Tandem Diabetes Care, Inc.

Good day, and thank you for standing by. Welcome to the Tandem Diabetes Care Second Quarter 2021 Earnings Conference Call. At this time, all participants are in a listening mode. After the speaker's 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 advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead.

Thank you. Good afternoon, everyone, and thanks for joining Tandem's 2021 Second 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 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 filing. 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. Today's call will be led by John Sheridan, our President and CEO, along with Brian Hansen, our EVP and Chief Commercial Officer, and Lee Vossler, our EVP and Chief Financial Officer. Following the prepared remarks, we'll open up 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.

Thank you, Susan, and welcome everyone to today's call. We are pleased to report another quarter of remarkable growth that far exceeded both our most recent guidance and market expectations. Our strength in the quarter was driven by both new customer demand and increasing renewal purchases from our installed base, and as a result, our worldwide sales grew 58%. In fact, we have now grown at rates exceeding 40% in nearly every quarter since we launched our first major software update on the T-Slim X2 in late 2017. I am proud not only of the significant progress we are making in expanding and further penetrating the insulin pump market in the U.S., but also the rapid uptake we are seeing in countries where we have just recently entered and where our business opportunity is at a very early stage. Just as important, we are continuing to provide superior care and support our customers both directly and in collaboration with our distribution partners. At the same time, we are looking to the future by advancing our product development efforts, and we are working to enhance both customers' and prescribers' experience with our company while managing our business with increased leverage and efficiency. Our worldwide install base has grown to nearly 270,000 people, and we are on track to achieve our goal of having at least half a million customers by year-end 2024. On these calls, we regularly talk about metrics like shipments and installed base, but behind each of these numbers are individual people, and diabetes remains a very personal disease. One of our customers, an endurance athlete and tandem ambassador named Sebastian Sasseville, recently completed an incredible journey to raise awareness for the JDRF campaign, Access Matters, by successfully cycling across Canada in only 14 days. It is a story like this that motivates here at Tandem, and we are proud that our TCMx2 with Control IQ can help people like Sebastian on adventures like this one. Congratulations again, Sebastian, for your remarkable achievement, and thank you for inspiring us to keep innovating. At Tandem, our connection with our customers and the diabetes community is rooted deep in our company culture. No one knows us better than Brian Hanson, who is connected to our customers each day, both directly and through our sales, customer service, and clinical teams. There's been a lot of interest this past quarter in our commercial environment, and so Brian joined us today to provide color on the quarter and his broader perspective. Brian?

Thanks, John. Looking back at the first half of 2021 and the second quarter in particular, it's been incredible to share the excitement surrounding our T-SLIM X2 technology as adoption continues to build. Our new pump shipments were the highest in our company's history, and the trends have us well-positioned for long-term growth. Domestically, it's been particularly encouraging to see the strong prescribing patterns behind the shipments. Two metrics that stood out were, one, that our number of unique prescribers in the quarter continue to increase, and two, that these healthcare providers are writing more prescriptions for the T-Slim X2 than ever before. Also, it's notable that the source of our sales was consistent in the second quarter with about half of our new customers converting from multiple daily injection and half converting from other pump manufacturers. The increase in our breadth and depth of coverage is a huge credit to both our inside sales team as well as our field team and the relationships they've established with healthcare providers even through the challenges of COVID-19. It can also be attributed to the strength of the clinical and real-world data that supports the tremendous physical and psychosocial benefits of our products. It's also credit to the support we offer and the adjacent systems we provide, such as T-Connect, and through our product innovations, such as Control IQ. The real-world data for people using control IQ technology continues to be overwhelmingly positive. As John mentioned, we hear testimonials every day from people experiencing time and range in the 70%, 80%, 90% ranges, and for the first time in their lives, dramatic A1C improvements. While not considered a core clinical outcome, we also hear equally compelling stories from people experiencing their first good night of sleep in years. At Tandem, we strive to provide people a positively different experience, and we are delivering on that goal with Control IQ technology. Experience matters in diabetes care, and we've set a new and higher bar for what people should expect in automated insulin delivery. This applies to our product performance, training, user experience, and healthcare provider interactions. We've missed seeing healthcare providers and customers face-to-face over the past year, but have also successfully maintained and even strengthened relationships during this time. Throughout Q2, we saw an increasing number of patients return to in-office visits domestically, and our sales and clinical teams also gradually started having more visits in person. As people became more comfortable with in-person professional interactions, we saw it carry over into their personal activities, too. There has been a notable increase this summer in healthcare providers and their patients taking some well-deserved vacation time that was put off earlier in the pandemic. Summer seasonality is something we typically see, particularly internationally, and we expect that this also will be reflected in our overall sales patterns in 2021. Throughout the pandemic, the amount of live interactions has varied widely by geography and even by individual office. More recently, we're seeing greater limitations and office restrictions being put back into place as the rate of COVID-19 diagnosis has increased in some areas. Regardless, we have proven that we can be effective both in person and remote environments. Internationally, our distribution partners are doing a great job in navigating the excitement surrounding the launch of our new technologies and the uncertainties of the pandemic. We had such a strong start to the year, it was difficult to predict how the second quarter would play out between COVID-19 restrictions and our distribution partners working to right-size their inventory relative to demand. As you saw in today's results, the early evidence we are seeing, combined with the large and under-penetrated natures of these markets, strengthens our conviction that our international business will be another long-term growth driver for Tandem. We now have more than 60,000 customers who live outside of the United States, which is incredible as it took us twice as long to reach the size of an installed base domestically. As a reminder, our T-SLIM X2 technology is now available in more than 20 countries worldwide, and we once again saw strength in ordering across all geographies. We have launched control IQ in the majority of these geographies and its reception outside the United States has mirrored the enthusiasm that we see domestically. Notably, Canada, Germany, and France make up more than half of our total international opportunity in terms of the number of people living with type 1 diabetes. We launched Control IQ in Canada in the second quarter, and our distribution partners are preparing to launch Control IQ in Germany and France. We've made great progress in the first half of the year and are well positioned both domestically and internationally for the remainder of 2021 and beyond. With that, I'll now turn the call back over to John.

