Tandem Diabetes at Leerink Conference: Strategic Growth Amid Challenges

On Wednesday, 12 March 2025, Tandem Diabetes Care (NASDAQ: TNDM) presented at the Leerink Global Healthcare Conference 2025, outlining its strategic vision amidst both promising growth prospects and notable challenges. The company reported a record fourth quarter for 2024, driven by the success of its Mobi pump, while also addressing economic headwinds and insurance-related obstacles. CEO John Sheridan expressed confidence in Tandem’s competitive position, supported by upcoming product launches and strategic initiatives.

Key Takeaways

• Tandem reported a record fourth quarter in 2024, with Mobi pump driving 60% of new starts.
• The company projects 13-14% revenue growth in the US for 2025.
• Tandem plans to expand into the Type 2 diabetes market with pilot programs in Q2 2025.
• Transitioning to a direct sales model outside the US is expected to impact 2025 revenue by $15-20 million.
• Targeting improved gross and operating margins of 65% and 25% respectively.

Financial Results

• 2024 Performance: Tandem achieved a record fourth quarter and overall strong year, led by the Mobi pump’s success.
• MDI Growth: MDI conversions accounted for 60% of new starts, with sequential quarterly growth from Q2 to Q4.
• 2025 Revenue Guidance: Anticipates 13-14% revenue growth in the US, with a 70% renewal rate target.
• OUS Revenue Impact: Direct sales transition outside the US to result in a $15-20 million negative impact.
• Margin Targets: Aiming for a 65% gross margin and a 25% operating margin, with a 3% adjusted EBITDA margin.

Operational Updates

• Mobi Pump: Continues to drive MDI conversions with positive reception.
• New Control IQ Algorithm: Launching a new version this month.
• Salesforce Realignment: Modest expansion and data-driven tools to enhance efficiency.
• Pharmacy Channel: Aims to reduce patient costs and improve access, with higher ASPs expected.
• Type 2 Diabetes Indication: Plans to pilot commercial strategies in Q2 2025.
• OUS Transition: Moving to a direct sales model outside the US.
• Product Pipeline: Upcoming Freestyle upgrade and Android compatibility for Mobi, with CE mark filed for OUS availability.

Future Outlook

• 2025 Focus: Emphasis on MDI growth, particularly via the Mobi pump.
• Type 2 Expansion: Pilot programs in select territories to commence in Q2 2025.
• Pharmacy Channel Growth: Aggressive expansion expected, with a 1-3 year timeline for significant impact.
• Tubeless Moby: Reprioritized ahead of t:slim X3, anticipated to restore competitive positioning.

Q&A Highlights

• Economic Concerns: December slowdown linked to economic anxieties and high-deductible insurance plans.
• Competitive Positioning: Confidence in upcoming product launches and strategic initiatives.
• Salesforce Realignment: Considered in the 2025 guidance.
• Guidance Confidence: Management is confident in meeting 2025 financial targets.

For more detailed information, readers are invited to refer to the full transcript below.

Full transcript - Leerink Global Healthcare Conference 2025:

Mike Kraki, Senior Med Tech Analyst, Leerink: Thanks everyone for joining. My name is Mike Kraki. I’m our senior med tech analyst here at Leerink.

Today, I’m thrilled to be joined by Tandem CEO, John Sheridan, and VP of IR, Katie Nicoletti. So

John Sheridan, CEO, Tandem: Hi, Mike.

Mike Kraki, Senior Med Tech Analyst, Leerink: Thank you both for joining. Great. So maybe it’d be helpful just to start to kick it off with a few opening remarks on the company for those maybe less familiar or just revisiting.

John Sheridan, CEO, Tandem: Sure. Well, Tandem has been around from about 02/2007. We actually commercialized our first product in 2012. It’s, our belief is that diabetes is not a one size fits all condition. And as a result of that, people want to control, interact and wear their devices differently.

And so we believe in a portfolio approach. We have designed our devices to be simple, intuitive and easy to use, very much like a consumer device. We think that ease of use drives adoption. It’s still a very underpenetrated market, roughly thirty five percent to forty percent penetrated in The U. S, meaning people who have Type one diabetes, about forty percent of them use pumps.

