Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc.

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Q1 FY2026 · Earnings Call TranscriptMay 7, 2026

Operator

Good day, and thank you for standing by. Welcome to the Tandem Diabetes Care First Quarter 2026 Earnings Conference Call.

At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session.

To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised.

To withdraw your question, please press *11 again. 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. Ma'am, please go ahead.

Susan Morrison

Hello, and welcome to Tandem's first quarter 2026 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 annual report on Form 10-K and quarterly report on Form 10-Q.

Today's discussion will also include references to both GAAP and non-GAAP financial measures. Unless otherwise noted, the financial metrics discussed today will be on a non-GAAP basis.

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 yourselves to one question before getting back into the queue.

With that, I'll hand the call over to John.

John Sheridan

Thanks, Susan, and welcome, everyone. In the first quarter of 2026, we delivered a strong financial and operational performance, setting the stage for another successful year.

This momentum reflects the dedication of our team and our commitment to execute our strategic objectives. Building on these results, we actively advanced several key initiatives that position Tandem for both immediate impact and long-term growth.

By modernizing our commercial operations, reshaping our business model, and introducing new technologies, we are not only achieving notable short-term gains, but also laying the foundation for sustained growth, profitability, and innovation. I'll now walk you through updates on each of these initiatives, beginning with the modernization of our commercial organization.

Globally, we have assembled a talented and impressive team. The group is deeply committed to bringing the benefits of our technology to people living with diabetes, and we are working to further support them by strengthening our systems, infrastructure, and processes.

For example, in the United States, we continued upgrading our sales and customer management infrastructure as part of our multiyear system investment to optimize sales efficiency, enhance effectiveness, and drive deeper customer insights. Internationally, a Q1 highlight was our launch of direct commercial operations in the UK, Switzerland, and Austria.

By doing so, we are better positioned to serve our customers, strengthen HCP relationships, and drive continued growth. The transition has been progressing smoothly, and we plan to continue expanding our direct operations later in 2026 and again in 2027.

This approach deepens our engagement with the diabetes community while providing Tandem greater ASP and improved margins. The second key initiative I'll be discussing today is reshaping our US business model through our transition to a multichannel strategy.

On our last call, we discussed how adopting pay-as-you-go, or Pay-Go, in the pharmacy channel provides us the opportunity to bring significant advantages to customers, healthcare providers, and payers, while delivering favorable economics to Tandem. Throughout March, we began executing contracts adapted for Pay-Go, covering both t:slim and Mobi pump supplies.

We've continued to expand access, with an increase to approximately 40% formulary coverage today. It's an important leading indicator for how quickly we can transition our business.

Operationalizing Pay-Go in the pharmacy channel is an end-to-end change in the way healthcare providers prescribe our technology, the way we service customers, and the way we process and fulfill orders. We knew this transition would take time.

It's still early in the process, and we are working to improve our efficiency and customer satisfaction by enhancing the pharmacy experience. Our early introduction of Pay-Go through the pharmacy reinforces our conviction in the meaningful opportunity this transition presents for our business and for our customers.

Finally, I'll provide an update on new technology across our portfolio. In March, we were excited to announce that Tandem Mobi, the world's smallest durable automated insulin delivery system, is fully available for use with Android smartphones in the US.

By expanding to Android, we are bringing the benefits of Tandem Mobi to even more people living with diabetes, underscoring our commitment to delivering choice in diabetes technology. In the second quarter, we are on track to deliver on a number of exciting new offerings.

In April, we received FDA clearance for use of Control-IQ+ in pregnant women with type 1. This is significant as it makes the t:slim X2 and Mobi the first and only commercially available AID systems cleared for use during pregnancy in the US.

We are also awaiting CE mark for this indication in Europe. Pregnancy requires a much tighter glycemic range.

This demonstrates that Control-IQ+ is designed to effectively support the unique therapy needs of pregnant women in addition to women considering pregnancy. We will be hosting a product theater highlighting pregnancy management with Control-IQ+ at the upcoming American Diabetes Association meeting in June.

We are also preparing for the international launch of Abbott's FreeStyle Libre 3 Plus integration with the t:slim, starting in select European countries in Q2 and scaling to additional countries throughout the year. This integration with Abbott's latest-generation sensor will allow even more CGM users to access the life-changing benefits of our Control-IQ technology.

Additionally in Q2, we will begin the commercial rollout of Tandem Mobi outside the United States. This brings together the best-in-class outcomes users have come to expect with Control-IQ+ and the benefits of Mobi's form factor.

Rounding out our Q2 launches, we will be upgrading both t:slim and Mobi for compatibility with Dexcom's G7 15-day sensor, ensuring we continue to provide our customers with the latest-generation technologies. It is also exciting because this software update will enable Tandem pumps to provide CGM data directly to our Sugarmate app, with future plans to add insulin data.

This provides visibility to sensor information across our device platforms for users and their loved ones. These launches are designed to be global and deployable to all markets where the relevant system combinations are available, which represents an important accomplishment by our team.

While progressing these new offerings to commercial availability, we also made great strides with our pipeline products. We're particularly excited about Mobi Tubeless, a novel infusion site option for the existing Mobi pumps that transforms it into a tubeless AID system, allowing for interchangeability between tubed and tubeless wear with one platform.