Thanks, Brian. Great job to our commercial and operations teams and everyone at Tandem whose hard work and efforts made this quarter such a success. Alongside our commercial progress this quarter, I'm also very proud of the advancements we're making in our clinical programs. Our clinical research efforts are focused on improving time and range and quality of life for people living with diabetes while reducing hypoglycemic events, hospitalizations, and the cost of managed care systems. Data generated from some of the recent research using our control IQ technology were presented at both ATTD and the ADA conferences in June. The results continue to be fantastic no matter how you cut it by age, ethnicity, people with type 1 or type 2 diabetes. The next level analysis on our control IQ technology is important as it shows high customer satisfaction and no algorithmic biases. across a large and diverse population of people in real-world use over extended time periods. This research is also helping inform future clinical efforts as we prioritize new feature offerings and pursue expanded labeling indications. Two good examples of these efforts are kicking off now. First, in the next few months, we plan to begin our first clinical study to support expanding our control IQ labeling to include people living with type 2 diabetes. We expect this study will be then followed by a second larger pivotal study in 2022. The other exciting trial already in motion with our control IQ technology is an independent multi-site study being conducted by UVA, Stanford, and the University of Colorado. We intend to use this data from the study along with other data to support a future regulatory filing to reduce our age indication from age six to age two and above. we plan to work as quickly as possible to bring this life-changing technology to a younger population of people living with diabetes. We are excited to move forward with both of these studies in support of our longer-term regulatory strategy. More near-term, you'll recall that we submitted some new features and enhancements to our control IQ technology to the FDA at the end of last year. Although we responded to early clarifying questions, We recently received substantive feedback on this filing, which is a positive step in any review process, but even more so with the extended FDA review timelines due to COVID-19. Based on our most recent interactions with the FDA, we believe our best path forward is to collect and submit additional supportive clinical data, some of which could come from the studies I've just touched on. For this reason, clearance timing remains difficult to predict, and we expect our next pump software update will include only minor feature updates and improvements that do not require regulatory review or clearance. We are also preparing for the launch of our mobile bolus feature for the T-Cell Next 2, which is also currently pending FDA clearance. This highly sought-after feature is designed to allow both iOS and Android users to deliver insulin from an app on their smartphone. We are in the process of responding to the FDA's questions, and our goal remains clearance before the end of this year. Strategically, we see great value in securing clearance for our mobile bullets feature in advance of our T-SPORT filing, as a foundational iOS and Android apps are essentially the same. Our approach has been stepwise strategy, much like how we introduced BaselIQ technology leading to ControlIQ. Introducing a personal smartphone-based mobile bolus feature will enable our patients and providers to experience and therefore build confidence and trust with the system leading into T-SPORT. The sequential nature of these filings has rolled our anticipated T-SPORT submission into 2022, but we believe our learnings from the mobile bolus strengthened our overall regulatory submission for T-SPORT and ultimately reduced the total time for its review. We'll update our timing expectations for the T-Sort submission following our receipt of mobile bolus clearance. Our manufacturing team began initial T-Sort validation builds last month, which is an important step in the manufacturing process. The experience will be valuable in helping shorten the time between clearance and launch. As you can see, 2022 is shaping up to be an exciting year for Tandem's product pipeline. In addition, we are also working hard, collaborating with our CGM partners, Dexcom and Abbott, on the integration of their sensors. We are also continuing to advance our digital health projects and reached an exciting milestone in Q2 as we began limited testing on the initial version of Tandem Source, our second-generation data management platform in the United Kingdom. With international demand for our T-Cell Next Dupont rapidly increasing, It heightens our desire to offer tandem data management applications to our international customers like we do domestically with T-Connect. Data and customizable reports empower healthcare providers, caregivers, and the people living with diabetes with information to help them and their therapy management. TandemSource is our first global data management platform, and we plan to expand our testing of the new platform in additional countries later this year. In addition to these efforts, we are bringing increased focus to the development initiatives associated with our longer-term portfolio. Across the R&D pillars of hardware platform expansion, AID leadership, digital health, and ecosystem advancements, we are working to advance our strategy which supports our longer-term leadership position in insulin therapy management. I look forward to sharing more in the upcoming quarters about these efforts, which focus on bringing innovation to the different segments of the diabetes community. I'll now turn the call over to Lee to discuss more of our quarterly results and updated guidance for the year.

