© 2024 Alpha Spread Limited. All Rights Reserved.
www.alphaspread.com is not operated by a broker, a dealer, or a registered investment adviser. Under no circumstances does any information posted on www.alphaspread.com represent a recommendation to buy or sell a security. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute, investment advice or recommendations. The information on this site is in no way guaranteed for completeness, accuracy or in any other way. In no event shall Alpha Spread Limited be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or available on www.alphaspread.com, or relating to the use of, or inability to use, www.alphaspread.com or any content, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Past performance is a poor indicator of future performance.
You don't have any saved screeners yet
Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
My name is Michele and I will be the operator for today’s conference. [Operator Instructions] As a reminder, today’s conference is being recorded. I will now turn the call over to Mr. Kevin Sayer. Sir, you may begin.
Thank you, operator. We apologize for being a bit late today. We have had some difficulties with our conference call service provider here, but we are up and running now. And we are excited to talk about a good quarter.
I am going to turn it over to Sean. Sean?
Thank you, and welcome to DexCom’s first quarter 2022 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 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 performance on the DexCom 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 strong first quarter results with organic revenue growth of 22% over the first quarter of 2021 or 23% on a constant currency basis. Demand for DexCom CGM remains very high globally across all of our customer segments. We have also seen a nice rebound in customer growth throughout the first quarter with new customer starts ramping after the Omicron wave and ultimately meeting our expectations for the quarter.
As many of you know, we have significantly scaled our business to drive demand and greatly expand the number of people with diabetes that we can serve globally. This scale goes beyond manufacturing capacity, extending to the efficiencies that we can bring as we serve customers and clinicians. Our relentless focus on meeting the needs of our customers continues to be validated in our results.
In the first quarter, our net promoter scores for G6 remained near record levels, with customers also indicating that the strategies and tools that we have implemented are simplifying their experiences with DexCom. The teams have driven several innovations that may not always draw the attention of our investors, but they are critically important to the experience of our customers. For example, our customers rely on DexCom to make dozens of decisions each day and therefore, a reliable supply of DexCom CGM is critically important.
In the first quarter, we established new records for on-time shipping for commercial orders and timing of replacement systems at 99.7% and 99.9% respectively. We are especially proud of this result given the challenges of current global supply chain dynamics. Product supply should never be on the minds of our customers and our operations team is making sure that this is the case. These efforts are delivering results in our performance as both retention and utilization levels have steadily improved since the launch of G6, reflecting a competitive strength as we engage with clinicians and payers on the value of our CGM systems. Building on this momentum, we are thrilled to now be underway with the initial launch of our G7 CGM system.
G7 builds upon the best-in-class G6 experience with a form factor that is 60% smaller with the reduced environmental footprint, a streamlined set of experience, including a 30-minute warm-up time, an improved app experience with CLARITY integrated into the core app and all of this with accuracy that improves upon the reliable performance that is a hallmark of DexCom CGM technology. Following the receipt of CE Mark for G7 in March, we initiated our limited launch of G7 in the UK in the subsequent weeks. During this brief window, we are assessing the functionality of the sensor and app in the real world and gathering initial feedback from our users, which has been very positive so far. Our plan is to extend the G7 launch to a steady cadence of additional international markets over the remainder of 2022 with a growing impact to our overall sensor mix in the second half of the year.
In the U.S., our 510(k) submission for the G7 sensor, receiver and Android and iOS apps remains under review. We are in the traditional back and forth that comes with these processes. And we appreciate the FDA’s ongoing attention to their view even as they juggle a very busy schedule. In the meantime, the teams are busy preparing for a seamless transition once G7 is available. This includes preliminary discussions with payers to drive market access, where possible in advance of approval. It includes significant preparations from our operations team to add incremental G7 lines in advance of the launch to support the expected ramp in demand. And it includes ongoing work with our insulin delivery partners to ensure that we are progressing towards the goal of connected pump and insulin pen systems that are integrated with our latest sensor technology.
