Tandem Diabetes Care, Inc. (TNDM)
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Bank of America Global Healthcare Conference 2023

May 10, 2023

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Good afternoon, everybody. Next up, we have Tandem Diabetes Care. I'm Travis Steed, the medical device analyst at BofA. We have, John Sheridan, CEO, and Leigh Vosseller, CFO. Welcome. I think, John, you wanted to-

John Sheridan
President and CEO, Tandem Diabetes Care

Sure. I just want to kind of give you guys a sense of the state. Thank you for having us, Travis. It's always great to be here. We prefer to be on the West Coast and in at least the same time zone that we kind of are from. It's a lot easier getting up in the morning and having those early meetings

I guess I wanted to start off by saying that, you know, we've been pretty clear over the last quarters, couple of quarters that, you know, there's been a good deal of pressure on the business from the macroeconomic factors and from the competitive issues as well. I would say that as we enter this year, we have seen some stabilization, which has been good. The stabilization doesn't mean we're not experiencing pressure.

We're still experiencing a good deal of pressure, I would say it's no better or no worse as we enter the year. That's something we view as a positive. I would say that we anticipate that this pressure is probably gonna exist for the next couple of quarters until we start to see this next wave of innovation that we have come to market in the second half of this year. You know, I think that when you talk to HCPs today, they still think we have the best product in the market. I think we are the number one rated product in the market today by a number of different third parties. Over the last couple of quarters, what we've been able to do is we've been able to go out into the market.

We've been able to talk to HCPs, talk to people who are using some of these competitive products and really begin to understand how to position ourselves against them. you know, that's something we didn't have immediately as soon as, you know, the product hit the market, but now we do. We really equipped our sales organization to do a much better job of working with HCPs so they understand the benefits of our technology and can position it competitively against the products that are on the market. We're excited about that, and we think that's going to have an effect on our business as we go forward into this year.

The other thing I'll say is that we, you know, the 780G just was approved, you know, a week ago or so, and I think there's also some concern about how that might impact the quarter and impact the year, in fact. I'll say, first of all, it's a better product, no question about it, but it still has weaknesses. I think that the benefit we have with the 780G is that we've been competing against it now for many quarters outside the United States, and we understand, you know, how to position ourselves competitively against it. As it starts to come to market immediately now we're in a much better position to compete against this product.

I will say that while it's a better product, you know, I think that the U.S. Endo community has lost some confidence in Medtronic's ability, and I think that it's just an issue they're going to have to deal with, in addition to the fact that the product still requires finger sticks, which I think is problematic. We feel comfortable competing against that device. I think that, as I said, this year, we have our next wave of innovation coming to market. Our team is excited. We're bringing four new products, which I think is unprecedented in diabetes to the market in the next several months.

I think that, we are very committed and convicted to our goals we set for the company, and I think we feel confident we can achieve them this year. Thanks for letting me say that.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Yeah, of course. Great opening remarks. Maybe we'll start with Q1, just reported last week. When you think through Q1, your initial expectations versus where the quarter shook up. Like, how do you think new starts, renewals, international, kind of all the pieces played out over the course of Q1, you know, versus kind of your initial expectations?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Sure. We came in pretty much in line with our expectations. I'll start with the OUS market. It's a bit different there right now, what's happening. We're going through an operational transition where we are moving distribution from a U.S. location to a center in the Netherlands, which is very beneficial to our OUS distributor partners because it will alleviate the headaches they've had with the supply chain challenges. We knew that we were gonna see about $25 million of sales headwinds in the first half of the year. In fact, most of that landed in the first quarter. We're excited to get that behind us so we can move on to a point where when we report sales outside the U.S., it will look more like true patient demand.

We don't have to have these conversations about fluctuations in ordering patterns, and we can talk about really what's happening in the market. Demand is still strong there, we're excited about the outlook for that part of the business. In the U.S., what we're seeing, as John said, is still an environment very similar to what we saw in the fourth quarter with some pressure to it. We did see shipments come in strong. One thing that I would highlight is that we're seeing a little bit of a lengthening of time between timing of starting an order to actually fulfilling the order with the customers.