This will be Tandem's first tubeless pump offering and the world's first with extended-wear technology. We plan to file our 510(k) submission for the Mobi Tubeless in the second quarter.

Finally, we continue to make good progress preparing our pivotal study for Tandem's first fully closed-loop system, and remain on track to start it this year. As you can see, we continue to make meaningful progress across the business while demonstrating strong financial results, which Leigh will now discuss.

Leigh Vosseller

Thanks, John. As a reminder, unless otherwise noted, the financial metrics discussed today will be on a non-GAAP basis.

In this quarter's performance, we continued the momentum from last year by achieving new first-quarter records for pump shipments and sales, as well as robust margin improvement and solid cash generation. We are reaffirming our annual 2026 guidance as we continue to execute on our bold business model transformation in both the US and international markets.

We set new first-quarter records with more than 29,000 pump shipments worldwide and $247 million in sales. Our US performance drove this achievement, where we shipped more than 19,000 pumps, representing approximately 10% year-over-year growth.

Renewals continued to account for more than 50% of our shipments, and new starts were predominantly MDI patients, representing roughly two-thirds of new customers. As John discussed, a key milestone in the quarter was our March launch of Pay-Go in the pharmacy channel.

Throughout the month, we successfully increased our formulary access outside of the traditional cycles for PBMs and payers. Adoption was within our range of assumptions in these first few weeks.

Fewer than 5% of customers ordered a pump through their pharmacy benefit. Similarly, less than 5% of our installed base purchased their supplies through this channel.

Our transition and pricing assumptions for the full year of 2026 remain unchanged. US sales were $161 million, growing 7% year-over-year, also representing our highest first-quarter US sales.

This reflects a headwind of approximately $1 million from the adoption of Pay-Go, as well as slight pressure in infusion set sales due to a key supplier's shortages. Overall, pharmacy sales represented 6% of sales in the US, which was significant based on our volumes.

Looking ahead to the second quarter, we're confident in our ability to deliver pump shipment growth with a seasonal curve similar to 2025, and expect US sales of approximately $175 million. This factors in an increasing Pay-Go headwind, of which the magnitude will depend on our pace of execution.

Turning to our international performance, we shipped more than 10,000 pumps and are executing well on our go-direct strategies. International sales totaled $86 million, representing 3% growth year-over-year.

Direct channel sales increased to approximately 11% of total international sales from less than 5% historically. This is the highest international sales quarter in our history, due in part to favorable currency dynamics.

Also as a reminder, the first quarter of 2025 included a $5 million benefit from timing of distributor orders, creating a tougher point of comparison. Our international business had a few puts and takes during the quarter compared to our original assumptions, including a delay in timing of expected headwinds from going direct, a one-time benefit in Switzerland related to the buyout of existing customer rental contracts from our former distributor, and the same infusion set shortage I referenced in the US.

In the second quarter, we expect that international sales will be approximately $80 million. This steps down from the first quarter, due in part to the delayed impact of $3 to $4 million headwinds associated with our go-direct transition.

This also incorporates expected order phasing tied to Mobi availability as we scale launch, with some distributor demand shifting into the third quarter. Turning to margins, gross margin for the quarter exceeded expectations at 55%, an improvement of nearly 5 percentage points year-over-year, and the highest first-quarter gross margin in company history.

Notably, we started the year higher than our full-year 2025 average, reflecting continued execution on our key drivers, including pricing discipline and product cost improvements. Both operating and adjusted EBITDA margins reflect a meaningful improvement year-over-year, due largely to $75 million IP R&D costs in the prior year.

Beyond that charge, we demonstrated leverage as operating expenses of $154 million remained essentially flat year-over-year. This included a slight reduction in R&D spending that offset increased commercial investments in support of global growth initiatives.

As a result, adjusted EBITDA was approximately 1% of sales, an improvement of 32 percentage points based on the IP R&D charge alone, and an additional 3 points of operating leverage. Operating margin improved even more substantially by 40 points to negative 7% of sales.

This was due largely to a reduction of stock-based compensation expense from 11% of sales in the first quarter of 2025 to 6% this quarter. With our focus on cost discipline and achieving our profitability goals, we generated $5 million in free cash flow this quarter.

We also completed a convertible debt financing in February, yielding net proceeds of $276 million with 0% interest, to further strengthen our balance sheet and provide flexibility as we execute against our strategic priorities. As a result, we ended the quarter with $570 million in total cash and investments.

Overall, we remain confident in our ability to deliver on our goals for 2026 and are reaffirming our 2026 financial guidance. Worldwide sales are expected to be in the range of $1 billion 65 to $1 billion 85.

This includes US sales in the range of $730 to $745 million, and international sales in the range of $335 to $340 million. For the second quarter, worldwide sales are expected to be approximately $255 million.

We expect gross margins of 56% to 57% and adjusted EBITDA of 5% to 6% for the year. Second-quarter margins are expected to remain consistent with the first quarter.

Further details on our guidance and assumptions for the year can be found in the earnings call slide deck posted in the Investor Center portion of our website. With that, I'll turn the call back to you, John.

