Tandem Diabetes Care, Inc. (TNDM)
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Morgan Stanley 21st Annual Global Healthcare Conference

Sep 11, 2023

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Yeah, why don't we kick this off? So it's Patrick on the U.S. MedTech team. I get the exciting disclaimers for you guys. So, for the disclosures, please go to Morgan Stanley Research Disclosure's website at morganstanley.com/researchdisclosures. I'm sure you'll all be going there. If you have any questions, feel free to reach out to your sales rep. I'll stay there bye-bye. So massive thank you to Tandem. We've got John Sheridan, obviously, and Leigh Vosseller here, agreed to join us as CEO and CFO. An open fireside chat, you know, should be a lot of fun. So thank you for joining us.

John Sheridan
President & CEO, Tandem Diabetes Care

Absolutely. Nice to be here, Patrick.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Thank you. Maybe as an opener, just to sort of set the scene, what do you feel gives Tandem its competitive edge in the pump market overall? Like, how do you feel? Like, what's the DNA of the company that really gives the edge to Tandem?

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, I mean, I think that over the last several years, we've just demonstrated the ability to innovate faster than our competitors. And we've been producing products at a rate of roughly every 12-18 months, we've been introducing a new device, and that's just much faster than our competition. This year, in particular, we're going to introduce four new products in a single year, which is almost unprecedented. And so I think that certainly the organization's just focused on developing products that really do improve the lives of people living with diabetes. That's what they, t he entire organization is just driven to do that, whether it's providing service and support for the customers we have or just developing products that are innovative, that are going to reduce the burden of diabetes in their lives.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

That makes sense. Maybe to jump in on the product side, you've got quite a lot of integration with CGMs coming up, G7, Libre, that side of things. How should we think about the impact on your business from successfully closing that loop and connecting up, from a growth perspective?

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, we've been working with Dexcom for about 10 years, and we've integrated four generations of their technology onto the pump. And they're a great partner, and I think we have definitely drafted off their success. Today, Dexcom is the only company really that has CGM integration with AID systems. And I think that they provide just a fantastic product. Again, we draft off their product. And I think largely, you know, our success has been because of the sensor and the excellent performance of that. But at the same time, there's a new product on the market, and we want to provide choice.

And so I think that, you know, we've been working with Abbott now for a year or two as well, and we intend to bring the Abbott integration to market this coming quarter. We're excited about that. I think that, you know, Abbott is a, it's a large company. It has a large presence of people with Type 1 in the U.S. who use their sensors, who don't use pump therapy. So it's a, it's a big opportunity for us to look to, to grow our business with that integration.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

I mean, Abbott, big install base of CGMs, not had a lot of connectivity, frankly, on the pump side. And therefore, quite a lot of green space to go after. Is there any idea for you like, you know, where to start or how to how aggressive to get? Like, how does like a sort of consumer outreach work in this way to sort of build up the education side? Is that the PCPs, is it the endos, or is it more DTC? How do you build that network quickly?

John Sheridan
President & CEO, Tandem Diabetes Care

At first, we're going to go after people that are living with Type 1. I mean, we, we don't have the indication yet for Type 2. We're working on it, but it's, it's a year or so away. So we'll be working with Abbott, collaborating with Abbott. We'll be co-marketing. We'll, we'll basically help people who have Abbott sensors that don't use pump therapy understand the benefits. And we've already started that. I mean, we've, we've been talking to thousands of people who have Abbott sensors, who don't use pumps. There's been some concern that maybe since they don't have pumps today, they don't want them. Well, that's not true. We, we find that there is a great deal of interest. I think it's just more of a, you know, it's personal preference, and it's also the human condition, where if you're using something, it's difficult to change.