In some cases, some of the economic questions are coming up, which is lengthening that to some extent, but it's not changing the dynamics of the number of people interested in the technology. Also occurring a little bit with the sales, supply sales side of it. Otherwise, you know, we look forward to the rest of the year. We feel like we have a number that's very achievable, and, based on the trends we've seen so far, have a lot of conviction in being able to deliver that.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Right. Some of the three things you've highlighted, you've highlighted kind of the staffing and the no offices, you've highlighted the economic impacts and then kind of competitive pressures from competitive launches. Like, how are those three buckets kind of playing out? Is the payment plan helping the economic side of stuff? Is the staffing getting better in the competitive launch? Like, how has that kind of trended over the last, you know, few months?

John Sheridan
President and CEO, Tandem Diabetes Care

I think that when it comes to competitive launch, I think there was a great deal of pent-up demand for the product when it first came to the market, which was in the late summer. I think that there's a number of early adopters that have tried the product. We know of at least from Tandem. In Tandem, we have roughly 15% of our employees have Type 1, a good deal of them tried the product. I think that they tried it. Some of them tried it for longer than others. I'd say most, if not all, have come back, and they just don't. The algorithm is not as aggressive as the Control-IQ system, and they really prefer that.

I think that we're hearing the same sorts of thing from many of the physicians in the marketplace where people have tried it. You know, but most people are coming back to Tandem. I think that what's happening today is that, you know, it's a definitely a different form factor, and the form factor is appealing to people. You know, we've talked about trying to get the pump penetration rate in the U.S. from 35%-40% today to 65% in the next couple of years. In order for that to happen, you know, companies like Tandem and Insulet, Medtronic, DexCom, Abbott, all have to innovate and provide solutions to diabetes that reduce the body burden and the mental burden of living with that condition.

I think that there's people out there who otherwise would not have come to pump therapy if they didn't have a tubeless option. Certainly what's going on today, I think, is that we're seeing, we're seeing the competition really for MDIs. People are going from pens and needles into pump therapy. That's where the competition is. We have people today who are using our product. We have renewals, and we see very little attrition. The people who are renewing right now, we're actually seeing improvement in our renewal rates. I think that, you know, I think the situation again, there was early excitement and interest. There still is. I think, though, as we bring this next wave of products to market, you know, we're gonna see that situation change dramatically.

We'll get back to the growth curves that we've seen in the past.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

The payment plan, is it helping?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yeah. It certainly is helping with the conversations. One thing that we frequently see is there's a misunderstanding at the cost of pump therapy, particularly on the durable side. People presume because there's an upfront, that it means it's more expensive overall. What we're doing is trying to change that perception. We've shared with people recently that about 30% of our customers today don't even have an out-of-pocket need. It really varies widely based on their insurance plans, and we want people to call in to make sure they understand what their responsibility will be. We couple that with the payment plan conversation so that we can equalize it.

Even those patients that have an upfront, if you take that with the out-of-pocket cost for the supplies averaged over the four-year timeframe, more than half of the people have less than $50 per month out of pocket. It's actually can be very affordable, and the payment plan can help us, you know, in terms of that messaging.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Right. On Q2, we talked about on the earnings call, you highlighted some of these pressures continuing as well as the Mobi delays. Just maybe kind of comment on what you're seeing early April to kind of give that color into Q2 at this point?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Sure. I wouldn't characterize it as a Mobi delay by any means. What we are seeing is that or what we're expecting maybe is more the better way to say it. It's gonna be a noisy quarter. There's never been a time in the diabetes space when a new product was launched that it didn't create some sort of disruption around it, whereas people are trying to understand what the product offers, and many times, physicians and patients need to experience it to really understand that. With the, you know, imminent launches of G7, the Abbott Libre, with the conversations around Mobi, as we continue to talk about getting closer and closer to clearance and preparing for launch.

