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

Okay. Good morning. Thanks for joining us for this session today with Tandem. I'm Matt Taylor, the U.S. Medical Supplies and Devices analyst here at Jefferies, and pleased to be joined by management from Tandem Diabetes, including John Sheridan, the CEO; and Leigh Vosseller, the CFO. So we'll have about 25 minutes here for a fireside chat and maybe some Q&A here at the end. And I always like to start a little bit high level for folks who may not be familiar with the story. So John, maybe you could start with talking about little bit of Tandem's history and bring us up to speed, there's a lot going on with the company.

First, just before we start, I just want to mention that we do have our safe harbor statement, which is on our website. If you have any questions about it, please ask us or get on the website and see it. And to start us off, yes, we're in a very different place than we were a year ago and we're very excited about that right now. We're participating in a very large market. It's large and underpenetrated, both in the U.S. and in the OUS states we're in. So a lot of opportunity there. We've been through some ups and downs. I mean, I think we continue to have the most exciting pipeline in diabetes. And I think we're innovating faster than our competitors. And I think that's really the moat that we have to just spend off a competitive situation that we experienced. In the last 5 or 6 months, we've introduced 5 new products to the marketplace. Substantial changes to the form factor of the product, which really is redefining what I would call wearability. I mean I think there is an argument that it was tube and tubeless. It's not tube and tubeless, it's wearability. And it's the ease of just locating the pump and the system anywhere you like on your body. And the small size that comes along with Mobi has really been very appealing to people. And so I think that we -- as we brought these new products to market, in the last few months, expect '25 to be really a transformational year for us, where we see our growth curve return to what it's been in the past. We see an inflection in the number of new starts we're getting from MDI, both in the U.S. and in the OUS. So we're very excited about where we are. And I think we've got a very exciting pipeline and future as well.

Fantastic. I mean that was almost the whole meaning right there.

That's right. I only have 25 minutes. I got to get it all out.

Great. Any questions. So maybe let's start with the pump market. Can you talk about how the pump market has been developing in the last few years. There've been a lot of innovation, not just from you but from the competition, and that's stimulated more people to come to pump therapy. And I guess I'm curious as to your thoughts about whether your innovations going forward and the competition is going to help to stimulate pump market growth. In general, can you just talk about the growth of the pump market going forward.

Well, I think that if you were to look back 5 or 6 years ago, the market was growing very slowly. There's about 25,000 people coming from MDI to pump therapy annually. We've seen a lot of innovation like Matt said, I think we brought Basal-IQ and Control-IQ to the market in 2018 and 2020. I think at that point, we really did see a step-up in the people coming from MDI therapy. And certainly, and slip with the Omnipod 5 has also brought -- helped the market grow where people who otherwise wouldn't have used pump therapy found that an appealing form factor and certainly started to use that system. So I think it's really been as these AID systems have come to market, it's now that we're seeing the growth. And I think that it's really -- it's just the beginning in my mind. Today, I'd say that if you were looking to the U.S., there's about 1.8 million or 1.9 million people that have type 1, and it's about 35% to 40% penetrated. So it's still relatively low. If you were to go OUS, it's a larger market. It's possibly roughly double the U.S. market, and it's about 10% to 15% penetrated. So a huge opportunity there. I think that in the U.S., we expect that the technology, the innovation that we're bringing to market. And some of our competitors and our partners as well, will drive adoption, ease of use drives adoption. You have to reduce the burden of wearing device 24/7 and at the same time, provide excellent therapy. And we're doing that. And so we expect it to get to 65% here in the U.S. in the next several years. And in the OUS countries, it's probably going to grow from 10% to 15% to 20% to 25%. So in both cases, those represent large groups of people with diabetes moving to pump therapy and we do feel confident that, that can happen. We're also at the pursuing type 1 in the U.S., the type 1 market is over 2 million people with insulin-intensive type 1 who have the pancreas is degraded. They have insulin resistance. They use quite a bit of insulin daily. And the situation is very much like somebody with type 1. That market is about 5% penetrated. So it's only roughly 100,000 people using pump therapy. Right now, all of the companies who make AID systems are working to get the indication for type 2. And I think that there's going to be a meaningful impact in that group as well. The uptake might not be as quick, but we absolutely think it's going to happen, and it's even larger OUS.