But we do anticipate that there'll be good, good uptake. I mean, right now in the U.S., there's 1.8 million people who have Type 1, who use pump, and of, of them, about 35% use pumps. And in my mind, there's no reason why, at a minimum, 35% of this Abbott population also wouldn't consider pump. And I think it's just one of those things that we as a company need to do, is to continue to sell the benefits, continue to provide excellent products, and move that number from 35% to 65%.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

I mean, in a way, the pump market's been an amazing success, but also in another way, it's surprising that penetration isn't higher, even in Type 1s than, you know, where it was. What do you think has been holding people back? Is it that CGM integration? Is it just ingrained behavior to just take time, no matter what you do, to sort of convert over? What's the thing we need to lever over to get from the 35 to the 60, 70, 80?

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, I mean, it's a great question, but I think if you look back over time, Medtronic was the first to bring pump therapy to people with Type 1, and that's been 20 or 30 years, I believe, when they started it. I would say the real and so that pump was just a pump. It didn't have CGM integration. It didn't have an algorithm on it. It wasn't really until we brought Control-IQ to the market in 2020 that it was really the first successful automated insulin delivery therapy that was on the market. And it substantially improved people's lives. I mean, it brought time in range up significantly. It improved the daily experience. People felt good.

So I really think that's the first time people have actually had an opportunity to understand what is it like to have a system controlling your insulin doses and reducing the burden. And so my sense is now we've got, you know, Insulet obviously has a device in the market with AID, and Medtronic has a new device in the market with AID. There's others coming. And so my sense is the reason that pump penetration hasn't really accelerated is because the innovation just hasn't been there. And I think that AID and these steps that are being taken now in AID will substantially change that, as well as innovation that's coming in the future with form factors, control mechanisms, and different algorithms.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Interestingly, you, you mentioned a Control-IQ. I mean, is there a difference between how the system works from a patient standpoint, whether you're using, say, like a Dexcom system or a Libre on the CGM side, like how the software connects? Is there any difference there, or is it-

John Sheridan
President & CEO, Tandem Diabetes Care

No, it's essentially the algorithm is on the pump. It takes the CGM data, it uses the data to predict forward and then make decisions on whether to suspend or increase the amount of insulin you get. So it'll happen essentially the identical way, just using a different source of the CGM information.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

And then the inevitable, GLP-1 question.

John Sheridan
President & CEO, Tandem Diabetes Care

Oh, good. That would be first.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

I almost don't need to say anything else, like, just like, I guess, you know, it's very early days in many ways. Obviously, essentially, it's not really a Type 1 topic, but as you think about it for Type 2, eventually, any thoughts on your mind, like, about how you think about that market evolves, any impact on patients, just any ideas you have about it?

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, I mean, I think there's a progression of people who have Type 2. You progress from medications to basal-only insulin to insulin-intensive therapy. And certainly, diet and exercise play an important role in that, and I think that, you know, a lot of weight, you know, makes it more challenging, I think, and you need more insulin to basically help, you know, address digestion and things like that. So the way we look at it today is that the GLP-1s are likely to slow that process down, where people may not move as quickly from medications to insulin-intensive therapy. But they're still, I mean, we believe they're still going to get there. So it's a large market as it is today. There's 2.3 million people in the U.S.

Today that have insulin-intensive Type 2, and, it's going to continue to grow. It may not grow at the same rate, but it's going to continue to grow as we see. So big market already. We are definitely committed to developing products to help people with Type 2. And I think that, you know, it's, it's a meaningful portion of our, development organization's, priorities at this point in time.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Then on the product side, you know, t:slim, Mobi, that side of things, how do you think about the different patient profile? Who would be interested in what, and how are you thinking about targeting the products respectively?

John Sheridan
President & CEO, Tandem Diabetes Care

That's a great question. We believe that diabetes is very segmented. There's people out there that have different needs, different use habits, different preferences in how they wear, how they interact with the system. And in that case, you know, there's, it's not a one-size-fits-all solution. A single pump is not going to address the needs of the entirety of the diabetes community. And so we believe in a portfolio of products. And as you said, t:slim's been on the market for about 10 years. It's a device that has a touchscreen that's on it. It's fairly large. I wouldn't say fairly large. It's convenient, you know, but the next device we're bringing to market right now is Mobi. And Mobi is about half the size of the t:slim.

