Q4 2024 Earnings Call Transcript

Thank you for standing by. My name is Abby, and I will be your conference operator today. At this time, I would like to welcome everyone to the DexCom, Inc. All lines have been placed on mute to prevent any background noise.

After the speakers' remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you.

I would now like to turn the call over to Sean Christensen, VP of Finance and Investor Relations. Please go ahead.

Thank you, Abby, and welcome to DexCom, Inc.'s fourth quarter and fiscal year 2024 earnings call. Our agenda begins with Kevin Sayer, DexCom, Inc.'s Chairman, President, and CEO, who will summarize our recent highlights and ongoing strategic initiatives, followed by a financial review and outlook from Jereme Sylvain, our Chief Financial Officer. Following our prepared remarks, we will open the call up for your questions. At that time, we ask analysts to limit themselves to one question each so we can provide an opportunity for everyone participating today.

Please note that there are also slides available related to our fourth quarter and fiscal year 2024 performance on the DexCom, Inc. Investor Relations website on the Events and Presentations page. With that, let's review our Safe Harbor statement. Some of the statements we will make on today's call may constitute forward-looking statements.

These statements reflect management's intentions, beliefs, and expectations about future events, strategies, competition, products, operating plans, and performance. All forward-looking statements included on this call are made as of the date hereof, based on information currently available to DexCom, Inc., are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in DexCom, Inc.'s annual report on Form 10-K, most recent quarterly report on Form 10-Q, and other filings with the Securities and Exchange Commission.

Except as required by law, we assume no obligation to update any such forward-looking statements after the date of this call or to conform these forward-looking statements to actual results. Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP. Unless otherwise noted, all references to financial measures on this call are presented on a non-GAAP basis. This non-GAAP information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP.

Please refer to the tables in our earnings release and the slides accompanying our fourth quarter fiscal year 2024 earnings call for reconciliation of these measures to their most directly comparable GAAP financial measure.

Thank you, Sean, and thank you everyone for joining us. Today, we reported fourth quarter organic revenue growth of 8% compared to the fourth quarter of 2023. This brought our full-year organic revenue growth to 12%, which was in line with our latest 2024 guidance. 2024 was a year of strategic investment for DexCom, Inc. Through these investments, we believe we entered 2025 in a stronger position to capitalize on our next wave of growth. To recap, over the past year, we broadened our commercial reach, launched new products that define the category, built greater scale, and advanced CGM reimbursement globally.

Through this work, we continue to lead the biosensing market and have positioned ourselves to impact millions of more lives around the world. We ended 2024 with more than 2.8 million customers globally on our G series and D series products as demand for DexCom, Inc. CGM remains high. This represents an increase of approximately 25% to our global customer base compared to 2023. This increase in customers was driven by momentum both in the category and through our improving execution in the field, which we are very excited about.

This was evident in the US where our sales force productivity metrics showed improvement in the fourth quarter. We have now grown our US prescriber base by more than 50,000 over the past year. Through these new relationships, we have successfully broadened our presence with primary care and made early inroads with emerging CGM care points like maternal fetal medicine. Importantly, across this growing physician base, we are also seeing prescribing depth improve.

It often takes only a single DexCom, Inc. experience for physicians to recognize the potential to deliver better care with DexCom, Inc. CGM. As these new physicians now expand their use of DexCom, Inc. CGM across their practices, we have seen the impact on our new patient performance build from the strong third-quarter finish we described on our last call.

This helped us achieve another quarter of record new customer starts. As discussed earlier in the year, we knew that the opportunity ahead was tremendous when expanding the US sales force. With this focus on execution, we will look to build upon our momentum in 2025 as we further cultivate these relationships and connect with the next leg of CGM prescribers. Our team is also helping many of these physicians navigate the evolving coverage landscape.

In the past two years alone, reimbursement procedures have significantly expanded as we have helped establish our clinical value well beyond insulin management. As many of you remember, a key milestone on this journey was the publication of our mobile randomized controlled trial, which demonstrated significantly improved outcomes beyond intensive insulin use. This data prompted clinical societies to update their standards of care and quickly led to widespread reimbursement for anyone on basal insulin. We are now seeing similar evidence build around the benefits of CGM regardless of where someone is in their diabetes journey.

In fact, some data has shown even greater health outcomes for those not on insulin as CGM is providing them real-time feedback on lifestyle decisions for the first time. There is also a growing economic argument for incorporating CGM earlier into care plans, as this has been shown to reduce hospitalizations, specialty visits, and utilization of healthcare resources. As this comprehensive body of evidence continues to grow, payers have started to act. We recently shared that as of January 2025, two of the three largest PBMs now cover DexCom, Inc.

CGM for anybody with diabetes. With these national formularies leading the way, by the end of the year, DexCom, Inc. will have coverage for more than five million people with type 2 diabetes who are not on insulin in the US. This came less than two years ago. For context, this is even larger than the type 2 basal reimbursement that we achieved.

And yet this only represents around 20% of the 25 million type 2 non-insulin users with diabetes in the US. In 2025, we will be actively pursuing coverage for the remaining 20 million lives. To strengthen our case even more, we recently announced that we initiated a randomized control trial for people with type 2 diabetes who are not on insulin and expect to complete enrollment soon. As we advance this important work to further expand coverage in the US, we have already significantly broadened access to DexCom, Inc. technology with the launch of our over-the-counter product, Stella.

In line with our mission to empower people to take control of their health, this product has allowed us to reach many more people. As we said at the JPMorgan Conference last month, more than 140,000 people were using Stella in the first four months of the launch, with demand spanning across the type 2 diabetes, prediabetes, and health and wellness populations. Importantly, regardless of where someone is in their metabolic health journey, we are quickly enhancing Stella to make it more personalized and drive greater engagement across our platform. Key to this will be DexCom, Inc.'s proprietary generative AI technology, which was recently launched in its initial feature in Stella and will become a key source of personalized content as we expand its functionality over time.