It’s less penetrated OUS. We just recently got the Type two indication, which we’re excited about, which essentially doubles the TAM. And, we’ll be rolling out products this year to support that.

Mike Kraki, Senior Med Tech Analyst, Leerink: Great. So why don’t we jump into the four So on the positive side, one thing that stood out was MDI represented 60% of your new starts in 2024. You saw double digit growth in MDI, and MDI starts also grew sequentially every quarter from 2Q to 4Q. So what were the key factors that drove that strength in 2024?

John Sheridan, CEO, Tandem: Well, I think that it was primarily resulting from a new product introduction that we had in the beginning of the year. We have a new product called Mobi that we brought to market in the first quarter, late first quarter. It’s about half the size of the t:slim pump and it has mobile control. So the whole intent of Mobi was to drive MDI conversions. We’ve definitely had some challenges over the last two years in terms of MDI growth, but we certainly saw great progress.

Mobi has been incredibly well received. People who have it love it. They forget they have it on. It’s one of the more common things that people say about it, which is a very positive statement when you’re wearing a body worn device. And the mobile app gives you great flexibility and convenience as well as discretion.

So I’d say most of the growth has been just driven by Mobi’s emergence onto the market.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. So you mentioned a couple of challenges. I wanted to address some of your recent commentary regarding the muted seasonality in the last couple of weeks of December. Can you just help unpack what happened and what may have contributed to some of that regular cadence of new starts in the last part of the quarter?

John Sheridan, CEO, Tandem: Yes. So as you said, we had a great year. In fact, that was a record year for us. The fourth quarter was a record quarter and December was a record month. And we track seasonality very carefully.

And if you look at the quarter, the fourth quarter in particular, every week we see a growth in opportunities and it just steps through the entire quarter. We were in the December time frame and about halfway through December, we still thought we were going to hit the high end of guidance. Unfortunately, what happened in the last two weeks of the quarter or the month, we saw softening in demand. And so, I think there’s been some belief it might be a competitive issue. It’s absolutely not related to competition.

The competition hasn’t changed. There’s nothing really different from in December than there was throughout the entire year. And I think we competed effectively against the three main competitors that we have in The US. I think we probably would ascribe the issues to two things. One, you know, there’s concern about the economy where, you know, inflationary pressure as well as I think potential recession, some concern and anxiety about the current administration, I think lead to people just being more cautious about spending.

And the other thing that we believe happened is as as time has gone on, people are getting higher deductible insurance plans. And, as you look at the purchase of the transition for sensors to pharmacy channel, they’re spending less out of pocket or spending less of their deductibles on the purchases for sensors and insulin, in fact. So I think what we what believe happened is that the high deductibles weren’t met in some cases, and then there were less people who were willing to purchase a pump in combination with the economic just mentioned.

Mike Kraki, Senior Med Tech Analyst, Leerink: Okay. Yes, understood. I mean in terms of that irregular pattern that you saw, can you talk about just maybe quantifying the magnitude of that or if any of that is carried into the first quarter so far?

John Sheridan, CEO, Tandem: I think that we always see a seasonal drop into the first quarter, which we anticipated. I think that, I don’t I think that in the first quarter, basically nobody has met their deductibles at this point. And so that’s why we see the drop. So we really haven’t seen any continuation of what happened in the fourth quarter. We did when we did indicate guidance for the first quarter and the year, we were roughly two months into the quarter.

And so we had a pretty good idea where things were going. So I think we feel pretty confident with what we stated.

Mike Kraki, Senior Med Tech Analyst, Leerink: Okay. And then you mentioned the competitive landscape. So what gives you the confidence that this isn’t some competitive pressure that you’re seeing as you get other competitors coming to market or new product offerings?

John Sheridan, CEO, Tandem: Yes. And I think that, well, we haven’t seen changes. There’s no new products. The same competitors are there. And in fact, you know, this this month, we’re bringing to to market a brand new version of Control IQ algorithm, which we’re excited about.

It’s going to have meaningful effect. If you look at the pipeline through the year, we have a number of other additions. We have Freestyle upgrade three coming to market. We have Android coming to market with Mobi. And we also have, we filed CE mark for an OUS, availability of Mobi, which will happen before the end of the year.

