Dexcom Inc Q2 FY2023 Earnings Call

Ladies and gentlemen, welcome to the Dexcom Second Quarter 2023 Earnings Release Conference Call. My name is Abby and I will be your operator for today's call. As a reminder, the conference is being recorded. And I will now turn the call over to Sean Christensen, Vice President of Finance and Investor Relations. Mr. Christensen you may begin.

Thank you, Abby and welcome to Dexcom's second quarter 2023 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 Jereme Sylvain, our Chief Financial Officer. Following our prepared remarks, we will open the call up for your questions. At that time we ask the analyst 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 performance on Dexcom's 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 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-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 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 first quarter earnings presentation for a reconciliation of these measures to their most directly comparable GAAP financial measure. Now I will turn it over to Kevin.

Thank you, Sean, and thank you, everyone, for joining us. Today we reported another great quarter for Dexcom with second quarter organic revenue growth of 26% compared to the second quarter of 2022. Demand for Dexcom's CGM continues to grow as access to our product is expanding faster than at any time in our company's history. In the first half of 2023 alone, we broadened our product portfolio strategy, extended our geographic reach and meaningfully expanded reimbursed coverage for Dexcom CGM. As we sit at the midpoint of this pivotal year for our company, we have a lot to be excited about. In the U.S., our launch of G7 continues to gain momentum. Customers and clinicians alike are sharing consistently great feedback around G7's ease of use, discrete form factor, faster warm up time and redesigned software platform. With this product, we've extended our leadership position in accuracy and product performance while taking a significant step forward in terms of simplicity. It has never been easier to use or prescribe a Dexcom CGM, and we are attracting new customers and prescribers to our ecosystem as a result. Similar to last quarter, we have seen a continuation of the trend that the majority of our G7 users have been new to Dexcom. Additionally, there are now 8,000 physicians writing scripts for G7 in the U.S that were previously not prescribing Dexcom. We designed G7 to hold broad market appeal, and these early prescribing trends are validating those efforts. Behind the scenes we continue to drive reimbursement for G7. As a reminder, we established Medicare and broad commercial DME coverage during the first quarter, while rapidly progressing our commercial pharmacy contracts. We further advanced this process in the second quarter as expected, and we are excited to share that all major PBMs now cover Dexcom G7. This occurred much faster than we originally anticipated and brings our total number of G7 covered lives nearly in line with our industry leading G6 levels. This further strengthens our position as the most covered CGM brand as we prioritize keeping out-of-pocket costs low for our customers. As a reminder, the majority of our customers are paying less than $20 a month out-of-pocket in the pharmacy channel, which is significantly less than our nearest competitor where the majority of customers are paying greater than $70 per month. We are also seeing G7 play a very important role for us as we move more broadly beyond intensive insulin management. We've taken a big step in that direction this year following the recent CMS decision to significantly expand coverage beyond intensive insulin use. As of mid-April, Medicare coverage officially kicked in for people with type 2 diabetes using basal insulin only as well as certain non-insulin using individuals who have experienced hypoglycemia. This resulted in a true step change in coverage for the industry. As we estimate, these two populations represent around 6 million to 7 million people in the U.S with roughly half being of Medicare age. It has also been encouraging to see commercial payers quickly follow suit. We have already established greater than 60% commercial coverage for the basal population, which we view as a validation of Dexcom's value proposition by payers. We are thrilled to have this level of coverage established as quickly as it provides us much greater commercial flexibility to promote this opportunity. While still early, the initial response from the clinical community has been very encouraging. Physicians have wasted no time in prescribing Dexcom to their basal patients as they recognize a clear potential for better outcomes among this population. We have also seen excitement coming directly from members of the basal community who are interested in engaging with their glucose data to make more informed lifestyle decisions. As a result, we have seen a notable uptick in demand in our Medicare business. In fact, Q2 was our highest new patient quarter within the Medicare channel in the history of our company. Considering this was only a partial quarter of expanded coverage, we view this as a very positive sign of things to come. In our international business, our share gains accelerated in the second quarter as our ongoing access initiatives and product portfolio strategy have helped us reach many more people with diabetes across the globe. We expanded our international G7 launch in the second quarter into 6 new markets. G7 is being met with a lot of enthusiasm in our initial launch countries and we are excited to bring it to additional geographies in the coming months. This will include our launch of G7 into Canada where we recently received regulatory clearance. We have plenty of inventory on hand to support this broader rollout, particularly with our Malaysia facility now producing commercial product. Another key international lever for us has been our broader rollout of DexCom ONE. DexCom ONE has proven to accelerate our entrance into new markets, broaden access within existing geographies and even serve as a catalyst for reimbursement in certain regions. Perhaps most noteworthy this past quarter is that we officially launched DexCom ONE in Argentina, which marks our initial entrance into Latin America. We expect this to only be a starting point for us in that region as we continue to expand our global reach in coming years. Finally, we came away from the American Diabetes Association's 83rd Scientific Sessions as excited as ever about our future. This year's event added to the growing body of evidence demonstrating Dexcom CGM's ability to drive greater health and economic outcomes across the diabetes care continuum, particularly, we are seeing more data suggesting a clear use beyond the intensive insulin population and even outside of insulin use altogether. For example, our team presented a real-world study of more than 7,000 adults with type 2 diabetes who were not using insulin. After only 3 months, this cohort saw a 40% increase in time in range and a clinically meaningful improvement in A1c levels. Perhaps just as important was the high level of engagement demonstrated as study participants wore Dexcom CGM more than 80% of the time. This was consistent with what we have seen in other broader type 2 studies, including the MOBILE trial where we saw high levels of utilization and a clear desire to continue to our Dexcom CGM full time. During ADA weekend we hosted an Investor Day where we shared our latest vision around the future of Dexcom. As part of the day we increased our LRP, provided new detail on the size of our recent access wins and shared our plan to launch a product specifically for people not on insulin. With this product we will leverage our G7 hardware, but provide a custom software experience tailored to this broader population. We expect to launch early next year with a 15-day wear time and cash pay option. This will simplify access out of the gate for users as we build the case with payers for broader coverage. Importantly, this new product also provides a glimpse into our future where we expect to utilize software to build tailored experiences and serve much larger populations. As we said at Investor Day we're just getting started. With that, I will turn it over to Jereme for a review of the second quarter financials.