John Sheridan

Thanks, Leigh. Before I wrap up our prepared remarks, I'd like to extend my thanks to the full Tandem team.

Your unwavering dedication, commitment to innovation, and teamwork have been the driving force behind our achievements. I also appreciate your resolve as we continue to navigate shortages from our infusion set supplier.

While they may only impact a small percentage of our customers, the impact on them and the healthcare providers is significant. I appreciate the extra care and service that you are providing during this time.

Thank you, everyone, for all you do. In conclusion, we are encouraged by the start to the year, and are confident in our strategic direction that we have set.

Our operational and commercial goals are firmly in focus, and we are committed to providing best-in-class technology to our customers in a more efficient and cost-effective way, while advancing our global business model and driving meaningful long-term value for our shareholders. Thank you again for joining us today.

We are excited about our opportunities ahead and look forward to sharing our progress in the upcoming quarters.

Operator

As a reminder, if you would like to ask a question, please press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.

In fairness to all, we ask that you please limit yourself to one question. If you have additional questions, please re-enter the queue, and we will answer as many questions as time allows.

One moment for our first question. Our first question is going to come from the line of Matt Miksic with Barclays.

Your line is open. Please go ahead.

Matt Miksic

Great, thanks so much, and congrats on a really solid quarter here. Appreciate all the color, and exciting to see kind of turning the corner here into Pay-Go.

I'm sure you noticed, one of the other pump companies in the space talked a little bit about the market, some tone or I don't know, seasonal, I don't know what it was exactly, but maybe sounded like some slowness, some temporary slowness. Great to get your perspective on that, what you've seen, and then also just any way that you would characterize the major drivers of the growth in the quarter, whether it's uptake in type 2, whether it's uptake through pharmacy, whether it's new sensor integrations.

I hate the all-of-the-above answer, but anything you can do to kind of give us a sense of what were the major drivers for the quarter. Thanks.

John Sheridan

Matt, I'll just start off and talk a little bit about the market and whether it's growing or not. I think it's still large and very underpenetrated.

It's great to have type 2 as part of the market force now. We're excited about the fact that we're bringing a great deal of new technology and business model changes that we believe will really help us grow new starts from MDI.

I think that if you look back in 2025, there is a number of pump companies in the market, I think they all did pretty well. I would say it definitely appears to us that the market is growing.

As I said, we're very excited about this year in particular because we have so much technology and business model modifications that are really going to position us for growth this year and beyond. I'll let Leigh answer some of the questions about seasonality.

Leigh Vosseller

Sure. I'll just say that we didn't see anything, I would say, unusual or different from what we typically see in the DME space starting off the year.

Our pump shipments came in line with where we expected, which was about a 30% sequential decline in the US from the fourth quarter, nothing really to note there. Unfortunately or fortunately, the answer to your question about the major drivers is it really is a little bit of all of the above.

We have a lot of things, as John suggested, working in our favor this year with our new product launches, our business model transformations, and I would say, as we start to gain traction, everything's coming together to drive us towards a very successful and strong growth year altogether.

Matt Miksic

Thanks, guys.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Chris Pasquale with Nephron Research. Your line is open.

Please go ahead.

Chris Pasquale

Thanks. I was hoping you could dig in a little bit on the international business.

International pump revenue was up despite pump shipments in that segment being down. You talked about a couple of one-time items, so, were those things related, and could you maybe quantify some of the one-timers that you had this quarter just so we can think about the go-forward run rate?

Leigh Vosseller

Sure. You're right, there were a lot of moving parts internationally, and it varies, the answer, depending on if you're comparing to last year, comparing to expectations.

I'll touch on a few of those. When you look year-over-year, a significant part of the growth was coming from currency fluctuation, there was favorability in the environment that helped that growth year-over-year.

When you look at also last year, first quarter and second quarter, in the first quarter, is a little bit tougher comparison for us because last year there was a shift in timing of sales. It was more favorable about $5 million in the first quarter versus the second quarter.

As we go into Q2, it will be an easier comparison for us. Then within the quarter, compared to when we set our guidance expectations, there were also a few moving parts.

One was just simply that we had estimated a headwind of approximately $5 million for going direct in certain international markets, and we're seeing a bit of a timing difference there. We realized about a million of that, and we expect $3 to $4 million to push into the second quarter.

Also, we did have some favorability in our Swiss market, just a one-time, I would say, accounting benefit that we had, which was largely offset by some of the infusion set noise that we saw as we're managing through some of these shortages we're seeing in the quarter. I think that it's a lot, but maybe the underlying comment I should make is that, overall, we're very excited about the international operations.

We still see strong demand in the market for our products. In the markets where we've gone direct, we're already hearing very positive reception to us in the market as we're closer now to the physicians and the patients.

Chris Pasquale

Great, thank you.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Matthew O'Brien with Piper Sandler. Your line is open.

Please go ahead.

Matthew O'Brien

Afternoon. Thanks for taking the question.

On Tubi, I know filing here in Q2, still nothing expected for revenue here this year in '26, and then if you do get the approval late this year, is it fair to think you don't want to disrupt what's typically a generally stronger DME part of the year, bigger launch next year in '27, no real disruption from launching Tubi or as people are expecting Tubi? I just don't want an air pocket in any of the quarters as people are waiting for that system.

