TNDM - NASDAQ

Good day, and thank you for standing by. Welcome to the Tandem Diabetes Care Third Quarter 2025 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Morrison, Executive Vice President and Chief Administrative Officer. Please go ahead.

Hello, everyone, and welcome to Tandem's Third Quarter 2025 Earnings Call. Today's discussion will include forward-looking statements. These statements reflect management's expectations about future events, our product pipeline, development timelines and financial performance and operating plans and speak only as of today's date. There are risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in our forward-looking statements, which are described in our press release issued earlier today and under the Risk Factors portion of our most recent quarterly report on Form 10-Q. Today's discussion will also include references to both GAAP and non-GAAP financial measures. Please refer to our earnings release issued earlier today and available on the Investor Center portion of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure and other information regarding our use of non-GAAP financial measures. John Sheridan, Tandem's President and CEO, will be leading today's call, and he'll be joined by Leigh Vosseller, Executive Vice President and Chief Financial Officer. Following their prepared remarks, the operator will open up the call for questions. Thanks in advance for limiting yourself to one question before getting back into the queue. I'll now turn the call over to John.

Thank you, Susan. Good afternoon, everyone, and welcome to our call today. In the third quarter, we achieved significant strategic milestones and delivered record Q3 sales. This year has represented a period of transformation for Tandem, and we are doing the right thing to position our company for success. Our substantial progress is starting to become evident in our financial results and serves as a testament to our strategic vision, hard work and the collective dedication of our entire team. There are three primary initiatives that we've been prioritizing to evolve our business, which will be the focus of my prepared remarks today. These include modernization of our commercial operations, driving innovation and reshaping our business model. In the U.S., we are beginning to see measurable benefits from our commercial changes implemented throughout the year. We have redefined end-to-end processes, begun deploying new technology platforms and restructured the organization to deepen our capabilities and to improve efficiencies. As a result, we're beginning to see improved sales productivity and effectiveness and plan to build on this momentum in the coming quarter and years. Pump shipments for Q3 met our expectations with favorable underlying sales trends and September was our strongest month of the quarter. About two-thirds of our new customers continue to adopt our technology for multiple daily injections. We also continue to see a healthy mix of both t:slim and Mobi adoption, highlighting the value of our portfolio approach in the highly segmented market. Outside the U.S., our commercial transformation is focused on preparing for direct operations in Europe. We have executed well against our transition plans, and I've been impressed with the high-caliber experienced people joining us. Our direct sales initiatives will begin in the U.K., Switzerland and Austria in early 2026, with additional countries to follow later in the year. In some locations, we've already started to hire our sales reps. Many of these individuals currently sell our technology through a distributor, which helps support a smooth transition. Establishing direct international operations is a critical step to strengthen our financial position by accelerating sales growth and driving margin expansion. It's also an opportunity to deepen our relationships with the European Diabetes Community and bring the benefits of Tandem's incredible technology to more people living with diabetes worldwide. Our second business initiative is focused on driving innovation. We have several recent and upcoming launches, which deliver on our portfolio promise of expanding choice. For example, the potential for Mobi is still not fully unlocked. We are awaiting FDA clearance for our Mobi Control app for Android, which is currently only available in iOS. Adding Android capability is an exciting opportunity as it significantly expands the worldwide addressable market. In addition, last week, we announced that t:slim X2 is now fully available with Abbott's FreeStyle Libre 3 Plus integration in the U.S., marking the first step in a broader global rollout. This integration has been in the early access phase of launch in the U.S. over the past several months with positive user feedback. We're excited to offer integration with Abbott's latest generation sensor as it provides even more CGM users access to the life-changing benefits of our Control-IQ+ algorithm. We are expanding the international rollout of our Source Cloud Infrastructure, which supports both the expansion of Mobi outside the United States and enables iOS and Android mobile applications for t:slim X2. Our t:slim mobile app is now live in 5 countries with another 7 scheduled for deployment before the end of the year and the remaining to follow soon after. This is a milestone in bringing our data management solutions to users worldwide and a testament to the world-class capabilities we are building in this space. Lastly, we continue to receive positive feedback from people with Type 2 diabetes who experienced real-world results similar to those in our study in the New England Journal of Medicine earlier this year. Control-IQ+ offers immediate and sustained improvement even without carb counting and regardless of bolus strategy, including when people don't bolus at all. Importantly, we're seeing that insulin-dependent people using GLP-1s get even better outcomes when used with Control-IQ+. In line with our expectations, t:slim's screen display resonates strongly with the Type 2 users, along with a 300-unit reservoir as it reduces the frequency of cartridge changes, helping reduce the daily burden of diabetes. Following this positive feedback, we expanded our Type 2 commercial efforts, moving from pilot to full promotion of Control-IQ+ for people with Type 2 diabetes. The market is highly underpenetrated and requires development. We're seeing evidence as the territories that participated in our pilot launch activities are now the most productive in bringing our technology to people with Type 2. Serving this population is a focus for us because it offers meaningful longer-term growth opportunity, doubling our addressable market in the U.S. The third initiative driving our business transformation is shaping our business model to drive growth and improve gross margin and profitability. We have been identifying and implementing changes to increase efficiency through leaner operations, greater automation and the implementation of new processes and systems. A major focus of reshaping our business model has been our pursuit and advancement of a multichannel reimbursement strategy. There are two key pharmacy-related accomplishments this quarter. First, we've successfully increased pharmacy benefit coverage for Tandem Mobi to more than 40% of U.S. lives, a milestone we plan to build on in 2026. The next highlight is that we started selling t:slim supplies to our large existing customer base through the pharmacy benefit in September. As you recall, we previously shared this was a goal for Q4, and it's now off to a great start. Early uptake has been encouraging with customers citing affordability, convenience and simplified refills as the top reasons for switching to their pharmacy benefit. This supports our thesis that pharmacy access is not only more efficient for Tandem, but also more appealing to our customers. Operationalizing pharmacy access for new and existing customers required significant internal effort. We've assembled a skilled team of market access and pharmacy distribution leaders with experience across leading PBMs, pharma and med tech organizations, enabling faster contracting and smooth implementation. Their expertise has accelerated this strategic shift, making our AID technology more affordable and accessible while establishing a scalable foundation for future growth. As you can see, we've meaningfully advanced our key initiatives in support of Tandem's mission and financial goals. I want to thank our employees as taking on these initiatives simultaneously has been quite an undertaking. The team's efforts are making a positive impact and starting to yield tangible results, positioning Tandem as a continued global leader in diabetes care. I'll now turn the call over to Leigh, who will expand on our third quarter results and future expectations. Leigh?

