seeing with these Dexcom integrated systems are outstanding, and we are proud that our commitment to connectivity is helping advance the market and enhance the quality of life for our customers. These accomplishments align with the strategic priorities that we established at the start of last year, showing the resilience and execution of the Dexcom teams in a challenging environment. These accomplishments are not merely 2021 events, but they are the foundation that we will continue to build on as we press forward in 2022 and beyond. Many of you likely saw the recent update to the IDF estimates for global diabetes prevalence and cost. There are now greater than 500 million adults with diabetes globally, and costs to treat the disease alone are estimated to be approximately $1 trillion per year. In addition, the CDC now estimates that 38% of adults in America, or 96 million people, have prediabetes. There is a real opportunity here for Dexcom to do something great to address this epidemic, empower diabetes management, and down the road even work towards diabetes prevention and better health outcomes broadly. The future for Dexcom is bright. With that, I will turn it over to Jeremy for review of the fourth quarter financials and discussion of the 2022 outlook. Jeremy? Thank you, Kevin.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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