DexCom Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
April 25, 2024

There are 19 speakers on the call.

Operator

My name is Abby, and I will be your operator for today's call. At this time, all participants are in a listen only mode and later we will conduct a question and answer session. As a reminder, the conference is being recorded. And I will now turn the call over to Shawn Christensen, Vice President of Finance and Investor Relations.

Operator

Mr. Christianson, you may begin.

Speaker 1

Thank you, Abby, and welcome to DexCom's Q1 2024 Earnings Call. Our agenda begins with Kevin Sayer, DexCom's Chairman, President and CEO, who will summarize our recent highlights and ongoing strategic initiatives, followed by a financial review and outlook from Jeremy Silvane, 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, so we can provide an opportunity for everyone participating today. Please note that there are also slides available related to our first quarter 2024 performance on the DexCom Investor Relations website on the Events and Presentations page.

Speaker 1

With that, let's review our Safe Harbor statement. Some of the statements we will make in 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 in this presentation are made as of the date hereof based on information currently available to DexCom, 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's annual report on Form 10 ks, most recent quarterly report on Form 10 Q and other filings with the Securities and Exchange Commission.

Speaker 1

Except as required by law, we assume no obligation to update any such forward looking statements after the date of this presentation 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 with respect to our non GAAP and cash based results. Unless otherwise noted, all references to financial metrics are presented on a non GAAP basis. The presentation of this additional 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 Q1 earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure.

Speaker 1

Now, I will turn it over to Kevin.

Speaker 2

Thank you, Sean, and thank you, everyone, for joining us. Today, we reported another great quarter for DexCom with 1st quarter organic revenue growth of 25% compared to the Q1 of 2023. Demand for DexCom CGM remains very high as customers continue to recognize and value our leading product performance and differentiated user experience. While it has only been a year since the launch of G7 in the U. S, we have seen a significant shift in the landscape over that time.

Speaker 2

We have attracted tens of thousands of new prescribers to our ecosystem, meaningfully improved our presence within primary care and experienced growing demand from people with diabetes who are benefiting from significant expansions in coverage over the last year. Much of this momentum can be directly attributed to our product performance and innovative features. With the launch of G7, we extended our leadership in sensor accuracy and took a significant step forward in ease of use. We also introduced a new software ecosystem, which was designed to improve our user experience and drive high levels of customer engagement and retention. Importantly, we have continued to enhance the G7 experience with ongoing improvements to both the hardware and software platforms.

Speaker 2

In fact, we have completed software updates almost monthly since the launch of G7, introducing new features, upgrading performance and connectivity and most recently establishing the ability to integrate insulin data into our app. These are great examples of how our new software architecture enables much faster innovation. We are constantly working to advance the customer experience and reinforce Dexcom as the technology leader in this space. Along those lines, we were very excited to receive clearance by the FDA for our direct to watch feature for G7 in the Q1. This approval will allow our customers to use their Apple Watch as a primary display rather than connecting through their mobile phone, providing even greater flexibility in how and where they interact with their glucose data.

Speaker 2

This added to our long list of industry first as G7 is the 1st FDA cleared CGM that can communicate directly from sensor to watch. To enable this, we built a robust connectivity infrastructure into the design of G7. With the ability to connect to 3 different Bluetooth devices at the same time, our customers can simultaneously connect to a phone, a pump or receiver and a watch. Dexcom is the only CGM system that gives customers these options. We have received great feedback since we launched our direct to watch software in the UK and Ireland and look forward to extending it to additional markets shortly.

Speaker 2

Features like these add to our standing as the innovator in the CGM industry, strengthening our sensor platform as global access and awareness continue to expand. As a reminder, we recently crossed the 1 year mark since the landmark CMS decision to expand coverage for all people using insulin and certain non insulin using individuals that struggle with hypoglycemia. This decision paved the way for greater commercial coverage for these populations, further strengthening our physician as the most covered CGM in the U. S. It also served to broaden our conversations with payers.

Speaker 2

While payers have long recognized DexCom's ability to help titrate insulin, there is now a growing appreciation for our ability to drive better outcomes through behavior change and customer engagement. There is also a growing awareness of these benefits in the clinical community. With much broader coverage now available, many physicians started incorporating DexCom CGM earlier into their customer care plans. They recognize lifestyle management as a cornerstone of the diabetes care and metabolic health landscapes and see CGM as a core tool to drive behavior alongside new drug therapies like GLP-1s. To that point in the Q2, we will be launching a medication logging module and activity integration tool within the G7 app to help those using DexCom CGM with these therapies.

Speaker 2

While this has helped us significantly expand our prescriber base over the past year, we are still only scratching the surface of this sizable opportunity. There are over 200,000 primary care physicians in the U. S. Who treat tens of millions of people with diabetes. There remains a clear opportunity for us to deepen our presence within this channel as we work to drive even greater care for their patients.

Speaker 2

As a result, we announced an expansion of our sales force this past quarter. We were blown away by the level of interest and the quality of talent that we were able to attract for these roles. By the end of the Q1, we had already completed our hiring and trained these new reps. This team is excited to hit the ground running and we look forward to seeing build momentum over the course of the year. As part of this initiative, beginning in the Q2, we are also taking steps to optimize the structure of our sales team to be most effective with our call points across endocrinologists and primary care physicians as well as leading practitioners in maternal fetal medicine.

Speaker 2

We expect our new team in this upgraded structure to help us better capitalize on the significant opportunities ahead. Along those lines, we hit another significant milestone in our company's history with the FDA's clearance of our newest product, StellO, the first glucose biosensor approved for use without a prescription in the U. S. Recognizing a significant unmet need for the 25,000,000 people with type 2 diabetes who are not on insulin or at risk of severe hypoglycemia, we developed Stell O as a more tailored solution for this population and work closely with the FDA to simplify access to this product. By removing the burden of a prescription, we expect STELLO to draw broad interest from both the clinical community and directly from members of the diabetes community who want to better understand their blood sugar.