Thanks, John. As a reminder, unless otherwise noted, the financial metrics I will be discussing today are on a non-GAAP basis. Reconciliations from GAAP to non-GAAP results can be found in today's earnings release as well as on the Investor Center portion of our website. Please note that 2025 sales and margins in the U.S. are no longer impacted by the Tandem Choice program, which ended in 2024. 2025 continues to be a strong year for Tandem. With revenue of $249 million, we once again set record third quarter sales. Our top line outperformance was primarily driven by ASP increases on both pumps and supplies in the U.S. as well as favorable foreign currency dynamics. Another highlight of the quarter was our profitability as our gross margin increased 3 percentage points year-over-year and adjusted EBITDA returned to positive. In the U.S., third quarter sales were approximately $176 million, marking our highest third quarter to-date and our second highest quarter ever. Pricing was the primary contributor, providing significant benefit from both the DME and pharmacy channels. Notably, pricing alone increasingly contributed to year-over-year revenue growth this year, driving 2% growth in Q1, 4% in Q2 and 5% in Q3. This is due in part to the scaling of our pharmacy business to 5% of U.S. sales this quarter. We are excited by the potential for future pharmacy contribution as we further expand into the channel. Pump shipments in the U.S. were over 20,000. Consistent with our expectations, this was slightly down from Q2 following the pharmacy stocking benefit that we recognized in Q2. We continue to see strong demand for our portfolio of products led by renewals from our large and loyal customer base. Renewals continue to track to our historical capture rate of more than 70% of eligible customers within 18 months after warranty expiration. Turning to our performance outside the United States. We achieved $74 million in sales, delivering another record third quarter. Total international sales primarily increased year-over-year due to favorable movements in foreign currency exchange rates. Pump shipments were just over 9,000 as we continue our preparations to go direct in select European countries next year. True market demand remains strong with end-user pump placements growing double digits year-over-year. In addition to our strong worldwide sales performance, we also demonstrated significant margin improvement. Our Q3 gross margin of 54% increased approximately 3 percentage points year-over-year and increased approximately 2 percentage points compared to Q2. Like sales, this reflects meaningful benefit from higher ASPs. The combination of price, channel benefit and scaling reductions in Mobi costs underpin both our near- and long-term gross margin goals. Turning to our operating cost structure, we continue to prioritize spending towards resources that will drive top line growth, generate efficiency and strengthen our competitive position. Operating expenses increased 4% year-over-year, primarily attributed to SG&A investments. The SG&A increase reflects commercial investments in sales infrastructure, including U.S. sales force expansion, costs to support direct operations in Europe and initiatives aimed at streamlining our operations. R&D costs declined year-over-year, a result of our commitment to investing in the development of highly innovative products for our customers while maintaining disciplined resource allocation and strategic portfolio management. We remain committed to enhancing efficiencies throughout the organization to strengthen our operating margin leverage. To further this initiative, we completed an organizational restructuring in the third quarter. Our Q3 operating expenses include approximately $3 million in costs associated with this restructuring, which are expected to deliver financial benefits in the coming quarters. In addition, in recent years, we updated our incentive stock grant practices to more closely align with benchmarks, culminating in a $5 million reduction in noncash stock-based compensation and costs compared to the prior year. As a result of our top line growth and cost optimization efforts, Q3 marked a return to positive adjusted EBITDA and free cash flow, and we ended the quarter with $319 million in total cash and investments. Looking at 2025 overall, we are on track to achieve double-digit growth at a milestone of $1 billion in worldwide sales. This includes U.S. sales of approximately $700 million, assuming a seasonal pump shipment curve that is consistent with our 2024 experience, where nearly 30% of shipments occurred in the fourth quarter. It also reflects greater strength from pricing as we capitalize on the launch of t:slim supplies with the pharmacy benefit. Outside the U.S., we anticipate sales of approximately $300 million. This represents 12% growth year-over-year, even with approximately $10 million in headwinds assumed for distributor inventory destocking and inventory buybacks in advance of taking certain markets direct in early 2026. We are reaffirming our 2025 gross margin expectation in the range of 53% to 54% of sales, with Q4 expected to be an all-time gross margin record in the mid- to high 50s. We are also reaffirming our adjusted EBITDA expectations of negative 5% of sales. As a reminder, our expectation was 3% prior to a change in treatment of an in-process research and development charge in the first quarter, which impacted adjusted EBITDA by 8 percentage points. We are focused on carrying our momentum from 2025 forward to the year ahead. We have a number of exciting opportunities across the P&L going into 2026. And while we are not providing guidance today, I would like to frame up some of the key baseline assumptions to think about for next year. In the U.S., we anticipate returning to new pump growth driven by MDI conversions from new product introductions and increased pharmacy access. Renewal opportunities from pumps sold in 2022 will be flat year-over-year at 80,000, but we still expect low double-digit sales growth based on the tail of customers who have not yet renewed from years past. Overall, more than 70% of our U.S. sales are expected to be generated by recurring and predictable revenue streams of renewals and supplies from our installed base of more than 300,000 customers. Additionally, the improved pricing we achieved this year foreshadows the value we can unlock with the multichannel market access strategy. We have contracts with all the major PBMs and are positioned well for increasing pharmacy channel access. We are also focused on optimizing our operations for volumes at a larger scale. Our fourth quarter progress will provide valuable information to guide the level of benefit to come from channel mix assumptions in 2026, and we look forward to providing you with a more detailed update on our year-end earnings call. Turning to our international expectations, we anticipate driving further market expansion and increasing contribution from renewals as well as growth from our direct operations that will scale across the year. We anticipate that nearly 15% of our international sales will be generated from direct market sales, up from less than 5% in 2025. The primary benefit of going direct will initially be from ASP uplift, which may be variable in each market. Generally, though, over the full year life of a patient, ASPs are anticipated to be at least 30% higher in a direct market versus our current distributor pricing. 2026 is also positioned to be an exciting year for both gross and operating margin leverage. We anticipate another step function improvement in gross margins from the combined benefit of lower product costs as Mobi scales and pricing contribution. Our goal is to deliver gross margin of at least 60% in Q4 2026. We are also focused on driving continued adjusted EBITDA improvement compared to the initial 3% operational target we set for 2025 as well as positive free cash flow. In summary, as we continue to execute our strategy, I remain confident in achieving our financial objectives. I'll now turn the call back to you, John.