With the 780G coming to market, we fully expect it's gonna be a very noisy quarter, not unlike we've seen at other times, and we just wanna be prepared for that. That's why when we talked about what to expect for Q2, there's a wide range of variability at what the sequential step-up has been in the past. We've cautioned people, let's think of it on the low end of what we've seen in the past, which is a low double-digit step-up in pump shipments in the U.S., just accounting for that noise in the market.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Is that something you said you're not seeing it now, but you're just kind of baking in the noisy market?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Exactly. We're anticipating that it will occur. We just wanna be cautious about what we might see. I think the other important point is it's not a loss of opportunity. It's a shift of timing because what we found in the past, for example, our Control-IQ launch, as we neared FDA approval, Control-IQ was gonna be offered with a simple software update. You find as you get nearer and nearer to the launch that sometimes people say, "I'd rather just wait, buy the pump with the software on it than to go through the software update process myself." That's why we think that there could be some timing elements, you know, associated with when people make their purchasing decision.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Right. When I put some of those comments in, into my model, we came out with like Q2 revenue for like $195 million. Street low is like $190 million. The street average is, you know, I think $206 million. I don't know if everybody's updated their models now, I was kind of curious if my number's right, the street number just kind of curious color on Q2 revenue, where we should be.

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Sure. I think the way I would frame it is I'm not sure everyone completely understood the message of going into Q2 and being on the softer side of expectations. I would encourage people to think about it as, you know, making that adjustment in their model so they can reflect that. I think the other element, even on the OUS side, I'm not sure it was fully captured the headwinds we expect to see in the second quarter, which is about $7 million, where we saw $18 million in the first quarter. I don't know that everyone fully got the message on some of those dynamics.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Do you feel like we got the message?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

I'm comfortable.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay, great. On, on Mobi, I think in the past, we've talked about like, some sort of like upgrade plan. Like if somebody gets a T2 today, they get to get an automatic upgrade. Is that something you're thinking about as you get ahead of Mobi?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Absolutely. That's the Tandem Choice program that we rolled out at the end of the third quarter last year. The idea behind it is, today, people know if they're in warranty, they always get free software updates. The question is, what happens when a new form factor comes to market? We wanted to assure people that even if you're in warranty, you're not precluded from having the latest and greatest technology. There is a cost to it because you can't give away pumps for free necessarily, but at least it reassures people that if they buy, they're not stuck in a lock-in period, and they can still access it. That's the conversation when people do bring up Mobi today that we reassure them that we have this plan in place.

As we get nearer and nearer the launch, you know, we'll continue to think about the ways to mitigate any pausing that there could be around the corner.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

How should we think about the launch? You know, where's the, I guess it's with the FDA right now. Just kind of curious any back and forth you could share, timing, expectations there?

John Sheridan
President and CEO, Tandem Diabetes Care

We have an ongoing constructive dialogue with the FDA right now. I mean, some people have been concerned that we're gonna have to do additional human factor studies or other studies that require interactions with people, and that's not the case. We're working on things that I would characterize as bench testing. We have to do additional bench testing that they've asked us to do, which we feel comfortable getting done. That's gonna be done here in the relatively near future. I would say that while there's been quite a few approvals in the last quarter, so been good to see. It's still difficult to predict when these things are going to happen. Rather than try to, we're basically just gonna be prepared to implement or to commercialize the product in the second half.

As soon as we get approval, we're gonna be ready to have the device on the market in two to three months after that. Most of the work is really in involving training our physicians. We really wanna make sure that the HCPs and their practices really understand the device and feel comfortable with it so they feel comfortable prescribing it. We wanna minimize any problems that they might experience by training. We also have to upgrade all the manuals. I mean, typically, you get feedback at the very last minute that has to do with labeling, we'll have to update manuals and get those pre-printed. Those are the things that take time.

Right now, our manufacturing teams, our commercial teams are really gearing up, expecting that we're gonna get clearance here in the relatively near future.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

How do you expect the launch to go once you get clearance?

John Sheridan
President and CEO, Tandem Diabetes Care

It's gonna be a phased launch where we scale. I mean, we will. It's a brand-new pump for us. I think we wanna be cautious at first. You know, we'll have thousands of people trying to use it at first. We will make sure that it's working the way we expect it to. I think once we have that experience, then we'll move more aggressively to get more people on it. I think it's taking a cautious approach when you've got a device like this, a brand-new technology is the right one.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Are you gonna prioritize your existing patients for renewals or MDIs?

