All set here on our side.
Okay, we're just making sure we're recording. All right, good morning, John Block at Stifel. And, you know, obviously we're just talking to John, but happy to have John Sheridan, President and CEO, and Leigh Vosseller, CFO, join us virtually for a fireside chat. As you just heard, they were looking forward to being here in person, but flight issues, they're not the only ones.
Thank you to Tandem, thank you to Tandem for being flexible and still keeping the fireside chat. John and Leigh, I just thought I would start open-ended and really jump into things. You just reported Q3 2025 results last week. It was a solid quarter, some outperformance relative to the street aided by price, but U.S. pumps were slightly down year-over-year. Maybe that's just a good place to start. If you could just talk to how the quarter played out versus your expectations, and then we'll go a little bit deeper after that.
Sure, thanks for the question, and we're happy to be here today. I'll say the quarter played out pretty much according to our expectations, particularly when you look at the volumes that came to the market. As we had talked about at our last call, we're going through a major transformation in the U.S., and it has created a bit of turbulence. We've seen the green shoots of changes in the velocity of the sales rep becoming more productive, really beginning in the third quarter as we go to the back part of the year here in the fourth quarter, which is usually our biggest quarter.
It's a good sign as we step into that. The outperformance in the quarter, though, what was really exciting to see was really the benefit that came from the pharmacy channel. We saw improved pricing in the third quarter beyond the expectations we already had for ourselves. In the first half of the year, the pricing was really more from DME benefit, but in the third quarter, it truly did transition more to the pharmacy benefit. I can attribute some of that to the fact that we were able to launch t:slim supplies in the pharmacy channel in September. That was a bit ahead of our expectations from a timing perspective.
That was great. Thanks, Leigh, for that. I'll get a little bit more about the price in a bit. I do want to follow up on one thing. I think on the call, you mentioned September was the strongest month for the quarter. To push you, you know, any momentum to call out so far in Q4 2025 or any commentary around October when we think about sort of that jump-off point that you alluded to in September?
Yeah, so I would say when you think about September being the strongest, that's the normal cadence of sales. What typically happens, especially as we get to the back half of the year, is month-over-month, you see increases all the way up through December, which is by far the largest month of the year. We're not going to speak to any particular intra-quarter trends for the fourth quarter, but we still feel very confident with where things are in terms of meeting the expectations that we've set.
Okay, fair enough. I'll jump around a little bit on you guys. I do want to talk about Mobi. Pharmacy reached 5% of U.S. revenue in the quarter, and that was essentially all Mobi or almost all Mobi, Leigh, as you just mentioned, because t:slim supplies were not available until September. Just to sort of level set, how do we think about Mobi as a percent of U.S. pumps in the most recent quarter being the three Q 2025 that was just completed?
Maybe a bit of a surprise, but really when we looked at the pharmacy benefit, it was almost as much from t:slim supplies as it was from Mobi. I think it's an interesting point. Mobi has been the only product in the pharmacy channel, obviously, up until September. When you look at t:slim supplies, the supply sales are such a large part of our business, it doesn't take much penetration at all to really get that benefit. I would attribute it more to t:slim supplies, even though there was benefit from Mobi, continues to progress as a, you know, from a shipment perspective and from a pharmacy perspective. t:slim really was the thing that helped us get over the edge here this quarter.
Okay, so you just changed the cadence of my questions. I'm going to jump around. That's really all good. That's really interesting. So one month of t:slim supplies being September, just because of the big installed base, right, and the opportunity there, it was sort of an equal contribution, if you would, to Mobi for the quarter. So just help us with, you know, how does that play out going forward? Right now, you're going to have a full quarter in Q4. It's going to ramp from there. Maybe just talk broadly about the early experience that you guys have seen from bringing t:slim supplies into the pharmacy channel?
Yes, I really love this question because it does highlight how powerful this business model shift can be for us as an organization. Maybe stepping back just a second, we came into the pharmacy channel with a lot to learn. To your point, we needed to understand what does pricing really look like. We've seen in the competitive landscape that it is improved over DME. We needed to confirm that really could be better for patients from an out-of-pocket perspective. We were seeing that with Mobi as we were building up traction.
