Thank you. It's nice to see everyone today. We appreciate you having us here. I'm just going to give a high-level overview of the company, what we do, the markets we operate in, and then we'll dive into some questions. We are with Tandem Diabetes Care, and we operate in a large and underpenetrated market. We have a great opportunity to continue to drive business growth. It starts with type 1. That's the market that we've operated in for the longest period of time. In the U.S., there are about 2 million people living with type 1 diabetes, and only 40% of them today use pump therapy. That means there are 60% of people that we can still meet the needs for through our products, through our business channel approach, through our market model.
Outside the U.S., the type 1 market in the countries where we operate has about 3 million people living with type 1 diabetes, and even less penetrated, less than 20% of people on average are using pump therapy today. We were proud to announce this year that we have actually doubled the size of our market opportunity in the U.S. with our type 2 indication. Now there are 2 million people living in the U.S. with type 2 diabetes that we can go out and attract to our therapy. Only about 5% are using pumps. As I said, a large opportunity for us to continue to grow the business, even with multiple competitors in the market. The way we have competed up until now, we've historically been focused mostly on product. Our thesis is ease of use, simplicity, and flexibility and choice.
In recent years we've added more choice to what we offer. We now have a portfolio of products. We have two platforms on the market: t:slim X2 , which has been around for a number of years, and Tandem Mobi , which we introduced last year in the U.S. We're very proud of what these offer. They meet different needs of people living with diabetes, and we will continue to drive that. We have more platforms in our portfolio in the future with our very rich pipeline. We have one of the richest pipelines in the diabetes space. We are expanding our business model. How are we going to grow differently? How can we drive that top line even further beyond just products as our entry into the market? We are very focused on how we approach the market in terms of the medical benefit versus the pharmacy benefit.
DME products have traditionally been a DME benefit product, but in recent years, there's been more of an openness to receiving them into the pharmacy channel. That's very important to our business model for a few reasons. There is some pricing benefit, which can help from a top line and a margin perspective. The most important thing that it offers to us is the ability to address one of the primary barriers as to why people do not adopt pump therapy. That's the out-of-pocket cost for the patients when they want to move to pump therapy. With the different rebating and tiering system that they have, combined with co-pay assistance, we can increase our reach to customers who have not yet seen pump therapy as a viable option through today.
We are also expanding and modifying our business model outside the U.S., where we have relied on a network of distributors up to now. We are looking at evolving that business model as well, and we'll be going direct in certain key markets beginning in 2026. That allows us again to optimize our revenue growth opportunity as well as our margins. I've mentioned margins a few times. We are keenly focused on driving top line, but expanding both our gross and operating margins simultaneously to really show that we can grow with a viable, sustainable business model. Today, we're proud to say that we do serve almost 500,000 customers worldwide, and we never get tired of meeting people on the street, meeting people in the wild, and hearing them say that our pump has made a difference in their life. It is a life-changing technology. Thank you, Bill.
If you want to, we'll turn it over to you for some questions.
Great. Thank you for the overview. That's, I think, very helpful. I'm going to start out with numbers that I'm going to work through, but I just want to start out with guidance. Obviously a tough week for the stock. I'm sure you're feeling that. You reframed your fiscal year 2025 guidance to be $1 billion. Step down in the U.S. to about $700 million. Step up for international markets. First, walk us through what you're seeing today. Kind of, why didn't you just lower the guidance? I've gotten that inbound feedback. They're like, should just lower the guidance and reset the bar because we're resetting it anyway. What are you seeing today in the U.S. and why the step down in expectations? We'll start there.
Okay. I'll respond to your comment about a tough week in the market for the stock too. There is a significant disconnect between everything that we offer as a business, as I just went through the overview, the breadth of the market, the way we're approaching the business and the market, and just where we are in terms of our growth and profit opportunity. It's pretty interesting how the stock does not seem to reflect anything that we offer today. When we looked at guidance, we did adjust. It is still within our original range of expectations, just at the lower end of that range at $1 billion in sales. I'd like to comment first, not go straight to the U.S., but actually the markets outside the U.S., because that's where we actually increased our expectations for the year. We've been seeing great strength in those markets.
We are competing very well, and this is mostly coming from new people new to pump therapy. We have yet had the opportunity to really capitalize on the recurring renewal revenue stream like we rely upon in the U.S. There we're still seeing attracting a great deal of people from MDI and competitive conversions, but we did this year start to see some real traction from the renewal opportunity. It's just the beginning of a recurring revenue stream to come in those markets outside the U.S. As I already mentioned, we also are transitioning to going direct in certain markets, and this year we anticipate that that will create a headwind in sales as we prepare and our distributors prepare for that transition.