Thanks, Leigh. To wrap up our prepared remarks, I have a few additional updates on our initiative to drive innovation throughout our product pipeline, which remains the most exciting insulin therapy management. In the recent quarters, we have been refining our road map to best leverage our deep technology portfolio that we have developed through organic investments and key acquisitions. Starting with Mobi Tubeless, which transforms Mobi into the world's first extended wear patch pump with a novel new cartridge and infusion site, Mobi becomes a solution for people who want to go 100% tubeless, people who prefer to use traditional infusion sets and people who want a choice and interchanging wear options. Our market research shows that offering a tubeless wear mode for Mobi significantly increases user preference. When implemented with extended wear, user preferences increases even higher. We expect Mobi Tubeless to be our first commercial offering featuring extended wear technology. We have prioritized its launch ahead of SteadySet, our extended wear infusion set based on the high level of market enthusiasm for extended wear patch pump. We are entering the final stages of Mobi Tubeless testing to support a 510(k) submission. Manufacturing scale-up activities are happening in parallel to reduce the time between clearance and the commercial launch in 2026. Rounding out our platform update, we have also been refining the design of our Sigi Patch Pump, which we acquired from AMF Medical. Bringing Sigi development to San Diego earlier this year produced a great outcome. The team identified opportunities to combine the best of our Mobi and Sigi platforms together, creating development synergies, enabling further miniaturization and enhancing competitive differentiation. We are excited about what this means for the Sigi technology as part of our tubeless roadmap. From a commercial perspective, we anticipate marketing this pump as our next-generation Mobi, building on the growing brand recognition of this new product family. Finally, I want to acknowledge the work of our team and our partners at the University of Virginia's Center for Diabetes Technology for their progress in developing fully closed-loop technology for Tandem's platforms. Our vision for fully closed loop is to give people the ability to interact with their pump as much or as little as they like. We remain committed to advancing these R&D efforts quickly, and our goal is to start a pivotal study for our new fully closed-loop algorithm next year. In conclusion, we began this year focused on business transformation, and I am proud of the progress we are making that positions Tandem for future success. As we approach year-end, we have an energized commercial organization, growing product momentum and a sharpened focus on our forward-looking road map. Tandem's achievements this year reflect our strategic vision and deep commitment to innovation in diabetes care. We have made measurable progress in modernizing our commercial operations, driving innovation and evolving our business model. Looking ahead, our focus remains on delivering meaningful solutions for people living with diabetes, fostering operational excellence and positioning Tandem for continued leadership and success in the global market. We appreciate your ongoing support and look forward to sharing further progress in the future quarters. Thank you again for joining us today.