Speaker 2

In our dialogue with the FDA, it became clear that iCGM accuracy remained critically important in establishing this new sensor category, both as a safety measure and to ensure that our customers are receiving reliable actionable information. STELLA will leverage the industry leading accuracy of our G7 sensor hardware, while providing a custom software experience to more directly meet the needs of those not taking insulin. We're on track to launch Stella this summer as a 15 day cash pay product and we'll continue to build our case with payers for broader coverage. Stellow will be fulfilled initially via a brand new e commerce website and available at one time purchases or subscription models. We look forward to providing greater detail on Stello features, including pricing immediately before launch, and we'll share further updates on our go to market strategy and ordering process at ADA and on our Q2 earnings call.

Speaker 2

In our international business, we also advanced some key strategic initiatives this past quarter. In February, we officially launched DexCom 1 Plus into 8 European markets, which is our first step in moving our entire DexCom COM1 product line into the G7 form factor. This transition brings several of the G7 technological benefits to this customer base, such as the smaller form factor, shorter warm up time and improved accuracy and further simplifies the prescribing process for physicians. Moving to a shared hardware platform also benefits our cost structure over time as it allows us to drive greater volume through our G7 lines and more quickly reach scale. We also completed our transition to a direct sales model in Japan, enabling us to begin commercial operations at the start of the second quarter.

Speaker 2

As a reminder, this is one of the only markets in the world with coverage for all people using insulin, which represents over 1,000,000 people. Despite this, market penetration remains in its early stages and we see a significant opportunity to drive greater uptake in DexCom CGM share. As a result, we believe Japan can become a key growth driver for us over time as we strengthen our presence in this market in the coming quarters. This is an incredibly exciting time for us. There will be a lot to learn with the launch of Stell O and we are thrilled to once again pioneer the CGM industry with a new subset of users.

Speaker 2

We look forward to sharing more updates with you as we begin this journey. With that, I will turn it over to Jeremy for review of the Q1 financials. Jeremy? Thank you, Kevin.

Speaker 3

As a reminder, unless otherwise noted, the financial metrics presented today will be discussed on a non GAAP basis. Reconciliations to GAAP can be found in today's earnings release as well as on our IR website. For the Q1 of 2024, we reported worldwide revenue of $921,000,000 compared to $741,000,000 for the Q1 of 2023, representing growth of 24% on a reported basis and 25% on an organic basis. As a reminder, our definition of organic revenue excludes the impact of foreign exchange in addition to our non CGM revenue acquired or divested in the trailing 12 months. U.

Speaker 3

S. Revenue totaled $653,000,000 for the Q1 compared to $526,000,000 in the Q1 of 2023, representing growth of 24%. Our recent momentum in the U. S. Continued this quarter as we again benefited from the largest expansion of reimbursed coverage in our company's history.

Speaker 3

This led to another quarter of significant new customer demand in the U. S. And contributed to our record new start quarter globally. As Kevin mentioned, we are excited to build on this momentum with our expanded sales force and look forward to seeing the new team ramp up in the months ahead. International revenue grew 24%, totaling $268,000,000 in the Q1.

Speaker 3

International organic revenue growth was 26% for the Q1. We executed very well across our international footprint and again took market share this quarter benefiting from our targeted access expansion and product portfolio strategy. We delivered a particularly strong quarter in our core European markets, which more than offset the pause in growth from Japan as we finalized its transition to direct sales. Our first quarter gross profit was $569,000,000 or 61.8 percent of revenue compared to 63.4 percent of revenue in the Q1 of 2023. This gross margin result was in line with our expectations as G7 continues to become a larger part of our product mix.

Speaker 3

As a reminder, G7 carries a lower margin than G6 today, but we expect this to change in the coming quarters as we drive more volume through our G7 lines in the U. S. And Malaysia. Between continued G7 demand, our pump integrations and moving Com 1 to the G7 platform, we continue to see more of our base moving to the G7 form factor. Operating expenses were 428 $900,000 for Q1 of 2024 compared to $391,200,000 in Q1 of 2023.

Speaker 3

This quarter was another demonstration of our ability to generate significant operating leverage as we grow. In fact, we grew our revenue at more than double the rate of operating in the Q1, resulting in more than 600 basis points of OpEx leverage compared to the Q1 of 2023. Operating income was $140,200,000 or 15.2 percent of revenue in the Q1 of 2024, compared to $78,600,000 or 10.6 percent of revenue in the same quarter of 2023. Adjusted EBITDA was $220,900,000 or 24 percent of revenue for the Q1 compared to $145,900,000 or dollars or 19.7 percent of revenue for the Q1 of 2023. Net income for the Q1 was 128,200,000 dollars or $0.32 per share.

Speaker 3

We remain in a great financial position, closing the quarter with approximately $2,900,000,000 of cash and cash equivalents on the back of nearly doubling our free cash flow year over year. This provides us significant flexibility to both support our organic growth opportunities and assess any strategic uses of capital. From a capacity perspective, we remain in a great position with Malaysia quickly scaling and we are further diversifying our footprint with the build out of our Ireland facility. This leaves us well positioned to support our near term growth opportunities, including the highly anticipated launch of Stellope this summer. Turning to guidance.

Speaker 3

We are raising the midpoint of our revenue guidance with an updated range of $4,200,000,000 to $4,350,000,000 representing organic growth of 17% to 21% for the year. For margins, we are reaffirming our prior full year guidance of non GAAP gross profit margin in a range of 63% to 64%, non GAAP operating margin of approximately 20% and adjusted EBITDA margin of approximately 29%. With that, we can open up the call for Q and A. Sean?

Speaker 1

Thank you, Jeremy. 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 and A instructions. Thank

Operator

you. Question from Danielle Antalffy with UBS. Your line is open.

Speaker 4

Hey, good afternoon, everyone. Thanks so much for taking the question and congrats on a strong start to the year. Kevin, so the Stell O over the counter clearance was obviously one of the most exciting things that we saw happen in the Q1. Can you help us understand how you think the OTC label expands your addressable market? And how you're aligning the new sales team to capitalize on it?