As we progress with the launch of G7, we continue to pursue creative solutions to expand access to our CGM technology and bring the value of real-time CGM to people who previously faced limited options for diabetes management. Beyond G7, we recently introduced DexCom ONE in Spain, which is the newest of our direct markets and will launch DexCom ONE in the UK shortly. These represent the first dual product markets for DexCom, bringing two excellent options for real-time CGM to customers and their respective health systems of these countries. We expect this dual product strategy to significantly expand the number of people with reimbursed access to our CGM technology, broadening our growth opportunity in these countries as well as additional countries where we plan to bring DexCom ONE in the future. And geographic expansion is only one element of the significant growth opportunity ahead for DexCom.
In the first quarter, we were also pleased to receive breakthrough device designation from the FDA for the CGM system that we are working to develop for use in the hospital setting. The breakthrough designation represents the FDA’s recognition of DexCom’s potential to offer a more effective solution for glucose management and patient outcomes in the hospital relative to the current standard of care. This recognition is designed to expedite the regulatory pathway as we continue to build evidence for the safety and impact of DexCom CGM in the inpatient setting.
As you can see, we have a busy year plan as we navigate some of the most exciting launches in DexCom history and build out the foundation of growth for years to come. The foundation for long-term growth emerges from the core values that motivate us and the noble mission that our employees embrace to drive greater health outcomes throughout the world. Along those lines, we are pleased to publish our third annual sustainability report shortly after the conclusion of the first quarter. This report demonstrates our commitment to our stakeholders and details some great progress in our reporting efforts, including the publication of our first SASB Index, which is the reporting framework we find to be most preferred among our stakeholders.
We also added updates to our efforts to drive access to our CGM technology globally via a comprehensive strategy that involves product differentiation, leveraging scale and demonstrating robust clinical outcomes. And we enhanced our disclosures around the composition of our workforce, employee engagement metrics, climate-related disclosure. And we are still early in our journey and these updates provide just a glimpse of the many things that made DexCom a company that I am truly proud to lead.
With that, I will turn it over to Jeremy for a review of the first quarter financials. Jeremy?
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 first quarter of 2022, we reported worldwide revenue of $629 million compared to $505 million for the first quarter of 2021, representing growth of 25% on a reported basis and 26% on a constant currency basis. Organic revenue, which excludes non-CGM revenue related to last year’s acquisition of our distributor in Australia and New Zealand, was 22% or 23% on a constant currency basis.
U.S. revenue totaled $451 million for the first quarter compared to $381 million for the first quarter of 2021, representing growth of 18%. As Kevin mentioned, we saw a nice reacceleration of new customer starts over the course of the quarter, coinciding with improved access to healthcare providers for our sales force as the impact of Omicron waned. Our team continues to do a great job expanding the DexCom prescriber base and making sure that these clinicians are aware of the DexCom stories and the benefits of our system, leaving us well-positioned to extend new customer growth both now and well into the future.
International revenue grew 43%, totaling $178 million for the first quarter. Organic revenue growth, which excludes the non-CGM revenue related to our distributor acquisition, was 33% for the first quarter. These international results include approximately $6 million of unfavorable impact from foreign currency or approximately 4% impact to our international growth result for the quarter. We continue to see very good international momentum as we broaden our commercial footprint. This includes the recently announced expansion of our DexCom ONE rollout that Kevin mentioned as well as additional access wins that have expanded our addressable market beyond the improvements that we achieved in 2021.
As we mentioned earlier this year, following the successful launch of DexCom ONE late last year, we saw two of the four regions we serve to establish reimbursement starting in the first quarter. We have also secured reimbursement for DexCom ONE in Spain in conjunction with our launch this month and are hopeful to have DexCom ONE added to the UK drug tariff shortly.
In Canada, we secured provincial coverage for people with Type 1 diabetes in Ontario. With this addition, DexCom has now established coverage for 7 provinces, representing greater than 93% of the Canadian population. Our first quarter gross profit was $398.1 million or 63.3% of revenue compared to 68.1% of revenue for the first quarter of 2021. Our first quarter gross margin reflects the traditional step down that we see from our fourth quarter as we see a greater mix of pharmacy revenue and less contribution from our DME customers with high deductible health plans.
