Tandem Diabetes Care, Inc. (TNDM) Earnings Call Transcript & Summary

February 24, 2022

NASDAQ US Health Care Health Care Equipment and Supplies conference_presentation 34 min

Earnings Call Speaker Segments

Joanne Wuensch

analyst
#1

Good morning, everybody. I actually just had to check the time to make sure it's still morning with everything going on. But I am Joanne Wuensch, the med tech analyst at Citi, if people don't hear me, but I'm very pleased to be kicking off this session with the management team of Tandem, including John Sheridan; Leigh Vosseller; and Susan Morrison. So everybody, thank you, and welcome.

John Sheridan

executive
#2

Good to see you, Joanne.

Joanne Wuensch

analyst
#3

I have a lot of questions about COVID and the insulin market or the insulin pump market, but I do want to start a little bit to think about your guidance. And how you put it all together, given all the many headwinds that you have, which is moving on. So I think that's a great place to lead with that.

Leigh Vosseller

executive
#4

Great. I'll start with that. And I would also like to start by saying there are many tailwinds -- John, do you mind muting -- and not focus on the headwinds first, but -- so right now, I would say, Control-IQ is still our biggest tailwind. It hasn't reached its full market potential. We continue to see growth from it in the U.S. We're hearing great reports on it. It's continuing to drive people from multiple daily injections. More people from competitor conversions, and it's also helping to drive our own renewal initiative. And more exciting outside the U.S., it has not even been there for very long. We started launching it in the back half of 2020, but on a scaling basis. And it only recently was introduced in our 2 largest markets, Germany and France. And so we look forward to 2022 to start to see the momentum grow from Control-IQ there. So when you put all that together and all the great drivers that are still in place today that have been in place for years, we're looking to see some really healthy growth in 2022. But to your point of the caution, and it is our nature to be cautious, particularly in environments where it's pretty unpredictable. And it's been that way for a couple of years now with COVID and all the challenges it has thrown our way. And I think the most challenging aspect of it is it's been a roller coaster, and it varies in every market that we're in. It never happens all at the same time. So you have one market opening, one closing, you've got supply chain challenges with our international distributors trying to figure out how and when to order, how much to order, also adapting in a very high-growth environment. So we put a level of conservatism in our guidance for 2022, and for the whole year, we're not going to try to predict when it's going to end. We just look forward to that timing when it comes.

Joanne Wuensch

analyst
#5

So one of the things you just brought up, which I want to make sure that we spend some time on is the renewal initiatives. And how you think about that contribution to 2022 revenue? And then even in the next couple of years because you've got a number of products which are rolling off.

Leigh Vosseller

executive
#6

Exactly. And I really like to start back and talk about the history for a minute first. 2016 was the first year where we had people with warranties expiring on a very small basis. But what was good was it gave us the time to figure out how to really go through the renewal process and how to be more effective and efficient with it. So if you look back at that time, we said we want to renew at least 70% of our patients. And interestingly, one of the biggest [indiscernible] was the amount of time between when someone's warranty expires and when they purchase that next pump. So that 2016 cohort, we got to 70%, we've surpassed it, but it wasn't until last year that, that happened. And as we look forward to now in 2021, at least, we've already renewed almost 50% of those warranties that have expired. And so we're well on our way to that 70% mark in a very short period of time, and as well as considering the fact that many of those warranties didn't expire until the fourth quarter. So you can see our progress we're getting more renewals every quarter. We're also getting them faster in the cycle, which bodes well for how we look forward. So when we look forward, what's really interesting or exciting is we're at the inflection point of our business 4 years ago. So our number of new renewal opportunities is stepping up. In 2021, it was around 15,000. We're going to see about 30,000 new opportunities in 2022. And so we expect that we will continue to have those same kinds of metrics that we've been seeing in terms of that renewing people faster. But because our growth is still so big on the new pump side, it still will be a small percentage of the business next year. For instance, in 2021, renewals were less than 20% of our shipments. But the point is that with that scaling opportunity growth, we're going to see large renewal growth in 2022 and going forward.

Joanne Wuensch

analyst
#7

So if in '21, 20% of total revenue came from renewals, can we put a similar statistic on 2022?