We are also building on the Stella experience through targeted partnerships that will consolidate multiple biomarkers into our platform. This includes our recently announced relationship with Oura, which will integrate DexCom, Inc. glucose data with vital signs, sleep, stress, heart health, and activity data from the Oura Ring to provide an even broader picture of health for our mutual customers. Overall, we have been thrilled by customer demand for Stella in these initial months, and we are excited to build on this momentum as we enter 2025. We see an opportunity to further elevate the Stella brand this year through product iteration, broad awareness campaigns, and new distribution channels.

This will include Stella's upcoming introduction on the Amazon storefront, which we expect to be live in the coming weeks. Finally, we ended the year on a high note across our international business. We have spoken time and time again about the importance of building greater access, and our most recent international coverage wins have again served as a nice catalyst for our business. Most notably, early in the fourth quarter, we finalized basal coverage for our DexCom, Inc.

One Plus system in France and saw strong demand in the first quarter of its implementation. France is another great example of our ability to leverage our product portfolio to match the needs of each customer and reimbursement system. It has also proven to be on the forefront of type 2 CGM coverage as one of the only two international markets with broad basal coverage today. In fact, across many of our markets, even type 2 intensive coverage is in much earlier stages.

We are seeing interest and reimbursements steadily build. As it does, we believe we are better positioned than at any time in our company's history to participate and lead growth in this category. As we look forward to 2025, there is a lot for us to be excited about. We remain in a unique position to help pioneer a fast-growing industry that has significant potential to broaden its impact.

With that, I'll turn it over to Jereme.

Thank you, Kevin. As a reminder, unless otherwise noted, the financial measures presented today will be discussed on a non-GAAP basis. Reconciliations to GAAP can be found in today's earnings release as well as the slide deck on our website. For the fourth quarter of 2024, we reported worldwide revenue of $1.11 billion compared to $1.03 billion for the fourth quarter of 2023, representing growth of 8% on both a reported basis and organic basis.

As a reminder, our definition of organic revenue excludes the impact of foreign exchange, in addition to non-CGM revenue acquired or divested in the trailing twelve months. US revenue totaled $803 million for the fourth quarter compared to $769 million for the fourth quarter of 2023, representing an increase of 4%. As Kevin mentioned, new customer demand has steadily built over the past two quarters as our sales force productivity metrics continue to improve. Rebate eligibility again negatively impacted our US growth rate by several points in Q4, but we expect this impact to step down in the first quarter and then be minimal over the course of 2025. In the DME channel, our share remained stable during the fourth quarter, in line with our expectations based on the strengthening performance of our sales team.

While channel mix again had the largest year-over-year impact on our revenue per customer in Q4, recent DME share trends should help this impact moderate over the course of 2025. International revenue grew 17%, totaling $311 million in the fourth quarter. International organic revenue growth was 19% for the fourth quarter. Our international business accelerated for the second quarter in a row, as new access wins and the expanded availability of G7 and DexCom, Inc. One Plus generated higher demand in many key markets.

In addition to France, another nice win came in New Zealand, where we unlocked broader type one coverage and saw a similar uptick in demand. These are great examples of how each market is unique, at different stages of reimbursement development. As Kevin mentioned, we still see a long runway ahead to build much greater global access, even within our existing markets. Our fourth quarter gross profit was $661.2 million or 59.4% of revenue compared to 64.2% of revenue in the fourth quarter of 2023. During the fourth quarter, our gross margin was negatively impacted by a $21 million non-cash charge.

The majority of this was related to inventory that our quality management system identified as being mishandled by one of our shipping partners. The remainder of this charge is related to new build configurations that lowered our production yield in the quarter. As a result of these disruptions, we are currently managing channel inventory tightly for the next few weeks. Our facilities are running at full capacity to rebuild optimal supply for our distribution partners, and we expect to have these levels back to normal by the end of the first quarter.

This is why we have made the investment in capacity to manage their growth and scale opportunities. Operating expenses were $451.7 million for Q4 of 2024 compared to $421.1 million in Q4 of 2023. Operating income was $209.5 million or 18.8% of revenue in the fourth quarter of 2024, compared to $242.7 million or 23.5% of revenue in the same quarter of 2023. Adjusted EBITDA was $300.1 million or 27.0% of revenue for the fourth quarter, compared to $321.5 million or 31.1% of revenue for the fourth quarter of 2023. Net income for the fourth quarter was $177.8 million or $0.45 per share. We remain in a great financial position, closing the quarter with approximately $2.6 billion of cash and cash equivalents.

This provides us significant flexibility to both support our organic growth opportunities and assess strategic uses of capital on an ongoing basis. Turning to 2025 guidance, as we stated last month, we anticipate total revenue to be $4.6 billion, representing growth of 14% for the year. This guidance assumes continued strong category growth, steady DME share, new access wins internationally, broader distribution for Stella, and several product advancements across our platform. We also expect to see US revenue and volume growth converging as the year progresses.

As we lap some of the unique rebate and channel dynamics discussed earlier. From a margin perspective, we expect full-year non-GAAP gross profit margin to be in a range of 64% to 65%, non-GAAP operating profit margin to be approximately 21%, and adjusted EBITDA of approximately 30%. Our guidance assumes gross margins will improve at least 200 basis points in 2025. As we convert more of our installed base to G7, and drive greater scale at our high-volume manufacturing facilities, it also assumes a second-half launch of our fifteen-day G7 system, which we expect to provide greater gross margin leverage beyond 2025 as we convert more of our installed base to the fifteen-day system.

With that, we can open up the call for Q&A. Sean?

Thank you, Jereme. In addition to Kevin and Jereme, we will also have Jake Leach, our Chief Operating Officer, joining us for our question and answer session. As a reminder, we ask our audience to limit themselves to only one question at this time, and then reenter the queue if necessary. Abby, please provide the Q&A instructions.

Ladies and gentlemen, we will now begin our question and answer session. If you have dialed in and would like to ask a question, please press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. We kindly ask everyone to limit themselves to one question and come back to join the queue for follow-up.

We will pause for just a moment to compile the Q&A roster. And our first question comes from the line of Larry Biegelsen with Wells Fargo. Your line is open.