Thank you, Kevin. 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 second quarter of 2023, we reported worldwide revenue of $871 million, compared to $696 million for the second quarter of 2022, representing growth of 26% on an organic basis. As a reminder, our definition of organic revenue excludes currency in addition to non-CGM revenue acquired in the trailing 12 months. U.S revenue totaled $617 million for the second quarter, compared to $511 million in the second quarter of 2022, representing growth of 21%. We delivered another record new customer start quarter in Q2 with continued momentum in the U.S as our G7 launch gained additional traction and the recently finalized CMS coverage provided a new tailwind to our Medicare business. As Kevin mentioned, we continue to progress our commercial pharmacy coverage in G7 for the second quarter, which further reduced our need to utilize the bridge program. The impact from this program was negligible in Q2, and we expect this number to remain small going forward. With broad coverage for G7 now available across all channels, there will be fewer customers that need to leverage this program to access their product. International revenue grew 38%, totaling $255 million in the second quarter. International organic revenue growth was 40% for the second quarter. We have been executing very well in international markets as our ongoing access work and product portfolio strategy continues to broaden our reach. We have seen a robust customer response to this expanded access and have consistently taken share across our footprint in recent quarters. In fact, this marks the ninth straight quarter that we have gained international market share. The U.K continues to be a great case study for us. In the past year, we have significantly broadened our reimbursement in that market, seen new clinical recommendations around real-time CGM use, and launched our newest generation product. Following these events, we have experienced an acceleration in this market. And in Q2, we posted one of our highest U.K growth rates in recent years. We also recently expanded our connectivity leadership in this market, as Insulet extended their launch of Omnipod 5, which is powered by our G6 system to the United Kingdom. Given our long track record in the pump market with over 1 million patient years of cumulative experience and the forthcoming connectivity with G7, we expect to remain the clear CGM leader for the connected insulin delivery market. Our second quarter gross profit was $553.5 million or 63.5% of revenue compared to 64.6% of revenue in the second quarter of 2022. The year-over-year decline in gross margin was expected as we take a temporary step back to scale G7 production. It is worth noting that some of our expected ramp-up costs extended into the third quarter, which increased Q2 gross margin relative to our expectations. It takes some time for our new manufacturing lines to fully scale, but the cost profile of G7 will gradually improve as we increased production volumes. Keep in mind, our Malaysia facility recently initiated commercial production. So you should expect to see a similar dynamic occurring in the near-term as we scale those lines. Operating expenses were $395.1 million for Q2 of 2023, compared to $347.6 million in Q2 of 2022. At our recent Investor Day, we highlighted some of our key cost initiatives, which we refer to as cost to execute. This represents our ongoing framework of how we think about operational efficiency, and how we ultimately see cost as a growth driver for our business. Our second quarter operating expense management was yet another demonstration of our commitment to this program, as we generated over 450 basis points of OpEx leverage. We are very proud of this result, as we have continued to support our ongoing investments and our global commercial efforts. We know this will ebb and flow over time based on the needs of the business, but it should serve as a reminder of this organization's ability to scale. Operating income was $158.4 million or 18.2% of revenue in the second quarter of 2023 compared to $101.9 million or 14.6% of revenue in the same quarter of 2022. Adjusted EBITDA was $232.6 million or 26.7% of revenue for the second quarter, compared to $175.5 million or 25.2% of revenue for the second quarter of 2022. Net income for the second quarter was $139.4 million or $0.34 per share. We closed the quarter with greater than $3.6 billion of cash and cash equivalents leaving us in a very strong financial position. This significant step up relative to our Q1 cash levels primarily reflects the convertible bond offering we completed early in the second quarter. With our 2023 converts coming due later this year, we saw an opportunity to refinance at very compelling terms, which provides significant financial flexibility. This supports our ongoing capital deployment goals, with a primary focus on extending our organic growth opportunity. As we mentioned, we reached a key milestone during this quarter as our Malaysia facility began producing commercial product. This plant will quickly scale to become our largest operation and help support our long-term cost target of $10 per sensor. Turning to guidance, we are raising our full year 2022 through revenue guidance to a range of $3.50 billion to $3.55 billion, representing growth of 20% to 22% for the year. Our updated revenue guidance reflects an increase of over $65 million at the midpoint compared to our previous guidance. This reflects our strong start to the year as well as our expectation to carry this momentum into the second half of 2023. From a margin perspective, we are updating our full year non-GAAP gross margin guidance 63%, which represents the high-end of our previous guidance range. Our operating expense management has also left us well-positioned to raise operating and EBITDA margin guidance for the year. We now expect non-GAAP operating margin of approximately 17% and adjusted EBITDA margin of 26.5% for fiscal year 2023. With that, I will pass it back to Kevin.