We had originally estimated about a $15 million - $20 million headwind this year in particular, but now, as we've gotten more information, we've become more confident that it will be more around the $10 million mark from a headwind perspective. We were very excited to share that the OUS business is doing very well, and we had increased confidence in our expectations there. Now I'll flip to the U.S. business, which is what you actually asked, and talk a little bit more about that reframing. You can really break it down into two pieces, if you will. There is a piece that I would say well within our control, and it's about a commercial transformation that we're executing on. People have asked, why are you doing this? What's the importance of it?
It is very important for us to make this change for our next level of growth for the organization. We have to be able to scale appropriately. It started with a Salesforce expansion. It's also about putting new tools in place for our Salesforce, for our internal teams where we have new systems. It will help us to operate much more efficiently in the future, and also as we pivot more into the pharmacy channel. This was necessary for us to do, and it was necessary to do at this time. What we saw, though, was that we expected more benefits to come more quickly, I would say. Where we are, as we look back over the first six months, the benefits are going to take a little longer time to realize.
That's part of what we factored into the expectations for the remainder of the year, that those benefits are going to be extended over time. In 2026, we expect to really reap the benefits of what we're doing today. The second piece of this I would point to is more of an external factor. It continues to be a highly competitive market. There is a new entrant this year. When we came into 2025, we fully expected that they would be launching this year, but what we learned more recently was the size and scale of their launch. The number of people they expect to have in the field is more than double what we originally anticipated.
If you follow the diabetes space, you will have seen over the years, anytime a new entrant comes to market or a new product is introduced, there tends to be some dynamics that create a little bit of turbulence. It's not really about the long-term competitiveness of us with the new entrant. It's more about the near term with physicians and patients alike, understanding what that product has to offer, digesting it, wanting to see it in the market before they make decisions. Many times it can create a pause in terms of timing and when people might make their pump purchase. Those factors together we factored in. I think it's important to say we haven't seen this turbulence yet. We haven't seen evidence of pausing. We're just being cautious because we've seen it time and time again, and it makes sense for us to factor it in.
Those are the pieces that went together to reframe the US. There is one really exciting benefit for us in the fourth quarter of this year. We have entered into the pharmacy channel with Mobi only. As Mobi's been building up volume, we're getting experience, and we're really learning and understanding what pharmacy offers to us. The proof points have proved out the thesis I said earlier, which is it can really reduce that barrier for patients, which is the out-of-pocket cost. We have decided to accelerate our strategy, and where we were starting just with Mobi, we are now moving t:slim supplies into the pharmacy channel. That will kick into gear in the fourth quarter.
As people are looking at the cadence of sales for the remainder of the year with this reframing, many folks are seeing what looks like might be an outsized fourth quarter and having trouble understanding those dynamics. It is more about when you do the normal building blocks, your renewal scaling, your typical seasonality, but it is the addition of this pricing benefit that we expect from this entry into the pharmacy channel with supplies.
I think, to jump around a little, you mentioned you have contracts with about 30% for pharmacy, which is that those supplies shift to pharmacy, not all of them, just the ones you're contracted for today or by then.
That's correct. That's correct. That's a good point you make there. We do have coverage for 30% of lives in the U.S. These are actual contracts, not just with PBMs, but with payers. We'll be adding the t:slim supplies to those contracts. We also have more coverage. We will have it in the coming weeks, effective this year. We will be increasing that 30% rate before the end of the year. Obviously, everyone's in the same cycle right now, already negotiating and discussing their 2026 coverage. 30% is the floor. We do expect to continue to grow that coverage in the coming years and ultimately have much broader access.
I think we had an investor dinner last night, and this is coming up a lot, just Tandem in general. I think for the investment community, especially those that have been investors in the company, the opportunity, the breadth of the product offering, the type 2, but it's like, we look at the new patient flow from some of the other competitors, and they're doing a little better. Where's the disconnect between the portfolio, the offering, and the competition, and the execution? I know you've said the tools and expanded the sales force, but I think we're still confused from the investment community of what exactly is going on. It seems like with just the product set, it's the broadest out there, right? Now you have type 2, you're the only second player with type 2, but it's not really a contributor.
Is that just you had, we'll start with type 2, you had a launch there yet, or kind of what's going on? We'll start with that.
Okay, so maybe I'll just broaden, and then we'll talk about type 2 in particular. I think what you're touching on is part of our evolution. We're on the cusp of many of these things coming to fruition. This commercial transformation, this was the right time. It puts us in the right place to capitalize on these other opportunities. For example, we have Freestyle Libre 3, which is in early access. We have type 2, which is in a pilot launch. We have pharmacy, which we are rapidly expanding. All of these provide tremendous opportunities for us going forward. It's a matter of where we are today. I think importantly, these are execution items, so they're within our control. We're not subject to outside factors that we can't manage or deal with. These are things that we can control how we move through them and how we capitalize on them.
Maybe, Susan, if you want to talk a little bit about the type 2 pilot in particular.