Leigh Vosseller

executive
#8

Yes. And I would say, let's call it pump shipments, so just under 20%. And I would say, in 2022, probably going to be something similar. And again, because there's still such a great growth on the new side. So it's really hard sometimes to measure the progress when you talk about renewals because we've been adapting, evolving, we've been investing in that team. But new growth is so high that you put them side by side, it's hard to really see. But the progress has been tremendous, and we look forward to that being a bigger part of our business in the long term.

Joanne Wuensch

analyst
#9

I'm sure when you said 70% 5 years ago, that seemed like, okay, that's a reasonable number. But the market has changed. And -- is it 70% still a reasonable number? Or are you going to be looking back in a couple of years from now saying, wow, we got it all or most of it or more than we thought.

Leigh Vosseller

executive
#10

I hope so. I hope we get it all. It was a different time. There were more people in the market, it was a little bit more crowded, and that was somewhat of the industry standard. At least that's what we've heard people were able to retain within their own business. Fortunately, we're the market leader right now. So I think we have great opportunities to exceed that. And I'll say that if you separate retention from renewal, our retention rates are very high, it's really moving people forward with that renewal purchase. And so as we look forward, though, and we think about the longer term, we do expect there to be more competition in the market. So we're thoughtful about 70% is still probably the right goal for us and our stretch goal will be to overachieve that.

Joanne Wuensch

analyst
#11

Okay. I like stretch goals. Let's spend some time talking about the market. In our market model, you came in the last couple of years and just over the last 5 years, just under 5% of the market to about -- or a little bit over 20% of the U.S. market, and you just called yourself the market leader. And I'm curious how you think about that pathway. I mean, how do you -- what do you think happens? Take your crystal ball out. How do you think this evolves? You've got new competition coming in or fresh competition, you have others who have obstacles in their regulatory pathways. How do you think about this?

John Sheridan

executive
#12

Well, today, we have about 240,000 people using our pumps in the U.S. market. And there's roughly 750,000 pumpers. So we would say that we have about 30% of the market today. And right now, I think when you look at the penetration, our pump starts come from MDI conversions and from competitive conversions and from renewals that Leigh just spoke about. And right now, it's about 50% MDI conversions and about 50% competitive conversions. So I think that as we continue to innovate and drive new technology to the marketplace, we think that we're going to continue to see growth in the competitive conversions. And the market itself has grown very rapidly over the last couple of years, largely driven by innovation. So today, we see -- we think it's about a market -- about 35% or 36% of the people who have -- that are pumping were formally from MDI. So the MDI conversion rate is about 35% today. We believe that can get up to 60% to 65% by continuing to focus on innovation, reducing the burden of diabetes. We think ease-of-use drives adoption. And so that's really where our technology and our pipeline is focused. It's focused on different segments in the market and just working to reduce the burden of diabetes in people's lives. And by doing that, you just reduced a hurdle that people have to overcome to put a pump on their body and benefit from the technology of the therapy.

Joanne Wuensch

analyst
#13

Okay. But you just described mostly the type 1 experience.

John Sheridan

executive
#14

Type 1. That's right.

Joanne Wuensch

analyst
#15

Let's take a minute and talk about type 2. And where you -- I mean, I know that you're working on a study just specifically to get Control-IQ indicated for type 2s. Walk us through not only how you think about the type 2 market, but how do you think about that study? What are the steps and using or leveraging it for your role in the type 2 market?

John Sheridan

executive
#16

Yes. The type 2 market is more complicated than Type 1. Today, there are approximately 2 million insulin-intensive people with type 2 and about 100,000 of them use a pump. So it's about 5% penetrated. Right now, as you said, we see -- we have about 20,000 people at Tandem that are currently Type 2 using our technology, and we see great results from them. So we think it's definitely a market to invest in. It's more complicated, it's probably going to require different simplifications of the technology itself to get people -- more people to use it who have Type 2. And as a result of that, we are focused on investing in our current technology. We have Control-IQ that is currently approved only for type 1. We're working to get the indication for type 2. That requires us to do a study, a number of studies. The first one, we're actually enrolling in the feasibility study today. It's a large and complicated feasibility study. We expect that we'll probably finish that sometime in the mid next year, we'll work with the FDA, and we would anticipate initiating a pivotal study in the latter part of '22 or early '23. That will probably take us the entire year. So we would expect that in 2024, we would get an indication for type 2. Now we have t:sport, our Mobi product, also it will be coming to market here shortly. And we think that when you have Control-IQ on Mobi, that becomes a very appealing product for the type 2 community. It's small, it's discreet, it has full mobile control. So there's a lot of factors that we think will be appealing to type 2. And so that's -- that will be our first foray. Let's get approval for Control-IQ, let's get Control-IQ onto Mobi and then let's market it to type 2 while we're looking at further pipeline initiatives to really appeal more to the type 2 in the longer term.