Thanks, Jereme. Our results this quarter read like a highlight reel. Q2 was our highest revenue quarter ever and represented the largest year-over-year dollar growth in our company's history. We again delivered record new customer starts worldwide and gained market share in nearly every major reimbursed geography. Our G7 launch continued to be marked by excellent execution across the board. We've now introduced this product into 13 international markets and quickly built broad reimbursement in the U.S. Through our commercial efforts we are bringing new physicians into our ecosystem, and our manufacturing initiatives are driving process improvements ahead of expectations. Additionally, our R&D team has already enabled five flawless upgrades to our completely redesigned G7 app. In addition, we are growing in a disciplined and sustainable manner. We have delivered over 450 basis points of operating expense leverage, doubled our earnings per share year-over-year and posted one of the largest free cash flow quarters in our company's history. I'm incredibly proud of our team for delivering this level of progress. When you experience results like these, it makes our stated vision much more tangible. We are truly on a mission to help people control their health through continued innovation and execution. With that I would now like to open the call up for Q&A. We will also have Jake Leach, our Chief Operating Officer join us for our question-and-answer session. Sean?

Thank you, Kevin. 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.

Thank you. We will now take our first question from Danielle Antalffy with UBS. Your line is open.

Hey, good afternoon. Sorry about that. I didn't realize I was lowering my hands. So apologies for that. But good afternoon, everyone. Thanks so much for taking the question. Guys, we saw a really nice revenue acceleration across the business this quarter. But that OUS number really does stand out, looks like one of your stronger growth quarters internationally in a while. Can you provide a little bit more color on the sources of that international strength as you think about the key regions that you've entered and extending both the G7 and the Dexcom ONE launches across these different geographies? Thanks so much.