Absolutely. For type 2, we got the indication in March, and at that time, we had a publication in the New England Journal of Medicine. It highlighted a few things. First was our ability to successfully demonstrate positive clinical outcomes when people were able to simplify their bolus process using fixed dosing. Oftentimes, the bolus process can be very intimidating for people, especially if you're not used to diabetes management. For type 2 in particular, it's a great feature to be able to promote. The other was ease of onboarding. At the time when somebody's starting a pump, rather than needing to enter a series of information, they're able to just put in their body weight as well as their total daily insulin use. What we wanted to do is to take this information and go out into pilot territories and talk to healthcare providers.
How do they receive that messaging? Do they have patients they feel confident putting onto the product? We've got two different great options from a product platform perspective. t:slim that has a 300-unit cartridge that's particularly well suited for people with higher insulin needs, as well as the Mobi Pump that has greater discretion and offers that flexibility to disconnect. Understanding how are both products resonating within the type 2 community. The other piece we wanted to focus on was training. This is a different patient population, again, with some of those ease-of-use features. Underlying all of it was better understanding the reimbursement environment. We were encouraged with what we learned. There was great feedback on our products as well as the ease of use of the products. We're expanding those efforts in the second half of this year.
You can think of them as scaling, and then you'll see the full benefit beginning in 2026.
I think it's, if I'm hearing you correctly, you made all the changes, you put everything in place. Maybe we got a little ahead of ourselves in expecting what was going to happen financially, and it sounds like you're queuing up to kind of exit the year running full speed with pharmacy in the fourth quarter, type 2 next year, and really the Salesforce hitting maturity and the tools being in place. Is that a fair assessment?
I think that's a fair takeaway.
I think the remaining kind of risk or fear is what's going on with the CMS these days, right? How that could impact you and what can that do to your cash flows. If you want to just, rather than me throw 20 questions at you, which I usually do, I'll let you kind of hit it from your standpoint of how you view it and how it can may or may not impact Tandem.
Sure. CMS has made two proposals. The first is to put insulin pumps out for competitive bidding, and the second is to convert to a pay-as-you-go model. In totality, when we heard the proposals, first of all, traditional Medicare is a small piece of our business. It's less than 10% of our business today. We're going to keep a close eye on it because we are pushing into the type 2 population at a greater rate, but any changes shouldn't have that material of an effect on us. The other piece of it is when you step back, you say, why are they making these changes? It should help make things more affordable. It should draw more people to pump therapy. Anytime that happens, that's an opportunity for us. We think that we could capitalize on that and drive more business for Tandem in particular.
That's where we stand right now on the proposals. When you think about pay-as-you-go, for example, in the pharmacy channel, we've already been contemplating that type of model. We feel like we would be able to manage that transition very well. That's part of the reason when you think about the t:slim supplies, why are we moving those into the channel today? We have hundreds of thousands of t:slim users, again, limited by the coverage piece. If we get supplies put in the channel at a premium to the pricing we see in DME, that will reduce the reliance on the pump sale in the future and/or mitigate or offset if there's any headwind on a pump sale in a transition to a pay-as-you-go model. It's actually setting us in a good spot for these types of changes in the future.
Competitive bidding is something that we've seen with insulin pumps before. There's been, I'll call it the threat of it. It's been on and off the list many times. It's never actually gone all the way to fruition. We'll see what comes out of it. For now, we're looking for it as a potential opportunity for us going forward.
What is the next major data point from CMS that you're looking for timing-wise? Is it the fall timeframe, and what specifically are you looking for?
Sure. There's a comment period, which we and I assume all the other players will participate in. We expect a ruling probably in November of what the outcome will be. It's unlikely that any of this would go into effect before 2027. There's plenty of time for us to adapt and pivot into and, you know, digest whatever that they put out there.
I think one of the biggest fears from investors is there are some, maybe a larger player that's lost share for a long time that may be willing to go where others won't on price just to grab share back. Any commentary on that thought?
We haven't seen price as being a challenge within our space in the many years that we've been here. That's something that we'll keep an eye on. Today, we're going to take advantage of all pricing opportunities that are in front of us with pharmacy, and we'll continue in the future to think about how we might manage differently. We see a nice premium opportunity in the coming years. We're also focused on our cost structure. If there's an inevitable time where maybe price becomes a bigger part of the conversation and there's price compression, we'll have adjusted the rest of our operating model to be able to sustain the business and to still show profitability.
I think that's kind of the final question concern, just looking at the balance sheet. You're just on that cusp of becoming free cash flow positive consistently. As you know, with all this uncertainty, it makes it a bit more challenging to clearly see where you can be in 2026, 2027, 2028. What level of confidence do you have that you're able to improve the free cash flow generation of the company? At the end of the day, it's all about future dilution, I think, which has been one of the big drivers down to this level.