Speaker 2

Well, thank you for the question. And it's been every bit as exciting for us as it's been as you can imagine. Danielle, we have had more media impressions and inquiries and buzz about Stell O from the outside than really anything we've ever done. It's been spectacular. We're very excited for it.

Speaker 2

The way it expands our access and as we thought through this, there's 25,000,000 people with type 2 diabetes who are not on insulin or who don't suffer from severe hypoglycemia. We wanted to get that product out quickly and make it very accessible to them. We studied this. We spent a lot of time thinking about it. The best way to do that is to eliminate the prescription process and not have to have them in the middle of that with physicians.

Speaker 2

And that's also helpful for the healthcare providers because they don't have to call the pharmacy and do prescriptions as well. So the key to this and particularly in getting to a lot of people is to make this very easy to obtain. And that's why we went over the counter with it. At the same time, as I said in my remarks, we're thrilled with the labeling and the fact that we still have iCGM controls around this sensor by going over the counter. We didn't just open the gates for everybody to come in.

Speaker 2

You still have to have an incredibly good product to go do something like this. So we think we have a very, very good advantage there. With respect to our sales expansion, I made a couple of comments about the expansion and positioning the sales force. We know for a fact that when we have coverage in the physician arena, when we call on doctors, we do extremely well. And so as we repositioned our sales force, I talked about repositioning between endocrinology primary care and also the maternal and fetal medicine markets as well.

Speaker 2

We've repositioned our group to whereby our we have specialists who spend more time in the endocrinology offices and with high prescribers, not so much with those who don't prescribe a lot. And a lot of the new adds, a lot of the expansion relates to primary care, where they will talk about STELL with primary care doctors who see almost all of the type 2 patients who aren't on insulin. So by expanding this way, we believe we'll be able to have more coverage with the physicians as well. And so they will take that message out and talk with the doctor as well. But this will also be a message driven direct to consumer in the same way that you see all the other Type 2 products gone.

Speaker 2

Jeremy, you might have a bit

Speaker 5

to add to that too. Yes. You asked the question a little bit

Speaker 6

about the sales force and Kevin certainly pointed to Stell o as a big part of the sales force and expanding the TAM. And so one of the reasons to expand is exactly as Kevin said, there's a massive opportunity there. However, there's also a massive opportunity in our existing markets. G7 is a wonderful product, G6 is a wonderful product. There's coverage continuing to expand as well in those categories.

Speaker 6

And so expanding the sales force also allows us to cover more in that category. And that quarter category continues to do incredibly well. We had a record new patient quarter this quarter. And so you can expect to see really growth on both ends of that as a result of the expansion of that sales force.

Operator

And we will take our next question from Robbie Marcus with JPMorgan. Your line is open.

Speaker 1

Great. Thanks for taking the question and congrats on a nice quarter. Wanted to talk about the leverage we saw down the P and L. It was pretty impressive. It will be by like 150 bps on operating margin.

Speaker 1

So just wanted to see how we should think about gross margin progression, operating margin progression throughout the year. I saw the reiterated guidance, but just trying to think about cadence, especially in light of the Stell O launch and the key drivers of that upside in the quarter and how we should think about that moving through the year? Thanks a lot.

Speaker 6

Yes, sure, Robbie. Thanks for the question. The way to think about gross margin and that of course over the course of the year, we talked when we guidance that this was going to look a little bit like a more typical year. And in a more typical year, you generally see 300 to 400 basis points of expansion over the course of the year. And that's what I'd expect to see over the course of this year.

Speaker 6

A lot happened last year with the transition from G6 to G7. It's not a typical year. We had a new manufacturing facility coming online. But as you kind of go back into years prior to that, you see that sort of cadence. That's how we're thinking about it, at least over the course of the year right now.

Speaker 6

And so that gives you some context for that cadence. From an op margin perspective or at least an OpEx spend perspective, we've already made the investment in the sales force and so that you see playing through in the Q1 and to your point, you saw some nice leverage in the Q1. We will be making investments, further investments in Japan here as we go live in the Q2 and that will play out over the course of the year. And then obviously associated with the launch of Stell O over the course of the summer, we'll be making investments there. So while we won't get the same leverage that you ultimately saw in the Q1 over the balance of the year, you should expect some leverage over the course of the year.

Speaker 6

And that ultimately contributes down to what you'd see as an expansion of op margin despite a gross margin guide. That's about a bit of a click back from the prior year. So that's the way to think about it. In terms of the over performance in the Q1, I think you're alluding to the beat in terms of margin. I think the takeaway here is it's an encouraging sign for us.

Speaker 6

We've demonstrated over the past few years, we can drive leverage into this business. This year is no exception. All of the efforts that we've been talking about in prior years continue. However, it's a little early to change how we're thinking about the full year. Q1, as you mentioned, nice start to the Q1 and we'll keep you updated on progress as the year progresses.

Operator

And we will take our next question from Larry Biegelsen with Wells Fargo. Your line is open.

Speaker 7

Good afternoon. Thanks for taking the question. Kevin, I'd love to ask about Stello. So, I heard your comments about an e commerce website. Why an e commerce website as opposed to pharmacies and retail?

Speaker 7

Maybe talk about how you see utilization playing out? And I know the indications only for type 2 oral patients, but do you see an opportunity beyond type 2 oral patients such as pre diabetes and health conscious people maybe down the road? Thanks for taking the question.

Speaker 2

I'll start with the AND and go back to the website. That product is labeled for people not on insulin. It's not necessarily labeled just for people with diabetes. We designed the experience to focus more on those with type 2 diabetes because we believe there's a very, very strong unmet need and a product tailored to that solution we think can do very well. We believe people will be interested who don't have diabetes and will in fact use it and will purchase it.

Speaker 2

But the focus out of the gate is in this marketplace where people have a direct need. Over time, we definitely see this platform and features in our software migrating towards those other markets. We just wanted to get started here first. With respect to the website and the reason we've gone with this direct distribution model, we've had great success with it launching products in some of the international markets as we rolled Dexcom 1 out. So we do know how to do this.