Again, even though small volumes, everything, you know, was checking all of the boxes, which is why we decided to go ahead and shift t:slim supplies into the pharmacy channel because of that broad opportunity. You know, with 300,000 people on the installed base in the U.S., that's something that, you know, a switch we can turn on much more quickly as opposed to just bringing new pumpers through. This is just the very beginning. We are still gathering data and trends to understand better how fast we can make this type of conversion, but it does really show the power of pricing and something that we know can be a multi-year benefit for us going forward.
It certainly shows the power of being in that one month to your earlier point, Leigh, of the equal contribution. I'll try to push you on a couple of things. And quite honestly, for me, from my seat and getting sort of up to speed on the name, this is something I struggled with, like just not having that line of sight or visibility. What percent of t:slim supplies are through pharmacy currently, approximately?
Sure. Two things you'd asked that I didn't address particularly too was the Mobi mix and the t:slim mix. We are not going to break down that mix, whether it's in shipments, volumes, % of pharmacy. It's still just very early when you look at it as 5% of our overall sales. As we look ahead, we'll continue to evaluate what data points we want to share with the market to help understand the complexion of the business. It's still an evolution at this point. We are still working through the best way to describe this.
What we can say is that it is proving to be beneficial. I think it's going to be very positive, especially as we think about 2026. I have told people, you know, from a modeling perspective, if nothing else for right now, look at the pricing that we were seeing in third quarter for pumps and supplies and think about that as a good baseline. We had mid-single-digit year-over-year improvement in price. Also, it's a fair way to start 2026.
Okay. Maybe just to try to push you a little bit more, that approximate premium for Tandem when the t:slim supplies go through the pharmacy, in other words, it seems like you're not going to give us the percentage. How do we ballpark the premium? Is it a 20-30% premium? Is it much greater and closer to, you know, the contracts of some of your pay-as-you-go competitors? How do we frame that premium that you're experiencing in the pharmacy channel specific to t:slim?
Sure. Clearly not going to give you the price uplift. There is a lot for us to think about as we evolve the business. We also want to be careful about the negotiation opportunities and competitive dynamics. It is fair to point out that the competitors are at a certain place, which is a good peg point and something that we would aspire to be. We look forward to giving you more information in the future as how this weaves into our business model.
Okay, fair enough. I had a try, but I'll move to some topics that I know you guys want to talk about. Maybe that's the pipeline. John, maybe I'll throw this back to you because the pipeline is certainly robust and maybe four or five things to tick through. For tubeless Mobi, you mentioned on the call 2026 approval, but any more details you can give on the timing? In other words, do you expect to submit the 510(k) before the year end? Are you going to notify the street if and when you do submit the 510(k)?
Yeah, we're very excited about extended wear Mobi. It's going to be the first extended wear patch on the market. And, you know, our testing has scored incredibly well. Great market preference share increases when we have Control-IQ, but when you add extended wear, it's even higher. In the situation that we're facing today, you know, we have SteadiSet, which is the infusion set, and then we have tubeless Mobi, which uses the same technology to enable us to have extended wear.
What we've decided to do is we're going to prioritize the implementation of Mobi tubeless over the commercialization of the SteadiSet. You know, we're doing everything we can to pull Mobi tubeless into the timeframe. I think that we certainly feel comfortable with 2026. I don't think we're going to give any information today that's new other than that. I think we'll stay tuned for the call in February. I think there'll be a lot more information about the 2026 pipeline at that point in time.
As I said, we understand the importance of the tubeless Mobi for our overall performance. We think it's going to be a highly competitive product and really drive, you know, double-digit growth and also profitability. Excited to see it come to market. It's absolutely going to happen in 2026. We just haven't been specific about when.
Fair enough. Let me try a little bit of a different angle. I'm going to jump out of the pipeline and then I'll go back to the pipeline because, again, there is a lot to talk about there. But Leigh, let me just sort of take John's commentary. And then on the call, I think what you discussed is think about new pump growth in 2026 as being back and weighted. I know in our model, we're down in 1H26 for new pumps. We've got growth, the resumption of growth in 2H. And our thought process there is that tubeless Mobi will help that process.
So, you know, do we think about tubeless Mobi being available commercial in 2H26? And then, Leigh, while I'm going down that road, is it sort of the inverse for the renewal opportunity, right? You still got the tail, but that tail will more dissipate in the back part of 2026 than the first half. Is that the right approach when we think about the new pump cadence and the renewal pump cadence specific to the U.S. for 2026?