We also took a write-off of some obsolete G5 inventory in the quarter as Australia, previously the largest remaining G5 market in the world, as it added G6 to its CGM subsidy as of March. With this update, we are now able to fully transition the Australian market to G6, something our customers have long awaited. That impact, combined with a one-time impact related to facility damage, impacted our gross margin for the quarter by 100 basis points. Our teams are doing a good job leveraging our significant volume growth and operational efficiencies to offset the inflationary environment, allowing us to remain on track our full year margin expectations as we continue to advance our G7 launch.
Operating expenses were $347.8 million for Q1 of 2022 compared to $297.5 million in Q1 of 2021. Despite ongoing investments in our commercial infrastructure, including the final quarter that includes incremental impact from our U.S. sales force expansion in 2021 as well as preparation for the G7 launch and pre-commercial G7 development costs that remained in our R&D expense, we still saw first quarter operating expenses as a percentage of sales decrease by 360 basis points compared to the first quarter of 2021. Operating income was $50.3 million or 8% of revenue in the first quarter of 2022 compared to $46.4 million or 9.2% of revenue in the same quarter of 2021, with the Q1 channel mix dynamic offsetting the operating leverage we continue to drive across the business.
Adjusted EBITDA was $112.4 million or 17.9% of revenue for the first quarter compared to $94.4 million or 18.7% of revenue for the first quarter of 2021. Net income for the first quarter was $32.3 million or $0.32 per share. We remain in great financial position as we closed the first quarter, with approximately $2.7 billion of cash and cash equivalents. This gives us the flexibility to support our ongoing organic growth investments, including the scale-up of our Malaysia manufacturing facility and global commercial infrastructure, while also being opportunistic to look at strategic options that accelerate our long-term growth potential through either our ventures unit or M&A.
Turning to guidance. We are pleased to be in a position to reaffirm our full year 2022 guidance for revenue and margin. This includes total revenue of between $2.82 billion and $2.94 billion, gross profit margins of approximately 65%, operating margins of approximately 16%, and adjusted EBITDA margins of approximately 25%. This guidance continues to factor in our strong customer growth momentum for our CGM platform, whether that is G6, DexCom ONE or G7, with approximately $15 million to $20 million of incremental currency headwinds versus our previous expectations. We are focused on meeting the complex operating environment and global inflationary pressures head on, with our teams committed to driving efficiencies and operating leverage for our shareholders.
With that, I will pass it back to Kevin.
Thanks, Jeremy. As you can tell, there is no shortage of exciting things underway at DexCom and we look forward to providing updates as they come throughout the course of the year. I would now like to open up the call for Q&A. 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. Operator, please provide the Q&A instructions.
Thank you, sir. [Operator Instructions] The first question in the queue comes from Jeff Johnson. Your line is open please proceed.
Thank you, good afternoon, guys. Thanks for taking the call. I tend to focus on your top line, but, Jeremy, I think I want to start maybe on a gross margin question, if I could. With the gross margin down to 480 basis points, it looks like G&A was up about $16 million year-over-year. I’m assuming that was largely driven by the G7 new manufacturing lines, if you could just confirm that? Obviously, you broke up the 100 basis points on the Australia write-off and the facility issue. That would still put gross margin down about 100 basis points year-over-year adjust for all those factors. Is that just some of those channel mix headwinds? Is there any other core pricing issues going on? Or what else is impacting on that other 100 basis points seems to be left over in my math? Thanks, guys.
Sure. Yes, no problem. And I can certainly give you some of the context in terms of that impact. There is a couple of other smaller pieces of gross margin. So we will first recap. We had about 50 bps associated with the impact we had at our facility, and that will be recovered via insurance on the balance of the year. So that’s certainly a temporal thing. We certainly talked about the G5 and, again, that’s a temporal thing as well as we have more folks on G6, that certainly will bode well for the balance of the year on margin. The other couple of pieces in there. There were some impacts associated with one-time use sensors. These are warranty sensors. It’s actually a good thing. They expired, and they expired because our warranty rates continue to come down. And so for the quarter, certainly, we had to take a charge for those. But for the balance of the year, we expect our warranties to do better. That was about 50 bps as well. So some of that is the equation you’re looking at. And there was a little bit of an impact of currency as it flows through. There is about 30 or 40 basis points of currency as you push that through. The remainder of that, and this will push you above the 65% number, is associated with mix and we talked a little bit about it in the prepared remarks. As more and more of the mix in Q1 is tilted towards pharmacy and more folks go through the pharmacy, there is a little bit of pressure as you have less DME in the first quarter. We expect that to normalize over the balance of the year, and that’s historically why you had that step back. As more and more goes to the pharmacy in the first quarter, you just get a little bit of a dynamic from that point of view from a gross margin perspective. But nothing pricing wise, nothing that would expect us to change the full year. In fact, that’s why we reiterated the full year gross margin. We certainly expect to get there.