Thank you.

John Sheridan

Thanks, Matt. I think that when it comes to our submission, we're on track to submit it this quarter.

We also plan on getting clearance in the second half. There's some uncertainty with the FDA, but they've been doing a really nice job lately in getting things done quickly.

As when it comes to guidance, we typically don't include new products yet until they're actually in the market. When it does come, let's just say we get the clearance in the second half, we have a phased commercialization process where we actually observe the product in small groups of people first, and increase the size of the group of people using it, and then get to the point where we feel we've uncovered or found nothing that we would want to make sure that we fix before it actually gets into full commercial launch.

This is just a practice that we've used from the very beginning, and while we do an excellent job of testing these products, you really can't find everything until you use it over time with a large groups of people. We'll go through that process, and I think that depends on the timing.

I think that if we can get it into the market before the fourth quarter starts, I think we'd want to do that, but we'll have to wait and see when the actual approval or the clearance occurs.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Mike Kratky with Leerink Partners. Your line is open.

Please go ahead.

Mike Kratky

Hey, everyone. Thanks for taking our questions, and congrats on a great quarter.

It looked like US sales through the pharmacy maybe ticked down slightly from 7% in the fourth quarter to 6% in the first quarter. Can you just talk a little bit about how that lined up with your expectations, what factors contributed to that, and what you've seen so far this quarter to support your confidence in the 15% for the year?

Leigh Vosseller

Sure. Great question.

I think most importantly, starting off, is you really can't compare our pharmacy experience this year in 2026 to what we saw in 2025. It's a whole different world with the change in the business model that we have going on.

For example, last year, our pharmacy contracts included reimbursement for the pump that was a premium to even what we get in DME, it's a very different environment. As we came into this year, the first quarter, we've had two major work streams that were focused on.

One is building up the coverage, and so we were pleased to be able to report that we're already at approximately 40% formulary coverage, and we expect that we can still increase that across the year as we look forward to the end of the year. The other piece of it was the operational piece, and that was implementing an end-to-end change in our workflows.

It changed everything of how physicians prescribe, how we engage with the patients, how we process and fulfill orders. That's what we've been focused on, the execution of that piece.

It really all started late in the first quarter, in the last few weeks of it, and so we're at the very early stages of it. Far, we're excited about the opportunity it presents.

Nothing's changed our conviction in our ability to grow and scale that across the year, and so we look forward to future quarters when actually we can report the headwinds that are coming from the volumes that we're bringing through.

Mike Kratky

Understood. Thanks, Leigh.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of David Roman with Goldman Sachs. Your line is open.

Please go ahead.

Great. This is Phil on for David.

Thanks for taking our questions. Think maybe touch on pricing.

I saw on the slides that it was reiterated and I think I heard in your comments as well, Leigh. We heard from a competitor yesterday that so far sounds like everybody's acting rationally or fairly, I think, maybe was the term they used.

Can you talk about how negotiations around pricing have gone so far, and what is baked into that 350 number expectation for the year, what level of conservatism is in there? Thanks.

Leigh Vosseller

Sure, happy to talk about that. I would agree, I would say, that we're all behaving rationally when it comes to pricing.

We are excited to be in this market and take advantage of the pricing opportunity that was already set in the pharmacy channel for insulin pump products. When we thought about how to set expectations for the year, I would call them more modeling assumptions right now because it is new for us and it's an early experience.

What we said was to expect about $350 per month per patient as they order supplies. What's factored into that would be there's an array of contracts that were entered into with varying rebate structures in them, and at this point, we don't have enough experience to say what that mix will look like on a sustainable basis.

That's the baseline that we've set for now. It's still the right way to think about it.

As we start delivering on more volumes and gain more traction and experience, we'll be able to update those assumptions in the future.

That's great, thanks.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Richard Newitter with Truist Securities. Your line is open.

Please go ahead.

Hi, it's Robbie on for Rich. Thank you for taking the questions.

Just two for me, and I guess I'll ask them both up front. Just first on the infusion sets shortage, would you mind quantifying that and or maybe suggesting what the impact might be in 2Q?

Cuz it looks like you're kind of guiding a little bit below consensus here but reiterating the for 2Q, but reiterating the full-year guide. Just curious if there's any impact from that there.

Then second, just on the sales force expansion, this is seems to be a theme now running across your peers and and and I guess Tandem now itself. Can you maybe talk about, what the opportunity is that this sales force is going to be going after and, maybe what patient population it can unlock?

Thank you very much.

John Sheridan

Let me just talk a little bit about the situation with infusion sets, and Leigh can talk about guidance. I'll say that it's unfortunate that our supplier has had some capacity challenges that actually began in the fourth quarter, but continue to pressure us in the first quarter, and this is both in the US and internationally.

We've been working very closely with them, and I think we practically have daily calls with them, the operational team as well as the executive team, and it's a top priority for us. I would say that when you actually look at the impact, it's only a small number of SKUs that are really subject to the capacity shortages, but the unfortunate part about it is for those people who are impacted and the HCPs who support them, it's really significant.

We're doing everything we can to be creative. We're looking for options in terms of lengths, colors, you name it, to see if we can provide intermediate solutions until this is taken care of.