You bet. Danielle, this is Kevin. I'll take that. And it was a great international quarter. There are three things that have driven that international business for us. The first is the plan we launched several quarters ago to increase access across the board and make our product more accessible in all these markets. And we've seen results of that in all the geographies, particularly in Germany. Second of all, you can't underestimate the effect of G7 in many of these markets. We've launched in 13 countries, as I said, in our prepared remarks. G7 is going very well. The third piece is the portfolio strategy where we have Dexcom ONE supporting expansion into geographies where we haven't been before, and broadening access into countries where we already exist. Those three strategic efforts have helped us tremendously. I don’t know, Jereme, if you've got anything you want to add to that?

No, I think the only thing I'd say is, really across the board, all the major countries we're in where there's reimbursement, we're taking share. And it's a common theme you're really seeing in our portfolio approach really allows us to do that. So wonderful quarter. And thank you for the question.

We'll take our next question from Robbie Marcus with JPMorgan. Your line is open.

Oh, great. Thanks for the question and congrats on a really nice quarter. Looks like you guys raised guidance for basically 2x the size of the beat in the quarter. So I'd love to just hear where the confidence is coming from? How to think about U.S., U.S growth in third and fourth quarters as we progressed and where that upside in guidance is coming from? And any color as it relates to type 2 basal within that guidance range? Thanks a lot.

Sure, Robbie. Thanks. This is Jereme, and I can address that. You’re correct that we raised our guidance, which reflects the strength we’re observing outside the U.S., along with some coverage and access successes we've achieved domestically. This is all supported by the launch of G7, which, as you know, is our most precise sensor and something we are very pleased with. If you consider the geography, the first half of the year will somewhat mirror the second half. That’s how the split will work, and you’ll see that. We anticipate a more challenging comparison in the U.S. during the latter half of the year, particularly compared to the second quarter, and we've taken that into account. We're also mindful that growth outside of the U.S. should continue to be strong, but we need to be cautious as we expand into new markets. Regarding the U.S. market, basal is a significant driver, and while we're not providing a specific number for basal, it is starting to integrate into our core business thanks to the coverage we've secured. You might wonder if there's further opportunity. We've given guidance based on our base case and have increased our confidence in that projection, which should be evident. Naturally, we aim to exceed those expectations as time progresses.

Great. Thanks a lot.

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

Thank you. Good afternoon, everyone. Jereme, I’d like to follow up on your comments regarding the U.S. and the basal only situation. Over the past four to five years, your U.S. revenue has usually increased sequentially from the first quarter to the second quarter by about $60 million to $70 million. This quarter, however, saw a $90 million sequential improvement. Can you specify whether half or a third of this increase was attributed to basal? I understand that we only had a partial quarter contribution, but could you provide some qualitative insight into how much of this larger-than-usual improvement was due to basal? Additionally, has there been any progress on basal only in France? I know your competitor has made advances, and I believe you were also working toward this. Any updates on basal only coverage in Europe would be appreciated. Thank you.

Sure, Jeff. In the U.S. during the quarter, there was a relatively small contribution from basal in Q2. However, we had a strong addition of patients, which aligned well with coverage starting in April, particularly in the DME channel. It typically takes three to four weeks to gain access to the product, so the contribution will gradually build throughout the year. While there was some contribution in the quarter, much of it was driven by gaining market share in existing areas, and we take pride in that achievement. Regarding France, we anticipate launching Dexcom ONE soon, and we expect a strong coverage model there. I won't go into specifics, as we are in the midst of that process, but we expect comprehensive coverage to compete effectively with our competitor. We have demonstrated that in markets where we have coverage, as seen in our international growth over the past nine quarters, and we are confident in capturing our fair share in that country once we launch.

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

Good afternoon. Thanks for taking the question. I guess, Jereme, let me ask on the guidance. I mean, it looks like you're guiding to about similar growth in the second half as the first half. One would think and the comps aren't too different when you look at it first half versus second half last year. And one would think that you have tailwinds, pricing coming down, the ramp of basal and G7. Is there anything you're seeing that that's concerning? Or is this conservatism and just if you could comment on just cadence, should we expect typical seasonality? Thanks for taking the question.

Yes, there's nothing that concerns us about the latter half of the year. I'll start with that. Given our record quarter and new patient numbers, we are confident in our outlook. We anticipate a strong second half of the year and have raised our guidance at the midpoint by over $65 million. There are no obstacles in our way. We have reduced the risks associated with our base case, which now reflects expected growth of 20% to 22%, along with a record number of new patients in Q2. We are optimistic about the upcoming months but are being cautious as we introduce the new basal product. If we surpass our expectations, we will share that information. In terms of timing and seasonal trends, we expect Q3 to follow a similar pattern to last year, at least from a global perspective. I anticipate that this seasonal trend will continue for the remainder of the year, resembling the patterns observed over the past two years.