Speaker 2

2nd of all, we want a little bit of control when the launch when we start, we want to understand what's going on, we want to track utilization patterns, we want to see how this goes and we felt this was the most efficient way to do it. And as you go back to my comments, I said initially, we will launch in this program. I think as this gets bigger, we'll seek other distribution channels if it's more efficient to get more product to people. We are very well positioned and we've done a lot of work setting this website up and then the distribution process will be extremely efficient. So we're not concerned about being overrun.

Speaker 2

Right now, we're in a really good position to get this product to people that want it through the website that we've set up. Yes. And then to

Speaker 6

your question on utilization, Larry, it's going to be a little bit of everything. I think there's going to be some users that do use it full time. I think some folks will use it intermittently. That's based on our market research. Our market research is basically has for the most part indicated once folks are on this product, they want to use it.

Speaker 6

And I think we've run studies where there was a high either utilization while in study and a high request to continue utilization post study. That all being said, as we think about modeling, we want to make sure we're prudent in doing so. And so we have a variety of utilization patterns that will ultimately put out there. So I think expect a little bit of everything that population is so big, You'll get, I think, a grab bag of everything. Fortunately, we always are surprised to the positive on how often folks want to wear these things.

Operator

And we will take our next question from Joanne Wuensch with Citibank. Your line is open.

Speaker 8

Thank you very much for taking the question and congrats on the quarter. With a 15 day stell o out in the market, what are the steps to bringing a 15 day sensor onto the G6 or G7 platform? And what are the economics of moving to that timeframe? Thank you.

Speaker 2

Yes. First of all, there won't be any G6 15 day. We're not going spend any more money on G6. I can assure you of that. One of the reasons we're launching cell with 15 days in our current G7 platform is to learn its performance in this type of environment.

Speaker 2

As we've talked earlier, we have a level of performance and reliability and expectations of our customers. We wanted to make sure we delivered those and we felt more comfortable at 10 days to start. We have numerous clinical efforts and R and D efforts to move the platform to 15 days for all the G7 product and including DexCom 1 plus in our international markets at some point in time. As we've said in our guidance and what we've done, that's not anticipated for 2024, but it's certainly anticipated not long after that. So you'll hear and see more about that over time.

Speaker 2

The economics are quite simple. You're selling 2 sensors over a 30 day period rather than 3. So we can see a significant margin pickup as long as we have the proper reliability on the other side because if you're shipping a sensor and a FedEx box to replace one that doesn't work, you've lost all your economies of scale anyway. So we're not only looking at 15 days making it reliable, we're looking very hard at offering the maximum most efficient customer experience for individuals when we go to 15 days, so they're ready. And so this delivers what we've always delivered because one of our in our CSAT scores and as we survey our customers, one of the things that we always hear about is how much people value that experience and the support that we give them.

Speaker 2

So it's a combination of all those things, but scientifically, we're well down the road to having 15 day product.

Operator

And we will take our next question from Jeff Johnson with Baird. Your line is open.

Speaker 9

Thank you. Good afternoon, guys. Congrats on the quarter. So wanted to ask on Basal, just any visibility you can give on how that's been scaling. Obviously, a record new start quarter this quarter, I would assume Basal is contributing nicely to that.

Speaker 9

But one of the sequential patterns look like the last few quarters, is it still sequentially growing at a pretty healthy rate, I'd assume, but any color you can provide there? And also there's been some debate obviously on market share within the basal population here in the U. S. Just love kind of any insights you can provide on that front as well. Thanks.

Speaker 6

Yes. Sure, I can take that one. Thanks, Jeff. I think when we talked about what we expected this year, we really talked about it in the context of basal adoption across the entire population. And we talked about exiting the year, right around that 15% adoption across the basal population in the U.

Speaker 6

S. And the year moving over the course of the year to 23%, so about an 8 points of penetration. So far through the Q1, things are going as we expected. Record new patients, I think, helps enforce that. And you are correct, a good chunk of our new patients are coming through that basal channel, and we continue to see really well performance in that category.

Speaker 6

So qualitatively, the things we talked about, the excitement in that channel, those still remain. In terms of share taking and how we look at that category, we get script data, we look at script data based on pathology. The debate there is no debate internally to us. We know we're taking share. And we see that data and I think a lot of you guys see that data.

Speaker 6

So for what it's worth, that data is out there. You can see the scripts continuing to come our way for the purpose we talked about. When we have coverage and when we compete head to head, we've typically won. So I think we can we maybe disagree with some comments out there. But I think the data is clear.

Speaker 6

When you look at the script data, I think it will continue to demonstrate where this is going over time. Hope that helps.

Operator

And we will take our next

Speaker 10

Just on STELLO, Kevin, you mentioned getting it out quickly, but you're not launching it until the summer and certainly don't mean to be impatient. But just outside of the sales force training, maybe the e commerce setup, what else are you doing to prep for the launch? And then just does the FDA need to approve anything else, I'm thinking of an app or the like before you launch?

Speaker 2

No, we have full FDA approval for launch. It has been our experience over time at DexCom, when we get a very rapid approval, we tend to become very impatient and we launch very quickly. And we've from time to time actually put ourselves in a bind by going out as quickly as we have. We have a launch plan for this product anticipating an FDA approval and it's going to come and we're going to stick to the launch plan that we have. We have manufacturing scheduled, we have lines set up, we have molds, we have everything, packaging, everything that we need ready to go, but we're going to stick to the plan that we have.

Speaker 2

We believe our timing is good and there's no need to rush anything. And so we're sticking to what we have and we're comfortable with it.

Operator

We will take our

Speaker 8

I wanted to hit something, Kevin, I think you had said earlier in your commentary that you're seeing growing coverage and plans for patients earlier in their care. So I just wanted to know if you're referencing basal, which obviously we've heard about, is it non insulin, pre diabetic, non diabetics, maybe things that are less traditional as the street thinks about that? And then and why? And then as it relates to STELLO, obviously, it was tied to that. But just any sense of a number of people that have proactively reached out on your website right now to buy the

Speaker 9

product when it launches? Thanks.

