Tandem Diabetes Care, Inc. (TNDM)
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The Baird 2024 Global Healthcare Conference

Sep 11, 2024

Moderator

Morning. It's from Tandem Diabetes, the manufacturer of the t:slim X2 Control-IQ insulin pump and the Mobi insulin pump. With us today from Tandem, we're happy to have Chief Administrative Officer, Susan Morrison, and Vice President of Investor Relations, Katie Nicoletti. Susan, I'll turn it over to you for a few slides, and then we'll go from there. Thanks.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Before we get started, of course, just the safe harbor disclosure that we will have forward-looking statements included. Information on this is included on our website if you want any additional details. For anyone not familiar with Tandem Diabetes Care, we have a mission to improve the lives of people living with diabetes through relentless innovation and revolutionary customer experience. If you look at the market overall for people living with diabetes, it's highly, highly underpenetrated. For people living with Type 1 diabetes in the United States, only about 40% of the two million people living with Type 1 use an insulin pump today. There's a similar market size for people living with Type 2 diabetes, who are insulin dependent in the U.S., who actually use an insulin pump, only about 5%. So very, very meaningful opportunity when we look at it from an overall market.

If we look at the international opportunity, there's about three million people in the twenty-five countries that we're in, who use an insulin pump... Or I'm sorry, who have Type 1 diabetes. Only about 20% use an insulin pump today. So it goes back to a huge market opportunity worldwide. So Tandem really focuses on a segmented market, and we really do market research to understand what are the needs and preferences of people living with diabetes. And what we've found is that there's different ways that people wanna wear their pump, different ways they wanna operate their pump, and also different preferences from healthcare providers and how they recommend the devices. So our first focus was really launching a durable device, and what that means is it uses an infusion set. So infusion sets are actually used by about two-thirds of the insulin pump market.

Our t:slim pump was our flagship offering. We launched it just over a decade ago, and it allowed for us to capture about one-third of the overall market share. Our second device that we launched just this year is the Tandem Mobi pump. It's a smaller pump, about half the size of t:slim, and is controlled through a mobile application, and so we have a scaling launch that actually started earlier this year, and what we see is this is really attracting a different segment of the market, people who wanna control their device through a mobile application, and also people who want greater discretion, and there really aren't other players who operate in this segment of the market, and so both of our products, both t:slim and Mobi, have Control-IQ technology, which is highly regarded and best regarded as the number one automated insulin delivery algorithm available.

It gives both immediate and sustained clinical outcomes, so in addition to attracting a large and growing market through our current offerings, we also have a stream of pipeline products that are intended to further expand the market, further bring people over from multiple daily injections, and we have the most exciting portfolio in our industry. Our business model is also underlined by the fact that people typically purchase a new insulin pump once every four years, and because of that, we've got a renewing stream of people who are purchasing the pumps from us once again. We've seen great success within this market, and an increasing number and rate of people who have been adopting our technology, and it's really a reflection of the high level of satisfaction that people have with our devices.

If we look to where we're investing, R&D is obviously a huge focus for us because we really believe that innovation is going to drive additional adoption and penetration within this market. We're also looking for opportunities to invest in leverage of our business model, ways that we can gain greater efficiency, which in turn, will be able to show that benefit within our operating margin progress. So overall, we're really focused on bringing the benefits of our technology to bringing to more people living with diabetes by driving that top line through innovation, as well as improved outcomes. In addition, we're working to drive leverage and enhance that business model as we work towards our 25% operating margin goals. So with that, Jeff, I think I'll turn it over to you for questions.

Moderator

Yeah, great. Thank you. So, why don't we just start on the overall market, and then we'll come back to, to Mobi especially, and, and maybe the, couple outlook questions in that. But, on the market itself, so the MDI market in the U.S.... I'm gonna move over one. I feel like I'm too far away from you. The MDI market in the U.S., for Type 1, seems like it's growing kind of mid-teens right now. Our math is probably a hundred thousand or close to a hundred thousand new users over the, trailing twelve-month basis. You know, are those kind of numbers sustainable? Do you think mid-teens growth in the pump market is sustainable, number one?