Good afternoon. Thanks for taking the question. Kevin, I wanted to start with the issues you identified, you know, on the Q2 call. The Salesforce issue and the DME issues.

And you know, Jereme gave some color in his prepared remarks, but I'd love to hear, you know, a little bit more from you on the status of each. Sounds like your share in the DME channel has stabilized. So how are you thinking about those issues that negatively impacted 2024, you know, in 2025? Thanks for taking the questions.

You bet, Larry. We've made great progress on those issues since we talked about them in the second quarter. We've worked very hard with our DME partners to identify opportunities to improve and to grow. We've also worked with our sales team to make sure we consider all channels across all markets and have that dual benefit offered where we can.

With respect to the US Salesforce, Larry, what we've seen is this group that we brought on board has now become more productive. I mentioned earlier that we've added 50,000 prescribers over the course of the year. And what we're seeing now, you know, when we initially expanded that group, we saw the prescriptions per healthcare professional come down. That number's come back up even though they're calling on more healthcare professionals now.

So we're seeing more productivity per prescriber even as we add more prescribers. So that group is doing what we asked them to. And I think that's really supported by the fact we've had record new starts each in the last two quarters. So both those things are going very well for us right now.

And our next question comes from the line of Jeff Johnson with Baird. Your line is open.

Thank you. Good afternoon, guys. Jereme, you talked on the call about narrowing that kind of volume versus revenue gap in the US that has been pretty wide here in the last couple of quarters. I mean, if I just put some numbers on it, it seems like in the fourth quarter, that gap was maybe sixteen points, seventeen points.

Again, I don't have the perfect volume estimates in my number, but sixteen or seventeen points, that's down from maybe twenty, twenty-one points, something like that in the third quarter. You know, where do you think that goes? You said it falls off in the one Q. Does it fall to low double digits, just that kind of volume versus revenue gap in the US?

And then as it further converges throughout the year, can you get that back into the single digits, into the mid-single digits? Just conceptually help us understand how to think about that gap between those US volumes and the US revenue growth. Thank you.

Sure. Yeah. I don't it didn't and thanks for the question. You know, it'll certainly converge, and we talked, you know, as we walk through it, I'll try to walk through it in the cadence over the course of the year.

So certainly, as we lap the rebate dynamic here in the first quarter, it will start to converge a little bit here in the second quarter. You know, as you start to then compare year-over-year channels, as we start to get those channels stability, you'll start to see that converge as you move into the third and the fourth quarter. I mean, as we get to the tail end of the year, and so the amount that you would expect to see it come in, it starts to get much, much closer to the numbers that you quoted. We haven't given a specific number, but what we would say is the delta between volume and price.

We've talked about our patient base being about 25% higher exiting the year. You've seen our growth numbers at 14% essentially as guide, and if you exclude Stella from that, it's more like 12%. So you can already see implied there that the numbers are coming in if you just assume that the patient base continues to grow into next year. So you're already seeing it.

I'd expect similar gaps as you see us exiting Q4 as we lap the rebate channel in 1Q, but you're gonna start to see that coming in more and more over the course of the year. We don't have a number specifically to give you at this point, but you're right. It'll start to come in closer and closer, especially as we exit 2025.

Your next question comes from the line of Robbie Marcus with JPMorgan. Your line is open.

Oh, great. Thanks for taking the question. Jereme, maybe just to follow-up on that. There's a lot of considerations on both the top line and down the P&L between fifteen days sensor lapping of some of the headwinds on pricing.

How should we think about cadence through the year? Obviously, the math points to a much stronger second half on a growth rate basis, but how should we think about cadence through the year? And particularly first quarter as we set up expectations here? Thanks a lot.

Sure. Yeah. And, you know, as you think about the first I'll start with the first quarter and then we can get to the year. You know, we talked a little bit about this at your conference actually, Robbie, about how the first quarter is gonna look a little bit, I don't know, similar to where you know, historical sequential patterns had taken us.

So if you look at our best sequential Q1 relative to Q4 in the past few years, it was about a 9% sequential decline. We talked about at JPMorgan it being about an 8% to 9% sequential decline. So it actually looks a little bit better in terms of seasonality here in the Q1, and we'd expect it to do that. Nothing's changed.

That was our guidance. We'd still expect that. Then typical seasonality over the course of the year, it should look relatively similar. I say that knowing full well that you know, one percentage point in a split, if you will, can create a few different points of growth.

But what I would say is there's gonna be a relatively stable cadence of improvement over the course of the year. Obviously, the comps in the back half of the year make it a little bit easier. So you would imply that. But in terms of just thinking about how you progress through the course of the year, dollar-wise, the progress through the course of the year dollar-wise should look pretty good and consistent with, I'd say, more normal years.

Last year was a bit of a unique year for us. So that'll help you get cadence from that perspective. In terms of gross margin, you know, typically from Q4 to Q1, we step back a couple hundred basis points. This quarter, we talked about Q4 being a little bit burdened by some, you know, one-time charges.

We've quantified those. You know, I would expect there to be a little bit of a step back from Q4 to Q1. If you adjust for those one-time items, it means Q1 be a little bit ahead of Q4. If you don't adjust for those items, moving up over the course of the year. We've gotta move through some of the Q1 dynamics as we move forward, which is going to include certainly working through some of the yields and improvements which you talked about in Q4. We'll work through a little bit of that in Q1. But as you move into the rest of the year, based on the volumes that we're moving through our Malaysia facility and really through our entire facilities, you're gonna see that continue to improve, and we have clear line of sight to our standard cost and what those margins look like.

Really looking good as we exit the year. So this is a year where you're gonna see a lot of the benefit of scale really drive that margin. You'll see a little bit of a benefit in the back half of the year from fifteen day as well. But the big driver is gonna be even without fifteen day.

You're seeing us the scale and volume that's running to our facilities will certainly make that back to the half of the year look pretty good on a margin basis.

And your next question comes from the line of Danielle Antalffy with UBS. Your line is open.