[Operator Instructions] Our first question comes from Matt Miksic with Barclays.

Congrats on a really strong quarter. So I wanted to get a sense of as we head into next year, maybe just kind of a broad question in terms of cadence. I know you may not give much color today on 2026 outlook, although I'm sure you get a lot of questions on it, but I'll ask mine around the idea of cadence. Some of the new products, the continued progression into pharmacy, some of the geographic initiatives that you've undertaken taking all those into account, can you maybe give us a sense of acceleration catalysts and sort of progressive growth throughout the year, if you were to map it out today, steering clear of what the headline number will be is and I'm sure you're going to get more questions on that. But that color would be great.

Matt, a lot to unpack there. Yeah, I think what I'll do is I'll kind of give you a sense of what the pipeline is going to look like. And then I'll let Leigh talk more about the pharmacy channel and some of the other initiatives that we've got going on. So I think that you can tell from the call here that we are really trying to increase our focus on what really matters for the business. Certainly, we are very excited about Mobi, and we think it really will be the workhorse for the company in the not-too-distant future. As we just explained in the call, we're waiting to get the Mobi Android approval here this -- before the end of the year. I think as you move into 2026, we're going to be moving Mobi to O-U.S. countries. We intend to implement FreeStyle Libre 3 and we also intend to implement the tubeless version of Mobi. And so I think when you think about that and when you include that with Control-IQ, I mean, that's a powerful product. And I think it's going to really significantly change the competitive dynamic that we face in the marketplace today. So we're certainly very excited about it. And I would say we feel very confident we're going to make these things happen in 2026. And I think it's going to have a market effect on the business. Leigh, do you want to talk a bit about the pharmacy work that we're doing?

Sure. I think to sum it up, just based on John's comments, the way you can think about it is these are building across the year in 2026. So a lot of them just began that full commercial rollout. A lot of things are in flight. We're very excited with our pharmacy progress. There's more to build on there. And our business transformation in the U.S. that we've been investing in, we're starting to see the green shoots from a productivity perspective coming out of our commercial team. And so a lot of these things are going to be coming to fruition and building across the year in 2026. And so that's how you can think about the cadence. And it also is not just the top line, but it flows down through the bottom line as well because we'll also begin to show more leverage across the year from these investments that we've made as we're generating the return on the top line. So you can also expect seasonality, but the building of the margin expectations and the EBITDA expectations as revenue grows.

Our next question comes from Larry Biegelsen with Wells Fargo.

Leigh, I wanted to focus my question on price and the uplift you can get from the supplies going through the pharmacy. So on price, the 5% benefit in Q3, where do you see that going in 2026? And you're launching the t:slim supplies in the pharmacy this quarter. Any incremental color on what the pricing uplift is and how long the transition will take? How do we think about your current supply revenue per user at about $1,000 going forward?

Sure. Thanks, Larry. It's a good question. We obviously haven't given a lot of color yet on how to think about it. One thing I'll point out is that as we've seen price increases across this year, and it's been increasingly a contributor to our revenue growth, the balance of it was really from DME in the first half of the year. And in the third quarter, it flipped around and the balance of it is coming from the pharmacy operations. And so as we go into Q4, I think you can back in pretty easily into what we're expecting from a pricing benefit on supplies. And that's probably a good way between Q3 and Q4, what you're seeing to think about as a baseline as we step into 2026. And as we accumulate more data and trends and information from our progress in the fourth quarter, the level of coverage that we expect to have as we step into the beginning of the year, when we give our guidance assumptions at the year-end earnings call, we can give a lot more color on how to think about that build. But I would say what you're seeing now is a solid baseline.

Our next question comes from Chris Pasquale with Nephron Research.

Leigh, I wanted to follow up on the guidance and the comment around seasonality. A year ago, 4Q didn't come together quite the way you guys expected, resulted in sales coming in below guidance. So can you just expand on what exactly you're assuming happens this time around? Is it similar to last year or a return to sort of what would have been normal in previous years?