Thank you. The next question in queue is from Danielle Antalffy. Your line is open pleas proceed.
Hi, good afternoon, everyone. Thanks so much for taking the question and better late the never right. So, just, Kevin, I’m curious, we’ve done a lot of work recently on CGN and adoption beyond the Type 1 patient population. And as I say, one of the things that has been very surprising is that they are still – even with the Endo community, some holdouts on Type 2s and whether the burden of therapy offsets the benefit you get from the CGM. And I know this is a high-level question. But I guess I’m just curious about what you think the right strategy is to get those people over the hump here? You have data. You have coverage for non-insulin intensive Type 2. So where to from here with these types of folks, which, I’m surprised, quite frankly, exists at all, but they do, I guess.
Well, we could take the rest of the call time, Danielle, and talk about this because it’s something we talk about a lot. Let’s get to the starting point, and that’s the evidence. The fact is over and over again. Every single time we use CGM and run a study in this patient group, people have much better outcomes than they had before. Getting the data from CGM absolutely changes people’s lives and their view of their health, and they make changes because they have feedback that gives them something exactly as to what they should do. We also need to remember that this group of patients, this Type 2 patient who is not on insulin, most of them don’t see endocrinologists or people that are always in the diabetes community, they see their primary care doctors. So we have to come up with a set of tools. It will make it very easy for that position and for this whole group to engage with CGM. Let’s take another look at some of the dynamics going on here. CGM, over time, the cost of CGM has come down, but the cost of these drugs has not come down. The cost of these drugs is very high. What a great way to titrate a new GLP-1 then to have somebody with a CGM to say, hey, this is helping you. This is the right dose. This isn’t the correct dose. It’s going to play a vital role in that space, and it’s going to be a very cost-effective solution for patients in that space, and it’s going to be cost-effective for all the payers.
We need to continue to push for reimbursement. Things really don’t grow until they are covered, but we have some very aggressive plans with our partners in the other programs. We have plans of our own. And quite honestly, the feedback we get from the individuals who do get coverage for this, like I said, it’s phenomenal. And none of them write me an e-mail or none of them say, I’m doing better because I’m on a new drug. They attribute their improved health to the CGM and the information that they have and the changes they have been able to make. So we remain bullish on this, but it does take time. I remember the first right along I ever did when I came here years ago, and I asked every doctor I visited, when you put a patient on CGM only after they have been on a pump for a few years because they are not serious about diabetes unless they wear a pump. We will look how that’s changed. We can change the other equation too. We just need a little more time and a little more evidence.
Yes. And when we read the study, Danielle, will certainly understand the questions you’re asking out there. If you were winded the results you got from that, say, 2 or 3 to 4 years ago, it would have been a much different outcome as well. And I think you’re just seeing that the recognition of this technology over time moves. But we do have to move people off of preconceived notions or the questions around the advancement of technology through education and awareness. So it’s a continued focus there. And again, it all kind of aligns to all the work we did last year around expanding the sales force, direct-to-consumer advertising, really getting that education and awareness out there. We have to continue to do that, and that should help us over time.
Thank you. And the next question in the queue comes from Robbie Marcus. Your line is open please proceed.
Great. Thanks for taking the question. Maybe if I can ask, in the U.S. business in fourth quarter, you talked about how you had difficulty accessing primary care channel. First quarter growth in the U.S. came in a little lighter than we would have expected. Maybe just talk about trends there and then conversely talk about some of the early responder trends and feedback you’re getting on G7 in Europe? Thanks.