Joanne Wuensch

analyst
#17

But just to clarify, the 2024 indication for type 2s, is that Control-IQ with Mobi? Or is that a different label for a different product?

John Sheridan

executive
#18

It's only has -- it's only for Control-IQ. Control-IQ is what we have to -- that's what we have to get approved for type 2. Right now, Control-IQ is only approved for type 1. We can use the Mobi pump and the t:slim pump in the type 2 community. We just can't -- we can't market because it's not approved with Control-IQ. And because of interoperability, when we get the when we get Control-IQ approved for Type 2, we can use it on our ACE pumps.

Joanne Wuensch

analyst
#19

Okay. The approval that you received, I think it was just 2 weeks ago for Mobi. Sorry, that one was -- yes, which leads to Mobi.

John Sheridan

executive
#20

We would like to have Mobi's approval right now.

Joanne Wuensch

analyst
#21

Okay. So it's a lot of Mobi, Mobile. And if you could just walk us through the technology a little bit and how one approval leads to the other and why that's important?

John Sheridan

executive
#22

Right. So we intentionally developed a strategy to get approval from Mobile Bolus first prior to Mobi. And we did that because we think that's the most important and critical aspect of the interaction between a mobile device, and the pump is bolus in for meals. And so that's essentially what a Mobile Bolus allows us to do. It's an addition to our current mobile app that allows the user to bolus from their phone and/or stop bolusing, but they can control the bolus function out from their phone. We think this is very important because if you look at our current type -- our current Control-IQ users -- the only reason they need to take the pump out of their pocket when they're interacting or going out in their daily life is to bolus for meals. Otherwise, the system is just operating in the background and basically controlling your blood sugar levels. So this is the #1 requested feature. And we think that by providing a mobile app that has the ability to bolus on it, it's a huge convenience improvement and it's also a huge discretion improvement. So we think that this is -- as Leigh were just talking about, renewals with Leigh, we think that by providing technologies to our in-warranty customers like Mobile Bolus, we get a great deal of interest, and it does tip the scale when it comes to renewal improvements. And as you mentioned, most of the technology that we're using in mobile bolus is also going to be used in Mobi. So all of the lessons that we've learned from Mobi now can be applied to the Mobi device, and therefore, we feel a lot more confident about the filing when we actually make it in the summer of this year.

Joanne Wuensch

analyst
#23

And is that still on track for the second half of this year approval?

John Sheridan

executive
#24

Yes. We are in the state right now, we're in this testing phase, I would say, where we're doing extensive human factors testing to prepare the data to submit. We're also doing verification validation testing inside the facilities. And we expect that to be complete here in the next couple of months, and we're planning on a summer submission.

Joanne Wuensch

analyst
#25

And I'm sorry, just to repeat the question, second half 2022 on track.

John Sheridan

executive
#26

Yes.

Joanne Wuensch

analyst
#27

Thank you. Needed to get that, yes.

John Sheridan

executive
#28

Yes, absolutely.

Joanne Wuensch

analyst
#29

At the Analyst Day, you unveiled a variety of new products. And I think it was a welcome -- I don't want to use the word surprise, but I do think it was a little bit of a surprise for investors to see that pipeline. Could you walk us through a little bit which products you think are the most important? And what are the steps that we should be looking for? What are the milestones?