Number two, on that hundred thousand number, you know, are there any rate-limiting steps we need to look at for the market, where there's only so many nurse practitioners who can train or so many endos who can prescribe these and things like that? Can that hundred thousand number keep going up each year?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, there's meaningful opportunity for growth here, and I do think that goes back to the underpenetrated nature of the market. And so we do expect for innovation to be able to be what drives those growth rates going forward. And as far as what's rate limiting, I think it's an important question, and one that's often underappreciated because we're investing heavily in things that improve back office efficiency. Our Tandem Source product, allowing for people to process things more quickly, more efficient in obtaining forms that are needed in order to process insurance requirements. And so even through the DME channel, some of these investments are allowing for us to create more of a pharmacy-like experience, even in the DME environment.

Pharmacy is obviously an initiative for us also, but we do think that there's opportunity for optimization, and that it isn't necessarily just adding more people, that technology can drive efficiencies that allow for us to support a greater number of people converting from MDI.

Moderator

All right. That's helpful. And then, you know, I think ultimately you guys have talked about maybe a 60% plus penetration rate for pump use in the U.S. You know, we've had other companies talk about 70%. I'm not saying who's gonna be right or wrong on that. And just, you know, 60, 70%, does that still sound like the right level? Has anything changed on that? And one and two, I think you're right at about 40%, that's where our math is, too, is penetration. You know, if we're adding four or five points of penetration, you think we start to bump up against kind of a ceiling in four years, five years? Is that the way to think about kind of T1 penetration for pumps?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, I think 60% is a milestone.

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It's not necessarily a ceiling-

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Right? And with this, it goes back to that innovation that brings people over, and that T1, there's room to run here, meaningful room to run, and that's when you start to look at Type 2, and Type 2 being only 5% penetration in the U.S. today, and then you look at outside the United States. And so these are all layers of opportunity, all based on the idea that it's so under-penetrated.

Moderator

All right. And then maybe the Type 2 opportunity, as you said, 5% penetrated. What do you think? I don't know that I've heard from you guys an expectation on what that could get to from a penetration standpoint. Obviously, it's gonna take a number of years to get there, but does T2 ever look like T1, and we get penetration rates that high, half that high? Just how conceptually do you think about the T2 opportunity in the U.S.?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, I mean, we've had recent research suggesting that 25% is very attainable.

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

But I also think that there's steps along the way. Even if you move from 5% to 10%, those are big numbers when you're looking at more than two million people in the U.S. who could be candidates for pump therapy, and again, every step along the way. And it's gonna take market development to get there-

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

... but at the same time, the clinical outcomes we see, the improvement in quality of life, all drive for greater support.

Moderator

Okay. And on that T2 opportunity, obviously, one of your competitors just got their label expansion. You guys are working towards that. I think the latest update was, what? Gonna file by the end of the year?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yep, file by the end of the year.

Moderator

File by the end of the year. You know, I think the thing that impressed me the most in Florence at ATTD earlier this year was, you know, we saw the SECURE- T2D data out of Omnipod that looked good for Type 2 use of AID. We saw some really strong real-world data for you guys, even for 780G, Medtronic 780G. You're starting to see some real-world data in Type 2. So what's it gonna take to get that penetration off the 5% level? Does it just take, you know, insulin in the next six months, you guys out there somewhere early, mid 2025 out there, just in the offices, really leave behinds and training these docs and talking to them? Is that what starts that penetration, or how do we get moving off that 5%?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, that market development effort is huge. People thinking of someone living with Type 2, the benefits that they can receive through insulin pump therapy, and a big piece of this now is the algorithms and Control-IQ, specifically, is so easy to use, and it delivers immediate and sustained outcomes, and because of that, when people adopt the technology, they quickly get to see the benefit and recognize the benefit, and so it allows for them to connect more with the devices and want more ongoing use with the devices. I also think Mobi starts to present a meaningful opportunity because it has smaller size, and there can be so many social stigmas associated with having Type 2 or living with Type 2 diabetes, that it allows for you to wear it in different ways that are more discreet.