Thank you.

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

Thank you. Is there a way to quantify the contribution of Dexcom ONE in the quarter outside the United States? I'm trying to get my head around the international growth, how much of that is coming from Dexcom ONE? How much from G7, if you can share? And then maybe some of it is from the opportunity to partner with insulin pumps, like walk me through that, please? Thank you.

Joanne, this is Kevin. We don't break those numbers out. But our growth comes from all of the above. Certainly Dexcom ONE has benefactor in those countries where we've launched it, but we haven't launched it in all of our international geographies yet. Our launch, as Jereme said earlier, we're about to launch in France. We just announced we're kicking off in Latin America here in Q3. And we've launched in a few other geographies, in those geographies it's doing well. G7 has been a strong contributor, particularly in the U.K and Germany, where those launches are more mature. And our pump partners, particularly as automated in some delivery reimbursement has broadened in some of the geographies. That's helped us tremendously. Our direct efforts in Australia where we acquired our distributor that distributor has performed extremely well and they've taken good share in the Australian New Zealand markets, in addition to that. So I mean, it's a blend of all the factors we talked about on the call.

Yes. To clarify some of our previous comments, we mentioned that about a third of our new patient starts come from Dexcom ONE, and that business has been growing throughout the year. Given that a third of the new starts are from Dexcom ONE, you can infer that most of the new patient starts are from the G series. While we don't specifically separate the two, we are aware of the numbers. The main takeaway is that it's a series within a platform, and the majority of the growth is indeed from the G series, consistent with what we've historically stated, and there have been no changes to that.

Thank you.

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

Thank you for the question. I have a follow-up regarding international growth and a quick inquiry about your promotional efforts for market development and brand awareness, particularly your advertisements on television and elsewhere. I'm curious about how you assess the effectiveness of those campaigns and their duration, whether in the U.S. or internationally. Additionally, regarding the international growth questions, could you remind us if there has been any stocking in new geographies? As you expand into new areas, are there aspects we should consider that might not be repeated in the next quarter or the following one? Thank you.

Hey, thanks, Matt. Thanks for the question. And I'll start with the second one first, and we can circle back. No, no significant stocking anything along those lines. This is really driven by robust patient growth. And so I think it's just taking share, deriving access and ultimately entering into these markets. In terms of your first question around promotional activities, we always look at what works. We use various versions of mixed marketing, mixed sales models to ultimately determine the effectiveness, and the return on investment of those and then how the response curves work. And Terry and the commercial leadership team, they do a wonderful job assessing that spend, looking at what makes in and then pivoting as needed. And so what you can expect to see is, there will always be mixes over time, but they will change. And so we’ll have campaigns, they'll change, they'll change based on what works best and we'll continue to learn from those. And so I would expect to see continued promotional materials. I'll continue to see demonstrating why we think Dexcom is the right product for folks and making sure that they know that we are the right product for them. And so I think you are seeing good feedback, we are seeing great returns. I mean, at the end of the day, what you see is record new patient quarters. And you see that in our acceleration of growth in the quarter. So that's what we'll continue to do. That's what will invest. I don't know, Kevin, any other thoughts on promotional materials?

I believe our promotional materials are ongoing and will develop further throughout the year as we have more to showcase and tailor our messaging to various markets. I feel our commercial initiatives have been quite successful. However, we are closely scrutinizing everything as we prepare for the upcoming years. This is not just a short-term focus for us.

And we will take our next question from Travis Steed with Bank of America. Your line is open.

Hey, Jereme, thanks for taking the question. I guess just wanted to clarify on the basal guidance. Before it was like 1.5% of total revenue for the year. Is that changing at all or moving? And what's a fair way to think about a full year of basal? So we think about that exit rate and multiplying it by fours, just thinking about kind of a full run rate for basal. Thank you.