We're also looking at managing inventory to do everything we can to provide as broad a coverage as possible. I will say, unfortunately, that this is something that probably won't be resolved for a quarter or two.

I think we expect to see some progress in the second half of the year, but that's what we're dealing with right now. As I said, we're taking it very seriously.

Leigh Vosseller

From the perspective of the impact, all we're sharing is that it was a modest impact in the quarter, both US and internationally, and we factored that same level of impact as we've set the expectations for the second quarter. As John said, we're managing it very closely, we're working through it, and so we see a line of sight to the end of this in the long term.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Josh Jennings with Baird. Your line is open.

Please go ahead.

Jeff Johnson

Hey, guys. Good afternoon.

Leigh, I guess I'll follow up just on the comment you made there on the infusion set impact. I know you're not quantifying it, but let me go after it this way.

Supplies missed our model by about $11 million this quarter. Very well could be that we're just bad modelers.

I've been told that before, I'll probably be told that many times in the future. If you missed our model by $11 million, does a lot of that get attributed to this shortfall, and is that also it sounds like you're assuming a similar shortfall in 2Q, even though you are trying to, I think, on some of the TruSteels move patients over to other infusion sets.

I guess I'm just trying to understand does the year-over-year impact stay the same in Q2 as it was in Q1, and am I anywhere near ballpark based on my model points? Thank you.

Leigh Vosseller

Sure, thanks for the question, Josh. I would say that that is a bit on the high side for the impact of this.

I would put it more modest than that. If you think about it, there's a couple of ways to think about the size of this.

There's back-order situations, but also, to John point, some of the ways we're helping to solve the problem for patients is offering an alternative. Just because we have some back-order situations doesn't mean that we haven't recovered sales in other ways in order to satisfy patient needs.

It's not near that big. It's something that we expect to be a bit disruptive again in the second quarter, but it's something that we can work through.

We'll continue to talk more and maybe more about the modeling assumptions in the supply sales, maybe it's a little bit of price or other pieces of it that are not working there.

Jeff Johnson

Thank you.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Matthew Taylor with Jefferies. Your line is open.

Please go ahead.

Hi, good afternoon. Thanks for taking our question.

This is Matt on for Matt Taylor. I wanted to ask a little bit on kind of product expansion.

First one on your clearance for type 1 pregnant women. The second one actually you kind of answered that one, but sticking with pregnant women, can you help us maybe frame the size of that opportunity and how incremental that could be?

Then maybe a third one on adding Android capability, is there any analog we can look at for thinking how that adds any sort of incremental growth in through coming quarters? Thank you.

John Sheridan

Sure. We're very excited to have received pregnancy clearance in the in it's actually just a few days ago, and it was based on data from CIRCE trial that was published in JAMA recently.

I'm I'm happy to say we're the first and only AID system approved for pregnancy in the US for both Mobi and t:slim using Control-IQ, and we also expect CE mark here this quarter. If you look at the clinical data, the control group the see the the the Control-IQ group experienced 12.5% improvement time in a tighter range of 63 to 140 milligrams per deciliter, and that's about 3 more hours a day, and it's was for the length of the pregnancy.

Really substantial improved in a great performance by the system. When it comes to the size, I would say that it's obviously pregnant women, but it's also women considering pregnant pregnancy.

I I, I think that, it's it's not a really large group of people, I don't think I can put a number on at this point in time, but it's a meaningful and important group of people, and we're very happy to have this. We're we're now in the in the in the midst of kicking off training and events for HCPs, and as I think I mentioned in the in the remarks that we do plan to have a symposium at the at the ADA.

Just real quickly, relative to Android, we have we have a number of people that we monitor who use Android and iOS applications on our on our mobile apps on on t:slim, and I would say roughly 60% of those use iOS, and so Android represents a big opportunity for us. I have friends who use our product and have been waiting for Android to become available.

It's meaningful. It's another great opportunity for us to just drive MDI growth in 2026 and beyond.

It's a it's a meaningful addition to the the portfolio.

Great, thank you.

Operator

Thank you. As a reminder, please limit yourself to one question before re-entering the queue.

Our next question will come from the line of Joanne Wuensch with Citi. Your line is open.

Please go ahead.

Joanne Wuensch

Oh, thank you so much. Sticking with the one-question rule, with Tubi being submitted in the second quarter to the FDA and on track for second-half approval, and assuming there's nothing in your guidance for how do we think about kicking off 2027 launching that product, and how are you preparing for it?

Thank you.

John Sheridan

I think for launching the product, as I mentioned, we have a phased commercial process to release it. We're hoping that we actually get it on the market this year, but I think that when it comes, we'll have to see what the timing looks like.

When you think about the market today, there really is a tubed market and a tubeless market. The tubed market is growing at maybe single digits, low single digits, whereas the tubeless market is growing in double digits, in the 20% range.

A significant opportunity, and I think that when you look at the competition that's out there today, we're in the pharmacy now, we're going to have a tubeless device, and I would say we feel like we have a better algorithm. I think that there's a big opportunity for us to do two things.

One, I think we're going to drive MDI conversions to our device, and at the same time, I think there's potential for competitive conversions. I think that's unless you want to add anything to that, Leigh, but that's pretty much what I would describe.