Because of that, we hear, we hear a lot of enthusiasm from people living with Type 2, who also like the flexibility to disconnect.

Moderator

Yeah, and that was gonna be my next question. I mean, I think, you know, we know that in Type 1, Mobi has already started to drive some good appeal on that smaller size, that greater discretion, the ability to disconnect, things like that. Will the benefits and/or challenges of a tube pump versus a patch, looking at the pros and cons of that, will Mobi play better in the Type 2 market than it does in the Type 1 market? Is it a better Type 1 product than a Type 2 product? Is there any difference in that patient population that would position Mobi differently in one versus the other from a preference standpoint?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

I think it actually appeals to a segment within both, and that's the thing that's exciting about it. There's a group of people who have sat on the sideline, using multiple daily injection today because they don't wanna have something stuck on their body, yet they want it, so they want that flexibility to disconnect, but they want greater discretion, and because of that, they've stayed using multiple daily injection. Mobi is a solution for them. For people living with Type 2, oftentimes, it's that same reason or that same motivator, and it's just making sure that you're providing the right solution. And so that, in combination with Control-IQ, right?

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

The outcomes, and the outcomes and how people feel, how they feel waking up, that's the type of thing that people share their experience on and really starts to build momentum in this market.

Moderator

All right. That's helpful. And then I wanna ask some specific numbers around MDI, around competitive converts, things like that, but before I do, you mentioned from the podium there that Mobi is appealing to a different segment of the market. Should I read that to mean that Mobi is largely incremental to your pump numbers? How much are you seeing cannibalization of a Control-IQ new user sale versus it’s expanding the market for you?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

We're seeing both.

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Do you wanna talk a little bit about Mobi?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Sure, absolutely. So when we really introduced Mobi, it was designed to bring more MDI users to pump technology.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

And we're definitely seeing that. And in initial data, we're seeing a younger demographic. We're seeing very high satisfaction rates. We're not speaking to exactly the mix because our strategy is to have a portfolio approach, both with t:slim and with Mobi, and to be able to have that offering of choice.

Moderator

Okay, that's helpful. So let me get a couple numbers here, and this is where Leigh usually rolls her eyes at me when I try to dig into these numbers and all that.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

So should I roll my eyes?

Moderator

Yeah, you can-

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Okay.

Moderator

... feel free. Believe me, many women in their lives, or in my life, have rolled their eyes at me. But if I look at MDI, so I think at your peak, kind of in 2021-ish, right after Control-IQ came out, you guys were killing it. You were doing about 8 - 10 thousand new MDI pumpers in the U.S. per quarter, so almost 40,000 for the year. I think exiting last year, you were down to 4 to 5 thousand per quarter. There's some competitive stuff in there and what have you. First quarter, 4,000. So you went 8 - 10, kind of came down a little bit, 4 - 5, and second quarter, you were at 7,000. This is all my math, and this is where I said-

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Fair.

Moderator

-we kinda-

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Yep.