Yes. So, Travis, it's interesting. So we're not going to give a specific number on basal anymore, just because it's now really folded into our business. There was a time when we said, hey, look, we have CMS coverage and we don't expect Medicare Advantage to come that fast, or we think commercial is going to take a little bit longer. And it's happened much, much faster. So now it's just really part of our core business. To your question, though, is it greater than 1.5%? Absolutely. It's part of the reason we raised the guidance. It's part of the performance in the quarter. And so you'd expect it to be higher than that. The way I would think about it is just now about any other patient really population where you ultimately want to analyze it, you'll think about attrition. So far there's been no differences in terms of attrition from the basal population that started today to our core population. And I think you start to annualize that exit rate and that's the way I'd apply it and going forward. And then of course, new ads. So I think you're thinking about it the right way, Travis and then in terms of is it greater than 1.5%? Yes, it is.

Okay. Thank you.

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

Hi. Thank you for taking the question. I just wanted to ask you one about the competitive environment. Basically, ask if you are seeing anything change in terms of share or pricing, anything else notable there that we should be aware of?

We have been clear about our market share position. Let me emphasize it again. In all major geographies where reimbursement is applicable, we have been gaining market share, and we have achieved this across most of these areas this quarter. We are performing very well. The G7 has been received positively as we intended. Most of our G7 users are new to Dexcom. There has been increased awareness among physicians now that they have this simple yet high-performing product. Our pricing trends show that our margins remain strong and our pricing levels are where we want them to be across all channels. We have communicated these points clearly, and there are no other changes to report.

Great. Thank you, Kevin.

And we will take our next question from Margaret Kaczor with William Blair. Your line is open.

Hey, good afternoon, everyone. Thanks for taking the questions. I wanted to maybe focus a little bit longer term and talk about basal adoption trends. Historically, I think even your math just the same as coverage has expanded for intensive insulin users. We've seen like this. 1,000 basis points plus of kind of incremental market adoption, at least by our math. I know it's early at this point, so you guys are being a little bit hesitant to get ahead of yourselves. But how do you compare, I guess the early weeks or months in basal right now versus what you saw when commercial coverage had opened up for intensive insulin users? And then longer term, why shouldn't we see that same level of patient acceleration in basal? I know it's a different market, but especially as commercial coverage is maybe come on faster than it did in those markets at that time. Thanks.

Margaret, this is Kevin. I'll take it to start. And if the other guys have more to add, they can. I think as I've traveled about and spoken with physicians and stuff, we've learned a lot about basal, just launching. Just the journey of a basal patient, they've been on other meds for quite some time and that step to call on insulin is a big step. And it's a step that they've in many cases been afraid of for a long time. So providing this group with information necessary to truly manage their condition and to see that they're getting the right dose to see that what behaviors they need to use to try not advance their type 2 diabetes is fast, we think there is a tremendous market here. And I think the reception and all fairness has probably been even warmer than I thought it was going to be, just as I've gone and spoken with people. We're also at a different point in time as far as CGM adoption and CGM awareness in general, as CGM is much more accepted than it was when we launched in other markets. Even from a distribution perspective, when we got Medicare approval the first time, I don't want to take you all back, but a Medicare patient couldn't use the phone app. When we got Medicare approval back in 2017, if they did, we had to give all the money back to CMS, we couldn't even get distributors to take our business. So that environment is all much, much more positive than has been before. The flip side of this is, it's new, there are a lot of them and there is still education to do and quite candidly, we're with a different physician group, because these people are usually primary care. While we've done everything we can or we think we've done a good job expanding into that market, we know there's more work to do there as well. So we're cautiously optimistic. We've seen great results so far. We've heard great things from the patients who use it. But it's just going to have to build over time. We considered all these things as we've looked at that market.

We'll take our next question from Matthew O'Brien with Piper Sandler. Your line is open.

Good afternoon. Thanks for taking my question. I would just love to hear a little bit more about G7 specifically. Those 8,000 new prescribing clinicians here in the state, can you talk about the composition of those between PCPs and then existing endos that are higher volume folks. And then internationally, I know, Jeremy, you said historically that G7 is a product where you're actually getting patients away from your competitor. Is the trajectory changing as far as that dynamic as far as getting patients away from your competitor? Just looking at that international number in the quarter. Thank you.

Thank you for the question. Regarding the 8,000 prescribing physicians, the majority are primary care physicians, many of whom had been prescribing continuous glucose monitors (CGMs) previously. The change we are experiencing is largely due to our competitive advantage. These physicians are recognizing the benefits of G7, including its ease of use and the expanded coverage we've developed over many years. This is driving significant change. Internationally, as noted by both Jake and Kevin, over half of the patients are new to CGMs, with a considerable number being switchers—not necessarily new to CGM but new to Dexcom. Many are expressing that this is the product they have been waiting for. We believe our performance in international markets is strong, with both new CGM patients and those switching to our products. We're very excited about this growth. We've been enthusiastic about G7 for years, and it seems the market feedback reflects that excitement.