Yeah. Thanks for the question, Chris. So when we built the seasonal curve expectations for 2025, we absolutely factored in our experience in 2024, which, to your point, was a bit more muted at the end of the year than what we had seen in years past. So what's underpinning, I guess, I would say, the fourth quarter shipments. Last year, we saw about 30% of the full year shipments landing in the fourth quarter. That's probably a good place to start for this year. And just the breakdown between new and renewal, you can still think about it as renewal being a little more than half. And a lot of that step-up from Q3 to Q4 is really underpinned by the new renewal opportunities coming to market in the fourth quarter. And so I think that's a great starting point. So just to sum it all up, I would say very similar to what we saw in 2024.

Our next question comes from Danielle Antalffy with UBS.

Leigh, thanks for the color on the renewal pumps. I guess just curious, I'm not sure if you guys can give any insights or clarity on what percentage renewals pump shipped -- excuse me, given that this was, I think you said a historically high quarter. So I don't know if it's easier to ask a question like percent that's new patients to pump or new patients to Tandem pump versus renewals or what. But I guess just trying to get a sense of like what number of new patients have come on to Tandem in the last quarter? And that's it for me.

Sure. Thanks for the question, Danielle. Happy to take it. So I would say the trends have remained consistent across each of the quarters this year where renewals have been a little bit more than half of the shipments. And then in the new start population, MDI conversions have been about 2/3 of the shipments. And so we did see continued pressure in the third quarter, and we expect again in the fourth quarter for new starts. And that was factored into our updated guidance expectations we talked about last quarter, where we said there would be a slight decline year-over-year. But I'll point back to all the opportunities that John laid out earlier from our initiatives between new product introductions, between pharmacy access and just our commercial transformation really taking hold and taking root. And we really expect to see a turnaround in that new start number and expect to return to growth in 2026.

Our next question comes from David Roman with Goldman Sachs.

You've got [ Jamie ] on for David today. Appreciated some of the building blocks you gave for 2026. I wanted to focus on the comment around returning to new pump growth driven by MDI conversions. And just getting a sense of what you're seeing in the market today, both in Type 1 and Type 2 and how you're expecting that to evolve both in terms of just market growth and competitive dynamics to get to that assumption that you've provided for 2026?

Thanks for the question. I would say that if you look at the basis of competition today, it's changed dramatically over the last couple of years. And I would say that form factor is a very important element of that and so is market access. And if you look at these transformational objectives that we've got going on right now, we're certainly focused on increasing our presence in the pharmacy channel. And we certainly think that by doing that, you reduce the out-of-pocket for patients, and it's easier for the physician to prescribe it. So I think that getting to the pharmacy channel is something that we think will definitely positively affect our MDI uptake. And then at the same time, if you look at the innovation that we've got going on, we have things that are in the works. These things are on deck and are going to happen. And so I mean, as of right now, as I mentioned, we just got the FreeStyle Libre 3 approval. That's gone out broadly in the U.S. We expect to get Mobi Android approved here shortly. And we have a number of other product-related feature enhancements that are going to really improve that, I think, the competitive basis of Mobi in the marketplace. So I think the combination of both of those really will affect MDI growth and get us to return to the point where we actually see growth in MDIs and the company will go back to double-digit growth like we've seen consistently in the past.

Our next question comes from Mike Kratky with Leerink Partners.

Congrats on the great quarter. I appreciate all the recent progress on gaining pharmacy traction. I think you mentioned over 40% of pharmacy coverage for Mobi. So can you just clarify how much of that 40% coverage you can actually get paid for in the pharmacy today? And what are the main milestones that can help bridge that gap, if any?

Sure. Thanks for the question, Mike. The way to think about our pharmacy coverage is starting with, we have contracts with all the major PBMs. The 40% we provide is really the payer lines that are attached to those contracts today. And as you can expect in any payer environment, some access is better than others. And that's what we've been working on across this year is improving our access both within the plans that we have and expanding that access through pull-through. And so as we think about pharmacy, it's been a measured approach this year. There's a lot to be ready for an organization of our size to be able to scale efficiently. So there's a lot of operational aspects with how we take an order, how we fulfill an order, how we communicate with patients and physicians on the way this will work in the future. And so that's what we've been doing in 2025 is shoring up access, preparing for us to step into 2026 and really push pharmacy at a much larger scale next year.

Our next question comes from Matthew O'Brien with Piper Sandler.

This is [ Anna ] on for Matt. So I guess I just wanted to ask specifically on the gross margin guide. I mean there was some solid improvement in Q3, so that was good to see. But you're still guiding to 53% to 54% for the full year, and you said mid- to high 60s in the fourth quarter, which is a pretty meaningful step-up. So just wondering sort of what's baked into the assumptions there and what gets you to the full year target?