Moderator

rolls our eyes. But over the next couple quarters, and I know you don't guide by to pump starts and things like that, but as I think about that move from four to five to seven, you know, arguably, Mobi didn't have a whole lot of... It had good traction, but not a whole lot of time to generate a ton of traction in 2Q. You were just kinda getting it into some of your DME partners and what have you. So should we see, or can you get back to that eight to 10 thousand number in the next couple of quarters? Should we see sequential lift off 2Q, or did you get the big bounce, and now it's let's see where it goes from there?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

I do like talking numbers.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

While I can't give, you know, specifics on MDI-

Moderator

Yeah

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

... I can help you with some of the trends. So, for those who may not be familiar with our revenue streams, we have recurring revenue, which is our supplies and our renewals, and then we have new starts, which historically have been 50% MDI, 50% competitive conversions. And with the introduction of Mobi, it was expected that we were gonna start to see MDI outpace our competitive conversions, and that is what we saw in Q2.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Granted, it is early in the launch, but we think that it's a good, encouraging data point, and as we move forward, you know, with the sequential question, we give revenue guidance, and while it's early in the launch, good data points, we still think that it's going to follow those seasonal trends that we've seen historically.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

So when you look at Q2 and Q4, those have historically, we've seen that larger sequential growth.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Which at this point, we think that that's a good assumption to maintain.

Moderator

Okay, and historically, Q2 to Q3 was usually flat to down a little bit.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Correct.

Moderator

I think, if memory serves, right?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Yep, correct.

Moderator

You think normal seasonality is the way to think about things for now?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Yeah, and we did give Q3 guidance 'cause there are a lot of-

Moderator

Yeah, sure

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

... different dynamics that go into a launch, so we think that that trend is a good way to think about it.

Moderator

All right. That's great. Let me stick on the numbers then with you. We'll cut you out for a second, Susan. But on the competitive converts, same kind of number. I think you guys peaked on competitive converts about eight to 10 thousand or so per quarter. More recently, that's down to four to five or so. Obviously, Medtronic has done a little better job of holding onto their seven eighty. They don't have a whole lot of patients left either, so that opportunity is shrinking, what have you. Does that number materially shrink? Do we get to a point where you guys are 80-90% MDI versus competitive converts? Just how to think about, you know, and I'm talking over a multi-quarter, two, three, five quarters.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

So we're really focused on new start growth in the second half. And we look at it holistically, that with our product, you know, our portfolio of products, we do think that we're gonna bring more users from MDI. But interestingly enough, in Q2, we also did see a larger volume of competitive conversion. So that was something-

Moderator

Versus Q1, you did, right?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

We got to see a noticeable increase, specifically with Patch Pump.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

So that was good to see, but really, we're just out there trying to make sure that we've got our winning set of products, and we're going after new starts and also retaining our loyal customer base.

Moderator

Yeah. All right, fair enough. The comps are easy in the second half. I think year over year, you know, I think we're all pretty comfortable. You're gonna get pretty good, healthy growth on a year over year basis against some of those easy second half comps from last year. But conceptually, and I know you're not guiding to twenty twenty-five, but if the market is growing U.S., we're still talking U.S. market is growing mid-teens, should you guys be an at-market grower? Should you be an above-market grower? How to think about, especially on the MDI front, kinda you versus market, and if that market is gonna be mid-teens or so?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

We're not, you know, we're very happy with the trends that we're seeing, but again, we're looking at those data points. We wanna make sure that we have the long-term trends before we can speak to, you know, twenty-five and beyond. But I would say we feel like we have a competitive portfolio to go out into the market.

Moderator

Okay. Maybe on international, sorry, not on Mobi, when should we be thinking about Mobi launching outside the U.S., and how much is that gonna help on the volumes there?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, we've been working through the regulatory pathway because it varies by country, and so we haven't given direction on when we'll be launching Mobi in which countries because of that. So right now, regulatory is the priority, doing language translations, things like that. So stay tuned on how that kind of feeds into international. Right now, in the international market, a big focus for us is preparation for launching Libre 3 next year.

Moderator

Yeah. Yep. Yeah, and I think you've committed, at least in New Zealand, to July 2025. We saw that in one document of Libre three integration. But is that what we should be thinking, kind of a, is a Control-IQ Libre three integration somewhere mid-2025 based on that New Zealand document, or?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It's gonna vary by country.

Moderator

It is.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah.