Sure. Yes, I’ll take the U.S. question, Robbie, and then Kevin can certainly cover the early feedback on G7. So in the U.S., and we talked a little bit about this as we kind of rounded out the year last year, in December – certainly, in December, we saw the impact of Omicron and that continued pretty heavily into January in terms of getting out there and getting in front of prescribers. And so as you kind of look through the quarter, the way the quarter worked out was you had a kind of a lower January. And as the quarter progressed, each month got a little bit better as things really opened up. And so what we saw was exactly that is January was a bit tough. February was better and March was even better than that. And so the momentum continues in the right way, and that’s the way I think we think about it. And so it played out a little bit how we expect when we gave guidance a little bit better as we’re kind of coming out a little bit about the top end of at least where we thought the quarter was going to run. But that momentum you’re seeing, I think, is pretty common to what we’ve seen and heard in the market. It’s also what we’ve seen as we’ve been getting in front of these positions. In terms of the experience in the UK on the G7 launch, Kevin?
Yes. We’re early on, Robbie, but the feedback has been exactly what we expected has been phenomenal. As you start with product features, size is the first thing everybody sees and even the smaller size of the applicator, lesser materials, size on the body, the half hour warm-up, people love the app being much different than what we’ve had before is being very well accepted and very easy to use, setup as much easier and much more friendly. So far so good with the limited launch. Everybody is very happy who’s on our products so far. And we continue to gather feedback and then we will take the feedback we get and incorporate anything we hear that would be valuable into the full launch when we roll it out later this year.
Thank you. The next question in the queue comes from Jayson Bedford. Your line is open.
Good afternoon and nice job on making this co-work. So my question is, typically, you commented on unit volume I don’t think I’ve heard that this quarter. So can you maybe, Jereme, talk about the interplay between volume growth and rev growth this quarter, both U.S. and international?
Sure. Yes. So I think you saw it play out about the same way you saw it in prior quarters. And as we kind of make that migration that’s happening, our unit volume growth was in the low 40s. And so as you kind of draw that correlation to what happened last quarter, it’s about a similar correlation, which is about what you would have expected, right, as we’re going into this year of the final major migration to the pharmacy as well as annualizing some of the access wins that we got. In terms of the split, U.S., o-U.S., we really don’t break it out. However, you generally know that there is price – there is channel mix and pricing in both of those. And so as you talk about the growth numbers, the unit volume numbers are generally higher than that, and it’s generally pretty proportionate. That’s generally where we sit today. And for the balance of the year, clearly, we have not changed on what we expect those headwinds to be. So hopefully that helps low 40% unit volume growth.
Thank you. The next question comes from Matthew O'Brien. Your line is open, sir.
Good afternoon. Thanks for taking the question. Here in the U.S., just to follow-up a bit more on the U.S. commentary, I think people are expecting a little bit more in Q1, understanding Omicron was a little bit of a headwind, but your 55%, 60% penetrated of Type 1s. Consumer confidence is dropping like a rock. You’re getting into some of the people that have been more hesitant to get on to CGM so far. So is there a risk that the domestic business could see a little bit more softness than expected throughout the course of this year or even into next year as those factors really kind of start to pile up? Thanks.
Matt, I appreciate the question. We do not feel that way at all. With respect to the U.S. population, again, Jereme hit unit volume growth. Our unit volume growth was outstanding this quarter, and our new patient numbers, once we got past the Omicron wave early in the quarter, our new patient as were very, very strong. And we finished where we plan to finish for the quarter in general. So we did not feel that softness at all. And with respect to confidence, people have never had more confidence in our product than they have in G6 right now. As I said earlier, our customer satisfaction scores are better than they have ever been. Patients are very satisfied with DexCom. As we look at further penetration in this marketplace, there are some very significant catalysts coming as well on the Type 1 side, and they’ll also be more applicable to Type 2 intensive users as well. You look at our integrated partners with Tandem and with Omnipod 5 on the horizon and then you look at a G7 product for those who aren’t on because we won’t be integrated with those pumps immediately out of the gate, but a G7 product for our MDI patients that is a much, much better experience than what we have now. And when we have now is world-class, we don’t lack for being bullish at all right now here in the U.S. We think we’re in a good spot.