It's a big opportunity for us, we recognize that, and we're really excited about it.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Suraj Kalia with Oppenheimer. Your line is open.

Please go ahead. Suraj, your phone might be on mute.

Suraj Kalia

Sorry about that. John, can you hear me all right?

John Sheridan

We can, yes.

Suraj Kalia

Perfect. John, I'm going to cheat and sneak in a two-parter if I could.

To Joanne's question, John, how would you define the low-hanging fruit for seven-day Tubi? Would there be a price differential?

Leigh, if I could quickly, US sales were up 5%, pump units up were roughly 12%, and then obviously there's a 6% PBM contribution. Can you help us thread the needle here?

Thank you for taking my questions.

John Sheridan

I think the financial benefit, Suraj, is the fact that the infusion plate lasts seven days, whereas an infusion set lasts three today. There's a margin benefit from having that extended time.

It's also a substantial customer experience improvement in that they don't have to change the product as frequently. I think that all this stuff adds up, and we're doing everything we can to get gross margin up, this is certainly a help in that.

I think the real benefit here is customer experience, and that's where our focus is.

Leigh Vosseller

To your question on the first quarter in the US, and so when you look at pump shipments, you're seeing it on a rounded basis. The actual growth rate was 10%, the spread between the growth rate on shipments and the sales growth is not as substantial as it might seem on the surface, it really is just pricing that's the differential.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Barry Bijlani with Wells Fargo. Your line is open.

Please go ahead.

Barry Bijlani

All right, thanks for taking the question. Leigh, I'll ask the new start question.

By my math, it looks like new starts were down slightly year-over-year in Q1, and down modestly sequentially by our math. Is that right, and do you still expect new starts in the US to grow in 2026?

Thanks for taking the question.

Leigh Vosseller

Sure, thanks, Barry. Yes, your math is accurate when we look at it year-over-year, and even down sequentially, mostly due to just the regular seasonal impact that we see.

This was how we had structured the year in terms of our own modeling assumptions, that we would continue to see that slight decline in the first quarter, but we would return to growth as we look ahead. We're very convicted in the ability to return to growth because we've been seeing improvement over the last few quarters from our low middle of last year, and it's really the traction we're seeing on our new product launches.

Then we look forward to pharmacy making a real difference there, too, now that we've removed that cost barrier. More and more people can move to pump therapy without having to worry about an upfront cost.

As we continue to build on that initiative and drive these new product launches, we do expect to see that return to growth this year.

Barry Bijlani

Thank you.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Michael Polark with Wolfe Research. Your line is open.

Please go ahead.

Michael Polark

Hey, good afternoon. I'm interested in learning about the process to convert someone in the base to pick up supplies at pharmacy.

I get the incentive for a new user with no upfront, but for that compliant happy user through DME, how do you get them to the pharmacy? What does the outreach from you to them look like?

What is the outreach from you to a physician look like? Can you remind me on the financial incentive, how different is patient out-of-pocket for supplies only in the DME versus pharmacy?

Thank you.

Leigh Vosseller

Sure, I'm glad you asked. It's a really good question because I think there might be an assumption that it would be easy just to move people over, but there is work involved to that point.

First and foremost, when a customer comes in to place their quarterly order, which is usually quarterly, I should highlight, mostly not monthly, but we will check their benefits to see if we have coverage for them on formulary. Then we'll share with them the out-of-pocket benefits, and that's the true motivator for them is the out-of-pocket is typically lower, or with copay assistance, we can make it be lower if nothing else.

Once we get them understanding and ready to move forward, it does require a new prescription, so that requires reaching out to the physician to get them involved to have them write the prescription. Getting their attention and time to focus on that, in some cases, they want to focus on customers who haven't yet moved to pump therapy, but it's a process.

That's something that we're working on, and it is one of the key drivers as we look ahead to really maximize this pharmacy opportunity. It's not only bringing more patients to Tandem, but it is converting that existing base we have, cuz if you think about the multiples you see when you could easily move 300,000 people and get that price benefit, that makes a significant difference on our revenue growth and our margins.

It is one of the activities we're very much focused on.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Priya Sachdeva with UBS. Your line is open.

Please go ahead.

Priya Sachdeva

Hey, guys, thanks so much for the question. Really nice to see the cash flow generation in the quarter.

In Q1, which has typically been a heavy cash burn quarter for you guys, would love to maybe hear about what changed this quarter, and then how sustainable is this level of cash generation going forward? Thanks so much.

Leigh Vosseller

Sure, thanks, Priya. A lot of this comes from the cost discipline that we have.

While we're focused on growing revenue, we're also equally focused on driving improved margins. This year, we demonstrated a 1% positive EBITDA in the first quarter, and I believe that's the first time we've done that since 2022.

To your point, Q1 is a tougher quarter because of the seasonal dynamics in our business. It's really meaningful to us that we were able to show positive EBITDA and this cash flow generation, I appreciate that you noticed that.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Jason Bedford with Raymond James and Associates. Your line is open.

Please go ahead.

Hi, this is Elaine on for Jason. Thanks for taking our question.

I had a question on the gross margin and how you're thinking about the cadence for the year. You gave us guidance for 2Q and 4Q, and we can get to an implied 3Q.