John Sheridan

executive
#30

Yes. Well, we've done a great deal of market research in the diabetes community. And it's a very segmented market. And there's just no one-size-fits-all product that will satisfy the needs of the community. So we think a portfolio approach is very important. And that's why we have t:slim X2 in the market today. We're going to bring Mobi to market, and we believe that having both of those products provides, again, more opportunity, different choices for people that have different needs and different preferences. And so we intend to continue along that pathway. So as we just discussed, we intend to submit Mobi to the FDA this summer, and we would expect to get an approval here in the near future, hopefully before the end of the year or early 2023. And then we've got 3 additional products that we introduced at our R&D Day. The first is t:slim X3. I mean t:slim X2 is a great device but it was developed 9 or 10 years ago and technology has greatly changed since then. So we think that it's very important to have that device on the market. And t:slim X3 will be our next product after Mobi. And that device will be a technology upgrade on the t:slim pump. So we'll bring it to current levels of technologies, microprocessors, this connectivity, wireless charging, those sorts of things that people have come to expect from their current consumer devices. We will have those now in t:slim X3. And what I hope that the R&D Day, we defined a time line of about -- from today, through 2027, we -- these are the products that we're going to be introducing. So of course, Mobi NOW. The next device will be t:slim X3 -- followed by a tubeless version of Mobi. And then the final product will be a patch. Now the tubeless version of Mobi is actually it's a wearable injection site where you attach that to your body, and you can actually insert the Mobi pump into it in a tubeless manner. So it gives people a choice of using a tubed or tubeless injector site for the Mobi pump. We think that will be very appealing, it addresses issues where, again, there's points of time in people's lives where they want to have tubeless or tubes and pumps. And this gives people the option to do that with one system that's durable, and will last for 4 years. And then finally, we're working on a patch and have been for a while. It's going to be a miniaturized patch that will likely use concentrated insulins. And that's going to be, again, another device that this builds out the portfolio of Tandem's products, which we think will be very appealing, not only to the type 1 community but the type 2 community. And it also gives us the opportunity to look at different business models as opposed to just DME. I think the pharmacy is something that we could actually consider at that point when we're looking at these other devices.

Joanne Wuensch

analyst
#31

Okay. Very helpful. Right now, the Control-IQ is attached, partnered with Dexcom's G6. There are 2 other CGMs in the process G7 and a Libre. And so walk us through how do we think about integrating these products? Or how do you think about integrating the products.

John Sheridan

executive
#32

Well, one of the great things that's happened over the last couple of years is the FDA has really sponsored this concept of [indiscernible]. And so if you can develop a pump, a sensor or an algorithm, that meet certain requirements, you can use them in an interoperable manner with other systems with a minimized regulatory burden. And so what that means is if we have an ACE pump, we can use an ACE pump with an interoperable sensor, and we can integrate the 2 of them without any regulatory work. So we have to do the engineering work, we have to test it. We have to say it. We have to make sure that it's all been done properly, but it doesn't require a regulatory filing, which can take a while, and there's a lot of work that goes into making the filing. So there's a simplification in the process. So currently, the G6 is an interoperable, it's an ICTM and we're using it on the t:slim pump, which is a base pump. And so that we're able to integrate that. Again, we integrated that back in the 2018 time frame without any regulatory filings. And so DexCom is working on G7. It will be an iCGM. And Abbott is also working to get the iCGM designation. And so once they both have that, we could integrate that onto the t:slim X2, onto Mobi, and future products as long as they are ACE pumps -- that's the intent. And so we're working right now with Abbott and Dexcom, they both have great products. And our intent is to integrate those devices and have them here certainly after their approval, the regulatory approval is completed.

Joanne Wuensch

analyst
#33

Okay. So it sounds once the approval is had, when you say shortly, 3 to 6 months.

John Sheridan

executive
#34

I would say, a quarter or 2 at the latest.

Joanne Wuensch

analyst
#35

And is there a regulatory filing you have to do? Or is it -- you've got an ACE pump, they've got an iCGM label?

John Sheridan

executive
#36

That's right. As long as they got the ICGM label, then we can integrate it without any regulatory filing. It's a letter to file. And again, we have to do all the internal engineering work to assure that it's been done properly and tested properly, but it doesn't require a regulatory filing, which is -- it's a great simplification of the process. It reduces the burden on the FDA, of course, because there's going to be so many people or so many of the companies integrating these devices. And we're going to be integrating more and more sensors as well in time.

Joanne Wuensch

analyst
#37

You got it. Excellent. I want to spend a little bit of time on profitability. And so Leigh, let's get started talking about gross margins in the fourth quarter and your full year gross margin guide.