Speaker 2

Well, we haven't had anybody reach out to buy it because we haven't offered it for sale, but we certainly had a lot of inquiries. And again, as you go to media impressions, articles, interviews, unsolicited stuff, things like that, Stellow has been the biggest offering that we've had as far as news. And as our reps walk into primary care doctor offices, I just spent a bunch of time with several of our field team members. That's the question the minute they walk in the door, when am I going to see Stell O and Hat? And when I was in at ATTD, it was interesting many of the physicians came up to me and said how does Stell O affect me in my practice.

Speaker 2

So there is a lot of interest and there is a lot of buzz on that. As far as using CGM earlier in treatment, we're certainly seeing that with basal. We're seeing that as somebody goes on basal insulin, look, you're going on basal insulin. You just as well use a sensor to know how this is affecting your body, so you can learn and so we can titrate your basal insulin the way it needs to be. And we're looking at product offerings and software enhancements to make that experience better.

Speaker 2

But even in the Type 1 population, Margaret, you now see kids leave the hospital with their Dexcom. They get diagnosed. They go to the hospital. And again, I talked with someone this morning even. The 6 year old was diagnosed and left the hospital wearing a Dexcom because there's no way that they were told they can manage this disease without it.

Speaker 2

So we have definitely become a product and offering that comes into play very, very quickly. I also think we see, particularly if there's coverage with somebody with type 2 diabetes who's not using insulin, physician knows the patient can get it, they'll get it to them and use it as a teaching aid, as a tool to help these people manage their condition. Across the board, CGM is becoming used earlier in treatment over and

Speaker 6

over again. Yes. And Margaret, this is one of the reasons why when we last year, I think we talked a little bit about this as we introduced a cash pay option on our G Series. One of the reasons in doing so is, as Kevin alluded to, really across the spectrum of managing your diabetes, there's been more interest. And so those plans that do have pockets that do cover everybody with diabetes and the cash pay option have there has been some uptake there, certainly not a majority of our uptake and certainly not, the materiality of our customer base, but the interest is there.

Speaker 6

And so you continue to see that taking place. It's why we're so bullish on Stell o, back to Kevin's point, why there's so much inbound interest in that product. So hopefully that gives you some context. There's a groundswell of attention to this and rightfully so, it can help a lot of people.

Operator

And we will take our next question from Matt Taylor with Jefferies. Your line is open.

Speaker 11

Hi. Thank you for taking the question. I wanted to ask you kind of a combined question when you were talking about moving earlier in the treatment paradigms and also with STELLO coming on and obviously you've got plans to try to broaden coverage and are having these conversations with payers about how that may benefit patients. So the question is really, are you seeing signs from the payers that you could actually get coverage for the G Series and or for STELLO in some other format this year, basically earlier in the treatment paradigm than basal? And how long do you think it will take to get any kind of coverage officially for

Speaker 6

Yes. So it's a fair question. There are some plans out there that actually do cover really all folks with diabetes, not a majority of plans, but these plans have seen early on the value of CGM as a lifestyle change, a preventative tool and something that ultimately yields results back to the system and it's the same economics we've talked to you about before. And so some plans have done that Again, it's not the majority. In terms of your question, though, more broad coverage or how do we introduce that earlier, I don't think we expect that to expand significantly this year.

Speaker 6

Certainly, plan by plan, you get wins here and there, but those aren't the majority of the national formularies at this point. And so I think the work has to continue to take place. I think one of the reasons why we did want to get STELLO out there is because the data that's going to come up in addition to all the clinical trials that are underway, the clinical work that's underway that we consistently do along with our partner organizations. Having that real world data, I think will be really helpful and then demonstrating to payers and employers why this is a good tool to ultimately improve health and reduce costs at the end of the day. So I don't expect it in 2024.

Speaker 6

If you asked us for the timeline, Kevin has been very clear, the 2 to 3 year window we think it takes to do so, we're highly incentivized to go quickly. Nevertheless, it's something we'll continue to work on and keep you posted on our progress as we make progress.

Operator

And we will take our next question from Matthew Blackman with Stifel. Your line is open.

Speaker 12

Good afternoon, everybody. Can you hear me okay?

Speaker 2

Yes.

Speaker 12

Okay, great. Maybe, Jeremy, this question for you. I know you're not going to give me precision here, but I'll ask anyway. Just on G7, where are we even in the roughest sense in terms of the mix of the installed base? And I guess the more important question is, what's the tipping point for gross margin accretion in terms of G7 mix?

Speaker 12

Is that something we hit this year? Is that part of the quarter over quarter potential improvement to get you to the full year guide? Or is that something that happens further out? And is AID integration a key component of that ramp?

Speaker 6

Yes. So it's here's my expectations. The way we're tracking and again, it's going to depend on how things play out over the course of the year. But we are tracking to a point where G7 as a percentage of our overall sales will eventually move ahead of G6 and I expect that here over the coming quarters in 2024. So that is moving.

Speaker 6

And it's really started to it started moving obviously at the back half of last year and having some of to your point, the AID integration was very helpful for the base. So that is happening and it is the reason for some of the leverage in the back half of the year. As G7 starts to be the primary product, the economies of scale start to kick in and that's where you start to see the cost come below G6. And so that could happen this year, it very well could happen as we move over. It's going to depend on at the velocity at which we move.

Speaker 6

I will tell you Q1 was a very strong velocity in movement. In terms of new patients coming in, and I think you guys can see it in the scripts, a majority of new patients are already moving to G7. So the great news, it's not a matter of if, it's when. And so it's really on converting that base. So I think the long it's a long way to answer, yes, some of the leverage this year in gross margin is because we do expect G7 to be the majority of product.

Speaker 6

When it gets lower, it's going to be kind of the timing thing. We don't have an exact date, but at the velocity we're going, it's happening very quickly and it should be a good guy. And happening very quickly and it should be a good guy. And AID will play a large part of it. It's already started with our Tandem base.

Speaker 6

I know we're talking about Insulet coming up here pretty soon. We're excited about both of those opportunities in converting that base.