Thank you, John. Good afternoon, everyone. Our financial results for the second quarter were the strongest in our company's history as we made meaningful progress against each of our key financial objectives. This includes record sales of $172 million and significant improvement across our growth, operating, and adjusted EBITDA margins. We also shipped our highest number of pumps in a quarter, reaching nearly 34,000 shipments worldwide. To put our performance and growth into context, our pump shipments in Q2 were approximately the same as we shipped in all of 2018. This highlights the incredible progress we are making in expanding the market and taking market share at levels greater than years past. Worldwide sales were 313 million on a year-to-date basis, which is an increase of more than 50% over last year. As our installed base has grown to nearly 270,000 customers, we see ongoing cartridge and infusion set purchases becoming a more meaningful part of our business. In addition, we are seeing a growing number of customers become eligible for insurance reimbursement following the expiration of their typical four-year warranty period. And as a result, we have an increasing number of repeat customers. Approximately half of our sales this year can be attributed to these reoccurring revenue streams, which enhances the predictability of our business. Our domestic business once again delivered strong growth in the second quarter with sales of 128 million, an increase of 43% over the prior year. This was primarily driven by more than 20,000 pump shipments. While the majority of our pump shipments continue to be largely made up of customers who are new to Tandem, we once again experienced an increase in our customer renewal metrics. Out of the total number of customers whose warranties have expired to date, the cumulative percentage of renewing customers is once again up this quarter. We are on track to reach a cumulative renewal rate of approximately 60% by the end of 2021 compared to 55% at the end of last year. Overall pump shipments also benefited year-over-year from gaining full access to the UnitedHealthcare members, an opportunity that was not available to us until the third quarter of last year. Lastly, recurring supply sales to our installed base of more than 200,000 customers also contributed meaningfully to our year-over-year sales growth, increasing 44%. This brings our domestic sales on a year-to-date basis to $231 million, representing 37% growth over the prior year. Turning to our international results, we demonstrated another standout performance in the international markets. We achieved record sales of $45 million in our international markets for the second quarter, as well as record pump shipments more than tripling to 13,200. On a year-to-date basis, our international sales of $82 million were more than double the prior year, representing 26% of our worldwide sales versus only 19% in the first half of 2020. These results once again well exceeded our expectations in this highly unpredictable environment. The demand for T-cell MEX-2 continues to gain momentum as awareness grows outside the U.S., particularly with the scaling launch of Control IQ. The markets we serve outside the U.S. are about two and a half times the size of the domestic Type 1 market, with pump penetration averaging about half the U.S. rate. It's been challenging to predict the sales cadence internationally between scaling launches and COVID-19 restrictions, but the overall progress we've seen in the first half of 2021 further strengthens our confidence that the international markets will continue to be a longer-term growth driver for Tandem. Taking into consideration our strong performance both domestically and internationally in the second quarter, We are increasing our 2021 worldwide sales guidance to a range of $670 million to $685 million, which is a growth rate of 34% to 37%. This includes international sales in the range of $160 million to $165 million, nearly doubling our 2020 international results. We are confident that our technology will continue to expand the