Hey. Good afternoon, guys. Thanks so much for taking the question. Congrats on a strong end to the year.

Just wanted to follow-up on the comment around some of the type two coverage. I think, you know, two of the three largest PBMs are now covering for non-insulin using type two. And, Jereme, give me this is for you and how to think about I appreciate what you're saying for 2025. As far as, you know, revenue growth converging with volume growth. But as more of these non-insulin using type two patients come online, how should we think about that?

So I guess this is more over the next few years. And will that diverge again before it reconverges or how do we think about that? Given that this is a less intensive patient population and just trying to get a sense of what you guys are seeing from a pricing perspective from those. So much.

Yeah. It's a good question. So maybe I can put some clarity there. So the unit economics of each purchase is actually similar across it.

We don't necessarily have a different purchase price for a month of sensors between one disease state or another. So type one and type two non-insulin using, generally is at the same price point in our contracts. So from that perspective, profitability-wise, you shouldn't see any impact there. Now I think in the models, the one thing you will have to be mindful of is when you look at a PMP wide, our type two users typically don't use the product as often.

They can go a weekend without it. There's, you know, lower retention utilization. Similar to what we disclosed at JPMorgan conference where we had, you know, our persistence and use of product there. So I think from a modeling perspective, profitability-wise, I don't think you make any changes there.

From a revenue per patient, just that you're modeling on a per year basis, I think you have to make those changes, and I think we've given the retention utilization data that's up on the website. So that'll be easy to at least model as you're moving through there. But good news there is I think you're kind of implying, hey. Is there an impact on gross margin, operating margin?

There is no.

Daniel, I'll just add to that. When we have coverage with these type two patients, our retention and utilization rates are actually quite high. It's not like it's a one month and then and you're done. These patients that this product's reimbursed we know they say, because they have such good outcomes.

So while the model may be slightly different in a reimbursed world, it's still very strong. There's very good utilization, very good patient retention.

And your next question comes from the line of Travis Steed with Bank of America. Your line is open.

Hey. Thanks for the question and congrats. Just wanted to ask on the G7 fifteen day. I know you don't usually comment, but wanted to see how the process the FDA is going.

I guess the question is really, like, giving you the confidence to still say, you know, second half launch? Here. And once you get that approval, should we think about that process rolling out, you know, there's a couple of quarters before the patient base is kinda fully converted?

Yeah. Thanks, Travis. This is Jake. The fifteen day review.

Right? We mentioned that we'd submitted it on the last call. So we're basically towards the tail end of that review. We've had a great interactive review with the FDA.

We feel like right at the tail end because we've basic and, you know, as we do have the confidence that we're gonna see an approval here shortly. We as as you kinda transition over to once we have approval, we do expect to launch that product in the second half of this year. Really, it's about securing coverage in our we wanna get that the fifteen day product out as fast possible, but we are mindful of user experience. We gotta make sure we've got coverage in place.

We have to be mindful of our pump integrations as we launch this fifteen day product. So, you know, that's why, you know, we expect approval here shortly, but we'll get it out here in a second. Second half of the year. We're also looking forward to presenting the fifteen day clinical data at ATTD next month in Europe.

So that'll be one of our lead investigators from that clinical trial is actually presenting the data. So we look forward to sharing that with all of you next month.

And your next question comes from the line of Joanne Wuensch with Citibank. Your line is open.

Thank you very much for taking the questions. Briefly, what does it take to get the fifteen day integrated with the pump? Is that a difficult process? And I'm gonna also ask I think they occurred or saw on a slide G8. Is there anything you can tell us about that? Thank you.

Sure. Yeah. So the good news is, you know, pump integration with the fifteen day sensor. We thought about that as we were doing the original G7 integrations.

So it is a much smaller lift than, for example, the difference between integrating, you know, as we moved it from G6 to G7, that was quite a big lift for our partners. In terms of security interfaces and the Bluetooth interface. But as we look at the fifteen day, there's a most of it stays exactly the same. The pump basically interrogates the sensor, and the sensor tells it it's a fifteen day.

There is a little bit once we get approval, a little bit our partners have to do on validations, but we do anticipate it to be quite quick in terms of the integration with fifteen day our pump partner base. So we'll be mindful, you know, as soon as they get those done. We'll be pushing the product out harder into the channels, but that's part of it. And then your question about G8 is, we are very actively in the development process on G8. It'll be our next hardware platform that we'll use across our portfolio of products.

I won't get in all the details, but a couple of highlights are it's a smaller wearable with even more capability built into it. And, you know, we're looking towards compatibility with pumps much closer to launch of that product. We've learned a lot through our G7 integrations, and so we were very excited about progress on G8, it also has a multi-analyte capability built into it.

I'd just add to that. We look at G8 also as a series of innovations. You know, the jump from G6 to G7, we learned a lot. Because we changed pretty much everything.

We're gonna do this more stepwise, and we'll have a literally a series of features leading to that configuration Jake is talking about where you get to multi-analyte somewhere down the road. So we're looking forward to revealing more about this product platform as time goes on.

And your next question comes from the line of Matt Taylor with Jefferies. Your line is open.

Hi, guys. Thank you for taking the question. I did want to ask one about the expanding coverage in terms of the PBMs now covering these lives and also thinking through to hopefully, next year or the year after getting a non-intensive type two coverage. But I just don't want you to understand how you think about the additional lives being covered as a driver, this should be expect that group to show in the numbers?

Is that contemplated in your guidance? And if you play through the study, when do you think you'll actually get more of an uptake in that non-insulin type two population?

Yeah. Thanks for the question, Matt. I can take that. You know, the expectation, we've included it in our guidance.

Now there's all sorts of levels of uptake and as you can imagine, every model has the ups and downs associated with it. We're really bullish on the long-term nature but I think it's about us getting out there and letting folks know they have coverage. So we're very mindful that there's education that we have to continue to do, and the sales force is really excited about it. I know that the materials are now out there circulating in the field, and so we're excited about pushing those.