Operator

And we will take our next question from shagun Singh with RBC. Your line is open.

Speaker 13

Great. Thank you so much. So U. S. Growth was pretty strong at 24% year over year, but it was roughly in line with expectations.

Speaker 13

And so I'm wondering if you can elaborate on pricing. I know that's been a big focus for you guys. What would trend year over year and sequentially? And then on Stell O pricing, is it fair to assume more in line with cash pay similar to what your competitor has indicated? Thank you.

Speaker 2

Stella pricing, I'll start with and then Jeremy can jump into the other. Stellar pricing is going to be competitive. We've got a number of models we're considering. We said we'd bring you more information on that on the next call at ADA and that's when you'll hear more. But we'll be very competitive with other cash offerings when we launch Cello.

Speaker 2

Yes. And then to

Speaker 6

your question on Q1 in terms of pricing dynamics, the pricing dynamics are stable. We don't have a lot of contracts year over year that are changing. And when we do have those contracts, in general, the pricing headwinds we do have that typical medical device headwind that's continued to play out. So that is stable. The one thing you do see as you get into the start of a year and benefits reset is we do see a lot of our new patients coming through the pharmacy channel.

Speaker 6

We still have a very strong DME business and certainly the DME business continues to be supported by our partners very, very well. But what we find is as we call on more and more primary care physicians who are seeing where basal patients are seen, there is a bit of a heavier tilt towards the pharmacy channel for new patients. Again, the base is pretty stable. So what you do find is, as you think about the mix, you do get a little bit more running through that channel given where the predominance of our new patients are coming from. I don't think we don't call that price, it's pretty consistent year over year, but it is helpful to understand those dynamics.

Speaker 6

It's not anything new, but it's something just to continue to be mindful of as we move into a new year.

Operator

And we will take our next question from Matthew O'Brien with Piper Sandler. Your line is open.

Speaker 11

Afternoon. Thanks for taking the question. And Jeremy, it sounds like you

Speaker 6

have a little bit

Speaker 11

of a cold, so I hope you feel better. When I look at the stock in the aftermarket, it's down about 8%. You just had your easiest top of the quarter or of the year, I'm sorry.

Speaker 2

And then the rest of

Speaker 11

the year just assumes a pretty nice acceleration throughout the course of the year, off of tougher comps. Even when you do it on a tier stack basis, it's still more than you just put up in Q1. I know Japan is going to be a little bit of a tailwind. You've got the more a broader sales force now, but those guys take time to kick in. Stella is not going to really kick in until Q3, Q4.

Speaker 11

So just why the confidence in being able to hit kind of the midpoint of the guidance range for the remainder of the year, just given some of these dynamics?

Speaker 6

Yes, sure. I'm happy to provide that, Matt, and thanks for the wishes on the call. I was trying to impress you with my deep voice. I guess that didn't work. In terms of how the confidence on the year, one of the things that as we go into a quarter, we try to set a base case.

Speaker 6

And the base case has risk in around things like competitors, things like adoption in the Basal base, things like what we would do in terms of channel mix and pricing, internationally expansion. And while we said Japan was going to launch, you have to be mindful of that, Talking about basal coverage and adoption outside the U. S, all of those go into as we set ranges for base cases. And as some of those get knocked down, we feel much more confident about raising the base case. And so that's the reason why we ultimately did it.

Speaker 6

We feel more confident in the base case as a floor. And so we certainly felt good there. We haven't talked about it yet, but I think one of the things we are really excited about is in France, we've submitted our final paperwork for DexCom 1 plus to launch with what we expect is basal coverage in the coming months. And so we talked about it. It was something we thought was coming.

Speaker 6

We knew was coming, but it was one of those things that we needed to make sure we did the appropriate steps. And so as we start to de risk it, that's one thing. In Germany, we have wonderful basal coverage there, I should say wonderful for the small population that's agreed to it. But that's a wonderful start for us in terms of now saying, well, there is a pocket of payers in Germany, albeit small, that do have basal coverage. It's a wonderful progression for us.

Speaker 6

And we are the leader in terms of basal coverage in Germany right now. And so these are the things that help derisk the year that hopefully give you guys a little bit more confidence in that base case. Certainly, it gives us confidence in that base case. And that's why when we come out and feel comfortable moving that up, it's that confidence that we have in that base case.

Operator

And we will take our next question from Marie Thibault with BTIG. Your line is open.

Speaker 14

Good evening. Thanks for taking the questions. I wanted to ask a question here on Japan. It certainly sounds like you have really broad favorable coverage for all people with using insulin. So I want to understand where was penetration into that market with your distributor partner?

Speaker 14

And what have been the barriers? What have really been the hurdles? And what are you going to do to try to attack those?

Speaker 2

Our penetration with our partner was next to very small. Japan has not been a big market for us in spite of the great coverage that has just come out, which is why we've gone direct and our distributor partner and us have gone our separate ways. We've had this experience in several geographies over the years. In those geographies where we acquire a distributor and existing infrastructure like we did in Australia, like we did many years ago in Germany, we get out of the gate very quickly and we can grow our market very fast because we have an infrastructure already in place. With respect to Japan, it's like some of the other geographies, we're starting from scratch, similar to how we like we're doing in France, for example, we're starting from scratch in France on our own.

Speaker 2

It will take us a while to build that growth engine and build that dynamic in Japan. I think what held us back more than anything else is we just didn't have enough infrastructure and in all fairness our distributor did what was most important for their business in their own minds. And there wasn't that commitment and that drive there. There will be that commitment and drive going forward. But it's going to take a while to build it.

Speaker 2

It's not going to happen overnight. We're very confident. We've hired a team that can develop the relationships necessary. Japan is very much a market driven by physician and hospital decisions. We think what we've got certainly from a leadership perspective, a team that can build those relationships and do the things that they need to do, but this can take a little while.

Speaker 2

As I'm talking to you, as we're talking to you 2 years from now, I have every expectation that's going to be a very large market for us, but we'll be very successful there.