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

Good afternoon, everybody. Thanks for taking my question. Wanted to ask on the PCP channel? Are you encountering any friction points in those offices above and beyond what you may have expected with basal? And I guess conversely, is there anything you anticipated would be challenging that, that may be playing out less challenging? And also, I'm curious, is your PCP sales force finding a meaningful number of type 1s in that channel? Thanks.

Yes, this is Kevin. The challenges we are facing are the ones we expected. The primary challenge, especially in the Medicare environment, is gathering documents and ensuring they reach the right distribution channels to serve these patients. Most of them go through the DME channel rather than directly through Medicare. Document collection, particularly in a primary care physician's office where not all patients with diabetes are seen regularly, is key. However, we anticipated this issue and have worked closely with our distributors to streamline the process. They have done an excellent job helping us get our products out and supporting our growth. As mentioned earlier, we have the largest cohort of new Medicare patients ever, and all of them went through distributors, which is a positive indicator for us. Overall, things are pretty much going according to plan. We do not have a dedicated primary care physician sales force; instead, our representatives have specific geographic territories and engage with both specialty diabetes clinics and primary care physicians. They manage their territories effectively and know whom to target, spending most of their time on the right accounts. They do a great job of driving the business forward.

Thank you.

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

Hi. Thanks for taking the questions and congrats on a great quarter. I wanted to ask my question here, we learned recently about a competitor's DTC launch. I think in the U.K have a wearable to monitor glucose for people without diabetes, more of a lifestyle sort of tool with Dexcom device for non-insulin users coming next year, any early thoughts on how your device will be differentiated? Whether that's features pricing, how you're targeting that market?

Yes, this is Jake. We're really excited about this new product that we're going to introduce specifically for non-insulin users. It is designed to meet the needs of those who aren’t using insulin but are trying to manage their glucose and improve their health. The features are tailored to their needs, focusing on connecting diet and exercise to glucose levels. Continuous Glucose Monitoring is the only tool that provides real-time feedback, and we're enthusiastic about its potential in this market. While we may expand the patient segment for this product over time, our initial focus is on type 2 non-insulin users.

All right.

In terms of pricing, there's a time and place for that discussion, but today isn't the best opportunity to share details. We want to keep some information under wraps until we get closer to the launch date. However, I want to express how truly excited we are about this; it's an incredibly exciting time for everyone at Dexcom.

And we will take our next question from Jayson Bedford with Raymond James. Your line is open.

Hi, good afternoon. And maybe just to follow-up on the last line of questioning, I think you mentioned that you're going to launch the non-insulin device early next year, which I think is kind of newish at least on timing in '24. Have you run a trial for the device? And I assume you'll file late this year or every file?

Yes, thanks for the question. Yes. So it's important to note, right, that product is a 15-day product or non-insulin product. And we have completed a clinical study on the G7 platform, showing survivability out to 15 days with great performance. We met the ICGM criteria in that study. And so that study is going to be used for the submission of that product. So that's why we're confident in our ability to say we're going to launch that product next year.

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

Thank you. Hi, everyone. I wanted to ask about basal and broader type 2 opportunity outside of the U.S., particularly in the EU, certainly another big opportunity. Are the new pieces that you were putting in place with G7 and Dexcom ONE enough to really go after penetration of that patient population, or are there additional reimbursement efforts needed there as well?

The access strategy is constantly evolving, which is why we have our product portfolio. In certain geographies, Dexcom ONE will definitely be our main product. We target the basal population in these areas, while in others, if reimbursement is sufficient, we can utilize the G series, analyzing each market individually. In some regions, we assess the situation state by state, determining the best product from our portfolio to ensure access and coverage. We are confident in our products to achieve this. The Dexcom ONE platform will soon transition to the G7 platform next year, marking a significant advancement for us. As we look ahead and extend the lifespan of our sensors, we will have increasing international opportunities. Our portfolio is well-equipped to tackle these challenges, though we still need to navigate the process of submitting paperwork, making bids, and meeting the right people to build our access team over time. This infrastructure has been developed over the last several years. Additionally, it’s important to note that many products outside the U.S. are available over-the-counter, meaning a prescription isn't always necessary for purchase, although it is essential for reimbursement. As new targeted products emerge that can be utilized more freely, we will find ways to adapt with the right design and features. As Kevin has mentioned, we believe we have the right portfolio, products, and software to be highly effective in those markets.