That will be some of the work we do over the course of this year. The work to be done now is we can talk a little bit about the PBMs. So it's working with we have two PBMs. And as you go deeper into those PBMs and you get to more my formularies.

We will be working with those PBMs to expand access even within there knowing full well the benefit that CGM provides those populations. We'll also be working with the third PBM, right, and looking and looking to at ways to ultimately gain coverage there. And so we're hard at work there. And make no mistake, on the flip side, we are also looking at how we would work with CMS.

Certainly to make sure that folks have access to the product. We know the benefits of folks using CGM and what it does to the system. And given the capitated nature of Medicare fee for service, even Medicare Advantage plans, those are real interesting things, and so we'll be working heavily there. What you generally need in those cases, not all the time, but it's always helpful, is an RCT and as you know, we've talked about in the past, we are running an RCT.

Jake would tell you we're already in enrollment right now, and we talked about really completing that enrollment here in the first half of this year. With early readouts at the back end of this year. So we'd be using that in conjunction with all of this evidence to look to expand coverage, but it is top of mind. So as we have our market access team, potentially even listening to this call, they all know it's in the goals and for the year is to make sure we advance this as much as we can.

And your next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is open.

Afternoon. Thanks for taking the question. I'm not sure if this is for Kevin or Jereme or Jake for that matter, but are you expecting a record new patient number here in 2025? And if so, can you just talk a little bit about the composition of where that's coming from?

Just given that we're getting a little bit more saturated on the intensive side and a lot more of this needs to come from basal and then non-intensively managed type two. So just maybe talk about the composition to get you to that level if you are committing to that and just making investors or helping investors feel comfortable you can do that given this patient population that historically you haven't been as strong with. Thanks.

Yeah. Sure. I can give you some at least how we're thinking about the year. Certainly, we do expect it to be a record patient year.

You know, we do see continued penetration across the insulin-intensive segment, and across T1 and T2 insulin-intensive. We still expect quite a bit of penetration in that market, and it still plays a very large portion of our new patient starts. We do expect a consistent penetration in Basal over the course of this year. And so as you think about Basil and the progress made across that population in 2024, would expect something similar here in 2025. And so that's continued steady adoption in Basil.

Remember, Basil is a big grower. Since it's a smaller base as part of that population. It'll continue to contribute there. And then, of course, we do expect a greater contribution this year on the type two non-insulin side given some of the coverage that's in place.

And so it's continuing to move along based. It's continuing to move along. Insulin coverage as you've certainly our insulin-intensive coverage with the addition of type two here. And, you know, what's interesting and this doesn't include Stella.

I think what's important is this is in our G series and D series. Approach, and so we're not even including Stella in those numbers. And so what should give you a little bit confidence as we move even beyond type two and in a prediabetes and health and wellness where we have an over-the-counter product like Stella, that's just even more opportunity for us to take advantage of that. Kevin, Javier?

No. I would add there's also some coverage wins that really start taking effect in 2025 in our US markets with basal coverage in France, some spotty, yep, growing basal coverage in Germany. We've had wins in Canada, Australia. We've got our direct team in Japan, you know, on the street now.

So we see international growth in those markets. And, you know, I kinda go along with what Jereme said. Now that we have more type two non-intensive open, obviously, that's gonna contribute a larger portion of the new patients than we've done in the past because we have access to those people. But we still believe there's growth in the insulin population.

I mean, as I disclosed earlier, with 60% penetration in type one and 55% penetration in type two intensive, we've still got a lot of people that need access to this technology to better control their health. And we believe with the field force their increased productivity, all the things we're doing, we're in a good place to get after it.

Your next question comes from the line of Jason Bedford with Raymond James. Your line is open.

Good afternoon. Excuse me. I apologize if this is redundant, but it sounds like there's no change to the STELLO expectation of 2% to 3% of sales. You confirm that.

Great. But can you just also talk about the stellar trend through the year, meaning specifically the timing of drivers? It sounds like Amazon's coming on soon. When did the five million newly reimbursed come online, and when do you have full app integration with Oura?

Thanks.

Yeah. Maybe I'll start with some of that, and I can hit off to Jake here. So let's start with the type two coverage first so that we can move into Stella. So type two coverage, that we announced effective one one.

So it's already in place right now. So that's good news. We all we I can also confirm that Stella is 2% to 3%. The expectation is 2% to 3% of revenue in a year.

So we've obviously considered the types two coverage in making that call. In terms of the cadence over the year and the integrations in Amazon, maybe I can hand it to Jake just to cover some of the expectations around that.

Sure. Yeah. So around STELLO, we're working fast and furious on a whole host of new capabilities. We actually just launched one within the past weeks that allows users to look back at their historic data within the app.

So that was something that was one of the number one requests we got after we launched Stella. And so we've got that functioning out in the field. We are working, as you mentioned, very closely with Oura on a deeper integration. Today, we do import already Oura data into the Stella platform, but working with the team over to Oura, we're working on a deeper integration where we have access to a lot more of the intrinsic data from the Oura platform, and so we're working to integrate that into our app.

So the first thing we're working on right now is just the pipes to get the data flowing in. And then we'll start working on visualizations. You will start to see those integrations coming out in the first half of this year, but we'll continue to we have two very innovative groups with the team over at Oura and our software team. And so they're I'm really excited to see what they've been developing and we'll be, you know, throughout the course of the year having multiple releases that continue to build on the functionality.

Yeah. And then I think the last question is in channel. And so channel, we are seeing DME channel selling it today. You're seeing partners selling it now. And I think the Amazon is expected in one Q. Jason. So we expect to see it here on in Amazon very, very shortly. And so keep your eyes out, but one Q is when we expect to launch.

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

Great. Thank you so much. Kevin and Jereme, I was hoping you could walk us through some of the assumptions behind the 14% growth rate for 2025. It looks like there are some areas of conservatism. I don't think you assume DME share gains.

You're assuming it to be flat. You know, why is that? You do have easy comps. You know, you guys typically guide mid to high teens, but you tend to exceed those.