Thank you, sir. The next question comes from Joanne Wuensch. Your line is open please proceed.
Good evening and thank you for pulling this off. I ask you what’s included in your guidance? You’ve got DexCom ONE going out the door in different regions. You’ve got G7 outside the United States and in the United States in the back half of the year, I would assume. How do you think about putting all those factors into your guidance?
Sure. So we’ve got a little bit of all. So what we do generally in our guidance is we look at multiple different scenarios. And so we have DexCom ONE in various country launches, timed to different times. It helps us align where that guidance should ultimately sit. We also have a G7 launch outside the U.S. as well as in the U.S. at various times throughout the course of the year that helps us understand the impact. And we run various scenarios to make sure that under all of these scenarios, whether it’s G7 or G6 or DexCom ONE, that we make sure that we’re putting out reasonable guidance around what we can achieve. And again, we will always try to outperform it. So the way to think about it is, is there is various difference in all of them ultimately play in to kind of coming up with a guidance number we feel comfortable coming out with. And let me give you an example about that. G7 comes out great. It can be an extra catalyst, but you still have to remember G6 is an incredible product that’s going to be connected to Omnipod 5, as Kevin previously referenced. So there is some catalysts there. DexCom ONE is certainly interesting. And when you win tenders, that can ultimately drive it, knowing when exactly you will win those tenders. Sometimes it’s hard to pick because we have various different scenarios that play in. So, a little bit of all of it is the way to think about it, and we expect to be able to hit guidance irrespective of the timing of a lot of these launches to the extent the launches fall the right way, we certainly hope to outperform.
Thank you. The next question comes from Mathew Blackman. Sir, you may proceed.
Good afternoon everyone. Thanks for taking my question. You mentioned the growing prescriber base, anything you are willing to share on the size of the prescriber base and in particular, the percent that primary care physicians comprised of that base today versus prior to the sales force expansion? Just anything to help us frame the progress of that newer call point? Thanks.
Sure. Yes. So, I would say, while we haven’t necessarily sized it and I don’t think we are ready to size it exactly today, it has grown dramatically. Like I think we have had, it’s doubled over the past, call it, 18 months, and it continues to grow faster. In fact, we expect it to grow another sizable portion this year as our folks call on more. In terms of the mix, it is predominantly primary care physicians at this point. When you think about the endocrinologists over – across the United States, there is about 6,600 endocrinologists across the United States, and we call on tens of thousands of prescribers. And so you can probably get a feel for how many we are calling on. The larger prescribers still in the endocrinologist community, so that still is where we spend a good chunk of our time. But at this point, due to the expansion of the sales force, we are calling on more primary care physicians than we are in endocrinologists.
Thank you. The next question comes from Larry Biegelsen. Your line is open sir.
Good afternoon. Thanks for taking the question. Just wanted to focus on G7, so Kevin, I know you can’t predict the FDA, but how are you feeling about having approval of G7 in the U.S. by ADA? Is it still plausible? And with the G6 launch, we saw a pretty big inflection when you launched that in the U.S. Do you think we could see something similar with G7? Thanks for taking the question.
Larry, thanks for asking. Let’s go back a little bit on G7. Remember, this is a global launch for us, not just a U.S. one. Our limited launch right now in the UK is going on. We have seen mark there. UK will be our first launch as we roll out internationally. And then we roll out to other countries after that as we go through the local approval and filing process. So, we are on track with our international plans. One of the things we have learned over the years is we really don’t give dates as far as when we think things are going to be approved. And we are in our back and forth time with the FDA. We applaud them for spending as much time as they have an effort doing a busy time with us in getting this done. And we are confident, we will have a meaningful U.S. launch of G7 this year. Approval more than likely will come after ADA as knowing what we know and what we see today. And we are comfortable with that. We are also comfortable that there are no showstoppers in the things we are discussing with them. We are having a very good dialogue and look forward to that launch. As far as a bolus with G7, you are absolutely right, we do believe this is going to be a great product launch for us and will lead to more people using CGM. I think it’s important that everybody remember, we are in a different time now with respect to reimbursement particularly with the time it will take to get this into the pharmacy channel. So, as you start lining things up, once you have approval, you file with CMS to get reimbursement that takes some time and the pharmacy contracts take some time. So, we will launch the product and absolutely seek to get reimbursement and approval every place we can as quick as we can and even some prelaunch where we can do that. We have those efforts going on as well. So, this will roll out as quickly as we can do it. We are optimistic we will get approved, but more than likely after ADA.