Moderator

Okay. Okay, and Mobi, the same thing? Sorry, timing on Mobi.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It's gonna vary by country.

Moderator

Vary by country.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah.

Moderator

Okay.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Exactly.

Moderator

All right. Fair enough, what else? Let's look at maybe Mobi's manufacturing costs. Obviously, they're lower than t:slim X2 without the screen and things like that. So on the LRP, you guys, I think, have contemplated six hundred basis points of gross margin improvement from just from the Mobi side. You know, how does that phase in? Does it still-- Is it a year from now before we start to hit those scale benefits and then the gross margin benefits of Mobi start coming through? Can they slowly start to build into the model over the next two to four quarters?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

Yep, so you're right. So we guided 2024 at 51%. We have a long-range goal of 65% for gross margin, and Mobi is a large piece of that. As you alluded to, the cost of the actual pump is 10%-15% lower than t:slim. The cartridge is over 20% lower. So with that, it will take some time for our installed base of Mobi to build for us to recognize those savings. But I'll also say in 2024, we were ramping manufacturing, so as we exit Q4, and we're really manufacturing at scale, we think we'll get away from that headwind that we had in 2024. But as I mentioned, that's a piece of the profitability story. We have other initiatives within Tandem. One, you know, you referenced the Tandem Source platform.

There is gonna be an opportunity to use automated processes for things that historically we've needed to scale customer support with install base, right? By automating different processes, that's a big focus within the company. And then I'd also say with the extended wear, SteadiS et, that's another area where we think that's gonna help get us to that 65%. So that's a general view of just kinda the timing and our goals.

Moderator

Okay. No, that's good. Also on Mobi then, you know, you've talked about moving some of that into the pharmacy channel. I think last week, John or Leigh made the comment of maybe even more than one contract or a decent-sized contract before year-end, so one or two contracts before the end of the year, and your confidence higher on that. I think I've been convinced. I've probably been dragged, kicking and screaming a little bit, but I've been convinced that some of the pharmacy payers do want competition in the pharmacy, even if it's a even if it's a-

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It's a shift, to be fair, right?

Moderator

Yeah, yeah, yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It's a mindset.

Moderator

I mean, right, it's a capital product.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah

Moderator

... and we don't usually see those go into pharmacy. I think I've come to realize, though, that especially the PBMs want somebody else in there who can offer some rebates and maybe offer some competition on rebates, as opposed to just the one player in that channel right now. But I guess my question is, you know, as we look at, like, one of your other tubed pump competitors that does have a pharmacy channel access right now through a couple payers, you know, it's maybe 5% or 10% of their pump sales or something like that. Is that a reasonable thing, area to think about what pharmacy could represent as a percentage of your US pump sales over the next couple of years?

It's not gonna go much above five to 10 until you really get to Sigi in 2027 or whenever, just how to conceptually think about the percentage.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It'll build over time-

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

... is the right way to think about it. And so especially, it's gonna depend on the size of the contracts-

Moderator

Mm

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

that we sign and when those go into place. So as a reminder, t:slim will continue to go through DME.

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

So you're always gonna have that portion of it. And then pharmacy, think about it kind of feathering in or layering in.

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

over time. But the size of those contracts, and depending, I mean, we're very focused on the profitable nature of those contracts.

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

and driving economic value, in addition to looking for opportunities to reduce the out-of-pocket cost for patients.

Moderator

Yeah.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

So with those objectives, if we continue to see traction and interest on the part of the payers, we may go faster, but we also may take it more metered, and so it's a little bit too soon to say definitively. I would agree that there's strong interest on the part of the payers. And Tandem is in a unique position because we have so much experience. We have so much data, and Tandem Source, again, being this rich resource for being able to show outcomes improvement, opportunity for cost-sharing benefit or cost savings benefits. And so being able to show people a full picture of what their cost of care is like for their members.