Leigh Vosseller

executive
#38

Sure. So when we look at our gross margins, we've guided -- I'll start the guidance part of it. We finished this year 54% for the full year and 54% in the fourth quarter, and we've guided to 54% in 2022. And so first, when you take year-over-year from 2020, we did step up our gross margin by 2 points. And a lot of that came from the fact that we continue to focus on cost-saving initiatives within our existing products, as well as just getting leverage from higher volumes as we go forward. And that's part of our long-term gross margin story is that we should see incremental improvements each year as we see a growth from leverage from growth as well as those same cost saving initiatives in place. In fact, in our production costs, we cut out about 10% year-over-year. What you typically see in a fourth quarter for us because of the way pump sales across the U.S. seasonally as it is the highest gross margin in the year. But indeed, this time, it was flat to Q3, and that's because we started to see some of the effects of inflation and supply chain challenges that everyone is facing around the world. So not new to us -- I mean, sorry, new to us, but not new to everyone else, I should say, everyone is going through the same thing. So as we thought about 2022, we expect that those will continue into next year. And we're not, at this point, putting a time stamp on it and saying, we think this will only be for the first half. We went ahead and put into our guidance for the full year, and we'll continue to see how things play out. We still expect to have cost saving initiatives to help offset or mitigate some of those costs or we might not see the gross margin expansion in 2022 that people may have expected.

Joanne Wuensch

analyst
#39

So does that -- does your LRP remain? I mean your LRP, you mentioned 65% by 2027, and now we're talking 54%. What is the path over the next 5 years to get from 54% to 67%?

Leigh Vosseller

executive
#40

Sure. And first of all, we still have full confidence that we'll reach that number in 2027. And really, it comes from 3 factors. So we'll continue to have these cost savings. And we really see these supply chain challenges as temporary. So it's really only a near-term hiccup for us. But one of the big step changes we'll see over time will be when we launch new products. So if you think about Mobi coming, as John mentioned, that cost is expected to be about 20% less than t:slim. So once we launch it and it gets to a level of scale, you'll see a step change in our gross margin with that product being integrated. And each new product that we are developing, we're focused on cost savings with it as well. So for every new product, we'll see step changes as they become a bigger piece of our business. Then the third element of our gross margin opportunity really comes from reimbursement initiatives. And that's also something that I would expect to see more incrementally across the years, much like I talk about the cost-saving initiatives. It's really working directly with the payers. It's shifting from distributor to direct contracts -- it's utilizing the direct contracts on a higher level. And it's also getting cost -- price increases from sharing our clinical data with the payers. We're starting to have really great experience as we take that information in and we show them pre and post Control-IQ outcomes with their own population. And so we're confident we'll be able to get price increases in the future.

Joanne Wuensch

analyst
#41

Okay. Similarly, for your other metrics for SG&A and for your operating margin metrics, what has to go right? And how much conservatism did you dial in when you set that?

Leigh Vosseller

executive
#42

Yes. So one of the major things is the gross margin expansion. So if we move that up 10, 11 points, we're going to see -- we expect to see that drop down to the bottom line. Where we are going to continue to invest, and I don't really expect to see leverage, honestly it is in the R&D area. We're continuing to focus on investing in those teams. We're expanding in our reach in terms of clinical trials. There's a lot more data that's being required by the FDA than ever before. So we expect to see continued spend in that area over time. SG&A is the real leverage opportunity. So when you look at our Q4, we started to increase our sales force for our 2022 expansion. So we start to see a bit of a step up in SG&A at that point as long as the customer support infrastructure. So we're prepared when those customers come and they can have the best customer experience from day 1, but it's very leverageable. And we're continuing to look at ways to leverage in our SG&A functions in the long term. And a lot of it is about how we touch the customer, how we reach the customer, but still making sure they get the best customer experience.

Joanne Wuensch

analyst
#43

And where is the majority of your manufacturing done right now?

Leigh Vosseller

executive
#44

So for the pump, it's still all done in San Diego. And for the cartridge, a large piece of it has been outsourced to a third party in Mexico.

Joanne Wuensch

analyst
#45

And do you have currently enough manufacturing facility as the company ramps and grows towards your goals?