So we have a lot of things going on from a product point of view, which we think is going to have a meaningful effect on our competitive positioning. And the other thing that we’ve got going on is the Type two indication, which we think is going to drive revenue, you know, beginning here in the not too distant future. The pharmacy channel is something that we’ve, done the team has done a great job in getting access to pharmacy. We’re going to be, you know, really stepping on the gas, I think, this year to get as much of our product through it. And that just gives us a level playing field when it comes to access and, lower out of pocket costs for patients, which we think will also help drive demand.

So I think, yeah, the the competitive situation is not going to change. In fact, it probably will become more competitive over time. But I think that we feel very good about where we stand with our products and our business strategy to deal with it.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Yeah. And a lot will circle back to you on that just in terms of future growth drivers. Quickly, in terms of the renewals standpoint, how have those trends compared to what you’ve seen historically?

John Sheridan, CEO, Tandem: I think we have done a great job in renewals. I think we have high confidence that we’re able to achieve roughly a 70% renewal rate, for people who have, who are coming off of warranty. And so I think that if you look through the year, we’ve seen continued progression and great performance when it comes to renewals. And the other thing about it that I think is really fantastic is that this is occurring in a very competitive environment. And I think that if, if anybody were to choose a different pump, it would be somebody, you know, coming off of renewals.

But we’re seeing very strong performance there. So we think that’s a great indication about the products we have as well as the service we provide. So, really good performance by the team in that area.

Mike Kraki, Senior Med Tech Analyst, Leerink: Great. And, you know, talking about some of the great performance, your OUS business has continued to track well ahead of expectations. So how much of that is market expansion versus higher penetration within your existing markets?

John Sheridan, CEO, Tandem: It’s really higher penetration in existing markets. We have, we we haven’t added any markets in the last year, but we have added, we have a new team in the OUS countries. We have a new leader. We’ve actually been bringing people into the OUS countries that are in country versus having people travel from The US. And these are clinical people, marketing people, you know, people who interact with the KOLs, etcetera.

And so that’s been very beneficial. So the team without any new products this year has really done a fantastic job because we have seen, really strong growth in The U. S.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. So let’s get into your 2025 guidance a bit. You’re expecting 13% to 14% revenue growth in The U. S. Can you help frame what’s being considered there just in terms of your type two, increased adoption in the pharmacy channel?

What’s really being considered?

John Sheridan, CEO, Tandem: Katie, you want to take that? Sure.

Katie Nicoletti, VP of IR, Tandem: I’d be happy to. So if you start with our reoccurring revenue streams, as John mentioned, we’re seeing really strong trends continue with renewals. We have a large install base, and with that, we see growing supply revenue. And then for new starts, we see growth in the single mid digits. And then, you know, we like to see sustained data driven trends before we’re going to put growth drivers into our guide.

So we have minimal impact for type two and for pharmacy.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Really helpful. I’d love to jump into that a little bit. So, you know, during your 4Q call, you talked about expecting that mid single digit growth in new pump starts in 2025. You know, we had a note earlier this week just trying to break out the math a little bit between MDI and competitive conversions.

So can can you help parse out the math just in terms of what is being considered between MDI and competitive conversions in 2025? And what gives you the confidence that you can really drive that mid single digit growth?

Katie Nicoletti, VP of IR, Tandem: Sure. Absolutely. So when we look at new starts, we break it into competitive conversions and MDI. And, historically, competitive conversions has been a growth driver for us. And moving into ’24, you know, we realized that while that split historically has been fifty fifty, we were gonna see MDI start to outpace competitive conversions, and that’s what we saw in ’24.

So in ’24, about 60% of our new starts were MDI, and we would continue we would assume that that would continue going forward. We feel like we have good momentum because in ’twenty four, we saw MDI increase quarter over quarter, and we saw double digit growth. So that kind of gives us momentum going into ’twenty five.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Is there a way to kind of quantify the degree of growth that you saw in either MDI or competitive conversions in 2024?

Katie Nicoletti, VP of IR, Tandem: The degree for MDI?

Mike Kraki, Senior Med Tech Analyst, Leerink: Basically, just the like, how much it grew or how much competitive conversions fell, if that’s something you can

Katie Nicoletti, VP of IR, Tandem: follow-up. Just that the split definitely changed, and we expect that MDI is gonna be, you know, really where we’re focused. And that’s where our KPIs are related, you know, in the company. We wanna see that continue to grow.