And so it's putting us, I'd say, in a strong negotiating position, and so we're really approaching it with that in mind, rather than saying we have to just check the box of having it at any cost.

Moderator

Okay, and when I think about Insulet going into the pharmacy channel a number of years ago, we saw a jump probably of 20%-25% in the revenue they received per pod. Is that about the kind of premium? Lee has talked a couple times about a premium price in the pharmacy channel. Is that ballpark what we should be thinking?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yep. We're not putting a dollar or percent on it now, but to see improvement is a fair sentiment and is a fair expectation. And so as we work through these contracts, we'll give better direction of what people should think about those looking like. But you're right in that it's an improvement.

Moderator

Okay. Conceptually, last question on pharmacy channel. Conceptually, I always think about the move to pharmacy shifts the risk, because in DME, obviously, there are hurdles to adoption.

You've got to write letters of medical necessity, maybe still get some testing done. I don't think you have to show glucose logs anymore, but there's a lot of stuff, right? That they try, I think, intentionally to limit access in the DME channel because these are big, expensive products. You go to pharmacy, now all of a sudden, most of those guardrails go away, and somebody can just write a script and walk out with a $5,000 pump. So the risk to the payer there is that their volumes are gonna balloon up, and they're gonna start paying a lot more. And so somebody has to shift that risk, in my mind, to where the payer doesn't wanna bear all that risk.

When we look at the Insulet model, the way they bear that risk and take it away from the payer is, if you stop using an Omnipod after six weeks, you're no longer consuming pods. You're no longer costing the payer money. You know, what I still don't understand about Tandem is how are you guys gonna recognize revenue, and how are you gonna shift that risk and take on some of that risk from the payer? Do you recognize the revenue over a multiple quarter period? And if you do, when somebody stops using the pump, do you take that pump back and repurpose it in an international market or something? Just what would the guts of a pharmacy contract potentially look like?

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

I'm happy to comment to that.

Moderator

Yeah.

Katie Nicoletti
VP of Investor Relations, Tandem Diabetes Care

I think the main point is that the contracts may look different. So historically, with DME, it could look like a similar contract where there's an upfront payment. It could also look like more of a subscription base. So the revenue recognition could be different with each of those. But I would say that we have to keep in mind that this is gonna be a multi-year process. So there's not gonna be a binary shift, that one day, you know, we're blowing up everyone's models, and there's a very large, you know, gap. But we are, as Susan mentioned, making sure that we're looking at each contract, making sure the economics work for us, and make sure that we are giving the access to the broad audience that we're looking for. So it could look different, is really the answer there.

Moderator

Okay. All right. I wanna shift over to a point you made on the competitive converts and in taking some of those competitive converts away from patch or from the patch pump. You know, I think one of the things that really helped Insulet when they launched in mid-2022 with Omnipod 5 was that pharmacy channel access, and somebody even that was on a Control-IQ for a year could all of a sudden jump over and get a pump through the pharmacy. There was no four-year restriction when you went from DME to pharmacy. I think that's come back and cut the other way a little bit here recently, because same thing, you can now go back to the DME if you were in pharmacy, and then it's two separate channels.

So I guess my question is, when you've taken some competitive converts from patches, you've said last quarter, especially, how many of those are Tandem patients kind of coming home-

versus they've never used a Tandem pump in the past, and now they're going from patch to Tandem?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, it's been a mix. We never lost a material portion of our business-

Moderator

Yeah

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

... to Insulet. I mean, there's always been some level of share exchange, but typically, we play in different segments of this market. And so with that, we ask people when they're purchasing a pump from us, "Are you using a different device right now? If so, which one?" So it's all self-reported data, so there's gonna be some variability in there. We can tell because if someone was a prior customer of Tandem, we're able to kind of triangulate, but what we can see is it's a mix. And the people who are returning, it's largely Control-IQ. The outcomes that they see are so great, and also with the new Mobi form factor, it maybe meets the needs of something else that they were looking for.