You do have a fully productive sales force, you know, more reps year over year, you know, two new product launches, and then, you know, you are looking for record new patient starts. So can you walk me through that to the assumptions? Should we assume the 14% growth as a base case? And then just on the fifteen day sensor, what is assumed in that guidance for the second half?

Thank you.

Sure. Yeah. I can give you some of the data points. We cover a little bit on the script, but I think it's helpful just to walk through them.

So you know, we do expect about one to two points to be growth related to STELLO. Obviously, if it was 1% last year and it's 2% to 3% this year, there's a couple points there. As you peel that back, you'll see that, you're to give the core, I'd say, G and D series business is still in the low teens growth. You know, 12%, 13%.

And as you break down what happened, you know, our international market, which we continue expect to continue to perform well, and the US market, you can see that US the old US market, we expect to grow a little of the year. But you still see the US the US performance doing quite well over course of the year. I would say what we've given you is the figures that we think is reasonable given the year. We understand that, you know, over the course of last year, we put a few things in place.

Those had us take a bit of a step back. We wanna make sure we put out some guidance that's very reasonable, that's very achievable, and that's what we've done here. To your point, there are some tailwinds in those assumptions. Kevin alluded to it earlier.

There's access wins outside the US, and that's going to be very interesting. In the US, we have a sales force that's now up and stable and running, and that's wonderful to see. They've done a really great job. And so really looking forward some of that.

Obviously, with more and more coverage wins, coming out there in the US over type two, these are all things that are potential upsides, and we'll certainly if we can achieve those, we'll certainly pass them along. But I think we wanted to be reasonable. When we put through that guidance. And certainly, it's an acceleration when you look at the back half of this year.

As we exit the year, we had a 3% and an 8%. So 14% would be a tailwind there. We do assume stable DME share. I think it's a prudent thing to do.

We will be working closely with our DME partners. I think they've been wonderful through these past, you know, few weeks as we've navigated through this quarter, and I think they're great partners, and we'll look to continue to partner with them. But I think that's a reasonable assumption to take a start into the year.

Yeah. I'd just add one other thing with respect to fifteen days. Yes. That's another tailwind.

But again, we don't have an approved product yet. We've talked about launching this in the second half of the year, but there is a time frame where we have to get coverage up and running with all the payers, get it through CMS for Medicare, and then get it on the shelves. And also integrate with our partners. There's a time frame for a launch here.

We learned a lot from the G7 launch. We'll apply all these to fifteen day, but make no mistake about it. There's a little bit of lag. It takes a little bit of time.

And so while it's a tailwind, it's gonna be helpful. It's not the big tailwind. There's certainly some upside if things were to go very quick but what we've assumed is a base case based on our knowledge of what we've experienced in the past.

And your next question comes from the line of Chris Pasquale with Nifron Research. Your line is open.

Thanks. I wanted to follow-up on STELLO. You're coming off your first holiday season, first New Year's resolution season with a and did you see an acceleration in subscription activity tied to those seasonal factors? And now with a few months under your belt of the launch, how are you feeling about your ability to keep users engaged after they've through their first couple sensors?

And you mentioned AI would just love to hear a little bit more about what role that plays in that engagement.

I'll start a bit and then let Jake take the AI question. We did see a nice spike of New Year's resolutions in January. January as the year started, and we saw a lot of people sign up to get the year started and kick things off. With respect to users continuing to use Stella, our subscription renewal rate for those who signed up to subscription plans has been excellent.

Once users have signed up and they bought more sensors. We feel very good about that. Ironically or not ironically, but just as a side note, the type two diabetes population in Stella certainly signs up and buys more frequently than the others, and that renewal rate has been very, very strong. So our initial design of that product, the way we thought the app would work, is really serving the audience that we targeted for, and then we'll features over the course of the year that will benefit those users in addition to the other user groups that we serve.

Jake, I'll let you take the AI stuff.

Yeah. Sure. So we did roll out the first generative AI capability within a glucose biosensor on Stella. And it's really around those insight reports that the users get after a week of wear.

And it's you know, we see good feedback. We actually did a staggered rollout of that. We rolled it out to half the users at first, and then we quickly ramped that up so we kinda compare some of the usage patterns. And so, you know, I think one of the key areas that I talked about, you know, earlier when I said we've got a robust sequence of releases, a lot of it will be to continue to build on the insight.

The number one thing now that we've got the historic data in the platform, the next request from users has been, you know, even deeper insights, which is clearly in our, you know, crosshairs as we look at integration with Oura data, and then the further utilization of that generative AI, report and feedback. The insights are gonna continue to get deeper and more personalized as we go. And really looking forward to releasing more of that capability throughout the year.

And your next question comes from the line of Steve Lichtman with Oppenheimer. Your line is open.

Hi. Thanks, guys. Yeah. Just building on Stella, you had ADA last year.

You talked purposely about, you know, focusing the Stella messaging on the non-insulin type two first. With the coverage making real progress here, are you thinking about that messaging changing over the next couple years? And being more of a bifurcation between G series for type two and STELLO for maybe prediabetes and beyond.

You know, that's a great question and something we discuss on a regular basis. Just we know that if product's reimbursed, we have a much better chance of getting into somebody in them staying out and using it all the time. So what you're gonna see is a migration of some of the features we put into STELLO geared towards type two patients, not on insulin, into the G series app. So our users can have the opportunity to identify their glucose spikes and their act with G7 with the AI module, and things like we put into the STELLO app.

Conversely, you'll see Stella will add more features, again, that would be more conducive to health and wellness and serving other populations prediabetes along those lines. But you'll see us migrate features from one app to the other where it makes a lot of sense. And that, you know, that's a credit to our software team, the software platform we built with our ability to iterate very quickly.

You know, one thing I'd add is that, you know, if you look at the indication for use on it is very, very broad, and that was purposeful. And we went then pioneered the over-the-counter indication. It's all adults, not an insulin. So it very much is indicated for use outside of diabetes and we intend to, over time, continue to build the feature set out to serve more and more users.