John Sheridan, CEO, Tandem: We did say MDI was 60% of our total new starts for the year.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it.

John Sheridan, CEO, Tandem: And we saw consecutive growth each quarter.

Mike Kraki, Senior Med Tech Analyst, Leerink: Yeah. No. That was certainly really encouraging. In terms of your OUS revenue guidance, can you just walk through quickly the underlying puts and takes there? You know, on the back of some really strong growth in 2024, what’s keeping the growth from being a little bit higher in ’25?

Katie Nicoletti, VP of IR, Tandem: Sure. I mean, it’s definitely a large and underpenetrated market, and we’re excited about the opportunities that we have. But we also are going through a transition, and we’re gonna go direct. And so because of that, we have, some headwinds baked into our guidance to the tune of 15 to 20,000,000. So we think that with that, we still are absolutely focused on, you know, getting growth OUS, but we also want to make sure that we’ve got expectations in ’25 that we’re comfortable with given the transition.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Maybe turning to your Salesforce realignment, what was the rationale for implementing that when you did? And where do you stand in the process there?

John Sheridan, CEO, Tandem: Well, I think when you look at the market, there’s additional competition. There’s new players out there that have their sales forces. And if you look at the our main competitors, our two main competitors, they’ve got larger sales force than us. And so, we have new sales leadership in The U. S, and it just was a logical step in my mind to expand the sales force.

Now it wasn’t a massive, it was, I’d say, a modest expansion. We basically hired the people in the fourth quarter and they started work roughly January 2 and have been trained now and are all on board. I’d say that there’s probably 95 plus percent of the people have been hired. They’re in place. They’re actually contributing.

And so, it was just a logical thing to do just based on the competitive nature of the market. The other thing that we’ve done is we have, we’ve been looking at the tools that that enable the sales force to be more efficient. And over the last six months, the last two quarters of twenty four, we really spent a lot of time piloting these tools in the marketplace. And these are data driven tools that help the sales organization prioritize who they should speak to and not only who they what what is the message and messaging when they get there. And, and so I think that that’s that’s another thing that’s being rolled out across the entire sales force this year.

And people have already been trained. We think that the combination of the sales force expansion and also the benefit we’re going to see in reach and frequency from the training is really going to have a favorable impact on the year.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. It sounds like a major consideration of the Salesforce realignment was to focus on some of your higher ROI call points. But is it fair to think that this move better positions you in Type two or some of the PCPs moving forward?

John Sheridan, CEO, Tandem: I think it’s the former. I think we realign the sales force so that there’s a higher there’s smaller areas, higher density of physicians, just so that, again, it’s more a matter of managing the efficiency of the team that we’ve got. I think that we’re certainly looking at Type II. We intend to move into the Type II space here shortly, probably at the beginning of the second quarter, and we’re going to pilot it. We’re going to have multiple territories that will be piloting the use of clinical you know, and advertising.

And we’re going to be evaluating the effectiveness of that. And as we as we see things that may need tweaking, we will. We’ll fix those. And then we’ll move more broadly beyond that to the rest of the sales force. So I think that’s another opportunity I think we’ll be looking at during the year.

But at this point in time, it’s going to be managed by the existing team.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. I’m sure you can appreciate some investor trepidation after seeing some disruption last year from a CGM company, following a Salesforce realignment. So what makes this different and what steps did you implement to mitigate some of the potential disruption?

John Sheridan, CEO, Tandem: Well, certainly, we were aware of it. And I have to say that we were very cautious in terms of our plans to implement the realignment as well as the additional salespeople. I mean, I think the biggest source of disruption is obviously having new physicians that you don’t know in your territory. And you’ve got to spend time getting to know them, getting them to know us, and that’s the source of disruption typically. And so as we did realign and expand, we made sure that there was a finite amount of new position as to each of these territories.

So the majority of the territory, the people who are in there already know the people. There’s just continued business as usual, and there’s a small number that are new. And by doing that, we think we have carefully planned for and managed the potential impact of disruption. The disruption is already contemplated as well in our guide for the year. So it’s but we don’t think it’s going to be a major problem.