Yes. From a free cash flow perspective, we expect to be positive in the back half of this year, and we're focused on maintaining that on a sustainable basis. When we look at how to do this too, it's back to the operating structure. For example, in gross margin, we have a few opportunities, mostly product-related. Mobi is the first big step for us. With our long-term gross margin goal of 65%, Mobi as a platform, when we get to full scale, will get us more than halfway there. We're starting to reap the benefits from the pump this year, and it will increasingly improve margin through the end of the year. Next year, cartridges will come into play and provide a bigger contributor to the gross margin movement.
With the pharmacy opportunity, that just solidifies our ability to really get to our gross margin target faster than we had originally anticipated. With those pieces, we're focused on, if you again, fixing that cost structure so that the pricing isn't as much of an element going forward. We're also very focused on operating expenses. Our R&D expenses have been flat for the last four or five quarters now. We had to make significant investments in prior years, but we're to the point where we can really leverage that. We're focused on our portfolio of products, how to get efficiencies across the platforms, how to appropriately invest, deliver on all these commitments, but not continue to drive an increase in spending going forward. This year, the investments have really been focused on the SG&A piece.
It's really about the commercial transformation, but that's just setting the building blocks for efficiency in the future. Our margin opportunity this year is expanding both on gross and EBITDA margin, excluding, I don't know if we want to talk about the one-time effect of the IPR&D charge. We've made a commitment to 2026 and beyond to continue to improve those margins, which again turns into free cash flow.
Okay. Eight points and $1 billion is $80 million. That helps. That helps a lot.
Yes, we are going to improve margin even without that in there. We are focused on the 3% operational EBITDA margin, and we will expand from there.
Excellent. Let's talk about, I mean, you just got the study set the day after earnings. Thanks, FDA, for waiting.
It actually was during the call.
During the call, even better. You can't, you didn't get to it real time. Congratulations. Okay. Is that the study set? Does that have the Tobii cartridge improvement? Give us some details on that actual approval and clearance and what all goes with it, because you've got a lot of moving parts on this.
Absolutely. It's an exciting technology that allows for us to have an infusion set that extends the wear time from three days to up to seven days. We're able to use that as part of an independent infusion set, which would then be used with the t:slim and with the Mobi pump today. We're also using that same technology as part of the set that's used for Mobi when you use it with a tubeless cartridge. Next year, we will launch Mobi in a patch configuration. It uses the same pump that's available today, but by using a modified cartridge, you're able to wear it as a patch pump. One of the things we announced on the call is that we're using this extended-wear technology as part of that site.
What it allows you to do is to change the portion that you wear in your skin separate from the timing of when you change the insulin cartridge. It allows for that extended wear time, reduction of burden to the patient, which is especially important for higher volume insulin users as we expand into type 2 diabetes. From here, we will launch the extended-wear site next year, along with a separate regulatory filing for the cartridge portion for Mobi that includes this extended-wear technology as a predicate device. That's another filing that we'll need to do, but we have the clearance today for the independent infusion set. We'll file another 510K for use of the extended-wear technology as part of the tubeless Mobi feature.
Okay. That's clear. You can't launch Tobii yet, but you can do Mobi and t:slim .
Exactly, it's an important step to get us towards offering.
I think you also press released, you need to build the manufacturing capability and build up inventory. It is a 2026 launch.
It's a 2026 event. Another thing to look forward to next year.
Okay. Any questions from the audience? I could go on forever, but I just want to see if anybody has anything. Okay. The closed-loop trial. Let's hit Siggy first because we only have a minute left, then we'll hit closed-loop. I think 27, if I remember correctly, is what the commentary was, or I may be putting words in your mouth.
We just don't have timelines that are out there for it. Stay tuned on that. To the closed-loop trial, I'd say those are the two areas we are investing heavily in within the internal R&D group. It's about advancing our product pipeline, the portfolio of the different platforms that we offer. What overlays them all, you're right, is that fully closed-loop trial. We are pursuing that actively. We completed a feasibility study in the second quarter. These are all stepping stones. They're milestones towards getting us to what our ultimate claim in the construction of the trial is going to be, which we haven't given timing to either. There are two projects that we have in active development. Stay tuned, and we'll continue to provide more updates.
Just simply for the audience, you know, if I think of Mobi, and I think about the tubeless Mobi, isn't the tubeless Mobi a patch pump? Why is it not? Why even bother with Siggy?
It is a patch pump. Next year, we will launch our first patch pump. Siggy is another option. It's more ergonomic. It uses a prefilled cartridge. Right now, we're looking at how some of the features and benefits that we offer through Mobi today are transferable over towards that Siggy platform. We think it's just continuing to enhance our overall portfolio.
I think with that, we're out of time. Thank you very much.
Thanks for having us.
Thank you.
Have a great last.