John Sheridan
President and CEO, Tandem Diabetes Care

Those are all good questions. We haven't been really specific about our commercialization plans yet other than it's gonna be a scaled launch. I think that once we get approval, we'll talk more specifically about that.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay. Just like thinking overall, which patients do you think is gonna be the bigger opportunity for renewals or MDIs? Just like bigger picture.

John Sheridan
President and CEO, Tandem Diabetes Care

I think all of the above. I mean, I think we think it's gonna drive MDI conversions. I think this is a new form factor controlled entirely by a mobile phone, a great deal of convenience and discretion that comes along with it. I think all of the above is gonna benefit from this.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

You've not included this in guidance, right?

John Sheridan
President and CEO, Tandem Diabetes Care

That's right.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

For 2023. When we look at the full year, both like the revenue side, the EBITDA side, it's a pretty steep ramp. You know, with the Q2 commentary, it's got a little steeper. Just how are you giving investors comfort with kind of the big step up in Q3 and Q4, excluding even the new product launch?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Sure. Well, first of all, couple of factors there. I'll start with if you just look at our history. In pretty much every year, the split between first half and back half has been about 40, 60 in the U.S. It's something that's very repeatable. We've demonstrated many times. The conviction we have in this year, in particular, if you think about some of the building blocks, the amount of sales that are coming from what I would call recurring sources is an even greater piece than we've had before. You have the supply sales on our very large installed base. You have the renewal opportunities, which are stepping up very substantially.

Four years ago, we shipped about 50,000 pumps, so you know, attribute that to what would be renewal opportunities this year, which is up from about 30,000 last year. In the face of everything that we've been seeing in the market, we have been capturing renewal patients, actually improved our rates last year and capturing them consistently with what we saw in 2022, even in this first quarter. You add to it the new pumpers. Really it just becomes seasonal scale. It's something that we see all the time, just because people face high deductibles in the first quarter. I would say in the insurance world, more and more people have high deductible plans, which I think pushes even more people out of that first part of the year.

It's not too unlike what we've seen before, and we feel very confident that we can achieve it, even in absence of benefit from new products.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay.

John Sheridan
President and CEO, Tandem Diabetes Care

Renewals are also back-end loaded.

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yeah.

John Sheridan
President and CEO, Tandem Diabetes Care

I mean, the most of the renewals will occur, opportunity becomes available in the back half.

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yeah.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay. The EBITDA is just a function of revenue or?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yes. Well, I can give a couple of points there too as well. The first half of the year is pressured, particularly by this OUS dynamic that we have with the transition to the new distribution center. The OUS markets, there's very little variable expense, and so when sales are up or when sales are down, it has a meaningful impact on EBITDA margin. That's a sort of a one-timer anomaly that's not gonna repeat itself. When you take that out of the way and you think about how pumps scale with the highest gross margin contribution, that's a driver of EBITDA. We're going to see a little bit of relief on gross margin from some higher inventory costs we've been seeing over the last three or four quarters.

We'll have consumed most of that inventory by middle of this year, and we've been reporting about 1-2 points of gross margin pressure because of that. Then the last element really is on the spending side, and I think this is the part maybe that people are struggling to understand because typically they see our spending dollars accelerate across the year in line with sales. This year in particular, we've had a heavy focus on cost optimization. We've made a number of efficiency improvements in the teams that support our growing installed base. So you can think about operating expenses being almost flattish across the year, which also will contribute to that improved or very improved EBITDA margin by the back half.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay. kind of longer term, OpEx, like, before it was like 30% OpEx growth. This year, I think it's closer to 15 or mid-teens. Like, how should we think about OpEx growth longer term here?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

We'll continue to drive towards our long-term targets, which is a 25% operating margin in 2027. A lot of that comes from gross profit contribution. From the spending side, we will continue to prioritize investments in R&D. We need to make sure we drive those initiatives that are going to continue to expand the market and drive top line. Focusing on these leverage opportunities. What you're gonna see this year, in terms of efficiency contribution on this SG&A side will continue as we go forward, because we'll continue to optimize those processes.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