Mike Kraki, Senior Med Tech Analyst, Leerink: Okay. Yes, that’s helpful. And just in terms of when you’d expect to start seeing a benefit from that Salesforce realignment, how do you think about, you know, how that could play out?

John Sheridan, CEO, Tandem: I’ll say that the people we hired are very experienced. They have come from the diabetes community. They already know the KOLs themselves. And so, you know, it’s a but there is they need to learn the company. They need to learn the product.

And so that typically takes a quarter or two. And so I think that, you know, roughly, it’ll probably be the first half of this year where there’s more, just getting increasing awareness of the company and the product. And on second half, we’ll see the benefit.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. So I think one of the things that we heard that was really encouraging on the 4Q call was just around the twenty percent of covered lives in The U. S. Having pharmacy access. So what are the factors there that you think are going to help people move to the pharmacy and and what’s being considered there just in terms of how quickly that could grow?

John Sheridan, CEO, Tandem: Well, let’s, I think the team again has done a great job there. We we had indicated that our goal is to get a million lives and we’ve substantially beat that. And we’re going to continue to focus on additional agreements, additional covered lives throughout the year. The reason we moved to the pharmacy channel is, one, most importantly, is to reduce the out of pocket for the patient. I mean, I think the co pays for, the devices in the pharmacy channel are just less than they are through the DME.

And so that’s a big advantage I think one of our competitors has, and it’s a it’s a main reason for us to go there. The other is just access. It’s just easier to get on to the pharmacy channel than it is through the DME. And so the combination of those two really level the playing field, I think, for us and also just provide more market opportunity. The added benefit, though, is that in the pharmacy channel, we do anticipate seeing higher ASPs.

And so I think that’s the and so as a result of those three opportunities, I think we’re going to be moving aggressively. We have to we’re in the process of establishing the operational systems to support pharmacy labeling, packaging and things like that. And that’s all going quite well. And I think that as we get through the year, we’re going to be focused on more aggressive movement of products through that channel versus DME.

Mike Kraki, Senior Med Tech Analyst, Leerink: So where do you think your pharmacy mix could be if we’re thinking about the back part of this year or next year?

John Sheridan, CEO, Tandem: I mean, it’s one of those things where it doesn’t happen overnight. I mean, the transition can take a year or two or three. And that’s when you look at some of our competitors, that’s pretty much how long it took them to really get meaningful percentage of their business. I will say, though, it’s a priority. We do want to move aggressively in that area.

And, I think that it’s again, just based on the opportunities that we just discussed, the organization will be moving as aggressively as possible. But it’s one of those things that just doesn’t happen overnight.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. You also mentioned the higher ASPs in the pharmacy channel. Would love to hear how you’re thinking about, you know, quantifying that. How much higher is the ASP going to be over the course of a four year warranty as you think about pharmacy versus DME?

John Sheridan, CEO, Tandem: When you, one one of the things that we’ve done when we interacted with the organizations and and doing the contractual work was to help them we educated them on the product, how it works in the DME. And as a result of that, when you look at our contracts, they’re very much like DME contracts even though they’re in the pharmacy where there’s a relatively large upfront for the pump and then the supplies are just paid on a quarterly basis for the four years. We’re not going to quantify exactly, but I will say that it’s higher than it’s not all the way as far as our competitor may experience in terms of the ASPs, but it’s certainly a positive from what we’ve got today. And we do expect it to help the top line for sure.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. Yeah. No, I think that’s really helpful. And maybe just from a bottom line standpoint as well, how should investors be thinking about the potential impact on your P and L or path to profitability over the next two to three years as your pharmacy mix increases?

John Sheridan, CEO, Tandem: Yes. I think that’s a very important part of it. I think we have, we’ve talked about our gross margin and our operating margin improvement plans, and I think it’s tied in large part to our pipeline. Now MOBE, as we’ve talked about, is a lot less expensive to build than the T Slim pump. And so as MOBE volume increases, we’re going to see favorable effects on gross margin.

So if you look at the plan, the plan right now, I think we ended ’24 at 51%. You know, our stated goal is 65. MOBE gets us about halfway there. So substantial benefit from that. We also have the seven day infusion set, which is gonna have a favorable impact.