We actually have quite a few of the users that have been using Stella to date are in that category of, you know, health and wellness and longevity. Just seeking to learn more about their metabolic health through using this system. So, you know, we did target diabetes and prediabetes at first, but clearly as the capability of the platform builds out gonna become more and more applicable to a broader group.

Your next question comes from the line of Issie Kirby with Redburn Atlantic. Your line is open.

Hi, guys. Thanks for taking my question. I wanted to ask about the G sensor and how we should be thinking around potential accuracy improvements really going after MARD on the glucose monitoring side with this device. Then you touched upon multi-analyte.

You know, what discussions are you having with payers about the ability to perhaps look at a premium price for a sense of these capabilities. Thanks.

Yeah. Thanks for the question. Yeah. So we are always striving to enhance the accuracy and reliability of our sensors.

You know, G7 is the most accurate sensor available, but there's still opportunities to enhance this technology and make it more accurate, more reliable for, you know, broader group of users. And so, you know, with even within the G7 platform, we're still working to further enhance the accuracy of that system. And so, you know, as we look to G8, we're actually building one of the things I mentioned, right, it's a smaller wearable but with more capability. And part of that capability is further ability to for fault detections as well as accuracy enhancements.

And so you we will we do intend to improve the accuracy of the system as we continue to build on the different hardware platforms. The multi-analyte is we got different analytes in various stages of development. There's actually quite a few. And so we're kinda early days during in terms of the use case applications and whether you know, I'm really have discussion around premium price yet.

But the way that we think about it is amplifying the value of the CGM by adding those additional analytes and, you know, broader use cases in chronic diseases around diabetes is certainly one of the areas that we'll consider once we get the technology a little farther.

And your next question comes from the line of Michael Polark with Wolfe Research. Your line is open.

Hi. Good afternoon. I wanna ask about the point estimate for the revenue guidance. Jereme, you have a history of providing a range of about five points in recent years. So why just one number and not a range? If you had us think about a range around this four six, is four six the floor, a midpoint, how would you frame that? Appreciate any color. Thank you.

Sure. Yeah. I mean, the reason we went with the point and, you know, obviously, we went out in January at JPM, and now, again, as you know, last year was a bit of a unique year for us. I think what's really important is we set everybody with what our best thoughts are around the year.

And so this is our best thoughts around the year. We don't necessarily wanna couch it as good low, high low, etcetera, because we'd be putting out a range again. And so the best way to think about it is we really wanted to give everybody a thought about the year in the eyes of management after a year that I know that had some folks on for a bit of loops over the course of the year. So I thought it was the right thing to do.

And as the year moves on and as the year progress, we'll certainly give you guys updates. But it was really just designed around that as making sure we got everybody on the same page with us and it'll we'll hopefully move all forward together.

Your next question comes from the line of Bill Plovanic with Canaccord Genuity. Your line is open.

I'm gonna go to a different angle here. You know, we've been talking about revenue a lot. We really wanna talk about profitability if we can. You know, obviously, 2024 was a tough year.

You know, we've really kinda tapped out at that twenty-ish percent operating level. You're looking for a little increase in 2025. How do we think about kind of the years after? Is this gonna be something where it's a, you know, one percent expansion per year in operating adjusted operating? Or are there any lever points that could really accelerate this?

Thanks for taking my question.

Sure. Thanks, Bill. Appreciate it. You know, I think there's a couple things.

One, you know, obviously, one of the big things that we've been focusing on is building a bunch of levers into the business on the operating expense side. I think you've seen it over the years. OpEx as a percentage of revenue has continued to come down. I would expect that to take place over future years.

That all being said, we do allocate a significant amount of money to R&D and that's intentional because of all the opportunities ahead us. And so we balanced this investment, reinvestment in the business across both R&D and sales and marketing. Because not only do we believe there's a lot of opportunities for development and growth, we also believe as we move into these new markets, there's a lot of opportunity to spread the word. And that's why we've invested in sales force expansion.

It's why we invest in marketing. So levers are you can invest less in the business. I don't think that's what we really wanna do. We are doing a wonderful job of managing G&A as an organization, and I think we'll continue to do that.

So that's where the leverage will come from. The other piece of leverage will come from gross margin. I mean, we've guided out to 65 over the years. If you look in the past year, we came in obviously lower than that in 2024. You know?

So I think as you think about gross margins, certainly getting back to 65, and I think you guys all know the levers with fifteen day and, you know, continuing to design cost out of the product. Those are opportunities that obviously can head back to the bottom line over the years. So I think those are the two levers to play with, and as long as there's an opportunity to continue to reinvest in the business, which we believe will drive long-term growth, we'll continue to do that. If that doesn't make sense, there's certainly leverage we can get in the P&L.

I think, Bill, you know this from, you know, all the years you've done this. Building levers is really important for a business. And some of those levers go into reinvestment, some of those levers will go back to return of investment. Those are the two things we're gonna make sure we balance to grow the company.

And your next question comes from the line of Patrick Wood with Morgan Stanley. Your line is open.

Beautiful. Thanks for taking the question. Fifteen day again, so apologies about that, but it's obviously a big impact. I guess, you know, how are you thinking long term about what the average wet time will do?

Because presumably, you know, there'd be a subset of patients who may want to change their sensor a little bit more frequently for all kinds of different reasons, whether it's, you know, how they react to the adhesive or gets dusty or things like that. Do you have any info from, like, early days in Stella to get a sense for change out rates or I was trying to think where where does it ultimately end up? It's obviously not completely fifteen days. I'm just trying to get a sense where you think the average consumer's gonna end.

Thanks.

Actually, our Stella users are very happy with the fifteen day wear so far. And as far as them being unhappy with sticky tape or something not looking right, that really hasn't been that much of an issue. The number of patients getting the fifteen days with Stella has been very strong so far. Look, fifteen days is the preferred use case for this patient population and for their certainly, there may be groups.

For example, children where they may change more frequently. We have right now a very generous and a very yet efficient service model with the sensor fails or if it falls off, we work with people to make sure they have the sensors that they need. We're looking at that service model as we go to fifteen days to make it as streamlined as possible so people do have the experiences that they want. At the same time, we increase our profitability and our margins across the way.