It is controlled entirely by a mobile app. It gives you a great deal of flexibility in terms of how you wear it, and where you locate it. But the fact that it's controlled by a mobile app gives you convenience and discretion. So we think that's important. And then we also have a device that we're bringing to market here in the not-too-distant future, that's a full patch. It's a patch that's actually rechargeable, which we think is an important element. There's a great deal of sensitivity to environmental issues here and in the OUS countries. So a rechargeable device that has a prefilled insulin cartridge, we think is very differentiating, and we think when it does get to market, it'll be quite successful.

We've looked at these segments, and we feel that, you know, these products here will do a much better job of providing the needs that people have, you know, for how they manage and control their situation.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Is there a pricing differential that we should think about in terms of the product range?

John Sheridan
President & CEO, Tandem Diabetes Care

At this point in time, I don't think we intend to at least introduce Mobi at the same price point, and I would imagine that that Sigi would be the same way.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Then the channel, obviously, you've got, you know, the DME side, and you've got the pharmacy side. How are you thinking about the relative differentials between the two and pushing to the pharmacy channel?

John Sheridan
President & CEO, Tandem Diabetes Care

I'll let Leigh answer that.

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Yeah. So, as you probably know, durable pumps are well-rooted in the DME channel. It's something that we've actually very successfully developed with our products. We have broad coverage there, but there are some limitations. There's a lot of extra effort, I would say, from the physician side of the house in terms of getting approval. So right now, because we have such a good established network there, we are pushing to put Mobi on market in the DME channel, where we are today, and continuing to try to optimize that. So reducing prior authorization requirements, so getting the product to patients faster, and then helping in any way we can to help patients from the cost perspective. So for example, we offer payment plans for people so they don't have to deal with the upfront cost that's typically known with a durable pump.

Having said that, pharmacy provides some interesting opportunities for us, and so we have been thinking, looking, researching whether it was possible for the last few years. And I would say we're at the point now where we feel very confident that we can put a durable pump like Mobi into the pharmacy channel. And so we're going to be pursuing that simultaneous with getting it on the DME contracts. Although, keep in mind, it does take time, so it's not an overnight sensation to build up the pharmacy channel. It usually takes many years to get there, to get broad coverage. We're using Mobi as the entry point, and we're actually changing the dynamics of the conversation.

So it's not about it being a durable pump made up of these components, the cartridge and the infusion set, but it's really about the system, the technology, the clinical outcomes, and the benefits it can bring. And so it's talking about it in a, in a different, innovative way that I think is more appreciated on the pharmacy side. And so with that, we look to also increase reimbursement over time, to, with data as the value proposition there. So it's something that we're very focused on. It's a high priority for the organization. But I think most importantly, as John mentioned Sigi earlier, we want to build that capability, build that muscle, so that when Sigi comes to market, we can go straight to the pharmacy channel with it.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

The pharmacy side is a little more consolidated from a distribution standpoint than DMEs. Does that make it easier for you? You know, working in partnership, you can get the product physically out there a little faster when you decide to sign a larger agreement, or is there no real difference?

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Yeah, you know, I would say pharmacy has its own set of complexities, very different from DME and more in how the organization, administration, everything is structured. And so what we hope is that the burden is on Tandem and not on the patients and the physician. So we hope to remove some of those upfront requirements for the physician and give back faster access for the patients and also improve the costs to them.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

There's, between products, there's another sort of form factor debate in the market, which is tubed and tubeless. How do you feel that debate is evolving and the patient profiles, preferences between the two?

John Sheridan
President & CEO, Tandem Diabetes Care

Well, I think that there definitely is a group of people out there that prefer a tubeless option, and we're aware of that, and certainly, that's why we're developing a tubeless pump ourselves. But we think that's not the only option that people care about. I mean, today, or in the past year, you know, one of our competitors has brought a new AID version of a tubeless system to market, and it's been very well received. And I would say that it's definitely there are people who otherwise probably would not have considered pump therapy if this system did not exist with an AID system. So they have taken more of the MDI conversions than we had prior to it coming to market.