On the gross margin side, I guess the impact of Mobi about the 7-day infusion set, how to think about those rolling in versus other things on the gross margin line?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Our gross margin target in 2027 is 65%, and Mobi will get us more than halfway to that target. The pump itself costs about 10%-15% less to manufacture than the t:s lim, and the cartridge also has significant cost improvement, more than 20% cost reduction. As that builds up as a bigger part of our installed base, you'll see an initial, first any new product, you have a little bit of a headwind until you get to scale. The pump will start to give immediate contribution, and then the supply side will grow over time as the installed base increases. The next biggest contributor comes from extended wear infusion set technology. We own the technology so that we have more opportunity to reduce costs there ourselves.

Just the way the structure of the reimbursement model works, we expect to see gross margin optimization there. Beyond that, it's your natural gross margin improvement opportunities. It's price improvement. It's general cost reductions, lead savings.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Anything else? The consumable piece is the lower gross margin of your business. Anything else to kinda outside of the seven-day infusion set to get that recurring revenue up to a higher margin?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yeah. You know, what strength Mobi can provide or what % it ends up being of the installed base will be a significant contributor. We did also just complete the full transition of our cartridge manufacturing to a third party in Mexico, something we've been undergoing for a couple of years, and that's been demonstrating some modest gross margin improvement, and that will continue here. Now that's complete and will be to the optimal state.

John Sheridan
President and CEO, Tandem Diabetes Care

I'd also say there's an opportunity on ASP improvement. In fact, you know, today, when you look at people who use Control-IQ, there's a substantial reduction in adverse events, which means less hospitalizations and ER visits. This is where the majority of the expenses come from payer organizations. I think that we're in the process now. Because we have such a large install base, we're talking to the right people in these organizations. We have dashboards that are set up to share exactly how their patient populations are doing. We're working with them to get their data so we can put this together and show them that there's a substantial benefit to their organizations by using Control-IQ. In having that, we would expect to share that benefit. I think that's an opportunity.

It's not gonna be immediate, but something that will happen over time.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Yep. Are those conversations started at all?

John Sheridan
President and CEO, Tandem Diabetes Care

Yeah.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay. Let's see what I was gonna ask next.

John Sheridan
President and CEO, Tandem Diabetes Care

You have the paper, right?

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Yeah, I know, right. Trying to think which direction to go in. Maybe we'll jump to Libre, and think through the integrations there. Libre two first, then Libre three next.

John Sheridan
President and CEO, Tandem Diabetes Care

Yep. Yeah, we've been working with Abbott now for at least I think 2 years. You know, the product that we anticipated coming to market first in the U.S. or getting approval and the reduction of the release of this issue with vitamin C was the Libre 2. That's where all of our effort has been put. I think when they got approval a few months ago, we didn't anticipate that they'd get Libre 3 at the same time. We plan to bring Libre 2 to market first in the U.S. and fast follow with Libre 3. We are also working to introduce the Libre integration OUS, and when that comes, it'll go Libre 3 first. As I said, we've been working with them for a while.

We said on the call that we are involved in walkabout testing, which means we have engineers walking around wearing the pump. It's talking to the sensor. It's kind of an optimization phase, and that we would anticipate actually having the early scaling launch occur in the third quarter.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Anything you've learned in that walkabout phase? You know, there's always been some questions how long it takes the sensor to start working and I don't know anything.

John Sheridan
President and CEO, Tandem Diabetes Care

I think what we can share is that, even before we started walkabout testing, we've done multiple sensor integrations now. We understand the iCGM, and all the interoperability guidelines that the FDA set forward, and we feel comfortable that the device will be safe to provide therapy from the time the sensor is integrated with the system. The algorithm will work for those first 12 hours, and we think it's gonna provide safe therapy.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

How do you think about, like, Abbott's got 300,000 Type 1 patients in their installed base in the U.S. How do you think about your opportunity there? It feels like the pharmacy channel, you've got Pod in the pharmacy channel, the CGM in the pharmacy channel, so you could be at a disadvantage versus that. You also there's, you know, you've got 25% of the pump market share. I'm just kind of curious how you're thinking about the opportunity within the Libre patients.