With people who are new to pump therapy, that obviously is people who are looking for either the form factor or the outcomes that we deliver.

Moderator

All right. Fair enough. A couple of questions on pipeline. We're down to three minutes here.

I don't wanna overread tone from John last week. I mean, we see from ICON yesterday, and that overreading tone maybe gets you in trouble sometimes. I thought he made some comments about Toby, which is the tubeless version of Mobi-

That maybe were like, "Yeah, it'll be nice, but it's, it's not as big a step forward as Mobi." And again, that's me just reading his tone in that. Is Sigi, obviously, if you get there in twenty-seven or whenever you get there, I think going to a patch is gonna be a big jump from, even from Mobi. Is Toby a big jump from Mobi, and what would be the different use case for Toby versus Mobi?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, we're excited about Toby.

Moderator

Okay.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah.

Moderator

Okay.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, we're excited-

Moderator

I'm glad about that.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

... about Toby.

Moderator

Okay.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

And so Mobi is the same pump, and so Toby is our internal name. It's tubeless Mobi, and it's just shorter, frankly, to say. And so we started saying it in certain environments, but for anyone not familiar with it, it's the same pump that we sell today with a cartridge that uses an infusion site rather than infusion set. And the thing that's so important in that is it even offers greater options in wearability. So someone may have a box of sets and a box of sites, and depending what they're doing in the next few days, depends how they determine the wearability, and they have that option. And so that's the biggest thing with our pipeline, is providing this optionality. So we're absolutely excited about the tubeless feature for Mobi.

I'd say that, look at these as incremental steps that all build and are all intended to bring more people over from multiple daily injections.

Moderator

All right. Fair enough. On Sigi, are there any... You know, we try to track, there's not a whole lot on ClinicalTrials.gov and all that, but I mean-

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah

Moderator

... you guys aren't necessarily updating timelines anymore. I get that for competitive reasons. I think John has recently commented, though, that, you know, 2027 is still, you're on track for that timeline or something.

I forget how he phrased it exactly. Are there any markers we can watch and kind of try to track to see progress that's being made towards the patch?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Yeah, on ClinicalTrials.gov, we do have the first new human-

Moderator

Yeah. Right

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

... that's posted for that, and so that would be kind of the public item to look for, and everything else we'll provide as updates on our earnings calls.

Moderator

But that'll have to be additional studies beyond that. And will we see a pivotal? I don't think we will, right?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

You don't.

Moderator

That's where it's hard to track.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

It is. You're right, it's different because really, especially launching in the U.S., this is a 510(k) product, and so the clinical outcomes-

... aren't required. The clinical data is really more associated with algorithm and algorithm improvements.

Moderator

Right. Exactly.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

You're right, you won't see as much visibility on this, and it'll be more on the company of how we provide updates getting closer to that launch.

Moderator

Okay, last question, thirty seconds. You guys currently have about $450 million of cash on the balance sheet, I think $100 million net cash or so really. You should be free cash flow positive sometime, probably next year, next year plus. Is that free cash flow turning positive next year still a reasonable expectation? And then how do we start thinking about those future cash flows, the use of those cash flows going forward?

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Sure. And so we absolutely internally have objectives that we are working toward from a profitability and an operating margin goal perspective. And so we're not providing any information on 2025 yet, but-

... I'd say that it's a concentrated and an intentional effort, and we're balancing driving that top-line growth with driving operational levers, where we can demonstrate improvement both in Adjusted EBITDA and overall operating margin.

Moderator

All right. With that, our time is up. Susan, Katie, thank you very much for a great overview of Tandem.

Susan Morrison
Chief Administrative Officer, Tandem Diabetes Care

Thanks for having us.

Moderator

As a reminder, the next presentation is set to begin at 10:15 AM, include Exact Sciences, Certara, Allogene Therapeutics, and then Cara Heart. Thank you.

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