And I think there’s also we are counting on a meaningful bump from the pharmacy channel as well. So I think that we have a path to 65% and pharmacy is certainly part of that. And as we get higher and the gross margin certainly drops to the bottom line, but we also have a number of initiatives that are focused on efficiency improvement and some of the more labor intensive operations that we’ve got that customer service for instance or order entry or insurance verification. There’s quite a few people that are involved in those teams. And right now, we’re focused on business process reengineering automation and things like that to really reduce the labor content, improve the experience, but also reduce the labor content, which we think will also help us get to the number of 25% for the operating margin.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Super helpful. So congrats on the recent Type two approval. On paper, as you mentioned, that obviously comes with significant TAM expansion. I realize you already had a small portion of your patients that were already coming from the type two side.

So to what extent do you think the type two approval itself represents an immediate commercial catalyst? And what work still needs to be done to really unlock that opportunity?

John Sheridan, CEO, Tandem: Well, I think that, you’re right. Immediately, we are working to enable the Salesforce as we talked about with with marketing materials, advertising, training materials, to get that going. And our our plan, as I stated, is to in early in the second quarter, we’re going to be rolling this out into a number of territories just to evaluate the effectiveness of the program. As we feel more comfortable with that, we’re going to roll it out to more. So I would say that we will see a benefit from Type II this year.

I don’t think it’s going to be a step function. I think it’s going to be a gradual increase over time. There’s also, there’s still some things we have to do, I think, to improve access. For instance, obviously, we’re moving into pharmacy channel, which is going to be a benefit. But the majority of our sales today go through DME.

And I think when you look at the commercial plans, all of the commercial plans cover Type II. I know it’s relatively easy to get on to Type II through the commercial plans, but But the government plans aren’t as efficient, if you like to. There’s more hurdles that people have to come through go through to get the Type two system working for you. And so what we’re definitely working with CMS, we have been working with a group called DTAT to just basically justify eliminating some of these hurdles that come through the government plans. And we anticipate that that’s going to be a benefit for us, but it’s going to take a little time for that that to that to clear.

We’re also, working on improvements to the product to improve the or reduce the the complexity of some of the systems that are in the product that are needed for Type one. So simplification is something that’s very important to us and we’re working on that for Type two. And the data is going to be presented next Wednesday at ATTD. I think it’s going to be I mean, I think people will be impressed with the results, very positive. The other thing that we’ve done, though, is we’ve developed, inside of this study, there’s several subgroups that have they have a, they followed a process to simplify the, the sort of carb counting and things like that.

We also have, subgroups where people went through the standard process of, you know, county carbs entering data. And then we evaluated the results of all of those. And so I think that’s going to be pretty enlightening for people to see that there’s things you can do to use the system that are very simple that I think will be appealing to the Type two community that will just benefit the uptake of the product.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. Yes, I know we and others will be keeping an eye out for that next week, so looking forward to that. You’ve also continued to indicate that tubeless MOBE remains on the horizon. So I’m curious if the first half of twenty twenty six is the right time frame to be expecting that coming to market, and how much of an impact you expect that to have on your commercial operations?

John Sheridan, CEO, Tandem: We are very excited about Tubeless Mobius. In fact, in the call a few a month ago, we basically indicated that we’ve reprioritized our pipeline and Mobius now the next excuse me, Tubeless Mobius is the feature that will be brought to market. It will be ahead of t:slim X3. We think it’s going to have a meaningful impact. We think that that restores the competitive position that we had prior to some of our competitors coming to market with AID systems.

And I think that we will see an impact on the slope of our growth here because of it. So you might imagine that it’s we understand the importance to the business. The team is very committed, and we’re driving to get this to market as quickly as we can. But we haven’t made any public statements about when that’s going to happen.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. Yes, understood. Outside of The U. S, I think one thing that was also encouraging is you talked about the CE mark for Mobi on an OUS basis. Maybe can you just comment on the timing of that and how meaningful you expect that to be, and any kind of commercial strategy that you have around that?

John Sheridan, CEO, Tandem: Yes. I mean, I think we think it’s going to be a big deal. I mean, Mobi has been a great catalyst in The US. We think it’s going to be just as impactful OUS. We, we believe that the timing will be this year.