You know, I think that's a very fair takeaway. To that point, the renewal opportunities year-over-year are flat. When we look at the tail, there is likely higher growth opportunity in the first half of the year than the back half. The one thing I would like to highlight, though, on new pump starts, I would not put it all in the bucket of Mobi tubeless. We do not need Mobi tubeless to get new starts to grow again. We have a number of other opportunities as well. While we are excited about tubeless and we think it can bring a lot of great benefit to the business, I just want to make sure people understand that there are other great opportunities, including FreeStyle Libre 3 plus.
There is the Type-2 indication. There is Mobi Android, which was just approved. There are a lot of ways we can grow new starts next year. I would say Mobi tubeless, you can just call it the gravy on top. All of these coming together, they are all in different phases of rollout and launch, which is why I would say, as you described it, you can think about the cadence pushing it more back half weighted in terms of that growth.
Okay. That was great. It's almost like you had my talk track because you gave me a good segue to go back to the pipeline. I think you got t:slim in Libre 3. John, how about the timing of Mobi in Libre 3 on that integration? Anything that you can give us there?
As you know, we just released the commercial launch of FreeStyle Libre 3 with t:slim. You know, as we've talked about, Mobi is, we're just unlocking the capabilities today. We've got Mobi with, you know, with iOS and Dexcom. We now have Android. You know, we expect to be in the OUS markets early next year. We expect also to have FreeStyle Libre 3 integration and also Mobi tubeless integration. You know, it's not far off, but we're not going to say specifically again back to the comment. I think this is something we'll probably say more about on the fourth quarter call in February.
Okay. Just to tick down the list within pipeline, you did discuss on the call fully closed loop pivotal trial to start next year. Is there a little bit more context that you can provide on what that will entail? Maybe more importantly, obviously, a lot of companies are going to go down this road and pursue fully closed loop. You have got a great algorithm as a sort of a tailwind behind you. What is going to be the ask or the bar from the FDA and the scrutiny that they are going to give this year behind fully closed loop just when we think about what the agency will demand?
Yeah, I mean, I think we have a unique vision when it comes to fully closed loop. We do think this is the North Star. This is the thing that's really going to unlock the overall performance of the company. I would say the way we're looking at it is that we want people to be able to interact with a pump as much as they want or not at all. I think that's a unique version when you can look and consider other technologies that are coming to market. As you know, we've been working with UVA.
They, you know, I would give them credit for helping us get Control-IQ to market. We started back in 2017 and got it to market in 2020. One of the reasons we started to work with them is they have a great algorithm, but it also had the most significant clinical data at the time. What that means is the FDA is very familiar with this data. Every single time they run a feasibility study or a small study, they have to get approval with the FDA and they have to share the data with them. Today we find ourselves in the exact same situation with their fully closed loop algorithm.
They have the most data. That data has been carefully reviewed by the FDA. There is nothing really for them to learn. All that is going to happen now is we will be implementing that algorithm onto our system. That's really where all of our effort right now is, is to get the algorithm implemented onto the pump so that we can begin the study in the 2026 timeframe. Just to give you a sense of what happens, it's going to take us a few months just to work out the agreements. There's a lot of work that has to get in place just to start the study.
The study itself will take at least a year. It's going to be a very comprehensive study that we would include Type-2 people, women who are pregnant. There's a lot of a larger, I think, size and diversity of entrants and people who will participate in it. That's, like I said, at least a year. Following that, it's about another six months to get the FDA to review it.
You know, we've been bringing them with us all the way forward and we have in the past. I think that just goes a long way to giving this confidence that the product will be received well by them and they'll have understood it and there won't be a whole lot of questions.
Okay. That was perfect. That was a lot of incremental. Thank you, John, for that. Maybe just one more down the pipeline road. On the call, there were sort of some comments around SIGGI in terms of giving, I think the framing that you used was giving tubeless Mobi room to run. You know, I think some may have viewed that as a little bit more conservative in regard to the SIGGI timeline.
How would you answer that? Is it like, look, we've got a fulsome pipeline and we want to take advantage and we don't want to shortchange tubeless Mobi here. For some of that incoming, would you push back on that or how do we think about that SIGGI timeline in regards to the commentary?