Let me double click on some of those product launches and catalysts that you mentioned. The first one I want to touch on is Mobi. So you press released the other day, 8-K the other day that you're integrated with G7 and Mobi's a very exciting product and form factor. Can you talk about the early days of the Mobi launch, the kind of feedback that you're getting from clinicians and patients and then how should investors expect Mobi to kind of layer into your results as you ramp it up?

So we've talked about the diabetes market is very segmented. There's not one -- it's not a one-size-fits-all condition. People out there want to wear their pump differently. They want to interact with it differently, they want to control it differently. And so we think that there is a -- we need to have a portfolio of products that deal better with the different segments that are in the marketplace. I think our competitors think that one size will get them adequate share, but we think that we need 3 products. And so t:slim has been on the market now for about 11 years. In the last couple of months, we brought Mobi, which is about half the size of t:slim. It doesn't have a touchscreen. It's controlled entirely by a mobile app. And you can wear it in a variety of different places. It fits into your coin pocket in your jeans. We also have an adhesive sleeve that you can put on it with a very small 5-inch infusion set. And that seems to be very appealing to people because you can literally put it in any place you would like to. On your legs, on your torso, on your abdomen, on your arms and we see people doing that. The thing that surprises people. I think when they see Mobi for the first time, it's just how small it is and how light it is. It really is -- it just -- it almost takes your breath away when you have it in your hand and you see that. And what people are telling us is they forget they have it on. They basically put the patch on and they forget it. And the convenience that comes along with cellphone-control, is also something that shouldn't be underestimated because first of all, there's a great deal of discretion. And people don't know you've got diabetes when you're interacting with your cellphone. You can be given yourself a bolus at a lunch with a bunch of your friends and nobody knows you're doing that. The other thing that it's very convenient. It's there all the time. And because of that, people are actually bolusing more regularly and more closer to the time they actually eat and people are seeing better results. So I think that people, I mean the way I would say is that it's redefining wearability, we're providing choice with sensors, and we have the best algorithm on the market. And so we think that, that combination really is going drive MDI growth. And we're seeing it right now. We absolutely are seeing people interested in Mobi. It's been a scaled launch. We introduced the product in the mid-February time frame. We had -- we did it originally just to the direct customers. We moved into the distribution near the end of the first quarter. And as Matt just mentioned, we've introduced it with G7 in just a few -- a week ago or so. And Dexcom has done a great job of converting their patient population in the U.S. to G7. And so there's a significant number of people that are out there today who are already using G7 and the physicians did not want them to go back to G6 and so they've been waiting. So there is a bit of a pent-up need right now or demand from people out there already using G7 who are interested in Mobi, and we expect to see that materialize in the second quarter. That's probably a good question to start.

That's a great preamble. I guess the punchline I'll ask for is, I guess, Leigh, maybe we'll turn to you. Can you talk about how Mobi is contemplated in the guidance? And for both of you. I've heard you in different meetings in the past, talk about Mobi shifting share back from Insulet in terms of new patient starts. Can you give us any updated thoughts on how you think Mobi will play out in the market in terms of bringing new patients back to Tandem?

Sure. So when we set expectations this year, we took a little bit different approach knowing that we have all these products launching, we based the guidance on our recurring revenue stream. So the more predictable streams being our supplies, installed base driving the supply sales growth, the renewal opportunity was growing significantly, growing more than 30% this year. And so both of those are the major pieces that underpin the guidance -- the growth we set at the very beginning of the year, which was 10% year-over-year. With all the new products launching, and as John just described the dynamics, there was going to be a lot of variability in the first few quarters as we balanced what we thought customers or how they would behave in terms of their purchasing patterns. And so we had some pent-up demand from last year. We also knew people would be waiting for the next feature to come along. And so at this point, rather than try to put in anything related to a new product inflection, we left that out of the guidance. So we leave that as an opportunity to overachieve our baseline expectations. And so first quarter, we had a very strong first quarter coming out of the gate, and we're excited about how the year began. The rest of the year, we left the guidance with the same philosophy where it really just does include the baseline, and then we'll continue to see how the new products perform. But Mobi in particular, has been the star of the show. We have a number of new products that contributed to the outperformance in the first quarter, but Mobi is really, as John said, focused on attracting a different segment. And so we really think it will make a difference from a competitive perspective in driving us further into that MDI opportunity.

Super. And what you've also talked about as being kind of your key into getting the pharmacy. And so I was wondering if you could talk a little bit about your progress there and how you see that playing out? You mentioned maybe one formulary win this year at least and tell investors how it would work, what you perceive is the business model in the pharmacy? And what could we hear more about that?