My question would be why would it stay relatively flat for the first three quarters, at least according to my math, and when we think about the year-over-year expansion, how much of it is driven by Mobi scaling versus the pharma transition? Thank you.

Leigh Vosseller

Sure, thanks, Elaine. It's a great question.

First, I'll start with the Q1 to Q2 being relatively flat. A little bit of that is really just product mix.

When you look at where revenue will go from Q1 to Q2, both US and internationally, more of that step-up is coming from supplies. Globally, even though supplies are going to have a better gross margin eventually in the US with our new reimbursement model in pharmacy, today, supplies will still have a lower gross margin than pumps.

It's really just reflective of the product mix going into the second quarter. Then it should start to step up from there, scaling towards that 60% in the fourth quarter, and that will come from our pricing benefit that we expect both with our direct operations outside the US continuing to build, and with the pharmacy benefit that can come from converting more customer in the supply base to pharmacy in the US.

I would say this year, price will be a very prominent driver of gross margin, but we are continuing to see benefit from Mobi as it's scaling in volumes. For pumps, we started seeing that benefit in 2025 as we were building more.

For supplies, with Mobi, we're really going to start to see that difference this year. That will be a contributor to the gross margin improvement across the year.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Jonathan Block with Stifel. Your line is open.

Please go ahead.

Jonathan Block

Great, guys, thanks. Maybe I'll just follow up on an earlier international question.

Just when I look at that international pump ASP, the actual ASP seemed to step up really nicely from recent quarters. Just, Leigh, any color, how much is FX, how much is the direct transition, does this even trend higher from the current 1Q result just as the percent that is direct continues to increase?

Maybe most importantly, any way to think about an exit '26 pump ASP as we head into the following year?

Leigh Vosseller

Sure. I will start by saying the assumption that we've made in guidance for the year is that pump ASPs outside the US with these changes with going direct should land somewhere in the 2,800 to 2,900 range.

We did see I'm going to say extra benefit in the first quarter because of this one-time accounting benefit we got in the Switzerland market. We were able to recognize a level of revenue there because of the acquisition of certain customer rental contracts that were already in existence from our distributor.

This one-time benefit is what really drove the incremental pump ASP in the first quarter. Otherwise, it should settle into that 2,800 to 2,900 range for the rest of the year.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Anthony Petrone with Mizuho Financial Group. Your line is open.

Please go ahead.

Anthony Petrone

Thanks. Good afternoon, everyone.

Maybe on the US side, competitor had a recall announcement. FDA came out in April, sort of reported more adverse events on one of the primary competitors.

Just wondering what the chatter is out there. Is that creating any opportunities just for share capture?

Certainly as you look to Mobi or even otherwise. Just a little bit on the competitive dynamics in the quarter.

Then in terms of the follow-up on spend as you get ready for the Mobi launch, just thinking a little bit on the DTC, is there a big DTC campaign that's planned around Mobi Tubeless? Thanks.

John Sheridan

Regarding recalls, it's unfortunate, but that's one of the things that happens in this marketplace. The real intent of the recall is to be sure that the the the diabetes community is aware of safety issues that might impact the use of their products.

I would say it's it's something that happens to everybody. When we when we have it happen, we do our very best to assure that patients are safe and they understand the the the risks.

I don't think I don't think that's going to give us There's no benefit that's going to come from that. You you don't like to see it happen, and but you'd you'd recognize that it's part of of of dealing in a in a market that has lifesaving technology.

When it comes to competition in general, I would just say, it's a large and expanding, underpenetrated market with new entrants. I would say Q1 was consistent with our expectations.

It's a very highly competitive market, but there's nothing really that specific to point to that changed. I'll also say that, we are very confident in our ability to deliver new technology to the market.

I think the team has done an amazing job in the last several quarters, and we continue to do it this quarter and in the second half of this year. And, I think it's it's it's a I think it's going to really impact the business when it comes competitively.

As well as we're now moving into, the the pharmacy benefit where the out-of-pocket is substantially lower, and that's going to be a big benefit. I I think that we feel very good about where we're heading competitively, but specifically to the marketplace today, I I don't think that it's it's very competitive, and but nothing's really changed.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Mathew Blackman with TD Cowen. Your line is open.

Please go ahead.

Mathew Blackman

Good afternoon, everybody. Can you hear me okay?

John Sheridan

We can, Matt.

Mathew Blackman

Great. Thanks for taking my question.

Leigh, I think I heard you say 40% formulary coverage to date. I guess I'm just trying to figure out sort of the proper context.

That feels like a lot of progress to date, we're just one quarter, quarter and a half deep in the year. I really don't know how to frame that relative to where you need to be at the end of the year to sort of hit your goals.

Could you frame that relative to your expectations where you hope to exit the year? Is the next sort of whatever percent, let's call it 60%, 60% a heavier lift?

Just any sort of framework to think about where you are today and where you need to be by the end of the year to hit some of these goals for pharmacy mix, etc.? Thank you so much.

Leigh Vosseller

Great, happy to put some context around that. I think what's important to understand is typically new formulary additions happen on a January 1st to July 1st cycle.