Operator

And we will take our next question from Bill Plovanich with Canaccord Genuity. Your line is open.

Speaker 15

Great. Thanks for taking my questions.

Speaker 2

Just I was wondering if

Speaker 15

you could just comment on attrition rates, reorder rates. What have you seen with the transition to G7 from G6? And then how do we think about this in the different patient populations as we get out of the IAT patients and into the basal hypo and then eventually in non using?

Speaker 6

Yes, it's a question we've asked ourselves quite a bit. So happy to give you our thoughts on it. From G6 to G7, we've seen a relatively consistent rate. There hasn't been much of a change in terms of retention utilization across those two products. And that's expected as we upgrade folks from one to the other.

Speaker 6

Obviously, we think the G7 experience is wonderful, but so is the G6 experience and we pride ourselves on the experiences that we offer. So that's been relatively consistent. What we've also found to date and I think it's important to start to date is that there isn't really as much of a difference in the populations we've served across those folks on our products today, we find that there's only really one category where retention and utilization is markedly different and it's those on AID systems. Everybody else seems to follow a pretty similar pattern of retention and utilization. And I say that to date because we are moving into new populations, We are moving more into basal.

Speaker 6

We are moving it more into non insulin using populations, albeit still a smaller part of our user base. And the hypothesis has always been we expect a high utilization in those spaces. We've always been positively surprised, but we are aware that as you move down the acuity curve, there is the potential opportunity for folks to use it maybe a little bit less. That being said, we haven't seen it to date, but we'll keep you posted as we're moving through what we're seeing to help you guys kind of get your arms around it. Kevin?

Speaker 2

Yes. And I would add as we head into non intensive insulin therapy, we think there could be a number of outcomes here and there could be a number of use cases for people. One of the reasons to maintain our distribution on our own website to start with is to begin to understand those patterns and to understand what the purchasing patterns, how many people prefer the subscription model versus individual one time purchases and how often do they come back and then use our tools to find out what the experience is like, what they like and what they didn't. The other thing I would add with respect to retention and attrition, one of our biggest barriers, particularly back in the day was the co pays of the Q1 when everybody was in the DME world. Now that we have pharmacy coverage, that barrier has been eliminated a bit and that's not as big a reason as to why we lose a customer at this point in time as it used to be in the past.

Speaker 2

We've been very successful in working that dynamic. The flip side is our DME patients have very strong retention rates and very strong utilization patterns because of the attention our fine distributors pay to them. So it's a mix of everything, Bill, but I think we're in a good spot. We will learn in a non intensive insulin therapy world and figure out how to build product offerings that maximize our experience with those users.

Operator

And we will take our next question from Michael Pollard with Wolfe Research. Your line is open.

Speaker 16

Good afternoon. I wanted to ask on one of your sales force comments, Kevin. I heard about the expansion faster and higher quality talent than expected. Those folks are hitting street in 2Q. I got that.

Speaker 16

I also heard about, a new team upgraded structure and it didn't quite follow what you're doing there and why it's impactful. So if you could unpack that update for me, I'd appreciate it. Thank you.

Speaker 2

Yes. As we look down over what we need to accomplish and where we needed more emphasis in the field, there are a couple of things that happened. Number 1, we realized as we had our reps who are calling on high prescribers also calling on a number of people who weren't prescribers are doing a bunch of going and finding new prescribers that we may not be paying enough attention to our high prescribers. And so as we've set things up, we do have a set of folks who spend more time in the endocrinology and high prescribing diabetologist world than with primary care. At the same time, we needed people to call on more primary care physicians.

Speaker 2

Consistently, we have learned over and over again that where we call on people, we win. And so we need to call on more folks, get more people out there. We've been much more aggressive by their sampling program over the past several months. We need to get samples to more individuals. We need to knock on more doors and have more relationships.

Speaker 2

A third element of that is education. As we get to some of these offices where we have somebody who's only written 2 or 3 CGM scripts, use to help train patients if they don't have type of training in the office. We made a little more investment there. And then last, there are many doctors, particularly as we get to Stell O and as we get more into the primary care world, who may not even see a rep. And so we do have more of an internal sales force, again, on a regional basis to do more of that work.

Speaker 2

So we're trying to go broader and deeper at the same time, deeper with our high prescribers in the endocrinology world and then broader across all aspects of primary care, including training and supporting patients.

Operator

And we will take our next question from Steve Lichtman with Oppenheimer. Your line is open.

Speaker 5

Thank you. Good evening, guys. I wanted to ask about the noninsulin hypo at risk group, which obviously does have coverage now and I think you've estimated before is about the same size as Basel. Are the sales force expansion and moves you're making that you just alluded to Kevin in the commercial organization helping with those education efforts. Any updates overall you could provide on sort of where you're at sort of tapping this opportunity would be great?

Speaker 6

Yes. And thanks for the question. You're right. It's a big opportunity for us, but it is one that has taken a little bit more time. Obviously, the focus is on basal, it's a known quantity, but the hypoglycemia unawareness or the severe hypoglycemia event, I should say, those are harder to educate folks.

Speaker 6

And so to your point, one of the things that we've done and Terri and her team have really focused on is really creating the educational materials and then arming the sales force accordingly to get out there. And so if you have a situation where we are expanding our sales force and reaching broader and touch points where a lot of these folks are seen, right, they're seen really across the gamut of the healthcare spectrum. That expansion does allow us to get out there and educate more. But the biggest challenge is the education. It doesn't come to top of mind for individuals and prescribers that when this event takes place, I qualify.

Speaker 6

And that's just some more work we're going to have to continue to do on education. Again, more touch points, a good thing and the team is working hard at that.

Operator

We will take our next question from Josh Jennings with TD Cowen. Your line is open.

Speaker 15

Hi, good afternoon. Thanks for taking the questions. Kevin, you mentioned that you'll have numerous iterations of STELLA over the course of the 1st 24 months of launch. And I wanted to just see if there's any other color you can provide on those iterations. And are they mostly going to be on the software side or is one of the iterations going to be an increase in the rate of sensors lasting the full 15 days?