Leigh Vosseller

executive
#46

Absolutely. That was part of the decision-making process behind moving some of the cartridge manufacturing or outsourcing it. It gives us the ability to flex and expand more rapidly, and then allows us to use our facility in San Diego for the newer products. So we can keep them closer to home near our R&D departments.

Joanne Wuensch

analyst
#47

And so as the company goes global, does that change your view of what kind of footprint that you need?

Leigh Vosseller

executive
#48

We'll continue to evaluate what we need. I would say it doesn't necessarily drive where our manufacturing may exist, but we will continue to think about what our footprint looks like outside the U.S. to better support our distributors and our customer relationships there.

Joanne Wuensch

analyst
#49

And similarly, it's -- again, I use the phrase going global, but you've got a -- you have a game plan here to, in some ways, be a much larger organization 5 years from now. So that's usually manufacturing, but it also with sales force infrastructure. I mean how do you think about ramping that to meet the needs?

Leigh Vosseller

executive
#50

Yes. So today, our relationships outside the U.S. are all distributor-based other than our Canada operation where it is direct. But with that one, we can leverage some of our U.S. infrastructure to help support that. Outside the U.S., we're very happy with our distributor partnerships, they bring a level of expertise to us that we don't have today. So in terms of the reimbursement environment, how you reach the customers, when you reach your customers, where you reach the customers. So those are very valuable to us. We'll continue to evaluate over time. Really, the big decision is, are we getting the market penetration we could get with our distributor relationships that as opposed to doing it ourselves. And so there are ways we can still collaborate and support our distributors and get some of those cost benefits of not having to build out that entire infrastructure. So in the near term, you won't hear us talking about changing -- switching to direct operations, it would be more of a long-term possibility.

Joanne Wuensch

analyst
#51

But I think also, I mean, to get to the type 2s, a lot of companies have talked about building a PCP sales force. Is that something do you think you might need?

Leigh Vosseller

executive
#52

That's -- as we think about type 2, we continue to evaluate what we think we'll need. And so that's part of the learnings in the next few years while we're getting the indication, where do we reach those patients? And what we've seen so far is that still the vast majority of people who are insulin-dependent are seeing an endocrinologist. So today, we call on all of the high prescribing insulin physicians, and that's probably still the right place, but it's part of the learnings that we expect to gain in the next year or 2.

Joanne Wuensch

analyst
#53

The CTM manufacturers have done a little bit more direct-to-consumer campaigning. I mean I know I'm up at night and I see it. Pumps, less so. Do you think that there is a place for that?

Leigh Vosseller

executive
#54

Well, I'd like to differentiate commercials on TV from direct-to-consumer because I think it's a piece of direct-to-consumer. And we do have DTC campaigns. You haven't seen a commercial for Tandem on TV, but there are places where people in the diabetes community, I would say, gather, if you will, online virtually. And so that's where our direct-to-consumer campaigns are focused. And we feel like it's more targeted and probably more effective for us. If you compare and contrast the CGM companies are looking at a much larger population, we're looking at type 1 and insulin-dependent type 2s. They're looking at type 2s well beyond insulin dependence. And so it's a different economic argument for where you have your DTC or where you invest in your DTC campaigns?

Joanne Wuensch

analyst
#55

So one of the things I'm trying to think about, again, as you look over the next couple of years, and this goes back to the question I sort of said at the beginning, where do you think your market share tops out? I mean how do you think about ramping towards that view of not just a market adoption of pump technology, but your share within that market?

Leigh Vosseller

executive
#56

Yes. I don't think we've put a number out there and where we think we top out. We -- I would say, we would expect to be a market leader. We have a strong innovation pipeline. And what's key to that pipeline is when you look at the community rather than thinking as a homogenous community, it's very segmented, and there are very different needs and preferences. And so what we're doing is we're focusing on products that will meet the needs of the different segments, which we think gives us the ability to continue to be a market leader. And so whatever that share percentage is, we haven't necessarily called out, but we think we'll still be one of the tops in the market even as other players come into the space.

John Sheridan

executive
#57

Joanne, the only thing I'd add to that is that in our R&D Day, we did update our long-term plans, and we've just spoken about our operating margin and gross margin. We've also indicated that we believe that we can touch 1 million people's lives with our technology, where our original goal was 0.5 million. So I think that allows you to draw some conclusions about where our market share might be in the next 5 years. But I think we prefer to look at how many people can we help with our technology as opposed to market share. And I think 1 million is a great number.