We think that Mobi, with its form factor, the fact that it's the same, roughly the same size, global control, the convenience and discretion that comes along with that, we think it's going to, as well as the sensor integration center, also come to market here in the not-too-distant future, are gonna get us to the point where we see a return to the growth that we've seen in the past, specifically with the MDI conversions.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

In terms of peers, I mean, there's quite a lot of movement in the market from product launches across kind of everybody simultaneously. How has the competitive dynamic evolved recently? What are you seeing in terms of attrition or new customer wins? Just any color around that would be helpful.

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, I would just, I'll tell you what I can do. I can talk about the products, and you can talk about what you're seeing in terms of attrition. But certainly the Insulet device came to market about a year ago. And I think as we entered this year, we would say that there's been quite a bit of pressure, but it's stabilized, and we haven't seen it deteriorate any further. It's stabilized, which we think is fine. Certainly, there's a, the Medtronic has a new device in the market, which is coming to market as we speak. And then Beta Bionics, they just received approval in the not-too-distant future. I think just in the recent past, excuse me. They, I think when you look at the 780G, it's the same form factor.

It's a sensor that requires finger sticks, and you put that up against Mobi, which is a brand new small pump, mobile control, using excellent sensors. We feel like we're in a great position to compete against it. But I can tell you that every single time a new product does come to market, there's always a pausing dynamic. And certainly, you know, even with a device like, you know, Medtronic, there's going to be pausing. There's excitement and interest to understand how does it perform, what's going on in the marketplace. And they're of course, they're of course, an effective marketing machine as well. So, but we think that, you know, as, as the dust settles, that our products will continue to be very competitive and we'll continue to take share from them. On the, on the, on Beta Bionics side, they're a small, young company just getting started.

They've just raised funding. I think they've got to hire a sales force. They've got to develop the commercial enterprise to support a product over a four-year lifespan. So there's a lot of work then for them to do still. But, you know, they're a company that we keep an eye on. It's just that we really haven't seen much of them in the marketplace at this point in time. And Lee, you want to talk a bit about attrition?

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Sure. So I would say when you look at a Tandem customer, they are very sticky. We have seen that through our own renewal dynamics, that once they make the choice to move to Control-IQ, they stay with it in the long term. And what I mean is, when we think about when people's warranties are expiring and the percent of people that we capture for a new pump purchase, in the last six quarters, so in through this challenging environment we've been seeing, we've seen our highest renewal rates ever. And so I think that's pretty important. It says, you know, what it says about attrition or retention, I should say.

When we look, you know, there's been conversations, I think people have been asking, well, are more people moving away from Tandem to other companies than you have seen in the past? When we look at all of our signals of whether or not people are staying or leaving, we're not seeing any changes in what I would call active behavior of our customers. Keep in mind, we have a lot of touch points with customers, so we can see these levels of activity. For example, our t:connect system. So vast majority of patients upload their data. You can see not only an upload, but it backfills with the activity. We have people that we sell direct supplies to. We have people that call into customer technical support.

There's a number of ways where we can measure the level of engagement, and it's remained very consistent in the last year.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Should we expect that going forward, with the proportion of growth coming from MDI and competitive conversions, it should be somewhat similar, like keeping that ratio roughly the same?

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Well, I'll start with looking back. What we've seen in our history is that our new pumpers have been about 50/50 mix between MDI and competitive conversions. It's been very stable, even up through this Q2, most recent quarter. As we look forward, we've always expected that MDIs will start to outpace competitive conversions. We've captured so many in the past. Many of those have become our own renewal customers now. And with our new products that we're introducing, as John described, they will be attracting people from different segments of the market than we have been reaching before. So MDI should continue to grow at a faster rate than I would say, competitive conversions in the future.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

On the topic of renewals, how some of that is coming up OUS, which is a market that doesn't get talked about a lot despite being most of the world. How should we think about the impact there? And also just sequentially blocking that on, just the OUS opportunity in general, 'cause again, we have a lot of good data for the US. OUS is always tricky.