Sure. So we need to anything about health care is very convoluted, especially when you start to talk about the differences between DME and the pharmacy channel. But I'll just start with our key goals as we go into the pharmacy channel are thinking about getting better access for the patients. So it's really about the out-of-pocket cost and addressing the affordability question. It's also looking for the opportunity to seek additional reimbursement for our products. In the pharmacy channel, much more value is placed on the data proposition that we offer with Control-IQ and so a year ago, the answer to the question would have been, we're working to see if a durable pump would be accepted in the pharmacy channel. Now we're very confident. There's not a question about whether or not a durable pump could be accepted. It's more to your point about the business model, how it's put on formulary, how that looks and what -- how it compares to other products in the pharmacy channel. And so I would say we are maybe shoulder deep in conversations with PBMs and different payers about the opportunity. So we're very excited and do believe that we will be able to announce a contract by the end of the year. There, we do not expect any impact in 2024 and probably only modest impact in 2025. The way we're focused on it is we're maintaining t:slim in the DME channel. We're looking -- we're thinking of Mobi almost as a pilot into the pharmacy channel. We have broad coverage already with DME. We're very focused on profitable access in that channel. And so we're not out there to just take any contract for the sake of having it. We really want to make sure it meets our goals and our objectives, and we'll continue to build up that presence with Mobi. But the ultimate goal, the end game here is to get Sigi directly into the pharmacy channel when we launch that. So we're in the midst of building the capability, as I said, having multitude of conversations. And so stay tuned on the progress there and what the business model ultimately looks like. What I can say is that it probably contract by contract will look different and it's a wide range of options that there are that exist. And it's unlikely that anything will be significant or material, I would say, in the coming -- like I said in the coming year.

Could you give us a little bit of a preview longer term what the pharmacy could do for you in terms of economics. We've seen both favorable coverage dynamics there. There's a lower cost to serve. And maybe talk about the reimbursement in the pharmacy back to Tandem versus the DME model too?

Yes. So we have seen, by example of other products in the channel that there is a premium placed on the products. And so we anticipate that we could get something higher than what we're achieving in DME today. Pharmacy is unique in that, though, you have to be cautious because as more competition goes into that channel, the plans start to play you against each other, if you will. So we're thoughtful, as I said earlier, about the type of contracts that we'll accept. We would not accept a contract that is not at least as good as the DME contracts we have in place, and some are very good today in terms of both reimbursement and access. We have a handful that don't even have an out-of-pocket cost and so they're very good for patient access. But we will look to optimize in the future from a pricing and a margin perspective with that -- with the foray into the pharmacy channel.

And the G7 integration is a nice win. Can you talk about that as a catalyst and also your integration with Abbott internationally in the U.S. this year. How could that be a catalyst for more people to come to pump therapy going forward?

Yes. I mean G7 is a fantastic product, it's much smaller than the G6, doesn't have a transmitter on it, and it also warms up much faster. And so there's definitely a lot of interest from the people who are using Dexcom sensors to move to the G7 system. We've always drafted off the -- our sensor partners, and I think that we're going to continue to see steady growth, improvement in growth as more and more people try the G7, they get accustomed to wearing the device 24/7 and they also get accustomed to the service and the benefits of working with a large company who helps you through this diabetes condition. And so they're more likely and more willing to consider pump therapy at that point in time. I think that the Libre sensor provides an interesting opportunity for us that if you look at the U.S. market in particular, there's about 300,000 to 400,000 people who use Libre sensor today that don't use a pump that have Type 1. So it's a large and underpenetrated market, completely underpenetrated. It really does represent this great opportunity for us. There are products that are available in the OUS countries today that use Libre 3 and they're seeing positive uptake. So it's not a question of whether the people who are using Libre sensors don't want pump therapy, they just want pump therapy with their Libre sensor. And so I think that as we've got Libre 2 now it's on t:slim, we're working to get Libre 3 available on both t:slim and on Mobi in the U.S. and the OUS markets. And when you look at our goals, we've indicated we have a goal to get to 1 million people using our product. When you have 300,000 or 400,000 people out there with other opportunities, it's going to be a significant part of that growth that we see over the next 3 to 5 years.

Do you have any thoughts on the percentage of Abbott's large base with sensors that could convert to pump therapy?