Sure. I appreciate the question. And so just to confirm, the fourth quarter is expected to be our all-time high, which is in the mid- to high 50s. And that's a launching point as we go into next year where we usually see a modest step down. But by the end of next year, we expect to be at 60% in the fourth quarter. And so what drives that step up this year, when you look at the drivers of our business that impact gross margin, the single biggest contributor has always been pumps, and it's pumps in the U.S. And so pumps come first. International has a little bit of pressure because of the pricing dynamics using distributors there. And then supplies have been the smallest contributor to gross margin. So as pumps does become a bigger percent of our business, you usually see margins scale. What I'll add to that is, I would say, the newer information is as we continue to penetrate pharmacy with our launch of t:slim supplies in the pharmacy channel. So think about the large installed base that we have and being able to get that price appreciation, that's also factored into contributing to our gross margin step-up in the fourth quarter of this year. So we are really excited about what pharmacy can deliver for us as a business because I think you're seeing measurable benefit already with just the small volumes that we had. So you can only imagine where this could go in the long term as we continue to broaden our access.

Our next question comes from Richard Newitter with Truist Securities.

It's [ Filipe ] on for Rich. Just on the pharmacy channel, you and a few of your competitors are entering the channel pretty quickly. So I'm just trying to understand or can you help us understand why we should or shouldn't see more competitive rebating strategies in the channel as more players enter. And just like what are overall expectations for pricing in the channel over the long-term?

Yeah. Thanks, Felipe. When we think about this, this is something as we've looked at over the years, there was a time when durable pumps weren't even accepted in the channel. And there is also always the concern that when you get into the pharmacy channel in any category that there will be price erosion over time. When we looked at our opportunity in the near-term for us, there's a significant step-up opportunity when you compare the DME to our base business today. So it makes sense for us to enter into that category, especially with the access we think we can offer to patients with a lower out-of-pocket cost. In the long term, it could mean pricing pressure. But for us, what we're doing is we're getting in, we're building a stable business off of it. We're preparing for that possibility if we're going to take full advantage of it in the near term as we enter that channel. And I think with all of us in the channel together, we all hope to get that pricing premium to continue to support our margins in the long-term. So it is a risk, but it's something that we think is we can mitigate and it's worth going into despite that.

I'd also just say that when you look at the two pump competitors that are out there today, their volume in the pharmacy channel is very low and probably will be for a while. I think -- ultimately, I think it's going to be Tandem with one of the large entity that have meaningful volume in the market. And I think we'll have to see how that dynamic plays out.

Our next question comes from Joanne Wuensch with Citibank.

I want to go back to something that you said about Sigi. And if I heard you correctly, you were calling it a next-generation Mobi. Maybe I just misunderstood that. But could you please sort of clarify how you think about launching that product into the market?

Sure. Well, I'll start off by saying that Mobi Tubeless is going to be the first extended wear pump in the market, and it's going to be a patch pump. And we've done quite a bit of research on Mobi Tubeless, and it scored very well. I mean availability of tubeless wear and Control-IQ provided meaningful uptake in user preference. And then with the implementation of extended wear capabilities, we also saw further increases in preference. So I think that we're seeing this great enthusiasm for Mobi. And as an extended wear product, it really gives us confidence that it's going to do very well in the marketplace. As we begin to see the design come together and based on this high level of enthusiasm, we believe that we only need one tubeless product on the market at a time. And we absolutely plan to continue to invest in Sigi's development. But on a forward-going basis, it's best to think about it as the next-generation Mobi product and part of the growing brand and product of that family. We want to give Mobi room to run, and I think it's going to do very, very well.

Our next question comes from Suraj Kalia with Oppenheimer & Co.

Hopefully, you can hear me all right. Perfect. So John, one question for you and one for Leigh, and I'll pose them upfront. John, you mentioned the fully closed-loop system. Obviously, it needs an input signal. I was curious if you could indicate which CGM or which camp are you leaning towards for the autonomous fully closed-loop system? And Leigh, for you, I just wanted to follow up on Danielle's question, right? And please correct me if my math is wrong. So U.S. pump revs down 2% year-over-year, price 5% benefit. So am I right in thinking units were down 7%? And I guess my real question then would be, if I look at patients that are switching or starting new from MDI versus repeat patients, where will -- how should we think about relative softness in these two buckets? Hopefully, my math is right, but please correct me if I'm not.

Well, I can tell you that when it comes to the fully closed-loop system, that it's going to work with all of the CGMs that are currently integrated with our product. The CGMs are interoperable, and it's really the fully closed-loop algorithm that matters. And so we're -- our team is doing a great job, and we've got a great collaboration going on with UVA right now in the Center for Diabetes Technology. I would say that the partnership with UVA has been something that's been ongoing. And if you look back to 2016, it largely resulted in Control-IQ. And we chose to work with UVA back then is because they had the most amount of clinical data for an AID system at that point in time. And the FDA was very, very familiar with the product as well. And so today, we find ourselves in a very similar position. We're working with UVA again, and we're working with them to implement their fully closed loop algorithm. And so once again, their algorithm has the most amount of clinical data that's out there, and it's very familiar to the FDA. So we're working expeditiously to get the system ready for trial. And as I said in the prepared remarks, our plans are to implement the fully closed loop pivotal study next year.