Yeah, I think that we have, I mean, I think the ongoing enthusiasm about Mobi tubeless really has led us to have a lot of confidence that it's going to do very well in the market. I think that, I mean, this is a question I've received quite often in the past, is there doesn't seem to be a lot of difference between Mobi and SIGGI. You know, the last thing we want to do is create confusion in the marketplace. I think you combine the fact that we think this product's going to do very well, the desire not to create confusion in the market, and then secondly, we just, we have this great technology.
You know, it's back into San Diego. Our team is working with both technologies and they've really, you know, there's a lot of opportunity, I think, to combine the best of both. You know, there's synergy as the team starts to look at it. If you look at Mobi, for instance, there's no reason we can't use the software that's currently been developed for Mobi on SIGGI. SIGGI has a lot of technology that helps miniaturize the system that we're definitely learning from.
You know, I think that we, you know, in my mind, it just makes sense. Let's give Mobi tubeless the opportunity, you know, to do well in the marketplace. Let's let it run for a while. I think that we'll be looking to develop an even better product that won't be, you know, won't be that long, but we'll have an even better product on the marketplace in the not too distant future after Mobi has done well.
Okay. We're going to call our look to the audience to see if there's any questions on pipeline or anything else to date. There's not, John and Leigh, so I'm going to press forward and I'll pivot a little bit to competition. We were not out with coverage yet, but, you know, we were listening to the 2Q 2025 earnings call. I thought on that earnings call, you talked a little bit about the market pausing a bit with new competition.
This go round in the third quarter conference call, I did not really think this theme was nearly as prevalent, you know, last week. Maybe it's a good opportunity just to sort of say to you, you know, can you provide us with an update on the competitive landscape and what you're seeing out there? Maybe I'll ask more specifically about one or two players.
Yeah. First of all, it's a very large and expanding market, not very well penetrated. You know, it's not a zero-sum game. We think that everybody can do well. There will be new entrants. I think the market has so much opportunity. It's not a surprise to see new entrants come to market. It's still very noisy, very competitive. I think that, you know, we have primarily two competitors, two large competitors. We have a new entrant who's scaling.
We have a startup that's just getting started. I think there was quite a bit of noise about the Salesforce, about their efforts to get into the market back after ADA. I think that, you know, every time a new product comes to market, you just need to be cautious because there typically is pausing. You know, I'd say that in this particular situation specific to them, you know, we know they're there. There are, you know, if you go into various endo practices, you'll see, you know, marketing materials and promotional information around there. We know that the physicians are beginning to sort of evaluate the product.
There's probably some pausing going on right now. You know, I think it's really early. You know, I would say that, you know, we need some more time, I think, to get more specific information. I think the fourth quarter is going to help us. You know, right now, I'd say it's early. They're definitely there. You know, I think that we'll just see how things go this quarter.
In my words and not yours, but I mean, I was at ADA and there did seem to be a lot of excitement around that startup. Would you say some of that fanfare may have abated a little bit specific to the third quarter relative to the second quarter, which was sort of fresh coming out of ADA?
I certainly think there was a lot more, you know, just a lot more information that had come out of ADA. There has not been another large conference since then. There has not been the opportunity, I think, to talk about it. I would say that is definitely true. But, you know, I think we are, you know, we are seeing it in the market. We just need a little bit more time, I think, to assess the impact and what the uptake is like. We know physicians are absolutely evaluating it, though.
Okay. Fair enough. Let me tie some of those comments back to the guidance. Leigh, you know, the 3Q outperformance certainly helped lower the bar for 4Q. You kept the billion dollars intact and the split between the $700 million and the $300 million. You know, you still got sort of 30% of the pumps in the fourth quarter. Now with your business model, I believe I've got this right, you know, with Mobi, you'd have a greater percentage going through pharmacy, which has different seasonality or diminished seasonality relative to DME.
When we think about what happened last year, you know, Q4 2024 and less seasonality, right, with Mobi through pharmacy and still that startup out there and another new competitor scaling, I guess it's a very long-winded question of saying, do you think you properly calibrated these changes, these different variables when you went ahead and updated the street for Q4?