Thank you. And the next question comes from Marie Thibault. Your line is open ma’am.
Hi. Good afternoon. Thanks for taking my question. I want to ask here on DexCom ONE as you expand that launch. I am curious who is appealing to how these early users are hearing about it? And who is telling them about how it’s being positioned versus the G-Series? Thanks so much.
Yes. This is Kevin. I will take that. Our first users in the BELL countries, this is all an e-commerce effort. This has been an e-commerce platform with some advertising from us. But by and large, our e-commerce platform has reached these people. That’s how they have heard about it and have paid cash for this product on their own. As far as positioning right now, DexCom ONE is positioned for insulin users, but it’s not positioned for those who are going to integrate with another device or even share data with others. It’s a simplified version of our product for that type of use. In the other countries that we rolled out, as Jereme said earlier, we are involved in the tender process. In Spain, we have reimbursement for DexCom ONE in Spain. In many of the European markets, there is a positioning of what you would call high-risk pool and then another pool of insulin using patients. We have always played very well on the high-risk pool with these patients because of our connectivity, our accuracy and our performance. And that is a higher price point within those geographies as well. With DexCom ONE, we now have access to the other patients. And again, the qualification of those patients varies tender-to-tender and country-to-country. But it gives us a much larger playing field – our playing field is going to be expanded anywhere between 80% and 90% in some of these countries where we launched DexCom ONE is a dual product. So, that’s there, that’s why we are doing it and that’s what we believe. So, expanding into new geographies with the product, with the e-commerce platform, but also expanding our reach and making available to more people.
Thank you. The next question comes from Travis Steed. Your line is open, please proceed.
Hi. Thanks for taking the question. Just wanted a little bit more color on the basal-only population and the conversations that you guys are having with payers. I am hearing more and more patients in that population getting entrance coverage. So, just kind of curious is that what you are seeing on your end as well in conversations with Medicare moving along?
Yes. So, I will start – thanks for the question, and welcome back. I will start with the CMS conversation. So certainly, we have the discussions. And that’s a process that takes a little bit more time, but it is simple and that’s where the significance of the basal population resides. And we are working with CMS to look at what that opportunity looks like. And so we will be making progress there over the course of the year. And as we have more and more information, we will certainly share it. In terms of the insurance coverage and the population on the commercial side, there are some insurance carriers that do cover it. It’s a little sparse in between. There are some that folks kind of get access to it to it through some edits or forms around those lines around insulin use without look backs. And so there are folks that are getting access to it. However, it is very, very light penetration at this point in that space. And so – but those conversations are going. We are having the similar conversations that we talked about having with CMS. We are having those with commercial payers, and we will continue to have those over time because we have shown and certainly with our MOBILE study was an obvious game changer that people on CGM do better. And I think that the insurance companies as well as CMS are starting to see it. So, more updates to come over time as we get those coverages and we will share those, certainly those that are significant in the future.
Thank you. And the next question comes from Steven Lichtman. Your line is open.
Thank you. Hi guys. I wanted to ask on the intensive Type 2 patient population in the U.S. where penetration still meaningfully trails Type 1. With the coverage efforts you have made over the past few years, are you seeing momentum pick up in this group? And what’s your outlook from where penetration can go over time?
Yes. This is Kevin. I will take that. Obviously, we are getting very good coverage in that segment. That population, again, Medicare covers that, and that is really our fastest-growing patient segment right now. We are doing very well in these Type 2 patients. Hence, the reason for expansion of the sales force and calling on more primary care physicians. As far as penetration in that population, their needs for CGM data are equal to those in our Type 1 population, and we believe not only is CGM going to be successful there, but we will be successful there with our pump partners as well through our integrated systems. So, I – many years ago, I have said 80% penetration for CGM in the Type 1 world and even people from our own company kind of gave me a funny look. I don’t see that as being a problem over time. If you are going to be intensively using insulin, there is no reason to not treat yourself with CGM. It is just a much better tool. So, I believe that penetration get every bit as high as the Type 1 population without any question.