There’s certainly unpredictability internally in dealing with regulatory bodies, but we’re getting ready for it this year. And I think that it’s the same kind of a process that we followed in The States where we’ll roll it out in more of a controlled manner first to be sure that all of the systems that we have to support it in the OUS countries are working properly. And once we get that level of confidence, then we’ll basically just step on the gas and make it available to everybody. So it’s a brief period of time just to confirm things are working the way they should be, and then we’re going to be moving aggressively to get it into the market. Can I ask you just a quick question?

Sure. Chris Harris, breaking the flow processes. I assume for a while you were discussing how tubeless is not necessarily a matter of the tube. Yeah. So now you the amount of tube is working.

So It’s it’s a size the mess It’s a matter of choice. I think it’s choice. I think that there are people who, would not come to pump therapy unless they had a tubeless option. And so that’s why we we believe in a portfolio of having a a tubed, a tubeless option that’s 100% tubeless, which is ciggy. And then we have the much more the wearability, sort of redefining wearability where you can use tubed or tubeless.

And so I think it’s it’s a portfolio because people people want to wear, control, interact with these devices differently. And so it’s just a matter of providing choice. And I think that, you know, again, there are people out there that wouldn’t wear it without it. And it does give people an amazing amount of flexibility and versatility, when you have the ability to use either. Well, we’re, we’re in a situation until the product is approved.

We really can’t market it or speak about it. And so and so so people are are very much aware of what’s going on with with with Moby. A lot of the physicians do pay attention to investor communication and they’re aware of it, but it’s not something we’re marketing heavily. The Salesforce the Salesforce, of course, is aware of it and very excited, but it’s just a huge upside potential for us as as we do bring it to the market. And it’s not that far away.

I mean, again, we’re working aggressively to get it into the market.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. So maybe just in terms of, say, EP on that, I know a competitor has kind of planted their flag, around 2027 for their patch pump. So how should investors be thinking about the timeline of you and your patch versus that bogey, and just your competitive positioning within that market?

John Sheridan, CEO, Tandem: Yeah. We’re not going to talk about timing for SIGI. I think that’s one of the things that we again, just because of competition, we’ve refrained from discussing dates. I think that we have done a lot of market testing though. And when you look at SIGI compared with the existing products in the market and products that are potentially on the market, we think it’s a real winner.

It scored very, very high, which is the reason we acquired the business. The product is being, we actually have taken resources from San Diego and have put them on the program. We have a lot of people in San Diego that just finished developing the Mobi pump, and they will now move over to the Siggy pump. And so we’re excited about it. We think it’s again, it’s a durable patch.

It has a prefilled insulin cartridge. It’s very ergonomic. And we think that it’s going to do really well in the marketplace. And so no timing at this point, but we have been working on it for years.

Mike Kraki, Senior Med Tech Analyst, Leerink: Got it. And maybe just on the bottom line, how should investors be thinking about the degree of operating leverage from here or just the level of confidence on that 3% adjusted EBITDA margin guidance?

John Sheridan, CEO, Tandem: We have very high confidence we can achieve it. I think that one of the things that’s interesting is that we have invested a significant amount in the sales force this year. And the growth of our existing U. S. Sales force as well as going OUS, going direct OUS require a lot of investment.

And we’ve been able to look for efficiencies in the business to enable us to make that investment and still see growth in the EBITDA. So I mean, we’re committed to profitability. As I said, we have a number of things that are happening over time that are going to drive gross margin improvement as well as you know, leverage the SG and A. And, I think that, you know, we feel confident we can get there.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Well, John, in the last thirty seconds or so, obviously, the stock’s coming off a period of pronounced volatility. So what’s the one thing or any messaging you have on what you think is underappreciated about the story for investors today?

John Sheridan, CEO, Tandem: I think we’re very excited about 2025 and beyond. We have made structural changes to our business, to the business model. And I think in doing so, we have positioned ourselves to get back to the growth curves that we’ve seen in the past and also achieve profitability. And I think that there’s four or five major things that have gone on here in ’twenty four and ’twenty five that really do get us back to growth. And I think that think there might be some concern that they’re going to be disruptive in the meantime.

We’re doing the best we can to manage that, but we are very confident about getting back on the saddle.

Mike Kraki, Senior Med Tech Analyst, Leerink: Understood. Well, John, Katie, we really appreciate you both joining today. Thanks so much, and thanks,

John Sheridan, CEO, Tandem: everyone, for good talking to you.

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