Joanne Wuensch

analyst
#58

Got it. Do you see entry into Asia in the 5-year LRP?

John Sheridan

executive
#59

I think we haven't really specified that. I think it's definitely an option for us. Right now, we're really focused on just trying to take advantage of the new larger markets that we're in, in Europe. And we are evaluating that possibility. It's -- a much longer regulatory pathway to get into them, and it's more complicated from a business model point of view. It is absolutely something that we're thinking about. I think -- but like in the short term, we're absolutely focused on the larger markets that we're in because they're really still very underpenetrated and we see great opportunity there. I mean if you look at the U.S. is about 1.8 million people with type 1 in the 20 or so markets that we're in, OUS is about 4 million. So there's a lot of opportunity to take advantage of that here in the short term, and that's really where our focus is immediately.

Joanne Wuensch

analyst
#60

Excellent. What else do you see happening in the diabetes landscape? So much has changed over the last couple of years. I don't think we could have ever -- when you and I were talking a couple of years ago, so we are here today. Looking forward, what should we be thinking about?

John Sheridan

executive
#61

I think that -- I think it's really been amazing over the last couple of years as you've seen innovation come to market. And as I mentioned, the penetration rates into MDI have really escalated. And I think that's because of this new technology. And I have to give my hats off to the FDA because they have -- I mean when you think of the FDA, sometimes you think of a large dodgy bureaucratic organization, that's kind of holding back progress. But I would say in working with the diabetes group at the FDA, they've been enabling technology and really encouraging us. I mean when you look at mobile technology, I would have thought a while ago, and in fact, I did maybe 4 or 5 years ago, I think that it's going to be hard to get this through the FDA. But in fact, they encouraged us to do it because they recognize that people would -- they don't want to carry around multiple components in their -- on their body and just getting rid of everything and having their cell phone control things is a real -- it's really something that's going to improve the overall experience. So -- but to your question, I think miniaturization is something that's going to continue to happen. I think we're going to see smaller devices. I think advances in mobile technology, communications and sensor technologies. We are looking at different analytes and possibly even different sensors. And I think that's -- I think, advances in the insulins also, faster insulins, potentially combinations with other hormones like Symlin and things like that, that basically improve the overall experience. And I think that -- I really do believe that data is going to be hugely important, and using data to deliver and develop algorithms that not only help the person that's using the pump and living with diabetes, but help the physicians manage people's diabetes more effectively by just providing the physician data and decision support tools and things like this to just improve the overall experience that they have as well. I mean, right now, when you think about it, they have 15 minutes every 3 months to interact with their patients, I think that by providing data and tools and insights, we can make that 15 minutes a lot more productive.

Joanne Wuensch

analyst
#62

Excellent. What do you think, if anything, investors are missing?

John Sheridan

executive
#63

I mean I think that we have a great story. I think we have had a great year, and we're excited about 2022. I think we have a lot of confidence in where we're going. I believe that there has been some concern about the competitive environment. I think that we believe that we have competitive responses to the new technology that's coming to market. We are currently the market leader in [indiscernible] technology, and we have a great deal of momentum behind us. I think it takes time to achieve that momentum. When you bring new technology to market, physicians have to evaluate it. They want to see it works. They want to see it works over periods of time. We were able to -- we were able to make that happen much faster by using the Tandem Device Updater in 2020 and in a relatively short period of time, we had 60,000 people using Control-IQ. So the physician community got to see how this thing worked very quickly and effectively. And so that has really driven the momentum behind us. So I think that as technology comes out, we plan to continue to innovate. We have Mobi. We have a great pipeline in front of us. We have -- we're developing data-driven tools and services to build an ecosystem around the products that we have that we think will really improve the overall experience for the whole ecosystem of people with diabetes, their loved ones and the physicians, and we think that's a winning strategy.

Joanne Wuensch

analyst
#64

Excellent. Well, John, Leigh and Susan, thank you so much for joining us in today's fireside chat. I know you have a full day ahead of you, and I hope you have a great day.

John Sheridan

executive
#65

Thanks, Joanne. Always great talking to you.

Leigh Vosseller

executive
#66

Thanks, Joanne.

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