market and capture share even in this challenging environment. We continue to factor in some conservatism relating to COVID-19. As we've seen in the past few weeks, it remains highly unpredictable. Our guidance expectations also factor in the potential for competitive noise in the market. As we look to our anticipated cadence of sales for the rest of the year, summer seasonality is expected to be reflected in the third quarter, particularly in the international markets. They may also be more heightened in the U.S. this year as we are seeing more prescribers and customers taking the opportunity to vacation post-COVID lockdowns. Moving on to margins, gross margin meaningfully increased to 54% in the second quarter, up from 50% in the prior year and 52% in the first quarter. We drove this improvement through manufacturing cost reductions for both pump and cartridges from process efficiencies and increased production levels, particularly as we continue to transition higher volumes to our third-party cartridge manufacturer. We also continue to generate cost savings and our other non-manufacturing costs overall, which primarily consist of warranty, customer training, freight, royalty, and digital health support costs. From an average selling price, or ASP, perspective, our domestic ASP for pumps remains strong, while the rapid increase in our international business has brought our global pump ASP down compared to the prior year. This is countered by a higher ASP on supplies for our growing international install base, which brings positive contribution to our supplies gross margin. With a gross margin of 53% year-to-date, we remain on pace to achieve a gross margin of approximately 55% for the full year. For adjusted EBITDA and operating margins, our sales growth far outpaced our increase in operating expenses, despite our ongoing investments in R&D initiatives to support our near and long-term product pipeline, as well as our customer support infrastructure. Adjusted EBITDA, which also excludes non-cash stock-based comp, more than doubled to 14% in the second quarter from 6% in the prior year. We have now reached an adjusted EBITDA margin of 12% on a year-to-date basis. This leverage is largely attributable to the growth in our international business where our network of distributors are responsible for much of the operating expense investment. Operating margin took an even bigger step up to 3% in the second quarter compared to negative 11% in the prior year. as our non-cash stock-based comp declined in absolute dollars and as a percent of sales. With the increase in our sales expectations, we are also narrowing our 2021 adjusted EBITDA expectations to approximately 15% of sales. In each of the last three years, we have achieved a positive operating margin and net income in the fourth quarter due to the highly seasonal nature of our business. Notably, this is our first time reaching this milestone in a second quarter, and we expect this positive trend to continue for the remainder of the year. We ended the quarter with total cash and investments of $545 million, an increase of $32 million in the second quarter, primarily due to strong cash flow generated from operations, as well as proceeds from the employee stock plans. This brings us to a cumulative increase of $60 million for the year, even as we continue to fund key investment areas. including product development for hardware, software, and digital health initiatives, strategic investments, and manufacturing scale-up for T-SPORT. In summary, we have increased our 2021 worldwide sales expectations to a range of $670 million to $685 million, which includes international sales of $160 million to $165 million. Growth margin for the full year is expected to be approximately 55%, and our adjusted EBITDA expectations are approximately 15% of sales. Our non-cash charges for stock compensation, depreciation, and amortization are unchanged at an expectation of approximately $80 million, included as components of both cost of sales and operating expense. With that, I will turn it over to the operator for questions.

Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. We ask that you please commit yourself to one question. Please stand by while we compile the Q&A roster. Our first question comes from Stephen Lichtman with Oppenheimer & Company. Your line is open.

Thank you. Hi, guys, and congratulations. I just wanted to touch on international. It sounds like with the RAISE guidance, you're expecting the momentum to continue here in the back half. what are the key countries that we should be focused on as incremental opportunities for you guys as we look out, you know, over the next few quarters? And are you seeing similar attrition patterns for patients outside of the U.S. versus inside? I know it's relatively early outside of the U.S., but just wondering on that front. Thanks.

This is Brian. As we mentioned earlier, being in over 20 countries now, we're getting quite a panoramic view of what's going on internationally. And we're truly just now getting kicked off in many of these major markets. We launched Control IQ in Canada in March of 2021 here. We're getting ready to launch Control IQ in Germany and France. I think those are the ones to really look at just due to the size of the markets that we were competing in there. And Really, 2021, the rest of the year is about execution and getting those pumps out the door for us. Control IQ is just hitting its stride in some of the markets and will be new in some of the major markets for us. I think those are the ones to look at and pump adoption in those markets. There's plenty of opportunity to still be had there. Very balanced growth, very encouraged, and our partners are super happy with the product they're representing right now. And as far as attrition is concerned, both domestically and internationally, it's a very small number, probably early to say, but we really don't hear much of that right now. I think, again, control IQ has a strong factor in that.

Thank you. Our next question comes from Rebecca Wang with SVV Leary. Your line is open.

Hi, this is Rebecca. I'm from Danielle in Tafei. Congrats on a super strong corner. I guess my question is, Now with some of the competitive launches pushed out, we often see a pause in the market before new product launches. Are you seeing a similar dynamic today in the U.S. with upcoming launches in the U.S.? And then you're going to launch Key2IQ in some of the key international markets. Are you also seeing a pause internationally? It doesn't seem to be.

Yeah, as expected, we're beginning to hear more noise around anticipated competitive launches here domestically, but recognizing that they're not FDA approved yet, the specifics are fairly limited. For us, control IQ is here and now, and we continue to promote the benefits of what we have, and it's been going very well. As for pausing, I'm sure there's some element of that occurring, but at what level is hard to quantify. I would say both domestically and internationally, we remain very, very busy, and we haven't really seen too many signs of that so far.

Thank you. Our next question comes from Travis Deed with Barclays. Your line is open.

Hi. Thanks for the question. So I was looking at the U.S. guidance, and the back half of the U.S. is about 23% growth versus the first half. And you usually do, you know, twice that. So I just want to make sure I understand what you're assuming in the U.S. here. And then in longer term, if you look at the 270,000 patients going, the 500,000 patients, that's about a 20% KGIRC. So I was curious if you could put some color on how you think the U.S. could grow in relation to that 20% growth globally.

Sure. Thanks for the question, Travis. To the guidance for domestic in particular, as you're accustomed to, we take into consideration a number of factors, starting with the positives, which is the great momentum we've seen from Control-IQ, and we expect that to continue through the back half of the year for certain. And, of course, we always expect Q4 to be the largest quarter of the year based on how insurance deductibles reset and really, you know, pump purchasing season. But there are a couple of factors where we've taken some caution for the back half of the year. Particularly, I would say it's mostly pointed towards COVID. There's been so much change in the market just even in the last few weeks, not only the last few months, where we've seen some ups and downs, openings and closings. Even more recently, as Brian mentioned in his prepared remarks, We've seen a lot of people on a concentrated level taking more vacations, I would say, this summer in the U.S. than ever before. So we expect that to have some very near-term pressure as we go into Q3. But for the most part, we're just being cautious about the impact that COVID could have on the rest of the year altogether. And then, of course, we've put in some conservatism around the competitive launches that may occur this year.

Thank you. Our next question comes from Alex Nowak with Craig Hallam. Your line is open.

Greg, good afternoon, everyone. Can you expand on the discussion you're having with the FDA with mobile bolus? The product would be absolutely fantastic for diabetics. I'm curious, does the FDA want to see more data around usability? Are they still somewhat concerned about cybersecurity? Or really, where is their pushback? And what sort of data do you need to submit for that? And then how quickly after mobile bolus is approved can you then submit T-SPORTS?

Thanks, Alex. Good question. Yeah, I mean, we've been working with the FDA on this now for, you know, several quarters. And, you know, early on, we really focused on cybersecurity issues. And I'll say our team did a fantastic job there, and I think we've really gotten to a point where that's behind us. I'd say most of the stuff we're focused on now really is the user experience. An example would be training. In the past, we typically would send a manual with the product, and people would use the manual. With the mobile app, what the FDA has asked us to do is to incorporate the training into the app. And so it's stuff that's very straightforward. It's not complicated. We just have to go through the process to design it in and then test it. And we are responding to the FDA actively. We've been working to collect this data over the last couple of months. We're about ready to provide our latest response to them in the next couple of weeks. And we still feel confident about this being approved this year. And we would agree with you. We think this is a huge product, the ease of use, the convenience, and the discretion that comes along with it. It's going to be really important to the entire diabetes community. So thanks for the question.