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Sure. I'll just start with the size of the markets that we're in. There are about four million people living with Type 1 Diabetes in the 25 countries that we operate outside the U.S., and it's vastly underpenetrated there. So in the range of 10% to 15% of people use pumps. So with all the innovation that we expect to bring to market, we expect to move the needle there. In terms of that stickiness factor, we're just lapping the first people who are coming up for their four year warranty renewal. And I would think about it much like we saw in the U.S., where we have a goal, and we consistently achieve. In the U.S., 70% of our customers renew within about 12 to 18 months of their warranty expiration.

It took more than 12-18 months in those first years. It was more like a two, three, four year cycle to get to that 70% rate. We have a lot of learnings that we can help train our distributors on outside the U.S. So I don't think it will take that long, but it will still be probably a slower uptake initially than what we're seeing in the U.S. today. Having said that, I also caveat the fact that, when you think about a four year warranty expiration in the U.S., pretty much you can look at shipments four years ago because pumps even go through distribution and get on a patient pretty quickly. Outside the U.S., those pumps have tended to sit on distributor shelves, on boats, on the ocean, whatever it may be, for 3+ months.

So I would say, even though looking back to 2019, we shipped about 19,000 pumps, we will just begin to see the beginnings of renewal opportunities, probably late 2024. So next year is our first real opportunity, probably more back half of the year, to start to really drive that renewal stream of business that we've seen has become pretty predictable here in the U.S.

John Sheridan
President & CEO, Tandem Diabetes Care

We also do quite a bit to incent people to renew. One of the most important things we do is we continue to develop software, you know, during the four year period that people have their pumps. And if we come out with a new version of software, we make it available for people who are in warranty for free of charge. And these are meaningful software changes. I mean, for instance, Control-IQ was, you know, it's a, it's a game changer in terms of just living with diabetes. Well, we made that free, made that available free to everybody in warranty. And we also really do, I think, an amazing job as a company, just, providing customer service and support, which is hugely important to people living with diabetes.

We have people that are available 24/7 to address any questions and issues that people may experience. And I think that the combination of those two things there are really important, I think, in maintaining and retaining, you know, the installed base.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Have you noticed any difference in patient profile, OUS versus U.S.? Like, do you have any observations about how patients differ, whether, like, preference of products or things like that, tube, tubeless patch, like, that split? Or is it very similar sort of profile between the different regions?

John Sheridan
President & CEO, Tandem Diabetes Care

You know, I think that we would probably expect it to be similar. I think that there's, you know, at least right now, you know, the patch device with the AID system is just coming to market. You know, we'll see how it does there. I think they have some of. They don't have some of the structural advantages that they have here with pharmacy channel there. So we'll have to wait and see how that goes, but I think that there's definitely still going to be a preference for it. You know, but at, you know, I think the bottom line is that people in the OUS countries want the same advantages as this technology is bringing.

I think that innovating as we have, as our competitors have, and as our partners have, will, you know, continue to drive the adoption of pump therapy.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

I mean, historically, we've had CGMs that have sort of started the patient journey of engaging with technology to manage their condition, and then pumps have been part of that as well. Is there any? Do you think the introduction of CGMs more into the basal population within Type 2 could help prime the patient's thought process, such that when they do drop into intensive, they're just more ready to engage with a pump in a more realistic way, or am I just overinterpreting?