Thank you. And then the last question in the queue comes from Margaret Kaczor. Your line is open now.
Hi everyone. Thanks for taking the question. I just wanted to focus on completely different opportunity that we haven’t talked too much about, but you guys mentioned in the prepared remarks. You have a lot of data that you have gathered in the hospital for inpatient use of CGM during COVID. You have breakthrough status. So, maybe could you just talk to us about what’s the next steps in that market clearly a meaningful opportunity for you, but maybe some market education, some market development work that needs to be done? So, what are you guys focused on this year? And what should we look out for progress there? Thanks.
Thank you for the question. This is definitely a passion of mine going way back to my early days in diabetes therapy back in ‘90s. One of the things we have done this year, we have hired a General Manager for our hospital business, a very experienced executive who spent a lot of time here, and we are starting to build a full team around him in that organization. We are running clinical studies right now to show how the product performs in the hospital environment. And we have had numerous discussions with the FDA. I think for us the key here is to get the sensing technology and the performance of the sensor validated and verified that it will be approved and usable in that environment. And the feedback we have gotten certainly during the pandemic has been very, very positive for those facilities that did use CGM. Once we do that and validate the product performance just from a technical perspective, then it becomes a question of what does that product look like, what does it connect to and what is the distribution channel and business model look like. And that’s why we have an experienced GM in the team built out here. We know how much better things work in a hospital if you have continuous data. I have had several experiences where people have told me about having their fingers stuck every 30 minutes without diabetes in a post-surgical order in an ICU, and it drives them crazy when they know they could be on CGM. As you look at the number of hospitalizations and the number of people hospitalized with diabetes and cardiovascular awards, in particular, the CGM opportunity here is vast. The questions we need to answer, business model, product configuration, ease of use, outcomes, all those things. And we have a great team that can put that data together for us. So, we are very optimistic and bullish about it over time. I do appreciate the question. Hopefully, we will have you some more information over the course of the year.
Thank you. We have one question in the queue from Frank Pinal. Your line is open sir.
Hi guys. Thanks for taking the question and squeezing me in here. Just one on FX really quickly. Seeing a few companies at this point raised their forward FX headwind expectations for the next two quarters to three quarters, and I am wondering to what degree is that – are you baking in FX? What’s in there now? Could we see that challenge to lower in the guide? Thank you.
Thanks for the question, Frank. And I think you will see it in our prepared remarks, we do expect $15 million to $20 million of FX headwinds, but we kept our guide the same. And so the way to think about it is we think we can grow through that in the current period. And so as you do the math for the full year, if you include the impact, the incremental impacts of headwind versus a 15% to 20% guide, it’s a 16% to 21% guide. So, that should give you some comfort that, yes, there are headwinds associated with currency. Yes, we do believe we can grow through it. And so a currency-adjusted growth rate certainly would reflect that. So, call it $15 million to $20 million on the year, but it doesn’t change our full year guide.
And sir, we have no further questions in the queue. Do you have any closing remarks?
Yes. This is Kevin. I absolutely do. We appreciate all of you for hanging with us today. Obviously, to say things have been a little hectic here would be an understatement. But as always, we get through it. I just – if you look at this quarter, again, $110 million in organic growth, volume increases in the low-40%, great new patient numbers post the Omicron care. DexCom ONE launched in Spain, launch announced in the UK. CE Mark for G7, limited launch for G7 in the UK, continued G7 progress in the U.S., continued scale in our business, positive momentum on the operating leverage side. There is not a whole lot more we could do. Times cannot be better and more hectic they are at DexCom right now. We appreciate everybody’s support and all the fine people who make this possible. Thanks everybody and have a great day.
Thank you, ladies and gentlemen. This concludes today’s teleconference. Thank you for participating. You may now disconnect.