And to your question on new pump starts. So the way to think about it in the third quarter is, first of all, I'll remind you that in the second quarter, we had a small stocking dynamic. And so if you normalize for that between Q2 and Q3, you would see pump shipments roughly flat, which is a normal seasonal trend. When you break it down between renewal and new pumps, we did see strong growth in renewal pumps as we have been demonstrating. But as we expected, new pumps continue to be slightly pressured. And when you further break down new pumps and focus on MDI conversions versus competitive conversions, the competitive conversions have been a large reason why we've seen some headwinds in new pump starts this year. One of the primary competitors that has been a big contributor, I would say, to our competitive conversions has started to retain more of their own customers and have less to share, I guess, I would say. So at the end of the day, we are very focused on the MDI conversion part of the population. And we've already -- I think you've heard many of the opportunities we've listed out that can really help drive and stimulate growth in MDI conversions as we look ahead.

Our next question comes from Jayson Bedford with Raymond James & Associates.

This is [ Elaine ] on for Jason. So you had a nice beat outside the U.S., especially in supplies. Can you talk about what drove the strength there? Did you see any impact from stocking or preparing to go direct? And also, you talked about a $10 million headwind. Is that more weighted towards third quarter or the fourth quarter?

Sure. So on our O-U.S. performance this quarter, I would say underlying trends were pretty much in line with our expectations. The outperformance is mostly attributed to a few million dollars benefit from foreign currency dynamics that worked in our favor this quarter. But to those underlying trends, what you're seeing are the effect of what the distributors are ordering from us. When you see what happens in the end market, we actually showed low double-digit growth in our placements in the market. The -- what's being shipped out the door is being impacted somewhat, as you mentioned, by the transition to going direct. What we've seen across this year is some destocking from some of the distributors as they're working down their inventory levels. So that's a part of the $10 million headwind we factored into our expectations. We expect to see a bit stronger impact from that in the fourth quarter as we near the actual launch in those markets and potentially have to enter into an inventory buyback situation. And so -- but the underlying market dynamics are really strong outside the U.S. We look forward to taking some of these markets direct ourselves and being able to even further accelerate that growth looking ahead.

Our next question comes from William Plovanic with Canaccord Genuity.

So I really wanted to dive into Type 2 here. You're 1 or 2 on label with it. It's been a big driver for one of your competitors. And I just -- I know you're just going to full launch. Is this something that you're really waiting for Mobi Tubeless before you kind of go full out and see a bigger impact? Is this waiting for pharmacy or is it you just got past the pilot phase and it's just -- it's only because you just got past the pilot phase?

Okay, Bill. I would say that.

And John, if I could also, what percentage of new patient starts were Type 2 this quarter? I don't know if you shared that. Sorry for interfering.

Yeah, sure. No problem. I would say that we're certainly leveraging the lessons from the pilot, and there's a lot of great information that comes back on our marketing, training and the sales execution. But as you say, you're right, we kind of evaluate the performance of the pilots, and now we're moving to full commercial launch. The pilot territories were very productive. And I think that we're getting very positive feedback from physicians and patients that they're seeing the same experiences that we saw in our new -- in our Type 2 trial, immediate sustained results that have simplification of the bolus process, and they're [indiscernible] with GLP-1 use. The preference so far, it's leaned towards screen displays and 300-unit reservoirs. And so t:slim is interestingly enough, the preference for most people, and that's fine. And I think that that's where we're going to go. Market development is needed, and certainly, we're going to do that. And I think having additional competitors out there doing market development at the same time is a positive thing for us. And pharmacy channel and tubeless are only going to improve the uptake. So I think we're going to start full blast here. It's actually started. We started in the third quarter. We're continuing to move aggressively with the products that we've got in the marketplace. But as we do access more of the pharmacy channel, we do get [ moving ] tubeless, we think that's going to also significantly improve our performance in that market. And certainly, it doubles the size of the addressable market for us. And so we're going to do everything we can to take advantage of that. And I will say we haven't said specifically what the number of starts that we have, and I'm not sure we're going to talk about that specifically in the future either.

Our next question comes from Michael Polark with Wolfe Research.

I want to just make sure I fully understand the updated comments on Tubeless Mobi. I heard 510(k) submission entering final stages. I also heard commercial launch in 2026. So if I were to assume you have 510(k) in by the end of the year, count 6 months, it's kind of midyear approval, 2H '26 launch. Is that a reasonable way to think about it? Two other pieces of this, I continue to hear the emphasis on extended wear. So is the best assumption that when this product comes to market, it will have the 7-day set exclusively? And then on manufacturing ramping in parallel, the expectation is you will be ready for kind of big bang introduction when these other boxes get checked or still would be a process post approval to ramp supply?

Yeah. I mean I think we understand the importance of Mobi Tubeless in the marketplace. And we think that product is going to really help us return to a very competitive position. So as a result of that, I indicated in the prepared remarks, we are going to prioritize Mobi Tubeless over SteadySet. We are going to introduce Mobi Tubeless first with the extended wear. So it will have 7 days when it does come to market. And we'll have SteadySet. I mean we're not deprioritizing SteadySet, but I think that you know that there's a great deal of enthusiasm for Mobi Tubeless. It's certainly going to drive business opportunity for us. And I think if we work one product versus two, we can get it to market faster. And we know Mobi Tubeless is going to sell a lot of pumps. So I think that -- we think this is a really important initiative. We haven't said specifically on the timing. We have said 2026, but I can guarantee you, we're doing everything we can, as I just indicated, prioritizing it over other products to make sure we bring it to market as fast as possible. And we think it's going to be a great product and really, again, differentiate Tandem in the marketplace again.