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

Hi, good afternoon. I was hoping to just better understand how you've had success kind of driving the average out-of-pocket costs for patients prescribed with G6, G7, down to $20. And is that something that you can market or have been marketing to patients or physicians? And is that been a driver of share gains in the US? Thanks for taking the question.

It certainly has been a driver of share gains in the U.S because we're, again, our focus is on that customer. And as we go for the lowest cost per customer, that's what we do, we do everything we can to keep that co-pay down. In some cases, it depends on the payer, the insurance company what the arrangement is, but we also are able to maintain a premium price due to the strength of our product and due to the fact that it provides such great outcomes and such good retention. Our retention rates are better than they've ever been as far as people saying our product and using it, and we know when people stay on the product, they're healthier. There's clinical data coming over the next several months from studies. This going to show that that extended use of CGM over time leads to just much better extended health. So you combine all those factors, the fact that patients stay in our product, the fact that it produces great outcomes, the fact that those outcomes are documented. We can go and command a lower co-pay. And we can go really position ourselves to do well. Now because of that you have to go through again, the access games or the access infrastructure that various payers play. One of our key initiatives right now is working on pre-authorizations into it, we have to keep those to make sure those are electronic to take that burden off the heads of the physicians' offices who prescribe our product, that's probably our biggest hurdle as far as ease of reimbursement right now. But we're working to do that as well. And we have very aggressive goals on that front over the next year. But the product and reputation and outcomes of Dexcom when able to do enable us to do that. One of the things we've talked about over the years is our strategy was to look at ways to get covered products make the easier burden longer term, I mean, think about people impacted by diabetes, there's already a significant burden on those individuals. And now you add in a large co-pay, that's a challenging things we've really worked on coverage. It's something we've known is out there, and it's something we worked on, and you're seeing it play through where us working very hard on coverage relative to that of perhaps our competitor has really driven us to be in a position where we can help patients better, longer term, because this is a long-term challenge. We want to be there throughout that.

Thank you.

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

Hi, good afternoon. Thank you for taking the question. My question is the non-insulin product that's going to launch next year, the 15-day sensor. In 2024, is this largely, is the base case expectation that this is a cash pay model in '24. And then over a multi-year period, there might be some uptake into traditional insurance channels or would you expect that next year? You will have kind of early at risk insurance coverage for this concept?

Yes, sure. I'll take that one. So yes, primarily, an initial launch, it's going to be cash pay. We do feel though, we're targeting this, this segment of customer. There's 25 million people in the U.S who fit into this category of with type 2 diabetes that are on insulin, so we feel a real opportunity to provide them with better outcomes. And we do feel that this product is specifically designed for this group can produce an outcome that a payer will pay for over time. But we got to generate that evidence in that population. We're starting to see evidence of CGM in that population and the benefits that can provide we feel like this custom tailored product is going to do a great job at delivering the outcomes that we're going to need. So it's going to take a little time. But we do feel that this is a place that ultimately will be reimbursed.

And this concludes our question-and-answer session for today. I will now turn the call over to Mr. Kevin Sayer for closing remarks.

Again, thanks, everybody, for participating on our call today. Just in wrapping up, I want to acknowledge all the great efforts here at our company, our commercial team around the world has had an incredibly successful G7 launch, not only in getting product out the door, but driving access, make it available, everything that we've asked them to do, we've done faster than we planned. And we're just very appreciative that our operations team has not missed a beat from supply chain and microchips and G6 manufacturing in addition to G7 along the way, our engineering team, this product is performed the way we wanted it to. It's done very, very well. They continue to work on making it better. We talked earlier about our app performance software is not just an add on, it is difficult. And those five upgrades of the app in this quarter. Seamless and delivering people better features every time. You can go through the entire organization, even the bond Offering this quarter. Kudos for that team. It is a great time to be here. And as I said earlier, in my prepared remarks, we're just getting started. And that's how we feel about things. So thanks, everybody for participating on our call today and we look forward to talking to you again soon.

Thank you ladies and gentlemen. This concludes today's conference. And you may now disconnect.