Yes. Yeah. The short answer is yes. I think that we did properly think about all those elements. I want to point out a few things with Mobi. Again, as very small volumes, I think it's too soon to change the outlook on the seasonal curve for the business. Even as we look ahead into 2026, I think we'll still see a pretty substantial step down from Q4 to Q1 as we've seen in years past as we're building up this pharmacy capability.
Secondly, I'll add that renewals are a major piece of what underpins that fourth quarter step up. Last year we did see, I would call it muted seasonality at the end of the year, but we factored 2024 seasonal curve into our 2025 expectations. I feel like we've thought about all those moving parts. We do have the pharmacy benefit, which I would say what we've anticipated in the fourth quarter mostly benefits the supply side. That is where we expect to see the incremental pricing benefit, very similar to how Q3 played out.
We feel good about the fourth quarter and also the competitive environment. That was part of the, if you want to call it, the adjustment we made to guidance where we rebalanced US and OUS, thinking about the fact that there could be some competitive noise out there. All those pieces were factored into our expectations.
Okay. Fair enough. I want to talk about Type-2 opportunity. And, you know, John and Leigh, to your earlier point, you said, hey, the resumption of new pump growth isn't all about tubeless Mobi and 2H. I'm guessing getting more aggressive in Type- 2 could also aid new pumps. The company recently moved from pilot to full promotion, maybe just a level set. What were the learnings from the pilot and what did it tell you or inform you on how you plan to attack the T2 market?
Yeah. I mean, I think first of all, we're very excited about the market. When you look at it, it essentially doubles the market size for us, which is a great opportunity. It's very underpenetrated. I only think that there's roughly 2.3 million people in the U.S. who have insulin-intensive Type-2 and only about 5% use pumps today. Great opportunity. I, you know, we did learn a lot. I mean, we're leveraging that. There was a lot about the marketing materials and promotional aspects of the pilot. Training and sales execution were all things that we focused on.
You know, I think that we got very positive feedback from physicians as we went through it. You know, we saw great results in our study and I think we were able to recreate those same results with people, you know, in the real world experiences that we've had. We saw immediate and sustained improvement in their blood sugar control. We also saw people, you know, sort of they definitely saw the advantages of the improved simplification from the bolusing process, which was a big step forward.
As we've talked about, there's a lot of synergy between Control-IQ and GLP-1 use. A lot of good lessons and I think that certainly we're seeing. If you look at the territories that were actually in the pilot, they had significantly more Type-2 adoption. That's one of the reasons that we've decided to expand it to the entire country. I think there was a preference for the screen display and the 300-unit reservoir, you know, in the early use. And, you know, the fact now that we've got two other competitors that have approval, you know, it's a market development initiative. We basically have to get out there and help people understand the benefits.
I think we're off to a really good start. You know, I think the pharmacy channel and tubeless Mobi is also going to help as we move into 2026. You know, I think things are, you know, moving to a full commercial launch was the right thing to do. We do expect to see meaningful growth from Type-2 over time. I think that, you know, we're starting to knock down the barriers and, you know, improve the opportunities for the business.
From that pilot, John, did it tell you anything or change your thought process on where you need to lean into? In other words, are you still just leaning into the endos? Do you feel like you have to go a little bit more aggressively after PCPs? Do you have the right sales force? Any changes or tweaks coming out of the pilot down that road?
I would say that when you actually look at Type-2, insulin-intensive Type-2, many of them use endos. Starting there makes a lot of sense. I think over time, we definitely will need to, and, you know, advance ourselves into the PCP market. I think that's something that we're looking at. We haven't communicated any changes or, but I think we're definitely evaluated. We typically wait till the end of the year to assess the sales force and the sales force productivity. Now that this is moving into the full commercial launch, it's something that we'll be doing here as well.
Okay. Maybe just one or two more down the Type-2 opportunity. You mentioned earlier the 5% of T2 IIs, you know, again, coming out of that pilot and your learnings, would you want to go ahead and guesstimate, you know, where that can land in terms of penetration over the next three to five years when we think about the opportunity there?
Yeah. I think that, you know, our sort of market development team has been looking very closely at this for the last couple of years. When we first got started on the initiative, I would have said it was probably like 5% going to maybe 15%. Now that AID has been on the market for quite a while, people are seeing the benefits of it. They're seeing that these are small, discreet, easy-to-use devices that produce great results.