Our next question comes from Jeff Johnson with Baird.

I think most of my questions have been answered. Maybe just back on the U.S. pharmacy comments. There were 5% of revenues this quarter. Can you just remind us what the breakdown is supplies versus pumps in that? I know you have the 40% lives under coverage for Mobi. Are you getting many pumps there? And Leigh, I think you and I have talked in the past on the pharmacy side that some of your pharmacy contracts even on the Mobi side may not be straight pay-as-you-go models where you kind of take that 4-year total price and just divide it by 48 months that you might actually get more Mobi revenue upfront and more supplies over those 48 months. But just kind of maybe refresh us on what structure of some of those pharmacy contracts might look like with Mobi as well.

Thanks for the questions, Jeff. So just to your comment about the 5% and where is the balance I would say that it's all been Mobi so far, except we -- we did introduce t:slim supplies in the channel in September. So it's a balance between pump and supplies before. It will start to lean more towards supplies as we look ahead in Q4 because there's such a large opportunity with t:slim with the large installed base that we have. So it will start to lean in the other direction on the supply side. And then in terms of the reimbursement model, you have a good memory there. We -- our contracts today are pretty much all structured like a traditional DME reimbursement model, not the price point necessarily, but how the breakdown is between pumps and supplies with reimbursement upfront for the pump and then ongoing reimbursement for the supplies. This hasn't been a headwind for patient adoption because we have such a great ability to influence the out-of-pocket for the patients with co-pay assistance programs. So we still get the same benefit with patients, and it's keeping the same structure in place that we've been accustomed to with DME. As we look ahead, in order to get the maximum or the most optimal access on pharmacy, we are looking at other reimbursement models. And we would consider anything from the DME-like model we have today all the way to a more pay-as-you-go model and anything in between, if you will. So it's something that you can -- we'll share more in the future as we get more coverage and we talk about the expansion of our pharmacy program. But for now, they are all that DME-like structure.

[Operator Instructions] Our next question comes from Travis Steed with Bank of America Securities.

This is Stephanie Piazzola on for Travis. I just wanted to follow up on a comment that John made about getting back to the double-digit growth you've seen in the past. And just wanted to clarify if that was referring to expectations for MDI patient growth next year specifically or over time and if that was a U.S. or a worldwide comment.

Yeah. Thanks for the question, Stephanie. I'll answer for John on that one. So we have often said that our goal long term is to have sustained double-digit growth with a dual focus on profitability. And that's what John was referring to, not any particular piece or part or period, but that's just what our financial goal is. And we look forward with all these opportunities to demonstrate and execute on that looking ahead.

Our next question comes from Jon Block with Stifel.

Leigh, [ I had ] revenues up $25 million Q-over-Q for the fourth quarter and a similar amount for EBITDA. So call it like roughly 100% drop-through on the incremental revenue to get to the EBITDA margin guidance of negative 5% on the fly math is always dangerous. But that's where I'm sort of spitting out for the model to get to the $1 billion and the negative 5% margin. So it's a high drop-through. I'm calculating the current drop-through in the most recent quarter and impressive, 50%, 60% but not 100%. So maybe if you could just bridge us. Obviously, you've got the gross margin. But then what are some of the other things that we should think about? I'm guessing is some of that the restructuring that you alluded to on the call. Any color would be great.

Sure. Happy to take that. So when you look at Q3 to Q4, the implied revenue step-up is mostly coming from the U.S. business. And as I mentioned earlier, there are the pump shipments stepping up in line with what we've typically seen seasonally. And when you have more pump shipments, we generally see a higher gross margin. But we have a particular assumption for price improvement on supplies in the fourth quarter as we've introduced t:slim into the pharmacy channel. So that really benefits the gross margin, which is [ P1 ], and you already acknowledge that's a nice step-up. And then dropping through to the bottom line, the incremental benefit is coming from that leverage we expect to see in our spending. As you mentioned, we did initiate a restructuring in the third quarter, which will yield benefit, but also just our entire commercial transformation that's underway. Part of it was changing the shape of how we go to market and make ourselves more competitive. And part of that is how to streamline and automate and improve our processes internally for how we engage with patients and the pump orders and the supply orders and so on. And so we are beginning -- we are expecting to start to see the benefit of that as we exit this year and going into 2026, we'll build on that even further. So again, we're very excited about what the future holds for us here. We look forward to demonstrating this profitability improvement that everyone has been waiting so eagerly for and continue to drive the business in a positive way with all the new innovations, business model changes and the transformation that we have going on right now. Thank you.