I mean in terms of percentages, I think if you just look at the -- we just said the U.S. market is about 35% to 40% penetrated. Why can't that just be a starting point, which it's 100,000-plus people in the U.S. and a much larger number in OUS. And then you look at type 2 it's even. It's a big opportunity for us. And I think it's a market development opportunity that we've got to get in and help the people who are using the Libre sensors, understand the benefits of our therapy. So you see just how much it makes you feel better on a daily basis, but also reduce the comorbidities that come along with diabetes when you're not in control. So there's this market development piece that we have to work with Abbott on, and we're doing that right now and it's both U.S. and OUS. But as I said, I think it presents a big opportunity for us in a point-on-point basis.

Can you talk a little bit about the competitive environment to Medtronics come out with 780G and it's working to use that to better retain patients and gain some new patients, and then you do have some new 2 pump competitors as well. Are you seeing anything shift there? And maybe you could talk about how you're countering that with the new product flow that you have.

Yes. I mean I think that in the U.S. and OUS really, I would say we have 2 main competitors, and they haven't changed. And we've experienced pressure from one of them over the last 18 months. And I think that we understand how to compete against it. We understand the benefits that the Tandem's product has. And I would say that in the situation when it comes to Insulet in particular, we did see pressure on MDI conversions. That's really where we saw the pressure. I think that with Mobi on the market now, and we do believe that Mobi is going to -- it's going to do much better in the MDI conversion market, and we think that's going to help us get back to where we were. I think that when you look at the Medtronic product, it's a much better product than the 670G. And I would say we would -- we believe that they're just retaining their own renewables better than they have in the past, but not a lot of MDI conversions I think are going that way. Other than that, I think that the new entrants, it's really they need to prove themselves still. It's early. They haven't been on the market that long. I think they've got to prove to the endos in particular, that they're going to be around for 4 years until the product is actually worthy of premier patients on. So that's still in the works, I would say. OUS, it's roughly the same. I'd say it's really primarily Medtronic and Insulet but there is [indiscernible] company that's got approval using the Libre 3 sensor in OUS. There's a bit of pressure from that. But I think that, as I said, when you look at our pipeline, and our pipeline is -- it's -- we are moving aggressively to get it into the U.S. markets. But equally as aggressive we did get these new devices and technologies to OUS. Because I think as they do get into the OUS markets, I think we'll see the same benefits as we are seeing here. And I think we expect that the OUS markets really will provide significant growth opportunities for us in the future.

And international was a bright spot for you in Q1, maybe I'll ask you to comment on a couple of things there. We love for you to comment on pricing and your assumptions there and guidance because it came in a little bit better. And then also maybe remind the audience where you are in terms of bringing your newest technologies in some of the larger markets international.

Sure. I'll start. From a pricing perspective, we did see some benefit. It's usually a function of geographical mix. So just who's ordering within the quarter. We had some benefit in the first quarter, particularly on a shipments perspective, we had telegraphed that in the fourth quarter when we adjusted guidance, some orders that got pushed because of the timing of the G7 launch outside the U.S. So there was some benefit there. What helped pricing too, we had some modest currency benefit in the first quarter and so last year was an unusual year because of our transition to our new distribution center. And so I tell people to think about the pricing that we were seeing a few years prior to that, which was on a pump perspective, more around $2,300 per patient. I think the good news though about this year, in particular, is we are through that distributor -- new distribution center transition. And so in years past, it wasn't very closely correlated to the orders that we would report or that the shipments we would report with what was going on patients in the end market. And so now you'll start to see a better correlation of what we report as an indication of true demand as we look ahead. So we'll take away some of that variability.

And then when it comes to the international -- the markets and just general in the pipeline, I would say that we understand the importance of the international markets. We introduced G7 in the U.S. and internationally at the same time at the end of last year. Obviously, we've got Mobi now that's available in the U.S. market. We're working to get it into the international markets wherein as quickly as possible. I would say that it's primarily a regulatory issue. There's really -- it's not technical from a qualification point of view. There's no studies or anything like that, that will be required. So we're going through the regulatory process to get into those markets, and we expect to get there as quickly as possible. We're also this year working on getting Tandem Source, which is our data management, our digital health application into the OUS markets, which will allow us to actually use a mobile app outside the U.S. as well. That's something that's going to be happening in the back half of this year. And certainly, we're working on Libre 3. We don't intend to bring Libre 2 to Mobi. We're going to go directly to Libre 3. And -- in the U.S. and OUS markets as quickly as possible. We have refrained from actually giving specific dates for competitive reasons. But I can tell you that the organization is really geared up and there's a lot of activity to get these new technologies into the OUS markets.