Speaker 15

And how important is that expansion to the success of Stello? Thanks so much.

Speaker 2

Well, we always work on sensor performance optimization and we have a very, very strong program on that across the board and Stellow is the G7 platform. So I think if we do a G7 certainly can apply to StellO. With respect to changes that we make, I think I can go back to what I said about G7. We've literally had a software iteration every month since we launched G7 and we brought several new features into G7. We expect a similar ramp with Stella once we launch it.

Speaker 2

And we have a number of features on a roadmap over the next 12 months that we would add to it from a software perspective, particularly as we learn what engages people as we start. But we've been very vague and we'll remain vague about the features we're going to have at launch and those that we're going to add for competitive reasons. We're just not going to give everybody else a roadmap.

Operator

And we will take our next question from Matt Mitsuk with Barclays. Your line is open.

Speaker 17

Great. Thank you so much for taking the question. And Kevin, I just wanted to maybe go back also to some of the comments you made earlier in the call on the STELLO approval and kind of maintaining the timeline for the launch. If you could just talk with you said things like want to make sure our manufacturing capacity is there and don't want us to rush the launch post approval. It'd be also great to understand just given the excitement about what this product could mean outside of the diabetes community.

Speaker 17

How you're thinking about prioritizing like supply and resources and business development, market development between these those two opportunities going forward? Thanks.

Speaker 2

Well, again, I appreciate that. And again, we're going to stick to our launch timing here. We have made great investments. We are ready to go. We're on our schedule.

Speaker 2

We're on our plan. And we're ready to launch, so we'll be ready when we launch it. Our approval timing was very rapid. We give the FDA tremendous credit for working through us with that and our team great credit for submitting for doing a wonderful submission. They did a great job to be able to get where we got so quickly.

Speaker 2

But we're going to stick to that timeframe. And we think one of the reasons this will be successful is we will have everything lined up and ready to go the way it's supposed to be when we launch it. In all fairness, I've lived through many product launches here and every time we go too early, I end up dealing with 3 days. I'm saying I because everybody's in my office with 3 days inventory and what are you going to do. We are devoting the proper resources.

Speaker 2

We have several G7 manufacturing lines in Malaysia. That factory just came up this summer. We manufacture G7 here in Arizona as well. So we've got plenty of G7 capacity and we'll be running those lines and we have lines dedicated to Stell O and we'll go there. But we're going to stick to our plan.

Speaker 2

We're very comfortable with it.

Speaker 6

We'll be ready to go when it's time. We think about resource allocation, Matt, there's obviously a combination of resource, which is what Kevin referred to as supply and that's absolutely something we have the capacity to go after it. But in terms of resource allocation then on the support, what do we do from a sales and marketing and where do the resources go? We're making the decisions that really quite frankly are in the best interest of returns to the company and in serving the unmet need. So expect us to continue to look at that accordingly.

Speaker 6

One of the things we are doing this year and I think you can see we've made it a priority is, as we go through the organization and drive efficiencies, it allows us to reinvest in the business and all those efficiencies we've been able to get and working through leverage in the business has allowed us to do all the work we're doing around Stella, which includes all of our launch plans. So we'll continue to do the robust work that we do around resource allocation. It's really important for us to do so in order to continue to scale, but also to scale efficiently and appropriately.

Operator

And we will take our final question from Mike Kratke with Leerink Partners. Your line is open.

Speaker 18

Hi, everyone. Thanks for taking our question. How are you thinking about the possibility of seeing additional pricing pressure for G7 as one of your competitors starts to see that AID integration, which has historically been part of your value proposition for payers?

Speaker 2

Well, again, that's also on a geographical basis. In the U. S, we're very comfortable with our pricing, our pricing contracts. That's been very consistent over the course of several years. When you look at the product offerings in the IV world, if you compare what we have to offer, we offer a number of features that make our offering much superior than anything else that's going to be out there.

Speaker 2

With Dexcom, patients can connect to 3 devices at the same time. They have the share follow system. They connect to the phone. They can connect to a pump. They can now connect directly to Apple Watch.

Speaker 2

We're very comfortable with our pricing position here over time. And our pricing is set up in our U. S. Contracts, regardless of whether it's AID or people who use sensors without it. Certainly, if we go to the tender system in Europe, there's a 2 tiered system in many countries.

Speaker 2

We offer the Dexcom 1 product at a lower price point to be able to address those who aren't on the ID systems. And our AD pricing in those countries, we have prices set for G7 that are set in the tender process. So we're very comfortable with where we are in those as well.

Operator

And there are no further questions at this time. I will now turn the call back to Mr. Kevin Sayer for closing remarks.

Speaker 2

Thanks everybody for participating on our call today. This really was a great quarter for DexCom and we continue to drive the most important innovations in our industry. We're continuing to widen the gap between DexCom Com and our competitors by driving more first in our CGM user experience, particularly in the G7 platform. Direct to watch has been the most requested to our experience ever since we launched G5 many years ago and now it's here. Our users are going to be able to, as I just articulated, have an incredibly discrete experience with CGM on an Apple Watch only, and that will include all of our shared follow system as well.

Speaker 2

So imagine again a parent who wants to send their kid to school without a phone, they will do everything on a watch that they used to be able to do on their phone. Access to CGM on a global basis continues to expand. We're very well positioned with our product portfolio to win these opportunities. And last, I'll just talk a bit about StellO. We went from a December filing with the FDA on StellO to a March approval for the 1st over the counter CGM product platform in the United States.

Speaker 2

This is going to greatly enhance the lives of many, many people and we'll learn so much about it during this launch in 2024, we will be very well positioned in 'twenty five and years going forward. And let's not forget the theme of this call, we continue to deliver products and R and D, and we have a very strong commitment to creating the scale necessary to drive this business where it needs to get and pursue all of our opportunities. Thanks everybody and we appreciate your support on the call today.

Operator

Ladies and gentlemen, this concludes today's call and we thank you for your participation. You may now disconnect.

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Earnings Conference Call
DexCom Q1 2024
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