John Sheridan
President and CEO, Tandem Diabetes Care

Well, you know, DexCom today provides their device through the pharmacy channel, and we're quite effective at integrating with them. I don't think the channel's gonna have a really an effect on it. I'll say that we're talking to people who use the Libre today, and what we're finding is that the people who actually do use the Libre sensor are interested in pump therapy. There is an opportunity out there. There's reasons they've selected a Libre because with the Libre today, you can't get access to the AID systems. You can't get access to pump therapy. This is, this could be their plan, it could be the expense, but we think it's a big opportunity. Like you said, we've heard it's the same thing. It's 300,000 people with Type 1.

It's even larger OUS. It just gives our sales organization the opportunity to work to sell, to convince this group of people the benefits of the therapy. I think that it's, it probably won't be this exponential. It, I think it'll be gradual, but it'll be gradual over a longer period of time 'cause it is a large population, and we see it having a meaningful effect on revenue over time.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

How does the OUS integration differ from the U.S.? Is that something that you can get on the market this year, or is OUS more-

John Sheridan
President and CEO, Tandem Diabetes Care

No, it won't be this year.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

It'll be next year.

John Sheridan
President and CEO, Tandem Diabetes Care

It'll be next year sometime. Yeah.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Okay. How should I think about the integration there? Obviously you have the FDA process here, you have AID and iCGM here. Is it a lot different internationally?

John Sheridan
President and CEO, Tandem Diabetes Care

We haven't really spoken directly about it. I will say that it'll be Libre 3. I think that from a regulatory point of view, we think it's relatively straightforward, and it's just a matter of getting the implementation completed.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

It's been a while since I've heard you talk about the pharmacy channel and the opportunity there. Any updated thoughts on your opportunity in the pharmacy channel?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

So while we're actively pursuing it, we're in the very beginning phases. It's really about starting conversations today and building relationships. We're taking the opportunity with Mobi to be the introductory product. It's unlikely that Mobi will ever be 100% in the pharmacy channel. I do think we can have some success with it. The most important part is, working with healthcare generally, building relationships is so critical, and it can take years to work your way to where you need to be. It'll be good for us to get started now. As we think about products in the future, like Sigi, we'll know what the expectations are. We'll know how to have those conversations, and we'll already be embedded with the, with the people in the top levels of the organizations.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

That's helpful. Internationally, you've got a competitive launch coming later this year or more next year. Just curious if you think that'll have an impact on the international business like you've seen in the U.S.?

John Sheridan
President and CEO, Tandem Diabetes Care

First of all, I don't think it'll be the same as the U.S. OUS, it's we deal or we sell through government healthcare plans, so the pharmacy channel doesn't exist there, which is an advantage I think they've got here in the States. I'd also, as I said a moment ago, we really do now understand the product, and we really know how to sell against it, and so that's a benefit that our distribution organizations will have. They still have to get started. I know that they're, they've talked about coming to the U.K. in the midyear and Germany at the end of the year. You know, we plan to have new competitive, interesting devices in the markets, you know, roughly at these same times here.

I think it's not gonna be the same as it was in this, the past two quarters, past three quarters. I think we'll definitely have a step up from that.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Then, AMF Medical, any updates how that, how that's going?

John Sheridan
President and CEO, Tandem Diabetes Care

It's still early. I mean, they're a great team. In fact, they're in San Diego this week. We've been working with them together with their engineering team and our engineering teams. We're, you know, I think what we're doing is we're just working through understanding what the product that comes to market looks like. That's one of the first things we have to do. There's also, I'd call it technical debt that we have to resolve to make sure that the device performs at a way that we feel comfortable with and would work in the marketplace. I think that we're working to put together the sort of the definitive plans to scale their organization to make sure that we've got the resources in place to achieve, you know, have the product on the market in the timeframe that we've indicated.

When we first said this, we said we were conservative. We said, "We'll have it in the market in 2027." You know, we're doing everything we can to pull that in. We understand the importance of this product, and we also think that by AMF is a very entrepreneurial, fast-acting team. We're not trying to mess with them. We're trying to let them keep that entrepreneurial spirit and introduce these products quickly. It's a great culture. They have a great culture. We really feel good working with them. Like I said, we're gonna do everything we can to get the product to market before 2027.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Is the limiting factor on timing more manufacturing? Is it clinical?