And this is something we look at and talk about on a regular basis, Patrick. But most people really do wanna wear it fifteen days if they can. They'd rather not change answer.

And I think it's safe to say. I mean, in the interim, you're a hundred percent right, Patrick. The timing is gonna be who moves, when they move, what the preferred longer term every one of those gonna be a good handy. So it's just a matter of timing as opposed to necessarily how many people are gonna stay on a ten day.

And your next question comes from the line of Marie Thibault with BTIG. Your line is open.

Good afternoon. This is Sam once Marie. Thanks for taking the questions here. Maybe I can just ask about the sustainability of international growth and just getting your thoughts about contribution from maybe the several levers you have, whether it's expanding into new markets, going direct in other countries, and, you know, just increasing your penetration through coverage ones. Thanks.

Our primary goal internationally, again, is to go to the large international markets where sensors are approved, where CGM is approved, and it's a growing technology. Certainly, there are countries in this group where there's more type one penetration to get. Many of the countries don't even cover type two intensive insulin usage. So we're looking to drive more access there.

And then basal insulin, as I said earlier, in the call, is only fully approved in two US markets, Japan and France. So we're looking to build the case in those markets. So we'll expand in the markets where CGM is already a proven technology. And becoming the standard of care for insulin use.

As far as other markets, you know, when we launched a I D one, the our DexCom, Inc. One product in the beginning, we built a very efficient model to launch a digital platform in those geographies and get those geographies up and running. What we've experienced in those geographies, in all fairness, is oftentimes, it grows to very quickly. When the government sees how many of these sensors are purchased in a great outcomes these patients have is physicians put pressure on the reimbursement authorities.

So we have good plans for those geographies where we're not that's not where the bulk of the international growth is gonna come from. This can become from the large markets where CGM is reimbursed as we expand deck and the category in general similar to what we've done in the domestic market.

And your next question comes from the line of Mike Kratky with Leerink. Your line is open.

Hi, everyone. Thanks for taking our question. You walked through some of the growth trends across the different segments of the diabetes population earlier on the call. Maybe as a follow-up to that, have you seen any noteworthy shifts in your market share that you're capturing across the different segments and anything in particular you'd expect to see in 2025?

Yeah. I mean, as you looked it over the course, call it, say, the fourth quarter, you know, we had a really good, you know, good bounce back in the third quarter and a really strong fourth quarter. You know? And in the fourth quarter, given it was record new patients and we saw, you know, strength really across the board, we saw some good really good share performance across really all of it.

Now the area when we historically, we've had, you know, the least share was in the area we haven't had coverage. And so as you fast forward into 2025, you know, coverage is a good opportunity for us there. And so I'd expect to us to continue to do well, especially with the expanded sales force and all of the innovation we're putting into the product, as well as having Stella on the bag, and that's really important as we call them physicians. So expect us to do really well in the markets we're in.

And in an area we alluded to a little bit earlier on the call where we haven't had coverage and we're excited see where this goes in 2025 is in the non-insulin space. I think that's an area where with coverage, we expect to perform well. But I think you saw performance in Q4. The new patient performance in Q4 is a precursor to really some a good jumping point for 2025.

And our next question comes from the line of Matt Miksic with Barclays. Your line is open.

Hey. Thanks so much for taking the question. So just one quick clarification and then a question on some of the comments you made about economics of patients. So the quick clarification was just I'm not sure if you've given us a time frame for G8 yet approximately.

Is it one year away, two years away? That'd be helpful. And then the question on the economics, was you know, I think the perception is among investors that as you move up and just call it to the right, lower acuity, patient non-insulin and so on. That the economics and the economic value of that per patient is lower.

And sounds like on a pre-unit basis, I think as you were describing earlier, not true. So is that purely driven by, you know, use case, utilization, renewed prescriptions, and so on. Or is there different rebates? Maybe how would you sort of like this.

Dispute that kind of perception out there about that's, you know, that segment of the market. Thanks so much.

Let's start with your G8 question. We've not given a timeline. Right now, we're all hands on deck for fifteen day G7. And that's the timeline we're most concerned about today as far as giving you guidance again. That's in the second half of the year as we look forward to approval in the not too distant future.

With respect to these other markets as we get into non-intensive diabetes treatment, even basal treatment when we started, we know that utilization rates amongst these patient groups are a bit different. But they're not as dramatically different as one would expect. Certainly, our type one patients who are made in some delivery systems, some of which don't even function without a sensor. The utilization there is gonna be very, very high, obviously.

And if they're having a good experience with their system, retention's incredibly strong as well. As we move down the acuity curve, what we see is utilization may decrease some. But as long as it's reimbursed, it doesn't decrease like, it doesn't go from 90% down to 40. It goes down a little bit. Now mind you, as we expand in these categories, you get more and more users.

Utilization patterns will change and they will shift. So maybe the value of a patient over the course of the year will come down a little bit. But if it's reimbursed, we don't expect it to come down that much. Where we have to build out models and learn more is with Stella.

With these cash pay patients, how many cents are they are they gonna purchase cash wise? How many are they gonna use, and what does that look like? And we're too early in that journey to really define it.

Yeah. And, Matt, I think, you know, the question earlier was, do the economics per transaction change? I think the answer is no. However, does utilization change?

The answer is yes. So it gets back to the per user per year. It may come down, but remember, the amount of sensors you sell comes down because it's a utilization question. So the gross margin, the op margin, remain the same.

I think that's the important part of it. So depends. Are you talking about the economics of the transaction, the economics of the lifetime value of customer? They are different, but I think there was a question about does the margins go down because you're moving to a different and the answer is no.

Ladies and gentlemen, that concludes our Q&A session. I will now turn the conference back over to Kevin Sayer for closing remarks.

Thank everybody for participating today. We're very pleased with our 2024 results. And a record new patients and the things we achieved in the fourth quarter. We're looking forward to a great 2025. Many levers in place for us to have a great year, and we look forward to your continued support. Thank you.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.