Thank you. Our next question comes from Robbie Mizra with Barenburg Capital Markets. Your line is open.

Hi, good evening. Thank you for taking the questions. So I was just kind of perusing through your queue as the call was going. And I wanted to kind of ask about supply chain lead times and your kind of outlook towards the end of 2025. Just curious, you know, you're expecting, give or take, about 25,000 patients a quarter as you kind of get to that kind of year-end half a million target by 2024. But you've been outperforming that number pretty substantially, at least this quarter and kind of on average. for the last couple of quarters. So just curious, you know, should we think about the, you know, seasonality aside, the cadence of your kind of production cycle? Like, what kind of outperformance would you guys need to have on kind of the new patient cycles before you'd run into some constraints on the supply issues around some of the semiconductors or copper? And can you help us kind of think about how that would kind of flow through margins? Thanks. Sorry if it's a kind of really wonky question, but I think given... All that's going on here, I'm just very curious to hear your take.

I think it's a good question, and I think that it's something that we provide a great deal of attention to. We have a great team in our manufacturing and supply chain organizations, and trust me, they are all over this. We're working to get supplies in place many quarters out. But when you talk about just the process that we follow on an ongoing basis, you know, we have teams that meet monthly. They talk about the sales demand, the potential upsides, and those sorts of things. And when you look at the cycle to actually bring in additional capacity for the automated assembly equipment, it's a year out in time. And so we're planning well ahead of the demand, and we're also planning to see the continued upside that we've been experiencing here when it comes to purchasing these components. and the automated systems. When it comes to the manufacturing of the pump itself, it's really a matter of just managing our suppliers carefully and just making sure that we have visibility out in time. Like I said, our operations teams are doing a great job there, and I feel that it's something that we're very attuned to. It's important, but we feel confident that the organization has it under control.

And the sales team is doing a good job, too.

We want the sales team to pressure us so that we have to continue to really be reactive. But, again, we have a great team and they're doing a great job, and I think that we are looking out that far in time as well. Good question.

Thank you. Our next question comes from Matthew Blackman with Stiefel. Your line is open.

Good afternoon, everyone. Thanks for taking my question. Lee, I just wanted to hone in a little bit more on your comments about the second half cadence, and the third quarter in particular. I think historically the third quarter is somewhere like 25%, 26% of annual sales, but it sounds like from your comments that it could be lower than that, perhaps in what's called the lower 20% range. Is that the right way to think about it? Am I capturing your commentary correctly? Any help there would be appreciated. Thanks.

Yeah, great question, Matt. And I'll talk about domestic a little bit, separate from international, and then I'll pull it all together with some worldwide commentary. But the way to think about it this year is we usually see some level of vacation pressure in the summer months in the U.S., but it's usually more diffused across the entire summer. In this case, what we're seeing is a more concentrated pattern of vacations that are happening right now. And so what we anticipate from Q2 to Q3 is domestically is that there will be an increase still just like we've seen, you know, we're accustomed to as we grow seasonally across the year, but it might not be at the same level that we've seen in the past as we work through this. But we're very confident that when schools open back up and people get back to their normal schedules, things will be on track again and Q4 will be a very robust quarter. If you contrast that to the OUS markets, it's very common to see this depression in the third quarter when it comes to the European summer holiday season. So we're fully expecting there to be a decline from Q2 to Q3 in the OUS markets, like you see in many businesses across the world. And again, then a rebound into the fourth quarter. So when you tie all that together and you think about it on a worldwide basis, from Q2 to Q3, we're expecting it really this year to be in line to slightly up from Q3 compared to Q2, and then a very robust fourth quarter to tie out the year.

Thank you. Our next question comes from Brooks O'Neill with Lake Street Capital. Your line is open.

Good afternoon, guys, and congratulations on just a terrific performance here. I'm curious, obviously, there's two sides to the coin in terms of constraints to your future growth. First, those things that are outside your control, and second, those things that are are generally perceived as or you think of as within your control. So as you think about the things within your control and you think about, let's call it intermediate term growth, what are the big things that you worry about and that you're working hard on to overcome so that you can continue to deliver the kind of performance we're seeing now?