And maybe pivot and talk a little bit about margins, too. So this year, you set a goal to be EBITDA breakeven. And I was wondering, if you could maybe talk about some of the kind of toggle points that would lead you to hitting that goal or potentially driving some upside to it. And then also longer term, can you talk about the big margin drivers for the company?

Sure. I'll start with the long term, if you will, that John mentioned earlier, our goal is to have 1 million customers in our installed base and our margin targets established associated with that goal would be 65% gross margins and 25% operating margins. And so this year, in particular, with our goal to be breakeven on an EBITDA perspective. There are a couple of factors, particularly related to our new product launches. One is that we needed to invest in sales and marketing to make sure that we effectively get those products launch, create awareness and drive the growth. Also with Mobi being launched into the market, we're not yet building at scale. So in the first half of this year, in particular, we're seeing some headwinds as we ship Mobi product, that was factored into the expectations. As we exit this year, we expect to start to see it become accretive to the business. And so really, from a gross margin perspective, the first real step towards that 65% margin target will happen in 2025 as Mobi becomes a bigger piece of the business. And it's twofold. It's the pump first, which is about a 10% to 15% lower manufacturing cost than the X2, but also the cartridge has a much lower manufacturing cost. And so as the installed base grows, using the Mobi product, you'll see continued tailwinds on the gross margin in the future. And so new products are one of the main drivers towards meeting our long targets. Mobi is just step 1. We also have our extended wear infusion set technology. And as you think about it with every product in the design process, it's a goal to reduce the cost compared to prior versions of products that we have on the market. Our Tandem Source product, while we don't talk about it a lot from a revenue perspective, it does drive stickiness with the physicians, and it provides an opportunity for us to greatly reduce the cost to serve our installed base and our physician community and so when we look at it from a customer perspective, in years past, as our installed base was growing, we were ratably adding people to support that base with Tandem Source providing opportunities for more efficiency, more automation for addressing phone calls that were coming and that we don't have to do manually anymore. So for example, someone can place their orders online, make payments online with Tandem Source and so as that rolls out and becomes a broader piece of our business, you'll see more leverage on the operating expenses going forward.

Super. And then we're almost out of time, but John, you talked about a really exciting pipeline. I was wondering if you could just touch on Mobi tubeless and Sigi and bring us up to speed on the progress there?

Well, we acquired Capillary Bio about 1.5 years, and it's a company that's making an extended wear infusion set for us. And the set is right now in clinical studies. And so we've got this team of engineers that understand how to deal with sort of the infusion site, the cannula and those sorts of things. And we've redeployed them onto Mobi tubeless, which is great. So now we've got a team of Tandem engineers and the Cap Bio team working aggressively to get this to market. We think it's a really important product. We think that Mobi by itself is going to help us return to the success rate that we've had in the past with MDI conversions. But when we have Mobi tubeless, that just provides a real significant enhancement in terms of the wearability. And we think that's even get more people who are interested in pump therapy to come because of the benefits of wearability. So that's something that is important. We're moving aggressively to get that. And we've also acquired a business called AMF Medical from Switzerland. They have Sigi, which is a patch pump that's small, has a very low profile. It's rechargeable and it uses a prefilled cartridge. So it has a bunch of benefits, and you can take it off if you'd like to. It's a device that will last for roughly 4 years. And so I think that there's benefits of rechargeability, I think that have to do with the environmental benefits. You're obviously not going to be throwing the single way every 3 days. And so I think that there's a significant appeal, particularly in the European countries to having environmentally sensitive devices and the simplicity of change in the cartridge, it just takes a few seconds. So I mean, again, this is another enhancement for wearability. And I think Sigi is out a little further than the Mobi tubeless device, but I think that these things will be coming in the cadence of introductions over the next couple of years. And we think that with that portfolio can really help people living with diabetes and really convert this market of people not using -- using pens and needles over to using the pumps because the pumps have such as, again, a substantial therapeutic benefit. We want to see people's lives improve and we think that our portfolio device is going to get us there.

Great. John, Leigh thanks so much for your time, and thanks, everybody, for your interest in Tandem.

Thank you.