John Sheridan
President & CEO, Tandem Diabetes Care

No, I would say that, I'm not sure whether that applies to basal and the transition from basal to insulin intensive type 2, but certainly it's the case when it comes to type 1. Because I think typically when you present with type 1 or you know, decide you want to try CGM therapy, you know, you get the support. You know, you get to see the benefits of a technology you're wearing 24/7. And we think people are more inclined to consider pump therapy at that point in time. So, I mean, as I said, we have drafted off you know, the great products that Dexcom has provided over the last five or six years, and I think that we intend to continue to let that happen now with two partners.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

You recently sort of changed your timelines associated with your, like, growth and EBIT margin, sort of long-term targets and sort of made them a bit more sort of lack of an exact year associated with them. I guess either what would you need to see to make you more uncomfortable, to make you more comfortable about a timeline on it? Or how should we think about the interplay for you between low penetration, investing to grow? I mean, it's a dynamic. You have to balance, right? Because you want to grow as quickly as you can because of low penetration, but then there's margins on the other side.

How are you thinking about the end-to-end interplay with the margins in the long term, let's say, targets, and what would you need to see to get you to sort of put a timeline back on them?

John Sheridan
President & CEO, Tandem Diabetes Care

Do you want to start with that one?

Leigh Vosseller
EVP & CFO, Tandem Diabetes Care

Sure. So, I'll start. Let's talk first about why we removed the timestamp on it. Based on the environment where we're in, which we have less visibility right now in the next few quarters, and it really comes about because of the timing of the Mobi launch. With it being known to wider audiences now since we got approval, with the actual launch not happening till after the first of 2024. So that's going to be very disruptive in the next few quarters, which caused us to reset our guidance to a baseline level. Having done that, we thought it was important to reset 2024 as well, so that people would have a baseline off of which to think what that could look like based on where 2023 sits now.

What's important to note is that 2024 does not have the upside opportunities that come from these new product launches. It's more about what Tandem can achieve, people seeing a pathway to it. So then, if people continue to draw that line to the 2027 goals we had out there, it would be difficult for them to see how we could get such a steep ramp and achieve those. I'll say that our goal and objective is still to reach that one million customers in 2027, but we needed to set it in a place where people could see achievability. So what we need to do really is evaluate the uptick of Mobi and really Abbott Libre integration next year and see what kind of momentum that drives for us to give confidence to put that timestamp back out there.

The margin targets were set with that one million customers in mind, but we still have ways to achieve those, and we have initiatives in place to achieve those. We could achieve those faster than the one million customers, but, one of the most important drivers of that would be the Mobi product. It's a much lower cost to manufacture than the t:slim product, and it drives us more than halfway to that 65% margin target that we had set. So it all comes back to the uptake of Mobi, the percentage of business that it drives, that will really help us give, give the confidence to put a, a date back out there. So you can look to that in the future after we start to, you know, put some of these products on the market.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

On the manufacturing side and the capacity, let's say, you know, Libre into Ocean, Mobi on that side, the volume end of the equation ends up coming faster and more aggressively than you would expect. What's your capacity to meet that demand, and what does that mean for margins?

John Sheridan
President & CEO, Tandem Diabetes Care

Well, it's a problem we'd like to have.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Sure.

John Sheridan
President & CEO, Tandem Diabetes Care

I think that the, you know, when we look at 2024, we've certainly modeled upside potential for, for pump sales because of Mobi, and we're certainly in a position now to meet that. We're building the product today. It's salable, and we have, you know, we really have strong conviction that we'll be able to meet whatever we're presented with. And again, the more, the merrier.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Outside of GLP-1, just fill it out for a little bit. You know, you do a lot of these meetings, you have a lot of these calls. For you, is there anything you're surprised that you don't get asked about more? Or like, where the external focus on something is more than the internal or vice versa. Like, is there like, you know, a split in the sort of attention to what you're spending?

John Sheridan
President & CEO, Tandem Diabetes Care

I think that recently, a lot of questions on the guidance change that we had. So that's been one thing that people have been very interested in, in learning. But also a lot of interest in the timelines for the new products. When will they be available? When will they sort of begin to contribute to revenues? So those have been really the two, the two things. I mean, I think the thing that, that, you know, again, I think we have the most innovative pipeline in diabetes, and we're executing on it. It's just around the corner. We're very excited about it, but I think we don't get any credit for that either.