John Sheridan
President and CEO, Tandem Diabetes Care

I think it's probably all of the above. I mean, de-developing the manufacturing equipment, it's all automated, so it's complex to do that. The device today doesn't have integration with a sensor. It doesn't have an algorithm on it. We've got to also start to work on that. There's some things that I would call... They're complicated engineering problems to solve, but they're solvable. It's not science. We're not like trying to invent things. These are all tractable things for us to... And we've got experience doing them. I think it's just a matter of working smart and working with them well to get to the market. It's an exciting product. It's gonna do very well in the marketplace.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

What about Control-IQ 2.0? I think that's something that this year, maybe?

John Sheridan
President and CEO, Tandem Diabetes Care

Well, we're working on a study right now. It's a study that's gonna help us understand exactly what a pivotal study will look like. This is the second study that we've done. We would expect that we would run the pivotal study for Control-IQ 2.0 next year, probably more like a 2024, 2025 product.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Is that more around the mealtime?

John Sheridan
President and CEO, Tandem Diabetes Care

It's gonna have a number. It's gonna have personalizations. It's gonna have simplification of the bolus workflow. It's gonna be more aggressive, you know. By more aggressive, I mean, it's gonna keep you in range for longer periods of time. I think simplification, personalization, are really the more important elements.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

More patient choice on the target.

John Sheridan
President and CEO, Tandem Diabetes Care

That's right. Exactly. Yeah.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

People-

John Sheridan
President and CEO, Tandem Diabetes Care

People want to have different set points. Some people prefer to operate at a lower blood sugar levels, others prefer to be higher. We're gonna give people the opportunity to choose which they like.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

That can roll out as a software upgrade.

John Sheridan
President and CEO, Tandem Diabetes Care

Yeah.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

it's another way to get people in to upgrade warranties.

John Sheridan
President and CEO, Tandem Diabetes Care

Exactly. I think that, you know, we think that the incentive provided by giving access to our install base, our warranty install base is huge. I think that's how we continue to see stickiness 'cause, you know, it's not like you're buying a product and you have to wait for the next one to come to market before you get the benefits of it. We make it available to our in-warranty customers free of charge whenever we are completed with the work.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Right. On the G7, you have to be in warranty to get G7 as that's, like, it's not quite integrated yet. Just kind of curious how you think about that driving upgrades on renewals as G7 launches.

John Sheridan
President and CEO, Tandem Diabetes Care

Yeah, I think that we're in the first phase. I'm sorry. Were you gonna say something, Blake?

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Go ahead.

John Sheridan
President and CEO, Tandem Diabetes Care

We're in kind of this walkabout phase right now. In the not too distant future, we'll start to do a scaled rollout. What we would expect is to have a meaningful number of people on the product in the third quarter.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

If you think about the out-of-warranty people today, is that a big opportunity in terms of like?

John Sheridan
President and CEO, Tandem Diabetes Care

Well, I think that this is a.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

...upgrades to renewals.

John Sheridan
President and CEO, Tandem Diabetes Care

I think that's gonna drive, it's gonna drive the renewals. I think it's definitely gonna be incentive for renewals. I know that you, once you.

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Well, I was just gonna add that, if you think about it, when we talk to people today about when they're ready to renew, the conversation starts to get stale at some point. Now it's a fresh opportunity to go out and talk about a new product offering. It could bring people from the sidelines that weren't compelled to buy their renewal pump before, but maybe it will move them forward now. We would see that as upside opportunity if it encouraged more, if we started renewing at a higher rate because of it.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

All right. Great. I think that's all we have time for. Thanks a lot.

John Sheridan
President and CEO, Tandem Diabetes Care

Thanks, Travis.

Travis Steed
Managing Director and Senior Equity Research Analyst, Bank of America

Yep.

Leigh Vosseller
EVP and CFO, Tandem Diabetes Care

Yeah. Thank you.

John Sheridan
President and CEO, Tandem Diabetes Care

Thanks, everybody.

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