Good question. Thanks, Brooks. I would say that the thing that we're very focused on now as an organization is hiring. And I think that across the board, as we grow as quickly as we do, We need to bring on engineering talent. We need to staff our manufacturing teams. And we also need to look at the leadership of the company. So I think that we're looking at this carefully. We're working with all the teams. Our HR organization is doing a great job. But so hiring is something that we really have a great deal of focus on. The other thing is the technology systems that we use to actually manage the company and interact with our customers. We really want to leverage the technology to make our organization a lot more lean and efficient. And so I think that's another thing that we've got a great deal of focus on. We're making really good progress there. But, you know, we're looking at using technology to eliminate, you know, voice-centric communication, which will reduce the need for people in our call center operations. Not reduce it, but it will just reduce the growth of these areas and really leverage the, you know, the financial benefits of that going forward. So I'd say it's really the people, and then it's also the technology to scale the business. Good question.

Thank you. Our next question comes from Matt Taylor with UBS. Your line is open.

Thank you for taking the question. So I just wanted to ask you a general question philosophically about competitive launches. When you're thinking about forecasting some conservatism into them, how much do you think about that in general? And on the timing of it, when do you see that pressure is likely coming? Is it slightly before the launch, the initial launch, a few months after. Just help me think about some of that specific dynamic that we could see over the next six to 12 months.

Sure. Thanks, Matt. I'll talk about it really from the perspective of how we think about it when we're building our guidance and looking forward. And so back to when we started the year, there was the anticipation that there was going to be a lot of competitive noise happening in the market all at one time here in the back half of the year. But Based on the way things have been moving through the FDA and what we've been seeing, at least, and what we've been hearing, we don't anticipate there's going to be that big bullet of noise, I guess I would say, happening all at one time, and that it will probably be dispersed and spread out, you know, across this year, maybe into next year a little bit. And so the concentration of it was the biggest concern when we were thinking about how we put caution into our guidance this year. Now as we're looking at the back half, it's less about the competitive noise that we think we'll face, and it's more about the COVID environment. And so not to switch gears, but that's really where we put more of our caution as we've thought about the guidance for the rest of this year.

Thank you. Our next question comes from Jeff Johnson with Baird. Your line is now open.

Thank you. Good evening, guys, or good afternoon. John, I just wanted to understand on some of the timing you talked about on kind of the next software updates being minor, did you draw a line in the sand when they could come and so we could think about, you know, the bigger updates beyond that, kind of what that timing is? could potentially look like, number one. And more importantly, you know, we've seen some of those studies you've talked about, even, you know, UVA has released some of the Rocket AP data and some other mealtime. What is the challenge in taking some of that stuff and just kind of iteratively getting it into the software and getting the FDA to kind of approve piecemeal kind of, you know, an improvement here, an improvement there? Why does it have to be kind of a bigger package that all comes in a bigger – you know, a longer timeline and a bigger package that goes out to users. Thanks.

Yeah, sure. Well, I mean, I think that you're referring to the fact that we had planned, we're working with the FDA right now on a version of the first iteration to control IQ, if you will. And there were a couple of features in there that really expand the population who can use it, people who have different weight requirements and also people who have different insulin use requirements. And we had done simulations and we had used real-world data to justify these changes. And in our interactions with the FDA, we found out that we're going to have to do some clinical studies to make those happen. So there's a lot of other changes that we have in there. things that are, I think, under the hood, if you will, you know, just maybe nuisance fixes and things like that that aren't really, they don't really rise to the occasion. We're going to be making those here in the near future, and we'll have to go back, as I said, and do additional clinical studies for this initial control IQ version I mentioned. We will benefit from the type 2 study that we're doing, and we'll benefit from this this PDAP study that we're doing as well. So, you know, I think that over time we intend to have a cadence of improvements to control IQ. Dr. Pinsker has really, he's jumped on this. He's brought a great deal of focus on our strategy. And he and the team are really working on clinical studies and a clinical study strategy to bring a cadence of improvements to control IQ over time. And so that's something that we're working on right now. I would also say that relative to the clinical studies, we work with a lot of different KOLs and institutions to support clinical studies. We have a number of studies that we're funding, all of those, and then we also have studies where we're just basically providing supplies. In each of these cases, we have agreements in place and we also have access to the data. So these studies really help us and inform us as to how control IQ performs in different settings. On the specific question about how come it takes so long, I mean, right now, in order to make changes, we have to confirm the changes in our design process, and then we have to go through some smaller clinical studies to make sure that these perform the way we do. And once we're comfortable with that, we have to do pivotal studies And this is just a requirement from the FDA. It's a process they follow. They need to make sure that they have high confidence in the safety of these changes, and that's just the process we have to follow. And it's not just tandem. It's everybody who is working in this diabetes industry that has to follow the same thing. I hope that answers your question.