I think it's really, it won't occur until the point in time when people actually start to see the MDI conversions move back into a growth rate where we've seen in the past. We'll start to see it at that point in time, but that's the thing. I also want, I mean, it's a large and growing market. I mean, I think that, again, there's one point in knowing people, only 35% use pumps. We think innovation is gonna drive that. So as the market continues to grow, both in the U.S. and in the OUS countries we're in today, we think there's an opportunity for all of the companies that are currently, you know, working to help people with diabetes; they, we can all be successful.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Everyone likes to talk about the algorithm side of things, only 'cause I think people like to sound smart by saying algorithm. But can you give us a sort of sense on how competitive that market is in terms of hiring the right people, remaining ahead of the pack? It's obviously an area people spend a lot of effort. And also, you know, is that something that you think will always sit on the pump? Do you ever worry that the CGM providers might try and, like, mitigate it and pull it over there, and then end up being essentially a transmitter with the data? Or how do you think about that as well?

John Sheridan
President & CEO, Tandem Diabetes Care

Yeah, all really good questions. I would say that we partnered with UVA and Type Zero back in 2016, because at that point in time, we didn't have a team developing an algorithm. And so it's really we felt it was the best algorithm on the market at that point in time, and we implemented it as it was, as quickly as possible. Since that point, we have hired our own teams, and we continue to develop a very capable group of people who understand how to develop and optimize algorithms. And we're we have been working on that for quite a while. We believe today that we have the best algorithm on the market. I think if you talk to any physician, they'll agree with that and tell you that's the case.

I will say that, you know, from a competitive point of view, it takes a long time to make changes, and I think that the FDA is very careful about these changes. They want to make sure that they're thoroughly evaluated before they actually even go into clinical studies. So that's the thing that, I mean, you know, we all want to move as quickly as we can, but there's limitations in terms of clinical studies, and you have to run several studies, I think, before you get to the point where you actually even can give them data on how these things perform and what changes you'd like to make. So I think that we're all facing that same challenge, really, is the time to make changes to the algorithms. But I think it's something that's certainly very important.

When it comes to where it resides, we think from a safety point of view, it's best to have it on the pump. I think that the CGM needs to talk to the pump and the algorithm needs to be on a pump. If it was on a cell phone or someplace else, you lost that, then obviously your system's no longer in closed loop and you're not getting the benefits. And so I think that as a company, we'll always have the algorithm on the pump, and we'll always have the sensor talking to the pump as well. So it's an important safety factor that we think is necessary.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

The CGM side of the market, obviously, your partners in business have been. It's essentially been a duopoly, in essence, for a while. But there's a few new entrants trying to think about pushing in, some of the smaller ones, but also companies like Roche. Is there tension for how your interplay with these other companies, where they're trying to pressure you to bring integration first or to exclude others? Like, do you get caught in the middle of it?

John Sheridan
President & CEO, Tandem Diabetes Care

You know, I think that, when you look at, Abbott and Dexcom, they invest billions in R&D. And I think that when you look, when you look at these small companies that, that are out there today, you know, for them to be successful, the only way they're gonna make it is to be acquired by one of the two big ones. So I think they have to have novel technology that Dexcom or Abbott is interested in, because the capital required to support that business is, is enormous. So I think that a nd, you know, I think that we wouldn't even consider an alternative until somebody had meaningful market share. I mean, we, we are only, you know, we're working with Abbott because they, they do have meaningful market share, and we want to provide choice to our patient population.

So those are the kind of factors that we consider as we make those decisions. But, you know, it's gonna be difficult for anybody that's out there today unless they do, you know, just join somebody else.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Amazing. John, Leigh, thank you so much. Really appreciate it.

John Sheridan
President & CEO, Tandem Diabetes Care

Nice talking to you.

Jacob Dodd
Research Associate, US MedTech Equity Research, Morgan Stanley

Thank you.

John Sheridan
President & CEO, Tandem Diabetes Care

Thanks very much.

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