You know, people that have insulin-intensive Type-2, it's pretty much the same as Type 1. I think there's more willingness to consider the technology. I would say now we have a more bullish attitude about the likely penetration. We think it can get up, you know, north of 25-30% over the next couple of years, which is a big number and a big opportunity for all the companies that are working to provide technology to support this group.
You feel like you now have the sales force and obviously, in the not too distant future, the complete product portfolio to properly go after that segment of the market
Yeah. I think that, you know, we feel like, you know, we're moving in the right direction from a portfolio point of view. We're constantly evaluating the sales force. You know, I think that as we move forward, I'm sure at some point in time, we'll consider adding. Right now, we're just in the evaluation phase.
We got about three minutes left. I want to make sure I hop over to international, right? A lot going on and moving to a direct model in some countries. Just sort of your, you know, blanket question of why now in terms of the move to direct? Maybe you can elaborate on that. And then Leigh, I'll sort of bug you a little bit on some of the nuances behind the ASP premium.
Sure. I guess I would say part of it is just generally speaking, it's the right time at the stage of the business that we're in. Just part of our maturity life cycle, we've been getting good information about the markets. We've been there now, first launched in 2018. Some of the larger markets were in 2020. Quite a bit of experience about how these markets operate, the way to sell into them.
The other piece then is, as you think about it, in specific markets, why we go to certain ones first and some later would be time based on, for example, when our distributor contracts are up for renewal, when tenders are up for submission. Those are other factors that play into which markets we pick at which cadence.
Okay. On the call, you talked about the 30% ASP premium that you'll capture by going direct. Of course, you're now also carrying the OPEX cost, right, versus the distributor model. When we take the ASP premium and we also factor in the OPEX, are these, I call it accretive in the first 12 months? How do we view that through the P&L?
Sure. First, I'd like to say at least 30%. That's the floor, if you will. It will vary by market, but that's the minimum that we expect to see as we transition in the different markets. We've actually already started incurring some of those costs this year. We did take a little bit of a step backwards from an EBITDA perspective because we haven't turned on the direct sales yet. As we look ahead, we look to at least maintain that and then improve it as we build up the revenues in those markets. Investments have already begun. We're excited as we turn the corner into 2026. We feel good about the contribution this will bring to the bottom line, even with the investments we need to make.
Okay. Very helpful. We've got one minute left. I'll pivot to some 2026 metrics. You guys were very helpful on the call giving some color in particular areas. One of them was just sort of gross margin, right? Exiting, I think it was 60% 4Q26. You and I discussed this a little bit, Leigh, earlier, but like if you go through that cadence, it's really hard for GMs not to be up at least roughly 300 basis points, 2026 versus 2025. Maybe let me pause there and say, you know, can I do some work around the cadence correctly? Is that a fair assumption?
Yes, it is a fair assumption. As I said earlier, same seasonal scale, we usually see a step down from Q4 of this year into Q1 of next year, but it will build up across the year for a couple of reasons. One, just as pump volumes grow. Two, pricing will start to create even greater benefit like it has started to do this year. Three, as we continue to scale Mobi volumes, we will get more and more leverage on the overhead. Between Mobi pumps and supplies, they will become an even greater contributor to gross margin.
The last question and kicker, so that takes sort of your 3% normalized, you know, adjusted EBITDA margin in 2025, almost bolts on at least 300 basis points. But then on top of that, we should see OPEX leverage because it seems like that is coming to fruition in Q4 2025. You're getting greater productivity out of the sales force. On the back end of that, you're also doing, it looks like, some restructuring work as well. Is that a fair assumption to extrapolate to 2026 on the OPEX leverage?
Yes. I'll say we've already talked about the international business where we'll start to get benefit from the top line dropping through. Also, part of our commercial transformation, it was not just about expanding the sales force and the new tools and the systems. It's about more automation and improvement of the processes for the internal teams. In the past, I would say an increase in install base equaled an increase in headcount. Going forward, we should be able to support a much larger install base at current headcount levels. That's where you'll begin to see the leverage in the U.S.
Okay. Okay. That was great color. Sorry to run one minute over. You know, I'm sorry I couldn't see you guys in person, but again, we really appreciate the flexibility of doing this virtually. Thanks very much for your time.
Yes. Thank you.
Thanks, John.
Take care.
Good luck in the rest of the conference.
Appreciate it, John.