Thank you. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is open. Thank you.

Hey, good afternoon. This is Jason on for Matt. Thanks for taking our questions and congrats on the results here. I wanted to follow up on an earlier question just on the international side and just really specifically asking about how you might be factoring in contributions of rolling out control IQ in Germany and France specifically here. You know, maybe how does the Canadian launch of control IQ influence your view of the penetration trajectory as you look at those two new markets? Thanks.

I mean, we're getting the same positive feedback from our Canadian launch that we certainly, you know, received here in the U.S., and it's a life changer to those patients who are, you know, coming on, and those patients are just now coming back in for their quarterly visits, and that's always a great advertisement with endocrinologists and the diabetes education center that they're working with. You know, as far as Germany and France are concerned, we are, you know, near term here on launching in Germany. We will look there already with Basel IQ, so the excitement to get pumps updated to Control IQ and launch and sell Control IQ pumps is very, very positive. And same thing in France, working for all the reimbursement issues and the things that we have to do to launch, but all that is on track. Our partner is extremely excited. G6 is available now in France, so that really sets our pump up there for success as well in fourth quarter and going into next year. Again, those three markets are the large ones, and then the Benelux countries as well, all new to control IQ, all new to the momentum we carry in the end of the year and in the next year. So, again, I hope that answers your question, but it looks really good for those, and they've been strong without it. So we really look forward to seeing it on the other side. Lee, maybe some commentary on your end?

I think you covered it well. I think one key point is what Brian just said is we've been operating remarkably well even without control IQ in those markets and competing effectively. And so we're very excited to get them there. I think it's really going to be more of a 2022 momentum driver than this year, but it's great all around.

Thank you. Our next question comes from Jason Bedford with Raymond James. Your line is open.

Hi, guys. Congrats on that great quarter. This is Pavan now for Jason. I have a few questions on whether if you can elaborate on the timing of the Type 2 study. When do you guys expect readout? And also, you guys have mentioned the 500,000 customer goal by year in 2024. Is any Type 2 users contemplated into that number, or is that mostly just Type 1 at U.S. and international?

Thank you very much. Sure, good question. I'll just start with the second half of the question first. The 500,000 contemplates all Type 1, so Type 2 is an opportunity to actually grow on top of that. And I'll say that the, you know, we had talked in the past on these calls about data that we had collected. It was real-world data we had collected on the Type 2 community who are using Control IQ, and we had hoped to use that data to get the indication for a Type 2 product. In conversations that we've had with the FDA, We have learned now that we need to do, we need to get additional clinical data. And as I mentioned just a moment ago, we're going to have to do a smaller study. It's going to start here in the next month or so. It'll probably take us through, you know, later in this year to complete. And we'll learn from that information and help us design a pivotal study. And the pivotal study will be run in 2022. So we're moving aggressively. Again, as I mentioned, Jordan Pinsker is bringing a lot of focus to our clinical organization and our clinical plans. And, you know, he's going to be driving this through tandem for the next several years, and we're looking forward to it. Thank you.

Thank you. Our next question comes from Larry Beagleson with Wells Fargo. Your line is open.

Hi, this is Leigh calling in for Larry, and thanks for taking my question. You've talked in past about the renewal opportunity, which increases a lot next year and even more so in 2023. Can you talk a bit about how do you get your fair share of that? And along with that, most of the renewals in 2023 will be control IQ patients. Just remind us, what's the incentive for a control IQ patient to renew? Thanks.

Sure. So from a renewals perspective, first of all, we're very focused on the customer experience because we think that's what's most important to retain the customers throughout their warranty cycle and want to keep them with us for the next pump purchase. And then from an R&D perspective, we're very focused on continuing to offer advancements in our technologies, even with Control IQ itself, that will compel them to want to move forward with pump purchases outside of their warranty cycle, since software updates are only available while they're in warranty. So those are our major areas of focus, and we're ramping our internal resources. We're improving our processes. We're working very hard to get prepared for the fact that next year is going to be a major step up in terms of the opportunities that come to the market, and and it will be one of our most significant growth drivers as we look out in the longer term.

Thank you. And I'm currently showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.