We're very excited that we've been able to add this coverage across the quarter, we're a bit off-cycle here. It shows first of all, the receptivity to us moving to this Pay-Go reimbursement model, and then also the acceptance of our products within the channel.

The team isn't stopping. I feel like when I look at my email, I see announcements every week that show another formulary addition, some bigger than and smaller than others, but still the team is working hard and working to drive that up across the year.

In order to achieve our goals for pharmacy this year, we're right on pace with where we need to be. I'm not going to share a specific goal, but I think we're very well-positioned to drive the pharmacy access in order to hit the targets that we've set out.

Mathew Blackman

All right. Thanks so much.

Operator

Thank you. One moment for our next question.

Our next question will come from the line of Bill Plovanic with Canaccord Genuity. Your line is open.

Please go ahead.

Hi, it's Zach on for Bill. Thank you for taking the question.

As for the type 2 ramp, can you give more context as to how that's going? You've talked about in the past difficulties you had with the C-peptide testing requirements.

Could you just give us an update on what's happening there?

John Sheridan

Sure. We're really excited about type 2.

It's a big opportunity and it's even less penetrated than the type 1 market US and internationally. Really our focus is on market development at this point in time.

I'm not going to talk specifically about numbers today. We really want to see sustained trends before we report numbers.

We're going to wait a little while. It's early for us.

That being said, there's many positive sources of growth that are happening right now in type 2. In the near future, we expect tailwinds from FreeStyle Libre 3, from Mobi Android, Mobi Tubeless, pharmacy.

Those are all great. We do anticipate positive news from Medicare access, and we think they're going to get rid of the C-peptide requirement, but we'll have to wait and see.

As far as the company goes, right now, we're focused on just creating awareness clinically and on the product benefits, but big market, underpenetrated, we've got a lot of positive things going on. We're excited about it, and we do anticipate seeing growth in type 2 starts, MDI starts this year.

Operator

Thank you. One moment for our next question.

Our next question is going to come from the line of Travis Steed with Bank of America. Your line is open.

Please go ahead.

Travis Steed

Hey, thanks for the question. Maybe focus on that, March 2026, where you're kind of moving the Pay-Go into the pharmacy.

Just help us understand how that went, how's the trend, you're seeing kind of increasing ability to kind of ramp into April and May, and the 40% coverage that you got, how much of that is kind of tier 1 at this stage?

John Sheridan

Sure, I'll answer the first part of the question, Travis. Our early experience really does reinforce our conviction that this is a great opportunity for us, for the business and for our customers.

We're moving forward aggressively. It's our top priority.

As Leigh mentioned, operationalizing pharmacy is there's a lot going on there. It's a change to the physicians' processes, the way we service our customers, and how we process and fulfill orders.

I'll say that right now, we're working to improve the experience. There's behavioral change that we have to work with, there's learning curve, there's efficiency opportunities, and these are things that we're very focused on right now.

Also we have a strong team, and we're making good progress. I think it starts off slow and will gradually increase as we get through the year.

Again, this will be a meaningful part of our business, certainly by the end of this year and as we move in 2027. Then

Leigh Vosseller

just a quick comment on your question about tiering. We have a variety of our contracts where we're on different tiers, and the real difference that it makes to us, at least, is the amount of rebate that you pay in the various tiers, and then the influence that has on the patient's out-of-pocket and the amount of copay assistance that we might have to use.

We're not sharing any breakdown of any of our contracts in particular, but we are on tier 1 in some, tier 2 in some, tier 3 in some. It does vary across the board.

Travis Steed

Thanks a lot.

Operator

Thank you. One moment for our next question.

Our next question comes from the line of Shagun Singh with RBC Capital Markets. Your line is open.

Please go ahead.

Shagun Singh

Great. Thank you so much.

I just had a quick question on Mobi Tubeless, and I apologize if it's been asked already. Can you maybe talk about how you think about the mix between the different products that you will be selling with Mobi Tubeless coming on board?

How we should think about pricing? How do you expect to compete with the current patch pump form factor, more from MDIs or competitive share gains?

Then just anything you can share on the go-to-market strategy that you haven't already discussed. Thank you.

John Sheridan

Shagun, the first thing I think that's important here is that we already have 325,000 customers in the US. A significant portion of those use the pump today already, and this is a infusion set option for them to choose.

We think there's probably going to be pretty good conversion amongst those people. I think people are going to try it out first, try both ways out and see what they like.

I think that the other aspect is certainly when it comes to new starts, now that we have a tubeless product in the market, we expect to see we're going to benefit from the fact that tubeless is very important to people. It's a form factor that they want, and we expect to see a lot of progress there.

Leigh, you want to add anything to that?

Leigh Vosseller

Just to your question on pricing, to John's point, with it being the Mobi pump, it's the same pump hardware regardless of which infusion set they choose. Then when it comes to pricing, we haven't discussed our approach yet, except that for now you can think about it as being similarly priced to Mobi supplies.

John Sheridan

It's a supply pricing issue. It's the same pump.

Obviously, same price for the pump.

Operator

Thank you. This will conclude today's question-and-answer session.

Ladies and gentlemen, this will also conclude today's conference call. Thank you for participating, and you may now disconnect.

Everyone, have a great day.